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[ "11495397", "8854297", "8378411", "2643356", "8837903", "1529737", "12860778" ]

[ "A double-blind, placebo-controlled study of fluoxetine in depressed patients with Alzheimer's disease.", "A double-blind placebo-controlled study of clomipramine in depressed patients with Alzheimer's disease.", "Video rating analysis of effect of maprotiline in patients with dementia and depression.", "Double-blind trial of imipramine in Alzheimer's disease patients with and without depression.", "Moclobemide in elderly patients with cognitive decline and depression: an international double-blind, placebo-controlled trial.", "A controlled multicenter clinical study of citalopram and placebo in elderly depressed patients with and without concomitant dementia.", "Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS." ]

[ "To examine the efficacy of fluoxetine in the treatment of depression in patients with probable Alzheimer's disease (AD).\n This double-blind, parallel-design study included a consecutive series of 41 AD subjects meeting DSM-IV criteria for major or minor depression who were randomized to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiety, and the Functional Independence Measure as secondary efficacy measures.\n Complete remission of depression was found in 47% of subjects treated with fluoxetine and in 33% of subjects treated with placebo. Both the fluoxetine and the placebo groups showed a significant decline in HAM-D scores over time, but the magnitude of mood improvement was similar for both groups. Fluoxetine was well tolerated, and most side effects were mild.\n Fluoxetine treatment for depression in AD did not differ significantly from treatment with placebo. Our study also confirms the presence of a placebo effect in the treatment of depression in AD.", "Twenty-one depressed patients with probable Alzheimer's disease (AD) were randomized to receive a 6-week treatment with clomipramine or placebo in a study with a double-blind crossover design. Main outcome measures were Hamilton Depression, Mini-Mental State (MMSE), and Functional Independence Measure (FIM) scores. Mood improved significantly on both clomipramine and placebo, but clomipramine was significantly more effective than placebo during the first 6-week treatment period. Patients started on clomipramine maintained improvement during the washout and placebo periods, whereas patients started on placebo worsened during the washout period. However, patients on clomipramine showed significantly lower MMSE scores overall than patients on placebo. No significant drug effects were found on FIM scores. Clomipramine proved to be a useful treatment of depression in patients with probable AD.", "In patients with dementia and mild depression (DSM-III-R 290.21), the effect of low doses of the antidepressant maprotiline (up to 75 mg/d) was examined. The main parameter was a video rating of global impression. The Mini-Mental State Examination (MMS) and the Geriatric Depression Scale (GDS) were applied to evaluate the effect of maprotiline on cognitive and depressive symptoms. The double-blind, placebo-controlled trial was of eight weeks' duration and included 127 patients, randomized in two groups. The antidepressant effect of maprotiline was reflected in the GDS. There was, however, no indication of an effect of maprotiline on cognitive performance. The global impression, evaluated by video rating, gave no indication as to a beneficial effect of the treatment. - The video analysis showed a significant interrater reliability. The discrepancy between the results of the video rating and the GDS is discussed. - The results confirm similar findings of other authors; i.e., that a sedating antidepressant with some anticholinergic effects cannot be expected to improve cognitive functions despite its antidepressant effect. The main interest of this study, however, lies in its methodology (video analysis).", "The authors divided 61 subjects with primary degenerative dementia of the Alzheimer's type into a group who also met DSM-III criteria for depression (N = 28) and a group who did not (N = 33). Both groups were randomly assigned to an 8-week double-blind trial of imipramine or placebo. Scores on the Hamilton Rating Scale for Depression, administered at baseline and weeks 2, 4, 6, and 8, indicated significant improvement in both groups. Two measures of cognitive function yielded differing results. The results suggest that moderate depression is a treatable condition in patients with Alzheimer's disease.", "The new reversible MAOl moclobemide was compared with placebo in the treatment of elderly patients with DSM-III diagnosis of dementia and/or of major depression.\n Six hundred and ninety-four elderly patients with symptoms of depression and cognitive decline entered an international, multi-centre, double blind trial in which they were randomly allocated to treatment with either moclobemide 400 mg daily or placebo for 42 days. Five hundred and eleven patients met DSM-III criteria for dementia and were also depressed (DEM+D); 183 did not meet DSM-III criteria for dementia but met the criteria for DSM-III major depressive episode and also suffered from cognitive decline (MDE+CD).\n Analysis of the 17 and 24-item Hamilton Depression Scale scores showed that moclobemide, compared with placebo, produced significantly greater improvement in both the demented and depressed groups (P = 0.001 both diagnostic groups). There was an improvement in cognitive function as measured by the SCAG Factor 1 in moclobemide treated patients (P = 0.005 DEM+D; P = 0.02 MDE+CD). There was no evidence of decline in cognitive function as the result of treatment. Clinical global assessment of tolerance was 'excellent' and 'good' in 88% of the moclobemide and in 92% of the placebo treated patients. The proportion of patients discontinuing treatment prematurely was similar in both treatment groups. There were no significant differences in side-effects between treatment groups. There were no significant changes in vital signs, ECG or laboratory findings in either treatment group. There were no dietary restrictions and no report of any tyramine reaction.\n Moclobemide was shown to be a safe, well tolerated and effective antidepressant, which did not cause impairment of cognitive function in elderly patients with a DSM-III diagnosis of dementia and/or DSM-III major depression.", "A total of 149 patients in 7 centers in Denmark, Norway and Sweden entered a 6-week double-blind trial intended to assess the antidepressant effect and safety of citalopram vs placebo in depressed elderly patients (65 years of age or older) who might also suffer from somatic disorders and/or senile dementia. Results of ratings on the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale provided consistent evidence that the citalopram-treated patients improved more than the placebo-treated patients. Results of ratings on the Gottfries-Bråne-Steen dementia rating scale indicated that both cognitive and emotional functioning improved significantly more in the citalopram-treated subgroup of patients with dementia than in the placebo-treated subgroup.", "Major depression affects about 25% of the patients who have Alzheimer disease and has serious adverse consequences for patients and caregivers. Results of prior antidepressant treatment studies have produced contradictory findings and have not fully assessed the benefits of depression reduction.\n To assess the efficacy and safety of sertraline hydrochloride for the treatment of major depression in Alzheimer disease, and to evaluate the effect of depression reduction on activities of daily living, cognition, and nonmood behavioral disturbance.\n Randomized, placebo-controlled, parallel, 12-week, flexible-dose clinical trial with a 1-week, single-blind placebo phase. The study was conducted between January 1, 1998, and July 19, 2001.\n University outpatient clinic.\n Forty-four outpatients who have probable Alzheimer disease and major depressive episodes.\n Sertraline hydrochloride, mean dosage of 95 mg/d, or identical placebo, randomly assigned.\n Response rate, Cornell Scale for Depression in Dementia, Hamilton Depression Rating Scale, Mini-Mental State Examination, Psychogeriatric Depression Rating Scale-activities of daily living subscale, and Neuropsychiatric Inventory to quantify patient behavior disturbance and caregiver distress.\n In the sertraline-treated group 9 patients (38%) were full responders and 11 (46%) were partial responders compared with 3 (20%) and 4 (15%), respectively, in the placebo-treated group (P =.007). The sertraline-treated group had greater improvements in the scores for the Cornell Scale for Depression in Dementia (P =.002) and Hamilton Depression Rating Scale (P =.01), and a statistical trend toward less decline in activities of daily living on the Psychogeriatric Depression Rating Scale-activities of daily living subscale (P =.07). There was no difference between the treatment groups in Mini-Mental State Examination (P =.22) or Neuropsychiatric Inventory (P =.32) ratings over time. When full responders, partial responders, and nonresponders were compared, full responders only, or full and partial responders had significantly better ratings on activities of daily living (P =.04), behavioral disturbance (P =.01), and caregiver distress (P =.006), but not on the Mini-Mental State Examination (P =.76). Safety monitoring indicated few differences in adverse effects between the 2 treatment groups.\n Sertraline is superior to placebo for the treatment of major depression in Alzheimer disease. Depression reduction is accompanied by lessened behavior disturbance and improved activities of daily living, but not improved cognition." ]

[ "17217216", "17234537" ]

[ "Pentoxifylline therapy: a new adjunct in the treatment of oral submucous fibrosis.", "Efficacy of lycopene in the management of oral submucous fibrosis." ]

[ "This study was designed to determine the effect of pentoxifylline (Trental) on the clinical and pathologic course of oral submucous fibrosis. This drug is a methylxanthine derivative that has vasodilating properties and was envisaged to increase mucosal vascularity.\n This investigation was conducted as a randomized clinical trial incorporating a control group (Standard drug group SDG, multivitamin, and local heat therapy) in comparison to pentoxifylline test cases (Experimental drug group EDG, 400mg 3 times daily, as coated, sustained release tablets). The stipulated treatment period was 7 months and a total of 29 cases of advanced fibrosis (14 test subjects and 15 age and sex matched diseased controls) were included in this study and 100% compliance was reported at the end ofthe test period.\n Mild gastric irritation that could be managed by diet protocols was the only untoward symptom reported during this trial. Review of the patients and controls was done at an interval of 30 days and subjective and objective measurements were recorded. The follow up data at each visit with respect to each other and to base-line values was calibrated using a nonparametric test of Mann-Whitney (Kruskal-Wallis test). Significant comparisons with regard to improvement were recorded as objective criteria of mouth opening (t=11.285, p= 0.000), tongue protrusion (t= 3.898, p = 0.002), and relief from perioral fibrotic bands (p = 0.0001554). Subjective symptoms of intolerance to spices (p = 0.0063218), burning sensation of mouth (p = 0.0005797), tinnitus (p=0.000042), difficulty in swallowing (p=0.0000714). and difficulty in speech (p=0.0000020) were also recorded significant improvement at the end of the trial period.\n This pilot investigation points to the effectiveness of pentoxifylline as an adjunct therapy in the routine management of oral submucous fibrosis.", "To evaluate the efficacy of oral lycopene therapy in patients with oral submucous fibrosis and to compare these effects with a placebo.\n Fifty-eight patients with oral submucous fibrosis formed the population for the study and were randomly divided into 3 groups, evaluated weekly over a 2-month period. Patients of group A (n = 21) received 16 mg of lycopene, those of group B (n = 19) received 16 mg of lycopene along with biweekly intralesional steroid injections, and those of group C (n = 18) were given a placebo. Paired and unpaired t tests were used for statistical evaluation.\n Mouth-opening values for the patients showed an average increase of 3.4 mm, 4.6 mm, and 0.0 mm for patients in groups A, B, and C, respectively. These values were statistically found to be highly significant.\n The observed effects suggest that lycopene can and should be used as a first line of therapy in the initial management of oral submucous fibrosis." ]

[ "2968548", "10599545", "8062954", "15900367", "1521653", "7641913", "12095487", "16785154", "19834718", "1555691" ]

[ "[Systematic inhibition of the luteinizing hormone with a gonadoliberin analog, triptorelin, during ovarian stimulation for fertilization in vitro. Choice of protocol].", "Good results of milder form of ovarian stimulation in an in vitro fertilization/intracytoplasmic sperm injection program.", "Should gonadotropin-releasing hormone down-regulation therapy be routine in in vitro fertilization?", "Evaluation of ovulation induction protocols for poor responders undergoing assisted reproduction techniques.", "Randomized, prospective comparison of luteal leuprolide acetate and gonadotropins versus clomiphene citrate and gonadotropins in 408 first cycles of in vitro fertilization.", "Luteal phase consequences of low-dose gonadotropin-releasing hormone agonist therapy in nonluteal-supported in vitro fertilization cycles.", "Comparison of stimulation with clomiphene citrate in combination with recombinant follicle-stimulating hormone and recombinant luteinizing hormone to stimulation with a gonadotropin-releasing hormone agonist protocol: a prospective, randomized study.", "Comparison of outcome of clomiphene citrate/human menopausal gonadotropin/cetrorelix protocol and buserelin long protocol--a randomized study.", "Comparison of mild stimulation and conventional stimulation in ART outcome.", "The routine use of gonadotropin-releasing hormone agonists for all patients undergoing in vitro fertilization. Is there any medical advantage? A prospective randomized study." ]

[ "The quality of ovarian stimulation for in vitro fertilization with or without an LH-RH analogue was investigated in a randomized trial involving 30 women divided into 3 groups. Group I women were treated with the conventional clomiphene citrate-human menopausal gonadotropin combination without LH-RH analogue. Group II women (long regimen) received a slow-release preparation of triptorelin (DTRp6-LH-RH), an LH-RH analogue, and human menopausal gonadotropin. Group II women (short regimen) were given triptorelin with human menopausal gonadotropin. Inhibition of the endogenous luteinizing hormone using triptorelin improved the results of in vitro fertilization in group II and group III women, but the short regimen was distinctly less compelling and less expensive than the long regimen.", "In a prospective study, we compared two protocols of ovulation stimulation, the clomiphene citrate and human menopausal gonadotropin (hMG) versus D-triptorelin, a long-acting gonadotropin-releasing hormone (GnRH) agonist and hMG in 324 couples having their first in vitro fertilization or intracytoplasmic sperm injection (IVF/ICSI) program, in terms of pregnancy rates and cost-effectiveness of drugs used. The GnRH agonist/hMG group was characterized by a greater mean number of ampoules of hMG used (31.7 versus 10.2), a larger number of oocytes collected (10.4 versus 4.2), and a larger number of embryos obtained (5.8 versus 2.9). With the policy of transferring only two of the best quality embryos, the mean number of embryos replaced were comparable (1.8 in clomiphene citrate/hMG and 1.9 in GnRH agonist/hMG group). The percentage of patients reaching embryo transfer was lower in the clomiphene citrate/hMG than in the GnRH agonist/hMG group (84.1% versus 93.1%, respectively). However, the combined results of the IVF and ICSI procedure in terms of pregnancy rate, both per patient and per embryo transfer were better, though not significantly in the clomiphene citrate/hMG than in GnRH agonist/hMG group (25.0% and 29.7% versus 23.7% and 25.5%, respectively). Similarly, the implantation rate was better (19.0% versus 13.5%, respectively). With the use of clomiphene citrate/hMG, a fivefold less costly drug regimen, we obtained pregnancy rates equivalent to those gained using GnRH agonist/hMG in our IVF/ICSI program.", "To compare the classic clomiphene citrate (CC) and hMG regime for ovarian stimulation before IVF in women who received hMG post-long protocol down-regulation with either 3 mg triptorelin [INN] IM or 150 mg buserelin acetate four times daily intranasally. Furthermore, if possible, to determine the preferred method of down-regulation.\n A prospective study of 150 women randomized blind to the clinician to one of three alternative ovarian stimulation regimes when passing for the first time through an IVF program during 1992.\n Triptorelin [INN] down-regulated significantly more quickly than buserelin acetate. The non-down-regulated group CC and hMG used significantly less hMG in a shorter time. In these women LH levels at hCG administration were significantly higher. No other intergroup differences were found. Pregnancy and take-home baby rates for the overall study were, respectively, 32%:25% (per cycle) and 42%:33%; (per ET) for the triptorelin [INN] group 28%:22% and 39%:31%; the CC group 32%:24% and 46%:34%; and the buserelin acetate group 34%:28% and 42%:34%.\n Triptorelin [INN] and buserelin acetate were comparable in all parameters except down-regulation. The former was significantly quicker and more sure. In none of the clinical end points measured, however, was the classic CC and hMG non-down-regulation regime significantly less effective or troublesome than where down-regulation was used. These results therefore show that although indications for down-regulation before IVF exist, it should not be used on all patients.", "To compare 3 stimulation protocols in poor ovulation responders undergoing in-vitro fertilization (IVF).\n The study was a randomized, prospective clinical trial from June 2003 to July 2004, in Royan Institute, Tehran, Iran. One hundred and fifty-four patients, who had poor responses to ovulation induction in at least one previous IVF attempt, were randomly divided into 3 groups. In the first group, human menopausal gonadotropin (HMG) was administered from day 3 of the cycle at a dose rate of 150 IU/day. In the second group, gonadotropin-releasing hormone (GnRH) agonist was started at a dose rate of 800 microg/day by nasal spray or 500 microg/day subcutaneously in the mid-luteal phase, followed by a standard HMG dose after pituitary down regulation was confirmed. In the third group, clomiphene at a dose rate of 100 mg/day was given from day 3 and HMG from day 6. Our main outcomes were number of mature oocytes, cancellation rate, number of HMG ampoules used and incidence premature luteinizing hormone (LH) surge.\n There was a high incidence of premature LH surge in all groups except in the GnRH group (p=0.0001) and there were significant differences between groups in HMG requirements (p=0.004). There were no significant differences between groups in number of mature oocytes recovered and cancellation rate.\n Results showed no advantage in the use of GnRH agonist compared to the older regimens of clomiphene plus HMG and HMG alone. The cancellation rate was similar for 3 protocols and HMG requirement was higher with the use of GnRH agonist. The treatment of poor responders in assisted reproductive technologies remains a challenge.", "To compare luteal phase leuprolide acetate (LA) initiated pituitary down regulation followed by human menopausal gonadotropins (hMG) versus clomiphene citrate (CC) and hMG for follicular recruitment and oocyte maturation before in vitro fertilization (IVF).\n Randomized, prospective comparison in first cycles of IVF.\n University Hospital, a tertiary referral center offering assisted reproductive technologies.\n Participants were couples undergoing their first ever cycle of IVF and consenting to participation in the trial.\n Luteal phase initiated LA/hMG was associated with a lower probability of cycle cancellation, improved folliculogenesis, and a higher probability of embryo transfer (ET) compared with CC/hMG alone. Implantation rates were not different.\n A higher rate of ET with LA/hMG suggests that gonadotropin-releasing hormone agonist for the induction of folliculogenesis before IVF may be appropriate.", "To determine the follicular and luteal phase impact of low-dose GnRH agonist (GnRH-a) treatment during follicular stimulation for IVF.\n A randomized prospective study compared patients receiving low-dose GnRH-a and hMG therapy to clomiphene citrate (CC) and hMG cycles.\n Patients were treated through a university-based IVF-ET program.\n Thirty-six patients underwent follicular stimulation with low-dose GnRH-a and hMG and were compared with 34 patients undergoing ovulation induction with CC and hMG.\n Significantly shorter luteal phase length occurred with GnRH-a and hMG therapy; however, there was no statistically significant difference in luteal P levels. Follicular parameters were the same (peak E2, number of follicles, and number of oocytes), suggesting that folliculogenesis was not altered. There were no statistical differences in pregnancy rates.\n Sustained low-dose GnRH-a therapy during follicular stimulation does not have a clinical effect on luteal function.", "To compare IVF-ET outcome with a new stimulation protocol using clomiphene citrate (CC) with recombinant FSH and LH to stimulation with the standard long GnRH-a protocol.\n Prospective randomized study.\n Outpatient infertility clinic in Vienna, Austria.\n Two hundred ninety-four infertile women undergoing IVF-ET; 154 IVF cycles stimulated with CC + recombinant FSH + recombinant LH (group A) and 140 cycles with long GnRH-a suppression + recombinant FSH (group B).\n Controlled ovarian hyperstimulation, egg retrieval, and ET.\n Cycle parameters (number of oocytes, fertilization, number of embryos) and outcome (pregnancy rate, cancellation rate, ovarian hyperstimulation syndrome [OHSS]).\n Pregnancy rate per ET was 42.9% (implantation rate, 21.3%) in group A and 36.6% (17.4%) in group B. Cancellation rates were similar. The OHSS occurred in four cases (3%) in group A and 12 cases (10%) in group B.\n Stimulation with CC + recombinant FSH + recombinant LH leads to comparable pregnancy rates vs. the long protocol. With this new stimulation, less gonadotropins are used and there is less need for monitoring (lower cost for patient and clinic). The risk of OHSS is reduced as well. Therefore, this protocol should be regarded as the first-line treatment.", "This study evaluates the efficacy of a stimulation protocol with clomiphene citrate (CC)/human menopausal gonadotropin (hMG)/cetrorelix and its effects on oocyte quality and endometrium. One hundred and twenty couples with male-factor infertility who were about to undergo their first intracytoplasmic sperm injection cycles were randomized into two groups. Sixty women were stimulated with the CC/hMG/cetrorelix protocol (cetrorelix group) and 60 received the buserelin long protocol (buserelin group). Fewer oocytes were recovered in the cetrorelix group than in the buserelin group (mean +/- standard deviation (SD): 11.1 +/- 4.0 vs. 17.3 +/- 5.8, p < 0.001); however, the percentages of metaphase II, metaphase I and germinal vesicle oocytes were similar between the two groups. Serum estradiol level was significantly lower in the cetrorelix than in the buserelin group (mean +/- SD: 2600.58 +/- 1189.11 vs. 3293.46 +/- 1221.49 pg/ml, p = 0.006), but the endometrial thickness was similar. The implantation rates (19.2% vs. 17.7%) and the pregnancy rates (41.7% vs. 40.0%) were similar between groups. The ampoules (mean +/- SD: 18.9 +/- 3.0 vs. 38.9 +/- 12.2, p < 0.001) and injections (mean +/- SD: 6.8 +/- 1.1 vs. 15.7 +/- 3.1, p < 0.001) of gonadotropin used were significantly lower in the cetrorelix group than in the buserelin group. No patients in either group developed a premature luteinizing hormone surge. The present study found no statistically significant difference between the two treatment modalities with regard to pregnancy rates.", "To provide a treatment for particular condition that is the most effective treatment with the least risk and cost for the patient we compared the efficacy of using clomiphene 100 mg + delayed low dose gonadotropin + flexible GnRH antagonist administration for ovarian stimulation protocol and GnRH agonist + gonadotropin for stimulation protocol in IVF outcome.\n Clinical outcome of 243 women with regularly menstruation who were candidate for IVF. They had undergone stimulation with GnRH agonist and gonadotropin (group A) or clomiphene citrate, gonadotropin and GnRH antagonist (group B). Main outcome was ongoing pregnancy.\n There were no significant difference in mean age, cause of infertility, basal FSH, BMI, duration of infertility, endometrial thickness on the day HCG administration in two groups. The number of recovered oocytes, obtained embryos, transferred embryos, peak of estradiol on the day HCG administration and OHSS were significantly higher in group A. Significantly more patients in control group had embryos for cryopreservation. There were no significant difference in clinical pregnancy rate and ongoing pregnancy rate between two groups.\n Clomiphene + delayed low dose gonadotropin + flexible GnRH - antagonist stimulation is an acceptable alternative protocol for IVF in patients with regularly menstruation.", "To determine if the routine use of gonadotropin-releasing hormone agonists (GnRH-a) for all patients undergoing in vitro fertilization (IVF) produces any significant medical advantage.\n Prospective randomized study.\n Three hundred eight patients having their first ever IVF attempt.\n Patients were randomly divided into four groups and received either human menopausal gonadotropin (hMG) alone for ovarian simulation (group A, n = 81); clomiphene citrate and hMG (group B, n = 77); a 3-day ultrashort course of GnRH-a and hMG (group C, n = 74); or pituitary desensitization with GnRH-a followed by hMG (group D, n = 76).\n The indications for IVF and mean age of all four groups of patients were comparable. There was a significant difference in the number of embryos cleaved and transferred among the groups, but there were no significant differences in the cancellation rate, mean number of oocytes collected or fertilized, and number of cases of failed fertilization. There were also no significant differences in the pregnancy and live birth rates per cycle commenced or per embryo transfer.\n The routine use of GnRH-a for all patients undergoing IVF has practical but no significant medical advantages." ]

[ "12975221", "15903284", "15006588", "15385274", "17493184", "16137215", "8610730", "19843492", "12816022", "12704485" ]

[ "The medical office of the 21st century (MOXXI): effectiveness of computerized decision-making support in reducing inappropriate prescribing in primary care.", "Does the addition of a pharmacist transition coordinator improve evidence-based medication management and health outcomes in older adults moving from the hospital to a long-term care facility? Results of a randomized, controlled trial.", "Effects of geriatric evaluation and management on adverse drug reactions and suboptimal prescribing in the frail elderly.", "An outreach geriatric medication advisory service in residential aged care: a randomised controlled trial of case conferencing.", "Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial.", "Pharmacist response to alerts generated from Medicaid pharmacy claims in a long-term care setting: results from the North Carolina polypharmacy initiative.", "A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy.", "Analysis of the North Carolina long-term care polypharmacy initiative: a multiple-cohort approach using propensity-score matching for both evaluation and targeting.", "Improving primary care in rural Alabama with a pharmacy initiative.", "Pharmacist's contribution in a heart function clinic: patient perception and medication appropriateness." ]

[ "Adverse drug-related events are common in the elderly, and inappropriate prescribing is a preventable risk factor. Our objective was to determine whether inappropriate prescribing could be reduced when primary care physicians had computer-based access to information on all prescriptions dispensed and automated alerts for potential prescribing problems.\n We randomly assigned 107 primary care physicians with at least 100 patients aged 66 years and older (total 12 560) to a group receiving computerized decision-making support (CDS) or a control group. Physicians in the CDS group had access to information on current and past prescriptions through a dedicated computer link to the provincial seniors' drug-insurance program. When any of 159 clinically relevant prescribing problems were identified by the CDS software, the physician received an alert that identified the nature of the problem, possible consequences and alternative therapy. The rate of initiation and discontinuation of potentially inappropriate prescriptions was assessed over a 13-month period.\n In the 2 months before the study, 31.8% of the patients in the CDS group and 33.3% of those in the control group had at least 1 potentially inappropriate prescription. During the study the number of new potentially inappropriate prescriptions per 1000 visits was significantly lower (18%) in the CDS group than in the control group (relative rate [RR] 0.82, 95% confidence interval [CI] 0.69-0.98), but differences between the groups in the rate of discontinuation of potentially inappropriate prescriptions were significant only for therapeutic duplication by the study physician and another physician (RR 1.66, 95% CI 0.99-2.79) and drug interactions caused by prescriptions written by the study physician (RR 2.15, 95% CI 0.98-4.70).\n Computer-based access to complete drug profiles and alerts about potential prescribing problems reduces the rate of initiation of potentially inappropriate prescriptions but has a more selective effect on the discontinuation of such prescriptions.", "Poorly executed transfers of older patients from hospitals to long-term care facilities carry the risk of fragmentation of care, poor clinical outcomes, inappropriate use of emergency department services, and hospital readmission.\n This study was conducted to assess the impact of adding a pharmacist transition coordinator on evidence-based medication management and health outcomes in older adults undergoing first-time transfer from a hospital to a long-term care facility.\n This randomized, single-blind, controlled trial enrolled hospitalized older adults awaiting transfer to a long-term residential care facility for the first time. Patients were randomized either to receive the services of the pharmacist transition coordinator (intervention group) or to undergo the usual hospital discharge process (control group). The intervention included medication-management transfer summaries from hospitals, timely coordinated medication reviews by accredited community pharmacists, and case conferences with physicians and pharmacists. The primary outcome was the quality of prescribing, measured using the Medication Appropriateness Index (MAI). Secondary outcomes were emergency department visits, hospital readmissions, adverse drug events, falls, worsening mobility, worsening behaviors, increased confusion, and worsening pain.\n One hundred ten older adults (67 women, 43 men; mean [SD] age, 82.7 [6.4] years) were recruited from 3 metropolitan hospitals and assigned to 85 metropolitan long-term care facilities. Fifty-six patients were randomized to the intervention group and 54 to the control group; 44 patients in each group were evaluable at 8-week follow-up. There were no significant differences in baseline characteristics between treatment groups, with the exception of the number of medications discontinued during hospitalization: a mean of 1.1 more drugs was discontinued in the control group compared with the intervention group (P = 0.011). The majority of patients (35 [62.5%] in the intervention group, 41 [76.0%] in the control group) changed physicians as part of the transition to a long-term care facility. At 8-week follow-up, there was no change in MAI from baseline in the intervention group, whereas it had worsened in the control group (mean [95% CI], 2.5 [1.4-3.7] vs 6.5 [3.9-9.1], respectively; P = 0.007). Patients who received the intervention and were alive at follow-up exhibited a significant protective effect of the intervention against worsening pain (relative risk ratio [95% CI], 0.55 [0.32-0.94]; P = 0.023) and hospital usage (i.e., the combination of emergency department visits and hospital readmissions) (0.38 [0.15-0.99]; P = 0.035), but did not differ from control patients in terms of adverse drug events (1.05 [0.66-1.68]), falls (1.19 [0.71-1.99]), worsening mobility (0.39 [0.13-1.15]), worsening behaviors (0.52 [0.25-1.10]), or increased confusion (0.59 [0.28-1.22]). When data for patients who had died were included, the intervention had no effect on hospital usage in all patients (0.58 [0.28-1.21]).\n Older people transferring from hospital to a long-term care facility are vulnerable to fragmentation of care and adverse events. In this study, use of a pharmacist transition coordinator improved aspects of inappropriate use of medicines across health sectors.", "To determine if inpatient or outpatient geriatric evaluation and management, as compared with usual care, reduces adverse drug reactions and suboptimal prescribing in frail elderly patients.\n The study employed a randomized 2 x 2 factorial controlled design. Subjects were patients in 11 Veterans Affairs (VA) hospitals who were > or =65 years old and met criteria for frailty (n = 834). Inpatient geriatric unit and outpatient geriatric clinic teams evaluated and managed patients according to published guidelines and VA standards. Patients were followed for 12 months. Blinded physician-pharmacist pairs rated adverse drug reactions for causality (using Naranjo's algorithm) and seriousness. Suboptimal prescribing measures included unnecessary and inappropriate drug use (Medication Appropriateness Index), inappropriate drug use (Beers criteria), and underuse.\n For serious adverse drug reactions, there were no inpatient geriatric unit effects during the inpatient or outpatient follow-up periods. Outpatient geriatric clinic care resulted in a 35% reduction in the risk of a serious adverse drug reaction compared with usual care (adjusted relative risk = 0.65; 95% confidence interval: 0.45 to 0.93). Inpatient geriatric unit care reduced unnecessary and inappropriate drug use and underuse significantly during the inpatient period (P <0.05). Outpatient geriatric clinic care reduced the number of conditions with omitted drugs significantly during the outpatient period (P <0.05).\n Compared with usual care, outpatient geriatric evaluation and management reduces serious adverse drug reactions, and inpatient and outpatient geriatric evaluation and management reduces suboptimal prescribing, in frail elderly patients.", "efficient strategies are needed to provide specialist advice in nursing homes to ensure quality medical care. We describe a case conference intervention involving a multidisciplinary team of health professionals.\n to evaluate the impact of multidisciplinary case conferences on the appropriateness of medications and on patient behaviours in high-level residential aged care facilities.\n cluster-randomised controlled trial.\n ten high-level aged care facilities.\n 154 residents with medication problems and/or challenging behaviours were selected for case conference by residential care staff.\n two multidisciplinary case conferences involving the resident's general practitioner, a geriatrician, a pharmacist and residential care staff were held at the nursing home for each resident.\n outcomes were assessed at baseline and 3 months. The primary outcome was the Medication Appropriateness Index (MAI). The behaviour of each resident was assessed via the Nursing Home Behaviour Problem Scale.\n 45 residents died before follow-up. Medication appropriateness improved in the intervention group [MAI mean change 4.1, 95% confidence interval (CI) 2.1-6.1] compared with the control group (MAI mean change 0.4, 95% CI -0.4-1.2; P < 0.001). There was a significant reduction in the MAI for benzodiazepines (mean change control -0.38, 95% CI -1.02-0.27 versus intervention 0.73, 95% CI 0.16-1.30; P = 0.017). Resident behaviours were unchanged after the intervention and the improved medication appropriateness did not extend to other residents in the facility.\n multidisciplinary case conferences in nursing homes can improve care. Outreach specialist services can be delivered without direct patient contact and achieve improvements in prescribing.", "To evaluate the effect of pharmaceutical care provided in addition to acute Geriatric Evaluation and Management (GEM) care on the appropriateness of prescribing.\n Randomized, controlled trial, with the patient as unit of randomization.\n Acute GEM unit.\n Two hundred three patients aged 70 and older.\n Pharmaceutical care provided from admission to discharge by a specialist clinical pharmacist who had direct contacts with the GEM team and patients.\n Appropriateness of prescribing on admission, at discharge, and 3 months after discharge, using the Medication Appropriateness Index (MAI), Beers criteria, and Assessing Care of Vulnerable Elders (ACOVE) underuse criteria and mortality, readmission, and emergency visits up to 12 months after discharge.\n Intervention patients were significantly more likely than control patients to have an improvement in the MAI and in the ACOVE underuse criteria from admission to discharge (odds ratio (OR)=9.1, 95% confidence interval (CI)=4.2-21.6 and OR=6.1, 95% CI=2.2-17.0, respectively). The control and intervention groups had comparable improvements in the Beers criteria.\n Pharmaceutical care provided in the context of acute GEM care improved the appropriate use of medicines during the hospital stay and after discharge. This is an important finding, because only limited data exist on the effect of various strategies to improve medication use in elderly inpatients. The present approach has the potential to minimize risk and improve patient outcomes.", "In response to burgeoning drug costs, North Carolina (NC) Medicaid encouraged pharmacists and prescribers to develop collaborative programs to reduce drug expenditures. One of these programs, the North Carolina Polypharmacy Initiative, was a focused drug therapy management intervention aimed at reducing polypharmacy in nursing homes. This intervention targeted patients with more than 18 prescription fills in 90 days, beginning in November 2002. These patients were believed to have a high likelihood of experiencing potential drug therapy problems (PDTPs). Consultant pharmacists were asked to utilize profiles displaying alerts generated from pharmacy claims to guide interventions in addition to usual-care drug regimen reviews. The pharmacists documented their reviews, recommendations, and resulting changes in drug therapy. Our objectives were to determine (1) the persistence of PDTP alerts following interventions by consultant pharmacists and (2) the impact of these interventions on patient drug costs from a payer perspective.\n A before-after study with comparison group design was used. Medicaid prescription claims data were compared for the 90-day periods prior to the intervention (June-August 2002) and following the intervention (March-June 2003). The 90-day post-intervention period allowed for 2 to 3 follow-up prescriptions and reduced the drop-out rate. The 5 categories of potential problem alerts included potentially inappropriate medications (Beers criteria), substitution opportunity for a lower-cost drug, 16 drugs or drug classes with specific quality improvement opportunities (Clinical Initiatives list), therapeutic duplication, and length of drug therapy evaluation.\n A total of 253 nursing homes, involving 110 consultant pharmacists and 6,344 patients, were in the intervention arm, with 5,160 patients (81.3%) remaining at the end of the follow-up period. At baseline, study-group patients used an average of 9.7 prescriptions per month, costing the NC Medicaid program 517 US dollars per patient per month (PPPM). There were 6,360 recommendations offered for 3,400 patients, or an average of 1.87 recommendations per patient. Physicians concurred with 59.8% (3,801 of 6,360) of all recommendations to change drug therapy, about half involving a switch to a lower-cost drug. Two of 5 alert categories had significant (P <0.01) reductions in alert persistence: -10.8% for the study group versus -0.7% for the comparison group for the Clinical Initiatives list and -29.7% for the study group versus -14.1% in the comparison group for the drug substitution opportunity. Median drug costs per patient in the study group decreased by 12.14 US dollars (-0.92%), from 1,329.46 US dollars to 1,317.32 US dollars, and increased in the comparison group by 44.98 US dollars (3.35%), from 1,341.25 US dollars to 1,386.23 US dollars, creating a relative cost reduction of 57.12 US dollars per patient in the 3-month follow-up period, or 19.04 US dollars PPPM.\n A supplemental program of medication reviews for nursing home patients targeted by high drug utilization resulted in a reduction in the persistence of PDTP alerts and was cost beneficial based solely on drug cost savings. This intervention may be a model for future medication therapy management services provided by prescription drug plans under Medicare Part D for patients in long-term-care settings and possibly ambulatory patients.", "To evaluate the effect of sustained clinical pharmacist interventions involving elderly outpatients with polypharmacy and their primary physicians.\n Randomized, controlled trial of 208 patients aged 65 years or older with polypharmacy (> or = 5 chronic medications) from a general medicine clinic of a Veterans Affairs Medical Center. A clinical pharmacist met with intervention group patients during all scheduled visits to evaluate their drug regimens and make recommendations to them and their physicians. Outcome measures were prescribing appropriateness, health-related quality of life, adverse drug events, medication compliance and knowledge, number of medications, patient satisfaction, and physician receptivity.\n Inappropriate prescribing scores declined significantly more in the intervention group than in the control group by 3 months (decrease 24% versus 6%, respectively; P = 0.0006) and was sustained at 12 months (decrease 28% versus 5%, respectively; P = 0.0002). There was no difference between groups at closeout in health-related quality of life (P = 0.99). Fewer intervention than control patients (30.2%) versus 40.0%; P = 0.19) experienced adverse drug events. Measures for most other outcomes remained unchanged in both groups. Physicians were receptive to the intervention and enacted changes recommended by the clinical pharmacist more frequently than they enacted changes independently for control patients (55.1% versus 19.8%; P <0.001).\n This study demonstrates that a clinical pharmacist providing pharmaceutical care for elderly primary care patients can reduce inappropriate prescribing and possibly adverse drug effects without adversely affecting health-related quality of life.", "The high cost and undesirable consequences of polypharmacy are well-recognized problems among elderly long-term care (LTC) residents. Despite the implementation of the 1987 Omnibus Budget Reconciliation Act, which requires pharmacist review of drug regimens in this setting, medical and drug costs for LTC residents have continued to increase.\n This study evaluates the North Carolina Long-Term Care Polypharmacy Initiative, a large-scale medication therapy management program (MTMP) that combined drug utilization review activities with drug regimen review techniques.\n This was a prospective records-based study that used a difference-in-difference model with both historical and nonintervention group controls. To ensure equivalence among subjects, propensity scoring was used to match study subjects from participating LTC facilities with comparison subjects from nonparticipating facilities. Residents with interventions were grouped for analysis by intervention type-retrospective only, prospective only, or dual type (residents with both prospective and retrospective interventions)-and by intervention stage-review, recommendation, and drug change-plus an all-inclusive \"all types\" grouping that aggregated groups by intervention type, for a total of 10 total cohorts.\n In the overall population of 5255 study subjects identified, a US $21.63 per member per month drug-cost savings was observed. Although only 1 of 10 cohorts had a change in the number of drug fills, substantial reductions in 2 of 5 types of drug alerts were observed in all 10 cohorts. A reduction in the relative risk for hospitalization (0.84 [95% CI, 0.71-1.00]) was observed in the cohort of residents receiving a retrospective review.\n This Initiative suggests that an MTMP can be quickly launched in a large number of LTC facility residents to produce monetary drug-cost savings and improved health outcomes. Additionally, the evaluation of this program illustrates the utility of using propensity scoring techniques to target future intervention groups in a cost-effective manner.", "The effect of pharmaceutical care on the prevention, detection, and resolution of medication-related problems in high-risk patients in a rural community was studied. Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were randomly assigned to a control group or an intervention group. The control group received standard medical care, and the intervention group received pharmaceutical care, including a medical record review, a medication history review, pharmacotherapeutic evaluation, and patient medication education and monitoring over a one-year period. A total of 69 patients completed the study (33 in the intervention group and 36 in the control group). The percentage of patients responding to hypertension, diabetes, dyslipidemia, and anticoagulation therapy increased significantly in the intervention group and declined in the control group. Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group. There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures. Medication compliance scores improved in the intervention group but not in the control group. Medication knowledge increased in the intervention group and decreased in the control group. Pharmaceutical care in a rural, community-based setting appeared to reduce inappropriate prescribing, enhance disease management, and improve medication compliance and knowledge without adversely affecting health-related quality of life.", "It has been cited that the management of congestive heart failure (CHF) requires a multidisciplinary approach; however, the role of the pharmacist has not been extensively studied. The roles for pharmacists are changing to meet the long term needs of patients in the community setting, including patients with CHF.\n To evaluate the effect of a pharmacist on the appropriateness of medications taken by patients in the heart function clinic using the Medication Appropriateness Index (MAI) and to measure the effect of a pharmacist on the patients' response to the pharmacist's interventions using the Purdue Directive Guidance (DG) scale.\n Eighty patients attending the heart function clinic at The University Health Network, Toronto General Hospital Toronto, Ontario were randomly assigned to an intervention group that received pharmacist services or a nonintervention group that received usual care from the clinic staff. Patients were assessed at baseline and at one-month follow-up.\n The change in MAI score from baseline was 0.74 and 0.49 for the intervention and nonintervention groups, respectively (P=0.605). The change in DG survey results was 9.97 and 1.00 for the intervention and nonintervention groups, respectively (P<0.001). The intervention group improved significantly in all components of the DG survey, especially those pertaining to feedback and goal setting.\n A benefit was demonstrated for 'directive guidance' of patients, in the form of education and goal setting as shown by positive survey results." ]

[ "1460407", "9706927", "3548793", "10553846", "9585282", "19475310" ]

[ "A comparative study of isobaric and hyperbaric solution of bupivacaine for spinal anaesthesia in caesarean section.", "Intrathecal hypobaric versus hyperbaric bupivacaine with morphine for cesarean section.", "Subarachnoid analgesia for caesarean section. A double-blind comparison of plain and hyperbaric 0.5% bupivacaine.", "Comparison of 9 mg of intrathecal plain and hyperbaric bupivacaine both with fentanyl for cesarean delivery.", "Small-dose hyperbaric versus plain bupivacaine during spinal anesthesia for cesarean section.", "Spinal anesthesia for cesarean section: comparative study between isobaric and hyperbaric bupivacaine associated to morphine." ]

[ "Though hyperbaric solution of bupivacaine following intrathecal injection had satisfactory spread of analgesia, it regressed rapidly with more side effects. Isobaric bupivacaine seemed to provide a slow regression of analgesia with fewer undesirable effects except for its inadequate spread of analgesia. As a result, if the dosages as well as the time of administration of isobaric solution are well adjusted, we believe that it is safe and reliable with an excellent level of analgesia for caesarean section.", "Both hyper- and hypobaric solutions of bupivacaine are often combined with morphine to provide subarachnoid anesthesia for cesarean section. Differences in the baricity of subarachnoid solutions influence the intrathecal distribution of anesthetic drugs and would be expected to influence measurable clinical variables. We compared the effects of hyper- and hypobaric subarachnoid bupivacaine with morphine to determine whether one has significant advantages with regard to intraoperative anesthesia and postoperative analgesia in term parturients undergoing elective cesarean section. Thirty parturients were randomized to receive either hyper- or hypobaric bupivacaine (15 mg) with morphine sulfate (0.2 mg). Intraoperative outcomes compared included extent of sensory block, quality of anesthesia, and side effects. Postoperative outcomes, including pain visual analog scale scores, systemic analgesic requirements, and side effects, were monitored for 48 h. Sedation effects were quantified and compared using Trieger and digit-symbol substitution tests. We detected no differences in sensory or motor block, quality of anesthesia, quality of postoperative analgesia, incidence of side effects, or psychometric scores. Both preparations provide highly satisfactory anesthesia for cesarean section and effective postoperative analgesia. Implications: Dextrose alters the density of intrathecal bupivacaine solutions and is thought to influence subarachnoid distribution of the drug. We randomized parturients undergoing cesarean section to one of two often used spinal bupivacaine preparations, hypobaric and hyperbaric. We detected no differences in clinical outcomes between groups.", "Equal volumes (2.5 ml, 12.5 mg) of plain 0.5% bupivacaine (glucose-free) and hyperbaric 0.5% bupivacaine (in 8% glucose) were compared in a randomized double-blind study of 40 patients undergoing Caesarean section under subarachnoid anaesthesia. There were no differences in the rate of onset, maximum spread, number of patients with high cervical levels, duration of anaesthesia or incidence of post-spinal headaches between the two solutions. The median maximum cephalad levels of analgesia were (hyperbaric) T1 (range C1-T4), and (plain) T2 (range C1-T4). Thirteen patients in the hyperbaric group and 10 in the isobaric group required i.v. ephedrine to treat hypotension. Nine patients (23%) developed a post-spinal headache, and three were treated with an extradural blood patch.", "We randomized 76 parturients to a double-blinded trial to receive spinal anesthesia with either hyperbaric or plain bupivacaine 9 mg with fentanyl 20 microg for elective cesarean delivery. A combined spinal-epidural technique was used. The onset and duration of anesthesia (absence of pinprick sensation), analgesia (absence of sharp sensation to pinprick), and absence of cold sensation and motor block were measured until recovery from the motor block. No major differences were seen in onset or duration of anesthesia between the groups. Motor block, however, vanished faster when hyperbaric bupivacaine was used (P < 0.05). The level of anesthesia (no pinprick sensation) required for painless operation was at dermatome T5. At this time, the absence of cold sensation ranged from dermatome T1 to C3. The median time for the anesthesia to reach dermatome T5 was 10 min. Cervical spread of pinprick anesthesia was noted in six patients, and five needed supplementary analgesics during surgery (not significant between the groups). Maternal satisfaction was good. Nine milligrams of either plain or hyperbaric bupivacaine with fentanyl intrathecally provided similar onset, depth, and duration of sensory anesthesia for cesarean delivery with good maternal satisfaction. Motor block developed and diminished faster with the hyperbaric solution.\n Nine milligrams of either plain or hyperbaric bupivacaine with fentanyl intrathecally provided similar onset, depth, and duration of sensory anesthesia for cesarean delivery with good maternal satisfaction. Motor block developed and diminished faster with the hyperbaric solution.", "In a double-blind, randomized trial, 98 parturients undergoing cesarean section received either hyperbaric or plain bupivacaine 6.6 mg combined with sufentanil 3.3 microg as part of a combined spinal-epidural procedure. To prevent hypotension, 1000 mL of lactated Ringer's solution, 500 mL of hydroxyethyl starch 6%, and ephedrine 5 mg were administered i.v. The height of the block was equal in both groups, but more patients in the plain group had blocks that were either too high or too low (P < 0.01). The number of patients requiring epidural supplementation was equal in both groups. Strict criteria were used to treat hypotension. The overall incidence of systolic blood pressure (<90 mm Hg) was 13%, whereas it was more pronounced in the plain group (21% vs 6% in the hyperbaric group, P < 0.05), which required more ephedrine (P < 0.05) and in which a greater incidence of nausea was noticed (P < 0.05). We conclude that the use of a small dose of intrathecal bupivacaine combined with sufentanil plus our described preloading regimen resulted in a lower incidence of hypotension. Further, we conclude that the use of hyperbaric bupivacaine in this manner provides a more reliable block and a lower incidence of hypotension than plain bupivacaine. Implications: A small dose of hyperbaric bupivacaine 0.5% combined with sufentanil used intrathecally during cesarean section offered a more reliable cephalad spread of the spinal block than the glucose-free combination, which was reflected in a lower incidence of hypotension and nausea.", "Bupivacaine preparations, plain or with glucose, are frequently used in the clinical practice. Blockade upper level is determined by local anesthetic spread in the CSF. This study aimed at comparing isobaric and hyperbaric bupivacaine in patients submitted to spinal anesthesia for Cesarean section.\n In this prospective, randomized and double-blind study 60 patients submitted to spinal anesthesia for Cesarean section were distributed in two groups: IB - (0.5% isobaric bupivacaine, 12.5 mg) and HB - (0.5% hyperbaric bupivacaine, 12.5 mg). After monitoring, venous puncture was performed followed by hydration with lactated Ringers solution. Spinal puncture was paramedially performed at L3-L4 interspace with 27G Quincke needle. Following the CSF dripping, morphine (100 microg) and bupivacaine were separately injected at the speed of 1 ml. 15 s(-1). With the patient back to supine position, two parameters were recorded: onset time (absence of sensitivity in L3) at 1-minute intervals as well as motor and sensory block after 20 minutes. All patients were kept with preanesthetic blood pressure levels until umbilical cord clamping, and if necessary, ephedrine was administered. Neonates were evaluated by Apgars score at 1 and 5 minutes. Sensory and motor blocks were also evaluated at PACU 120 minutes after local anesthetic injection.\n Groups were homogeneous. Onset time: Group IB (1', 50\") and HB (1', 33\"), with no statistical difference. Motor and sensory block at twenty minutes showed no significant difference. Ephedrine consumption: IB (11.83 mg) and HB (14.17 mg), showed also no statistical difference. PACU motor block evaluation showed significant differences.\n We concluded that 12.5 mg isobaric and hyperbaric bupivacaine associated to morphine (100 microg) in spinal anesthesia for Cesarean section in term pregnant women are effective and present similar profiles." ]

[ "16103847", "1962157", "16079422", "11506215", "6215669", "21177034", "17413465", "19139673", "15585539", "19333174", "10767816", "9460148" ]

[ "A randomized controlled trial of an educational intervention to prevent the chronic pain of whiplash associated disorders following rear-end motor vehicle collisions.", "A controlled study of the effect of neck school in medical secretaries.", "Simple educational intervention to improve the recovery from acute whiplash: results of a randomized, controlled trial.", "No significant differences between intervention programmes on neck, shoulder and low back pain: a prospective randomized study among home-care personnel.", "Patient compliance in back and neck pain.", "Effectiveness of small daily amounts of progressive resistance training for frequent neck/shoulder pain: randomised controlled trial.", "Neck collar, \"act-as-usual\" or active mobilization for whiplash injury? A randomized parallel-group trial.", "Efficacy of a patient-educational booklet for neck-pain patients with workers' compensation: a randomized controlled trial.", "Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.", "Randomized trial of therapeutic massage for chronic neck pain.", "Active treatment of chronic neck pain: a prospective randomized intervention.", "Acute treatment of whiplash neck sprain injuries. A randomized trial of treatment during the first 14 days after a car accident." ]

[ "Concealed allocation, multicenter, single-blind, randomized controlled clinical trial.\n To assess the efficacy of an educational video in the tertiary prevention of persistent WAD symptoms following rear-end motor vehicle collisions (MVCs).\n Whiplash-associated disorders (WAD) are an important and costly health problem. There is a lack of high quality evidence surrounding efficacy of treatments for WAD. Existing research supports active interventions and early return to regular activities.\n Consecutive patients presenting to four tertiary care emergency departments following rear-end MVCs were eligible. Following informed consent, patients were allocated, using central randomization, to receive an educational video plus usual care or usual care alone. The video provided reassurance, and advice about posture, return to regular activities, exercises, and pain-relief methods. Data were collected by telephone using standardized questionnaires. The primary outcome was presence of Persistent WAD Symptoms at 24 weeks postinjury, based on the frequency and severity of neck, shoulder, or upper back pain. The absolute difference in proportion of patients with persistent WAD symptoms and rate ratios were calculated. Changes in pain scores were compared using the Mann-Whitney U test.\n The intervention (n = 206) and control (n = 199) groups were similar at baseline (mean age 38.4 years; 64% female). Overall, the proportion of subjects with Persistent WAD Symptoms decreased from 89.1% at baseline to 33.6% at 24 weeks after injury. At 24 weeks, the proportion of subjects with persistent WAD symptoms in the intervention group was 7.9% (95% CI, -2.0, 17.8) lower than the control group. The median improvement in pain score at 24 weeks was 3 for the intervention group and 2 for the control group (P = 0.016).\n The presence of persistent WAD symptoms following simple rear-end MVCs was high in this sample. The video group demonstrated a trend toward less severe WAD symptoms. We recommend evaluating other educational interventions that could reduce WAD symptoms.", "The effect of \"neck school\" on neck and shoulder disorders was studied in medical secretaries. A neck school reinforced with compliance enhancing measures (group B) was compared with a traditional neck school (group A) and a control group (group C). The results show that ergonomical knowledge was good even before the secretaries attended the neck schools and that compliance was significantly higher for group B. When comparisons were made within groups some improvements on neck and shoulder fatigue and pain were noted, particularly for group B. When workload was controlled no significant group differences were found. No differences were noted for range of neck motion, or sick leave in any group. Our conclusion is that neck schools, despite good compliance, appear to be of limited clinical value for prevention of neck and shoulder disorders.", "To determine if an educational intervention in the acute stage of whiplash injury may improve the recovery rate.\n Consecutive subjects were randomized to one of two treatment groups: educational intervention or usual care. The intervention group received an educational pamphlet based on the current evidence. The control group did not receive these materials but received usual emergency department care and a standard nondirected discharge information sheet. Both groups underwent follow-up by telephone interview at two weeks and three months. The primary outcome measure of recovery was the patient's response to the question, \"How well do you feel you are recovering from your injuries?\"\n A total of 112 subjects agreed to participate. Age, gender, precollision employment level and health, initial symptoms, collision parameters, and emergency treatments were similar between the groups. At two weeks postcollision, 7.3% in the treatment group reported recovery compared with 8.8% in the control group (absolute risk difference, -1.5%; 95% confidence interval = -12.6% to 9.7%). At three months postcollision, 21.8% in the treatment group reported complete recovery compared with 21.0% in the control group (absolute risk difference, 0.8%; 95% confidence interval = -14.4% to 16.0%). At three months, there were no clinically or statistically significant differences between groups in severity of remaining symptoms, limitations in daily activities, therapy use, medications used, lost time from work, or litigation.\n An evidence-based educational pamphlet provided to patients at discharge from the emergency department is no more effective than usual care for patients with grade 1 or 2 whiplash-associated disorder.", "The effects of two different prevention programmes on: (1) reported neck, shoulder and back pain, (2) perceived physical exertion at work and perceived work-related psychosocial factors, were evaluated by questionnaires after 12 and 18 months. Female nursing aides and assistant nurses (n = 282) working in the home-care services, were randomly assigned to one of three groups for: (1) individually designed physical training programme, (2) work-place stress management, (3) control group. Results revealed no significant differences between the three groups. However, improvements in low back pain were registered within both intervention groups for up to 18 months. Perceived physical exertion at work was reduced in the physical training group. Improvements in neck and shoulder pain did not differ within the three groups. Dissatisfaction with work-related, psychosocial factors was generally increased in all groups. As the aetiology of neck, shoulder and back disorders is multifactorial, a combination of the two intervention programmes might be preferable and should be further studied.", "nan", "Regular physical exercise is a cornerstone in rehabilitation programs, but adherence to comprehensive exercise remains low. This study determined the effectiveness of small daily amounts of progressive resistance training for relieving neck/shoulder pain in healthy adults with frequent symptoms; 174 women and 24 men working at least 30 h per week and with frequent neck/shoulder pain were randomly assigned to resistance training with elastic tubing for 2 or 12 minutes per day 5 times per week, or weekly information on general health (control group). Primary outcomes were changes in intensity of neck/shoulder pain (scale 0 to 10), examiner-verified tenderness of the neck/shoulder muscles (total tenderness score of 0 to 32), and isometric muscle strength at 10 weeks. Compared with the control group, neck/shoulder pain and tenderness, respectively, decreased 1.4 points (95% confidence interval -2.0 to -0.7, p<0.0001) and 4.2 points (95% confidence interval -5.7 to -2.7, p<0.0001) in the 2-minute group and 1.9 points (95% confidence interval -2.5 to -1.2, p<0.0001) and 4.4 points (95% confidence interval -5.9 to -2.9, p<0.0001) in the 12-minute group. Compared with the control group, muscle strength increased 2.0 Nm (95% confidence interval 0.5 to 3.5Nm, p=0.01) in the 2-minute group and 1.7Nm (95% confidence interval 0.2 to 3.3 Nm, p=0.02) in the 12-minute group. In conclusion, as little as 2 minutes of daily progressive resistance training for 10 weeks results in clinically relevant reductions of pain and tenderness in healthy adults with frequent neck/shoulder symptoms. Trial registration: www.isrctn.org/ISRCTN60264809. In generally healthy adults with frequent neck/shoulder muscle pain, as little as 2 minutes of daily progressive resistance training reduces pain and tenderness.\n Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.", "Randomized, parallel-group trial.\n To compare the effect of 3 early intervention strategies following whiplash injury.\n Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only.\n Participants were recruited from emergency units and general practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to \"act-as-usual,\" or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12 months postinjury. Treatment effect was measured in terms of headache and neck pain intensity (0-10), disability, and work capability.\n A total of 458 participants were included. At the 1-year follow-up, 48% of participants reported considerable neck pain, 53% disability, and 14% were still sick listed at 1 year follow-up. No significant differences were observed between the 3 interventions group.\n Immobilization, \"act-as-usual,\" and mobilization had similar effects regarding prevention of pain, disability, and work capability 1 year after a whiplash injury.", "A randomized controlled trial of an educational booklet for patients with first-time neck pain.\n To assess the clinical impact of a novel educational book on patients' functional outcomes and beliefs about neck pain.\n Previous research has shown that a novel education booklet (The Back Book) had a positive impact on patients with low back pain' beliefs and clinical outcomes. The current study sought to evaluate the efficacy of a similar education booklet (The Neck Book) for neck-pain patients.\n Workers' compensation patients were given either the experimental booklet, a traditional booklet or no booklet. The primary outcome measures, collected at 2-weeks, 3-months, and 6-months after baseline, were The Fear Avoidance Beliefs Questionnaire and The Neck Pain and Disability Scale. Health-related functional measures were also collected at these intervals.\n Only 34% (N = 187) of an original cohort of patients (N = 522) had data for all of the follow-up periods. For these 187 patients, repeated-measures analyses of covariance, using the baseline measure as the covariate, revealed no significant differences among the 3 groups on any of the outcome measures at any of the follow-up periods. For example, at 6-months, the experimental booklet, traditional booklet, and no-booklet groups reported The Neck Pain and Disability Scale mean scores (SDs) of 31.3 (15.5), 35.3 (17.0), and 31.8 (15.6), respectively. Similarly, there were no significant effects for The Fear Avoidance Beliefs Questionnaire scores-35.9 (21.5), 40.3 (22.1), and 38.0 (23.4), respectively.\n This study demonstrates that the educational booklets studied were not associated with improved outcomes in patients with neck pain receiving workers' compensation. Whether these results would apply to a nonworkers' compensation population requires further study. The loss of many patients to follow-up also makes any other firm conclusions more difficult to determine.", "Firstly, to compare the effectiveness of a brief physiotherapy intervention with \"usual\" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome.\n Non-inferiority randomised controlled trial eliciting preferences independently of randomisation.\n Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire.\n 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned.\n The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement.\n At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy.\n Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.", "Little is known about the effectiveness of therapeutic massage, one of the most popular complementary medical treatments for neck pain. A randomized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain.\n Sixty-four such patients were randomized to receive up to 10 massages over 10 weeks or a self-care book. Follow-up telephone interviews after 4, 10, and 26 weeks assessed outcomes including dysfunction and symptoms. Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinically meaningful improvements in dysfunction and symptoms (ie, >5-point improvement on the Neck Disability Index; >30% improvement from baseline on the symptom bothersomeness scale) at each time point.\n At 10 weeks, more participants randomized to massage experienced clinically significant improvement on the Neck Disability Index [39% vs. 14% of book group; relative risk (RR)=2.7; 95% confidence interval (CI), 0.99-7.5] and on the symptom bothersomeness scale (55% vs. 25% of book group; RR=2.2; 95% CI, 1.04-4.2). After 26 weeks, massage group members tended to be more likely to report improved function (RR=1.8; 95% CI, 0.97-3.5), but not symptom bothersomeness (RR=1.1; 95% CI, 0.6-2.0). Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks. No serious adverse experiences were reported.\n This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term. A larger trial is warranted to confirm these results.", "A randomized comparative study with single-blind outcome assessments.\n To compare the efficacy of a multimodal treatment emphasizing proprioceptive training (ACTIVE) with activated home exercises (HOME) and recommendation of exercise (CONTROL) in patients with nonspecific chronic neck pain.\n The efficacy of active exercises and passive physiotherapy for neck trouble has been somewhat disappointing in the previous few studies.\n Seventy-six patients (22 men, 54 women) with chronic, nonspecific neck pain participated. Sixty-two participated the 1-year follow-up. Subjective pain and disability, cervical ranges of motion, and pressure pain threshold in the shoulder region were measured at baseline, at 3 months, and at 12 months. The ACTIVE treatment consisted of 24 sessions of proprioceptive exercises, relaxation, and behavioral support. The HOME regimen included a neck lecture and two sessions of practical training for home exercises and instructions for maintaining a diary of progress. The CONTROL treatment included a lecture regarding care of the neck with a recommendation to exercise.\n The average self-experienced total benefit was highest in the ACTIVE group, and the HOME group rated over the CONTROL group (P < 0.001). Differences between the groups in favor of the ACTIVE treatment were recorded in reduction of neck symptoms and improvements in general health and self-experienced working ability (P < 0.01-0.03). Changes in measures of mobility and pressure pain threshold were minor.\n Regarding self-experienced benefit, the multimodal treatment was more efficacious than activated home exercises that were clearly more efficacious than just advising. No major differences were noted in objective measurements of cervical function between the groups, but the content validity of these assessments in chronic neck trouble can be questioned.", "A single-blinded, randomized treatment study with a follow-up period of 6 months.\n To study the long-term consequences of whiplash neck sprain injuries in patients treated with two different regimes during the first 14 days after the car accident. Patients in the first group were encouraged to act as usual, i.e., continue to engage in their normal, pre-injury activities; that group was compared with another group of patients who were given time off from work and who were immobilized using a soft neck collar. The end point of the comparison was the evaluation of subjective symptoms 6 months after the accident.\n Few randomized treatment studies have been performed to evaluate the clinical outcome for patients with neck sprain.\n Patients who participated in the study were recruited from the Emergency Clinic at the University Hospital in Trondheim, Norway. The study group included 201 patients (47% of the study group) with neck sprain that resulted from a car accident. Neck and shoulder movements and subjective symptoms, which were assessed using several different measurements, were assessed during the follow-up period.\n There was a significant reduction of symptoms from the time of intake to 24 weeks after the treatment period in both groups. There was a significantly better outcome for the act-as-usual group in terms of subjective symptoms, including pain localization, pain during daily activities, neck stiffness, memory, and concentration, and in terms of visual analog scale measurements of neck pain and headache.\n The outcome was better for patients who were encouraged to continue engaging in their normal, pre-injury activities as usual than for patients who took sick leave from work and who were immobilized during the first 14 days after the neck sprain injury." ]

[ "11088092", "10604693", "14584770", "10450010", "5846044", "2089969", "2265339", "2230239", "7709947", "10860688", "17785483", "963410", "8506804", "2187551", "15364311", "2190840" ]

[ "A randomized crossover study of silver-coated urinary catheters in hospitalized patients.", "Efficacy of antimicrobial-impregnated bladder catheters in reducing catheter-associated bacteriuria: a prospective, randomized, multicenter clinical trial.", "Assessment of nosocomial urinary tract infections in orthopaedic patients: a prospective and comparative study using two different catheters.", "Clinical application of the Bardex IC Foley catheter.", "Siliconized Foley catheters.", "[A controlled trial of a new material for coating urinary catheters].", "Comparison of urethral reaction to full silicone, hydrogen-coated and siliconised latex catheters.", "Prevention of catheter-associated urinary tract infection with a silver oxide-coated urinary catheter: clinical and microbiologic correlates.", "A large randomized clinical trial of a silver-impregnated urinary catheter: lack of efficacy and staphylococcal superinfection.", "Randomized multi-centre trial of the effects of a catheter coated with hydrogel and silver salts on the incidence of hospital-acquired urinary tract infections.", "Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial.", "Comparison of hydrophilic polymer-coated latex, uncoated latex and PVC indwelling balloon catheters in the prevention of urinary infection.", "[Clinical study on efficacy of a Foley catheter coated with silver-protein in prevention of urinary tract infections].", "Silver alloy coated catheters reduce catheter-associated bacteriuria.", "A comparative multicentre study on the incidence of catheter-associated urinary tract infection between nitrofurazone-coated and silicone catheters.", "Refinements in the coating of urethral catheters reduces the incidence of catheter-associated bacteriuria. An experimental and clinical study." ]

[ "Urinary tract infections (UTIs) account for 30% to 40% of nosocomial infections resulting in morbidity, mortality, and increased length of hospital stay.\n To assess the efficacy of a silver-alloy, hydrogel-coated latex urinary catheter for the prevention of nosocomial catheter-associated UTIs.\n A 12-month randomized crossover trial compared rates of nosocomial catheter-associated UTI in patients with silver-coated and uncoated catheters. A cost analysis was conducted.\n There were 343 infections among 27,878 patients (1.23 infections per 100 patients) during 114,368 patient-days (3.00 infections per 1000 patient-days). The relative risk of infection per 1000 patient-days was 0.79 (95% confidence interval, 0.63-0.99; P =.04) for study wards randomized to silver-coated catheters compared with those randomized to uncoated catheters. Infections occurred in 291 of 11,032 catheters used on study units (2.64 infections per 100 catheters). The relative risk of infection per 100 silver-coated catheters used on study wards compared with uncoated catheters was 0.68 (95% confidence interval, 0.54-0.86; P =.001). Fourteen catheter-associated UTIs (4.1%) were complicated by secondary bloodstream infection. One death appeared related to the secondary infection. Estimated hospital cost savings with the use of the silver-coated catheters ranged from $14,456 to $573,293.\n The risk of infection declined by 21% among study wards randomized to silver-coated catheters and by 32% among patients in whom silver-coated catheters were used on the wards. Use of the more expensive silver-coated catheter appeared to offer cost savings by preventing excess hospital costs from nosocomial UTI associated with catheter use. Arch Intern Med. 2000;160:3294-3298.", "To examine the efficacy of bladder catheters impregnated with minocycline and rifampin in reducing catheter-associated bacteriuria.\n A prospective, randomized clinical trial was conducted at five academic medical centers. Patients undergoing radical prostatectomy were randomized to receive intraoperatively either regular silicone bladder catheters (control catheters) or silicone bladder catheters impregnated with minocycline and rifampin (antimicrobial-impregnated catheters). Catheters remained in place for a mean of 2 weeks. Urine cultures were obtained at about 3, 7, and 14 days after catheter insertion. Bacteriuria was defined as the growth of organism(s) in urine at a concentration of 10(4) colony-forming units per milliliter or greater.\n Kaplan-Meier analysis demonstrated that it took significantly longer for patients (n = 56) who received the antimicrobial-impregnated catheters to develop bacteriuria than those (n = 68) who received the control catheters (P = 0.006 by the log-rank test). Patients who received the antimicrobial-impregnated catheters had significantly lower rates of bacteriuria than those in the control group both at day 7 (15.2% versus 39.7%) and at day 14 (58.5% versus 83.5%) after catheter insertion. Patients who received the antimicrobial-impregnated catheters had significantly lower rates of gram-positive bacteriuria than the control group (7.1% versus 38.2%; P <0.001) but similar rates of gram-negative bacteriuria (46.4% versus 47.1%) and candiduria (3.6% versus 2.9%). The antimicrobial-impregnated catheters provided zones of inhibition against Enterococcus faecalis and Escherichia coli, both at baseline and on removal.\n Bladder catheters impregnated with minocycline and rifampin significantly reduced the rate of gram-positive catheter-associated bacteriuria up to 2 weeks after catheter insertion.", "Catheter-related nosocomial urinary tract infection in postoperative orthopedic and trauma patients was studied prospectively using nitrofuroxone-impregnated urinary catheters (study group) and regular silicone-coated Foley catheters. Fifty adults in each group were randomly assigned. In Group A, antibiotic-impregnated catheters were used, and in the other, non-antibiotic-impregnated urinary catheters were used (Group B). The variables studied were age, sex, type of surgery, duration of surgery, number of catheter days, days of intravenous line, and hospital days. In patients, urinary tract infection (UTI) was diagnosed by culture and the organism was isolated. The average age in the study group was 43.90 years (range, 14-95 years) compared with the control group (mean age, 42.22 years; range, 14-102 years). Catheter days in the nitrofuroxone-impregnated catheters was 7.9 days (range, 2-37 days) versus 7.2 days (range, 2-30 days). The intravenous line in the group was 9.16 days (range, 2-35 days) versus 8.8 days (2-22 days). There were six infections (P = 0.028) in the control group compared with the study group. The length of operation was similar in each group. Our study indicates that nitrofuroxone-impregnated catheters have the potential to reduce nosocomial catheter-related UTIs in postoperative orthopedic and trauma patients.", "We performed two randomized prospective studies with the silver-coated Bardex IC catheter in order to evaluate the incidence of bacteriuria during short- and medium-term catheterization after urological procedures.\n During catheterization only consecutive suprapubic urine samples were taken and cultured. After removal of the catheter the patient was allowed one wash-out void, and before the second micturition a suprapubic puncture was performed to collect a culture specimen.\n In the first trial, after radical prostatectomy 18 patients with the Bardex IC catheter were compared to 17 patients with a silicon catheter after the same procedure. There was no significant difference in bacteriuria after 14 days (50.0 vs. 53.3%). In the second part of the study 180 patients were evaluated 101 with latex and 79 with Bardex IC catheters. The median catheterization time was 5 days. The results show a significant delay in the onset of bacteriuria when a silver alloy catheter is used (p < 0.003). On day 5 only 6.3% had bacteriuria in the Bardex IC group versus 11.9% in the latex group.\n We conclude that, after urological procedures, short-term catheterization with the Bardex IC catheter is superior to the classical latex catheter.", "nan", "Hydrogel is a highly biocompatible material which is used for coating Foley catheters. It has, in vitro and in vivo, demonstrated the lack of irritation to the surrounding urothelium. This controlled, randomized trial study the effectiveness of hydrogel-coated catheter (H catheter) compared with silicone-coated catheter (S catheter) in the prevention of nosocomial urinary tract infections (N.U.T.I.) for intensive care patients. To be included in this trial, subjects should have no urinary tract infection and no Foley catheters. Preliminary results concern 266 subjects (129 with H catheter, 137 with S catheter) Sex ratio M:F was 0.95; mean age was 50.7 years. The main criteria of judgement was the cumulative incidence of N.U.T.I. There was no significant difference between the two groups: 15.8% for H catheter versus 12.9% for S catheter. In the two groups mean duration of catheterization was longer for patients with N.U.T.I. Other evaluations seem to be necessary in order to confirm these results.", "Indwelling urinary catheter may induce an inflammatory reaction or even stricture of the urethra. Catheter encrustation and urinary infection are other disadvantages associated with long-term catheterisation. In the present study, 77 male patients were catheterised randomly as part of their normal treatment with 1 of 3 different types of catheter: 22 siliconised latex, 28 hydrogel-coated latex and 27 full silicone catheters. The mean duration of catheterisation was 2.2 days. The urethral inflammatory reaction was assessed from cytological urethral swab specimens. Catheter encrustation was studied using scanning electron microscopic (SEM) analysis. The full silicone catheters induced the mildest degree of inflammation in the urethra, the percentage mean of inflammatory cells in smears being 20%. In both latex catheter groups the value was 36%. Neither the age of the patients nor the duration of catheterisation had any effect on the inflammatory reaction, which was more marked in patients with haemodynamic abnormalities. The hydrogel coating effectively prevented encrustation, while siliconised latex catheters were the least resistant to encrustation. The inflammatory reaction was variable in all patients. The use of urethral catheters should be restricted and suprapubic tubes should be used instead, particularly in patients with shock-like circulatory changes. By developing the biocompatibility and physical properties of urinary catheters, more compatible devices may be manufactured.", "In a prospective clinical trial involving 482 acutely hospitalized patients, the overall incidence of catheter-associated urinary tract infection (UTI; 10%) was similar in recipients of a silver oxide-coated urinary catheter (silver catheter) or a control silicone catheter. However, female sex and absence of antimicrobial use were independently associated with an increased risk of UTI. After stratification for these variables, the silver catheter reduced the incidence of UTI among women not receiving antimicrobial agents (19% for control catheter vs. 0 for silver catheter, P = .04; confidence interval for the difference in incidence, 0.4%-38%) but not in the other subgroups. Gram-positive UTI was associated with absence of antimicrobial use, the control catheter, and catheter care violations. Gram-negative and candidal UTIs were more common after 7 days of catheterization, and candidal UTI was associated with being female and antimicrobial use. These findings demonstrate that several clinical variables influenced the incidence and microbiology of catheter-associated UTI and that the silver catheter appeared to prevent UTI among women not receiving antimicrobials.", "The antibacterial activity of silver-containing compounds has recently been employed in constructing medical devices, such as vascular and urinary catheters, that may be effective in blocking infection. The present study was designed to evaluate the efficacy of a silver oxide-coated urinary catheter.\n A total of 1,309 hospitalized patients who required placement of an indwelling urinary catheter for 24 hours or longer were randomly assigned to receive either a silicone catheter coated externally with 5% silver oxide or a standard silicone elastomer-coated latex catheter. Daily catheter-urine specimens were collected aseptically and catheter-care violations were monitored daily for the duration of the catheterization.\n Bacteriuria developed in 85 of 745 patients (11.4%) in the silver-coated catheter group and in 73 of 564 patients (12.9%) in the control group (P = 0.45). In women who did not receive antibiotics, the rates were 29.3% and 30.4%, respectively (P = 0.98). In men who did not receive antibiotics, the rate of bacteriuria was significantly higher with the silver-coated catheter (29.4% compared to 8.3%, respectively, P = 0.02). Staphylococcal species were isolated more often from the silver-coated catheter group than from the control group (25% versus 8% of all isolates, respectively, P = 0.002).\n This study, the largest ever reported evaluating any silver-impregnated device, has not only failed to demonstrate the efficacy of silver in prevention of catheter-associated bacteriuria, as suggested in prior studies, but it has also shown a significantly increased incidence of bacteriuria in male patients and a significantly increased occurrence of staphylococcal bacteriuria. These results suggest the need for caution and for similar large-scale trials before silver-containing compounds are widely used for preventing device-associated infections, both in vascular and urinary catheters.", "Catheters coated with hydrogel and silver salts have been proposed to prevent hospital-acquired urinary tract infections (UTI). We carried out a randomized, prospective, double-blind multi-centre trial to compare those catheters with classical urinary tract catheters. We included in the study 199 patients requiring urethral catheterization for more than three days: 109 in group 1 (classical catheter) and 90 in group 2 (catheter coated with hydrogel and silver salts). Urine from the patients was tested for 10 days after the insertion of the catheter (reactive dipsticks each day and diagnostic urinalysis every two days). The UTI associated with catheterization was defined on the basis of bacterial and cytological criteria (>10(5)cfu bacteria per mL and >10 leucocytes per mm(3)). Twenty-two UTIs were recorded: 13 in group 1 and nine in group 2. The cumulative incidence of UTI associated with catheterization was 11.1% overall, 11.9% for group 1 and 10% for group 2; the odds ratio was 0.82 (95% confidence interval: 0.30 to 2. 20); the cumulative incidence for UTI, calculated by the Kaplan-Meier method was 36.3 overall, 35.2 in group 1 and 36.0 in group 2; the overall incidence density was 19 per thousand days of catheterization, 21 in group 1 and 18 in group 2. The differences between the two groups were not significant. Overall, we feel that there is not enough evidence to conclude that catheters coated with silver salts and hydrogel give greater protection than classical catheters and to recommend widespread use.\n Copyright 2000 The Hospital Infection Society.", "Urinary tract infection is one of the most common nosocomial infections in hospitalized patients. It is predominantly associated with indwelling urinary catheters.\n To determine whether nitrofurazone-impregnated urinary catheters reduce the incidence of catheter-associated bacteriuria and funguria (CABF).\n Randomized, double-blind, controlled trial.\n Copenhagen Trauma Center, Copenhagen, Denmark.\n 212 consecutive adult trauma patients admitted between July 2003 and August 2005. Eligible patients needed a urinary catheter on arrival and were excluded if they were HIV positive, were pregnant, had a primary burn injury, or were receiving steroid treatment or if informed consent was unattainable. Interventions: Nitrofurazone-impregnated or standard silicone catheter throughout the duration of catheterization.\n Catheter-associated bacteriuria and funguria, defined as at least 10(3) colony-forming units/mL, was assessed daily until removal of the catheter, with a prespecified minimum of 24-hour follow-up for the primary analysis. The microbiologist was blinded to study group assignment.\n 1190 urine cultures were obtained over 1001 catheter-days. Catheter-associated bacteriuria and funguria occurred less frequently in the nitrofurazone catheter group than in the silicone catheter group (7 of 77 [9.1%] vs. 19 of 77 [24.7%]; incidence per 1000 catheter-days, 13.8 vs. 38.6; adjusted risk, 0.31 [95% CI, 0.14 to 0.70]; P = 0.005). Onset of CABF was delayed in the nitrofurazone group (P = 0.01), and nitrofurazone catheters led to fewer instances of new or changed antimicrobial therapy (adjusted risk, 0.27 [CI, 0.10 to 0.69]; P = 0.006).\n The clinical significance of asymptomatic bacteriuria and funguria is unclear. Data were missing in 27% of patients, and the magnitude of effect of the nitrofurazone catheters varied by assumptions about outcomes in patients who did not complete 24-hour follow-up.\n Nitrofurazone-impregnated urinary catheters reduced the incidence of CABF in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. ClinicalTrials.gov registration number: NCT00192985.", "Latex, hydrophilic polymer-coated latex and PVC balloon indwelling urethral catheters were compared in respect of the urinary tract infections arising in association with their use in male patients. The polymer (Hydron) coating conferred no benefit over uncoated latex which in turn was indistinguishable from PVC. No significant differences in the spectra of infecting organismns were observed between the 3 catheter types.", "We evaluated the clinical efficacy and safety of a Foley catheter coated with silver-protein (ProAg catheter) in the prevention of catheter-associated bacteriuria. ProAg catheter significantly reduced the incidence of extraluminal catheter-associated bacteriuria compared with usual latex Foley catheter although it did not inhibit intraluminal bacteriuria. There was no difference between ProAg catheter and latex catheter in the side effects such as urethral discharge, catheter-associated pain and allergic reaction. The ProAg catheter may be useful as an indwelling urethral catheter.", "The tendency of indwelling catheters to cause urinary tract infection was evaluated in a randomised clinical study of 223 patients. A Foley catheter coated with silver alloy on both inner and outer surfaces was used in 60 patients; 60 others received a Teflonised latex Foley's catheter and the remaining 103 patients were excluded because of antibiotic treatment, diabetes, etc. There was a statistically significant difference in the incidence of catheter-associated bacteriuria (greater than 10(5) organisms/ml) in the 2 groups after 6 days' catheterisation: 6 patients with the silver coated catheter developed bacteriuria compared with 22 who had the Teflonised latex catheter. This suggests that the silver impregnated urethral catheters reduce the incidence of catheter-associated urinary tract infection.", "The efficacy of nitrofurazone-coated urinary catheter in inhibitory activity of catheter-associated urinary tract infection (CAUTI) was evaluated. The incidence rate and onset of CAUTI after catheterisation of standard silicone urinary catheters and nitrofurazone-coated catheters was compared. There was no statistical significance between the two groups in the incidence rate of CAUTI. However, in patients who had indwelling urinary catheters for 5-7 days, the incidence rate of CAUTI was significantly lower in the experimental group. Logistic regression analysis showed that the two variables, including age and period of insertion, affected the incidence rate of CAUTI significantly. Nitrofurazone-coated catheters can be useful for inhibition of CAUTI in patients who have indwelling urinary catheter for 5-7 days and in old-age patients.", "The tendency to develop bacteriuria during the use of various forms of indwelling catheters was evaluated in a randomized trial in 90 patients. A silver alloy and hydrogel-coated Foley catheter (SHC) was compared to a non-coated catheter (NC) and a catheter coated only with hydrogel (HC). Three patients (10%) with SHC catheters, 10 (33%) patients with HC catheters, and 15 (50%) patients with NC catheters developed bacteriuria (greater than 10(5) organisms/ml). The difference in the rate of bacteriuria after 5 days of catheterization was statistically significant between the SHC catheter and the NC catheter (p less than 0.002). There was no significant difference between the SHC catheter and the HC catheter, nor was there a significant difference between the HC catheter and the NC catheter. The toxic effects, as estimated by the IC50 value, of the urinary catheter material used was elucidated in an experimental fibroblast model. The IC50 value for the NC catheter was 33.9%, HC catheter 72.2% and for the SHC catheter 98.1%." ]

[ "11865836", "1582236", "10781212", "10506039", "12137725" ]

[ "Treatment of venous ulcers with pentoxifylline: a 6-month randomized, double-blind, placebo controlled trial.", "Pentoxifylline in the treatment of venous leg ulcers.", "Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial.", "Randomised, double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers.", "Pentoxifylline--efficient in the treatment of venous ulcers in the absence of compression?" ]

[ "The aim of this study was the evaluation of treatment with pentoxifylline in patients with venous ulcers in a 6-month, randomized, controlled trial. Treatment with placebo or pentoxifylline (PXF; 400 mg, 3 times daily) lasted 6 months and was associated to elastic bandaging. The endpoints were the number of limbs with complete healing and the variation in the area of ulceration. A group of 172 patients were included: 82 in the PXF group and 88 in the placebo group; 82 completed the study in the PXF group and 78 in the placebo group. Results. The two groups were comparable for age and sex distribution. The treatment was well tolerated. Complete healing was obtained in 67% of patients in the PXF group and 30.7% in the placebo group (p<0.02). The variations in the average area of ulceration were 86.7% (decrease) in the PXF group and 47% in the placebo group. The cost of treatment increased 21% with PXF but the cost due to non-healing of the ulcer was equivalent to a 44% increase (in comparison with the PXF group). In conclusion PXF is effective and cost-effective in improving ulcer healing in patients with chronic venous hypertension.", "A double-blind, placebo-controlled study was carried out in 12 patients suffering from chronic venous insufficiency and persistent leg ulcers to assess the efficacy of pentoxifylline treatment as an adjunct to compression bandaging in the conservative management of venous leg ulcers. Six patients were allocated at random to receive twice-daily infusions of 200 mg pentoxifylline intravenously and 400 mg pentoxifylline orally 3-times daily for 7 days then 400 mg oral doses 3-times daily for a further 60 days. The control group received matching placebo in an identical regimen. Treatment outcome was assessed by changes between the start and end of the study in venous ulcer surface area, and continuous wave Doppler ultrasound was used to monitor ankle/arm systolic pressure ratio, venous pressure at the ankle, valvular competence and possible venous reflux at intervals throughout the study period. The results showed that in the patients treated with pentoxifylline complete ulcer healing took place in 4 out of 6 and there was a significant reduction in mean ulcer surface area. In the control group, complete ulcer healing was recorded in 1 out of 6 patient only and the ulcer area was only moderately reduced in the others. There was no statistically significant differences between the two groups in the variables monitored by Doppler ultrasound but the difference between treatment outcome was significant. Treatment was well-tolerated.", "Several small studies have indicated that the systemic administration of pentoxifylline may accelerate healing of venous leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of pentoxifylline on healing. The study used a prospective, randomized, double-blind, parallel group placebo controlled design in a multicenter outpatient setting. Patients with one or more venous ulcer were enrolled, with all patients receiving standardized compression bandaging for treatment for their ulcers. Patients were also randomized to receive either pentoxifylline 400 mg, pentoxifylline 800 mg (two 400 mg tablets), or placebo tablets three times a day for up to 24 weeks. The main outcome measure was time to complete healing of all leg ulcers, using life table analysis. The study was completed as planned in 131 patients. Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to complete healing was 100, 83, and 71 days for placebo, pentoxifylline 400 mg, and pentoxifylline 800 mg three times a day, respectively. Over half of all patients were ulcer free at week 16 (placebo) and at week 12 in both pentoxifylline groups. Whereas the placebo group had only achieved complete healing in half of the cases by week 16, all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely. Treatment with pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups. Complete wound closure occurred at least 4 weeks earlier in the majority of patients treated with pentoxifylline by comparison to placebo. A higher dose of pentoxifylline (800 mg three times a day) was more effective than the lower dose. We conclude that pentoxifylline is effective in accelerating healing of leg ulcers.", "To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.\n Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.\n Leg ulcer clinics of a teaching and a district general hospital in southern Scotland.\n 200 patients with confirmed venous ulcers and in whom other major causal factors were excluded. Interventions: Pentoxifylline 400 mg three times daily or placebo.\n Complete healing (full epithelialisation) of all ulcers on the trial leg.\n Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.\n The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.", "The aim of the study was to test the efficacy and tolerability of pentoxifylline on the healing of venous ulcers in the absence of standard limb compression. The study used a prospective randomized, open, controlled, comparative, parallel group design. The study included 80 eligible patients with confirmed venous ulcers (with clinical and photoplethysmography findings). The patients received either pentoxifylline 1200 mg per day (3 x 400 mg) orally in addition of local therapy, or the same local therapy alone. The main outcome measures were complete healing of ulcers, change in the ulcer area over the six-month observation period, and tolerability of the drug. The results showed that complete healing occurred in 23 (57.5%) patients receiving pentoxifylline and 11 (27.5%) patients without pentoxifylline (log rank test =2.49, p=0.013). Unwanted effects of pentoxifylline occurred in 11/40 (27.5%) patients but were mild. Pentoxifylline is concluded to be efficacious in healing of venous ulcers in patients unable to tolerate compression therapy." ]

[ "1510394", "2019772", "3551829", "3546144", "3909956", "12884163", "10837439", "1829879", "2959198", "3526884", "6367466" ]

[ "Vancomycin is not an essential component of the initial empiric treatment regimen for febrile neutropenic patients receiving ceftazidime: a randomized prospective study.", "Vancomycin added to empirical combination antibiotic therapy for fever in granulocytopenic cancer patients. European Organization for Research and Treatment of Cancer (EORTC) International Antimicrobial Therapy Cooperative Group and the National Cancer Institute of Canada-Clinical Trials Group.", "Randomized prospective study of ceftazidime versus ceftazidime plus cephalothin in empiric treatment of febrile episodes in severely neutropenic patients.", "Empiric antimicrobial therapy in febrile granulocytopenic patients. Randomized prospective comparison of amikacin plus piperacillin with or without parenteral trimethoprim/sulphamethoxazole.", "A randomized prospective study of ceftazidime versus ceftazidime plus flucloxacillin in the empiric treatment of febrile episodes in severely neutropenic patients.", "Vancomycin versus placebo for treating persistent fever in patients with neutropenic cancer receiving piperacillin-tazobactam monotherapy.", "A prospective, randomized, double-blinded, placebo-controlled trial of empirical teicoplanin in febrile neutropenia with persistent fever after imipenem monotherapy.", "Ceftazidime as monotherapy or combined with teicoplanin for initial empiric treatment of presumed bacteremia in febrile granulocytopenic patients.", "Prospective randomized clinical trial of teicoplanin for empiric combined antibiotic therapy in febrile, granulocytopenic acute leukemia patients.", "Empiric use of vancomycin during prolonged treatment-induced granulocytopenia. Randomized, double-blind, placebo-controlled clinical trial in patients with acute leukemia.", "A randomized study of tobramycin plus ticarcillin, tobramycin plus cephalothin and ticarcillin, or tobramycin plus mezlocillin in the treatment of infection in neutropenic patients with malignancies." ]

[ "The use of vancomycin as part of the initial antibiotic therapy of febrile neutropenic patients has become a controversial issue. Some studies support its incorporation in the initial regimen, and others suggest that vancomycin can be added later. We examined this issue in a prospective, randomized trial. We randomized 127 febrile neutropenic patients to receive either ceftazidime alone or ceftazidime plus vancomycin as the initial empiric antibiotic treatment. We added vancomycin to the ceftazidime arm of the study when fever persisted after 96 h of monotherapy, when new fever occurred after this time, or when a moderately ceftazidime-resistant gram-positive bacterium was isolated. Each of these regimens had similar initial response rates, similar durations of initial fever, similar frequencies of new fever during therapy, similar microbiological cure rates, similar superinfection rates, and similar survival rates. We observed more renal and cutaneous toxicities in patients receiving vancomycin and ceftazidime as initial therapy. We conclude that ceftazidime is appropriate as initial therapy for febrile neutropenic patients and that the addition of vancomycin is appropriate when fever persists after 4 days of monotherapy or when fever recurs following an initial response.", "A total of 747 febrile granulocytopenic patients with cancer were randomized to receive ceftazidime plus amikacin (CA) with or without vancomycin (V) as initial empirical therapy. Single gram-positive bacteremias responded in 29 (43%) of 68 patients treated with CA and in 48 (72%) of 67 treated with CAV (P = .001). For single gram-negative bacteremias and clinically documented and possible infections the response rates of CA and CAV were 80% and 63% (P = .17), 55% and 75% (P = .009), and 74% and 81% (P = .16), respectively. However, for patients with gram-positive bacteremia and for all other patients, there were no differences by treatment regimens in the proportion of febrile patients on each trial day (P = .85, P = .82, respectively) or in the duration of fever (P = .22, P = .93, respectively). Moreover, no patient with gram-positive bacteremia died during the first 3 days of true empirical therapy. Antibiotic-associated nephrotoxicity was more frequent in patients treated with vancomycin (6% vs. 2%, P = .02). These results do not support the empirical addition of vancomycin to initial antibiotic therapy in cancer patients with fever and granulocytopenia.", "In a prospective randomized study, ceftazidime monotherapy was compared with a combination of ceftazidime plus cephalothin in 102 febrile neutropenic patients. Thirty bacteriologically documented infections, of which 23 were bacteremias, in 48 clinically assessable patients were treated with ceftazidime alone. Twenty-four bacteriologically proven infections, of which 18 were bacteremias, in 42 clinically assessable patients were treated with a combination of ceftazidime and cephalothin. The clinical response rates in assessable patients were 77% for ceftazidime monotherapy and 88% for the combination. The bacteriological clearance rate was 70% for ceftazidime monotherapy and 79% for the combination. Efficacy against gram-negative pathogens appeared to be excellent, with 93% clearance for ceftazidime monotherapy and 100% clearance for the combination. The bacteriological clearance of gram-positive infections was only 60% for both regimens, with failures mainly due to Streptococcus faecalis and Streptococcus sanguis, which are primarily resistant to both ceftazidime and cephalothin. After addition of vancomycin to those infections which did not respond to empiric therapy, bacteriological clearance rates of 94% (ceftazidime plus vancomycin) and 90% (ceftazidime and cephalothin plus vancomycin) were achieved. Three superinfections were registered in the ceftazidime group and two were seen in the combination group. Other adverse effects of ceftazidime were minimal and were not enhanced by combination with cephalothin. It is concluded that ceftazidime is an effective drug for the empiric treatment of febrile neutropenic patients, especially if one is prepared to modify therapy if resistant gram-positive strains or mycotic infections are encountered. Neither the clinical nor bacteriological cure rates could be substantially improved by adding cephalothin to ceftazidime in initial empiric treatment of febrile neutropenic patients.", "In a prospective randomized trial parenteral trimethoprim/sulphamethoxazole was added to amikacin plus piperacillin in order to compare triple-drug antibiotic combination with a standard regimen as empiric therapy of fever in patients with granulocytopenia. One hundred and sixty-one episodes were evaluated; 74 episodes with amikacin plus piperacillin and 87 episodes with amikacin plus piperacillin plus trimethoprim/sulphamethoxazole. The overall response to therapy (63% vs. 84%) as well as the response of microbiologically documented infections (60% vs. 82%) was significantly better in patients treated with the triple-drug combination (p less than 0.05). However, no statistically significant differences in response to antibiotics at different infection sites or with regard to any single pathogen was found between the two groups. Trimethoprim/sulphamethoxazole seemed to be responsible for additional toxicity (nausea and vomiting) when added to amikacin plus piperacillin, but these side-effects were clearly related to the rate of infusion of trimethoprim/sulphamethoxazole. The findings of this study support the use of a three-drug versus a two-drug combination as empiric antibiotic regimen in febrile granulocytopenic patients.", "In a prospective, randomized study, ceftazidime monotherapy was compared with a combination of ceftazidime and flucloxacillin in 100 febrile neutropenic patients. Thirty-four bacteriologically documented infections, of which 26 were bacteremias, in 51 patients were treated with ceftazidime alone. Thirty-four bacteriologically proven infections, of which 29 were bacteremias, in 49 patients were treated with a combination of ceftazidime and flucloxacillin. The clinical response rate for ceftazidime monotherapy was 80%; the bacteriological cure rate was 90%. Efficacy against gram-negative pathogens appeared to be excellent, achieving a 100% cure rate. The clinical response and bacteriological cure rates for the combination were 76 and 86%, respectively. Three superinfections were registered in the ceftazidime group, and four, involving six pathogens, were registered in the combination group. Other side effects of ceftazidime were minimal. It is concluded that ceftazidime is an effective drug for the empiric treatment of febrile neutropenic patients. It offers the opportunity to avoid the aminoglycosides in first-line treatment. It may be appropriate to combine ceftazidime with cephalothin or vancomycin or to modify therapy if resistant gram-positive strains are encountered.", "This prospective, double-blind trial assessed whether the addition of a glycopeptide would be able to reduce the time to defervescence in neutropenic patients with cancer who had persistent fever 48-60 h after the initiation of empirical piperacillin-tazobactam monotherapy. Of 763 eligible patients, 165 with persistent fever were randomized to receive piperacillin-tazobactam therapy plus either vancomycin therapy or placebo. Defervescence was observed in 82 (95%) of 86 patients in the vancomycin group and in 73 (92%) of 79 patients in the placebo group (P=.52). The distributions of the time to defervescence were not statistically significant between the 2 groups (estimated hazard ratio, 1.03; 95% confidence interval, 0.75-1.43; P=.75). The number of additional episodes of gram-positive bacteremia and the percentage of patients for whom amphotericin B was empirically added to their therapy regimen were also similar in both groups. This study failed to demonstrate that the empirical addition of vancomycin therapy to the treatment regimen is of benefit to persistently febrile neutropenic patients with cancer.", "Glycopeptide antibiotics are used extensively in the empirical treatment of febrile patients with neutropenia. To come to a more rational and restricted application of these expensive drugs and to reduce the risk of emergence of resistance, we carried out a prospective, double-blinded, placebo-controlled single-centre study to investigate whether the addition of teicoplanin improved the outcome of neutropenic patients who remained febrile after 72-96 h of imipenem monotherapy. Patients with known infections caused by imipenem-resistant microorganisms were excluded. From the 114 evaluable episodes (out of a total of 125) in 105 patients who met the eligibility criteria, 56 episodes were randomized to receive teicoplanin and 58 to placebo. At 72 h after the start of the assigned intervention, 52 (45.6%) of the patients were afebrile; at the end of the aplastic phase, 10 (8.8%) had succumbed. There was no difference between the two study arms. When febrile episodes were subdivided between microbiologically documented infections, clinically documented infections and fevers of unknown origin, again no significant differences were observed. With the exception of methicillin-resistant bacteria, Gram-positive infections seemed to respond well to imipenem monotherapy. It is concluded that the addition of teicoplanin on empirical grounds, i.e. for persistent fever only, is not necessary and that the use of glycopeptides should be restricted to well-defined clinical situations where methicillin-resistant bacteria are involved. Furthermore, it seems that many neutropenic patients respond slowly over more than 72-96 h even when they are treated with antibacterial drugs such as imipenem that are effective against the causative microorganism.", "In a prospective randomized study, 120 febrile, granulocytopenic patients received as initial therapy ceftazidime with or without teicoplanin. At the onset of fever, patients had no obvious infectious focus. For 103 assessable episodes, initial bacteremias were detected in 18 of 51 patients (35%) given ceftazidime and 20 of 52 patients (38%) given the combination; 13 and 17 bacteremias caused by gram-positive bacteria occurred in these groups, respectively. There was no difference in terms of the final response (25 of 51 patients [49%] treated with ceftazidime alone versus 33 of 52 patients [63%] given the combination), and the morbidity was comparable for both treatment groups. The duration of fever and of total antibiotic therapy were similar in both groups. Initial therapy was modified in 26 patients (51%) treated with ceftazidime, with 20 surviving the infection, and in 19 patients (37%) treated with the combination, with 15 surviving. Persistent fever was the main reason for changing treatment, and no patient died of a gram-positive infection. Subsequent infective events occurred in 16 patients (31%) given ceftazidime and in 25 patients (48%) given the combination. Lung infiltrates developed in 12 and 13 patients, respectively, but more new infections occurred in the combination group. Allergic skin reactions were also more frequent in this group. Thus, while teicoplanin provides simple, reliable, and safe treatment of patients with presumed gram-positive infections, it is not useful when given empirically to this patient population, and treatment may result in more infective complications and adverse events.", "The increasing prevalence of bacteremia caused by gram-positive bacteria in granulocytopenic acute leukemia patients prompted us to evaluate, in a prospective randomized trial, the role of teicoplanin, a new glycopeptide antibiotic, when it was added to amikacin plus ceftazidime, as an empiric therapy of fever in these patients. Of 47 evaluable episodes, 22 were treated with the teicoplanin regimen and 25 were treated with the combination of amikacin and ceftazidime. The overall response to therapy of patients treated with teicoplanin was slightly better (82% improvement) than that obtained with amikacin plus ceftazidime (52%). The response rate of patients with gram-positive bacteremias was 80% (4 of 5) to the regimen that included teicoplanin; 25% (1 of 4) of the patients treated with amikacin plus ceftazidime responded to treatment; and for patients with gram-negative bacteremias, the response rates were, respectively, 100% (4 of 4) and 70% (7 of 10). The better results obtained with amikacin-ceftazidime-teicoplanin treatment were most evident in patients with profound (less than 100/mm3) and persistent neutropenia (83 versus 30% improvement). Furthermore, a good response rate of patients with gram-positive bacteremias (seven of eight; 87% improvement) was achieved in a small group of bone marrow transplant patients who were all treated with amikacin-ceftazidime-teicoplanin. No severe side effects were documented in any patient. Teicoplanin, as a drug administered as a single daily dose, seems to be a safe and useful anti-gram-positive agent when used in combination with amikacin-ceftazidime as an empiric therapy of febrile episodes in granulocytopenic acute leukemia patients.", "Because gram-positive infections cause morbidity following intensive antileukemic chemotherapy, the effects of vancomycin versus placebo were evaluated in a randomized, double-blind, placebo-controlled trial in 60 adult patients with acute leukemia and first infectious fever during prolonged (mean of 32 days) granulocytopenia. Gram-positive sepsis was associated with first fever in 17 (28 percent) of the 60 patients. None of 31 patients randomly assigned to receive vancomycin demonstrated gram-positive infection, whereas 16 of 22 patients randomly assigned to receive placebo subsequently had gram-positive infection (seven had sepsis, and nine had local infections; p less than 0.005). All patients with gram-positive infection were then given vancomycin, and all showed prompt clinical responses. The predominant gram-positive organism causing infection was beta-lactam-resistant Staphylococcus epidermis (19 of 44 isolates). Patients randomly assigned to receive vancomycin had more rapid resolution of first infectious fever and fewer total febrile days during the granulocytopenic course than did patients randomly assigned to receive placebo. Although vancomycin had no effect on the presence or absence of documented fungal infection, patients treated with vancomycin received empiric amphotericin B for recurrent or persistent fever later (mean of 14 days after initial antibiotic coverage was begun) than did patients receiving placebo (mean of 9.9 days; p less than 0.005), and thus received fewer total days of empiric amphotericin B therapy (mean of 16.3 days) than did patients given placebo (mean of 24.6 days; p less than 0.01). These data demonstrate that empiric use of vancomycin reduces the morbidity of gram-positive infections following intensive antileukemic therapy and decreases the need for empiric use of toxic amphotericin B.", "Two hundred twenty-five patients with 358 febrile episodes were treated with tobramycin and ticarcillin (TT), tobramycin and mezlocillin (TM), or tobramycin, ticarcillin and cephalothin (TTC). There were no statistically significant differences in the response rates for patients who were proven to have infection (67% with TT, 69% with TTC and 53% with TM). Patients were more often cured of their infection if their neutrophil count rose during therapy. In this study, the addition of cephalothin to TT did not increase the frequency of azotemia (10% and 12%, respectively). Although mezlocillin has a broader spectrum of activity in vitro than ticarcillin, it was not more efficacious when combined with tobramycin than ticarcillin plus tobramycin for the treatment of infections in neutropenic patients." ]

[ "2201941", "10216323", "8135557", "3510384", "2882288", "766619", "9375539", "3053605", "2188543", "7899118", "7846337", "8414819" ]

[ "Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial.", "Rapid improvement of peak flow in asthmatic patients treated with parenteral methylprednisolone in the emergency department: A randomized controlled study.", "Prednisolone and salbutamol in the hospital treatment of acute asthma.", "A controlled trial of methylprednisolone in the emergency treatment of acute asthma.", "Effect of a single oral dose of prednisolone in acute childhood asthma.", "A controlled study of the effects of single doses of hydrocortisone on the resolution of acute attacks of asthma.", "Early parenteral corticosteroid administration in acute asthma.", "High-dose methylprednisolone as initial therapy in patients with acute bronchospasm.", "Early administration of corticosteroids in emergency room treatment of acute asthma.", "A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children.", "Early administration of hydrocortisone in the emergency room treatment of acute asthma: a controlled clinical trial.", "Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma." ]

[ "A controlled double-blind trial was carried out to assess the effect of the early introduction of combined corticosteroid and beta-adrenergic drugs for the treatment of acute asthma in infants and toddlers. Seventy-four emergency room patients (aged 7 to 54 months) who were treated for acute asthma were studied. Treatment included, in addition to salbutamol inhalations, a single dose of intramuscular methylprednisolone (4 mg/kg) or normal saline as placebo. The patients were reevaluated 3 hours after initiation of treatment. At that time, patients were either admitted or discharged based on a clinical decision. Only 8 (20%) of 39 patients treated with steroids were admitted, compared with 15 (43%) of 35 in the placebo group (P less than .05). Sequential analysis of 33 pairs, matched by age and severity of symptoms, revealed statistically significant reduced admission rates in patients treated with steroids. In the younger patients (6 to 24 months), admission rate was significantly lower for those treated with steroids (18%) as compared with those treated without steroids (50%) (P less than .05). In the older group (24 to 54 months), the trend was similar but not statistically significant: 23% vs 31% in the steroid and placebo groups, respectively. These data indicate that corticosteroid treatment combined with an adrenergic agent, given early during an acute asthmatic episode, significantly reduces the hospital admission rate of infants and toddlers.", "Corticosteroids are thought to exert their physiologic effects in asthma over the course of several hours. In this study we tested the hypothesis that intravenous methylprednisolone improves airflow in a shorter time frame (2 hours) in adults with acute asthma.\n In a randomized, double-blind, placebo-controlled trial, 56 adult asthmatic patients with peak expiratory flow rates (PEFRs) less than 50% predicted after an initial albuterol aerosol treatment were studied. These patients were randomly assigned to treatment with either 125 mg of intravenous methylprednisolone or an equivalent volume of normal saline solution (placebo). Patients were also treated with identical schedules of nebulized ipratropium and albuterol. Patients were recruited from an emergency department at an urban academic medical center. The primary endpoints were changes in PEFR and in percent predicted PEFR over time. PEFRs were assessed at baseline and at 1 and 2 hours. Heart rate changes over time and the proportion of admissions in the 2 groups were also compared.\n The increases in PEFR and percent predicted PEFR over time were both significantly greater in the methylprednisolone treatment group (P =. 002 and P =.005, respectively). The increases in geometric mean peak flow at 60 and 120 minutes were 79 and 96 L/min for the methylprednisolone group and 54 and 68 L/min for the placebo group. There was also a significantly different change in heart rates with time between the methylprednisolone and placebo groups (P =.029), with the placebo group showing a moderate increase in heart rate over time. Although the proportion of patients admitted for status asthmaticus was less in the methylprednisolone treatment group (8/30) compared with the placebo group (10/26), this difference in proportions (-.118, 95% confidence interval -.363 to.127) was not significant.\n These data suggest that use of corticosteroids should be considered relatively early in the treatment of patients with acute asthma in whom initial bronchodilator therapy fails to produce an adequate response.", "The use of oral prednisolone (2 mg/kg) to treat children admitted to hospital with acute asthma was assessed in a placebo controlled study. Children were further randomised to receive either 0.15 mg/kg salbutamol every 30 minutes for the first three hours of admission, or 5 mg salbutamol every one to four hours as needed. Treatment was double blind and the assessor was unaware of the nebuliser regimen given. Children were examined before and after treatment with salbutamol on arrival and reassessed four hours after admission. Seventy children completed the study. Seventeen (46%) of 37 children receiving prednisolone and six (9%) of 33 receiving placebo were fit for discharge after four hours of treatment. There was no significant difference between the two nebuliser regimens. Clinical parameters indicative of asthma severity were improved in all groups. Between group comparisons at reassessment showed higher peak flows in those receiving prednisolone and nebulisers every 30 minutes but differences were not significant for other parameters. Objective parameters indicating steroid efficacy over placebo were minimal. Despite this, those receiving prednisolone were more readily identifiable as being fit for discharge within four hours of treatment.", "Ninety-seven acutely ill patients with bronchial asthma were enrolled in a double-blind, placebo-controlled, randomized trial of intravenous methylprednisolone (125 mg), given on presentation in the emergency room in addition to standard emergency treatments for asthma. Subjective and spirometric indexes of the severity of the asthma were similar on entry into the study in all patients, but only 9 of 48 patients (19 percent) treated with methylprednisolone required hospital admission, as compared with 23 of 49 patients (47 percent) in the control group (P less than 0.003). Our results suggest that prompt use of glucocorticoids in the emergency treatment of severe asthma can prevent significant morbidity, reduce the number of hospitalizations, and effect substantial savings in health care costs.", "140 children of 184 with acute asthma entered a randomised double-blind trial of oral prednisolone (n = 67) compared with placebo (n = 73) administered soon after admission. The dose of prednisolone was 30 mg in children under 5, otherwise 60 mg. All children also received salbutamol. All had moderate or severe dyspnoea. Initial evaluation was similar for both groups. On reassessment after a few hours 20 children in the prednisolone group were fit for discharge compared with only 2 in the placebo group. There were no early reattendances. Children remaining in hospital had a shorter median duration of stay and were less likely to require further steroid therapy if they had initially received prednisolone. In acute asthma the prompt use of a single dose of oral prednisolone can reduce morbidity and the need for hospital care.", "To evaluate the effects of corticosteroids on the resolution of acute attacks of asthma, 38 young, acutely ill, asthmatic subjects were given a single intravenous injection of either 0.25, 0.50 or 1.0 g of hydrocortisone hemisuccinate or a placebo (sterile saline solution) in a random, double blind manner. Each was then treated with isoproterenol, at hourly intervals, for a minimum of six hours, and the serial changes in plethysmography, spirometry, lung volumes, subjective complaints and physical findings that occurred as the patients improved were observed. No statistical differences were found in any of the physiologic or clinical variables between those patients given any dose of steroids and their matched controls. From this it has been concluded that hydrocortisone, in the doses and route of administration employed, does not produce any immediate benefits in the treatment of acute asthma.", "To test the hypothesis that early parenteral corticosteroid administration may be associated with a rapid improvement in airflow obstruction in adult asthmatic patients, a randomized, double-blind placebo-controlled study was carried out. Forty-five adult asthmatic patients, with initial peak expiratory flow rates (PEFRs) of < 200 L/sec received an intravenous bolus of either 125 mg methylprednisolone (MP) or normal saline before any other emergency department treatments. This was immediately followed by 3 aerosol treatments of 2.5 mg of albuterol separated by 20-minute intervals. PEFRs and heart rates were measured over a 1-hour time frame. There was not a significantly higher rate of increase of PEFR in the MP group compared with the saline group. Similarly, the rate of increase in percent PEFR showed a trend to being higher in the saline group (P = .061). There was no significant difference in the proportion of hospitalizations and side effects between the two groups. Adjustment for other variables did not result in a model showing an enhanced PEFR improvement with MP treatment. This study does not support the concept that corticosteroid treatment effects are beneficial within the first hour after administration. Further studies of rapid-acting modalities to enhance bronchodilation are needed in treating acute asthmatics.", "The use of steroids in treating acute respiratory obstruction is still controversial. In this double-blind controlled trial, we decided to examine the beneficial effects of a single large dose of methylprednisolone (MSSP), using objective criteria. In the emergency setting, methylprednisolone (30 mg/kg) has been shown to decrease the need for hospital admission in patients with acute bronchospasm. No difference in this improvement was seen among patients in the steroid-dependent or non-steroid-dependent populations. Based on our findings, we suggest that the early use of single-dose steroid therapy is appropriate treatment for patients with acute bronchospastic attacks.", "To determine the effect of early administration of high-dose intravenous corticosteroids on duration of emergency room treatment and hospital admission rate in patients with acute asthma.\n Randomized, double-blind, placebo-controlled trial.\n The emergency room of a large, urban hospital with primary and referral care responsibilities.\n Eighty-one patients from 18 to 45 years of age with acute bronchial asthma and without pneumonitis or other serious underlying illnesses were studied on 91 occasions and were randomly assigned to control or experimental groups.\n The steroid group received 125 mg of intravenous methylprednisolone whereas the control group received intravenous normal saline 30 minutes after initial treatment. Additional treatment included aerosolized metaproterenol and oral theophylline therapy. Six hours after study entry, remaining patients were treated with 40 mg of intravenous methylprednisolone. Hospitalization was mandatory if total treatment time was greater than 12 hours.\n Age, sex, peak expiratory flow at entry, and prevalence of recent corticosteroids use were similar in both groups. Duration of emergency room treatment was 6.7 +/- 4.2 (SD) hours in the steroid group and 6.3 +/- 4.1 hours in the control group (P = 0.66). Hospitalization was necessary in 18% (95% CI, 7% to 30%) of the steroid group and in 13% (CI, 3% to 22%) of the control group. Frequency of return visits for acute asthma 2 days after emergency room discharge was 11% (CI, -1% to 22%) in the steroid group and 13% (CI, 2% to 23%) in the control group.\n These results fail to show any benefit for early administration of corticosteroids in patients with acute asthma. Routine administration of corticosteroids on initial presentation in such patients may not be warranted.", "Asthma continues to be a leading cause for pediatric hospitalizations. A study using high-dose intravenous (i.v.) steroids early in the emergency department (ED) care of adults with acute asthma reported a 60% reduction in hospitalization rate. Limited data are available for children. We hypothesized that the addition of early administration of high-dose methylprednisolone (MP) in routine ED care of asthmatic children would reduce the need for hospitalization by 50%. Eighty-eight children with asthma, aged four to 18 years, were enrolled into a prospective, randomized, double-blind, placebo-controlled study of MP given within 45 (mean 23) minutes of arrival to the ED. After initial evaluation, children received either 2 mg/kg of MP IV or an equivalent amount of placebo (P). Patients then received the usual ED management of their acute exacerbation. Groups were similar in age, sex, and severity of illness (by asthma scoring, respiratory rate, and peak flow). ED treatment (number of aerosols and the use of theophylline) was similar for both groups. The mean time to disposition was 2.9 hours. Sixty-four percent of the children were discharged from the ED. No significant differences were found between the admission rates of the MP and P groups (41% MP vs 33% P, P = 0.44, chi 2, 95% CI for decrease in MP vs P groups -28 to +12%). The average hospital stay was shorter for those children treated with MP (79 hours vs 90 hours). We conclude that IV methylprednisolone given as an adjunct to routine ED care of children with acute asthma is unlikely to markedly reduce hospitalization rates.", "To determine whether early administration of a single dose of intravenous hydrocortisone (500 mg) modified the need for hospitalization and duration of treatment, and improve pulmonary function assessed by subjective and objective criteria of acute asthma patients.\n Randomized, double-blind, placebo-controlled trial.\n The emergency room (ER) of a large, urban hospital with primary and referral care responsibilities.\n Ninety-eight patients from 18 to 50 years of age with acute bronchial asthma, with a PEFR and FEV1 in the first second below 50% of predicted value (FEV1 mean % of predicted = 27.8 +/- 10.0) and without history of chronic cough or other medical disease.\n The corticosteroid group received 500 mg of intravenous hydrocortisone whereas the control group received intravenous normal saline immediately after arrival to the ER. Additional treatment included salbutamol delivered with metered-dose inhaler into a spacer device (Volumatic), in four puffs actuated in rapid succession (100 micrograms per actuation), at 10-min intervals. The final mean dose was 5.7 mg for the steroid group and 5.6 mg for the control one (P = 0.86). Hospitalization was mandatory if total treatment time was greater than 6 h.\n Age, sex, PEFR, FEV1, FVC, symptom index, and corticosteroids use were similar in both groups. FEV1 expressed as mean % of predicted was 54.6 +/- 17.3% in the control group and 54.6 +/- 17.4% in the steroid group (P = 0.75). Duration of ER treatment was 2.22 +/- 1.75 h in the corticosteroid group and 2.24 +/- 1.70 h in the control group (P = 0.81). The hospital admission rate was 10.2% for the corticosteroid group and 8.16% for the control group. There were no differences between the groups when patients admitted or discharged were examined separately.\n Early administration of corticosteroids does not modify outcome of ER treatment of asthma, and does not improve pulmonary function in the first 6 h of treatment. In accord with this, administration of corticosteroids to these patients could be delayed by several hours without modifying clinical outcome. When an aggressive beta-agonist bronchodilator regimen is used, it obviates the need for steroids in this early stage of treatment.", "Recent studies have shown that the use of parenteral corticosteroids in the emergency department decreases the hospitalization rate for patients with acute asthma. We studied the efficacy of oral corticosteroids in the emergency department treatment of moderately ill children with acute asthma.\n Emergency department patients aged 1 through 17 years whose chief complaint was acute asthma were assigned a pulmonary index, based on clinical evaluation. Those with a moderate exacerbation (pulmonary index = 9 through 13) received either 2 mg/kg of oral prednisone or placebo in a randomized, double-blind fashion. Patients in each group were then treated with an identical regimen of frequent aerosolized albuterol, for up to a maximum of 4 hours.\n Seventy-five patients were assessed. Overall, 11 (31%) of 36 in the prednisone group required hospitalization compared with 19 (49%) of 39 in the placebo group (P = .10). Among the sickest patients (initial pulmonary index > 10), 7 (32%) of 22 prednisone-treated patients required hospitalization compared with 13 (72%) of 18 placebo-treated patients (P < .05). Among patients who had a suboptimal response to initial beta 2-agonist therapy and who therefore would have been hospitalized had treatment been restricted to 2 hours, 9 (45%) of 20 in the prednisone group ultimately required hospitalization when duration of care was extended 2 additional hours compared with 15 (83%) of 18 in the placebo group (P < .05). In addition, prednisone-treated patients had a significantly greater improvement in median pulmonary index (5.0 vs 3.0, P < .001).\n These data demonstrate that oral prednisone, within 4 hours of its administration, reduced the need for hospitalization among a subset of children treated in the emergency department for acute asthma." ]

[ "16256917", "11344395", "8051642", "20693796", "2293938", "12463081", "16131892", "19626807", "3904673", "19651954", "6177735" ]

[ "Paint-only is equivalent to scrub-and-paint in preoperative preparation of abdominal surgery sites.", "Prospective randomized comparison of two preoperative skin preparation techniques in a developing world country.", "Effect of pre-operative skin preparation on post-operative wound infection.", "Minimizing wound contamination in a 'clean' surgery: comparison of chlorhexidine-ethanol and povidone-iodine.", "Comparison of a one-step iodophor skin preparation versus traditional preparation in total joint surgery.", "Preoperative skin preparation of cardiac patients.", "Chlorhexidine provides superior skin decontamination in foot and ankle surgery: a prospective randomized study.", "Comparison of surgical wound infection after preoperative skin preparation with 4% chlorhexidine [correction of chlohexidine] and povidone iodine: a prospective randomized trial.", "Development of a safe and effective one-minute preoperative skin preparation.", "Efficacy of surgical preparation solutions in shoulder surgery.", "A comparison of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative wound infection." ]

[ "Antiseptic preoperative skin site preparation is used to prepare the operative site before making a surgical incision. The goal of this preparation is a reduction in postoperative wound infection. The most straightforward technique necessary to achieve this goal remains controversial.\n A prospective randomized trial was designed to prove equivalency for two commonly used techniques of surgical skin site preparation. Two hundred thirty-four patients undergoing nonlaparoscopic abdominal operations were consented for the trial. Exclusion criteria included presence of active infection at the time of operation, neutropenia, history of skin reaction to iodine, or anticipated insertion of prosthetic material at the time of operation. Patients were randomized to receive either a vigorous 5-minute scrub with povidone-iodine soap, followed by absorption with a sterile towel, and a paint with aqueous povidone-iodine or surgical site preparation with a povidone-iodine paint only. The primary end point of the study was wound infection rate at 30 days, defined as presence of clinical signs of infection requiring therapeutic intervention.\n Patients randomized to the scrub-and-paint arm (n = 115) and the paint-only arm (n = 119) matched at baseline with respect to age, comorbidity, wound classification, mean operative time, placement of drains, prophylactic antibiotic use, and surgical procedure (all p > 0.09). Wound infection occurred in 12 (10%) scrub-and-paint patients, and 12 (10%) paint-only patients. Based on our predefined equivalency parameters, we conclude equivalence of infection rates between the two preparations.\n Preoperative preparation of the abdomen with a scrub with povidone-iodine soap followed by a paint with aqueous povidone-iodine can be abandoned in favor of a paint with aqueous povidone-iodine alone. This change will result in reductions in operative times and costs.", "Povidone-iodine (PI) is a scarce and expensive item for some hospitals in developing countries. This prospective, randomized study was performed at Baptist Medical Centre (BMCO) in Ogbomoso, Nigeria to determine if the use of PI for preoperative skin preparation would result in a lower postoperative wound infection rate and to identify other factors influencing the infection rate. Two hundred patients undergoing inguinal hernia repair were randomized to receive skin preparation with either: (1) locally available, inexpensive market soap and methylated spirit or (2) imported PI. The two groups were equally stratified. The overall postoperative wound infection rate was 5.5%, and there was no significant difference between the groups (5.1% vs. 5.9%). Factors that did not affect the infection rate included gender, age, type of anesthesia, type or duration of the operative procedure, and number of breaks in optimal technique. There were eight abscesses and three cases of cellulitis without suppuration diagnosed an average of 10 days postoperatively. Staphylococcus was the only bacterium identified on Gram stain or culture. The expense of procuring PI is not justified at BMCO. Available funds may better be used for preoperative antibiotics or for improvement in hospital infrastructure, which should result in fewer breaks in optimal operating room technique.", "A prospective randomised trial was carried out to compare the efficacy of method of scrubbing the operative site for ten minutes with an antiseptic (GpA; n = 68) with a simplified method where the antiseptic was merely painted onto the operation site (GpB; n = 67). The median age, sex distribution and the types of procedures done in each group were similar as was the antibiotic policy. There were a total of 11 patients who got infected, 6 in the group A and 5 in the group B. No significant difference could be demonstrated in the infection rates between the two groups. It is concluded that the old method of prolonged scrubbing the operation site can safely be omitted to a more simplified version.", "There is limited work analyzing the efficacy of different antiseptics in reducing wound contamination by the skin flora during hernia repair and its influence on the incidence of wound infection, which continues to be a major problem in the developing world. This study was designed to test if chlorhexidine-ethanol has superior antimicrobial efficacy compared with povidone-iodine.\n In a prospective randomized trial, the efficacy of chlorhexidine-ethanol and povidone-iodine in the reduction of colony counts of the skin flora and the incidence of surgical site infection was compared.\n Both povidone-iodine and chlorhexidine-ethanol produced significant reduction in the skin bacterial colony counts, from 18.66 x 10(2) to 2.34 x 10(2) colony-forming units with povidone-iodine (59%) and from 12.34 x 10(2) to 0.93 x 10(2) colony-forming units (82%) with chlorhexidine-ethanol. Infection rates with the use of povidone-iodine and chlorhexidine-ethanol groups were not significantly different (9.5 vs. 7.0; p = 0.364). The reduction in colony counts in those who developed infection was only 15.6% compared with 77.1% in those who did not develop infection.\n The antibacterial efficacy of chlorhexidine-ethanol and povidone-iodine is comparable in open hernia repair.\n Copyright © 2010 S. Karger AG, Basel.", "The purpose of this study was to compare a traditional two-step method of preoperative skin preparation using aqueous iodophors with a one-step method using an iodophor-in-alcohol solution. Sixty patients having clean total joint surgery were randomly divided into two preoperative skin preparation groups (30 in each). In one group, the skin was prepared with a traditional five-minute aqueous iodophor scrub followed by the application of an aqueous iodophor solution as a paint. In the other group, the skin was prepared with a one-step application of a water-insoluble iodophor-in-alcohol solution applied as a paint. Bacterial colony counts were made by sampling the incision area with culture plates before skin preparation and just prior to wound closure. The one-step application of a water-insoluble iodophor-in-alcohol solution was equally as effective as the traditional scrub-and-paint preparation in reducing the number of bacteria about the operative site. The water-insoluble preparation also resulted in significantly improved drape adhesion as compared to the standard scrub-and-paint procedure. The one-step water-insoluble iodophor-in-alcohol solution fulfills the requirements for an operative site skin preparation and significantly improves drape adhesion. It is more convenient, easier to apply, less time consuming, and potentially less expensive than the traditional scrub-and-paint method.", "Nurses at a large southwestern hospital undertook an initiative to optimize the preoperative skin preparation of patients undergoing open heart surgery. After an extensive review of the literature, a proposal was submitted to and accepted by the surgeons and internal review board of the hospital. High-risk patients were identified before surgery and randomized into groups to receive one of four different skin preps. The incidence of infection was lower in the two groups of patients who were prepped with insoluble iodine, indicating that the type of surgical skin prep could affect whether patients develop surgical site infections. The clinical practice of skin preparation in this hospital changed based on the results.", "Feet are prone to bacterial contamination. We hypothesized that chlorhexidine scrub and isopropyl alcohol paint provide superior local flora reduction than povidone-iodine scrub and paint. Patients with intact, uninfected skin having clean elective foot and ankle surgery were prospectively enrolled and randomly assigned to skin preparation with povidone-iodine (Group 1) or chlorhexidine scrub and isopropyl alcohol paint (Group 2). Culture swabs (aerobic, anaerobic, acid fast, fungus, and routine antibiotic sensitivity) were taken from all web spaces, nail folds, toe surfaces, and proposed surgical incision sites. One-hundred twenty-seven patients were enrolled (mean age, 46 years; range, 16-85 years). Sixty-seven patients were assigned to Group 1; 60 patients were assigned to Group 2. In Group 1, 53 of 67 patients (79%) had positive cultures; in Group 2, 23 of 60 patients (38%) had positive cultures. These data indicate that chlorhexidine and alcohol provide better reduction in bacterial carriage than povidone-iodine. Based on these data, we recommended chlorhexidine as the surgical preparatory agent for the foot and ankle.\n Therapeutic study, Level I-1a (significant difference). See the Guidelines for Authors for a complete description of levels of evidence.", "Antiseptic scrub and paint can reduce bacterial colonization and postoperative wound infection. Two forms of antiseptics, povidone iodine and chlorhexidine, are commonly used in the operating theater.\n To study the efficacy of the reduction of bacterial colonization and surgical wound infection among these antiseptic.\n Five hundred surgical patients were randomly divided into two groups. Povidone Iodine and Chlorhexidine were used for skin preparation in group 1 and 2 respectively Bacterial colonization and postoperative wound infection were examined after skin preparation. Demographic data was analyzed by student's t test; the culture result and surgical wound infection were analyzed by Mantel-Haenszel method for relative risk and 95% CI.\n There was a significant reduction of bacterial colonization and wound infection after skin preparation in group 2 compared with group 1.\n Colonization of bacterial and postoperative surgical wound infection were significantly reduced in the chlorhexidine group. Chlorhexidine antiseptic should be the first consideration for preoperative skin preparation.", "Three consecutive controlled randomized clinical trials utilizing 1,324 patients were conducted to study the efficacy of incise drapes to prevent wound infections. When a polyester antimicrobial incise drape (loban 2 Antimicrobial Film) was applied to an operative area after a one-minute skin preparation using either 70% alcohol or 2% iodine in 90% alcohol, the clean wound infection rate (1.3%) and overall wound infection rate (2.5%) were comparable to those following a standard ten-minute skin preparation with Betadine (1.3% and 2.3%, respectively). During preliminary studies, it was demonstrated that separation of polyethylene antimicrobial incise drapes from the skin during operation was associated with a sixfold increase in infection rate when compared with operations in which the incise drape did not lift. Design of the drape and technique of application are important considerations in preventing lift from the skin.", "Deep infection following shoulder surgery is a rare but devastating problem. The use of an effective skin-preparation solution may be an important step in preventing infection. The purposes of the present study were to examine the native bacteria around the shoulder and to determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.\n A prospective study was undertaken to evaluate 150 consecutive patients undergoing shoulder surgery at one institution. Each shoulder was prepared with one of three randomly selected solutions: ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol), DuraPrep (0.7% iodophor and 74% isopropyl alcohol), or povidone-iodine scrub and paint (0.75% iodine scrub and 1.0% iodine paint). Aerobic and anaerobic cultures were obtained prior to skin preparation for the first twenty patients, to determine the native bacteria around the shoulder, and following skin preparation for all patients.\n Coagulase-negative Staphylococcus and Propionibacterium acnes were the most commonly isolated organisms prior to skin preparation. The overall rate of positive cultures was 31% in the povidone-iodine group, 19% in the DuraPrep group, and 7% in the ChloraPrep group. The positive culture rate for the ChloraPrep group was lower than that for the povidone-iodine group (p < 0.0001) and the DuraPrep group (p = 0.01). ChloraPrep and DuraPrep were more effective than povidone-iodine in eliminating coagulase-negative Staphylococcus from the shoulder region (p < 0.001 for both). No significant difference was detected among the agents in their ability to eliminate Propionibacterium acnes from the shoulder region. No infections occurred in any of the patients treated in this study at a minimum of ten months of follow-up.\n ChloraPrep is more effective than DuraPrep and povidone-iodine at eliminating overall bacteria from the shoulder region. Both ChloraPrep and DuraPrep are more effective than povidone-iodine at eliminating coagulase-negative Staphylococcus from the shoulder.", "nan" ]

[ "12637459", "11251000", "12439707", "10615229", "10561297", "10673513", "10561296", "12586793", "11986765", "12118025", "10334526" ]

[ "Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial.", "Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial.", "Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure.", "Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group.", "Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer.", "Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over.", "Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.", "Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193).", "Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines.", "Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial.", "Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group." ]

[ "This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC).\n Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m(2) plus docetaxel 75 mg/m(2) (n = 214) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (n = 215) on day 1, every 3 weeks for up to eight cycles.\n Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank P =.014; median TTF, 25.6 v 23.7 weeks; log-rank P =.048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P =.009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v 41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P =.01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%).\n AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.", "This phase III trial compared the efficacy and safety of doxorubicin and paclitaxel (AT) to 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) as first-line therapy for women with metastatic breast cancer.\n A total of 267 women with metastatic breast cancer were randomized to receive either AT (doxorubicin 50 mg/m(2) followed 24 hours later by paclitaxel 220 mg/m(2)) or FAC (5-fluorouracil 500 mg/m(2), doxorubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2)), each administered every 3 weeks for up to eight cycles. Patients had to have measurable disease and an Eastern Cooperative Oncology Group performance status of 0 to 2. Only one prior non-anthracycline, nontaxane-containing adjuvant chemotherapy regimen was allowed.\n Overall response rates for patients randomized to AT and FAC were 68% and 55%, respectively (P =.032). Median time to progression and overall survival were significantly longer for AT compared with FAC (time to progression 8.3 months v 6.2 months [P =.034]; overall survival 23.3 months v 18.3 months [P =.013]). Therapy was generally well-tolerated (median of eight cycles delivered in each arm). Grade 3 or 4 neutropenia was more common with AT than with FAC (89% v 65%; P <.001); however, the incidence of fever and infection was low. Grade 3 or 4 arthralgia and myalgia, peripheral neuropathy, and diarrhea were more common with AT, whereas nausea and vomiting were more common with FAC. The incidence of cardiotoxicity was low in both arms.\n AT conferred a significant advantage in response rate, time to progression, and overall survival compared with FAC. Treatment was well-tolerated with no unexpected toxicities.", "This multicentre, randomised phase III study compared docetaxel with 5-fluorouracil+vinorelbine in patients with metastatic breast cancer after failure of neo/adjuvant or one line of palliative anthracycline-based chemotherapy. One hundred and seventy-six metastatic breast cancer patients were randomised to receive docetaxel (100 mg m(-2)) every 3 weeks or 5-fluorouracil+vinorelbine: 5-fluorouracil (750 mg m(-2) per day continuous infusion) D1-5 plus vinorelbine (25 mg m(-2)) D1 and D5 of each 3-week cycle. Eighty-six patients received 516 cycles of docetaxel; 90 patients received 476 cycles of 5-fluorouracil+vinorelbine. Median time to progression (6.5 vs 5.1 months) and overall survival (16.0 vs 15.0 months) did not differ significantly between the docetaxel and 5-fluorouracil+vinorelbine arms, respectively. Six (7%) complete responses and 31 (36%) partial responses occurred with docetaxel (overall response rate 43%, 95% confidence interval: 32-53%), while 4 (4.4%) complete responses and 31 (34.4%) partial responses occurred with 5-fluorouracil+vinorelbine (overall response rate 38.8%, 95% confidence interval: 29-49%). Main grade 3-4 toxicities were (docetaxel vs 5-fluorouracil+vinorelbine): neutropenia 82% vs 67%; stomatitis 5% vs 40%; febrile neutropenia 13% vs 22%; and infection 2% vs 7%. There was one possible treatment-related death in the docetaxel arm and five with 5-fluorouracil+vinorelbine. In anthracycline-pretreated metastatic breast cancer patients, docetaxel showed comparable efficacy to 5-fluorouracil+vinorelbine, but was less toxic.", "The aim of this study was to compare the efficacy and tolerability of docetaxel to methotrexate and 5-fluorouracil in advanced breast cancer after anthracycline failure. A randomised multicentre trial was conducted in 283 patients with advanced breast cancer who had failed previous anthracycline treatment. Docetaxel at a dose of 100 mg/m2 every 3 weeks (n = 143) was compared with sequential methotrexate and 5-fluorouracil (MF; n = 139) given at day 1 and 8 every 3 weeks at dosages of 200 mg/ m2 and 600 mg/m2, respectively. After progression, crossover to the alternative treatment group was recommended. There was a significantly higher overall response rate in the docetaxel 42% (CR 8% + PR 34%) than in the MF arm 21% (CR 3% + PR 18%) (P < 0.001). The median time to progression (TTP) was 6.3 months in the docetaxel arm and 3.0 months in the MF arm (P < 0.001). Docetaxel also had a significantly higher response rate of 27% following crossover compared with MF (12%). Significantly more side-effects (leucopenia, infections, neuropathy, oedema, asthenia, skin, nail changes, alopecia) were seen in the docetaxel than in the MF group. However, grade 3 and 4 side-effects were infrequent with both drugs, with the exception of fatigue, alopecia and infections. Median overall survival (OS) including crossover phase was 10.4 months in the docetaxel and 11.1 months in the MF arm (P = 0.79). Based on the response rate and the primary endpoint of TTP, docetaxel is superior to sequential methotrexate and 5-fluorouracil in advanced breast cancer after anthracycline failure.", "To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer.\n Patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m(2)/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy.\n A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P =.025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P <.001), nausea or vomiting (P =.003), and fever without documented infection (P =.007), and less hospitalization for febrile neutropenia than did CMFP (P =.001). Alopecia, peripheral neuropathy, and myalgia or arthralgia were more severe with paclitaxel (all P <.0001). Overall, quality of life was similar for both treatments (P > = .07).\n Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP.", "To compare the efficacy of paclitaxel versus doxorubicin given as single agents in first-line therapy of advanced breast cancer (primary end point, progression-free survival ¿PFS) and to explore the degree of cross-resistance between the two agents.\n Three hundred thirty-one patients were randomized to receive either paclitaxel 200 mg/m(2), 3-hour infusion every 3 weeks, or doxorubicin 75 mg/m(2), intravenous bolus every 3 weeks. Seven courses were planned unless progression or unacceptable toxicity occurred before the seven courses were finished. Patients who progressed within the seven courses underwent early cross-over to the alternative drug, while a delayed cross-over was optional for the remainder of patients at the time of disease progression.\n Objective response in first-line therapy was significantly better (P =.003) for doxorubicin (response rate ¿RR, 41%) than for paclitaxel (RR, 25%), with doxorubicin achieving a longer median PFS (7.5 months for doxorubicin v 3.9 months for paclitaxel, P <.001). In second-line therapy, cross-over to doxorubicin (91 patients) and to paclitaxel (77 patients) gave response rates of 30% and 16%, respectively. The median survival durations of 18.3 months for doxorubicin and 15.6 months for paclitaxel were not significantly different (P =.38). The doxorubicin arm had greater toxicity, but this was counterbalanced by better symptom control.\n At the dosages and schedules used in the present study, doxorubicin achieves better disease and symptom control than paclitaxel in first-line treatment. Doxorubicin and paclitaxel are not totally cross-resistant, which supports further investigation of these drugs in combination or in sequence, both in advanced disease and in the adjuvant setting.", "This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy.\n Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m(2) or doxorubicin 75 mg/m(2) every 3 weeks for a maximum of seven treatment cycles.\n A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P =.008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel.\n The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.", "Between February 1993 and September 1995, 739 patients with metastatic breast cancer were entered on an Intergroup trial (E1193) comparing doxorubicin (60 mg/m(2)), paclitaxel (175 mg/m(2)/24 h), and the combination of doxorubicin and paclitaxel (AT, 50 mg/m(2) and 150 mg/m(2)/24 h, plus granulocyte colony-stimulating factor 5 mg/kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression.\n Patients were well balanced for on-study characteristics.\n Responses (complete response and partial response) were seen in 36% of doxorubicin, 34% of paclitaxel, and 47% of AT patients (P =.84 for doxorubicin v paclitaxel, P =.007 for v AT, P =.004 for paclitaxel v AT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P =.68 for doxorubicin v paclitaxel, P =.003 for doxorubicin v AT, P =.009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P = not significant). Responses were seen in 20% of patients crossing from doxorubicin --> paclitaxel and 22% of patients crossing from paclitaxel --> doxorubicin (P = not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups.\n (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity; (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy.", "Capecitabine, an oral fluoropyrimidine carbamate, was designed to generate 5-fluorouracil preferentially at the tumour site. This randomised, phase II trial evaluated the efficacy and safety of capecitabine or paclitaxel in patients with anthracycline-pretreated metastatic breast cancer. Outpatients with locally advanced and/or metastatic breast cancer whose disease was unresponsive or resistant to anthracycline therapy were randomised to 3-week cycles of intermittent oral capecitabine (1255 mg m(-2) twice daily, days 1-14, (22 patients)) or a reference arm of i.v. paclitaxel (175 mg m(-2), (20 patients)). Two additional patients were initially randomised to continuous capecitabine 666 mg m(-2) twice daily, but this arm was closed following selection of the intermittent schedule for further development. Overall response rate was 36% (95% CI 17-59%) with capecitabine (including three complete responses) and 26% (95% CI 9-51%) with paclitaxel (no complete responses). Median time to disease progression was similar in the two treatment groups (3.0 months with capecitabine, 3.1 months with paclitaxel), as was overall survival (7.6 and 9.4 months, respectively). Paclitaxel was associated with more alopecia, peripheral neuropathy, myalgia and neutropenia, whereas typical capecitabine-related adverse events were diarrhoea, vomiting and hand-foot syndrome. Twenty-three per cent of capecitabine-treated patients and 16% of paclitaxel-treated patients achieved a > or =10% improvement in Karnofsky Performance Status. Oral capecitabine is active in anthracycline-pretreated advanced/metastatic breast cancer and has a favourable safety profile. Furthermore, capecitabine provides a convenient, patient-orientated therapy.\n Copyright 2002 Cancer Research UK", "To compare the efficacy and tolerability of the combination of doxorubicin and paclitaxel (AT) with a standard doxorubicin and cyclophosphamide (AC) regimen as first-line chemotherapy for metastatic breast cancer.\n Eligible patients were anthracycline-naive and had bidimensionally measurable metastatic breast cancer. Two hundred seventy-five patients were randomly assigned to be treated with AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel 175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. A paclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) dose escalation was planned at cycle 2 if no grade >or= 3 neutropenia occurred in cycle 1. The primary efficacy end point was progression-free survival (PFS). Secondary end points were response rate (RR), safety, overall survival (OS), and quality of life.\n A median number of six cycles were delivered in the two treatment arms. The relative dose-intensity and delivered cumulative dose of doxorubicin were lower in the AT arm. Dose escalation was only possible in 17% and 20% of the AT and AC patients, respectively. Median PFS was 6 months in the two treatments arms. RR was 58% versus 54%, and median OS was 20.6 versus 20.5 months in the AT and AC arms, respectively. The AT regimen was characterized by a higher incidence of febrile neutropenia, 32% versus 9% in the AC arm.\n No differences in the efficacy study end points were observed between the two treatment arms. Treatment-related toxicity compromised doxorubicin-delivered dose-intensity in the paclitaxel-based regimen", "This phase III study compared docetaxel with mitomycin plus vinblastine (MV) in patients with metastatic breast cancer (MBC) progressing despite previous anthracycline-containing chemotherapy.\n Patients (n=392) were randomized to receive either docetaxel 100 mg/m2 intravenously (i.v.) every 3 weeks (n=203) or mitomycin 12 mg/m2 i.v. every 6 weeks plus vinblastine 6 mg/m2 i.v. every 3 weeks (n=189), for a maximum of 10 3-week cycles.\n In an intention-to-treat analysis, docetaxel produced significantly higher response rates than MV overall (30.0% v 11.6%; P < .0001), as well as in patients with visceral involvement (30% v 11%), liver metastases (33% v 7%), or resistance to previous anthracycline agents (30% v 7%). Median time to progression (TTP) and overall survival were significantly longer with docetaxel than MV (19 v 1 weeks, P=.001, and 1 1.4 v 8.7 months, P=.0097, respectively). Neutropenia grade 3/4 was more frequent with docetaxel (93.1 % v62.5%; P < .05); thrombocytopenia grade 3/4 was more frequent with MV (12.0% v 4.1%; P < .05). Severe acute or chronic nonhematologic adverse events were infrequent in both groups. Withdrawal rates because of adverse events (MV, 10.1%; docetaxel, 13.8%) or toxic death (MV, 1.6%; docetaxel, 2.0%) were similar in both groups. Quality-of-life analysis was limited by a number of factors, but results were similar in both groups.\n Docetaxel is significantly superior to MV in terms of response, TTP, and survival. The safety profiles of both therapies are manageable and tolerable. Docetaxel represents a clear treatment option for patients with MBC progressing despite previous anthracycline-containing chemotherapy." ]

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[ "Bupropion for smokers hospitalized with acute cardiovascular disease.", "Telephone booster sessions for optimizing smoking cessation for patients in rehabilitation centers.", "A randomized controlled trial of smoking cessation counseling after myocardial infarction.", "Efficacy of an internet program for smoking cessation during and after inpatient rehabilitation treatment: a quasi-randomized controlled trial.", "Stepped care approach to smoking cessation in patients hospitalized for coronary artery disease.", "The effectiveness of smoking cessation groups offered to hospitalised patients with symptoms of exacerbations of chronic obstructive pulmonary disease (COPD).", "Nurse case-managed tobacco cessation interventions for general hospital patients: results of a randomized clinical trial.", "Predictive value of the transtheoretical model to smoking cessation in hospitalized patients with cardiovascular disease.", "[Efficacy of an intervention in smoking cessation in patients with myocardial infarction].", "A case-management system for coronary risk factor modification after acute myocardial infarction.", "[Efficacy of a smoking relapse prevention program by postdischarge telephone contacts: a randomized trial].", "[A pre assessment for nursing intervention to support tobacco cessation in patients hospitalized for cardiac problems: a pilot study (So-Live)].", "[Smoking cessation among patients with acute heart disease. A randomised intervention project].", "Randomised controlled trial of smoking cessation intervention after admission for coronary heart disease.", "[Effectiveness of telephone aftercare following a smoking cessation program for women on inpatient rehabilitation].", "[Smoking cessation for hospitalized patients: a quasi-experimental study in Quebec].", "The effects of counseling on smoking cessation among patients hospitalized with chronic obstructive pulmonary disease: a randomized clinical trial.", "High rates of sustained smoking cessation in women hospitalized with cardiovascular disease: the Women's Initiative for Nonsmoking (WINS).", "Bupropion for smoking cessation in patients with acute coronary syndrome.", "Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients.", "Smoking cessation after acute myocardial infarction: effects of a nurse-managed intervention.", "Predictors of smoking cessation after coronary artery bypass graft surgery. Results of a randomized trial with 5-year follow-up.", "Interactive voice response telephony to promote smoking cessation in patients with heart disease: a pilot study.", "A randomised controlled trial to evaluate the efficacy of a nurse-provided intervention for hospitalised smokers.", "A smoking-cessation intervention for hospital patients.", "Smoking cessation in hospitalized patients. Results of a randomized trial.", "The TEAM project: the effectiveness of smoking cessation intervention with hospital patients.", "Implementation and effectiveness of a brief smoking-cessation intervention for hospital patients.", "Brief intervention during hospital admission to help patients to give up smoking after myocardial infarction and bypass surgery: randomised controlled trial.", "Transdermal nicotine replacement for hospitalized patients: a randomized clinical trial.", "Smoking cessation and severity of disease: the Coronary Artery Smoking Intervention Study.", "General hospital admission as an opportunity for smoking-cessation strategies: a clinical trial in Brazil.", "Intensive smoking cessation counseling versus minimal counseling among hospitalized smokers treated with transdermal nicotine replacement: a randomized trial.", "Smoking cessation after surgery. A randomized trial.", "Efficacy of a smoking cessation program for hospital patients.", "Randomized controlled trial of two cigarette quit programmes in coronary care patients after acute myocardial infarction.", "Transdermal nicotine plus support in patients attending hospital with smoking-related diseases: a placebo-controlled study.", "Smoking cessation in hospital patients given repeated advice plus nicotine or placebo chewing gum.", "A minimal-contact intervention for cardiac inpatients: long-term effects on smoking cessation.", "Sustained-release bupropion for hospital-based smoking cessation: a randomized trial.", "Tobacco dependence treatment for hospitalized smokers: a randomized, controlled, pilot trial using varenicline.", "Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial.", "Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients." ]

[ "Smoking cessation after myocardial infarction reduces cardiovascular mortality, but many smokers cannot quit despite state-of-the-art counseling intervention. Bupropion is effective for smoking cessation, but its safety and efficacy in hospitalized smokers with acute cardiovascular disease is unknown.\n A five-hospital randomized double-blind placebo-controlled trial assessed the safety and efficacy of 12 weeks of sustained-release bupropion (300 mg) or placebo in 248 smokers admitted for acute cardiovascular disease, primarily myocardial infarction and unstable angina. All subjects had smoking counseling in the hospital and for 12 weeks after discharge. Cotinine-validated 7-day tobacco abstinence, cardiovascular mortality, and new cardiovascular events were assessed at 3 months (end-of-treatment) and 1 year.\n Validated tobacco abstinence rates in bupropion and placebo groups were 37.1% vs 26.8% (OR 1.61, 95% CI, 0.94-2.76; P=.08) at 3 months and 25.0% vs 21.3% (OR, 1.23, 95% CI, 0.68-2.23, P=.49) at 1 year. The adjusted odds ratio, after controlling for cigarettes per day, depression symptoms, prior bupropion use, hypertension, and length of stay, was 1.91 (95% CI, 1.06-3.40, P=.03) at 3 months and 1.51 (95% CI, 0.81-2.83) at 1 year. Bupropion and placebo groups did not differ in cardiovascular mortality at 1 year (0% vs 2%), in blood pressure at follow-up, or in cardiovascular events at end-of-treatment (16% vs 14%, incidence rate ratio [IRR]1.22 (95% CI: 0.64-2.33) or 1 year (26% vs 18%, IRR 1.56, 95% CI 0.91-2.69).\n Bupropion improved short-term but not long-term smoking cessation rates over intensive counseling and appeared to be safe in hospitalized smokers with acute cardiovascular disease.", "Smokers with smoking-related diseases who are hospitalized in rehabilitation centers should be offered smoking cessation. This is the first study evaluating whether telephone booster sessions after intensive inpatient treatment are an effective strategy. The present study was conducted in 13 rehabilitation centers for somatic disorders as a prospective multicenter study with a randomized treatment-control group design. We compared abstinence rates after hospital discharge from treatment that included a group smoking cessation program with (treatment group) and without telephone booster sessions (control group). Data from 290 smokers were analyzed. After 6 and 12 months the treatment group achieved abstinence rates twice as high as those of the control group. Men profited more from telephone booster sessions than did women. Results indicated that telephone booster sessions were highly effective (even) after an inherently intensive group program during a hospital stay. Further research should focus on the special needs of women receiving telephone counseling.", "Smoking cessation after myocardial infarction (MI) has been associated with a 50% reduction in mortality but in-hospital smoking cessation interventions are rarely part of routine clinical practice.\n One hundred cigarette smokers consecutively admitted during 1996 with MI were assigned to minimal care or to a hospital-based smoking cessation program. Intervention consisted of bedside cessation counseling followed by seven telephone calls over the 6 months following discharge. Primary outcomes were abstinence rates measured at 6 months and 1 year post-discharge.\n At follow-up, 43 and 34% of participants in minimal care and 67 and 55% of participants in intervention were abstinent at 6 and 12 months. respectively (P<0.05). Abstinence rates were calculated assuming that participants lost to attrition were smokers at follow-up. Intervention and self-efficacy were independent predictors of smoking status at follow-up. Low self-efficacy combined with no intervention resulted in a 93% relapse rate by 1 year (P<0.01).\n A hospital-based smoking cessation program consisting of inpatient counseling and telephone follow-up substantially increases smoking abstinence 1 year after discharge in patients post-MI. Patients with low self-efficacy are almost certain to relapse without intervention. Such smoking cessation programs should be part of the management of patients with MI.\n Copyright 2000 American Health Foundation and Academic Press.", "To test the feasibility and efficacy of an internet program for smoking cessation during and after inpatient treatment in rehabilitation centers.\n A total of 7574 consecutively admitted inpatients from three German rehabilitation centers were assessed for smoking status. Daily smokers or former daily smokers who regularly used the internet and e-mail were proactively invited for study participation. Out of 749 eligible patients, 477 (64%) participated in the study and were randomly assigned to an intervention or an assessment only control group based on the calendar week of admission. Patients of the intervention group had the possibility to use an internet program for smoking cessation for a period of six months. The program provided at least one but up to seven individual counseling sessions through a computer expert system, informational websites and a message board.\n At six-months follow-up, seven-day point prevalence smoking abstinence was twice as high in the intervention group as in the control group (OR=2.0; CI 1.1-3.8; p=.02).\n Proactive recruitment of smokers in combination with the provision of an internet program for smoking cessation allow for an inexpensive and effective smoking cessation support during and after inpatient rehabilitation treatment.\n Copyright © 2011 Elsevier Ltd. All rights reserved.", "Smoking cessation is an important goal for smokers with coronary artery disease (CAD) because it reduces cardiac morbidity and mortality. Effective interventions for cigarette smokers with CAD exist, but they often are considered to be intensive and expensive. Stepped-care interventions have been proposed as a promising way to allocate smoking cessation treatments in a cost-effective manner. Stepped care refers to the practice of initiating treatment with low-intensity intervention and then exposing treatment failures to successively more intense interventions.\n To address the efficacy of this approach, 254 cigarette smokers hospitalized with CAD were provided a brief cessation intervention. The participants then were assigned randomly to either a more intensive stepped-care treatment (counseling and nicotine patch therapy) or no additional treatment. Outcomes were point-prevalent abstinence measured 3 months and 1 year after hospital discharge.\n Stepped-care treatment increased smoking cessation rates from 42% to 53% during a 3-month follow-up period (P =.05), but showed little effect at the 1-year follow-up assessment, as evidenced by a cessation rate for the minimal intervention group of 36% versus 39% for the stepped-care group (P =.36).\n A stepped-care approach to smoking cessation increased short-but not long-term point-prevalent abstinence in patients with CAD. For improvement of long-term effectiveness, refinement of the timing and content of stepped-care interventions needs to occur.", "Chronic obstructive pulmonary disease (COPD) is a major contributor to morbidity and mortality. Smoking is the leading cause of COPD. Results from randomised trials regarding smoking cessation in hospitalised patients with COPD are few.\n To assess the effect of smoking cessation groups (SCG) in patients with COPD admitted to hospital.\n Two hundred and twenty-three patients admitted to hospital were assigned to either a control group (n = 102) or an intervention group (n = 121) by matter of vacancy. The smokers in the intervention group were offered participation in an SCG. Smoking status and change in self-reported symptoms were assessed after 1 year. Smoking status was self-reported and verified with carbohemoglobin measurement. Survival and hospital admissions were assessed after 5 years through national registers.\n Forty-eight patients participated in an SCG. After 1 year, 36 (30%) patients in the intervention group were abstinent compared with 13 (13%) patients in the control group [odds ratio (95% confidence interval): 2.83 (1.40-5.74)]. There was a significant difference between the intervention group and the control group regarding change in self-reported phlegm. There was a non-significant tendency towards better survival in the intervention group (50.4%) compared with the control group (43.1%). After 3 years, the intervention group had a significantly fewer total number of days admitted to hospital and number of days hospitalised with COPD.\n This study shows that an intervention consisting of offering participation in an SCG to chronic patients makes it possible to obtain higher abstinence rates. Furthermore, this intervention showed impact on phlegm, survival and hospital readmissions.", "This randomized clinical trial was designed to test the efficacy of intensive versus brief smoking cessation interventions for hospital patients. The interventions included advice and pamphlets for Brief and bedside counselling, take-home materials, and 7 post-discharge telephone counselling calls over 2 months for Intensive. Confirmed 1-year abstinence was 28% for Intensive (85/301) and 24% for Brief (76/315). Abstinence was significantly higher for patients who did not use pharmacotherapy (36%) versus those who did (16%) and for patients with CVD (40%) versus other diagnoses (20%). Because this was a replication trial, benchmarks for planning can be suggested: 12% to 15% recruitment of identified smokers, 90% plus completion for Intensive, 15% drop-out, and 75% abstinence corroboration. The results consolidate findings for general inpatients, including expected absolute abstinence and treatment outcomes, the effect of CVD patients on outcomes, the reproducibility of high abstinence in a universal health-care system, and the need for more research to inform practice.", "Several authors have questioned the transtheoretical model. Determining the predictive value of each cognitive-behavioural element within this model could explain the multiple successes reported in smoking cessation programmes. The purpose of this study was to predict point-prevalent smoking abstinence at 2 and 6 months, using the constructs of the transtheoretical model, when applied to a pooled sample of individuals who were hospitalized for a cardiovascular event.\n The study follows a predictive correlation design.\n Recently hospitalized patients (n=168) with cardiovascular disease were pooled from a randomized, controlled trial. Independent variables of the predictive transtheoretical model comprise stages and processes of change, pros and cons to quit smoking (decisional balance), self-efficacy, and social support. These were evaluated at baseline, 2 and 6 months.\n Compared to smokers, individuals who abstained from smoking at 2 and 6 months were more confident at baseline to remain non-smokers, perceived less pros and cons to continue smoking, utilized less consciousness raising and self-re-evaluation experiential processes of change, and received more positive reinforcement from their social network with regard to their smoke-free behaviour. Self-efficacy and stages of change at baseline were predictive of smoking abstinence after 6 months. Other variables found to be predictive of smoking abstinence at 6 months were an increase in self-efficacy; an increase in positive social support behaviour and a decrease of the pros within the decisional balance.\n The results partially support the predictive value of the transtheoretical model constructs in smoking cessation for cardiovascular disease patients.", "The aim of this study was to evaluate the efficacy of an structured intervention based on a medical advice versus to the ordinary anti-tobacco advice in patients with miocardial infarction who are attended in an Intensive Care Unit (ICU).\n 90 patients were randomly selected to receive either the specific intervention (intervention group) or the ordinary advice (control group). The medical advice was given during the ICU hospitalization and during the second, the third and the fourth week. One year later the smoking habit was evaluated.\n After one year 26 patients of the intervention group and 31 patients of the control group had stopped smoking (RR = 0.88 [CI 95% RR] 0.57 to 1.37).\n The percentage of patients who stop smoking after a miocardial infarction is high. The structured medical counselling was not effective to reduce the number of smokers at one year.", "To evaluate the efficacy of a physician-directed, nurse-managed, home-based case-management system for coronary risk factor modification.\n Randomized clinical trial in which patients received a special intervention (n = 293) or usual medical care (n = 292) during the first year after acute myocardial infarction.\n 5 Kaiser Permanente Medical Centers in the San Francisco Bay area.\n 585 men and women aged 70 years or younger who were hospitalized for acute myocardial infarction.\n In the hospital, specially trained nurses initiated interventions for smoking cessation, exercise training, and diet-drug therapy for hyperlipidemia. Intervention after discharge was implemented primarily by telephone and mail contact with patients in their homes. All medically eligible patients received exercise training; all smokers received the smoking cessation intervention; and all patients received dietary counseling and, if needed, lipid-lowering drug therapy.\n Smoking prevalence and plasma low-density lipoprotein cholesterol (LDL) concentrations were measured 2 months after infarction, and functional capacity was measured 6 months after infarction.\n In the special intervention and usual care groups, the cotinine-confirmed smoking cessation rates were 70% and 53% (P = 0.03), plasma LDL cholesterol levels were 2.77 +/- 0.69 mmol/L and 3.41 +/- 0.90 mmol/L (107 +/- 30 mg/dL and 132 +/- 30 mg/dL) (P = 0.001), and functional capacities were 9.3 +/- 2.4 METS and 8.4 +/- 2.5 METS (P = 0.001), respectively.\n In a large health maintenance organization, a case-management system was considerably more effective than usual medical care for modification of coronary risk factors after myocardial infarction.", "This randomized controlled trial assessed the efficacy of a smoking relapse prevention program featuring 3 postdischarge telephone contacts with subjects who had quit smoking on hospitalization.\n Patients were randomly assigned to public health nurse-mediated behaviorally oriented in-patient counseling focused on relapse prevention (control group, n = 49), or the same inpatient counseling with postdischarge telephone contacts at 7, 21 and 42 days after discharge (intervention group, n = 57). The main outcome measure, smoking cessation rate, was obtained from self-reports at 3, 6 and 12 months after discharge. Smoking cessation at 12 months after discharge was confirmed by urinary nicotine concentration.\n At 3, 6 and 12 months smoking cessation rates were 83%, 63% and 56% for the intervention group, and 76%, 65% and 51% for control group. After adjustment for sex, age, having any complication, number of family members, smoking status on admission, strength of nicotine dependence and self confidence to quit smoking, the odds ratio of cessation among the intervention group were 1.46 (95% confidence interval (CI): 0.48-4.47), 0.82 (95% CI: 0.31-2.17) and 0.99 (95% CI: 0.40-2.45) at 3, 6 and 12 months after discharge, respectively.\n This program had limited efficacy to maintain postdischarge smoking abstinence. We should re-consider the modality of smoking cessation program for relapse prevention among hospitalized patients.", "The aim of this study was to evaluate the effect of a smoking cessation intervention provided after discharge from a specialized cardiac hospital.\n A randomized pilot study (N = 40); after discharge, the experimental group (EG) received 6 phone calls from a nurse specialized in tobacco cessation counselling.\n Patients in the EG showed improved scores on two aspects of illness representations (perceive their illness as chronic and reported less negative emotional representations). No significant difference in smoking cessation was observed at 6 months (p = 0.72).\n The non-significant difference may be explained in part by the smoking characteristics within this sample exemplifying the more nicotine dependent \"hard core\" smokers who persist in their smoking habits despite the serious health consequences incurred by continued smoking. This population of smokers may require a more intensive, specialized intervention to achieve smoking cessation.", "Our goal was to investigate whether ambulatory smoking cessation among patients in a cardiologic department would (1) reduce the number of smokers by at least 25% after 12 months compared to a control group and (2) influence whether the individual patient was readmitted to hospital. We used a randomised, controlled, prospective intervention project design.\n Everyone hospitalised during the project period was screened. Those who fulfilled the criteria for inclusion were randomised for inclusion in either the intervention group or the control group. Both groups were given the department's smoking cessation information. In addition, the intervention group attended five ambulatory smoking cessation intervention sessions. Each patient's smoking status was registered after 12 months. chi2-test and logistic regression analysis were used to test differences, associations and control of confounders.\n In all, 3,982 patients were screened, 29.5% of whom were smokers. The study included 105 patients: 54 in the intervention group and 51 in the control group. After 12 months, 52% of those in the intervention group compared to 39% in the control group had become non-smokers, which was non-significant (p = 0,14). Ischemic heart disease (IHS) was significantly associated with smoking cessation. After adjustment for this confounder, the result was enhanced (p = 0,06). Readmission to hospital was not affected by smoking cessation (p = 0,73).\n Ambulatory smoking cessation intervention had no significant effect on smoking cessation on an unselected group of patients in a cardiologic hospital department. The project does indicate that ambulatory smoking cessation interventions could have an effect on patients with IHS.", "To determine whether a nurse led smoking cessation intervention affects smoking cessation rates in patients admitted for coronary heart disease.\n Randomised controlled trial.\n Cardiac ward of a general hospital, Norway.\n 240 smokers aged under 76 years admitted for myocardial infarction, unstable angina, or cardiac bypass surgery. 118 were randomly assigned to the intervention and 122 to usual care (control group).\n The intervention was based on a booklet and focused on fear arousal and prevention of relapses. The intervention was delivered by cardiac nurses without special training. The intervention was initiated in hospital, and the participants were contacted regularly for at least five months.\n Smoking cessation rates at 12 months determined by self report and biochemical verification.\n 12 months after admission to hospital, 57% (n = 57/100) of patients in the intervention group and 37% (n = 44/118) in the control group had quit smoking (absolute risk reduction 20%, 95% confidence interval 6% to 33%). The number needed to treat to get one additional person who would quit was 5 (95% confidence interval, 3 to 16). Assuming all dropouts relapsed at 12 months, the smoking cessation rates were 50% in the intervention group and 37% in the control group (absolute risk reduction 13%, 0% to 26%).\n A smoking cessation programme delivered by cardiac nurses without special training, significantly reduced smoking rates in patients 12 months after admission to hospital for coronary heart disease.", "Rehabilitation centres for mothers are a suitable setting to offer smoking cessation treatment to these women. Telephone aftercare could enhance the effectiveness of an inpatient smoking cessation program. We investigated whether non-directive, supportive aftercare or a structured, smoking specific counselling give more benefit.\n 527 smoking mothers participated in a smoking cessation program during their stay in a prevention/rehabilitation centre. Afterwards they were randomly assigned to one of three aftercare conditions: no aftercare (control group), structured telephone aftercare or non-directive telephone aftercare. At the end of the inpatient program and 6 months later the smoking status of the participants was assessed.\n The structured telephone aftercare resulted in the highest abstinence rates after 6 months (31.5%; odds ratio 2.0; confidence interval: 1.1 - 3.8). The non-directive telephone counselling had no significant effect on abstinence rates.\n A structured telephone aftercare proves to be an effective intervention for women, which stabilizes the abstinence rate following a clinic based smoking cessation program.\n Georg Thieme Verlag KG Stuttgart-New York.", "The purpose of this study was to evaluate the impact of a smoking cessation intervention for hospitalized patients, implemented by regular staff and incorporated into their routine care of patients.\n The intervention was conducted in one experimental hospital and in two control hospitals.\n One year after discharge, 15% of smokers became non-smokers in the experimental hospital versus 8% in the control hospitals. This difference is not statistically significant (p = 0.08), however a small sample in the control hospitals had an influence on the statistical power. A logistic regression highlights program participation as the only variable predictive of a non-smoker status one year after discharge, considering both types of hospitals (experimental and control).\n Establishing relevancy of smoking cessation intervention for hospitalized patients is probably no longer needed. But research should be carried on towards finding better ways to convince the staff to intervene, towards establishing relevancy for specialized staff and defining intensity of required interventions before and after hospitalization.", "Seventy-four cigarette-smoking patients admitted with COPD to the Chest Unit of a 600-bed teaching hospital served as subjects for a randomized trial of smoking cessation counseling. All patients were advised to quit smoking and smoking in the unit was not allowed. One-half of the patients were, in addition, provided with a self-help manual and three to eight 15- to 20-min counseling sessions on alternate days while in hospital. Self-reports of smoking status were obtained at 3 and 6 months, a sample of which were validated with serum COHb. The results were disappointing. Differences between the counseled group and the controls both in rates of cessation at 6 months (33.3% vs 21.4%) and, for patients still smoking, reductions in amount smoked would have lacked practical significance even if statistical significance had been obtained. Some alternative treatment approaches are suggested for this group of patients.", "Although men hospitalized with cardiovascular disease (CVD) show high smoking-cessation rates, similar data for women are lacking. We tested the efficacy of smoking-cessation intervention in women hospitalized for CVD.\n In this randomized controlled trial conducted from 1996 to 2001, 277 women diagnosed with CVD (mean age 61+/-10 years) were randomly assigned within 1 of 12 San Francisco Bay Area hospitals to a usual-care group (UG; n=135) or intervention group (IG; n=142). Baseline histories were obtained, and interviews to ascertain self-reported smoking status occurred at 6, 12, 24, and 30 months after hospitalization. The UG received strong physician's advice, a self-help pamphlet, and a list of community resources. The IG received strong physician's advice and a nurse-managed cognitive behavioral relapse-prevention intervention at bedside, with telephone contact at intervals after discharge. The groups were similar demographically and had smoked cigarettes for a median of 38 (IG) or 40 (UG) years. Time to resumption of continuous smoking was assessed by Kaplan-Meier analysis, and risk differences between groups were determined. Time smoke-free was significantly greater for the IG than the UG (P=0.038). Point prevalence for nonsmoking at the interviews was somewhat greater for the IG than the UG (P>0.15 at all times).\n Cognitive behavioral intervention resulted in longer average times to resumption of smoking, but in these 2 groups of older women with limited social and financial resources, long-term success rates were similar. Systematic identification of smokers and even the brief intervention afforded the UG yielded a high smoking-cessation rate over time.", "Smokers hospitalized with acute coronary syndrome (ACS) are at high risk for subsequent ischemic events. Nevertheless, over two-thirds of patients continue to smoke after an acute myocardial infarction. Bupropion hydrochloride has proven efficacy as a smoking cessation aid, but data regarding its safety and efficacy in ACS patients are limited.\n In a double-blind, randomized controlled trial, we compared the safety and efficacy of 8 weeks of treatment with bupropion slow-release (SR) or placebo for smokers hospitalized with ACS as an adjunct to nurse-led hospital- and telephone-based support. Primary efficacy outcome was smoking abstinence at 1 year. Primary safety outcome was clinical events at 1 year.\n A total of 151 patients were enrolled; all but 2 completed follow-up. Abstinence rates at 3 months were 45% and 44% in the bupropion SR and placebo groups, respectively (P = .99); 37% vs 42% (P = .61) at 6 months; and 31% vs 33% (P = .86) at 1 year. On multivariate analysis, an invasive procedure performed during index hospitalization was an independent predictor for smoking abstinence at 1 year (odds ratio [OR], 4.2; 95% confidence interval [CI], 1.22-14.19). Presence of adverse effects attributed to treatment was a negative predictor for smoking cessation (OR, 0.23; 95% CI, 0.07-0.78). Treatment with bupropion SR was not associated with an increase in clinical events or change in blood pressure or body mass index, but dizziness was more common compared with placebo (14% vs 1.4%; P = .005).\n In hospitalized patients with ACS who received continuous, intensive nurse counseling about smoking cessation, bupropion did not increase the rates of smoking abstinence.", "We analysed the effectiveness of a high intensity behavioural-cognitive intervention compared to minimal intervention started during a hospital stay, to see if the combination of nicotine replacement therapy (NRT) can increase the quitting rate at 12 months of follow up.\n A total of 2560 active smokers were studied during their hospital stay. Of these, 717 smokers refused to enter the study and after a minimal intervention they were asked if we could telephone them after one year to ask if they still smoked. The remaining 1843 smokers who received high intensity cognitive therapy were randomised to receive or not receive NRT. The follow up after discharge was carried out by outpatient visits or with telephone sessions.\n At one year of follow up, 7% of those who declined to enter the study had stopped smoking compared to 27% of those who entered the study (p<0.001). There were significant differences between the group that only had behavioural therapy (21% stopped) compared to the group that also had NRT (33% stopped; p=0.002). In this latter group there were significant differences (p=0.03) between those who had follow up in clinics (39% stopped) compared to those who were followed up telephone sessions (30%). In the multivariate analysis, the predictors of quitting at 12 months were: to have used NRT (OR 12.2; 95% CI, 5.2-32; p=0.002) and a higher score in the Richmond Test (OR 10.1; 95% CI, 3.9-24.2; p=0.01).\n A cognitive type intervention started on smokers when admitted to hospital increases quitting rates at 12 months, compared to a minimal intervention, and these rates increase even more significantly if NRT is added.\n Copyright © 2010 SEPAR. Published by Elsevier Espana. All rights reserved.", "To determine the effect of a nurse-managed intervention for smoking cessation in patients who have had a myocardial infarction.\n Randomized, with a 6-month treatment period and a 6-month follow-up.\n Kaiser Foundation hospitals in Redwood City, Santa Clara, Hayward, and San Jose, California.\n Sequential sample of 173 patients, 70 years of age or younger, who were smoking before hospitalization for acute myocardial infarction. Eighty-six patients were randomly assigned to the intervention and 87 to usual care; 130 patients (75%) completed the study and were available for follow-up.\n Nurse-managed and focused on preventing relapse to smoking, the intervention was initiated in the hospital and maintained thereafter primarily through telephone contact. Patients were given an 18-page manual that emphasized how to identify and cope with high-risk situations for smoking relapse.\n One year after myocardial infarction, the smoking cessation rate, verified biochemically, was 71% in the intervention group compared with 45% in the usual care group, a 26% difference (95% CI, 9.5% to 42.6%). Assuming that all surviving patients lost to follow-up were smoking, the 12-month smoking cessation rate was 61% in the intervention group compared with 32% in the usual care group, a 29% difference (95% CI, 14.5% to 43.5%). Patients who either resumed smoking within 3 weeks after infarction or expressed little intention of stopping in the hospital were unlikely to have stopped by 12 months.\n A nurse-managed smoking cessation intervention largely conducted by telephone, initiated in the hospital, and focused on relapse prevention can significantly reduce smoking rates at 12 months in patients who have had a myocardial infarction.", "To test the efficacy of a smoking cessation program for inpatients recovering from coronary artery bypass graft surgery and to identify predictors of cessation.\n Randomized, controlled clinical trial.\n Postoperative cardiac surgery unit of a large teaching hospital.\n Patients scheduled for coronary artery bypass surgery by participating surgeons between 1 July 1986 and 1 July 1987 who had smoked 1 or more packs of cigarettes in the 6 months before admission. Of 120 eligible patients, 93 enrolled and 87 were discharged alive. All survivors were followed for at least 1 year; 94% were followed for a median of 5.5 years.\n A three-session, nurse-delivered behavior modification program using a videotape and face-to-face counseling was compared to usual care.\n Smoking status was assessed six times in the year after surgery and 5.5 years after surgery. Self-reported nonsmoking was validated by saliva cotinine assay 1 and 5.5 years after surgery.\n No statistically significant differences were found between control (n = 43) and intervention (n = 44) groups at baseline. One and 5.5 years after hospital discharge, validated continuous nonsmoking rates were identical in intervention and control groups (51% at 1 year; 44% at 5.5 years). Multiple logistic regression identified four factors that were independently associated with nonsmoking for 1 year: fewer than 3 previous attempts to quit (odds ratio, 7.4; 95% Cl, 1.9 to 29.1); more than 1 week of preoperative nonsmoking (odds ratio, 10.0; Cl, 2.0 to 50.2); definite intention to quit smoking (odds ratio, 12.0; Cl, 2.6 to 55.1); and no difficulty not smoking in the hospital (odds ratio, 9.6; Cl, 1.8 to 52.2). Nonsmoking for 5.5 years was independently associated with two of these factors: fewer than three previous attempts to quit and intention to quit smoking after surgery. Cessation was not related to demographic factors, daily cigarette consumption, disease severity, hospital course, social support, or beliefs and attitudes.\n Even without specific intervention, nearly one half of smokers quit for 5 years after coronary artery bypass surgery. A short inpatient education program did not increase this rate. Future efforts should target the time after discharge and focus on increasing motivation in patients who have repeatedly failed to quit.", "A pilot study was conducted to determine the feasibility and potential efficacy of an interactive voice response (IVR) follow-up system for smokers recently hospitalized with coronary heart disease (CHD).\n Ninety-nine smokers hospitalized with CHD completed a baseline questionnaire, were provided with bedside counseling, and offered nicotine replacement therapy. They were randomly assigned to a usual care (UC) or an IVR group. The IVR group received automated telephone follow-up calls 3, 14 and 30 days after discharge inquiring about their smoking status and confidence in remaining smoke-free. When deemed necessary, they were offered additional counseling. Smoking status was determined 52 weeks after hospital discharge.\n The 52-week point prevalence abstinence rate in the IVR group was 46.0% compared to 34.7% in the UC group (OR=1.60, 95% CI: 0.71-3.60; P=.25). After adjustment for education, age, reason for hospitalization, length of hospitalization, and quit attempts in the past year, the odds of quitting in the IVR group compared to the UC group were 2.34 (95% CI: 0.92-5.92; P=.07).\n IVR is a promising technology for following CHD patients attempting to quit smoking following discharge from hospital, however, a larger trial is required to confirm its efficacy.\n IVR may enhance the timely provision of follow-up counseling for smoking cessation in patients with CHD.", "Does the provision of a nurse-based intervention lead to smoking cessation in hospital patients?\n At tertiary teaching hospital in Newcastle, Australia, 4,779 eligible (aged 18-80, admitted for at least 24 hours, and able to provide informed consent) and consenting (73.4%) in-patients were recruited into a larger cross-sectional survey. 1,422 (29.7%) smokers (in the last 12 months) were randomly assigned to control (n = 711) or intervention group (n = 711). The brief nurse-delivered intervention incorporated: tailored information, assessment of withdrawal, offer of nicotine replacement therapy, booklets, and a discharge letter. Self-reported cessation at 12 months was validated with CO and salivary cotinine.\n There were no significant differences between groups in self-reported abstinence at three or 12 months post intervention, based on an intention to treat analysis. At three months, self-reported abstinence was 27.3% (I) and 27.5% (C); at 12 months was 18.5% (I) and 20.6% (C). There were no differences in validation of self-report between intervention and control groups at 12 months.\n This brief nurse-provided in-patient intervention did not significantly increase the smoking cessation rates compared with the control group at either three or 12-month follow-up.\n A systematic total quality improvement model of accountable outcome-focused treatment, incorporating assertive physician-led pharmacotherapy, routine assessment and recording of nicotine dependence (ICD 10 coding), in- and outpatient services and engagement from multidisciplinary teams of health professionals may be required to improve treatment modalities for this chronic addictive disorder.", "Many patients attempt to stop smoking during hospitalization, but most relapse after discharge. This study developed and evaluated a brief smoking-cessation and relapse-prevention program for hospitalized smokers. All hospitalized smokers (n = 1,119) were identified by questionnaire at hospital admission and then received either usual care or usual care plus a hospital-based smoking-cessation intervention regardless of interest in stopping smoking. Intervention components included a 20-minute bedside counseling session, a 12-minute videotape, a variety of self-help materials, and a follow-up telephone call. Special attention was given to techniques for preventing relapse after hospital discharge. Defining ex-smokers as those who reported no tobacco use at both 3- and 12-month follow-up assessments, and counting those lost to follow-up as smokers, the intervention increased the proportion of patients who quit smoking by one half (9.2% vs 13.5%, P < 0.05). These results demonstrate the efficacy of a brief in-hospital intervention and suggest that relapse-prevention efforts are needed to convert temporary cessation during hospitalization into long-term abstinence.", "Few research studies have evaluated the effectiveness of smoking interventions in hospitalized patients. This randomized controlled trial compared the efficacy of 2 smoking cessation programs in patients hospitalized in 4 community hospitals in a large health maintenance organization within the San Francisco Bay Area in California.\n Patients were randomly assigned to usual care (n = 990), nurse-mediated, behaviorally oriented inpatient counseling focused on relapse prevention with 1 postdischarge telephone contact (minimal intervention, n = 473), or the same inpatient counseling with 4 postdischarge telephone contacts (intensive intervention, n = 561). The main outcome measure, smoking cessation rate, was corroborated by plasma cotinine determination or family confirmation, 1 year after enrollment.\n At 1 year smoking cessation rates were 27%, 22%, and 20% for intensive intervention, minimal intervention, and usual care groups, respectively (P = .009 for intensive vs usual care). Subgroup analyses by diagnosis revealed that the odds of cessation among patients with cardiovascular disease or other internal medical conditions were greater among those receiving the intensive intervention than among their counterparts receiving usual care (odds ratios, 1.6 and 2.0, respectively).\n A multicomponent smoking cessation program consisting of physician advice; in-hospital, nurse-mediated counseling; and multiple postdischarge telephone contacts was effective in increasing smoking cessation rates among hospitalized smokers. Hospital-wide smoking cessation programs could substantially increase the effectiveness of hospital smoking bans.", "This study evaluated the effectiveness of three smoking cessation interventions for this population: (1) modified usual care (UC); (2) brief advice (A); and (3) brief advice plus more extended counseling during and after hospitalization (A + C).\n Smokers (2,095) who were in-patients in four hospitals were randomly assigned to condition. Smoking status was ascertained via phone interview 7 days and 12 months post-discharge. At 12 months, reports of abstinence were validated by analysis of saliva cotinine. Intent to treat analyses were performed.\n At 7-day follow-up, 24.2% of participants reported abstinence in the previous 7 days. There were no differences between conditions. At 12-month follow-up, self-reported abstinence was significantly higher in the A + C condition (UC (15.0%) vs. A (15.2%) vs. A + C (19.8%)). There was no significant difference among conditions in cotinine-validated abstinence, however (UC (8.8%) vs. A (10.0%) vs. A + C (9.9%)).\n These interventions for hospital in-patients did not increase abstinence rates. Features of the study that might have contributed to this finding were the inclusiveness of the participation criteria, the fact that pharmacological aids were not provided, and a stage-matching approach that resulted in less intensive counseling for participants unwilling to set a quit date.", "Previous research has documented that hospital-based smoking-cessation counseling is efficacious and cost-effective when delivered by research staff. This study evaluated the implementation and effectiveness of this intervention program when delivered by respiratory therapists chosen from the regular hospital staff.\n A total of 1,173 hospitalized smokers were randomly assigned to either usual care or a stage-based bedside counseling program supplemented with a videotape, self-help materials, and a follow-up telephone call.\n Using an intent-to-treat analysis and counting those lost to follow-up as smokers, we did not find a significant difference in outcome between intervention (14.2% reported being abstinent for > or =6 months at the 1-year follow-up) and usual care conditions (13.6% abstinence). Process analyses revealed that these results were due to a combination of failure to reach many patients and reduced effectiveness of respiratory therapist interventionists compared with experienced professional counselors in a previous study conducted in the same hospitals.\n We recommend implementation of hospital-based smoking-cessation counseling by professional counselors whose primary responsibility is to deliver the intervention. Recommendations for future research and for innovative ways to reach hospitalized smokers who are not receiving intervention are discussed.", "To evaluate a smoking cessation intervention that can be routinely delivered to smokers admitted with cardiac problems.\n Randomised controlled trial of usual care compared with intervention delivered on hospital wards by cardiac rehabilitation nurses.\n Inpatient wards in 17 hospitals in England.\n 540 smokers admitted to hospital after myocardial infarction or for cardiac bypass surgery who expressed interest in stopping smoking.\n Brief verbal advice and standard booklet (usual care). Intervention lasting 20-30 minutes including carbon monoxide reading, special booklet, quiz, contact with other people giving up, declaration of commitment to give up, sticker in patient's notes (intervention group).\n Continuous abstinence at six weeks and 12 months determined by self report and by biochemical validation at these end points. Feasibility of the intervention and delivery of its components.\n After six weeks 151 (59%) and 159 (60%) patients remained abstinent in the control and intervention group, respectively (P=0.84). After 12 months the figures were 102 (41%) and 94 (37%) (P=0.40). Recruitment was slow, and delivery of the intervention was inconsistent, raising concerns about the feasibility of the intervention within routine care. Patients who received the declaration of commitment component were almost twice as likely to remain abstinent than those who did not receive it (P<0.01). Low dependence on tobacco and high motivation to give up were the main independent predictors of positive outcome. Patients who had had bypass surgery were over twice as likely to return to smoking as patients who had had a myocardial infarction.\n Single session interventions delivered within routine care may have insufficient power to influence highly dependent smokers.", "This study was undertaken to assess the safety and efficacy of a treatment involving brief counseling and the nicotine patch among hospital inpatients and to identify variables associated with long-term smoking cessation following hospitalization.\n One hundred eighty-five patients were randomly assigned to one of three smoking cessation interventions: (1) A Minimal Care (MC) condition, consisting of a brief physician-delivered motivational message to stop smoking, (2) a Counseling + Active Nicotine Patch (CAP) condition in which patients received the motivational message, a 6-week supply of nicotine patches, and extended bedside and telephone counseling, and (3) a Counseling + Placebo Patch (CPP) condition identical to the CAP condition except the supplied patches contained no nicotine.\n At 6-month follow-up, abstinence rates for the three treatments were 4.9, 6.5, and 9.7% for the MC, CPP, and CAP treatments, respectively. These differences were not statistically significant. Patients admitted for respiratory disease were more likely to quit than patients with any other diagnosis. The nicotine patch was well tolerated by hospital inpatients.\n The initiation of nicotine patch therapy during hospitalization appears to be safe when used among patients carrying a wide range of diagnoses. Our study provided no evidence of the superiority of nicotine patches versus placebo, but this does not preclude the possibility that future research using larger samples might detect differences between patch groups. Hospital interventions for smoking cessation may be most effective among patients hospitalized for a smoking-related illness such as respiratory disease.", "We tested the effectiveness of an individually delivered behavioral multicomponent smoking intervention (SI) against offering advice only (AO) to 267 patients after coronary arteriography. After 6 months, 51% of AO patients and 62% of SI patients reported abstinence. Validated rates were 34% and 45% for AO and SI patients, respectively. Logistic regression analyses, controlling for severity of illness, stage of change, and self-efficacy, among other variables, showed that, at 6 months, the SI had the most effect for patients with more severe coronary artery disease (CAD) who had been admitted with a myocardial infarction (95% confidence interval = 2.05, 124.85). At 12 months, only severity of disease mediated SI effects (95% confidence interval = 3.10, 58.00). Similar results were seen for cotinine-validated cessation. This study confirms the effectiveness of individually administered SI for more seriously ill patients with CAD and raises questions as to how to better intervene with those individuals with less severe disease.", "To compare the results of 6-month follow-ups for hospitalized patients who were divided into two groups of low- and high-intensity treatments for smoking cessation and compared to the results of standard hospital treatment.\n A total of 2414 patients were screened. Two hundred thirty-seven current smokers were randomly assigned to high-intensity intervention (HII; 30-min motivational interview plus seven routine telephone calls after hospital discharge) or to low-intensity intervention (LII; 15-min counseling about the benefits of quitting) and 80 comprised the usual care (UC) group. Six months after hospital discharge, all participants were contacted by phone. The main outcome measure was smoking cessation.\n The smoking-cessation rates were 44.9%, 41.7% and 26.3% for the HII, LII and UC groups, respectively (P = .03). The multivariable analysis identified the following variables which are associated with the failure to stop smoking: the absence of a tobacco-related disease (TRD), younger age and a low motivation for cessation at the initial contact.\n There was a great difference between intervention and nonintervention. The LII had an impact similar to the HII. The variables associated with no smoking cessation demonstrate the need for more personalized interventions for smokers who present lower indexes of motivation, are younger and do not have smoking-related diseases.\n Copyright © 2010 Elsevier Inc. All rights reserved.", "To determine whether an intensive cognitive-behavioral intervention begun during hospitalization when combined with transdermal nicotine replacement therapy is more effective than a minimal counseling intervention combined with transdermal nicotine replacement therapy in helping inpatients to quit smoking.\n A total of 223 patients who smoked were enrolled in a hospital-based randomized smoking cessation trial at the San Francisco Veterans Affairs Medical Center. One hundred and seven participants (48%) received intensive counseling and outpatient telephone follow-up; 116 participants (52%) received minimal counseling. All study participants received 2 months of transdermal nicotine replacement therapy. We determined 6-month quit rates by self-report and measured saliva cotinine levels or obtained proxy reports to confirm self-reported smoking cessation at 12 months. Analyses adjusted for baseline differences in the distribution of coronary disease.\n At 6 months, 35% (36/103) of the intensive intervention group reported quitting, compared with 21% (23/109) of the comparison group (relative risk [RR] = 1.7; 95% confidence interval [CI]: 1.1 to 2.7). At 12 months, the self-reported quit rate was 33% (33/99) in the intensive intervention group versus 20% (21/103) in the comparison group (RR = 1.7; 95% CI: 1.1 to 2.7). Based on biochemical or proxy confirmation, 29% (30/102) in the intensive intervention group versus 20% (21/107) in the comparison group quit smoking at 12 months (RR = 1.6; 95% CI: 0.96 to 2.5).\n Hospital-initiated smoking cessation interventions that include transdermal nicotine replacement therapy can improve long-term quit rates.", "Cigarette smoking is the greatest cause of preventable mortality in the United States. Because most smokers would like to quit and most hospitals are smoke free, surgical admissions represent a window of opportunity for tobacco cessation interventions.\n A total of 324 patients (98% men), aged 25 to 82 years, who were current smokers and who underwent noncardiac surgery were enrolled in a randomized controlled trial at the Veterans Affairs Medical Center, San Francisco, Calif. One hundred sixty-eight participants (52%) received a multicomponent intervention designed to increase self-efficacy and coping skills that included face-to-face in-hospital counseling, viewing a smoking cessation videotape, self-help literature, nicotine replacement therapy, and 3 months of telephone follow-up. One hundred fifty-six participants (48%) received self-help literature and brief counseling lasting 10 minutes. Serum or saliva cotinine levels were measured to confirm self-reported smoking cessation.\n At 12 months of follow-up, the self-reported quit rate was 27% among the intervention group and 13% among the comparison group (relative risk, 2.1; 95% confidence interval, 1.2-3.5; P < .01). Based on biochemical confirmation, 15% of the intervention group, compared with 8% of the comparison group, quit smoking at 12 months (relative risk, 2.0; 95% confidence interval, 1.0-3.9; P = .04).\n A smoking cessation intervention targeted at smokers hospitalized for noncardiac surgery can increase long-term quit rates. Surgical hospitalizations provide an opportunity to reach smokers who want to quit smoking.", "Hospitalization may be an opportune time to change smoking behavior because it requires smokers to abstain from tobacco at the same time that illness can motivate them to quit. A hospital-based intervention may promote smoking cessation after discharge.\n We tested the efficacy of a brief bedside smoking counseling program in a randomized controlled trial at Massachusetts General Hospital, Boston. The 650 adult smokers admitted to the medical and surgical services were randomly assigned to receive usual care or a hospital-based smoking intervention consisting of (1) a 15-minute bedside counseling session, (2) written self-help material, (3) a chart prompt reminding physicians to advise smoking cessation, and (4) up to 3 weekly counseling telephone calls after discharge. Smoking status was assessed 1 and 6 months after hospital discharge by self-report and validated at 6 months by measurement of saliva cotinine levels.\n One month after discharge, more intervention than control patients were not smoking (28.9% vs 18.9%; P=.003). The effect persisted after multiple logistic regression analyses adjusted for baseline group differences, length of stay, postdischarge smoking treatment, and hospital readmission (adjusted odds ratio, 2.19; 95% confidence interval, 1.34-3.57). At 6 months, the intervention and control groups did not differ in smoking cessation rate by self-report (17.3% vs 14.0%; P=.26) or biochemical validation (8.1% vs 8.7%; P=.72), although the program appeared to be effective among the 167 patients who had not previously tried to quit smoking (15.3% vs 3.7%; P=.01).\n A low-intensity, hospital-based smoking cessation program increased smoking cessation rates for 1 month after discharge but did not lead to long-term tobacco abstinence. A longer period of telephone contact after discharge might build on this initial success to produce permanent smoking cessation among hospitalized smokers.", "Tobacco cessation after acute myocardial infarction (AMI) substantially improves outcome but how effective individual programmes are needs to be established. To date, few studies have examined this factor.\n To assess the outcome of two smoking cessation programmes after AMI.\n One hundred and ninety-eight current smokers admitted to coronary care with an AMI participated in a randomized controlled study comparing two outpatient tobacco interventions, the Stanford Heart Attack Staying Free (SF) programme and a Usual Care (UC) programme.\n Log-rank analyses revealed that patients in the SF programme were retained longer (P < 0.001) and had higher cotinine validated abstinence rates (P < 0.001) compared with patients in the UC programme. Twelve months after intervention, 39% of the SF programme compared with 2% of the UC programme demonstrated cotinine validated tobacco cessation, representing a significant reduced relapse rate in the SF programme (chi2, P< 0.001).\n The SF smoking cessation programme initiated in hospital can significantly reduce smoking rates at 12 months after myocardial infarction. Although superior to the UC quit programme, Australian outcomes were lower than the American programme originators' published outcomes.", "Cessation rates in smokers attending special clinics or their General Practitioners can be increased by transdermal nicotine (TNS). This study assesses the efficacy of TNS as an adjunct to advice and support in helping patients attending hospital with smoking-related diseases to stop smoking.\n In a double-blind, placebo-controlled, randomized manner, 234 inpatients and outpatients with smoking-related respiratory or cardiovascular disease, aged 18-75 years, who were willing to try to stop smoking, were advised by their hospital doctor to stop smoking. This was reinforced by repeated advice and encouragement from the Smoking Cessation Counsellor initially and at 2, 4, 8 and 12 weeks, supplemented by a 24 h patch in adjusted doses over that period. Those not smoking at 12 weeks were followed up at 26 and 52 weeks. Self-reported complete abstinence from 12 to 52 weeks was validated by expired air carbon monoxide measurement at 12, 26 and 52 weeks.\n Twenty-four (21%) of 115 TNS patients were verified as non-smokers at 12, 26 and 52 weeks and claimed continued abstinence, compared with 17 (14%) of 119 in the placebo (P) group (P = 0 center dot 15) -5% confidence limits for odds ratio of abstinence on TNS compared to P: 0 center dot 83, 3 center dot 37. Cessation was related to increasing age (P = 0 center dot 02) and lower Fagerstrom score (P = 0 center dot 05). Minor skin reactions were more frequent in the TNS group (47% TNS; 34% P), as was nausea (12% TNS; 3% P). Severe skin reactions were rare (5% TNS; 4% P).\n The suggestion that TNS produces an increase of 50% in relative terms (7% absolute increase) in smoking cessation over placebo in this population of hospital patients is sufficiently strong to warrant a further study large enough to answer whether or not this result was due to chance.", "nan", "This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac inpatients.\n The multicenter study included cardiac inpatients who had smoked prior to hospitalization. A pretest-posttest quasi-experimental design was used. Patients' experimental condition depended on the hospital they were assigned to. The design was partially randomized: 4 of the 11 hospitals selected the experimental condition themselves (2 experimental, 2 control), while the remaining 7 hospitals were randomly assigned. The experimental group consisted of patients of 5 hospitals (N = 388). Patients of 6 other hospitals served as the control group (N = 401). The intervention included stop-smoking advice by the cardiologist, brief counseling by the nurse, the provision of self-help materials, and aftercare by the cardiologist.\n Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence. The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition.\n While short-term effects were found, the minimal-contact intervention did not result in significant effects after 12 months, at least if patients lost to follow-up were treated as posttest smokers. Efforts should be made to improve the intervention, especially the aftercare.", "Bupropion is a first-line pharmacological aid for smoking cessation; however, no clinical trials have been conducted in a general population of hospitalized smokers.\n We enrolled 85 smokers in a hospital-based randomized smoking cessation trial conducted at the San Francisco Veterans Affairs Medical Center. A total of 42 participants received a 7-week course of sustained-release bupropion and 43 participants received placebo. All participants received cognitive-behavioral counseling. We screened 14,997 patients, of whom 25% were current smokers. Of the 536 smokers who met the entry criteria, 451 opted not to enroll. We determined on-medication, end-of-medication, 3-month, and 6-month smoking cessation rates.\n At the end of 7 weeks of drug treatment, self-reported quit rates were equivalent in the bupropion and placebo arms, 37% versus 33%, respectively (p = .82). The validated quit rates for the bupropion and placebo groups were 27% versus 29%, respectively (p = 1.00). At 6 months, the self-reported quit rates were 29% in the bupropion group and 41% in the placebo group (p = .36). In a comparison of 6-month quit rates, validated either by salivary cotinine or by spousal proxy, we found nonsignificantly higher quit rates in the placebo group than in the bupropion group, 31% versus 15% (p = .12).\n The addition of sustained-release bupropion to counseling did not increase quit rates, but the study was underpowered. Because of the secular trend toward shorter hospital stays, recruitment was very difficult, raising questions regarding the feasibility of future hospital-based smoking cessation trials and interventions.", "The hospital can be an important opportunity for smoking cessation interventions. This is the first randomized, double-blinded, placebo-controlled pilot trial utilizing varenicline and post-discharge, in-person behavioral treatment for hospitalized smokers.\n Seventy-nine smokers admitted to a university-based hospital with various diagnoses were enrolled from 2007 to 2009. The primary outcome was biochemically confirmed abstinence at 24 weeks following discharge. Secondary outcomes included withdrawal symptoms, motivation, utilization of treatment, and medical events.\n Overall abstinence at 24 weeks was 27% with no difference between varenicline and placebo treatment groups (23% vs. 31%). There were no significant differences in motivation to stop smoking or withdrawal symptoms. Over 40% of all subjects utilized post-discharge behavioral treatment with significantly higher abstinence rates compared with those who did not (53.1% vs. 8.5%, p<0.01). Overall adverse events were similar in both treatment groups with the only significant difference being more nausea in the varenicline group (25% vs. 5%; p<0.01). Twenty-three subjects were re-hospitalized with no significant differences between treatment groups (13 varenicline vs. 10 placebo).\n This pilot trial of varenicline in hospitalized smokers demonstrated feasibility of implementation, produced some hypothesis-generating findings, and suggested the potential benefit of face-to-face treatment following discharge.\n Copyright © 2011 Elsevier Ltd. All rights reserved.", "Programs for smoking cessation for cardiac patients are underused in Canada. We examined the efficacy of an intervention for smoking cessation for patients admitted to hospital for coronary artery bypass graft (CABG) or because of acute myocardial infarction (MI).\n Nurses randomly assigned 276 sequential patients admitted because of acute MI or for CABG who met the inclusion criteria. Participants received an intensive or minimal smoking-cessation intervention. The minimal intervention included advice from physicians and nurses and 2 pamphlets. The intensive intervention included the minimal intervention plus 60 minutes of bedside counselling, take-home materials and 7 nurse-initiated counselling calls for 2 months after discharge. The outcomes were point prevalence of abstinence at 3, 6 and 12 months after discharge.\n The 12-month self-reported rate of abstinence was 62% among patients in the intensive group and 46% among those in the minimal group (odds ratio [OR] 2.0, 95% confidence interval [CI] 1.2-3.1). Abstinence was confirmed for 54% of patients in the intensive group and 35% in the minimal group (OR 2.0, 95% CI 1.3-3.6). Abstinence was significantly lower among those who used pharmacotherapy than among those who did not (p < 0.001). Continuous 12-month abstinence was 57% in the intensive group and 39% in the minimal group (p < 0.01). It was significantly higher among patients admitted for CABG than among those admitted because of acute MI (p < 0.05).\n Providing intensive programs for smoking cessation for patients admitted for CABG or because of acute MI could have a major impact on health and health care costs.", "Guidelines recommend that smoking cessation interventions are offered in all clinical settings to all smokers willing to make a quit attempt. Since the effectiveness of routine provision of behavioural counselling and nicotine replacement therapy (NRT) to smokers admitted to hospital has not been established, a randomised controlled trial of these interventions given together compared with counselling alone or minimal intervention was performed in hospital inpatients.\n Medical and surgical inpatients who were current smokers at the time of admission were randomised to receive either usual care (no additional advice at admission), counselling alone (20 minute intervention with written materials), or NRT plus counselling (counselling intervention with a 6 week course of NRT). Continuous and point prevalence abstinence from smoking (validated by exhaled carbon monoxide <10 ppm) was measured at discharge from hospital and at 3 and 12 months, and self-reported reduction in cigarette consumption in smokers was assessed at 3 and 12 months.\n 274 inpatient smokers were enrolled. Abstinence was higher in the NRT plus counselling group (n=91) than in the counselling alone (n=91) or usual care (n=92) groups. The difference between the groups was significant for validated point prevalence abstinence at discharge (55%, 43%, 37% respectively, p=0.045) and at 12 months (17%, 6%, 8%, p=0.03). The respective differences in continuous validated abstinence at 12 months were 11%, 4%, 8% (p=0.25). There was no significant difference between counselling alone and usual care, or in reduction in cigarette consumption between the treatment groups.\n NRT given with brief counselling to hospital inpatients is an effective routine smoking cessation intervention." ]

[ "8112068", "11553137", "7935145" ]

[ "The efficacy of a moisturizer (Locobase) among cleaners and kitchen assistants during everyday exposure to water and detergents.", "The efficacy of a protective cream in a real-world apprentice hairdresser environment.", "[Efficacy of the use of barrier creams in the prevention of dermatological diseases in textile dyeing and printing plant workers: results of a randomized trial]." ]

[ "Workers exposed to various irritants are widely advised to use moisturizers. To evaluate the efficacy of a moisturizer (Locobase), we studied 111 cleaners and kitchen workers during everyday exposure to water and detergents. All took part in a standardized interview. After randomization, 1/2 the workers (n = 56) used Locobase during a period of 2 weeks (period L), followed by a period without any emollient (period C), or vice versa (n = 55). Clinical assessment and measurements of the skin surface temperature, electrical capacitance and transepidermal water loss (TEWL) were performed on the fingers, hands and arms on entry to the study, after 2 weeks and 4 weeks, or at drop out. The final evaluation showed that 70 (63%) were able to complete the study; 23 (21%) completed period L, but withdrew from period C after a mean of 6 days because of progressive dryness of the skin and eczema; and 12 (11%) were excluded because they used topical corticosteroids or emollients. The remaining 6 (5%) participants were lost to follow-up. Clinically, we observed a significant increase in dryness (p < 0.001) during periods of no treatment (period C), and normalization of the skin texture during use of Locobase. Clinical observations were confirmed by statistically significant differences (p < 0.001) in the electrical capacitance (epidermal hydration), which decreased during period C and increased to pre-study values during period L. No significant differences were found in skin temperatures and TEWL rates.(ABSTRACT TRUNCATED AT 250 WORDS)", "The object of this study was to compare the protective action of a new barrier cream (Excipial Protect, Spirig Pharma AG, Egerkingen, Switzerland) to its vehicle in the context of hand irritation of apprentice hairdressers caused by repeated shampooing and exposure to hair-care products. This was a double-blind cross-over comparing Excipial Protect (containing aluminium chlorohydrate 5% as active ingredient) against its vehicle alone. The efficacy of the creams was evaluated taking into account: (1) clinical scores by researchers, (2) biometric measurements, (3) subjective opinions of the subjects. An analysis of variance was performed considering order of application, degree of atopy, and reported number of shampoos. We observed very little difference in efficacy between the protective cream and its vehicle. The presence, however, of aluminium chlorhydrate in the protective cream was shown to have a positive effect against work-related irritation. The cosmetic qualities of the creams seemed, to the participants, to be as important as their real protective and hydrating properties, an important factor in compliance issues.", "A total of 942 workers of 13 dyeing and printing factories in the area of Como (N. Italy) were examined in order to detect skin complaints on the hands and forearms. Of these, 868 were eligible for and consented to participate in a controlled and randomized experiment aimed at assessing the efficacy of using barrier creams in practical circumstances. 657 workers underwent all three control examinations arranged over about one year. In the randomized group for treatment with barrier creams the cumulative incidence of objective skin lesions was significantly lower than in the group in which no particular recommendation of use was made (44.5% versus 54.4% positive for objective examination in at least one of the three control examinations after recruitment: 95% confidence limits of the difference between 2%-17% percentages; 39.9% versus 47.0% in subjects who were negative at the recruitment examination, 59.0% versus 76.8% in subjects who were positive at the recruitment examination). The use of a hydrocarbon cream was significantly more effective than using a silicone cream (95% confidence limits of the differences of cumulative incidences: -10.9% +20.7% comparing silicone creams with non-treatment; 2.8%-20.2% comparing hydrocarbon creams with non-treatment)." ]

[ "7941212", "8416595", "15767195", "9293675" ]

[ "[Effects of information on and reflection of women's pain experience during mammography].", "Impact of patient-controlled compression on the mammography experience.", "Mammography with breast cushions.", "Compression in mammography and the perception of discomfort." ]

[ "At mammography, strong compression of the breasts is required to reduce the radiation dose and to obtain radiographic images of high quality. In recent times the mass media have received a number of letters with complaints about the painfulness of the examination and an unsympathetic reception by the personnel. The aim of this study was to find out what effect information and a special manner of reception (\"reflection\") had on the experience of pain at mammography. Reflection meant that the X-ray nurse, in an accepting manner, reflected the feelings and facts which the woman expressed. The study was performed as a 2 x 2 factorial design. One independent variable was a letter of information, with the two alternatives letter of information and no letter of information, and another was reflection, with the two alternatives reflection and no reflection. Seventy-six women were randomly allocated to these four conditions. The letter of information stated why the examination was to be performed, how it is done and how it is usually experienced. The results showed that all women in all groups experienced relatively little pain. They considered that they were well received and were satisfied with the information. The difference between the groups was small. There was a tendency for those who were both received with reflection and were given a letter of information to be more satisfied with the examination as compared with the other women. A larger number of women in this former group than in the other groups stated reasons for their assessment. This result was significant.(ABSTRACT TRUNCATED AT 250 WORDS)", "The authors tested the hypothesis that giving women control over the compression portion of the mammography examination results in a less painful experience, greater overall patient satisfaction, and a radiographic image as good as that produced by means of technologist-controlled compression. One hundred nine women undergoing screening mammography at a hospital-based outpatient clinic were studied. Each underwent two-view, screen-film mammography performed in routine fashion except that, by random assignment, one breast was compressed by the technologist and the other breast, by the patient. Patient-controlled compression was significantly (P = .003) less painful than technologist-controlled compression. Overall patient satisfaction (96% [105 of 109]) and willingness to repeat the experience were extremely high. The majority of images (93.5% [202 of 216]) were rated as having good to excellent compression. With minimal patient education, self-compression resulted in an image at least as good as that produced with technologist-applied compression. Further study of this technique is warranted.", "We conducted a randomized clinical trial to determine the impact on pain and image quality when breast cushions were used to pad the surfaces of the mammography equipment during film-screen mammography.\n We recruited a consecutive volunteer sample of 394 participants. Breast cushions were used for only one breast, with laterality and sequence of use assigned randomly. Data collected from participants included demographic data, rating of pain from previous mammography, and rating of pain from present mammography using both a numeric rating scale and a visual analogue scale. Research assistants also collected breast compression and radiation exposure data. Radiologists were blinded to the laterality of cushion assignment while reading the mammograms and assessing image quality.\n Participants were primarily white women (75.3%), mean age 55.4 years. Most (94.4%) reported having previous mammography. Eight percent (n = 32) of those surveyed had thought about skipping or delaying mammography because of the pain involved. The pain associated with mammography was significantly (p < .001) less during oblique and craniocaudal views when breast cushions were used during the procedure. Retakes were required for 2% of the 1576 views with the most common reason being positioning (53%).\n The use of breast cushions significantly reduced the pain during film-screen mammography. Image quality with the cushions was reduced in a very small subset of women probably due to the difficulty in positioning the breast without visual clues. More research needs to be done prior to the routine use of these cushions in clinical practice.", "Breast compression in mammography is an uncomfortable experience for most women. The discomfort experienced has the potential to deter women from attending regular breast screening by mammography. The aim of the present study was to assess factors related to the degree of discomfort experienced by women attending for first-time mammography at the Central and Eastern Sydney BreastScreen Service. Prior to the mammogram, expectations of discomfort, menstrual status, existing breast pain, and other breast problems were recorded on a questionnaire. At the time of the mammogram, breast size and weight were estimated. During the mammogram one of the craniocaudal views of the breast was taken at a slightly lower level of compression and after the procedure the participants were asked if they perceived any difference in discomfort between the normally compressed view and the less compressed view. Radiologists were asked to comment on any differences in image quality between the same two cranio-caudal films. A total of 200 women, including non-English-speaking women, participated in the present study. A total of 29% of women reported moderate, considerable or severe discomfort, a much higher level than reported in previous studies. The source of expectations (P = 0.001) had a significant relationship to the expectation of discomfort. Prior expectations (P = 0.01) and breast weight (P = 0.001) were the only factors found to have a significant relationship to the experience of discomfort. The analysis of differences in level of compression and discomfort indicates that the relationship between mammography discomfort and level of compression is complex and not simply the result of the amount of compression applied. However, analysis of the relationship of varying compression and image quality suggests that a slight lowering in the level of compression is unlikely to significantly compromise perceived image quality. Directions for further research are suggested." ]

[ "1518513" ]

[ "Treatment of hemifacial spasm with botulinum toxin." ]

[ "The effectiveness of botulinum toxin injections in 11 patients with hemifacial spasm was investigated in a prospective placebo-controlled blinded study. The patients were treated with four sets of injections to various facial muscles, selected by clinical evaluation. Three injections were with graded doses of toxin and one was with placebo. The order of injections was random and unknown to the patients. Results were scored both subjectively by patient assessment of symptoms and objectively by blinded review of videotapes made one month after each injection. Subjective improvement occurred after 79% of injections with botulinum toxin, regardless of dose of toxin. Only 1 patient improved after placebo. Objective improvement was seen after 84% of injections with botulinum toxin. No patient showed objective improvement after placebo injection. The most frequent side effect was facial weakness, seen after 97% of injections of botulinum toxin. Facial bruising (20%), diplopia (13%), ptosis (7%), and various other mild side effects were seen less frequently. Botulinum toxin appears to be an effective and safe method of therapy for hemifacial spasm." ]

[ "16126933", "9377917", "16884530", "3547970", "1503286", "10771799", "2386281", "2060336", "1613206", "1540363", "7697277", "2774261", "2589661", "8968181", "11584255", "7956294", "9677791", "9142578", "9377886", "10378563", "9118709", "8915237", "16505654", "6628007", "6536517", "9515854", "8674333", "2295234", "12771595" ]

[ "Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial.", "A prospective, randomized comparison of an in-line heat moisture exchange filter and heated wire humidifiers: rates of ventilator-associated early-onset (community-acquired) or late-onset (hospital-acquired) pneumonia and incidence of endotracheal tube occlusion.", "Ventilator-associated pneumonia using a heated humidifier or a heat and moisture exchanger: a randomized controlled trial [ISRCTN88724583].", "[Moistening of inspired air during respirator treatment. Comparison between the water-bath evaporator and hygroscopic moisture heat exchanger].", "[Effect of hygrophobic filter or heated humidifier on peroperative hypothermia].", "The effects of passive humidifier dead space on respiratory variables in paralyzed and spontaneously breathing patients.", "Maintenance of body temperature in elderly patients who have joint replacement surgery. A comparison between the heat and moisture exchanger and heated humidifier.", "Heat and moisture exchanger vs heated humidifier during long-term mechanical ventilation. A prospective randomized study.", "Comparison of hydrophobic heat and moisture exchangers with heated humidifier during prolonged mechanical ventilation.", "Do heated humidifiers and heat and moisture exchangers prevent temperature drop during lower abdominal surgery?", "Mechanical ventilation with heated humidifiers or heat and moisture exchangers: effects on patient colonization and incidence of nosocomial pneumonia.", "Passive and active inspired gas humidification in infants and children.", "Passive or active inspired gas humidification increases thermal steady-state temperatures in anesthetized infants.", "Gradual reduction of endotracheal tube diameter during mechanical ventilation via different humidification devices.", "A randomized clinical trial to compare the effects of a heat and moisture exchanger with a heated humidifying system on the occurrence rate of ventilator-associated pneumonia.", "Preservation of humidity and heat of respiratory gases in patients with a minute ventilation greater than 10 L/min.", "Comparison of three different humidification systems during prolonged mechanical ventilation.", "Unfavorable mechanical effects of heat and moisture exchangers in ventilated patients.", "Clinical utility of hygroscopic heat and moisture exchangers in intensive care patients.", "Bedside evaluation of efficient airway humidification during mechanical ventilation of the critically ill.", "Safety of combined heat and moisture exchanger filters in long-term mechanical ventilation.", "Comparison of the effects of heat and moisture exchangers and heated humidifiers on ventilation and gas exchange during weaning trials from mechanical ventilation.", "Double-heater-wire circuits and heat-and-moisture exchangers and the risk of ventilator-associated pneumonia.", "Pulmonary function in mechanically-ventilated patients during 24-hour use of a hygroscopic condensor humidifier.", "Heated humidification in major abdominal surgery.", "A randomized clinical trial comparing an extended-use hygroscopic condenser humidifier with heated-water humidification in mechanically ventilated patients.", "Effects of heat and moisture exchangers on minute ventilation, ventilatory drive, and work of breathing during pressure-support ventilation in acute respiratory failure.", "Heat and moisture exchangers and vaporizing humidifiers in the intensive care unit.", "Mechanical effects of airway humidification devices in difficult to wean patients." ]

[ "The respective influence on the incidence of ventilator-associated pneumonia of currently available systems used for warming and humidifying the gases delivered to mechanically ventilated patients, that is, heated humidifiers and heat and moisture exchanger filters, remains controversial.\n We addressed this question in a multicenter randomized study comparing heated humidifiers (with heated circuits) and filters in an unselected population of 369 intensive care patients receiving mechanical ventilation for more than 48 h.\n The diagnosis of pneumonia was confirmed according to strict microbiologic criteria. There was no difference in pneumonia rate between the two groups (53 of 184 [28.8%] versus 47 of 185 [25.4%] for humidifiers versus filters; p = 0.48), or in the incidence density of pneumonia (27.4/1,000 ventilatory days versus 25.3/1,000 ventilatory days for humidifiers versus filters; p = 0.76). The mean duration of mechanical ventilation did not differ between the two groups (14.9 +/- 15.1 versus 13.5 +/- 16.3 days for humidifiers versus filters, p = 0.36). Endotracheal tube occlusion occurred, respectively, in five patients and one patient in the humidifier and filter groups (p = 0.12). Intensive care mortality was identical in the two groups (about 33%).\n These results suggest that both heated humidifiers and heat and moisture exchanger filters can be used with no significant impact on the incidence of ventilator-associated pneumonia and that other criteria may justify their choice.", "To compare the performance of an in-line heat moisture exchanging filter (HMEF) (Pall BB-100; Pall Corporation; East Hills, NY) to a conventional heated wire humidifier (H-wH) (Marquest Medical Products Inc., Englewood, Colo) in the mechanical ventilator circuit on the incidence of ventilator-associated pneumonia (VAP) and the rate of endotracheal tube occlusion.\n This report describes a prospective, randomized trial of 280 consecutive trauma patients in a 20-bed trauma ICU (TICU). All intubated patients not ventilated elsewhere in the medical center prior to their TICU admission were randomized to either an in-line HMEF or a H-wH in the breathing circuit. Ventilator circuits were changed routinely every 7 days, and closed system suction catheters were changed every 3 days. HMEFs were changed every 24 h, or more frequently if necessary. A specific endotracheal tube suction and lavage protocol was not employed. Patients were dropped from the HMEF group if the filter was changed more than three times a day or the patient was placed on a regimen of ultra high-frequency ventilation. The Centers for Disease Control and Prevention (CDC) criteria for diagnosis of pneumonia were used; early-onset, community-acquired pneumonia was defined if CDC criteria were met in < or =3 days, and late-onset, hospital-acquired pneumonia was defined if criteria were met in >3 days. Laboratory and chest radiograph interpretation were blinded.\n The patient ages ranged from 15 to 95 years in the HMEF group and 16 to 87 years in the H-wH group (p=not significant), with a mean age of 46 years and 48 years, respectively. The male to female ratio ranged between 78 to 82%/22 to 18%, respectively, and 55% of all admissions were related to blunt trauma, 40% secondary to penetrating trauma, and 5% to major burns. There was no difference in Injury Severity Score (ISS) between the two groups. Moreover, there was no significant difference in mean ISS among those who did not develop pneumonia and those patients who developed either early-onset, community-acquired or late-onset, hospital-acquired pneumonia. The HMEF nosocomial VAP rate was 6% compared to 16% for the H-wH group (p<0.05), and total ventilator circuit costs (per group) were reduced. There were no differences in duration of ventilation (mean+/-SD) if the patient did not develop pneumonia or if the patient developed an early-onset, community-acquired or a late-onset, hospital-acquired pneumonia. Moreover, total TICU days were reduced in the HMEF group. In addition, the incidence of partial endotracheal tube occlusion was not significantly different between the H-wH and the HMEF groups.\n The HMEF used in this study reduced the incidence of late-onset, hospital-acquired VAP, but not early-onset, community-acquired VAP, compared to the conventional H-wH circuit. This was associated with a significant reduction in total ICU stay. Disposable ventilator circuit costs in the HMEF group were reduced compared to the H-wH group in whom circuit changes occurred at 7-day intervals.\n The use of the HMEF is a cost-effective clinical practice associated with fewer late-onset, hospital-acquired VAPs, and should result in improved resource allocation and utilization.", "Some guidelines to prevent ventilator-associated pneumonia (VAP) do not establish a recommendation for the preferential use of either heat and moisture exchangers (HMEs) or heated humidifiers (HHs), while other guidelines clearly advocate the use of HMEs. The aim of this study was to determine the incidence of VAP associated with HHs or HMEs.\n A randomized study was conducted in the intensive care unit of a university hospital involving patients expected to require mechanical ventilation for >5 days. Patients were assigned to two groups; one group received HH and the other group received HME. Tracheal aspirate samples were obtained on endotracheal intubation, then twice a week, and finally on extubation, in order to diagnose VAP. Throat swabs were taken on admission to the intensive care unit, then twice a week, and finally at discharge from the intensive care unit in order to classify VAP as primary endogenous, secondary endogenous, or exogenous.\n A total of 120 patients were assigned to HMEs (60 patients) and HHs (60 patients); 16 patients received mechanical ventilation for less than five days and were excluded from the analysis. Data analysis of the remaining 104 patients (53 HMEs and 51 HHs) showed no significant differences between groups regarding sex, age, Acute Physiology and Chronic Health Evaluation II score, pre-VAP use of antibiotics, days on mechanical ventilation, and diagnosis group. VAP was found in eight of 51 (15.69%) patients in the HH group and in 21 of 53 (39.62%) patients in the HME group (P = 0.006). The median time free of VAP was 20 days (95% confidence interval, 13.34-26.66) for the HH group and was 42 days (95% confidence interval, 35.62-48.37) for the HME group (P <0.001). Cox regression analysis showed the HME as a risk factor for VAP (hazard rate, 16.2; 95% confidence interval, 4.54-58.04; P < 0.001).\n The patients mechanically ventilated during more than 5 days developed a lower incidence of VAP with a heated humidifier than heat and moisture exchanger.", "nan", "A study was carried out to find out whether the use of a hygrophobic filter (Pall, Ultipor) or of a heated humidifier (Dräger, Aquapor) during surgery had any effect on a patient's intraoperative core temperature and thermal balance. Seventy-five ASA I or II patients scheduled for gynaecological surgery were randomly assigned to three groups: group A (n = 25), where no warming device was used; and two groups (n = 25 for each) where inhaled gases were humidified and heated with either a hygrophobic filter set up between the endotracheal tube and the Y-piece (group B) or a heated humidifier set to 100% saturation at a temperature of 41.5 degrees C (group C). The patients were all anaesthetised with the same technique (thiopentone 5 mg.kg-1, dextromoramide 0.03 mg.kg-1 and 0.1 mg.kg-1 of either pancuronium or vecuronium, followed by enflurane with nitrous oxide in oxygen); the perfused fluids were not heated. Room, tympanic, rectal, oesophageal and four skin (thorax, arm, leg, thigh) temperatures were measured with calibrated Exacon thermistances, on arrival in the operating theatre, during induction, every ten minutes for two hours, and then every twenty minutes for two hours more. Ramanathan's and Burton's formulae were used to calculate mean skin temperature and heat loss respectively. In the recovery room, patients were warmed up with an electric blanket. Shivering was ranked from \"0\" to \"+ +\". There were no differences between groups as far as age, drug doses, perfusion volumes and room temperature were concerned.(ABSTRACT TRUNCATED AT 250 WORDS)", "Passive humidifiers have gained acceptance in the intensive care unit because of their low cost, simple operation, and elimination of condensate from the breathing circuit. However, the additional dead space of these devices may adversely affect respiratory function in certain patients. This study evaluates the effects of passive humidifier dead space on respiratory function.\n Two groups of patients were studied. The first group consisted of patients recovering from acute lung injury and breathing spontaneously on pressure support ventilation. The second group consisted of patients who were receiving controlled mechanical ventilation and were chemically paralyzed following operative procedures. All patients used 3 humidification devices in random order for one hour each. The devices were a heated humidifier (HH), a hygroscopic heat and moisture exchanger (HHME) with a dead space of 28 mL, and a heat and moisture exchanger (HME) with a dead space of 90 mL. During each measurement period the following were recorded: tidal volume, minute volume, respiratory frequency, oxygen consumption, carbon dioxide production, ratio of dead space volume to tidal volume (VD/VT), and blood gases. In the second group, intrinsic positive end-expiratory pressure was also measured.\n Addition of either of the passive humidifiers was associated with increased VD/VT. In spontaneously breathing patients, VD/VT increased from 59 +/- 13 (HH) to 62 +/- 13 (HHME) to 68 +/- 11% (HME) (p < 0.05). In these patients, constant alveolar ventilation was maintained as a result of increased respiratory frequency, from 22.1 +/- 6.6 breaths/min (HH) to 24.5 +/- 6.9 breaths/min (HHME) to 27.7 +/- 7.4 breaths/min (HME) (p < 0.05), and increased minute volume, from 9.1 +/- 3.5 L/min (HH) to 9.9 +/- 3.6 L/min (HHME) to 11.7 +/- 4.2 L/min (HME) (p < 0.05). There were no changes in blood gases or carbon dioxide production. In the paralyzed patient group, VD/VT increased from 54 +/- 12% (HH) to 56 +/- 10% (HHME) to 59 +/- 11% (HME) (p < 0.05) and arterial partial pressure of carbon dioxide (PaCO2) increased from 43.2 +/- 8.5 mm Hg (HH) to 43.9 +/- 8.7 mm Hg (HHME) to 46.8 +/- 11 mm Hg (HME) (p < 0.05). There were no changes in respiratory frequency, tidal volume, minute volume, carbon dioxide production, or intrinsic positive end-expiratory pressure.\n These findings suggest that use of passive humidifiers with increased dead space is associated with increased VD/VT. In spontaneously breathing patients this is associated with an increase in respiratory rate and minute volume to maintain constant alveolar ventilation. In paralyzed patients this is associated with a small but statistically significant increase in PaCO2.\n Clinicians should be aware that each type of passive humidifier has inherent dead space characteristics. Passive humidifiers with high dead space may negatively impact the respiratory function of spontaneously breathing patients or carbon dioxide retention in paralyzed patients. When choosing a passive humidifier, the device with the smallest dead space, but which meets the desired moisture output requirements, should be selected.", "The effect of a heat and moisture exchanger on intra-operative aural canal (core) and mean skin temperatures was investigated in elderly patients who had elective total hip arthroplasty under general anaesthesia with artificial ventilation of the lungs. Group 1 (n = 20) did not receive any form of artificial humidification while in group 2 (n = 20) a heat and moisture exchanger was inserted in the breathing system and in group 3 (n = 20) the inspired gases were humidified and warmed at 40 degrees C by means of a heated humidifier. Time of surgery, intravenous fluid administration and operating theatre temperature were standardised. Mean (SD) aural canal (core) temperature decreased significantly in groups 1 and 2 (p less than 0.001), while there was a fall of 0.3 degrees C (0.6) in group 3, which was not significant. Mean skin temperature decreased during anaesthesia and surgery in both groups 1 and 2 (p less than 0.05), while it increased in group 3. There was a significantly greater loss of body heat in groups 1 and 2 compared with group 3 intra-operatively (p less than 0.001). We conclude tha a heat and moisture exchanger did not prevent the decrease in intra-operative body temperature in elderly patients.", "Adequate humidification of inspired gases with HMEs during long-term MV remains controversial. In this study, a comparison is made between tracheal secretions during long-term MV either with HME or conventional HH. Both the HME and HH groups were similar with respect to age, sex, diagnosis, duration of MV, SAPS and mortality. Temperature of gases in the tracheal tube was lower and the amount of tracheal instillations was greater in the HME group than in the HH group. Tracheal secretions became thicker between day 1 (control) and day 5, in the HME group than in the HH group. Four and two tube occlusions occurred in HME and HH groups, respectively. Tracheal bacterial colonization was similar in the two groups. Given the advantages of HME (reduced nurses' work and financial cost), HME could be routinely used under cautious surveillance and replaced by HH if difficulty in suctioning occurs.", "Inspired gases must be warmed and humidified during mechanical ventilation. In a prospective randomized study we compared the performance of a heated humidifier (HH) (Draegger Aquaport) and a heat and moisture exchanger (HME) (Pall Filter BB 2215). A total of 116 patients requiring mechanical ventilation (Servo 900 C Siemens) were enrolled into the study and were randomly assigned to 2 groups. Patients in group I were ventilated with a traditional breathing circuit with HH and patients in group II using a simplified circuit with HME. Pre-existing and hospital acquired atelectasis and pneumonia, occurrence of endotracheal tube (ET) occlusion and ventilatory parameters (respiratory rate, tidal volume) were studied. No statistical difference was found between groups for each parameter except the greater frequency of ET occlusions in the II group (0/61 vs 9/55) (p = 0.0008). Pall Filter (PF), a hydrophobic filter, humidifies the dry gases from the condensed water which is put down on the HME surfaces during cooling of saturated expired gases. This purely physical property is linked to the magnitude of the thermic gradient between the expired gases and the ambiant temperature. Performance impairment of PF in our study might be due to high ambiant temperature in the intensive care unit (usually around 28 degrees C) which reduces thermic gradient and water exchanges. We conclude that efficiency of PF may be weak in some conditions of ambiant temperature.", "To compare the effects of using a heated humidifier (HH), a heat and moisture exchanger (HME), or no warming device in maintaining body temperature during surgical procedures of 1 to 4 hours' duration.\n A randomized, controlled study.\n Operating room, Thomas Jefferson University Hospital, Philadelphia, PA.\n 51 ASA physical status I, II, and III patients, age 16 to 69 years, scheduled for a variety of lower abdominal procedures under general endotracheal anesthesia anticipated to last 1 to 4 hours.\n We randomly assigned patients to receiving an HH, an HME, or no warming device during the procedure. We then measured the patient's sublingual temperature every 5 minutes prior to induction, every 15 minutes intraoperatively, and every 15 minutes postoperatively until he or she was discharged from the postanesthesia care unit, (PACU). We also measured the esophageal temperature every 15 minutes intraoperatively.\n Sublingual temperature or esophageal temperature probes placed at the site of maximal heart tones indicated that the patients' temperatures dropped significantly from baseline values in all three groups during the first 60 minutes of surgery, then remained constant during the next 120 minutes of surgery. Patients who had no warming device shivered and felt cold significantly more often than patients in the HH group but not more often than patients in the HME group. There was no difference in shivering between the HH and HME groups. The patients who received an HH tended to have a higher temperature (a mean of 0.5 degrees C) throughout the study, but this did not reach statistical significance.\n Results indicate that these warming devices provide little benefit in preventing a temperature drop during procedures of 1 to 4 hours' duration, although patients with an HH tended to have a higher temperature than those with an HME or no device.", "The contribution of ventilator circuit bacterial contamination to the occurrence of ventilator-associated pneumonia remains controversial. In a previous study, we found that the incidence of pneumonia was identical with ventilator circuit changes every 48 h and with no ventilator circuit changes. The present study prospectively assessed whether keeping ventilator circuits clean with a heat and moisture exchanger exhibiting antimicrobial barrier properties affects patient colonization and the incidence of nosocomial pneumonia in patients receiving mechanical ventilation for more than 48 h. Consecutive patients were randomly allocated to humidification with either a heat and moisture exchanger (Group 1, n = 61) or a heated humidifier (Group 2, n = 70). In both groups, no circuit changes were performed throughout ventilatory support. Duration of mechanical ventilation was identical in both groups (10 +/- 8.6 d (range: 2 to 47) in Group 1 and 12.5 +/- 14.2 d [range: 2 to 85] in Group 2). The incidence of pneumonia (positive quantitative culture of protected brush specimen) was similar in both groups (6/61 and 8/70 in Groups 1 and 2, respectively; p = 0.8), as was duration of ventilation prior to pneumonia (9 +/- 5.9 versus 8.2 +/- 5.7 d; p = 0.8). Ventilator tubing contamination was considerably reduced with the use of a heat and moisture exchanger. In contrast, bacterial colonization of the pharynx and trachea was identical in both groups. These results suggest that circuit colonization plays little or no role in the occurrence of ventilator-associated pneumonia, provided usual maintenance precautions are applied.(ABSTRACT TRUNCATED AT 250 WORDS)", "The hypothesis that both active and passive airway humidification prevents hypothermia in infants and children, but that neither decreases the duration of postoperative recovery was tested. Twenty-seven ASA physical status 1 or 2 patients were studied who weighed between 5 and 30 kg, underwent superficial operations, were anesthetized with halothane and 70% N2O, and whose lungs were ventilated via a Rees modification of an Ayre's t-piece. The children were randomly assigned to receive active airway humidification and warming using an MR450 Servo airway heater and humidifier set at 37 degrees C (n = 10), passive airway humidification using the Humid-Vent 1 heat and moisture exchanger placed between the Ayre's t-piece and the endotracheal tube (n = 8), or no airway humidification and heating (control, n = 9). Distal tracheal and tympanic membrane temperatures and airway humidity were recorded during the first 90 min of surgery. Rectal temperature was measured during the postanesthetic recovery period. Relative humidity of inspired respiratory gases was approximately 30% in the control group and approximately 90% in the group given active airway humidification. Initial inspired humidity in the passive humidification group (50%) increased to approximately 80%, a level not significantly different from that in the active group after 80 min of anesthesia. Central body temperature increased 0.25 degrees C during active active airway humidification and heating, whereas temperature decreased 0.25 degrees C during passive humidification and 0.75 degrees C without airway humidification. Distal tracheal temperature was significantly higher in the groups given passive and active humidification than in the control group.(ABSTRACT TRUNCATED AT 250 WORDS)", "We tested the hypothesis that active and passive airway humidification minimize hypothermia in infants, but that maintaining normothermia does not decrease the duration of postoperative recovery. A circle system was used to ventilate the lungs of anesthetized, intubated infants who were randomly assigned to active airway humidification and warming with use of an MR450 Servo airway heater and humidifier set at 37 degrees C (n = 10), passive airway humidification with use of the Humid-Vent Mini heat and moisture exchanger placed between the Y-piece of the circle and the endotracheal tube (n = 10), or no airway humidification and heating (control, n = 10). Anesthesia was induced with thiopental and maintained with isoflurane and nitrous oxide in oxygen. The relative humidity of inspired respiratory gases was approximately 35% in the control group and approximately 90% in the group undergoing active airway humidification. Initial inspired humidity in the passive humidification group (45%) increased to approximately 80% after 1 h of anesthesia. Humidity differed significantly across groups at all times (P less than or equal to 0.05). Steady-state rectal temperatures (100-120 min after induction) were 36.2 +/- 0.7 degrees C in patients given active humidification and heating, 35.7 +/- 0.9 degrees C in the passively humidified group, and 35.2 +/- 0.4 degrees C in the control group (P less than or equal to 0.05 between each group). Recovery from general anesthesia was rapid in all patients and did not correlate with central temperature changes or type of humidification (P = NS).(ABSTRACT TRUNCATED AT 250 WORDS)", "Limited data suggest that increased resistance to flow within endotracheal tubes (ETT) may occur in patients whose lungs are mechanically ventilated for more than 48 h, especially when airway humidification is inadequate. This could lead to sudden ETT obstruction or induce excessive loading during spontaneous breathing.\n Twenty-three such patients were randomly assigned to three types of airway humidifier based on three different working principles: a Fisher Paykell hot water system (n = 7), a Pall BB2215 heat and moisture exchanger (HME) hydrophobic filter (n = 8), and a Dar Hygrobac 35254111 HME hygroscopic filter (n = 8). The decrease in internal pressure along the ETT and the flow rate were measured in each patient every 2 days. An \"effective inner diameter\" was derived from these measurements and allowed the inner ETT configuration to be monitored.\n On the first day of intubation, the mean diameter was similar in the three groups, and was slightly smaller than the in vitro diameter (mean +/- SD: 7.6 +/- 0.6 mm for Fisher-Paykell, 7.7 +/- 0.4 for Pall, and 7.5 +/- 0.4 for Dar). The mean diameter tended to decrease from day to day. At the end of the study, the overall reduction in mean diameter was significantly greater with the hydrophobic HME (Pall) than with the two other systems (Pall: -6.5 +/- 4% vs. 2.5 +/- 2.5% for Dar and 1.5 +/- 3% for Fisher-Paykell; P < 0.01 with analysis of variance). The same was true of the mean reduction in effective inner ETT diameter expressed per day of ventilation (-1.6 +/- 1.5% per day for Pall vs. -0.5 +/- 0.4% for Dar and -0.2 +/- 0.4% for Fisher-Paykell; P < 0.01). In four patients, the ETT became obstructed and emergency repeated tracheal intubation was required. The Pall HME and the Fisher-Paykell system were being used in three and one patient, respectively. Before obstruction, the reduction in ETT diameter was significantly greater for these four patients than for the remaining 23 patients (7.8 +/- 1.4% vs. 3.1 +/- 4.1%; P < 0.01).\n During prolonged mechanical ventilation, significant alterations in inner ETT configuration occur frequently and are influenced by the type of humidification device used. In vivo monitoring of ETT mechanical properties might be clinically useful.", "The purpose of this study was to compare the performance of heat and moisture exchanger filters with heated humidifying systems in the mechanical ventilator circuit on the incidence of ventilator-associated pneumonia (VAP) and bacterial colonization.\n Two hundred and forty-three consecutive patients who required mechanical ventilation for 48 hours or more in the adult intensive care unit were randomized to either a heat and moisture exchanger (HME) or a heated humidifying breathing circuit.\n The VAP rate among the group with HME was 11.4%; the rate among the group with heated humidifying system (HHS) was 15.8%. The difference was not statistically significant. Approximately 68% of the patients in the HME group had no pathogen isolated compared with 50% of the patients in the HHS group. This difference was statistically significant (P =.006). However, the distribution of the pathogens among those patients who had the isolated pathogens was mostly identical in the 2 groups.\n Even though the study did not find HME to be significantly advantageous over the HHS, in as much as VAP rate is concerned, other advantages such as reduced nurses workload, reduced financial cost, and better safety made HME a more favorable device for use in our adult intensive care unit.", "To compare the temperature and humidification output of one heated humidifier system (Bennett Cascade 2 Humidifier) and two heat and moisture exchangers (Pall Ultipor, BB 50, and Humid-Vent Filter) in intensive care unit (ICU) patients submitted to a minute ventilation of > 10 L/min.\n Prospective, controlled, randomized, unblinded study.\n ICU of a university hospital.\n Eleven sedated and paralyzed patients who required controlled mechanical ventilation with a minute ventilation of > 10 L/min for > 3 days.\n After a randomized selection process, the patients were ventilated for 24-hr periods with the humidifier and one of the heat and moisture exchangers. Both heat and moisture exchangers were first tested for 45 mins; then, the heat and moisture exchanger that demonstrated the best performance in terms of temperature and water preservation was tested for 24 hrs.\n During the inspiration phase for each patient, the following measurements were performed: mean and minimum values of temperature, relative and absolute humidity of inspired gases. During the 45-min test period, the Humid-Vent Filter had a better temperature and humidification output than the Pall Ultipor Filter and thus was tested for 24 hrs. The Bennett Cascade 2 Humidifier and the Humid-Vent Filter had a better thermic capacity than the Pall Ultipor Filter (p < .001). No difference was ever observed between the Bennett Cascade 2 Humidifier and the Humid-Vent Filter regarding relative humidity. The Pall Ultipor Filter had a lower temperature and humidification output when compared with the other two systems (p < .007). Concerning absolute humidity of inspired gases, the Pall Ultipor Filter achieved a lower performance than any other tested systems (p < .02). A small but significant decrease in temperature and absolute humidity, but not in relative humidity, was seen after 24 hrs of use with the Humid-Vent Filter. However, with this heat and moisture exchanger, all patients had an absolute humidity of > 28 mg H2O/L and a relative humidity of > 93% after 24 hrs of use.\n In patients with a minute ventilation of > 10 L/min (> 10.5 to 16.0 L/min), the Humid-Vent Filter had a temperature and humidification output close to the reference system (the Bennett Cascade 2 Humidifier). The Pall Ultipor Filter had a significantly lower temperature and humidification output in these patients.", "An efficient humidification system is expected to maintain fluid and easily drainable airway secretions. This study aims to compare the efficiency and safety of three humidification systems during prolonged mechanical ventilation.\n Two-center, prospective, randomized study.\n 45 critically ill patients undergoing mechanical ventilation were included in the study and allocated to receive one of three humidification techniques: 1) Bennett Cascade water-bath humidifier (Bennett group); 2) Fisher & Paykel servocontrolled humidifier (F & P group); 3) HME Hygrobac DAR (HME group). Clinical and experimental observations were conducted for 3 to 7 consecutive days and included: body T degree, room T degree, inspired gas T degree, tracheal T degree, relative and absolute humidity, heat and water loss, airway secretion score, need for endotracheal saline instillation and incidence of ETT occlusion.\n The HME group showed a lower temperature of inspired gases compared to the F & P group (p < 0.05); it also showed a lower absolute humidity compared to both Bennett and F & P groups (p < 0.05). A better airway secretion score was obtained in Bennett and F & P groups compared to the HME group (p < 0.01).\n Passive humidification systems provided low degrees of humidity and temperature and could not maintain good secretions. Active systems appeared to satisfy the recommended standards and to allow fluid and easily drainable secretions.", "To investigate the mechanical effects of artificial noses.\n A general intensive care unit of a university hospital.\n 10 patients in pressure support ventilation for acute respiratory failure.\n The following three conditions were randomly tested on each patient: the use of a heated humidifier (control condition), the use of a heat and moisture exchanger without filtering function (HME), and the use of a combined heat and moisture exchanger and mechanical filter (HMEF). The pressure support level was automatically adapted by means of a closed-loop control in order to obtain constancy, throughout the study, of patient inspiratory effort as evaluated from airway occlusion pressure at 0.1 s (P0.1). Patient's ventilatory pattern, P0.1, work of breathing, and blood gases were recorded.\n The artificial noses increased different components of the inspiratory load: inspiratory resistance, ventilation requirements (due to increased dead space ventilation), and dynamic intrinsic positive end-expiratory pressure (PEEP). The additional load imposed by the artificial noses was entirely undertaken by the ventilator, being the closed-loop control of P0.1 effective to maintain constancy of patient inspiratory work by means of adequate increases in pressure support level.\n The artificial noses cause unfavorable mechanical effects by increasing inspiratory resistance, ventilation requirements, and dynamic intrinsic PEEP. Clinicians should consider these effects when setting mechanical ventilation and when assessing patients' ability to breathe spontaneously.", "To compare the degree of bacterial circuit colonization, frequency of ventilator-associated pneumonia (VAP), character of respiratory secretions, rewarming of hypothermic patients, disposable costs, and air flow resistance in intensive care patients ventilated using either a heat and moisture exchanger (HME) or hot water (HW) humidifier circuit.\n A prospective, randomized blinded trial of patients in the intensive care unit undergoing mechanical ventilation.\n A metropolitan teaching hospital.\n One hundred sixteen patients undergoing mechanical ventilation for a minimum period of 48 hrs were enrolled.\n Patients were randomized to three ventilation groups using a) an HW circuit with a 2-day circuit change (n = 41); or b) a bacterial-viral filtering HME in the circuit, with either a 2-day (n = 42); or c) a 4-day circuit change (n = 33).\n Circuit colonization was assessed using quantitative culture of washings taken from the circuit tubing and semiquantitative culture of swabs from the Y connectors. Sixty-seven percent of HW circuits became contaminated compared with 12% in the two HME groups (p < .0001). Median colony counts were lower in the HME groups (p < .0001). If circuits at first circuit change were contaminated in the HW group, 89% of subsequent circuit changes became contaminated compared with 0% and 25% for the 2- and 4-day HME groups, respectively. The frequency of VAP, the time to resolution of admission hypothermia, and the volume and fluidity of secretions were similar for all groups. The resistance of the HME after 24 hrs of use was < 0.025 cm H2O/L at gas flows of 40 L/min. HME use resulted in a cost reduction of $1.48 (Australian)/day.\n Circuits with a bacterial-viral filtering HME are less readily colonized by bacteria. Contamination is a random event. Humidification technique has no influence on the frequency rate of VAP, the effectiveness of rewarming, nor the character of the respiratory secretions. Breathing resistance is generally low and disposable costs are reduced when an HME is used.", "To determine the correlation between simple rating of condensation seen in the flex-tube connecting the heating and humidifying device used with the endotracheal tube and hygrometric parameters (absolute and relative humidity and tracheal temperature) measured by psychrometry.\n Prospective randomized clinical trial.\n Medical ICU of Louis Mourier Hospital, Colombes, France, a university-affiliated teaching hospital.\n Forty-five consecutive mechanically ventilated critically ill patients.\n Patients undergoing mechanical ventilation were randomly assigned to receive humidification with one of the four heat and moisture exchangers (HMEs) tested or with a conventional heated humidifier.\n The hygrometric performances of four HMEs (BB2215, BB50, and BB100 from Pall Biomedical, Saint-Germaine-en-Laye, France; and Hygrobac-Dar from Mallinckrodt, Mirandola, Italy) and a heated humidifier (Fisher & Paykel; Auckland, New Zealand) were studied after 3 h and also after 48 h of use for the Hygrobac-Dar and correlated to a clinical visual inspection rating the amount of condensation in the flex-tube of the endotracheal tube.\n A total of 95 measurements in 45 patients were performed. The best hygrometric parameters were obtained with the heated humidifier (p < 0.001). The Hygrobac-Dar yielded significantly higher values for both humidities and tracheal temperature than the other three HMEs (p < 0.001). The performance of Hygrobac-Dar was unchanged after 48 h of use. There was a significant correlation between the condensation seen in the flex-tube and the hygrometric parameters measured by psychrometry (absolute humidity, rho = 0.7; relative humidity, rho = 0.7; tracheal temperature, rho = 0.5, p < 0.0001).\n In mechanically ventilated ICU patients, visual evaluation of the condensation in the flex-tube provides an estimation of the heating and humidifying efficacy of the heating and humidifying device used, thus allowing the clinician bedside monitoring of airway humidification.", "To evaluate the safety of a combined heat and moisture exchanger filter (HMEF) for the conditioning of inspired gas in long-term mechanical ventilation (MV).\n Randomized controlled trial.\n Medical ICU in a large teaching hospital.\n One hundred fifteen consecutive patients who required > or = 48 h of MV.\n Patients were randomized at intubation time (day 1) to receive inspired gas conditioned either by a water-bath humidifier heated at 32 degrees C (HWBH) or by an HMEF (Hygroster; DAR; Mirandola, Italy).\n The two study groups were comparable in terms of primary pathologic condition at the time of hospital admission, disease severity as measured by the Simplified Acute Physiology Score, and ICU mortality. They did not differ with respect to ventilator days per patient (mean +/- SD: HMEF, 7.6 +/- 6.5; HWBH, 7.8 +/- 5.8), incidence of endotracheal tube obstruction (HMEF, 0/59; HWBH, 1/56), and incidence of hypothermic episodes (HMEF, five; HWBH, two). In 41 patients receiving MV for > or = 5 days, the morphologic integrity of respiratory epithelium was evaluated on day 1 and day 5, using a cytologic examination of tracheal aspirate smears. The state of ciliated epithelium was scored on a scale from 0 (poorest integrity) to 1,200 (maximum integrity), according to a well-described method. In both patient groups, the scores slightly but significantly decreased from day 1 to day 5 (mean +/- SD: HWBH, from 787 +/- 104 to 745 +/- 88; HMEF, from 813 +/- 79 to 739 +/- 62; p < 0.01 for both groups); there were no statistically significant differences between groups.\n These data indicate acceptable safety of HMEFs of the type used in the present study for long-term mechanical ventilation.", "Heat and moisture exchangers (HME) are increasingly used to warm and humidify inspired gases in intubated ventilated patients. But these devices add dead space that may alter the alveolar ventilation. This could impair the efficiency of spontaneous ventilation (SV) during weaning trials from mechanical ventilation. Fifteen patients were tested with an HME (Hygrobac-DAR) and a heated humidifier (HH) (Fischer-Paykel MR 450) in a random order during weaning trials in SV with inspiratory pressure support. Minute ventilation VE, tidal volume), and respiratory rate were recorded and arterial blood was sampled for blood gas analysis with each device. The HME gave a significantly greater VE than the HH (9.3 +/- 0.8 L/min vs 8.1 +/- 0.8 L/min; p < 0.005), because of increased respiratory rate (21 +/- 2/min vs 19 +/- 2/min; p < 0.05). Tidal volume was unchanged for HME and HH (470 +/- 32 mL vs 458 +/- 39 mL). The higher PaCO2 with HME than with HH (44 +/- 2 mm Hg vs 42 +/- 2 mm Hg; p < 0.005) revealed an insufficient alveolar ventilation response to the increase in dead space. Arterial Po2 rose with the HME, but not significantly above the HH values (103 +/- 6 mm Hg vs 97 +/- 6 mm Hg; p = 0.055), possibly because of a positive end-expiratory pressure effect of the HME. The need to increase VE in SV when an HME is used should be taken into account during difficult weaning from mechanical ventilation.", "To compare the incidence of ventilator-associated pneumonia (VAP) in patients ventilated in intensive care by means of circuits humidified with a hygroscopic heat-and-moisture exchanger with a bacterial viral filter (HME) or hot-water humidification with a heater wire in both inspiratory and expiratory circuit limbs (DHW) or the inspiratory limb only (SHW).\n A prospective, randomized trial.\n A metropolitan teaching hospital's general intensive care unit.\n Three hundred eighty-one patients requiring a minimum period of mechanical ventilation of 48 hrs.\n Patients were randomized to humidification with use of an HME (n=190), SHW (n=94), or DHW (n=97).\n Study end points were VAP diagnosed on the basis of Clinical Pulmonary Infection Score (CPIS) (), HME resistance after 24 hrs of use, endotracheal tube resistance, and HME use per patient. VAP occurred with similar frequency in all groups (13%, HME; 14%, DHW; 10%, SHW; p=0.61) and was predicted only by current smoking (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.1-3.9; p=.03) and ventilation days (AOR, 1.05; 95% CI, 1.0-1.2; p=.001); VAP was less likely for patients with an admission diagnosis of pneumonia (AOR, 0.40; 95% CI, 0.4-0.2; p=.04). HME resistance after 24 hrs of use measured at a gas flow of 50 L/min was 0.9 cm H2O (0.4-2.9). Endotracheal tube resistance was similar for all three groups (16-19 cm H2O min/L; p=.2), as were suction frequency, secretion thickness, and blood on suctioning (p=.32, p=.06, and p=.34, respectively). The HME use per patient per day was 1.13.\n Humidification technique does not influence either VAP incidence or secretion characteristics, but HMEs may have air-flow resistance higher than manufacturer specifications after 24 hrs of use.", "Hygroscopic condensor humidifiers (HCH) are reportedly capable of humidifying even the driest of ventilator source gases with at least 30 mg H2O/liter of ventilation. To assess the adequacy of the HCH during mechanical ventilation, we studied 26 patients over a 72-hour period (alternating 24-hour periods of humidification by a conventional cascade and the HCH). In these patients, we found no significant difference in static lung compliance, airway resistance, PaO2, and PaCO2 on either system. Additionally, estimates of sputum volume (over a four-hour collection period) and clearance of aerosolized 99mTc labelled DTPA (in five of these patients) also showed no significant differences between the two systems. We conclude that the HCH is capable of supplying necessary heat and moisture to most mechanically-ventilated patients for at least a period of 24 hours.", "The influence of heated humidification on body temperature and postoperative shivering was studied in 30 patients undergoing major intra-abdominal surgery. In the control group (I) the anaesthetic gases, administered in a non-rebreathing system, were humidified by a sponge heat and moisture exchanger. In group II the gases were humidified and heated to 37 degrees C and in group III up to 40 degrees C. Anaesthesia, surface insulation and warming of the infusions were standardized. The temperature was registered at the lower oesophagus and the big toe. Shivering and the feeling of cold were estimated at 15 min intervals postoperatively. A good correlation was found between heat gain during the first hour of recovery, the feeling of cold and intensity of shivering. Intraoperative heat loss was minimal in all groups. Heated humidification had no statistically significant effect on the body temperatures or postoperative shivering and thus provided no additional advantage compared to the control group.", "To determine the safety and cost-effectiveness of mechanical ventilation with an extended-use hygroscopic condenser humidifier (Duration; Nellcor Puritan-Bennett; Eden Prairie, Minn) compared with mechanical ventilation with heated-water humidification.\n Prospective randomized clinical trial.\n Medical and surgical ICUs of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital.\n Three hundred ten consecutive qualified patients undergoing mechanical ventilation.\n Patients requiring mechanical ventilation were randomly assigned to receive humidification with either an extended-use hygroscopic condenser humidifier (for up to the first 7 days of mechanical ventilation) or heated-water humidification.\n Occurrence of ventilator-associated pneumonia, endotracheal tube occlusion, duration of mechanical ventilation, lengths of intensive care and hospitalization, acquired multiorgan dysfunction, and hospital mortality.\n One hundred sixty-three patients were randomly assigned to receive humidification with an extended-use hygroscopic condenser humidifier, and 147 patients were randomly assigned to receive heated-water humidification. The two groups were similar at the time of randomization with regard to demographic characteristics, ICU admission diagnoses, and severity of illness. Risk factors for the development of ventilator-associated pneumonia were also similar during the study period for both treatment groups. Ventilator-associated pneumonia was seen in 15 (9.2%) patients receiving humidification with an extended-use hygroscopic condenser humidifier and in 15 (10.2%) patients receiving heated-water humidification (relative risk, 0.90; 95% confidence interval=0.46 to 1.78; p=0.766). No statistically significant differences for hospital mortality, duration of mechanical ventilation, lengths of stay in the hospital ICU, or acquired organ system derangements were found between the two treatment groups. No episode of endotracheal tube occlusion occurred during the study period in either treatment group. The total cost of providing humidification was $2,605 for patients receiving a hygroscopic condenser humidifier compared with $5,625 for patients receiving heated-water humidification.\n Our findings suggest that the initial application of an extended-use hygroscopic condenser humidifier is a safe and more cost-effective method of providing humidification to patients requiring mechanical ventilation compared with heated-water humidification.", "To evaluate the effect of two commonly used heat and moisture exchangers on respiratory function and gas exchange in patients with acute respiratory failure during pressure-support ventilation.\n Prospective, randomized trial.\n Intensive care unit of a university hospital.\n Fourteen patients with moderate acute respiratory failure, receiving pressure-support ventilation.\n Patients were assigned randomly to two treatment groups, in which two different heat and moisture exchangers were used: Hygroster (DAR S.p.A., Mirandola, Italy) with higher deadspace and lower resistance (group 1, n = 7), and Hygrobac-S (DAR S.p.A.) with lower deadspace and higher resistance (group 2, n = 7). Patients were assessed at three pressure-support levels: a) baseline (10.3 +/- 2.4 cm H2O for group 1, 9.3 +/- 1.3 cm H2O for group 2); b) 5 cm H2O above baseline; and c) 5 cm H2O below baseline. Measurements obtained with the heat and moisture exchangers were compared with those values obtained using the standard heated hot water humidifier.\n At baseline pressure-support ventilation, the insertion of both heat and moisture exchangers induced in all patients a significant increase in the following parameters: minute ventilation (12.4 +/- 3.2 to 15.0 +/- 2.6 L/min for group 1, and 11.8 +/- 3.6 to 14.2 +/- 3.5 L/min for group 2); static intrinsic positive end-expiratory pressure (2.9 +/- 2.0 to 5.1 +/- 3.2 cm H2O for group 1, and 2.9 +/- 1.7 to 5.5 +/- 3.0 cm H2O for group 2); ventilatory drive, expressed as P41 (2.7 +/- 2.0 to 5.2 +/- 4.0 cm H2O for group 1, and 3.3 +/- 2.0 to 5.3 +/- 3.0 cm H2O for group 2); and work of breathing, expressed as either power (8.8 +/- 9.4 to 14.5 +/- 10.3 joule/ min for group 1, and 10.5 +/- 7.4 to 16.6 +/- 11.0 joule/min for group 2) or work per liter of ventilation (0.6 +/- 0.6 to 1.0 +/- 0.7 joule/L for group 1, and 0.8 +/- 0.4 to 1.1 +/- 0.5 joule/L. for group 2). These increases also occurred when pressure-support ventilation was both above and below the baseline level, although at high pressure support the increase in work of breathing with heat and moisture exchangers was less evident. Gas exchange was unaffected by heat and moisture exchangers, as minute ventilation increased to compensate for the higher deadspace produced in the circuit by the insertion of heat and moisture exchangers.\n The tested heat and moisture exchangers should be used carefully in patients with acute respiratory failure during pressure-support ventilation, since these devices substantially increase minute ventilation, ventilatory drive, and work of breathing. However, an increase in pressure-support ventilation (5 to 10 cm H2O) may compensate for the increased work of breathing.", "A prospective, randomized, controlled study was undertaken to compare the Pall Ultipor breathing circuit filter (PUBCF), a heat-and-moisture exchanger, and heated hot water systems (HHWSs) in ICU patients submitted to controlled mechanical ventilation. Humidification of inspired gas and bacterial contamination of breathing circuits were evaluated. During the study, there were six episodes of tracheostomy tube (TT) occlusion in six patients included in the PUBCF group. No patient out of 42 included in the HHWS group experienced this complication (p less than 0.01). There were 4 percent of days with thick and tenacious bronchial secretions in the PUBCF group and no case in the HHWS group (p less than 0.02). In the PUBCF group, 23 percent of days with hypothermia were noted as opposed to 12 percent in the HHWS group (p less than 0.01). Fewer breathing circuits were found to be contaminated in the PUBCF group (11 percent) than in the HHWS group (54 percent, p less than 0.01). In patients with an organism growing in bronchial specimens, the same organism was found to contaminate the breathing circuit in 10 percent of cases in the PUBCF group and 77 percent of cases in the HHWS (p less than 0.01). We conclude that, in the conditions of this study, the PUBCF did not provide sufficient humidification of inspired gas in ICU patients. Protection against contamination of breathing circuits was effective, but 10 percent of patients remained at risk for this complication.", "To evaluate the influence of airway humidification devices on the efficacy of ventilation in difficult to wean patients.\n A prospective, randomized, controlled physiologic study.\n A 22-bed medical intensive care unit in a university hospital.\n Chronic respiratory failure patients.\n Performances of a heated humidifier and a heat and moisture exchanger were evaluated on diaphragmatic muscle activity, breathing pattern, gas exchange, and respiratory comfort during weaning from mechanical ventilation by using pressure support ventilation. Eleven patients with chronic respiratory failure were submitted to four pressure support ventilation sequences by using the heated humidifier and the heat and moisture exchanger at two different levels of pressure support ventilation (7 and 15 cm H(2)O).\n Compared with the heated humidifier and regardless of the pressure support ventilation level used, the heat and moisture exchanger significantly increased all of the inspiratory effort variables (inspiratory work of breathing expressed in J/L and J/min, pressure time product, changes in esophageal pressure, and transdiaphragmatic pressure; p <.05) and dynamic intrinsic positive end-expiratory pressure (p <.05). Similarly, the heat and moisture exchanger produced a significant increase in Paco(2) (p <.01) responsible for severe respiratory acidosis (p <.05), which was insufficiently compensated for despite a significant increase in minute ventilation (p <.05). This resulted in respiratory discomfort for all patients with the heat and moisture exchanger (p <.01). Adverse effects were partially counterbalanced by increasing the pressure support ventilation level with the heat and moisture exchanger by >or=8 cm H(2)O.\n The type of airway humidification device used may negatively influence the mechanical efficacy of ventilation and, unless the pressure support ventilation level is considerably increased, the use of a heat and moisture exchanger should not be recommended in difficult or potentially difficult to wean patients with chronic respiratory failure." ]

[ "1312317", "1553930", "9625132", "10696629" ]

[ "Dietary supplementation with fish oil in ulcerative colitis.", "Fish oil fatty acid supplementation in active ulcerative colitis: a double-blind, placebo-controlled, crossover study.", "Distal procto-colitis, natural cytotoxicity, and essential fatty acids.", "Comparison of omega-3 fatty acids and sulfasalazine in ulcerative colitis." ]

[ "To determine the efficacy of fish oil supplementation in patients with active ulcerative colitis.\n Multicenter, randomized, double-blind, placebo-controlled, crossover trail with 4-month treatment periods (fish oil and placebo) separated by a 1-month washout.\n Four gastroenterology divisions.\n Twenty-four patients with active ulcerative colitis entered the study. Five dropped out, and one was noncompliant. Eighteen patients completed the study. All patients had active disease as manifested by diarrhea and rectal inflammation.\n Treatment with prednisone and sulfasalazine was continued. Fish oil supplementation consisted of 18 Max-EPA (eicosapentaenoic acid) capsules daily (eicosapentaenoic acid, 3.24 g; and docosahexaenoic acid, 2.16 g). Placebo supplementation consisted of 18 identical capsules containing isocaloric amounts of vegetable oil.\n Patients were evaluated at study entry and after each diet period. Evaluations included a review of symptoms, flexible sigmoidoscopy, rectal biopsy, and rectal dialysis to measure prostaglandin E2 and leukotriene B4 levels.\n Fish oil supplementation resulted in a significant decrease in rectal dialysate levels of leukotriene B4 from 71.0 to 27.7 pg/mL (average change, -43.3 pg/mL; 95% CI, -83 to -3.6). Significant improvements were seen in acute histology index (average change, -8.5 units from a baseline of 10.5 units; CI, -12.9 to -4.2) and total histology index (average change, -8.5 units from a baseline of 14.80; CI, -13.2 to -3.8) as well as significant weight gain (average weight gain, 1.74 kg, CI, 0.94 to 2.54). No significant changes occurred in any variable during the placebo period. Seven patients received concurrent treatment with prednisone. During the fish oil supplementation period, the mean prednisone dose decreased from 12.9 mg/d to 6.1 mg/d and rose from 10.4 mg/d to 12.9 mg/d during the placebo diet period (P greater than 0.20).\n Four months of diet supplementation with fish oil in patients with inflammatory bowel disease resulted in reductions in rectal dialysate leukotriene B4 levels, improvements in histologic findings, and weight gain.", "Arachidonic acid metabolites formed by both the cyclooxygenase and lipoxygenase pathways may contribute to the clinical diarrhea and colitis of inflammatory bowel disease. Patients with active ulcerative colitis have increased levels of leukotriene B4 in their rectal mucosa, and these levels tend to correlate with severity of the disease. In this study, we evaluated the efficacy of ingestion of fish oil n-3-omega-fatty acids, inhibitors of leukotriene synthesis, in the treatment of ulcerative colitis. Eleven patients with ulcerative colitis of mild to moderate severity were studied in a 8-month, double-blind, placebo-controlled, crossover trial of dietary supplementation with fish oil, which provided about 4.2 g of omega-3- fatty acids per day. A disease activity index based on patient symptoms and sigmoidoscopic appearance was used to assess efficacy. Mucosal leukotriene B4 production was measured by radioimmunoassay. Mean disease activity index declined 56% for patients receiving fish oil and 4% for patients on placebo (p less than 0.05). There were no statistically significant differences in histopathologic scores or colonic mucosal leukotriene B4 levels. All patients tolerated fish oil ingestion and showed no alteration in routine blood studies. No patient worsened; anti-inflammatory drugs could be reduced or eliminated in eight patients (72%) while receiving fish oil. We conclude that fish oil dietary supplementation results in clinical improvement of active mild to moderate ulcerative colitis but is not associated with significant reduction in mucosal leukotriene B4 production, compared with placebo therapy. Further studies are needed to elucidate the mechanism of action and optimal dose and duration of fish oil supplementation in ulcerative colitis.", "Recently, it has been postulated that patients with ulcerative colitis have altered natural cytotoxicity, in particular natural killer (NK) and lymphokine-activated killer (LAK) cell activities. These cellular mechanisms have been postulated to play an etiological role in the pathogenesis of the disease process. We have shown previously that the essential fatty acids (EFA) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) specifically inhibit natural cytotoxicity. Our aim was to evaluate the role of omega-3 EFA in the modulation of natural cytotoxicity and disease activity in patients with distal procto-colitis.\n In this pilot study patients were randomized into two groups. Each patient received either fish oil extract (EPA, 3.2 g, and DHA, 2.4 g) (n = 9) or sunflower oil (placebo) (n = 9) daily in a double-blind manner for 6 months. Monthly assessments of disease activity (clinical and sigmoidoscopic scores) and histological evaluation of mucosal biopsies were carried out. Also, the circulating levels and activities of NK and LAK cells, using flow cytometric analysis (CD16+ CD56+) and in vitro 51 chromium release assays (K562), respectively, were monitored.\n After 6 months' supplementation with EFA, there was improvement in the clinical activity compared with pretreatment evaluation. There was significant reduction in the sigmoidoscopic and histological scores in the EFA group compared with the placebo group. Essential fatty acid supplementation for 6 months also induced significant reduction in the circulating numbers of CD16+ and CD56+ cells and the cytotoxic activity of NK cells, compared with the placebo group.\n This pilot study has demonstrated that omega-3 fatty acids can suppress natural cytotoxicity and reduce disease activity in patients with distal procto-colitis. These findings suggest a therapeutic strategy for managing patients with inflammatory bowel disease.", "Fish oil omega-3 fatty acids exert antiinflammatory effects on patients with ulcerative colitis. However, a comparative study in patients with mild to moderate ulcerative colitis receiving only sulfasalazine or omega-3 fatty acids has not been performed. We sought to detect changes in the inflammatory disease activity with the use of either fish oil omega-3 fatty acids or sulfasalazine in patients with ulcerative colitis. Ten patients (five male, five female; mean age = 48 +/- 12 y) with mild to moderate active ulcerative colitis were investigated in a randomized cross-over design. They received either sulfasalazine (2 g/d) or omega-3 fatty acids (5.4 g/d) for 2 m.o. Disease activity was assessed by clinical and laboratory indicators, sigmoidoscopy, histology, and whole-body protein turnover (with 15N-glycine). Treatment with omega-3 fatty acids resulted in greater disease activity as detected by a significant increase in platelet count, erythrocyte sedimentation rate, C-reactive protein, and total fecal nitrogen excretion. No major changes in protein synthesis and breakdown were observed during either treatment. In conclusion, treatment with sulfasalazine is superior to treatment with omega-3 fatty acids in patients with mild to moderate active ulcerative colitis." ]

[ "11335737", "8108199", "9651453", "12640369", "12824660" ]

[ "Resuscitation with room air instead of 100% oxygen prevents oxidative stress in moderately asphyxiated term neonates.", "Resuscitation of asphyxic newborn infants with room air or 100% oxygen.", "Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study.", "Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen.", "Resuscitation of asphyxiated newborns with room air or 100% oxygen at birth: a multicentric clinical trial." ]

[ "Traditionally, asphyxiated newborn infants have been ventilated using 100% oxygen. However, a recent multinational trial has shown that the use of room air was just as efficient as pure oxygen in securing the survival of severely asphyxiated newborn infants. Oxidative stress markers in moderately asphyxiated term newborn infants resuscitated with either 100% oxygen or room air have been studied for the first time in this work.\n Eligible term neonates with perinatal asphyxia were randomly resuscitated with either room air or 100% oxygen. The clinical parameters recorded were those of the Apgar score at 1, 5, and 10 minutes, the time of onset of the first cry, and the time of onset of the sustained pattern of respiration. In addition, reduced and oxidized glutathione concentrations and antioxidant enzyme activities (superoxide dismutase, catalase, and glutathione peroxidase) were determined in blood from the umbilical artery during delivery and in peripheral blood at 72 hours and at 4 weeks' postnatal age.\n Our results show that the room-air resuscitated (RAR) group needed significantly less time to first cry than the group resuscitated with 100% oxygen (1.2 +/- 0.6 minutes vs 1.7 +/- 0.5). Moreover, the RAR group needed less time undergoing ventilation to achieve a sustained respiratory pattern than the group resuscitated with pure oxygen (4.6 +/- 0.7 vs 7.5 +/- 1.8 minutes). The reduced-to-oxidized-glutathione ratio, which is an accurate index of oxidative stress, of the RAR group (53 +/- 9) at 28 days of postnatal life showed no differences with the control nonasphyxiated group (50 +/- 12). However, the reduced-to-oxidized-glutathione ratio of the 100% oxygen-resuscitated group (OxR) (15 +/- 5) was significantly lower and revealed protracted oxidative stress. Furthermore, the activities of superoxide dismutase and catalase in erythrocytes were 69% and 78% higher, respectively, in the OxR group than in the control group at 28 days of postnatal life. Thus, this shows that these antioxidant enzymes, although higher than in controls, could not cope with the ongoing generation of free radicals in the OxR group. However, there were no differences in antioxidant enzyme activities between the RAR group and the control group at this stage.\n There are no apparent clinical disadvantages in using room air for ventilation of asphyxiated neonates rather than 100% oxygen. Furthermore, RAR infants recover more quickly as assessed by Apgar scores, time to the first cry, and the sustained pattern of respiration. In addition, neonates resuscitated with 100% oxygen exhibit biochemical findings reflecting prolonged oxidative stress present even after 4 weeks of postnatal life, which do not appear in the RAR group. Thus, the current accepted recommendations for using 100% oxygen in the resuscitation of asphyxiated newborn infants should be further discussed and investigated.", "To test the hypothesis that room air is superior to 100% oxygen when asphyxiated newborns are resuscitated, 84 neonates (birth weight > 999 g) with heart rate < 80 and/or apnea at birth were allocated to be resuscitated with either room air (n = 42) or 100% oxygen (n = 42). Serial, unblinded observations of heart rates at 1, 3, 5, and 10 min and Apgar scores at 1 min revealed no significant differences between the two groups. At 5 min, median (25th and 75th percentile) Apgar scores were higher in the room air than in the oxygen group [8 (7-9) versus 7 (6-8), p = 0.03]. After the initial resuscitation, arterial partial pressure of oxygen, pH, and base excess were comparable in the two groups. Assisted ventilation was necessary for 2.4 (1.5-3.4) min in the room air group and 3.0 (2.0-4.0) min in the oxygen group (p = 0.14). The median time to first breath was 1.5 (1.0-2.0) min in both the room air and oxygen groups (p = 0.59), and the time to first cry was 3.0 (2.0-4.0) min and 3.5 (2.5-5.5) min in the room air and oxygen groups, respectively (p = 0.19). Three neonates in the room air group and four in the oxygen group died in the neonatal period. At 28 d, 72 of the 77 surviving neonates were available for follow-up (36 in each group), and none had any neurologic sequelae.(ABSTRACT TRUNCATED AT 250 WORDS)", "Birth asphyxia represents a serious problem worldwide, resulting in approximately 1 million deaths and an equal number of serious sequelae annually. It is therefore important to develop new and better ways to treat asphyxia. Resuscitation after birth asphyxia traditionally has been carried out with 100% oxygen, and most guidelines and textbooks recommend this; however, the scientific background for this has never been established. On the contrary, theoretic considerations indicate that resuscitation with high oxygen concentrations could have detrimental effects. We have performed a series of animal studies as well as one pilot study indicating that resuscitation can be performed with room air just as efficiently as with 100% oxygen. To test this more thoroughly, we organized a multicenter study and hypothesized that room air is superior to 100% oxygen when asphyxiated newborn infants are resuscitated.\n In a prospective, international, controlled multicenter study including 11 centers from six countries, asphyxiated newborn infants with birth weight >999 g were allocated to resuscitation with either room air or 100% oxygen. The study was not blinded, and the patients were allocated to one of the two treatment groups according to date of birth. Those born on even dates were resuscitated with room air and those born on odd dates with 100% oxygen. Informed consent was not obtained until after the initial resuscitation, an arrangement in agreement with the new proposal of the US Food and Drug Administration's rules governing investigational drugs and medical devices to permit clinical research on emergency care without the consent of subjects. The protocol was approved by the ethical committees at each participating center. Entry criterion was apnea or gasping with heart rate <80 beats per minute at birth necessitating resuscitation. Exclusion criteria were birth weight <1000 g, lethal anomalies, hydrops, cyanotic congenital heart defects, and stillbirths. Primary outcome measures were death within 1 week and/or presence of hypoxic-ischemic encephalopathy, grade II or III, according to a modification of Sarnat and Sarnat. Secondary outcome measures were Apgar score at 5 minutes, heart rate at 90 seconds, time to first breath, time to first cry, duration of resuscitation, arterial blood gases and acid base status at 10 and 30 minutes of age, and abnormal neurologic examination at 4 weeks. The existing routines for resuscitation in each participating unit were followed, and the ventilation techniques described by the American Heart Association were used as guidelines aiming at a frequency of manual ventilation of 40 to 60 breaths per minute.\n Forms for 703 enrolled infants from 11 centers were received by the steering committee. All 94 patients from one of the centers were excluded because of violation of the inclusion criteria in 86 of these. Therefore, the final number of infants enrolled in the study was 609 (from 10 centers), with 288 in the room air group and 321 in the oxygen group. Median (5 to 95 percentile) gestational ages were 38 (32.0 to 42.0) and 38 (31.1 to 41.5) weeks (NS), and birth weights were 2600 (1320 to 4078) g and 2560 (1303 to 3900) g (NS) in the room air and oxygen groups, respectively. There were 46% girls in the room air and 41% in the oxygen group (NS). Mortality in the first 7 days of life was 12.2% and 15.0% in the room air and oxygen groups, respectively; adjusted odds ratio (OR) = 0.82 with 95% confidence intervals (CI) = 0.50-1.35. Neonatal mortality was 13.9% and 19.0%; adjusted OR = 0. 72 with 95% CI = 0.45-1.15. Death within 7 days of life and/or moderate or severe hypoxic-ischemic encephalopathy (primary outcome measure) was seen in 21.2% in the room air group and in 23.7% in the oxygen group; OR = 0.94 with 95% CI = 0.63-1.40. (ABSTRACT TRUNCATED)", "To test the hypothesis that resuscitation of asphyxiated infants with pure oxygen causes hyperoxemia and oxidative stress.Study design Asphyxiated term newborn infants (n = 106) were randomly resuscitated with room air (RAR = 51) or 100% oxygen (OxR = 55). The Apgar score, time of the first cry, and establishment of a sustained pattern of respiration were recorded. Assays performed included: blood gases; reduced glutathione (GSH) and oxidized glutathione (GSSG) in whole blood; glutathione-related enzyme activities; and superoxide dismutase activity (SOD) in erythrocytes.\n The RAR group needed less time of ventilation for resuscitation (5.3 +/- 1.5 vs 6.8 +/- 1.2 min; P <.05). Pure oxygen caused hyperoxemia (PO(2), 126.3 +/- 21.8 mm Hg) that did not occur with the use of room air (PO(2), 72.2 +/- 6.8 mm Hg). GSH was decreased and GSSG, the glutathione cycle enzymes, and SOD activities were increased in both asphyxiated groups. However, the 100% oxygen-resuscitated group showed significantly greater alterations that correlated positively with hyperoxemia.\n Asphyxia causes oxidative stress in the perinatal period, and resuscitation with 100% oxygen causes hyperoxemia and increased oxidative stress. Because there are no advantages to resuscitation with 100% oxygen, room air may be preferred under certain circumstances for the resuscitation of asphyxiated neonates.", "To compare the short-term efficacy of room air versus 100% oxygen for resuscitation of asphyxic newborns at birth.\n Multicentric quasi randomized controlled trial.\n Teaching hospitals.\n Asphyxiated babies weighing greater than 1000 grams, with heart rate less than 100 per min and/or apnea, unresponsive to nasopharyngeal suction and tactile stimuli and having no lethal abnormalities.\n Asphyxiated neonates born on odd dates were given oxygen and those on even dates room air for resuscitation.\n Primary: Apgar score at 5 minutes; Secondary: Mortality and Hypoxic ischaemic encephalopathy (HIE) during first 7 days of life.\n A total of 431 asphyxiated babies, 210 in the room air and 221 in 100% oxygen group were enrolled for the study. Both the groups were comparable for maternal, intrapartum and neonatal characteristics. The heart rates in room air and 100% oxygen groups were comparable at 1 minute (94 bpm and 88 bpm), 5 minutes (131 bpm and 131 bpm) and 10 minutes (135 bpm and 136 bpm). Median apgar scores at 5 min [7 versus 7] and 10 minutes [8 versus 8 ], in the room air and oxygen groups respectively, were found to be comparable. Median time to first breath (1.5 versus 1.5 minutes) was similar in the room air and oxygen group. Median time to first cry (2.0 versus 3.0 minutes) and median duration of resuscitation (2.0 versus 3 minutes) were significantly shorter in the room air group. The number of babies with HIE during first seven days of life in the two treatment groups (35.7% babies in room air and 37.1% in the 100% oxygen group) were similar. There was also no statistically significant difference in the overall and asphyxia related mortality in the two treatment groups (12.4% and 10.0% in room air versus 18.1% and 13.6% in oxygen group).\n Room air appears as good as 100% oxygen for resuscitation of asphyxic newborn babies at birth." ]

[ "9921995", "12655535", "8490912", "2686429", "1349112", "10423464", "11112678", "15067098", "10391572", "10423465", "10657866", "10870071", "11083625" ]

[ "Outpatient therapy with oral ofloxacin for patients with low risk neutropenia and fever: a prospective, randomized clinical trial.", "Outpatient, sequential, parenteral-oral antibiotic therapy for lower risk febrile neutropenia in children with malignant disease: a single-center, randomized, controlled trial in Argentina.", "Outpatient treatment of febrile episodes in low-risk neutropenic patients with cancer.", "Multicenter, randomized trial of ciprofloxacin plus azlocillin versus ceftazidime plus amikacin for empiric treatment of febrile neutropenic patients.", "Randomised comparison of oral ofloxacin alone with combination of parenteral antibiotics in neutropenic febrile patients.", "A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy.", "Oral cefixime is similar to continued intravenous antibiotics in the empirical treatment of febrile neutropenic children with cancer.", "Randomized trial of oral versus intravenous antibiotics in low-risk febrile neutropenic patients with lung cancer.", "Outpatient treatment of fever and neutropenia for low risk pediatric cancer patients.", "Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.", "Oral ciprofloxacin vs. intravenous ceftriaxone administered in an outpatient setting for fever and neutropenia in low-risk pediatric oncology patients: randomized prospective trial.", "Oral administration of cefixime to lower risk febrile neutropenic children with cancer.", "Monotherapy with intravenous followed by oral high-dose ciprofloxacin versus combination therapy with ceftazidime plus amikacin as initial empiric therapy for granulocytopenic patients with fever." ]

[ "Hospitalization and treatment with broad-spectrum intravenous antibiotics is the standard care for patients with neutropenia and fever. This randomized clinical trial evaluated the feasibility and efficacy of ambulatory care with oral ofloxacin for patients with low risk, chemotherapy-induced neutropenia and fever.\n Patients with solid tumors who were treated with conventional dose chemotherapy, presented with fever (axillary temperature >38 degrees C on 2 occasions or >38.5 degrees C on a single occasion) and neutropenia (absolute neutrophil count, <500 cells/microL), and met low risk criteria were eligible for this study. They were randomized either to hospitalization and treatment with broad-spectrum intravenous antibiotics, which consisted of a combination of cefazidime and amikacin, or to outpatient treatment with oral ofloxacin. The definitions of fever of unknown origin, clinical and microbiologic infection, success, success with modification, and failure were the usual ones for this type of study.\n One hundred episodes were randomized, and 95 were evaluable (47 were randomized to ceftazidime/amikacin and 48 to ofloxacin). Baseline characteristics, as well as the proportion of patients with microbiologic and clinical infections, were similar in the two groups. In 91% of episodes in the inpatient group and 89% in the ofloxacin group, patients recovered uneventfully (P=1; 95% CI for the difference, -0.09 to 0.13), with 2 and 5 patients requiring modification of the antibiotics, respectively. Eight percent of episodes in the control group and 10.4% in the experimental group resulted in treatment failure. Eight patients (16%) in the outpatient group experienced failure with ambulatory care and were admitted to the hospital.\n Outpatient oral antibiotic therapy with oral ofloxacin for patients with low risk neutropenia and fever is safe and similar in efficacy to hospitalization and treatment with broad-spectrum parenteral antibiotics.", "Recent reports and previous randomized trials conducted at the authors' institution suggested that children with lower risk febrile neutropenic (LRFN) may benefit from substitution of oral antibiotic therapy for parenteral therapy. The objective of this study was to determine the efficacy of parenteral-oral outpatient therapy in the management of children with LRFN who were receiving treatment for malignant disease.\n From August 2000 to April 2002, 135 children with a median age of 7.5 years (range, 1.6-15.8 years) who had a total of 177 episodes of LRFN were included in a prospective, randomized, single-institution trial. Children with LRFN received a single dose of ceftriaxone and amikacin and completed a risk-assessment work-up. All patients were discharged immediately and, at 24 hours, were allocated randomly to two groups: Group A (89 episodes) received oral ciprofloxacin, and Group B (88 episodes) received intravenous ceftriaxone.\n Most patients (61% in Group A and 51% in Group B) were receiving treatment for leukemia (P value not significant [NS]). Twenty-eight children (31%) in Group A and 22 children (25%) in Group B displayed unexplained fever (P value NS). No significant differences in sites of initial infection were found between the two groups. The median duration of neutropenia was 4.2 days and 4.7 days for Group A and Group B, respectively (P value NS); the median duration of fever was 2.3 days and 2.6 days, respectively (P value NS); and the median duration of antibiotic treatment was 4.5 days and 4.8 days, respectively (P value NS). The overall results of the study were excellent. Only four treatment failures in Group A (5%) and 6 treatment failures in Group B (7%) were observed. These patients were readmitted to the hospital and did well with appropriate treatment.\n In children with LRFN who are receiving treatment for malignant disease, outpatient oral ciprofloxacin after 24 hours of a single dose of intravenous ceftriaxone and amikacin was as safe and efficacious as parenteral ceftriaxone. Outpatient management and early antibiotic withdrawal were safe for both groups.\n Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11251", "Hospitalization and intravenous (IV) broad-spectrum antibiotics are the standard of care for all febrile neutropenic patients with cancer. Recent work suggests that a low-risk population exists who might benefit from an alternate approach.\n A prospective randomized clinical trial was performed comparing oral ciprofloxacin 750 mg plus clindamycin 600 mg every 8 hours with IV aztreonam 2 g plus clindamycin 600 mg every 8 hours for the empiric outpatient treatment of febrile episodes in low-risk neutropenic patients with cancer.\n The oral regimen cured 35 of 40 episodes (88% response rate), whereas the IV regimen cured 41 of 43 episodes (95% response rate, P = 0.19). Although the cost of the oral regimen was significantly less than that of the IV regimen (P < 0.0001), it was associated with significant renal toxicity (P < 0.05), which led to early termination of the study. Overall, combining its safety and efficacy, the IV regimen was superior (P = 0.03).\n This prospective study suggested that outpatient antibiotic therapy for febrile episodes in low-risk neutropenic patients with cancer is safe and effective. Better oral regimens are needed.", "In a multicenter, randomized clinical trial, the efficacy of ciprofloxacin plus azlocillin was compared with that of a standard regimen of ceftazidime plus amikacin for the initial empiric treatment of fever in neutropenic cancer patients. In addition, the efficacy of early conversion from intravenous therapy to orally administered ciprofloxacin was compared with that of continued ceftazidime plus amikacin. Seventy-one oncology patients with 79 episodes of fever and neutropenia were randomly assigned to receive initial empiric antibiotic therapy with either intravenously administered ciprofloxacin and azlocillin followed by orally administered ciprofloxacin (regimen 1, 25 episodes); ceftazidime and amikacin (regimen 2, 30 episodes); or ceftazidime and amikacin followed by oral ciprofloxacin (regimen 3, 24 episodes). Microbiologically documented infections were the cause of fever in 10 (40 percent), seven (23 percent), and nine (38 percent) episodes in regimens 1, 2, and 3, respectively, including six, five, and four episodes of bacteremia. Patient survival was 90 to 92 percent in each regimen; however, some modification of antimicrobial therapy occurred in 65, 44, and 41 percent of surviving patients in regimens 1, 2, and 3, respectively. The rate of clearance of initial bacteremia was 67 percent (four of six) in regimen 1, 100 percent (five of five) in regimen 2 and 50 percent (two of four) in regimen 3. Patients in regimens 1 and 3 were able to convert to orally administered ciprofloxacin in 32 (65 percent) of 49 episodes after a mean of six days of intravenous therapy. Superinfections occurred in 24, 10, and 12 percent of patients receiving regimens 1, 2, and 3, respectively, and occurred similarly for patients receiving orally administered ciprofloxacin, 12 percent (four of 32), and intravenous therapy, 17 percent (eight of 47). Parenteral ciprofloxacin was generally well tolerated. One (4 percent) of 25 patients receiving regimen 1 experienced oto- or nephrotoxicity, compared with eight (15 percent) of 54 patients receiving regimens 1, 2, and 3 (p = 0.15), including three patients who required premature termination of aminoglycoside therapy. Our data suggest that the combination of ciprofloxacin and azlocillin is an effective alternative to ceftazidime and amikacin for the initial empiric therapy of febrile neutropenic patients, is generally well tolerated, and avoids the oto- and nephrotoxicity associated with aminoglycoside use. In addition, a majority of patients could change to orally administered ciprofloxacin alone after six days of parenteral therapy.", "Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral combination antibiotics, but newer antibiotics with broad-spectrum bactericidal activity have made monotherapy feasible. Ofloxacin, a broad-spectrum fluoroquinolone, has the additional advantage that bactericidal concentrations can be achieved with oral administration. We have compared ofloxacin as an oral single agent with standard parenteral combination antibiotics for the management of neutropenic febrile patients in a prospective, randomised trial. Patients with severe neutropenia (absolute neutrophil count less than or equal to 0.5 x 10(9)/l), fever above 38 degrees C, and ability to take drugs by mouth were eligible for the study. After initial investigations, 60 patients were randomly assigned to oral ofloxacin 400 mg twice daily and 62 to parenteral combination antibiotic therapy (amikacin 15 mg/kg daily, plus, at various times in the trial, carbenicillin, cloxacillin, or piperacillin). Patients were examined 72 h and 7 days after the start of treatment and when neutropenia resolved. 24 (40%) ofloxacin-treated and 26 (42%) combination-treated patients had pyrexia of unknown origin (PUO). In both treatment groups, the treatment success rate was higher for such patients than for those with clinically or microbiologically documented infections (92% vs 67% [p less than 0.05] for ofloxacin; 85% vs 64% for combination). There were no significant differences in success rates of ofloxacin and combination treatment for these subgroups or overall (77% vs 73%). Patients with neutropenia for less than 1 week had better responses to both treatments than patients with longer-lasting neutropenia. There were 4 (7%) deaths in the ofloxacin group and 6 (10%) in the combination group. Both regimens were well tolerated. We conclude that oral single-agent ofloxacin is as effective as parenteral combination antibiotic therapy in neutropenic febrile patients, especially those expected to have short durations of neutropenia.", "Among patients with fever and neutropenia during chemotherapy for cancer who have a low risk of complications, oral administration of empirical broad-spectrum antibiotics may be an acceptable alternative to intravenous treatment.\n We conducted a randomized, double-blind, placebo-controlled study of patients (age, 5 to 74 years) who had fever and neutropenia during chemotherapy for cancer. Neutropenia was expected to be present for no more than 10 days in these patients, and they had to have no other underlying conditions. Patients were assigned to receive either oral ciprofloxacin plus amoxicillin-clavulanate or intravenous ceftazidime. They were hospitalized until fever and neutropenia resolved.\n A total of 116 episodes were included in each group (84 patients in the oral-therapy group and 79 patients in the intravenous-therapy group). The mean neutrophil counts at admission were 81 per cubic millimeter and 84 per cubic millimeter, respectively; the mean duration of neutropenia was 3.4 and 3.8 days, respectively. Treatment was successful without the need for modifications in 71 percent of episodes in the oral-therapy group and 67 percent of episodes in the intravenous-therapy group (difference between groups, 3 percent; 95 percent confidence interval, -8 percent to 15 percent; P=0.48). Treatment was considered to have failed because of the need for modifications in the regimen in 13 percent and 32 percent of episodes, respectively (P<0.001) and because of the patient's inability to tolerate the regimen in 16 percent and 1 percent of episodes, respectively (P<0.001). There were no deaths. The incidence of intolerance of the oral antibiotics was 16 percent, as compared with 8 percent for placebo (P=0.07).\n In hospitalized low-risk patients who have fever and neutropenia during cancer chemotherapy, empirical therapy with oral ciprofloxacin and amoxicillin-clavulanate is safe and effective.", "Empiric oral antibiotic therapy for febrile neutropenic cancer patients has been suggested as a means to decrease hospitalization, but the safety of this approach has not been adequately studied in children. We compared continued iv antibiotic therapy with switching treatment to orally administered cefixime in a group of selected febrile neutropenic children for whom blood cultures were sterile after 48 h of incubation. Two hundred episodes of febrile neutropenia were studied (156 patients), and 100 episodes were randomized to receive each treatment. Failure to respond to therapy was defined by documented or suspected bacterial infection, recurrent fever, or discontinuation of assigned therapy for any reason before neutropenia resolved. Rates of treatment failure were similar in the oral cefixime group (28%) and in the iv antibiotic group (27%; P=1.0). Results support the safety of oral cefixime therapy for low-risk febrile neutropenic children, a therapeutic approach that would facilitate earlier outpatient management and decrease the costs of treatment.", "Neutropenic fever is one of the most serious adverse effects of cancer chemotherapy. Neutropenia may cause a life-threatening bacterial infection. Therefore, febrile neutropenic inpatients are empirically treated with intravenous broad-spectrum antibiotics. Recently, several studies have suggested the presence of low-risk groups among febrile neutropenic patients.\n A prospective randomized trial was conducted to compare treatment with oral ciprofloxacin (200 mg) and amoxicillin-clavulanate (375 mg) administered every 8 h against that with intravenous ceftazidime (1 g) administered every 12 h in low-risk febrile neutropenic patients with lung cancer. All patients received chemotherapy and antibiotic therapy while being hospitalized.\n A total of 177 patients with lung cancer agreed to participate in this study prior to undergoing chemotherapy. Among them, a total of 36 neutropenic patients with 42 febrile episodes were enrolled in the study. Treatment was successful without the need for modification in 91% of the episodes in patients receiving the oral regimen and 79% of the episodes in patients receiving the intravenous regimen. No treatment-related deaths occurred. One patient developed nausea while receiving the oral regimen, so the oral regimen was changed to the intravenous regimen in this patient.\n This prospective study suggested that treatment with oral antibiotics ciplofloxacin plus amoxicillin-clavulanate was effective for low-risk febrile neutropenic patients after chemotherapy.", "Fever and neutropenia (F&N) is a common complication of cancer chemotherapy. It is conveniently managed by hospitalization and empiric administration of parenteral antibiotics. This study attempted to determine whether pediatric cancer patients with F&N identified as low risk for morbidity and mortality by clinical criteria at the time of presentation could be treated safely as outpatients.\n Seventy-three episodes of F&N in 41 patients were studied prospectively over 2 years. Eligibility criteria included age > or =2 years, reliable caretakers, and residence within 1 hour of the hospital. Exclusion criteria included hemodynamic instability, dehydration, severe mucositis, pneumonia, leukemia/lymphoma induction therapy, bone marrow transplantation, or other serious comorbidity. Patients were evaluated, received a single dose of intravenous ceftazidime, and were observed for 3-16 hours. They were randomized to receive either oral ciprofloxacin or intravenous ceftazidime as outpatients. Patients were seen daily until they had been afebrile for at least 48 hours and had a rising absolute phagocyte count of >500 cells/microL.\n Sixty-three of 73 episodes (86%) were successfully managed on an outpatient basis. For 31 of 33 episodes in the ceftazidime arm, the patients remained outpatients, compared with 32 of 40 in the ciprofloxacin arm; this difference was not statistically significant. On average, patients remained febrile for 2.7 days and were treated for 4.7 days. Seventy-seven percent of episodes required no modification of initial antibiotic therapy. Of the 10 patients who were hospitalized, 4 had prolonged fever and 3 had emesis. Protracted neutropenia was associated with the need for hospitalization. There were no deaths, intensive care unit transfers, or serious complications.\n Carefully selected low risk children with fever and neutropenia can be treated safely as outpatients. Close daily medical scrutiny is required.", "Intravenously administered antimicrobial agents have been the standard choice for the empirical management of fever in patients with cancer and granulocytopenia. If orally administered empirical therapy is as effective as intravenous therapy, it would offer advantages such as improved quality of life and lower cost.\n In a prospective, open-label, multicenter trial, we randomly assigned febrile patients with cancer who had granulocytopenia that was expected to resolve within 10 days to receive empirical therapy with either oral ciprofloxacin (750 mg twice daily) plus amoxicillin-clavulanate (625 mg three times daily) or standard daily doses of intravenous ceftriaxone plus amikacin. All patients were hospitalized until their fever resolved. The primary objective of the study was to determine whether there was equivalence between the regimens, defined as an absolute difference in the rates of success of 10 percent or less.\n Equivalence was demonstrated at the second interim analysis, and the trial was terminated after the enrollment of 353 patients. In the analysis of the 312 patients who were treated according to the protocol and who could be evaluated, treatment was successful in 86 percent of the patients in the oral-therapy group (95 percent confidence interval, 80 to 91 percent) and 84 percent of those in the intravenous-therapy group (95 percent confidence interval, 78 to 90 percent; P=0.02). The results were similar in the intention-to-treat analysis (80 percent and 77 percent, respectively; P=0.03), as were the duration of fever, the time to a change in the regimen, the reasons for such a change, the duration of therapy, and survival. The types of adverse events differed slightly between the groups but were similar in frequency.\n In low-risk patients with cancer who have fever and granulocytopenia, oral therapy with ciprofloxacin plus amoxicillin-clavulanate is as effective as intravenous therapy.", "Infections are one of the major complications in children undergoing chemotherapy. Monotherapy with either ciprofloxacin or ceftriaxone is safe and efficient in low-risk patients (solid tumors and stage I/II lymphomas). The same drugs may be used in an outpatient setting, decreasing costs and the risk of nosocomial infections.\n Low-risk patients (N = 70) with episodes of fever and neutropenia (N = 116) were randomized to receive either oral ciprofloxacin or intravenous ceftriaxone as outpatients. Only one patient had a central venous catheter.\n Episodes of fever and neutropenia were classified as fever of unknown origin (41% vs. 32%) or clinically documented infection (56% vs. 63%) in the ciprofloxacin and ceftriaxone groups, respectively. Most of these infections were of upper respiratory tract, skin, or gastrointestinal origin. The mean duration of neutropenia was 5 vs. 6 days. Fever persisted for 1-9 days (mean 2 vs. 3 days). Therapy was successful with no modifications in 83% vs. 75% of the episodes. Patients were admitted in 7% vs. 4% of the episodes. No bone or joint side effects were seen in either group. All patients survived.\n Outpatient therapy with either oral ciprofloxacin or intravenous ceftriaxone for fever and neutropenia is effective and safe in pediatric patients with solid tumors and stage I/II non-Hodgkin lymphoma (low-risk patients).\n Copyright 2000 Wiley-Liss, Inc.", "Febrile neutropenia is a heterogeneous condition. Recently, several risk factors have been defined, permitting the definition of a lower risk group of patients who may benefit form less aggressive therapy. The use of an oral antibiotic approach was tested in the current trial.\n From May 1997 to March 1998, 154 episodes of lower risk febrile neutropenia in 128 children with a mean age of 62 (range, 8-200) months were enrolled in this randomized, single-institution trial. Inclusion criteria were fever (> 38 degrees C), neutropenia (absolute neutrophil count < 500/mm(3)), lower risk features (i.e., absence of severe comorbidity factors, good clinical condition, negative blood cultures, control of local infection, no fever during the last 24 hours), and compliance of parents. After 3 days of ceftriaxone (100 mg/kg/day administered intravenously [i.v.]) every 12 hours plus amikacin (15 mg/kg/day i.v.) every 24 hours for 3 days, all patients were discharged and randomized to be allocated to 2 treatment arms. Group A (n = 74) received ceftriaxone cefixime (8 mg/kg/day administered orally) every 24 hours for 4 days, whereas Group B (n = 80) was treated with ceftriaxone plus amikacin for 7 days. Failure was defined as the need for second hospitalization during the same episode of neutropenia, or fever during the 7 days after discharge.\n Most of the patients (49% in Group A and 55% in Group B) had acute leukemia. Fifty-four (72%) children in Group A and 46 (56%) in Group B had fever of unknown origin (P = not significant [NS]). No significant differences were found in the sites of initial infection between the two groups. Overall results were outstanding, with a favorable outcome in 73 of 78 cases (98.6%) in Group A and 78 of 80 cases (97.5%) in Group B (P = NS). Three patients needed a second hospitalization due to failure of the initial therapy: one in Group A and two in Group B. All three did well with secondary treatment.\n In lower risk febrile neutropenic children receiving anticancer therapy, the efficacy of oral cefixime, given for 4 days after 72 hours of intravenous ceftriaxone plus amikacin, was similar to that of 7 days of parenteral ceftriaxone plus amikacin. The oral outpatient therapy approach to the treatment of lower risk febrile neutropenia after chemotherapy is safe and may be cost-saving. This strategy might be adopted as standard therapy in the future.\n Copyright 2000 American Cancer Society.", "The aim of the present study was to obtain clinical experience with the use of high-dose ciprofloxacin as monotherapy for the treatment of febrile neutropenia episodes (granulocyte count, <500/mm(3)) compared to a standard regimen and to clarify whether ciprofloxacin administration may be switched to the oral route. In a prospective randomized study ciprofloxacin was given at 400 mg three times a day (t.i.d.) for at least 72 h followed by oral administration at 750 mg twice a day (b.i.d). That regimen was compared with ceftazidime given intravenously at 2 g t.i.d. plus amikacin given intravenously at 500 mg b.i.d. The frequency of successful clinical response without modification at the end of therapy was almost identical for ciprofloxacin (50% [62 of 124 patients]) compared with that for ceftazidime plus amikacin (50.8% [62 of 122 patients]) in an intent-to-treat analysis; the frequencies were 48.3% (57 of 118 patients) versus 49.6% (56 of 113 patients), respectively, in a per-protocol analysis (P values for one-sided equivalence, 0.0485 and 0.0516, respectively; delta = 10%), with no significant differences among patients with bacteremia and other microbiologically or clinically documented infections and fever of unknown origin. For 82 (66.1%) patients, it was possible to switch from parenteral ciprofloxacin to the oral ciprofloxacin, and the response was successful for 61 (74.4%) patients. The efficacies of the regimens against streptococcal bacteremias were 16.6% (one of six patients) for the ciprofloxacin group and 33.3% (one of three patients) for the combination group (it was not statistically significant), with one breakthrough streptococcal bacteremia observed among the ciprofloxacin-treated patients. Adverse events were mostly self-limited and were observed in 27 (20.6%) ciprofloxacin-treated patients and 26 (19.7%) patients who were receiving the combination. This study demonstrates that high-dose ciprofloxacin given intravenously for at least 3 days and then by the oral route is therapeutically equivalent to the routine regimen of intraveneous ceftazidime plus amikacin even in febrile patients with severe neutropenia (polymorphonuclear leukocyte count, <100 mm(3)). However, it is very important that before an empirical therapy is chosen each hospital determine bacteriologic predominance and perform resistance surveillance." ]

[ "1623701" ]

[ "Extending recall intervals--effect on resource consumption and dental health." ]

[ "The dental health of children has improved in recent years. This has stimulated more flexible planning and implementation of public dental care programs. The aim of the study was to compare time required for dental care and changes in dental health over a 2-yr period for patients examined and treated every 12 months and patients examined and treated every 24 months. The material comprised 185 children aged 3, 16 and 18 yr. Children with high caries prevalence were not included in the material. Time used for examination and treatment and dental health parameters were recorded. The data were analyzed using multiple linear regression analysis. Mean time used for examinations and mean total time used by the dental health service over the 2-yr period were significantly less for patients examined every 24 months than for patients examined every 12 months, while the treatment times did not differ between the groups. The longer recall interval was associated with greater DMFS increment but this was not statistically significant. The study indicates that the dental health service in Norway could save resources, i.e. increase the productivity in the short term by extending the intervals between examinations." ]

[ "19393784", "9183475", "17666698", "12371782", "10868754", "16051180", "18836954", "11235801", "18325421", "18606284", "11829283", "14693888" ]

[ "Evaluation of the Scottsdale Loop 101 automated speed enforcement demonstration program.", "Increased police enforcement: effects on speed.", "Reducing road traffic injuries: effectiveness of speed cameras in an urban setting.", "Further results from a trial comparing a hidden speed camera programme with visible camera operation.", "Evaluation of photo radar program in British Columbia.", "The effects of speed enforcement with mobile radar on speed and accidents. An evaluation study on rural roads in the Dutch province Friesland.", "Evaluation of automated speed enforcement in Montgomery County, Maryland.", "The crash reduction effectiveness of a network-wide traffic police deployment system.", "The effects of mobile speed camera introduction on road traffic crashes and casualties in a rural county of England.", "Evaluation of automated speed enforcement on Loop 101 freeway in Scottsdale, Arizona.", "Speed and safety effect of photo radar enforcement on a highway corridor in British Columbia.", "Are mobile speed cameras effective? A controlled before and after study." ]

[ "Speeding is recognized as a major contributing factor in traffic crashes. In order to reduce speed-related crashes, the city of Scottsdale, Arizona implemented the first fixed-camera photo speed enforcement program (SEP) on a limited access freeway in the US. The 9-month demonstration program spanning from January 2006 to October 2006 was implemented on a 6.5 mile urban freeway segment of Arizona State Route 101 running through Scottsdale. This paper presents the results of a comprehensive analysis of the impact of the SEP on speeding behavior, crashes, and the economic impact of crashes. The impact on speeding behavior was estimated using generalized least square estimation, in which the observed speeds and the speeding frequencies during the program period were compared to those during other periods. The impact of the SEP on crashes was estimated using 3 evaluation methods: a before-and-after (BA) analysis using a comparison group, a BA analysis with traffic flow correction, and an empirical Bayes BA analysis with time-variant safety. The analysis results reveal that speeding detection frequencies (speeds> or =76 mph) increased by a factor of 10.5 after the SEP was (temporarily) terminated. Average speeds in the enforcement zone were reduced by about 9 mph when the SEP was implemented, after accounting for the influence of traffic flow. All crash types were reduced except rear-end crashes, although the estimated magnitude of impact varies across estimation methods (and their corresponding assumptions). When considering Arizona-specific crash related injury costs, the SEP is estimated to yield about $17 million in annual safety benefits.", "Results of a field experiment in which a 35-km long stretch of road was subjected to an increase in police enforcement--mostly as stationary speed controls--are presented. A group of police officers was invited to plan and perform the enforcement based on their own experience and ideas. The level of enforcement reached a daily average of nine hours throughout an enforcement period of six weeks. Speed measurements were done in 60 and 80 km/h speed-limit zones before, during and after enforcement withdrawal, and were compared to another stretch of road. Average speeds were reduced by 0.9-4.8 km/h in both speed-limit zones and for all times of day. For some time intervals, the average speed and the percentage of speeding drivers were reduced for several weeks of the after-period, demonstrating a time-halo effect of eight weeks at most. The percentage of speeding drivers was reduced in both speed-limit zones for all hours of the day except the morning rush hours 6.00-9.00 A.M. It is suggested that commuting drivers in the morning rush hours are most resistant to speed reduction. These results were statistically significant at alpha = 0.01.", "We assessed the effectiveness of speed cameras on Barcelona's beltway in reducing the numbers of road collisions and injuries and the number of vehicles involved in collisions.\n We designed a time-series study with a comparison group to assess the effects of the speed cameras. The \"intervention group\" was the beltway, and the comparison group consisted of arterial roads on which no fixed speed cameras had been installed. The outcome measures were number of road collisions, number of people injured, and number of vehicles involved in collisions. We fit the data to Poisson regression models that were adjusted according to trends and seasonality.\n The relative risk (RR) of a road collision occurring on the beltway after (vs before) installation of speed cameras was 0.73 (95% confidence interval [CI]=0.63, 0.85). This protective effect was greater during weekend periods. No differences were observed for arterial roads (RR=0.99; 95% CI=0.90, 1.10). Attributable fraction estimates for the 2 years of the study intervention showed 364 collisions prevented, 507 fewer people injured, and 789 fewer vehicles involved in collisions.\n Speed cameras installed in an urban setting are effective in reducing the numbers of road collisions and, consequently, the numbers of injured people and vehicles involved in collisions.", "As described in a previous paper [Accident Anal. Prev., 33 (2001) 277], the hidden camera programme was found to be associated with significant net falls in speeds, crashes and casualties both in 'speed camera areas' (specific signed sites to which camera operation is restricted) and on 100 km/h speed limit roads generally. These changes in speeds, crashes and casualties were identified in the trial area in comparison with a control area where generally highly visible speed camera enforcement continued to be used (and was used in the trial area prior to the commencement of the trial). There were initial changes in public attitudes associated with the trial that later largely reverted to pre-trial levels. Analysis of 2 years' data of the trial showed that falls in crash and casualty rates and speeds associated with the hidden camera programme were being sustained. It is not possible to separate out the effects of the concealment of the cameras from other aspects of the hidden speed camera programme, such as the four-fold increase in ticketing. This increase in speed camera tickets issued was an expected consequence of hiding the cameras and as such, an integral part of the hidden camera programme being evaluated.", "This article presents the results of an evaluation of the speed and traffic safety effects of the photo radar program in British Columbia (BC) after 1 year of full operation. Traffic speed data were collected from the photo radar units and from induction loops installed across the province. Traffic collision and injury data were obtained from police investigation reports and from BC ambulance services records. The study employed a number of analytical frameworks, including simple before and after comparison, time-series cross-sectional analysis, and interrupted time series analysis. The study revealed a dramatic reduction of speed at photo radar deployment sites. A reduction of 2.4 km/h in mean speed was also observed at selected monitoring sites where enforcement was not likely to be present. The reduction of speed was accompanied by a decrease in collisions, injuries and fatalities. The analysis found a 25% reduction in daytime unsafe speed related collisions, an 11% reduction in daytime traffic collision victims carried by ambulances and a 17%, reduction in daytime traffic collision fatalities.", "In an evaluation study, the effects of targeted speed enforcement on speed and road accidents were assessed. Enforcement was predominantly carried out by means of mobile radar and focused on rural non-motorway roads. Information and publicity supported the enforcement activities. The evaluation covered a period of 5 years of enforcement. The speed data of these 5 years and the year preceding the enforcement project showed a significant decrease in mean speed and the percentage speed limit violators over time. The largest decrease was found in the first year of the enforcement project and in the fourth year of the project, when the enforcement effort was further intensified. There were similar decreases in speeding at both the enforced roads and at the nearby comparison roads that were not subjected to the targeted speed enforcement project, which may be explained by spillover effects. The best estimate for the safety effect of the enforcement project is a reduction of 21% in both the number of injury accidents and the number of serious casualties. This was based on comparison between the number of accidents/casualties during the enforcement project (5 years) and and the 8 preceding years on the enforced roads and at all other roads outside urban areas in the same region.", "Almost one quarter of speeding-related fatalities occur on streets with speed limits of 35 mph or less. In 2007, Montgomery County, Maryland, implemented the state's first automated speed enforcement program, with camera use limited to residential streets with speeds limits of 35 mph or less and school zones. The purpose of the present study was to evaluate initial effects of camera enforcement on traffic speeds and to assess public attitudes.\n Vehicle speeds were measured approximately 6 months before and 6 months after speed cameras were deployed and warning signs were installed. Speed data were collected on a sample of roads with and without camera enforcement in Montgomery County, as well as on a sample of roads in a comparison community that did not have speed cameras. In addition, telephone surveys were conducted in Montgomery County.\n Relative to speeds of drivers on roads in the comparison community, the proportion of drivers in Montgomery County traveling more than 10 mph above posted speed limits declined by about 70% at locations with both warning signs and speed camera enforcement, 39% at locations with warning signs but no speed cameras, and 16% on residential streets with neither warning signs nor speed cameras. Public opinion surveys found 74% of Montgomery County drivers thought speeding on residential streets was a problem. Six months after enforcement began, 60% of drivers were aware of the camera program and 62% supported it.\n The camera program was effective at reducing speeding on targeted streets. The finding of speed reductions beyond targeted locations is evidence that highly visible automated enforcement can promote community-wide changes in driver behavior. Although a majority of drivers supported automated speed enforcement, about one third opposed it. Jurisdictions planning to implement speed cameras should draw on international experience to anticipate controversies that generally arise and take steps to address them.", "Random Road Watch (RRW) is a traffic policing program in operation in Queensland, Australia. It differs from conventional traffic policing in that an explicit resource management technique is used which randomly schedules low levels of police enforcement in a manner intended to provide long-term, widespread coverage of a road network and hence maximise road safety benefits. Implementation of the program studied in Queensland covered 55% of total crashes within the state. This study aimed to measure the crash effects of the RRW program in Queensland. A quasi-experimental study design was used for the evaluation incorporating Poisson regression statistical analysis techniques. Analysis of the effects of the Queensland RRW program on crash frequency has shown the program to be effective overall. Estimated program effects were largest on fatal crashes, with an estimated reduction of 31%. Estimated aggregate program crash effects reduced with crash severity and increased with time after program introduction. Crash reductions in the third year after program introduction translated into savings, at state level, of some 12% of the state's crashes of all severities and some 15% of the state's fatal road crashes. Overall, the program produced a significant 11% reduction in total crashes in areas outside of metropolitan Brisbane. The opportunity-cost benefit/cost ratio for the program was estimated to be 55:1.", "This study assesses the impact of crash and casualty numbers in correspondence to the introduction of mobile speed cameras in the rural county of Norfolk, England.\n Road traffic accident casualty and crash data were collected for two years before the introduction of cameras and two years subsequently. The casualties and crashes occurring at 29 camera sites were identified and separated from those occurring in the rest of the county. Trends in crashes and casualties, and their severity, were examined graphically and comparisons were made between before and after periods. The regression to the mean effect at individual sites was estimated.\n After the introduction of cameras, overall crashes declined by 1% and crashes involving fatalities or serious injuries declined by 9% on the roads without cameras. At the camera sites, crashes decreased by 19% and fatal and serious crashes by 44%. The reduction in total crashes was significantly greater than that expected from the effect of regression to the mean in 12 out of 20 sites tested.\n The introduction of cameras appears to have resulted in real and measurable reductions in crash risk in this rural county.\n Our results suggest the deployment of mobile speed cameras is an effective tool for organizations wishing to reduce road traffic casualties in areas where high crash rates have been associated with excessive vehicle speeds.", "Speed cameras can reduce speeding and injury crashes, but in many communities they are confined to low-speed settings such as residential streets and school zones. In 2006 the city of Scottsdale, Arizona, implemented a 9-month pilot program to evaluate the feasibility and effects of highly visible speed camera enforcement on a busy urban freeway. This was the first use of fixed speed cameras on a major US highway. Deployment of six cameras along an 8-mile corridor was associated with large declines in mean speeds and an 88% decrease in the odds of vehicles traveling 11 mph or more above the 65 mph limit. Traffic speeds increased soon after the pilot program was suspended. In addition to reducing speeding along the enforcement corridor, speed cameras were associated with large reductions in speeding on the same highway but 25 miles away from the camera installations. However, traffic speeds were fairly stable on urban freeways in Scottsdale that were not part of the study road. Public opinion surveys found widespread concerns about speeding on the Loop 101 freeway and high levels of support for speed camera enforcement on this road.", "This study evaluates the effect of the photo radar program on traffic speed and collisions at photo radar (PRP) influence locations (PRP location) and interleaving non-PRP locations on the Vancouver Island portion of Highway 17 (Pat Bay Highway) in British Columbia (BC). Simple before-after comparison was used to summarize the speed effect while observational before- after method was employed to estimate the safety effect. To control for regression to the mean and time effect, Empirical Bayes (EB) method with comparison groups was employed in collision analysis. The study found a 2.8-km/h reduction in mean speed and a 0.5-km/h reduction in speed standard deviation at a monitoring site 2 km south of the treatment area. Corresponding to speed reduction. the study revealed a 14%+/-11% reduction in expected collisions at the PRP locations, a 19%+/-10% reduction at the non-PRP locations, and a 16%+/-7% reduction along the study corridor as a whole. No evidence was found for a localized effect in a 2-km range of the photo radar direct influence area, over and above those at the interleaving non-PRP locations. The results support the hypothesis of a distance spillover effect--that the program not only improved safety at the PRP locations, but along the entire enforcement corridor as well. It suggests that the unpredictable nature of the deployments lead drivers to modify their behavior along the length of the corridor because they could not discern 'safe' from 'unsafe' segments.", "To identify the most appropriate metric to determine the effectiveness of mobile speed cameras in reducing road traffic related injuries.\n Controlled before and after study which compares two methods for examining the local effectiveness of mobile speed cameras-a circular zone around the camera and a route based method to define exposure at various distances from sites.\n South Wales, UK.\n Persons injured by road traffic before and after intervention.\n Use of mobile speed cameras at 101 sites.\n Rate ratio of injurious crashes at intervention and control sites.\n Camera sites had lower than expected numbers of injurious crashes up to 300 metres using circles and up to 500 metres using routes. Routes methods indicated a larger effect than the circles method except in the 100 metres nearest sites. A 500 metre route method was used to investigate the effect within strata of time after intervention, time of day, speed limit, and type of road user injured. The number of injurious crashes after intervention was substantially reduced (rate ratio 0.49, 95% confidence interval 0.42 to 0.57) and sustained throughout two years after intervention. Significant decreases occurred in daytime and night time, on roads with speed limits of 30 and 60-70 miles/hour and for crashes that injured pedestrians, motorcycle users, and car occupants.\n The route based method is the better method of measure effectiveness at distances up to 500 metres. This method demonstrates a 51% reduction in injurious crashes." ]

[ "8951255", "17197590", "12146564", "9511686", "7928125", "17273450", "19181730", "15530582", "2235229", "15330879", "15296584", "15467529", "16045516", "16958717" ]

[ "A randomized controlled trial of prenatal pediatric visits for urban, low-income families.", "Simple antenatal preparation to improve breastfeeding practice: a randomized controlled trial.", "Breastfeeding education program with incentives increases exclusive breastfeeding among urban WIC participants.", "Positive effects of an antenatal group teaching session on postnatal nipple pain, nipple trauma and breast feeding rates.", "The effect of a culture-specific education program to promote breastfeeding among Vietnamese women in Sydney.", "Development and testing of a prenatal breastfeeding education intervention for Hispanic women.", "Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial.", "A breast-feeding promotion and support program a randomized trial in The Netherlands.", "Breast-feeding rates among black urban low-income women: effect of prenatal education.", "Two mid-pregnancy interventions to increase the initiation and duration of breastfeeding: a randomized controlled trial.", "Breastfeeding attitudes, intention, and initiation in low-income women: the effect of the best start program.", "Dads as breastfeeding advocates: results from a randomized controlled trial of an educational intervention.", "Breastfeeding expectations versus reality: a cluster randomised controlled trial.", "Randomized controlled trial to determine effects of prenatal breastfeeding workshop on maternal breastfeeding self-efficacy and breastfeeding duration." ]

[ "Prenatal pediatric visits have been recommended by the American Academy of Pediatrics to allow the pediatrician to counsel parents on infant care issues, establish a supportive relationship, and provide pediatric practice information to parents. We hypothesized that prenatal pediatric visits would have an impact on breastfeeding decisions, health care behaviors, health care utilization, and the doctor-patient relationship.\n We conducted a randomized controlled trial of prenatal pediatric visits for urban, low-income families to measure the impact on breastfeeding decisions, infant car safety seat use, circumcision, health maintenance, and emergency room visits and the pediatrician's perception that he/she would know the mother better. Pregnant women were recruited prenatally from the obstetrics clinic. Outcomes were measured by maternal interview prenatally and when the infant was 2 months old, in addition to review of the nursery record. Physicians were interviewed after the 2-month visit. Health care utilization was measured by chart review at 7 months.\n A total of 156 pregnant women were enrolled and randomized, 81 to the intervention group and 75 to the control group. Of mothers who breastfed, 45% in the intervention group changed their mind in favor of breastfeeding after enrollment compared with 14% in the control group. Mothers in the intervention group compared with the control group were more likely to make fewer emergency room visits, 0.58 compared with 1.0. Pediatricians were more likely to think that they knew mothers in the intervention group well, 54% versus 29% in the control group, yet 67% of mothers in both groups agreed their pediatrician knew them well. There were no differences between groups in initiation or duration of breastfeeding at 30 or 60 days, infant car safety seat use, circumcision, or health maintenance visits.\n Prenatal pediatric visits have potential impact on a variety of health care outcomes. Among urban, low-income mothers, we found beneficial effects on breastfeeding decisions, a decrease in emergency department visits, and an initial impact on the doctor-patient relationship. We suggest urban practices actively promote prenatal pediatric visits.", "To address the impact of simple antenatal educational interventions on breastfeeding practice.\n A randomized controlled trial was carried out in a tertiary referral center from May 2002 to December 2004. A random sample of eligible low-risk antenatal patients was recruited from clinics in the National University Hospital, Singapore. Group A received breastfeeding educational material and individual coaching from a lactation counselor. Group B received breastfeeding educational material with no counseling. Group C received routine antenatal care only.\n A total of 401 women were recruited. Mothers receiving individual counseling and educational material practiced exclusive and predominant breastfeeding more often than mothers receiving routine care alone at 3 months (odds ratio [OR] 2.6, 95% confidence interval [CI] 1.2-5.4) and 6 months (OR 2.4, 95% CI 1.0-5.7) postpartum. More mothers practiced exclusive and predominant breastfeeding at 6 months among women receiving individual counseling compared with women exposed to educational material alone (OR 2.5, 95% CI 1.0-6.3).\n Where breastfeeding practices are suboptimal, simple one-encounter antenatal education and counseling significantly improve breastfeeding practice up to 3 months after delivery. Provision of printed or audiovisual educational material is not enough. Health care workers should make every effort to have one face-to-face encounter to discuss breastfeeding with expectant mothers before they deliver.\n (www.ClinicalTrials.gov), NCT002770192\n I.", "nan", "To assess whether an antenatal teaching session on position and attachment of the baby on the breast had an effect on postnatal nipple pain, nipple trauma and breast feeding duration. The study was planned as a pilot study to allow an adequate sample size to be calculated for a larger study.\n An observer blind experimental design was used. Women were randomly assigned to either the experimental group teaching session or the control group.\n One public hospital in Western Australia.\n 70 primiparae who intended to breast feed their baby were recruited from the antenatal clinic of the study hospital at 36 weeks' gestation.\n Antenatal group sessions on position and attachment of the baby on the breast were conducted by a lactation consultant.\n During the first four postnatal days, position and attachment was measured by LATCH (Latch on, Audible swallow, Type of nipple, Comfort and Help) (Jensen et al 1994), nipple pain was measured by the Visual Analogue Scale (VAS) and nipple trauma was measured by the Nipple Trauma Index (NTI). The analysis of variance (ANOVA) results indicated that the women in the experimental group were better able to attach the baby on the breast and had significantly less nipple pain and trauma than the control group. At six weeks postnatally, 31 of the 35 women in the experimental group were breast feeding compared to 10 of the 35 in the control group.\n These initial findings suggest that midwives can make the best use of decreasing resources by using practical 'hands on' antenatal group teaching as an effective strategy to increase breast feeding rates.", "The rate of breastfeeding among immigrant Vietnamese women in Western countries is low compared to those in Vietnam. To counteract this trend, a language and culture specific education program was developed. An experimental design was used to test the effectiveness of this program. The sample consisted of 182 prenatal Vietnamese women. Data collection included questionnaires and interviews. Results suggested that the education program had significant effects on knowledge, attitudes, planned and actual behaviour towards breastfeeding. However, the effect did not sustain until 6 months postpartum. Implications for nursing practice and further research are discussed.", "Many immigrant Hispanic women in the United States choose to bottle-feed rather than breastfeed. This article describes an intervention that was developed and tested in a two-step process. Two studies were undertaken. First, a qualitative inquiry explored the breastfeeding beliefs, attitudes, meanings, and practices of Hispanic women. Results informed the design of a culturally appropriate prenatal breastfeeding education intervention. Secondly, the researchers undertook a quantitative study of the intervention's success in increasing breastfeeding duration among Hispanic women. Methodology and findings of this study have implications for future interventions that promote breastfeeding.", "To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding.\n Cluster randomised controlled trial.\n Community antenatal clinics in one primary care trust in a multiethnic, deprived population.\n 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care.\n An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks' gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population.\n Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered.\n The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not.\n A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates.\n Current Controlled Trials ISRCTN16126175.", "In the Netherlands, the initiation rate of breast-feeding (BF) was 80% in 2002, but only 35% of the mothers continued to breast-feed for 3 months. This study examined the effectiveness of a breast-feeding promotion program to increase the continuation of breast-feeding.\n A cluster-randomized intervention trial was used. Ten child health care centers in three regions of the home health care were randomly allocated to the program or usual care. Elements in the program were health counseling, measures to enhance cooperation, early signaling of breast-feeding problems and continuity of care, and lactation consultancy. Pregnant mothers who applied for home health care in the intervention or usual care regions were enrolled and were followed up from pregnancy until 6 months postpartum (n = 683). The primary outcome measure was the continuation of breast-feeding until at least 3 months.\n The 3-month breast-feeding rate was 32% in the intervention and 38% in the control groups (OR = 0.79, 95% CI = 0.58-1.08).\n The program was not effective. We discuss possible explanations from the design and execution of the trial and give some points for improvement of our program, such as the categories of caregivers involved and the number and duration of contacts after parturition.", "Many factors are associated with low breast-feeding rates among black low-income women. This study examines whether, despite such factors, health professionals' prenatal education of black poor women is associated with increased breast-feeding rates. Black women born in the United States who attended a midwives prenatal clinic (N = 159) were randomly assigned to two types of prenatal education or were followed up in a control group. All women were interviewed on entry into the study and after delivery of their infants. Women assigned to group classes attended at least one session discussing myths, problems, and benefits of breast-feeding. Women assigned to individual prenatal counseling spoke with a pediatrician or nurse practitioner, who discussed breast-feeding topics similar to those covered in the classes. Women in the control group received no additional prenatal education. The three study groups had significantly different percentages of women who breast-fed (controls 22%, classes 46%, individual sessions 53%). Higher percentages of women in the study groups carried out their prenatal plans to breast-feed (controls 50%, classes 86%, individual sessions 62%) or breast-fed despite prenatal plans to bottle-feed (controls 10%, classes 26%, individual sessions 48%). After multivariable analysis controlling for age, prenatal plans to breast-feed, prior breast-feeding experience, perceived support for breast-feeding, education, gravidity, and employment plans, women in intervention groups had a higher likelihood of breast-feeding than control subjects. These findings suggest that an increase in relatively simple, not-too-time-consuming educational efforts in institutions and offices serving black low-income women might yield significant narrowing of the gap in breast-feeding rates between white affluent women and black low-income women.", "Despite high levels of breastfeeding initiation in Australia, only 46 percent of women are still breastfeeding (exclusively or partially) 6 months later, with marked differences between social groups. This study aimed to determine the influence of mid-pregnancy breastfeeding education on the proportions of women breastfeeding at hospital discharge, and on the duration of breastfeeding.\n A randomized controlled trial to compare two strategies for increasing the initiation and duration of breastfeeding was conducted, in which 981 primiparas who attended a public, tertiary women's hospital in Melbourne, Australia, were randomized to one of two interventions or to standard care (327 in each group). The interventions were a 1.5-hour class on practical aspects of breastfeeding using a previously tested tool (Practical Skills), and two 1-hour classes exploring family and community attitudes toward, and experiences of, breastfeeding (Attitudes). Both interventions took place in interactive small groups when women were in mid-pregnancy. Breastfeeding initiation was ascertained by interview 2 to 4 days after birth, and breastfeeding duration was assessed by telephone interview 6 months after birth.\n Neither intervention increased breastfeeding initiation or duration compared with standard care. Rates at initiation were 97 percent (296/306) for the Practical Skills intervention, 95 percent (291/308) for the Attitudes intervention, and 96 percent (297/310) for standard care. Rates at 6 months were, respectively, 55 percent (162/297), 50 percent (146/293), and 54 percent (162/299).\n In settings where breastfeeding initiation is already high, neither study intervention could be recommended as an effective strategy to increase breastfeeding initiation or duration.", "This study compared breastfeeding attitudes, intention, and initiation among low-income women exposed or not exposed to the Best Start program. A between- (experimental vs control group) and within-factor (pretest vs posttest) repeated measures design was employed. A nonprobability sample of 54 subjects was randomly assigned to a control group (n = 28) or an experimental group (n = 26). Using the Breastfeeding Attrition Prediction Tool, statistically significant group by time interaction effects were found for negative breastfeeding sentiment, positive breastfeeding sentiment, and breastfeeding control scales. Compared to the control group, the experimental group had significantly increased positive breastfeeding sentiment (P <.01), decreased negative breastfeeding sentiment (P <.01), and increased breastfeeding control (P <.01) from pretest to posttest. Following exposure to the Best Start program, subjects in the experimental group showed statistically significantly higher breastfeeding intention and initiation than did those in the control group. Practical implications are discussed.", "Recognizing that an expectant father may influence a mother's decision to breast- or formula-feed, we tested the effectiveness of a simple, educational intervention that was designed to encourage fathers to advocate for breastfeeding and to assist his partner if she chooses to breastfeed.\n We conducted a randomized controlled trial in which expectant fathers (n = 59) were assigned randomly to attend either a 2-hour intervention class on infant care and breastfeeding promotion (intervention) or a class on infant care only (control group). The classes, which were led by a peer-educator, were interactive and informal and utilized different media to create an accessible environment for participants. Couples were recruited during the second trimester from a university obstetrics practice.\n Overall, breastfeeding was initiated by 74% of women whose partners attended the intervention class, as compared with 41% of women whose partners attended the control class (P = .02).\n Expectant fathers can be influential advocates for breastfeeding, playing a critical role in encouraging a woman to breastfeed her newborn infant.", "To evaluate the affect of an antenatal educational breastfeeding intervention on women's breastfeeding duration.\n Cluster randomised controlled trial. Unit of randomisation: electoral ward. The primary outcome was the proportion that fulfilled their antenatal breastfeeding expectation. Secondary outcomes were the number of women breastfeeding on discharge and at four months. Data were collected using a series of questionnaires and diaries.\n Teaching hospital in North West of England.\n Women who expressed a desire to breast-feed at the start of their pregnancy.\n Women were allocated to either routine antenatal education or an additional single educational group session supervised by a lactation specialist and attended by midwives from their locality.\n The proportion of women who fulfilled their expectation of breastfeeding.\n One thousand three hundred and twelve women were randomised, with 1249 (95%) women available for analysis. There was no difference between the groups in the proportion of women who attained their expected duration of breastfeeding (OR 1.2; 95% CI 0.89-1.6; chi(2)= 1.4, df= 1, P= 0.2; mean cluster size 156, design effect 1.6). There were no differences between the groups in the uptake of breastfeeding on discharge (OR = 1.2; 95% CI 0.8-1.7; chi(2)= 1.1, df= 1, P= 0.3; mean cluster size 163, design effect = 2.0) or exclusively at four months (OR = 1.1; 95% CI 0.6-1.8; chi(2)= 0.07, df= 1, P= 0.8; mean cluster size 156, design effect 1.6).\n The provision of a single educational group session supervised by a lactation specialist, and attended by midwives and women, failed to promote the uptake of breastfeeding. Public health interventions, which encourage positive attitudes to breastfeeding within the family and wider community, should be developed and evaluated.", "To determine the effects of a prenatal breastfeeding workshop on maternal breastfeeding self-efficacy and breastfeeding duration.\n Randomized controlled trial.\n Large tertiary hospital in Ontario, Canada.\n 110 primiparous women expecting a single child, an uncomplicated birth, and planning to breastfeed. Intervention: 2.5-hour prenatal breastfeeding workshop based on adult learning principles and self-efficacy theory.\n Maternal breastfeeding self-efficacy and the numbers of days and amount of breastfeeding were measured at four and eight weeks postpartum. RESULTS/DATA ANALYSIS: Over time, maternal breastfeeding self-efficacy scores increased in both groups. Women who attended the workshop had higher self-efficacy scores and a higher proportion were exclusively breastfeeding compared to women who did not attend the workshop. There was little difference in the average number of days of breastfeeding, but the intervention group had less weaning.\n The workshop increased maternal breastfeeding self-efficacy and exclusive breastfeeding.\n (c) 2006, AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses" ]

[ "3829914", "1888619", "9582768", "11298254", "2569323", "6829580", "12213142", "9641933", "3219992", "11324797", "15175486", "9558184", "10298549", "7146854", "3562679", "10473477", "5046455", "2090478", "3773181" ]

[ "Effectiveness of a printed leaflet for enabling patients to use digoxin side-effect information.", "Evaluation of drug information for cardiology patients.", "Evaluation of information given to rheumatology patients using non-steroidal anti-inflammatory drugs.", "Randomized trial of psychotropic medication information leaflets for people with intellectual disability.", "The benefits of prescription information leaflets (1).", "Application of psychological principles to the design of written patient information.", "Presenting risks and benefits to patients.", "Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial.", "An assessment of drug information sheets for diabetic patients: only active involvement by patients is helpful.", "Do undereducated patients read and understand written education materials? A pilot study in Isparta, Turkey.", "Comparison of two methods of presenting risk information to patients about the side effects of medicines.", "A randomized double blind trial of verbal NSAID education compared to verbal and written education.", "An evaluation of four methods of pharmacist-conducted patient education.", "[Comparative study of a new package insert for benzodiazepines adapted for patients].", "The effects of a psychiatric patient education to medication program on post-discharge compliance.", "Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial.", "Evaluation of the use of programmed instruction for patients maintained on Warfarin therapy.", "Manufacturer's information insert and subjective theophylline side-effects.", "The impact of a drug information sheet on the understanding and attitude of patients about drugs." ]

[ "The effectiveness of a printed leaflet designed to inform patients about digoxin was evaluated. The printed leaflet alone was compared to the verbal consultation alone and the verbal consultation in addition to the printed leaflet. The study assessed patients' decisions about the appropriate course of action to take if side-effect symptoms occurred. Patients receiving the printed leaflet alone scored higher than patients receiving the verbal consultation; however, they scored lower than patients receiving both the printed leaflet and verbal consultation together. Patients receiving both verbal and printed information scored significantly higher than those receiving verbal consultation only. The findings suggest that printed materials together with verbal consultation are essential for enabling patients to make appropriate decisions with respect to side effects. There is not enough evidence to support the use of printed materials in place of verbal consultation. Health practitioners should use printed materials as an adjunct to verbal information.", "1. Cardiologists and pharmacists at the University Hospital of Wales collaborated to write 20 individual leaflets incorporating guidelines for a range of drugs used in the treatment of cardiology patients. The Plain English Campaign advised on the intelligibility and presentation of the information. 2. One hundred and twenty-five patients from the Regional Cardiology Unit, University Hospital of Wales were randomly allocated to receive usual verbal counselling about their drug treatment with or without an individualised drug information wallet. Two weeks after discharge from hospital patients completed a postal questionnaire to determine their satisfaction with the information about their drug treatment and their understanding of it. Forty-nine questionnaires were returned from the leaflet group and 52 from the control group. 3. The provision of written guidelines resulted in significant improvements in patients' satisfaction with their drug treatment (chi 2 = 33.3, P less than 0.001) and their understanding of it (P less than 0.001, Mann-Whitney test). Overall, patients who received leaflets were more likely to be aware of the potential side effects of their drugs but less likely to be apprehensive about them. Succinct guidelines concerning drug therapy can be assimilated by cardiology patients and provide them with a permanent record for future reference.", "This paper reports the findings of a study of information given to rheumatology patients using non-steroidal anti-inflammatory drugs. One hundred and twenty patients were randomized to three groups. Group A received an information leaflet, Group B received both a leaflet and a verbal explanation and Group C received only a verbal explanation. Information was gathered on demography, knowledge base, sources of information, satisfaction with the leaflet and further information requirements. Data were collected by questionnaires which were completed before randomization and 8-12 weeks later. Analysis indicates the potential benefits of giving information to patients although the full implications of these benefits are not clear and further research is indicated in this important area.", "People with intellectual disability (ID), like other patient groups, are known to have a limited knowledge of medication. Leaflets are seen as an appropriate means of providing patient information. To test the hypothesis that medication information leaflets would improve the knowledge and care of the target group, the present authors designed a randomized trial and planned to do subgroup analyses where appropriate. The participants were individually randomized to two groups. A control group was given verbal medication information by their nurse or psychiatrist, and a study group was given specifically designed leaflets in addition to verbal information. The present authors recruited 54 people with mild to moderate ID and mental illness, aged 18 years and older, who were taking psychiatric medications. Questionnaires administered by a blind interviewer recorded outcomes such as medication knowledge and satisfaction at two time points. The participants with mild ID in the leaflet group had significantly reduced medication knowledge and understanding. There were no significant differences in satisfaction with clinicians and medication. Patient information leaflets may confuse people with mild ID in the short term. Other patient groups with cognitive deficits may have similar outcomes. Evaluation of outcomes of health education initiatives is important.", "1. Prescription information leaflets (PILs) giving information about non-steroidal anti-inflammatory drugs (NSAIDs), beta-adrenoceptor antagonists and inhaled bronchodilators were evaluated in three small Hampshire towns, while a fourth, in which no leaflets were distributed, acted as a control. 2. Seven hundred and nineteen (82%) patients prescribed one of these medicines agreed to be interviewed in their homes, 1 to 2 weeks after the medicine had been prescribed. Four hundred and nineteen of them had received leaflets, while 300 received no written information. Two hundred and sixty patients received their leaflets from a pharmacist while 159 were given them by their general practitioner. 3. Patients who received leaflets were better informed about every item of knowledge tested, except for the name of the medicine. Awareness of the side effects showed the greatest improvement, but there was no evidence that these leaflets produced spurious side effects. 4. Much improved levels of satisfaction were recorded amongst patients who received leaflets, especially those for NSAIDs (P less than 0.001) and for beta-adrenoceptor antagonists (P less than 0.01). 5. Subsequently, three hundred and fifty-eight (77%) of the patients prescribed either a NSAID or a beta-adrenoceptor antagonist 1 year earlier responded to a postal questionnaire. The benefits in terms of knowledge and satisfaction were still apparent, although less marked than previously. Of the patients still taking beta-adrenoceptor antagonists 70% had retained their leaflets over the intervening 12 months. 6. Ninety-seven per cent of patients read their leaflet regardless of whether it was distributed by a general practitioner or pharmacist. However, those who obtained it from a pharmacist tended to be more knowledgeable and satisfied. 7. We conclude that patients welcome the idea of receiving PILs. They improve patients' knowledge of how to take their medicines correctly and their awareness of potential side effects. Importantly, patients who receive leaflets are more satisfied than those who do not. These overall benefits justify the use of leaflets on a routine basis.", "nan", "To investigate whether patients are influenced by the order in which they learn the risks and benefits of a treatment and whether this effect is attenuated by a treatment's associated risk and/or benefit.\n Subjects were randomized to review 1 of 6 medical treatment information brochures.\n Waiting rooms of primary care physicians at an academic health center.\n Six hundred eighty-five subjects, ages 18 to 70 years.\n Subjects reviewed 1 of 3 treatments for symptomatic carotid artery disease. The first (aspirin) was low-risk/low-benefit, the second (carotid endarterectomy surgery) was high-risk/high-benefit, and the third (extracranial-to-intracranial bypass surgery) was high-risk but of unknown benefit. Patients were also randomized to receive information about risk either before or after benefit. Patients were asked to rate the favorability of the treatment on a scale of 0 to 100 and whether they would consent. Finally, subjects rated how their decisions were influenced by the risk and benefit information.\n Subjects evaluating aspirin therapy were influenced by the order of the risk/benefit information. Those learning about risks after benefits had a greater drop in their favorability ratings than subjects learning about risks before benefits (-10.9 vs -5.2 on a 100-point scale; P = .02) and were less likely to consent (odds ratio, 2.27; P = .04). In contrast, subjects evaluating carotid endarterectomy and extracranial-to-intracranial bypass were not influenced by information order. When subjects were influenced by the order of information, they also reported that the treatment's risk had less influence on their decision making (P < .01).\n When patients evaluate low-risk medical interventions, they may form less favorable impressions of the treatment and be less likely to consent to the treatment when they learn about the risks after the benefits. Order effects were not observed with high-risk treatments regardless of potential benefits.", "To assess whether provision of educational leaflets or questions on contraception improves knowledge of contraception in women taking the combined contraceptive pill.\n Randomisation of women into three groups according to type of educational leaflet on contraceptive information. These groups were subdivided into two on the basis of questions on contraception asked by the doctor or practice nurse. The women were followed up by postal questionnaire 3 months later.\n 15 general practices in South and West region.\n 636 women attending check up appointment for repeat prescription of the combined contraceptive pill.\n Knowledge of: factors causing pill failure, subsequent action, emergency contraception, and all the rules (pill rules) that apply to the contraceptive pill.\n 523 women returned completed questionnaires (response rate 82%). Knowledge of contraception with no intervention was low with only 10 (12%) women knowing all the pill rules. Educational intervention had a highly significant effect on knowledge of: factors causing pill failure (likelihood ratio chi2=22); subsequent action (21); emergency contraception (24); and all the pill rules (22) (P<0.01 in all cases). Improvement in knowledge of all the pill rules occurred with provision of the summary leaflet (28% knew all the rules, adjusted odds ratio 4.04, 95% confidence interval 1.68 to 9.75), the Family Planning Association's leaflet (27%, 3.43, 1.45 to 8.09), and asking questions (26%, 3.03, 1.30 to 7.00). Asking questions in addition to provision of leaflets improved knowledge of contraception further for the summary leaflet (39%, 6.81, 2.85 to 16.27) but not for the Family Planning Association leaflet (21%, 2.58, 1.07 to 6.18).\n Women attending check ups for repeat prescriptions of the contraceptive pill should be provided with educational leaflets on contraception or asked relevant questions to help improve their knowledge of contraception. Asking questions in addition to providing a summary leaflet is time consuming, but results in the most knowledge gained.", "Insulin/sulphonylurea-treated diabetics attending a busy university diabetic clinic were studied to determine whether issuing drug information sheets and/or age influenced understanding and behaviour regarding their disease and its treatment, especially with respect to avoiding hypoglycaemia. Patients were each asked 10 basic questions (each correct answer scoring 1), stratified by age (20 were less than or equal to 45 years and 91 greater than 45 years). According to a single-blind randomised protocol, they were issued or not issued with drug information sheets (providing information to correctly answer all 10 questions). After 2-3 months, 107 (88 aged greater than 45 years) were retested and asked whether they recalled an information sheet, read it themselves or had it read to them. Whether or not patients received sheets, corresponding mean aggregate scores were very similar in both age groups and there was no correlation with age. Second test scores yielded clinically and statistically significant increments in both the sheet and no sheet groups, respective mean aggregate scores increasing from 4.48 to 5.80 and 5.14 to 6.27 (P less than 0.001). Among patients issued with sheets, 32 who recalled reading them achieved the greatest improvement in mean scores (4.53 to 6.16, P less than 0.001). Active interaction/communication (participation in first test, recall and reading of information sheet) had a favourable educational impact irrespective of age, but merely issuing drug information sheets had no benefit.", "The aim of our study is to evaluate the effect of written information in improving the knowledge of the undereducated nonsteroidal anti-inflammatory drug (NSAID) users about the side effects of NSAIDs and to investigate the compliance of patients with the written information materials.\n Thirty patients received only verbal information, 38 patients received only written, and 40 patients received both verbal and written information. After seven or ten days a questionnaire was administered to the patients on the phone to assess the patients' knowledge.\n Sixty one (78.2%) patients read the leaflets. Higher number of correct answers was obtained with both verbal and written information. Written information better informed than verbal information alone (p=0.02).\n We conclude that the undereducated patients will read and understand written education materials especially when the materials are written simple and short.", "To determine whether the use of verbal descriptors suggested by the European Union (EU) such as \"common\" (1-10% frequency) and \"rare\" (0.01-0.1%) effectively conveys the level of risk of side effects to people taking a medicine.\n Randomised controlled study with unconcealed allocation.\n 120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction.\n Cardiac rehabilitation clinics at two hospitals in Leeds, UK.\n A written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, \"common\" or 2.5%; for pancreatitis, \"rare\" or 0.04%).\n The estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine.\n The mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors.\n Patients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine.", "We performed a double blind randomized controlled trial to investigate whether patients taking nonsteroidal antiinflammatory drugs (NSAID) knew more about these drugs at followup depending on whether they were randomized to receiving or not receiving an NSAID information sheet. The patients were unaware they were in a study.\n All patients received verbal education on the side effects of NSAID that was standardized and always given by the same rheumatologist. Thirty patients randomly received an NSAID information sheet and 26 patients did not. At next clinic followup, after reading a letter of explanation about the study and signing a consent form, patients completed a questionnaire asking about their knowledge of NSAID.\n Outcome variables assessed within the questionnaire included whether NSAID : (1) can decrease inflammation; (2) help with pain; (3) cause stomach upset and bleeding in the bowels. None of these variables were statistically significant. The only variable that was statistically significantly different between the groups was their report of whether they had received an information sheet about NSAID (p<0.00004). A greater proportion of patients who received the NSAID information sheet correctly reported they had received one compared to those who had not received one and who said they had not received one (85% in the former group, 70% in the latter group). The group who received the NSAID information sheet were more apt to say that NSAID can help with their pain (odds ratio 6.1, p<0.05). Education level was positively correlated with knowledge (p<0.04). However, level of education explained only 11% of the variance in overall knowledge scores (r=0.34) among all patients.\n An information sheet may not add educational value over verbal information by a physician in a clinic setting.", "nan", "A standardized, patient-oriented package insert for benzodiazepines has been compared with four package inserts printed by manufacturers for these drugs. The leaflets were submitted to 222 hospitalized patients randomly allocated to two groups; 108 received a manufacturer's notice and 114 the standardized notice. The patients were interviewed two or three days later and found the standardized notice more comprehensible than those of the manufacturers. Two independent experts assessed the adequacy of the notices and also found the standardized notice more appropriate for patients. The patients answered a questionnaire about the effects of the drugs and the precautions while using them. Those who had read the standardized notice were significantly better informed than those who had read manufacturers' notices. However, the level of understanding varied largely from one item to another, and depended on the level of education and age.", "The effect of a structured program of education on subsequent psychiatric patient compliance with medication-taking was investigated. The subjects consisted of 150 hospitalized patients housed on four acute-care receiving wards and ready for discharge from Fallsview Psychiatric Hospital in Ohio. They were randomly assigned to one of three groups. Results indicated that subjects who received written information with verbal reinforcement were significantly more compliant than the control subjects. These findings suggest that, if the hand-out is discussed with them, the patients given medication handouts similar to those used in the study will comply with medication-taking after discharge at a higher rate than those given no hand-out. Implications of these findings for increased psychiatric patients' post-discharge compliance with medications are discussed.", "To evaluate two different methods of improving adherence to antidepressant drugs.\n Factorial randomised controlled single blind trial of treatment leaflet, drug counselling, both, or treatment as usual.\n Primary care in Wessex\n 250 patients starting treatment with tricyclic antidepressants.\n Adherence to drug treatment (by confidential self report and electronic monitor); depressive symptoms and health status.\n 66 (63%) patients continued with drugs to 12 weeks in the counselled group compared with 42 (39%) of those who did not receiving counselling (odds ratio 2.7, 95% confidence interval 1.6 to 4.8; number needed to treat=4). Treatment leaflets had no significant effect on adherence. No differences in depressive symptoms were found between treatment groups overall, although a significant improvement was found in patients with major depressive disorder receiving drug doses of at least 75 mg (depression score 4 (SD 3.7) counselling v 5.9 (SD 5.0) no counselling, P=0.038).\n Counselling about drug treatment significantly improved adherence, but clinical benefit was seen only in patients with major depressive disorder receiving doses >/=75 mg. Further research is required to evaluate the effect of this approach in combination with appropriate targeting of treatment and advice about dosage.", "nan", "In Western Europe medicine packages contain an insert prepared by the manufacturer which enumerates the drug side-effects. We investigated the influence of this insert on alleged theophylline side-effects. Forty literate adult asthmatics were randomly allocated into two groups (n = 20 each): theophylline packages contained the manufacturer's insert in group A but not in group B. Theophylline was prescribed (10 mg.kg-1 body weight qd) for one week. During this period the patients filled a diary grading 13 different symptoms from 0 to 3; 5 of these symptoms were listed on the insert as theophylline side-effects. On the eighth day the patients were interviewed and theophylline blood levels measured. Theophylline side-effects were significantly more marked in group A than in group B, whereas the other symptoms were of similar magnitude. Eight patients prematurely stopped their treatment in group A vs 3 in group B, because of alleged intolerance. Theophylline blood levels did not differ significantly in the two groups; neither did they in the subgroup which stopped treatment and in the one which complied to prescription. We conclude that side-effects were suggested to the patients by the insert and/or that the insert increased their awareness of side-effects, with a subsequent detrimental influence upon compliance to therapy.", "A proposed Food and Drug Administration program to require written information with prescription drugs could cost $500 million annually; the American Medical Association has implemented a similar, voluntary program costing more than $3 million. However, the educational impact of written drug information has not been studied. We evaluated one-page drug information sheets using an objective examination. The baseline score of 71 patients was 3.9 of 6.0. Patients tested before and one day after receiving the drug sheet improved their score by +1.4. In the second phase, patients randomized to receive the drug sheet improved their score after one month by +1.1; those not given the sheet had no improvement. Changes in attitudes and incidence of reported adverse effects seemed to be random and unrelated to the information sheet. Thus, a drug information sheet may be a useful adjunct to patient education." ]

[ "15986343", "21551510" ]

[ "Effects of doxycycline on progression of osteoarthritis: results of a randomized, placebo-controlled, double-blind trial.", "The effects of doxycycline on reducing symptoms in knee osteoarthritis: results from a triple-blinded randomised controlled trial." ]

[ "To confirm preclinical data suggesting that doxycycline can slow the progression of osteoarthritis (OA). The primary outcome measure was joint space narrowing (JSN) in the medial tibiofemoral compartment.\n In this placebo-controlled trial, obese women (n = 431) ages 45-64 years with unilateral radiographic knee OA were randomly assigned to receive 30 months of treatment with 100 mg doxycycline or placebo twice a day. Tibiofemoral JSN was measured manually in fluoroscopically standardized radiographic examinations performed at baseline, 16 months, and 30 months. Severity of joint pain was recorded at 6-month intervals.\n Seventy-one percent of all randomized subjects completed the trial. Radiographs were obtained from 85% of all randomized subjects at 30 months. Adherence to the dosing regimen was 91.8% among subjects who completed the study per protocol. After 16 months of treatment, the mean +/- SD loss of joint space width in the index knee in the doxycycline group was 40% less than that in the placebo group (0.15 +/- 0.42 mm versus 0.24 +/- 0.54 mm); after 30 months, it was 33% less (0.30 +/- 0.60 mm versus 0.45 +/- 0.70 mm). Doxycycline did not reduce the mean severity of joint pain, although pain scores in both treatment groups were low at baseline and remained low throughout the trial, suggesting the presence of a floor effect. However, the frequency of followup visits at which the subject reported a > or = 20% increase in pain in the index knee, relative to the previous visit, was reduced among those receiving doxycycline. In contrast, doxycycline did not have an effect on either JSN or pain in the contralateral knee. In both treatment groups, subjects who reported a > or = 20% increase in knee pain at the majority of their followup visits had more rapid JSN than those whose pain did not increase.\n Doxycycline slowed the rate of JSN in knees with established OA. Its lack of effect on JSN in the contralateral knee suggests that pathogenetic mechanisms in that joint were different from those in the index knee.", "Evidence suggests that doxycycline might have disease-modifying properties in osteoarthritis. However, the clinically relevant question as to whether doxycycline also modifies symptoms in knee osteoarthritis is unanswered. The objective of this study was to investigate the effectiveness of doxycycline on pain and daily functioning in symptomatic knee osteoarthritis.\n A 24-week, randomised, triple-blind, placebo controlled trial on the symptomatic effectiveness of doxycycline twice a day 100 mg in knee osteoarthritis patients according to the clinical and radiological American College of Rheumatology classification criteria. The primary endpoint was the difference in the proportion of participants in both study groups achieving a clinical response defined by the OMERACT-OARSI set of responder criteria. Secondary endpoints included pain, stiffness, daily functioning, patient global assessment, quality of life, osteoarthritis-related medication and side effects.\n 232 patients were randomly assigned. At study end, 31% of participants met the primary endpoint in both groups. Except for more adverse events in the doxycycline group, no differences were also found on the secondary endpoints.\n Doxycycline is not effective in reducing symptoms in knee osteoarthritis patients over a 24-week study period, but is associated with an increased risk of adverse events. Although a possible structure-modifying effect of doxycycline was previously suggested, this is not accompanied by symptom relief in the short and medium term. Dutch Trial Register no NTR1111." ]

[ "21377034" ]

[ "A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response." ]

[ "Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials.\n To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study.\n In this multicenter study, children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge (OFC) at approximately 1 year. Titrated skin prick tests (SPTs) and laboratory studies were performed at regular intervals.\n Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study because of allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (n = 16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), whereas placebo subjects (n = 9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg; P < .001). In contrast with the placebo group, the peanut OIT group showed reductions in SPT size (P < .001), IL-5 (P = .01), and IL-13 (P = .02) and increases in peanut-specific IgG(4) (P < .001). Peanut OIT subjects had initial increases in peanut-specific IgE (P < .01) but did not show significant change from baseline by the time of OFC. The ratio of forkhead box protein 3 (FoxP3)(hi): FoxP3(intermediate) CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects.\n These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance.\n Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved." ]

[ "19956961", "7926135", "21457973", "17908411", "19729161", "20577748", "21114583", "16169420", "19214545", "12137881", "19944418", "9262275", "1534881", "19892338", "18794162" ]

[ "A prospective randomized trial comparing the clinical and endocrinological outcome with rosiglitazone versus laparoscopic ovarian drilling in patients with polycystic ovarian disease resistant to ovulation induction with clomiphene citrate.", "A prospective study comparing unilateral and bilateral laparoscopic ovarian diathermy in women with the polycystic ovary syndrome.", "Reproductive outcome after letrozole versus laparoscopic ovarian drilling for clomiphene-resistant polycystic ovary syndrome.", "Unilateral ovarian drilling in polycystic ovarian syndrome: a prospective randomized study.", "Comparison of metformin treatment and laparoscopic ovarian diathermy in patients with polycystic ovary syndrome.", "Letrozole versus laparoscopic ovarian diathermy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.", "Combined metformin and clomiphene citrate versus laparoscopic ovarian diathermy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.", "Plasminogen activator inhibitor 1 and miscarriage after metformin treatment and laparoscopic ovarian drilling in patients with polycystic ovary syndrome.", "Evaluation of unilateral versus bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome.", "A randomized controlled trial of laparoscopic ovarian diathermy versus gonadotropin therapy for women with clomiphene citrate-resistant polycystic ovary syndrome.", "Clomiphene citrate plus tamoxifen versus laparoscopic ovarian drilling in women with clomiphene-resistant polycystic ovary syndrome.", "The use of laparoscopic ovarian electrocautery in preventing cancellation of in-vitro fertilization treatment cycles due to risk of ovarian hyperstimulation syndrome in women with polycystic ovaries.", "The effect of short-interval laparoscopic lysis of adhesions on pregnancy rates following Nd-YAG laser photocoagulation of polycystic ovaries.", "Metformin versus laparoscopic ovarian drilling in clomiphene- and insulin-resistant women with polycystic ovary syndrome.", "Randomized controlled trial comparing laparoscopic ovarian diathermy with clomiphene citrate as a first-line method of ovulation induction in women with polycystic ovary syndrome." ]

[ "Rosiglitazone, an insulin sensitizing agent is used currently in women with clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS). Our study proposed to compare the efficacy of rosiglitazone and CC with laparoscopic ovarian drilling (LOD) and CC in terms of biochemical effects, ovulation rate and pregnancy rate in patients of PCOS resistant to CC.\n This prospective randomised trial included 43 patients of PCOS resistant to CC. Twenty-two women were assigned to the rosiglitazone (4 mg twice daily) and CC group and other 21 patients underwent unilateral LOD and then received CC and multivitamins. The treatment continued for six cycles in both the groups. The biochemical response, ovulation rate and pregnancy rate over a follow up period of 6 months were compared.\n Treatment with rosiglitazone and CC or LOD and CC resulted in increased ovulation (80.8 vs. 81.5%) and pregnancy (50 vs. 42.8%), respectively. There was no statistical difference between the two groups in terms of biochemical response, ovulation rate and pregnancy rate.\n To avoid the risk of adverse effects of LOD preference may be given to the use of rosiglitazone and CC therapy in patients of PCOS resistant to CC.", "To assess the efficacy of unilateral laparoscopic ovarian diathermy in the induction of ovulation in anti-estrogen-resistant polycystic ovary syndrome (PCOS).\n A prospective randomized study was performed to compare unilateral with bilateral ovarian diathermy.\n Specialist Reproductive Endocrine Unit.\n Ten patients with anti-estrogen-resistant PCOS.\n Randomization to unilateral (4 patients) or bilateral laparoscopic ovarian diathermy (6 patients).\n Rate and side of ovulation and change in endocrine profiles after ovarian diathermy.\n Unilateral ovarian diathermy resulted in ovulation from both ovaries. Fifty percent of the patients responded to diathermy and those who responded had a significantly greater fall in serum LH concentrations than those who failed to respond.\n The mechanism of action of laparoscopic ovarian diathermy is via a correction of disturbed ovarian-pituitary feedback. Hypersecretion of LH appears to be the most significant endocrine disturbance in these patients.", "To compare the clinical outcomes of letrozole and laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).\n In the present prospective randomized trial, 140 women with clomiphene-citrate-resistant PCOS were randomly allocated to receive 5mg letrozole from day 3 to day 7 of menses for 6 consecutive cycles, or to undergo LOD. When a leading follicle of at least 18 mm was present, ovulation was triggered with human chorionic gonadotropin (hCG). The 6-month rates of ovulation, pregnancy, abortion, and live births were evaluated.\n The groups were similar with regard to baseline clinical characteristics and hormonal profiles. The ovulation rate was significantly higher in the letrozole group than in the LOD group (59.0% versus 47.5%). On the days of the hCG injection, women in the letrozole group had a significantly thicker endometrium than those in the LOD group (P<0.0001). Women receiving letrozole had a higher pregnancy rate (35.7% versus 28.6%) and a lower rate of spontaneous abortion (8.0% versus 20.0%, respectively), but these differences were not statistically significant.\n Letrozole seems to be a suitable second-line ovulation-inducing alternative to LOD in women with PCOS who do not conceive with clomiphene citrate.\n Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.", "Ovarian drilling is a well-accepted intervention for ovulation induction in clomiphene citrate-resistant polycystic ovarian syndrome (PCOS) patients. The aim of this study was to evaluate the effect of unilateral and bilateral ovarian drilling by electrocautery in PCOS women. In this prospective randomized clinical study, 87 patients with ovulation failure as a result of PCOS were randomly allocated to either unilateral (group A; n = 43 patients) or bilateral (group B; n = 44 patients) laparoscopic ovarian drilling by electrocautery. The average time required for unilateral ovarian drilling was shorter than for bilateral drilling. In patients who ovulated after drilling, there was a significant fall in serum LH concentration (group A, P < 0.05, group B, P < 0.05). Ovulation, pregnancy and miscarriage rates were similar in both groups. It seems that unilateral ovarian drilling in PCOS is effective, less time-consuming and probably associated with fewer complications.", "To compare hormone levels and clinical outcomes in patients with polycystic ovary syndrome (PCOS) after metformin therapy or laparoscopic ovarian diathermy (LOD) at 6 months follow-up.\n A randomized trial was conducted in 126 patients with PCOS who had a history of infertility for at least 1 year and resistance to clomiphene citrate (CC). Patients (n=63) received metformin treatment or underwent LOD (n=63).\n Levels of follicle-stimulating hormone did not change in either group after the intervention (P>0.05). Serum levels of testosterone (P<0.001) and luteinizing hormone (P<0.001) were significantly lower after the treatment in both groups. The proportion of women with regular menstrual cycles increased significantly to 35% (P<0.001) in the LOD group and to 49% (P<0.001) in metformin group compared with before the intervention. Although proportion was higher in the metformin group compared with the LOD group, the difference was not significant (odds ratio 1.81; 95% CI, 0.88-3.69, P=0.1). Hirsutism decreased significantly from 100% to 79.37% (P<0.001) in both groups.\n CC-resistant patients with PCOS were treated effectively by both metformin and LOD.", "To compare the effect of letrozole with laparoscopic ovarian diathermy (LOD) for ovulation induction in clomiphene citrate (CC) resistant women with polycystic ovary syndrome (PCOS).\n Two hundred and sixty anovulatory women with CC-resistant PCOS were selected in this randomized controlled trial. Group A (n = 128) received 2.5 mg letrozole daily for 5 days for up to six cycles. Group B (n = 132) underwent LOD with 6 months follow-up. Outcome measures were ovulation rate, midcycle endometrial thickness, pregnancy, miscarriage and live birth rates.\n Ovulation occurred in 335/512 cycles (65.4%) in letrozole group and 364/525 cycles (69.3%) in LOD group without significant difference between both groups. Resumption of regular menstruation was similar in both treatment groups. A significant increase in midcycle endometrial thickness was observed in letrozole group (8.8 ± 1.1 mm vs. 7.9 ± 1.2 mm) (P < 0.05). Pregnancy rate was similar in both groups (15.6 vs. 17.5%). There were no statistical significant differences as regards miscarriage and live birth rates between both groups. No multiple pregnancy or ovarian hyperstimulation occurred in either group.\n Letrozole and LOD are equally effective for inducing ovulation and achieving pregnancy in CC-resistant PCOS patients.", "To compare the effect of combined metformin and clomiphene citrate (CC) with laparoscopic ovarian diathermy (LOD) meant for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS).\n Two-hundred and eighty-two anovulatory women with CC-resistant PCOS were selected in this randomized controlled trial. Patients (n = 138) received combined metformin-CC for up to six cycles or underwent LOD (n = 144) with six months follow up. The outcome measures were: ovulation rate, midcycle endometrial thickness, pregnancy and miscarriage rates.\n Ovulation occurred in 386/576 cycles (67%) in the combined metformin-CC group and 381/558 cycles (68.2%) in LOD group without a significant difference between the groups. Resumption of regular menstruation was similar in both groups. A significant increase in midcycle endometrial thickness was observed in the combined metformin-CC group (9.2 ± 1.2 mm vs 7.6 ± 1.1 mm) (P < 0.05). The pregnancy rate was similar in both groups (15.4% vs 17%), and there were no statistically significant differences regarding the miscarriage rate between both groups. Four twin pregnancies occurred in the metformin-CC group. No ovarian hyperstimulation occurred in either group.\n Combined metformin-CC and LOD are equally effective for inducing ovulation and achieving pregnancy in CC-resistant PCOS patients.\n © 2010 The Authors. Journal of Obstetrics and Gynaecology Research © 2010 Japan Society of Obstetrics and Gynecology.", "In women with polycystic ovary syndrome, metformin administration, not laparoscopic ovarian drilling, reduces plasminogen activator inhibitor 1 (PAI-1) activity. The lack of a decrease in PAI-1 activity is related to a high risk for miscarriage.", "Laparoscopic ovarian drilling (LOD) has been put forward as the treatment of choice in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS), with tubo-ovarian adhesion formation as the major disadvantage. Our study proposed to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in terms of ovulation and pregnancy rate with the expected advantage of decreasing postoperative adhesion rate and change in fimbiro ovarian relationship with unilateral drilling.\n This prospective randomized study included 44 patients with anovulatory infertility due to PCOS. Twenty-two patients underwent unilateral ovarian drilling in group-I and 22 patients underwent bilateral ovarian drilling in group-II between June 2005 and June 2007. The number of drilling site in each ovary was limited to five. The clinical and biochemical response, ovulation and pregnancy rates over a follow-up period of 1 year were compared. Tubo-ovarian adhesion rate was compared during cesarean section or during repeat laparoscopy.\n There was no statistical difference between the two groups in terms of clinical and biochemical response, ovulation rate and pregnancy rate. Postoperatively, tubo-ovarian adhesions could be assessed in 36.3% of the patients and no adhesions were found in a single case in either group.\n Unilateral drilling cauterization of ovary is equally efficacious as bilateral drilling in inducing ovulation and achieving pregnancy. Unilateral ovarian drilling may be a suitable option in clomiphene citrate resistant infertility patient of PCOS which can replace bilateral ovarian drilling with the potential advantage of decreasing the chances of adhesion formation.", "To compare the effectiveness of laparoscopic ovarian diathermy with gonadotropin ovulation induction for women with clomiphene citrate-resistant polycystic ovary syndrome.\n Randomized controlled trial.\n A tertiary referral fertility clinic.\n Women with anovulatory infertility secondary to clomiphene-resistant polycystic ovary syndrome. Inclusion criteria were age of <39 years, body mass index of <35 kg/m(2), failure to ovulate with 150 mg of clomiphene citrate for 5 days in the early follicular phase, >12 months of infertility, and no other causes of infertility.\n Laparoscopic ovarian diathermy versus three cycles of urinary or recombinant gonadotropins.\n Cumulative pregnancy and miscarriage rates.\n Cumulative pregnancy rates were 28% at 6 months for laparoscopic ovarian diathermy and 33% for three cycles of ovulation induction with gonadotropins. There were three miscarriages in each group. Women in the laparoscopic ovarian diathermy arm of the study had four additional spontaneous pregnancies 6 to 12 months after surgery.\n There was no statistically significant difference in pregnancy or miscarriage rates during the 6-month follow-up period or the three cycles. Laparoscopic ovarian diathermy is a safe and effective alternative to ovulation induction with gonadotropins.", "To compare the efficacy of clomiphene citrate (CC) plus tamoxifen with that of laparoscopic ovarian drilling in clomiphene-resistant women with polycystic ovary syndrome (PCOS).\n We randomly allocated 150 women with CC-resistant PCOS to a combined medication group (group 1) or a laparoscopic surgery group (group 2). The primary outcome was the live birth rate in each group; secondary outcomes were the rates of ovulation, clinical pregnancy and miscarriage.\n There were no significant differences between the groups regarding rates of ovulation (81.3% vs 85.3%), pregnancy (53.3% vs 50.7%), or live births (49.3% vs 44.0%), but the mean endometrium thickness was significantly greater on the day of human chorionic gonadotropin administration in group 1 (P<0.001).\n Clomiphene citrate plus tamoxifen was as effective as laparoscopic ovarian drilling in promoting ovulation and pregnancy.", "Fifty women with polycystic ovaries took part in a prospective randomized study. All women required treatment by in-vitro fertilization (IVF) for reasons other than anovulation. They had all previously undergone ovarian stimulation with gonadotrophin therapy which had failed to result in pregnancy or had been abandoned due to high risk of developing ovarian hyperstimulation syndrome (OHSS). Twenty-five women were treated by long-term pituitary desensitization followed by gonadotrophin therapy, oocyte retrieval and embryo transfer (group 1). Twenty-five women underwent laparoscopic ovarian electrocautery after pituitary desensitization followed by gonadotrophin therapy, oocyte retrieval and embryo transfer (group 2). A significantly higher number of women in group 1 had to have the treatment cycle abandoned due to impending or actual OHSS, determined by endocrine and clinical findings. In addition, the development of moderate or severe OHSS in completed cycles was higher in group 1. The pregnancy rate and miscarriage rates in the two treatment groups were similar. The authors propose that laparoscopic ovarian electrocautery is a potentially useful treatment for women who have previously had an IVF treatment cycle cancelled due to risk of OHSS or who have suffered OHSS in a previous treatment cycle.", "Laparoscopic Nd-YAG laser photocoagulation of the ovaries was performed in 40 anovulatory women with clomiphene citrate-resistant polycystic ovary disease. Following this procedure, the subjects were randomly assigned to have either a second-look laparoscopy with lysis of adhesions within 3-4 weeks of the initial laparoscopy (N = 19) or expectant management (N = 20). One patient assigned to the laparoscopy group refused the procedure. Minimal and mild adhesions that did not distort the normal tubo-ovarian relationship were encountered in 13 patients (68%) in the second-look laparoscopy group; these adhesions were easily lysed using sharp or blunt dissection. The pregnancy rates over 6 months were similar in the two groups (47% in the second-look group and 55% in the expectant-management group; P greater than .05). These data suggest that early laparoscopic lysis of adhesions does not improve short-term conception rates following laparoscopic Nd-YAG laser photocoagulation of polycystic ovaries.", "To compare the hormonal-metabolic profiles and reproductive outcomes in clomiphene-resistant patients with polycystic ovary syndrome and insulin resistance between women receiving metformin and those undergoing laparoscopic ovarian drilling.\n A total of 110 eligible participants were randomly allocated to diagnostic laparoscopy plus metformin therapy (group 1, n=55) or laparoscopic ovarian drilling (group 2, n=55). The t test was used for mean comparisons of hormonal-metabolic parameters and OGTT values before and after treatment. The chi(2) test was used for comparisons of ovulation, pregnancy, and abortion rates.\n Groups 1 and 2 showed a significant decline in testosterone, insulin-like growth factor-1 (P<0.001 vs P<0.001), and luteinizing hormone (P<0.05 vs P<0.001), while the glucose to insulin ratio was significantly increased (P<0.001 vs P<0.05) compared with baseline. Group 2 patients had more regular cycles and higher rates of ovulation and pregnancy compared with group 1: 76.4% [42/55] vs 58.2% [32/55], P<0.04; 50.8% [131/258] vs 33.5% [94/281], P<0.001; and 38.2% [21/55] vs 20.0% [11/55], P<0.03, respectively. The difference in the early abortion rate between the groups was not statistically significant.\n Although metformin results in a better attenuation of insulin resistance, laparoscopic ovarian drilling is associated with higher rates of ovulation and pregnancy.\n Copyright 2009 Elsevier Ireland Ltd. All rights reserved.", "Laparoscopic ovarian diathermy (LOD) is currently accepted as a successful second-line treatment for ovulation induction (OI) in clomiphene citrate (CC)-resistant women with polycystic ovary syndrome (PCOS). The aim of this study was to test the hypothesis that LOD may be superior to CC as a first-line treatment.\n The study included 72 anovulatory women with PCOS who were randomized to LOD (n = 36) or CC (n = 36). Women who remained anovulatory after LOD were offered CC. Similarly, women receiving CC who failed to ovulate or conceive were offered LOD. Pregnancy rates were compared between the two groups using chi(2) and odds ratio with 95% confidence interval (OR, 95% CI).\n After randomization, six women conceived before starting treatment and another patient postponed treatment. The remaining 65 women received the treatment (33 underwent LOD and 32 received CC). After the primary treatment, more pregnancies (44%) occurred in women receiving CC than in those undergoing LOD (27%), although the difference did not reach statistical significance [P = 0.13, OR 2.1 (0.7 - 5.8)]. After adding the second treatment, the pregnancy rate was still higher, but to a less extent, in the CC group [63% versus 52%, P = 0.2, OR 1.6 (0.6 - 4.2)].\n LOD is not superior to CC as a first-line method of OI in women with PCOS. The trial is registered with ClinicalTrials.gov with an identifier number NCT00220545." ]

[ "7756226", "1492408", "1349049", "12636950", "10740336" ]

[ "A randomised double blind placebo controlled trial of fish oil in high risk pregnancy.", "Effects of a combination of evening primrose oil (gamma linolenic acid) and fish oil (eicosapentaenoic + docahexaenoic acid) versus magnesium, and versus placebo in preventing pre-eclampsia.", "Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration.", "A randomized trial of docosahexaenoic acid supplementation during the third trimester of pregnancy.", "Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team." ]

[ "To determine whether n-3 fatty acid (EPA/DCHA) prophylaxis is beneficial in high risk pregnancies.\n A randomised, double blind, placebo controlled trial.\n Antenatal clinic of St James's University Hospital, Leeds.\n Two hundred and thirty-three pregnant women at high risk of developing proteinuric or nonproteinuric pregnancy induced hypertension or asymmetrical intrauterine growth retardation.\n Active treatment was 2.7 g of MaxEpa daily (1.62 g of eicosapentaenoic acid and 1.08 g of docosahexaenoic acid). Placebo were matching air-filled capsules.\n Occurrence of proteinuric, nonproteinuric pregnancy induced hypertension or birthweight < 3rd centile.\n There was no difference in an intention to treat analysis between the placebo and active treatment groups for occurrence of proteinuric pregnancy induced hypertension (relative risk (RR) = 0.88; 95% CI 0.47-1.66), nonproteinuric pregnancy induced hypertension (RR = 0.89; 95% CI 0.48-1.64), birthweight < 3rd centile (RR = 0.89; 95% CI 0.48-1.64), or the duration of pregnancy (difference of mean durations = 0.1 days; 95% CI -4.8 to 4.9 days). Analyses stratified by use of tobacco, and analyses excluding known major protocol violators gave essentially identical results.\n There is no evidence from this study for any useful effect of fish oil supplementation for women at high risk of adverse outcomes from a pregnancy, but a small protective effect remains a possibility.", "In a placebo controlled, partially double-blinded, clinical trial, a combination of evening primrose oil and fish oil was compared to Magnesium Oxide, and to a Placebo in preventing Pre-Eclampsia of Pregnancy. All were given as nutritional supplements for six months to a group of primiparous and multiparous pregnant women. Some of these women had personal or family histories of hypertension (21%). Only those patients who received prenatal care at the Central Maternity Hospital for Luanda were included in the study. Compared to the Placebo group (29%), the group receiving the mixture of evening primrose oil and fish oil containing Gamma-linolenic acid (GLA), Eicosapentaenoic acid (EPA), and Docosahexaenoic acid (DHA) had a significantly lower incidence of edema (13%, p = 0.004). The group receiving Magnesium Oxide had statistically significant fewer subjects who developed hypertension of pregnancy. There were 3 cases of eclampsia, all in the Placebo group.", "The high birthweights and long duration of pregnancy in the Faroe Islands led us to suggest that a high intake of marine-fat-derived n-3 fatty acids might prolong pregnancy by shifting the balance of production of prostaglandins involved in parturition. We have compared the effects on pregnancy duration, birthweight, and birth length of a fish-oil supplement, a control olive-oil supplement, and no supplementation. 533 healthy Danish women in week 30 of pregnancy were randomly assigned in a ratio of 2/1/1 to fish oil (four 1 g Pikasol capsules [containing 2.7 g n-3 fatty acids] per day), olive oil (four 1 g capsules per day), or no supplement. The three groups differed in mean length of gestation (p = 0.006), which was highest in the fish-oil group and lowest in the olive-oil group; the result was similar when the analysis was restricted to women with an estimate of gestation length based on early ultrasound findings (443 women). Pregnancies in the fish-oil group were on average 4.0 (95% confidence interval 1.5-6.4) days longer than those in the olive-oil group; the difference in birthweight was 107 (1-214) g. The effect of supplementation on length of gestation was influenced by intake of fish and of fish oil: the difference between fish-oil and other groups was increased by a low fish intake at baseline. Fish-oil supplementation in the third trimester seems to prolong pregnancy without detrimental effects on the growth of the fetus or on the course of labour.", "To hypothesize that higher intake of docosahexaenoic acid, an n-3 long chain polyunsaturated fatty acid, would increase duration of gestation and birth weight in US women.\n This was a randomized, double-blind, controlled, clinical trial. Subjects were enrolled in an ambulatory clinic where they received prenatal care. This was a population-based sample. Most subjects received government assistance for medical care and most were black (73%). Subjects were enrolled between the 24th and 28th week of pregnancy and consumed docosahexaenoic acid (33 or 133 mg) from eggs until parturition. Gestational age and birth weight were the main study outcomes. Infant length and head circumference, preterm birth, and low birth weight were secondary outcomes.\n Eighty-three percent of subjects completed the study (291 of 350 enrolled). No subject was discontinued for an adverse event. After controlling for important predefined risk factors and confounding variables, gestation increased by 6.0 +/- 2.3 days (P =.009) in the higher docosahexaenoic acid group. Birth weight, length, and head circumference increased, but did not reach statistical significance (P =.06-.18), although the increases could be clinically important indications of enhanced intrauterine growth. No safety concerns were raised by the study.\n Duration of gestation increased significantly when docosahexaenoic acid intake was increased during the last trimester of pregnancy. The increase in gestation was similar to that reported for interventions with much larger amounts of n-3 long chain polyunsaturated fatty acids.", "To test the postulated preventive effects of dietary n-3 fatty acids on pre-term delivery, intrauterine growth retardation, and pregnancy induced hypertension.\n In six multicentre trials, women with high risk pregnancies were randomly assigned to receive fish oil (Pikasol) or olive oil in identically-looking capsules from around 20 weeks (prophylactic trials) or 33 weeks (therapeutic trials) until delivery.\n Nineteen hospitals in Europe.\n Four prophylactic trials enrolled 232, 280, and 386 women who had experienced previous pre-term delivery, intrauterine growth retardation, or pregnancy induced hypertension respectively, and 579 with twin pregnancies. Two therapeutic trials enrolled 79 women with threatening pre-eclampsia and 63 with suspected intrauterine growth retardation.\n The fish oil provided 2.7 g and 6.1 g n-3 fatty acids/day in the prophylactic and therapeutic trials, respectively.\n Preterm delivery, intrauterine growth retardation, pregnancy induced hypertension.\n Fish oil reduced recurrence risk of pre-term delivery from 33% to 21% (odds ratio 0.54 (95% CI 0.30 to 0.98)) but did not affect recurrence risks for the other outcomes (OR 1.26; 0.74 to 2.12 and 0.98; 0.63 to 1.53, respectively). In twin pregnancies, the risks for all three outcomes were similar in the two intervention arms (95% CI for the three odds ratios were 0.73 to 1.40, 0.90 to 1.52, and 0.83 to 2.32, respectively). The therapeutic trials detected no significant effects on pre-defined outcomes. In the combined trials, fish oil delayed spontaneous delivery (proportional hazards ratio 1.22; 1.07 to 1.39, P = 0.002).\n Fish oil supplementation reduced the recurrence risk of pre-term delivery, but had no effect on pre-term delivery in twin pregnancies. Fish oil had no effect on intrauterine growth retardation and pregnancy induced hypertension, affecting neither recurrence risk nor risk in twin pregnancies." ]

[ "19029470", "16781381", "19245970", "16510747", "15505091", "14557355", "19261602", "18242535", "12866763", "17318445", "15175057", "17239094", "18442966", "16782716", "16214831", "19207759", "18775050", "19351628", "16302895", "15184286", "16344401", "17062959", "17161267", "15520310", "17562956", "17490437", "15928285", "14610012", "17338763" ]

[ "Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study.", "Left atrial ablation versus biatrial ablation for persistent and permanent atrial fibrillation: a prospective and randomized study.", "A randomized assessment of the incremental role of ablation of complex fractionated atrial electrograms after antral pulmonary vein isolation for long-lasting persistent atrial fibrillation.", "Circumferential pulmonary-vein ablation for chronic atrial fibrillation.", "Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study.", "Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation.", "Prophylactic cavotricuspid isthmus block during atrial fibrillation ablation in patients without atrial flutter: a randomised controlled trial.", "Single procedure efficacy of isolating all versus arrhythmogenic pulmonary veins on long-term control of atrial fibrillation: a prospective randomized study.", "A randomized clinical trial of the efficacy of radiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrial fibrillation.", "Pulmonary vein isolation and linear lesions in atrial fibrillation ablation.", "Ablation of superior pulmonary veins compared to ablation of all four pulmonary veins:.", "Achievement of pulmonary vein isolation in patients undergoing circumferential pulmonary vein ablation: a randomized comparison between two different isolation approaches.", "Pulmonary vein isolation combined with superior vena cava isolation for atrial fibrillation ablation: a prospective randomized study.", "Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a prospective randomized comparison.", "Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study).", "Does electrogram guided substrate ablation add to the success of pulmonary vein isolation in patients with paroxysmal atrial fibrillation? A prospective, randomized study.", "Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy.", "A randomized trial to compare atrial fibrillation ablation using a steerable vs. a non-steerable sheath.", "Left mitral isthmus ablation associated with PV Isolation: long-term results of a prospective randomized study.", "Changes in atrial fibrillation cycle length and inducibility during catheter ablation and their relation to outcome.", "Techniques, evaluation, and consequences of linear block at the left atrial roof in paroxysmal atrial fibrillation: a prospective randomized study.", "Is circumferential pulmonary vein isolation preferable to stepwise segmental pulmonary vein isolation for patients with paroxysmal atrial fibrillation?", "A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study.", "Prevention of iatrogenic atrial tachycardia after ablation of atrial fibrillation: a prospective randomized study comparing circumferential pulmonary vein ablation with a modified approach.", "Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study.", "Randomized comparison between open irrigation technology and intracardiac-echo-guided energy delivery for pulmonary vein antrum isolation: procedural parameters, outcomes, and the effect on esophageal injury.", "Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial.", "Randomized study comparing combined pulmonary vein-left atrial junction disconnection and cavotricuspid isthmus ablation versus pulmonary vein-left atrial junction disconnection alone in patients presenting with typical atrial flutter and atrial fibrillation.", "Efficacy of adjuvant anterior left atrial ablation during intracardiac echocardiography-guided pulmonary vein antrum isolation for atrial fibrillation." ]

[ "The mainstay of treatment for atrial fibrillation (AF) remains pharmacological; however, catheter ablation has increasingly been used over the last decade. The relative merits of each strategy have not been extensively studied.\n We conducted a randomized multicenter comparison of these 2 treatment strategies in patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug. The primary end point was absence of recurrent AF between months 3 and 12, absence of recurrent AF after up to 3 ablation procedures, or changes in antiarrhythmic drugs during the first 3 months. Ablation consisted of pulmonary vein isolation in all cases, whereas additional extrapulmonary vein lesions were at the discretion of the physician. Crossover was permitted at 3 months in case of failure. Echocardiographic data, symptom score, exercise capacity, quality of life, and AF burden were evaluated at 3, 6, and 12 months by the supervising committee. Of 149 eligible patients, 112 (18 women [16%]; age, 51.1+/-11.1 years) were enrolled and randomized to ablation (n=53) or \"new\" antiarrhythmic drugs alone or in combination (n=59). Crossover from the antiarrhythmic drugs and ablation groups occurred in 37 (63%) and 5 patients (9%), respectively (P=0.0001). At the 1-year follow-up, 13 of 55 patients (23%) and 46 of 52 patients (89%) had no recurrence of AF in the antiarrhythmic drug and ablation groups, respectively (P<0.0001). Symptom score, exercise capacity, and quality of life were significantly higher in the ablation group.\n This randomized multicenter study demonstrates the superiority of catheter ablation over antiarrhythmic drugs in patients with AF with regard to maintenance of sinus rhythm and improvement in symptoms, exercise capacity, and quality of life.", "The aim of this study was to compare--in patients with persistent and permanent atrial fibrillation (AF)--the efficacy and safety of left atrial ablation with that of a biatrial approach.\n Left atrium-based catheter ablation of AF, although very effective in the paroxysmal form of the arrhythmia, has an insufficient efficacy in patients with persistent and permanent AF.\n Eighty highly symptomatic patients (age, 58.6 +/- 8.9 years) with persistent (n = 43) and permanent AF (n = 37), refractory to antiarrhythmic drugs, were randomized to two different ablation approaches guided by electroanatomical mapping. A procedure including circumferential pulmonary vein, mitral isthmus, and cavotricuspid isthmus ablation was performed in 41 cases (left atrial ablation group). In the remaining 39 patients (biatrial ablation group), the aforementioned approach was integrated by the following lesions in the right atrium: intercaval posterior line, intercaval septal line, and electrical disconnection of the superior vena cava.\n During follow-up (mean duration 14 +/- 5 months), AF recurred in 39% of patients in the left atrial ablation group and in 15% of patients in the biatrial ablation group (p = 0.022). Multivariable Cox regression analysis showed that ablation technique was an independent predictor of AF recurrence during follow-up.\n In patients with persistent and permanent AF, circumferential pulmonary vein ablation, combined with linear lesions in the right atrium, is feasible, safe, and has a significantly higher success rate than left atrial and cavotricuspid ablation alone.", "This study sought to determine whether ablation of complex fractionated atrial electrograms (CFAEs) after antral pulmonary vein isolation (APVI) further improves the clinical outcome of APVI in patients with long-lasting persistent atrial fibrillation (AF).\n Ablation of CFAEs has been reported to eliminate persistent AF. However, residual pulmonary vein arrhythmogenicity is a common mechanism of recurrence.\n In this randomized study, 119 consecutive patients (mean age 60 +/- 9 years) with long-lasting persistent AF underwent APVI with an irrigated-tip radiofrequency ablation catheter. Antral pulmonary vein isolation resulted in termination of AF in 19 of 119 patients (Group A, 16%). The remaining 100 patients who still were in AF were randomized to no further ablation and underwent cardioversion (Group B, n = 50) or to ablation of CFAEs in the left atrium or coronary sinus for up to 2 additional hours of procedure duration (Group C, n = 50).\n Atrial fibrillation terminated during ablation of CFAEs in 9 of 50 patients (18%) in Group C. At 10 +/- 3 months after a single ablation procedure, 18 of 50 (36%) in Group B and 17 of 50 (34%) in Group C were in sinus rhythm without antiarrhythmic drugs (p = 0.84). In Group A, 15 of 19 patients (79%) were in sinus rhythm. A repeat ablation procedure was performed in 34 of 100 randomized patients (for AF in 30 and atrial flutter in 4). At 9 +/- 4 months after the final procedure, 34 of 50 (68%) in Group B and 30 of 50 (60%) in Group C were in sinus rhythm without antiarrhythmic drugs (p = 0.40).\n Up to 2 h of additional ablation of CFAEs after APVI does not appear to improve clinical outcomes in patients with long-lasting persistent AF.", "We conducted a randomized, controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation.\n A total of 146 patients with a mean (+/-SD) age of 57+/-9 years who had chronic atrial fibrillation were randomly assigned to receive amiodarone and undergo two cardioversions during the first three months alone (the control group) or in combination with circumferential pulmonary-vein ablation. Cardiac rhythm was assessed with daily telephonic transmissions for one year. The left atrial diameter and the severity of symptoms were assessed at 12 months.\n Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation, ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent. An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year (P=0.05). Among the 69 patients in the control group, 53 (77 percent) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 (4 percent) were in sinus rhythm without antiarrhythmic-drug therapy or ablation. There were significant decreases in the left atrial diameter (12+/-11 percent, P<0.001) and the symptom severity score (59+/-21 percent, P<0.001) among patients who remained in sinus rhythm after circumferential pulmonary-vein ablation. Except for atypical atrial flutter, there were no complications attributable to circumferential pulmonary-vein ablation.\n Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy, cardioversion, or both. The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter.\n Copyright 2006 Massachusetts Medical Society.", "An anatomic approach of left atrial radiofrequency circumferential ablation (LACA) to encircle the pulmonary veins is often effective in eliminating paroxysmal atrial fibrillation (AF). However, no electrophysiological end points other than voltage abatement and/or conduction slowing or block across ablation lines have been used. It has been unclear whether noninducibility of AF is a clinically useful end point.\n In 100 patients with paroxysmal AF (mean age, 55+/-10 years), LACA to encircle the left- and right-sided pulmonary veins was performed during AF, with additional ablation lines in the posterior left atrium and mitral isthmus, with an 8-mm-tip catheter. After completion of this lesion set, sinus rhythm was present, and AF lasting >60 seconds was not inducible in 40 patients (40%; group 1). The 60 patients in whom AF was still present or who still had inducible AF were randomly assigned to no further ablation (group 2; 30 patients) or to additional ablation lines along the left atrial septum, roof, and/or anterior wall where there were fractionated electrograms (group 3; 30 patients). In group 3, AF was rendered noninducible in 27 of 30 patients (90%). At a 6-month follow-up, 67% of patients in group 2 were free of AF without drug therapy compared with 86% of patients in group 3. (P=0.05, log-rank test). Left atrial flutter occurred in 17% and 27% of patients in each group, respectively (P=0.3).\n After LACA in patients with paroxysmal AF, AF usually can be rendered noninducible by additional ablation at sites of fractionated electrograms. Noninducibility of AF attained by additional electrogram-guided left atrial ablation may be associated with a better midterm clinical outcome than when AF is still inducible after LACA alone.", "Segmental ostial catheter ablation (SOCA) to isolate the pulmonary veins (PVs) and left atrial catheter ablation (LACA) to encircle the PVs both may eliminate paroxysmal atrial fibrillation (PAF). The relative efficacy of these 2 techniques has not been directly compared.\n Of 80 consecutive patients with symptomatic PAF (age, 52+/-10 years), 40 patients underwent PV isolation by SOCA and 40 patients underwent LACA to encircle the PVs. During SOCA, ostial PV potentials recorded with a ring catheter were targeted. LACA was performed by encircling the left- and right-sided PVs 1 to 2 cm from the ostia and was guided by an electroanatomic mapping system; ablation lines also were created in the mitral isthmus and posterior left atrium. The mean procedure and fluoroscopy times were 156+/-45 and 50+/-17 minutes for SOCA and 149+/-33 and 39+/-12 minutes for LACA, respectively. At 6 months, 67% of patients who underwent SOCA and 88% of patients who underwent LACA were free of symptomatic PAF when not taking antiarrhythmic drug therapy (P=0.02). Among the variables of age, sex, duration and frequency of PAF, ejection fraction, left atrial size, structural heart disease, and the ablation technique, only an increased left atrial size and the SOCA technique were independent predictors of recurrent PAF. The only complication was left atrial flutter in a patient who underwent LACA.\n In patients undergoing catheter ablation for PAF, LACA to encircle the PVs is more effective than SOCA.", "This randomised trial evaluated if patients with atrial fibrillation (AF) and no history of atrial flutter (AFL) had any benefit of prophylactic cavotricuspid isthmus block (CTIB) in addition to circumferential pulmonary vein ablation (CPVA).\n 149 patients with AF (54% paroxysmal) were randomised to CPVA and CTIB (group CTIB+, n = 73) or CPVA alone (group CTIB-, n = 76). Patients were followed for 12 months with repetitive 7-day Holter monitoring after 3, 6 and 12 months.\n Six patients (4%) had cardiac tamponade, and one patient had a stroke. No difference was found in the cumulative AFL-free rate between the two treatment groups (CTIB+: 88% vs CTIB-: 84%, hazard ratio (HR) 0.80, 95% CI (0.34 to 1.90), p = 0.61). There was no difference in the cumulative AF-free rate between the groups (CTIB+: 34% vs CTIB-: 32%, HR 0.93, 95% CI (0.63 to 1.38), p = 0.71). Overall, 33% of the patients were free of AF after a single procedure. Including reprocedures, a complete or partial beneficial effect was noted in 62% of the patients at 12 months. At 12-month follow-up, 24 (50%) patients with documented AF or AFL in the Holter recordings were asymptomatic.\n It was not possible to demonstrate any beneficial effect of CTIB in addition to CPVA with regard to AFL or AF recurrences during follow-up. Repetitive long-term Holter monitoring demonstrated a 33% rate of freedom from AF during a 1-year follow-up. Including additional CPVA procedures, a clinical effect was noted in 62% of the patients at 12 months. Patients with AF or AFL recurrences were often asymptomatic.", "Current atrial fibrillation (AF) ablation involves isolation of all pulmonary veins (PVs) with or without additional linear lesions. However, whether such extensive ablation is necessary is unclear.\n The purpose of this study was to assess the efficacy of different ablation strategies on long-term AF control.\n We prospectively randomized patients to undergo isolation of all versus arrhythmogenic PVs (identified by standardized stimulation protocol). PV isolation was guided by circular mapping catheter. The endpoint was entry/exit block persisting for > or = 20 minutes. Patients were evaluated at three clinic visits (at 6 weeks, 6 months, and 1 year) and multiple transtelephonic monitoring periods. Antiarrhythmic drugs were discontinued at 6 weeks. Primary study endpoint was long-term AF control (freedom or >90% reduction in AF burden off or on previously ineffective antiarrhythmic drugs at 1 year after a single ablation procedure).\n Over a 20-month period, 105 patients (76 men and 29 women, age 57 +/- 9 years; paroxysmal AF = 77) were randomized, and 103 patients completed 1-year follow-up (51 patients in all-PV arm, 52 patients in arrhythmogenic PV arm). The primary endpoint was achieved in 75 (73%) patients and was similar in patients randomized to all-PV arm versus arrhythmogenic PV arm [38 (75%) patients vs 37 (71%) patients, respectively; odds ratio 1.18, 95% confidence interval 0.50, 2.83, P = .70]. Secondary study endpoints, including freedom from AF off antiarrhythmic drugs, total procedure/fluoroscopy times, and occurrence of serious adverse events, were not different between the two groups.\n In a randomized comparison, isolation of arrhythmogenic veins was as efficacious as empiric isolation of all veins in achieving long-term AF control.", "The limited efficacy and proarrhythmic risks of antiarrhythmia agents have resulted in alternative therapeutic approaches. Radiofrequency ablation has been reported to be an effective treatment of patients with atrial fibrillation. However, there is no randomized clinical trial comparing drug and radiofrequency ablation. The authors randomized 30 patients with chronic atrial fibrillation refractory to medication into amiodarone and radiofrequency ablation. The primary objective of this study was to compare the efficacy of amiodarone and radiofrequency ablation in the maintenance of sinus rhythm at 1 year after randomization. Pulmonary vein isolation and linear ablation of right atrium was the technique used for radiofrequency ablation. There were no significant differences in baseline patient characteristics between the 2 groups. The results of this study showed that the probability of free from atrial fibrillation was better in the radiofrequency ablation group compared to amiodarone (78.6% in the ablation group and 40% in the amiodarone group, p = 0.018). Radiofrequency ablation results in a significant reduction in symptoms relating to atrial fibrillation and a significant improvement in quality of life, whereas amiodarone had no significant effect on symptoms and quality of life. There was an ischemic stroke as a major complication related to radiofrequency ablation. Amiodarone was associated with adverse effects in 46.7 per cent of patients and needed discontinuation in 1 patient. In conclusion, radiofrequency ablation is an effective alternative treatment in patients with atrial fibrillation refractory to medication.", "Various strategies have been used for atrial fibrillation (AF) ablation. It is unclear whether adding linear lesions to pulmonary vein (PV) isolation has significant advantages.\n We assessed the clinical benefit of adding linear lesions in patients undergoing PV isolation for AF.\n One hundred patients (63 male and 37 female; mean age of 59 +/- 11 years) with documented paroxysmal AF were included in the study. Patients were randomized into two groups. The first group underwent PV isolation alone. The second group underwent PV isolation and had two linear lesions created; one line between the superior PVs, and a second line from the left inferior PV to the mitral valve annulus. Patients' clinical progress after the ablation was evaluated and compared at 1, 3, and 9 months after their respective ablation procedures.\n The linear lesions group maintained sinus rhythm and had fewer symptoms than the lone PV isolation group (86 vs. 58%, respectively) (p < 0.05) at 1 month. At 9 months, when patients who reverted to AF underwent additional management to regain sinus rhythm (90 vs. 82%, respectively) (p = NS), there was no statistical difference between the groups regarding the use of antiarrhythmics, the need for electrical cardioversion, and subjective improvement.\n The addition of linear lesions to PV isolation more effectively achieved sinus rhythm initially and fewer patients required additional management to maintain their rhythm when compared to patients who underwent lone PV isolation. However, at 9 months, the overall results were similar in both groups.", "Isolation of all pulmonary veins (PV) is advocated for treatment of paroxysmal atrial fibrillation (PAF). However, the superior PVs are responsible for most AF triggers, whereas the inferior PVs carry the higher risk for ablation-induced ostial stenosis. The aim of this study was to compare a superior PV isolation approach with isolation of all PVs for treatment of PAF.\n Fifty-two patients with PAF were randomized to either left superior pulmonary vein (LSPV) isolation followed by additional isolation of the right superior pulmonary vein (RSPV) in case of AF recurrence (group A, n = 27) or isolation of all four PVs followed by a repeat procedure in case of recurrence (group B, n = 25). At 1-year follow-up, 11 patients (41%) in group A and 8 patients (32%) in group B had AF relapse (P = 0.55). No significant differences in AF relapse were detected between groups at 3 and 12 months (log rank = 0.36, P = 0.54) and by Cox proportional hazards model analysis (P = 0.62). Nonsignificant PV stenosis was detected in two patients from group B. Total radiofrequency energy delivery and fluoroscopy and procedure times were lower in group A: 8.9 +/- 1.4 minutes vs 25.6 +/- 3.7 minutes (P < 0.001), 22.2 +/- 6.8 minutes vs 62 +/- 10.3 minutes (P < 0.001), and 131.8 +/- 26.5 minutes vs 222.2 +/- 32.3 minutes (P < 0.001), respectively.\n A staged superior PVs isolation approach confers equal success rates but with reduced radiofrequency energy delivery and fluoroscopy and procedure times compared to isolation of all PVs at the initial ablation attempt.", "Circumferential pulmonary vein ablation (CPVA) with the endpoint of pulmonary vein (PV) isolation has been developed as an effective therapy for atrial fibrillation (AF). This endpoint can be achieved either by closing gaps along circular lines or by segmental PV isolation inside the circular lines after creation of initial CPVA lesions. We investigated whether the clinical outcome depends on the PV isolation approach used during the first-time CPVA procedure.\n One hundred consecutive patients (69 male; age, 56.7 +/- 11.6 years) who underwent first-time CPVA for treatment of symptomatic AF were enrolled. PV isolation was randomly achieved either by CPVA alone (aggressive CPVA [A-CPVA] group, n = 50) or by a combination of CPVA with segmental PV ostia ablation (modified CPVA [M-CPVA] group, n = 50). Recurrence of atrial tachyarrhythmias (ATa) within 3 months after the initial procedure occurred in 30 patients (60%) in the M-CPVA group and in only 15 patients (30%) in the A-CPVA group (P < 0.01). ATa relapse after the first 3 months was detected in 21 patients (42%) in the M-CPVA group, compared with 9 patients (18%) in the A-CPVA group (P = 0.01). At 13 +/- 4 months, patients treated by the A-CPVA approach had greater freedom from ATa recurrence than patients who underwent M-CPVA (P = 0.01). The M-CPVA approach was the only independent predictor associated with procedural failure (RR 0.318; 95% CI 0.123-0.821; P = 0.02).\n When PV isolation is the endpoint of CPVA, the efficacy of the A-CPVA approach is better than that of M-CPVA.", "Circumferential pulmonary vein isolation (CPVI) is an established strategy for atrial fibrillation (AF) ablation. Superior vena cava (SVC), by harbouring the majority of non-pulmonary vein (PV) foci, is the most common non-PV origin for AF. However, it is unknown whether CPVI combined with SVC isolation (SVCI) could improve clinical results and whether SVCI is technically safe and feasible.\n A total of 106 cases (58 males, average age 66.0 +/- 8.8 years) with paroxysmal AF were included for ablation. They were allocated randomly to two groups: CPVI group (n = 54) and CPVI + SVCI group (n = 52). All cases underwent the procedure successfully. Pulmonary vein isolation was achieved in all cases. The procedural time and fluoroscopic time were comparable between the two groups. The mean ablation time for SVC was 7.8 +/- 2.7 min. Superior vena cava isolation was obtained in 50/52 cases. In the remaining two cases, SVCI was not achieved because of obviating diaphragmatic nerve injury. During a mean follow-up of 4 +/- 2 months, 12 (22.2%) cases in the CPVI group and 10 (19.2%) cases in the CPVI + SVCI group had atrial tachyarrhythmias (ATa) recurrence (P = 0.70). Nine of 12 cases in the CPVI group and 8/10 cases in the CPVI + SVCI group underwent reablation (P = 0.86), and PV reconnection occurred in 7/9 cases in the CPVI group and in 8/8 cases in the CPVI + SVCI group. All PV reconnection was reisolated by gaps ablation. There was no SVC reconnection in the CPVI + SVCI group. In two cases without PV reconnection from the CPVI group, SVC-originated short run of atrial tachycardia was identified and eliminated by the SVCI. At the end of 12 months of follow-up, 50 cases (92.6%) in the CPVI group and 49 (94.2%) in the CPVI + SVC group were free of ATa recurrence (P = 0.73).\n In our series of paroxysmal AF patients, empirically adding SVCI to CPVI did not significantly reduce the AF recurrence after ablation. Superior vena cava isolation may be useful, however, in selected patients in whom the SVC is identified as a trigger for AF. However, because of the preliminary property of the study and its relatively small sample size, the impact of SVCI on clinical results should be evaluated in a large series of patients.", "To investigate the effectiveness of additional substrate modification (SM) by left atrial (LA) linear lesions as compared with pulmonary vein isolation (PVI) alone in patients with persistent atrial fibrillation (AF) in a prospective randomized study. Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF. The benefit of PVI alone and additional linear lesions has not been validated in a randomized study so far.\n Sixty-two patients with persistent AF (median duration 7, range 1-18 months) were randomly assigned to either PVI alone (n = 30) or additional SM (n =32) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus. Procedures including SM were performed using a three-dimensional mapping system (EnSite NavX, St Jude Medical, St Paul, MN, USA). Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups. Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient's symptoms. PVI was successful in 98% of all targeted veins in both groups. Additional SM did not increase fluoroscopy time (72.1+/-18.7 vs. 72.9+/-17.3 min, P=0.92) because of the use of three-dimensional navigation in the PVI+SM group. AF recurrences within the first 4 weeks following ablation were more common after PVI alone (77%) than additional SM (44%, P=0.002). After a follow-up time of 487 (429-570) days, only 20% of patients undergoing stand alone PVI remained in sinus rhythm when compared with 69% following PVI combined with SM (P=0.0001). Two patients assigned to PVI+SM experienced procedure-related complications (cardiac tamponade and minor stroke) which resolved without sequelae.\n PVI alone is insufficient in the treatment of persistent AF. However, additional left linear lesions increase the success rate significantly. Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM.", "We conducted a multi-centre, prospective, controlled, randomized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation (AF) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed.\n One hundred and thirty seven patients were randomized to ablation and antiarrhythmic drug therapy (ablation group) or antiarrhythmic drug therapy alone (control group). In the ablation group, patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation. The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting >30 s in the 1-year follow-up period, after 1-month blanking period. Three (4.4%) major complications were related to ablation: one patient had a stroke during left atrium ablation, another suffered transient phrenic paralysis, and the third had a pericardial effusion which required pericardiocentesis. After 12 months of follow-up, 63/69 (91.3%) control group patients had at least one AF recurrence, whereas 30/68 (44.1%) (P<0.001) ablation group patients had atrial arrhythmia recurrence (four patients had atrial flutter, 26 patients AF).\n Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed.", "Pulmonary vein isolation (PVI) is an established treatment for paroxysmal atrial fibrillation (AF). The ablation of complex fractionated atrial electrograms (CFAE) has emerged as a novel treatment approach. We sought to evaluate the additional effect of CFAE ablation to PVI in paroxysmal AF.\n Ninety-eight patients with paroxysmal AF (57 +/- 10 years, 74 male) were randomized to the PVI (n = 48) or PVI + CFAE group (n = 50). After PVI, CFAE ablation was performed in patients with inducible AF in the PVI + CFAE group. The primary endpoint was combined objective (7-day Holter ECG) and subjective (symptoms) freedom of atrial tachyarrhythmia 3 months after ablation. Long-term follow-up (19 +/- 8 months) was available in 94 of 98 patients. CFAE ablation was performed in 30 of 50 patients of the PVI + CFAE group. After 3 months, 36 of 48 patients (75%) in the PVI group and 38 of 50 patients (76%) in the PVI + CFAE group were in stable sinus rhythm (P = NS). During long-term follow-up (19 +/- 8 months), 34 of 46 patients (74%) in the PVI group and 40 of 48 patients (83%) in the PVI + CFAE group were in sinus rhythm (P = 0.08). In a subgroup analysis, a significantly better long-term outcome was achieved if inducible AF after PVI had been treated by additional CFAE ablation as compared with PVI only (sinus rhythm in 25/28 patients; 89% vs 22/30 patients 73%; P = 0.003).\n In the intention-to-treat analysis, additional CFAE ablation did not improve the success rate of PVI in patients with paroxysmal AF. However, during long-term follow-up, patients with still inducible AF after PVI seemed to profit from additional CFAE ablation.", "Atrial fibrillation (AF) and diabetes mellitus type 2 (DM2) often coexist; however, a small number of patients with DM2 undergoing catheter ablation (CA) of AF have been included in previous studies. The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF.\n From January 2005 to September 2006, 70 patients with a diagnosis of DM2 and paroxysmal (n = 29) or persistent (n = 41) AF were randomized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment (ADT) with a 1-year follow-up. The primary endpoint was the time to first AF recurrence. By Kaplan-Meier analysis, at the end of follow-up, 42.9% of patients in the ADT group and 80% of patients who received a single ablation procedure and were without medications were free of AF (P = 0.001). In the ablation group, a significant improvement in quality-of-life (QoL) scores as compared with ADT group was observed. Six patients in the ADT group (17.1%) developed significant adverse drug effects. Hospitalization rate during follow-up was higher in the ADT group (P = 0.01). The only complication attributable to ablation was one significant access-site hematoma.\n In patients with DM2, CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.", "Catheter positioning and stability are recognized challenges in catheter ablation of atrial fibrillation (AF). This prospective randomized study assessed whether routinely using a steerable sheath affects procedure outcomes.\n Fifty-six AF patients were randomized to ablation using either an Agilis NXT (St Jude Medical, St Paul, MN, USA) steerable sheath or a fixed-curve Mullins sheath (Cook Medical Inc., Bloomington, IN, USA) for the ablation catheter. A mapping system with CT integration was used to isolate the pulmonary veins (PVs) in pairs and further ablation performed if AF persisted. There was no significant difference in time to gain trans-septal access, CT registration time, time to isolate PVs, fluoroscopy time for PV isolation, total procedure time, or total fluoroscopy time. A learning curve was seen for the steerable sheath, and after correcting for this, CT registration time and right PV isolation were quicker in this group. One patient crossed over from fixed-curve to steerable. Acute, 3-, and 6-month single procedure success were similar in both groups.\n Allowing for the usage learning curve, a steerable sheath reduced time for some elements of AF ablation. Although this did not result in improved success, it may be useful for inexperienced operators, but at increased procedure cost.", "The deployment of an ablation line connecting the left inferior PV to the mitral annulus (mitral isthmus line [MIL]) enhances the efficacy of pulmonary vein disconnection (PVD) in preventing atrial fibrillation (AF) recurrences.\n To investigate the long-term effect of the additional linear lesion in a prospective randomized study.\n One hundred and eighty-seven patients (37 females, mean age: 55 +/- 11 years) with paroxysmal (126) or persistent (61 patients) AF, were prospectively randomized into two groups: PVD (group A, 92 patients) or PVD combined with MIL (group B, 95 patients), performed by means of an irrigated-tip ablation catheter.\n Successful disconnection of all PVs was achieved in all patients. A bidirectional block (BB) along the left atrial isthmus was obtained in 72 of 95 (76%) patients in group B, most of whom required additional RF pulses from within the distal CS. A transient ischemic attack occurred in 1 patient of group A, and a cardiac tamponade occurred in 1 patient of group B. At 1 year, 53 +/- 5% (group A) and 71 +/- 5% (group B) remained arrhythmia free (P = 0.01); subgroup analysis highlights a higher improvement among patients with persistent AF (74 +/- 9% vs 36 +/- 9%; P < 0.01) than what was observed in paroxysmal AF (76 +/- 6% vs 62 +/- 6%; P < 0.05); antiarrhythmic drugs were continued in 56% and 50%, respectively, in groups A and B (P = ns).\n The addition of mitral isthmus line to the PV disconnection allows a significant improvement of sinus rhythm maintenance rate, particularly in patients with persistent AF, without the risk for major complications.", "The modification of atrial fibrillation cycle length (AFCL) during catheter ablation in humans has not been evaluated.\n Seventy patients undergoing ablation of prolonged episodes of AF were randomized to pulmonary vein (PV) isolation or additional ablation of the mitral isthmus. Mean AFCL was determined at a distance from the ablated area (coronary sinus) at the following intervals: before ablation, after 2- and 4-PV isolations, and after linear ablation. Inducibility of sustained AF (> or =10 minutes) was determined before and after ablation. Spontaneous sustained AF (715+/-845 minutes) was present in 30 patients and induced in 26 (AFCL, 186+/-19 ms). PV isolation terminated AF in 75%, with the number of PVs requiring isolation before termination increasing with AF duration (P=0.018). PV isolation resulted in progressive or abrupt AFCL prolongation to various extents, depending on the PV: to 214+/-24 ms (P<0.0001) when AF terminated and to 194+/-19 ms (P=0.002) when AF persisted. The increase in AFCL (30+/-17 versus 14+/-11 ms; P=0.005) and the decrease in fragmentation (30.0+/-26.8% to 10.3+/-14.5%; P<0.0001) were significantly greater in patients with AF termination. Linear ablation prolonged AFCL, with a greater prolongation in patients with AF termination (44+/-13 versus 22+/-23 ms; P=0.08). Sustained AF was noninducible in 57% after PV isolation and in 77% after linear ablation. At 7+/-3 months, 74% with PV isolation and 83% with linear ablation were arrhythmia free without antiarrhythmics, which was significantly associated with noninducibility (P=0.03) with a recurrence rate of 38% and 13% in patients with and without inducibility, respectively.\n AF ablation results in a decline in AF frequency, with a magnitude correlating with termination of AF and prevention of inducibility that is predictive of subsequent clinical outcome.", "There are no reports describing the technique, electrophysiological evaluation, and clinical consequences of complete linear block at roofline joining the superior pulmonary veins (PVs) in patients with paroxysmal atrial fibrillation (AF).\n Ninety patients with drug-refractory paroxysmal AF undergoing radiofrequency ablation were prospectively randomized into 2 ablation strategies: (1) PV isolation (n=45) or (2) PV isolation in combination with linear ablation joining the 2 superior PVs (roofline; n=45). In both groups, the cavotricuspid isthmus, fragmented peri-PV-ostial electrograms, and spontaneous non-PV foci were ablated. Roofline ablation was performed at the most cranial part of the left atrium (LA) with complete conduction block demonstrated during LA appendage pacing by the online mapping of continuous double potential and an activation detour propagating around the PVs to activate caudocranially the posterior wall of the LA. The effect of ablation at the LA roof was evaluated by the change in fibrillatory cycle length, termination and noninducibility of AF, and clinical outcome. PV isolation was achieved in all patients with no significant differences in the radiofrequency duration, fluoroscopy, or procedural time between the groups. Roofline ablation required 12+/-6 (median 11, range 3 to 25) minutes of radiofrequency energy delivery with a fluoroscopic duration of 7+/-2 minutes and was performed in 19+/-7 minutes. Complete block was confirmed in 43 patients (96%) and resulted in an activation delay that was shorter circumventing the left than the right PVs during LA appendage pacing (138+/-15 versus 146+/-25 ms, respectively; P=0.01). Roofline ablation resulted in a significant increase in the fibrillatory cycle length (198+/-38 to 217+/-44 ms; P=0.0005), termination of arrhythmia in 47% (8/17), and subsequent noninducibility of AF in 59% (10/17) of the patients inducible after PV isolation. However, LA flutter, predominantly perimitral, could be induced in 10 patients (22%) after roofline ablation. At 15+/-4 months, 87% of the roofline group and 69% with PV isolation alone are arrhythmia free without antiarrhythmics (P=0.04).\n This prospective randomized study demonstrates the feasibility of achieving complete linear block at the LA roof. Such ablation resulted in the prolongation of the fibrillatory cycle, termination of AF, and subsequent noninducibility and is associated with an improved clinical outcome compared with PV isolation alone.", "Stepwise segmental pulmonary vein isolation (SPVI) and circumferential pulmonary vein isolation (CPVI) have been developed to treat patients with atrial fibrillation (AF), but the preferable approach for paroxysmal AF (PAF) has not been established.\n One hundred and ten patients with symptomatic PAF were randomized into a stepwise SPVI group (n=55) or CPVI group (n=55). Systemic SPVI combined with left atrial linear ablation tailored by inducibility of AF was performed in the stepwise SPVI group. Circumferential linear ablation around the left and right-sided pulmonary veins (PVs) guided by 3-dimensional electroanatomic mapping was performed in the CPVI group. The endpoints of ablation are non-induciblity of AF in the stepwise SPVI group and continuity of circular lesions combined with PV isolation in the CPVI group. After the initial procedures, atrial tachyarrhythmis (ATa) recurred within the first 3 months in 23 of the 55 patients (41.8%) who underwent stepwise SPVI and in 20 of the 55 patients (36.4%) who had CPVI (p=0.69). Repeat procedures were performed in 7 patients from the stepwise SPVI group and 5 from the CPVI group (p=0.76). During the 3-9 months after the last procedure, 46 patients (83.6%) from the CPVI group and 43 (78.2%) from the stepwise SPVI group did not have symptomatic ATa while not taking anti-arrhythmic drugs (p=0.63). Severe subcutaneous hematoma or PV stenosis occurred in 3 patients.\n The efficacy of stepwise SPVI is comparable to that of CPVI for patients with PAF.", "We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF).\n Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge.\n One hundred ninety-eight patients (age, 56 +/- 10 years) with PAF of 6 +/- 5 years' duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT.\n By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p < 0.001); a repeat ablation was performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia (3%). At 1 year, 93% and 35% of the CPVA and ADT groups, respectively, were AT-free. Ejection fraction, hypertension, and age independently predicted AF recurrences in the ADT group. Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations (p < 0.01). One transient ischemic attack and 1 pericardial effusion occurred in the CPVA group; side effects of ADT were observed in 23 patients.\n Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show; NCT00340314).", "Circumferential pulmonary vein ablation (CPVA) is effective in curing atrial fibrillation (AF), but new-onset left atrial tachycardia (AT) is a potential complication. We evaluated whether a modified CPVA approach including additional ablation lines on posterior wall and the mitral isthmus would reduce the incidence of AT after PV ablation.\n A total of 560 patients (291 men, 52%; age, 56.5+/-7.3 years) entered the study; 280 were randomized to CPVA alone (group 1) and 280 to modified CPVA (group 2). The primary end point was freedom from AT after the procedure. In group 1, 28 patients (10%) experienced new-onset AT, and 41 (14.3%) experienced recurrent AF. In group 2, 11 patients (3.9%) experienced AT, and 36 (12.9%) had recurrent AF. Group 1 was more likely to experience AT than group 2 (P=0.005). Freedom from AF after ablation was similar in both groups (P=0.57). Among those in group 1, gap-related macroreentrant AT was documented in 23 of the 28 patients (82%), and focal AT was found in 5 (18%). In group 2, gap-related macroreentrant AT was found in 8 of the 11 patients (73%), and focal AT was seen in 3 (27%). Two patients in group 1 and 1 patient in group 2 had both AT and AF. The strongest predictor of AT was the presence of gaps (P<0.001).\n Modified CPVA is as effective as CPVA in preventing AF but is associated with a lower risk of developing incessant AT.", "Pulmonary vein (PV) isolation is a promising new treatment for atrial fibrillation (AF). We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV.\n A total of 110 patients, 67 with paroxysmal AF and 43 with persistent AF, were randomly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs. The isolation of each individual PV was an electrophysiologically guided, ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter (group I). Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block (group II). In both groups, an irrigated-tip ablation catheter (25 to 35 W) was used to achieve complete isolation. Procedure and ablation times were longer in group II, whereas fluoroscopic time was significantly shorter (P < or = 0.001). After a follow-up period of 15+/-4 months, 27 patients in group I (49%) and 37 patients in group II (67%) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure (P < or = 0.05).\n The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation.", "We performed a prospective study to compare efficacy and safety of both open irrigation tip (OIT) technology with intracardiac echo (ICE)-guided energy delivery in patients presenting for PVAI.\n Fifty-three patients presenting for PVAI were randomized to ablation using an OIT catheter (Group 1, 26 patients; temperature and power were set at 50 degrees and 50 W, respectively, with a saline pump flow rate of 30 mL/min) or radiofrequency (RF) energy delivery under ICE guidance (Group 2, 27 patients; energy was titrated based on microbubbles formation). The mean procedure time and fluoroscopy exposure were lower in Group 1 (164 +/- 42 min and 7,560 +/- 2,298 microGray m2 vs 204 +/- 47 min and 12,240 +/- 4,356 microGray m2; P = 0.005 and 0.008, respectively). Moreover, the durations of RF lesions applied per PV antrum was lower in Group 1 compared with Group 2 (5.1 +/- 2.2 min vs 9.2 +/- 3.2 min, P = 0.03, respectively). Within 24 hours after PVAI in 35.7% (all erythema) of Group 1 and 57.1% (21.4% erythema and 35.7% necrosis) of Group 2, patients' esophageal wall changes were documented. After 14 +/- 2 months of follow up, recurrences were documented in 19.2% of Group 1 and 22.2% of Group 2 patients.\n Although both OIT and ICE-guided energy delivery possess a similar effect in treating AF, OIT seems to be superior in terms of achieving isolation and shortening fluoroscopy exposure. Moreover, a lower incidence of esophageal wall injury was observed utilizing OIT for PVAI.", "Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation (PVI) with radiofrequency ablation may cure AF, obviating the need for antiarrhythmic drugs and anticoagulation.\n To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF.\n A multicenter prospective randomized study conducted from December 31, 2001, to July 1, 2002, of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs.\n Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up.\n Recurrence of AF, hospitalization, and quality of life assessment.\n Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up. At the end of 1-year follow-up, 22 (63%) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 (13%) of 32 patients who received PVI (P<.001). Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the antiarrhythmic drug group compared with 3 (9%) of 32 in the PVI group (P<.001). In the antiarrhythmic drug group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (P = .01). At 6-month follow-up, the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey. There were no thromboembolic events in either group. Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 (6%) of 32 patients in the PVI group.\n Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF. Larger studies are needed to confirm its safety and efficacy.", "Atrial flutter (AFL) and atrial fibrillation (AF) frequently coexist in the same patient. Recently it has been demonstrated that the triggers for both AF and AFL may originate in the pulmonary veins (PVs). We hypothesized that in patients with both AF and typical AFL, pulmonary vein-left atrial junction (PV-LAJ) disconnection may eliminate both arrhythmias.\n Consecutive patients with documented symptomatic AF and typical AFL were randomly assigned to have PV-LAJ disconnection combined with cavotricuspid isthmus (CTI) ablation (group 1, n=49) or PV-LAJ disconnection alone (group 2, n=59). Within the first 8 weeks after ablation, 32 of the group 2 patients had typical AFL documented, whereas none was seen in group 1. Twenty of these 32 converted to sinus rhythm after initiating antiarrhythmic drugs (AADs). Twelve were cardioverted, and AADs were started. After 8 weeks, all AADS were stopped, and only 3 patients continued to have recurrent sustained typical AFL that was eliminated by CTI ablation. Beyond 8 weeks of follow-up, 7 patients in group 1 and 6 patients in group 2 (14% and 11%, respectively) continued to have AF. Ten of these 13 patients underwent a repeat PV-LAJ disconnection procedure and were cured. The remaining 3 remained in normal sinus rhythm while taking AADs.\n In patients with both AFL and AF, PV-LAJ disconnection alone may be sufficient to control both arrhythmias. CTI block reduced early postablation recurrence of arrhythmias, which in the majority of patients reflects a short-term clinical problem.", "Recent data have shown that the septum and anterior left atrial (LA) wall may contain \"rotor\" sites required for AF maintenance. However, whether adding ablation of such sites to standard ICE-guided PVAI improves outcome is not well known.\n To determine if adjuvant anterior LA ablation during PVAI improves the cure rate of paroxysmal and permanent AF.\n One hundred AF patients (60 paroxysmal, 40 persistent/permanent) undergoing first-time PVAI were enrolled over three months to receive adjuvant anterior LA ablation (Group I). These patients were compared with 100 randomly selected, matched first-time PVAI controls from the preceding three months who did not receive adjuvant ablation (Group II). All 200 patients underwent ICE-guided PVAI during which all four PV antra and SVC were isolated. In group I, a decapolar lasso catheter was used to map the septum and anterior LA wall during AF (induced or spontaneous) for continuous high-frequency, fractionated electrograms (CFAE). Sites where CFAE were identified were ablated until the local EGM was eliminated. A complete anterior line of block was not a requisite endpoint. Patients were followed up for 12 months. Recurrence was assessed post-PVAI by symptoms, clinic visits, and Holter at 3, 6, and 12 months. Patients also wore rhythm transmitters for the first 3 months. Recurrence was any AF/AFL >1 min occurring >2 months post-PVAI.\n Patients (age 56 +/- 11 years, 37% female, EF 53%+/- 11%) did not differ in baseline characteristics between group I and II by design. Group I patients had longer procedure time (188 +/- 45 min vs 162 +/- 37 min) and RF duration (57 +/- 12 min vs 44 +/- 20 min) than group II (P < 0.05 for both). Overall recurrence occurred in 15/100 (15%) in group I and 20/100 (20%) in group II (P = 0.054). Success rates did not differ for paroxysmal patients between group I and II (87% vs 85%, respectively). However, for persistent/permanent patients, group I had a higher success rate compared with group II (82% vs 72%, P = 0.047).\n Adjuvant anterior LA ablation does not appear to impact procedural outcome in patients with paroxysmal AF but may offer benefit to patients with persistent/permanent AF." ]

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[ "Prevention of iron deficiency anemia in adolescent and adult pregnancies.", "Impact of micronutrient supplementation during pregnancy on birth weight, duration of gestation, and perinatal mortality in rural western China: double blind cluster randomised controlled trial.", "Impact of prophylactic iron supplementation in healthy pregnant women on maternal iron status and birth outcome.", "Supplementation with vitamin A and iron for nutritional anaemia in pregnant women in West Java, Indonesia.", "Further observations on the relation between iron and folate status in pregnancy.", "Iron stores in pregnancy.", "Iron supplementation studies among pregnant women.", "A WHO collaborative study on iron supplementation in Burma and in Thailand.", "Iron supplementation during pregnancy, anemia, and birth weight: a randomized controlled trial.", "Iron deficiency prophylaxis during pregnancy.", "Changes in blood manganese levels during pregnancy in iron supplemented and non supplemented women.", "Moderate NaFeEDTA and ferrous sulfate supplementation can improve both hematologic status and oxidative stress in anemic pregnant women.", "Serum ferritin as a measure of iron stores during and after normal pregnancy with and without iron supplements.", "Serum ferritin and iron stores during pregnancy.", "Efficacy and tolerability of low-dose iron supplements during pregnancy: a randomized controlled trial.", "A prophylactic trial of iron and folic acid supplements in pregnant Burmese women.", "Absorption of supplemental iron during pregnancy - a longitudinal study with repeated bone-marrow studies and absorption measurements.", "Effects of iron and folic acid antenatal supplements on maternal haematology and fetal wellbeing.", "The effects of iron supplementation during pregnancy, given by traditional birth attendants, on the prevalence of anaemia and malaria.", "Iron status markers in nonanemic pregnant women with and without iron supplementation.", "Iron-storage deficiency and iron supplementation in pregnancy.", "A comparison of the hematologic responses following the routine prenatal administration of intramuscular and oral iron.", "Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial.", "Maternal erythropoietin in singleton pregnancies: a randomized trial on the effect of oral hematinic supplementation.", "A randomised placebo-controlled trial to determine the effect of iron supplementation on pregnancy outcome in pregnant women with haemoglobin > or = 13.2 g/dl.", "IRON DEFICIENCY AND ITS RELATION TO FOLIC-ACID STATUS IN PREGNANCY: RESULTS OF A CLINICAL TRIAL.", "Effect of high-dose iron supplements on fractional zinc absorption and status in pregnant women.", "Haemoglobin levels in pregnancy; the effect of the rationing scheme and routine administration of iron.", "Hemoglobin as a predictor of response to iron therapy and its use in screening and prevalence estimates.", "[Prevention of iron-deficiency anemia in pregnancy using early iron supplementation: a controlled trial].", "Iron supplementation during pregnancy. Effect on iron status markers, serum erythropoietin and human placental lactogen. A placebo controlled study in 207 Danish women.", "A combination of iron and retinol supplementation benefits iron status, IL-2 level and lymphocyte proliferation in anemic pregnant women.", "Iron supplement in pregnancy and development of gestational diabetes--a randomised placebo-controlled trial.", "[Therapy and iron supplements with ferritin iron during pregnancy. Randomized prospective study of 458 cases].", "Effect of iron supplementation on the iron status of pregnant women: consequences for newborns.", "Supplementation of iron alone and combined with vitamins improves haematological status, erythrocyte membrane fluidity and oxidative stress in anaemic pregnant women.", "A randomized trial of oral iron on tests of short-term memory and attention span in young pregnant women.", "The prevention of anaemia in pregnancy in primigravidae in the guinea savanna of Nigeria.", "Effect of oral iron supplementation during pregnancy on maternal and fetal iron status.", "Effect of time of initiation and dose of prenatal iron and folic acid supplementation on iron and folate nutriture of Korean women during pregnancy.", "Iron requirement in normal pregnancy as assessed by serum ferritin, serum transferrin saturation and erythrocyte protoporphyrin determinations.", "A randomized comparison of routine versus selective iron supplementation during pregnancy.", "Milk fortified with iron or iron supplementation to improve nutritional status of pregnant women: an intervention trial from rural Vietnam.", "THE VALUE OF IRON SUPPLEMENTATION DURING PREGNANCY.", "Evaluation of a gastric delivery system for iron supplementation in pregnancy.", "Effect of iron supplementation on serum ferritin levels during and after pregnancy.", "The effects of prophylactic iron given in prenatal supplements on iron status and birth outcomes: a randomized controlled trial." ]

[ "Worldwide attention over iron deficiency anemia (IDA) in pregnancy has shifted recently from providing supplements during pregnancy to attempting to ensure that women, especially adolescents, have adequate iron stores prior to conception. We sought to determine whether adolescent and/or adult women still need supplements during pregnancy to avoid IDA, even if iron stores are adequate, and whether the IDA translates into maternal and/or infant morbidity and mortality.\n Randomized, double-blind clinical trial with placebo control.\n Multicenter clinic setting in central Wisconsin.\n Adolescent women 18 years or less in their first pregnancy, and adult women 19 years or older, who were found to be healthy and iron sufficient at their first prenatal visit.\n Participants were randomized to receive iron supplementation (60 mg/day elemental iron) or placebo. Serum ferritin of 12 ng/mL or less with simultaneous hemoglobin of 11 g/dL or less defined IDA. When IDA occurred at the second trimester, a therapeutic supplement of 180 mg of elemental iron per day was initiated.\n Forty-seven percent of all placebo-supplemented and 16% of all iron-supplemented patients exhibited IDA (p<0.001); 59% of adolescent placebo-supplemented and 20% of adolescent iron-supplemented patients exhibited IDA (p=0.021). Nausea, vomiting, diarrhea, and constipation were not significantly different in the iron supplemented group compared to the placebo group, and no significant differences were seen in maternal or neonatal health, but the number of women studied was limiting for analysis of these adverse events.\n IDA is common in healthy, iron-sufficient adolescent pregnant women during the second trimester, and body stores of iron decline in both adolescent and adult pregnancies. The incidence of IDA during adolescent and adult pregnancies is substantially reduced with 60 mg of elemental iron per day. However, there remains no clear evidence that maternal or neonatal health will benefit from correcting these deficits.", "To examine the impact of antenatal supplementation with multiple micronutrients or iron and folic acid compared with folic acid alone on birth weight, duration of gestation, and maternal haemoglobin concentration in the third trimester.\n Cluster randomised double blind controlled trial.\n Two rural counties in north west China.\n 5828 pregnant women and 4697 live births.\n Villages were randomised for all pregnant women to take either daily folic acid (control), iron with folic acid, or multiple micronutrients with a recommended allowance of 15 vitamins and minerals.\n Birth weight, length, and head circumference measured within 72 hours after delivery. Neonatal survival assessed at the six week follow-up visit.\n Birth weight was 42 g (95% confidence interval 7 to 78 g) higher in the multiple micronutrients group compared with the folic acid group. Duration of gestation was 0.23 weeks (0.10 to 0.36 weeks) longer in the iron-folic acid group and 0.19 weeks (0.06 to 0.32 weeks) longer in the multiple micronutrients group. Iron-folic acid was associated with a significantly reduced risk of early preterm delivery (<34 weeks) (relative risk 0.50, 0.27 to 0.94, P=0.031). There was a significant increase in haemoglobin concentration in both iron-folic acid (5.0 g/l, 2.0 to 8.0 g/l, P=0.001) and multiple micronutrients (6.9 g/l, 4.1 to 9.6 g/l, P<0.001) groups compared with folic acid alone. In post hoc analyses there were no significant differences for perinatal mortality, but iron-folic acid was associated with a significantly reduced early neonatal mortality by 54% (relative risk 0.46, 0.21 to 0.98).\n In rural populations in China antenatal supplementation with iron-folic acid was associated with longer gestation and a reduction in early neonatal mortality compared with folic acid. Multiple micronutrients were associated with modestly increased birth weight compared with folic acid, but, despite this weight gain, there was no significant reduction in early neonatal mortality. Pregnant women in developing countries need sufficient doses of iron in nutrient supplements to maximise reductions in neonatal mortality. Trial registration ISRCTN08850194.", "In spite of the beneficial effect of iron supplementation in iron-deficient pregnant women, iron supplementation may not be needed for women who are iron replete or not anemic. Moreover, the theoretical possibility of adverse effects, such as oxidative damage,from administration of iron supplements during pregnancy has been raised.\n To determine the effect of prophylactic iron supplementation on iron status and birth outcomes among nonanemic pregnant women. METHODS. A randomized, triple-blind clinical trial was conducted. One hundred forty-eight nonanemic pregnant women with hemoglobin > 110 g/L, serum ferritin > 12 microg/L, and gestational age < 20 weeks were randomly assigned to receive either ferrous sulfate (60 mg elemental iron) (n = 70) or placebo (n = 78) until delivery. Hemoglobin concentration and serum ferritin were measured by electronic counter and radioimmunoassay, respectively. Data were analyzed by independent t-tests, ANCOVA, and repeated measures.\n At delivery, the incidence of iron deficiency was significantly lower in the iron than in the placebo group. There were no significant differences between the two groups in maternal hemoglobin and ferritin concentrations at delivery or in the infant's birthweight, birth length, or length of gestation.\n Iron supplementation during pregnancy in nonanemic women with low serum ferritin may have benefits beyond the prevention of iron-deficiency anemia.", "Nutritional anaemia, thought to be caused by iron deficiency, affects 50-70% of pregnant women in the developing world. The influence of vitamin A and iron supplementation was studied in anaemic pregnant women in West Java, in a randomised, double-masked, placebo-controlled field trial. 251 women aged 17-35 years, parity 0-4, gestation 16-24 weeks, and haemoglobin between 80 and 109 g/L were randomly allocated to four groups: vitamin A (2.4 mg retinol) and placebo iron tablets; iron (60 mg elemental iron) and placebo vitamin A; vitamin A and iron; or both placebos, all daily for 8 weeks. Maximum haemoglobin was achieved with both vitamin A and iron supplementation (12.78 g/L, 95% Cl 10.86 to 14.70), with one-third of the response attributable to vitamin A (3.68 g/L, 2.03 to 5.33) and two-thirds to iron (7.71 g/L, 5.97 to 9.45). After supplementation, the proportion of women who became non-anaemic was 35% in the vitamin-A-supplemented group, 68% in the iron-supplemented group, 97% in the group supplemented with both, and 16% in the placebo group. Improvement in vitamin A status may contribute to the control of anaemic pregnant women.", "This study was planned to determine whether iron deficiency in pregnancy predisposed to the development of folate deficiency and also the smallest daily iron supplement that maintained haemoglobin levels in pregnancy.Three groups of women were given oral ferrous fumarate supplying 30, 60, and 120 mg of iron; a fourth group was given 1 g of parenteral iron in early pregnancy followed by oral iron (60 mg); a fifth group received a placebo. Tablets were taken once daily.Oral iron 30 mg once daily maintained haemoglobin levels throughout pregnancy. Women whose marrows lacked demonstrable iron at the 37th week had a significantly higher incidence of megaloblastic haemopoiesis (28.7%) than those with demonstrable iron stores (15.3%); women taking oral iron did not have a lower frequency of megaloblastosis than those given a placebo. We concluded that iron does not have a direct effect on folate status in pregnancy, that the association of iron deficiency and megaloblastic anaemia in pregnancy is the result of poor nutrition, and that there is no cause-and-effect relation between them.", "Serum ferritin concentration has been measured during the course of pregnancy in 154 women. There was a rapid decrease in iron stores during early pregnancy irrespective of any iron therapy. Oral iron did, however, prevent the stores reaching iron deficient levels during the second half of pregnancy. The results suggest that maternal erythroid activity starts early in pregnancy and may exhaust the iron stores before the fetal demands for iron can be met.", "The effect of iron supplementation alone or in combination with ascorbic acid as a preventive and or corrective measure against anemia were tested using pregnant women seeking pre-natal consultation at various health centers in Greater Manila Area. One tablet containing 65 mg iron alone or in combination with ascorbic acid per day during a supplementation period which varied from 16.5 to 17.8 weeks maintained initial hemoglobin and hematocrit levels in non-anemic women. Three tablets of the same iron preparation (total of 195 mg iron) daily resulted in significant increases in hemoglobin and hematocrit in anemic women. Ascorbic acid had no apparent beneficial effect. Considering the positive response to iron treatment, it is recommended that a nationwide program of iron supplementation of pregnant Filipinos be undertaken.", "Studies on the treatment and prevention of iron deficiency anemia, in pregnant and nonpregnant women and in men, were conducted in Thailand and Burma. The effects of the dose of Fe, duration of Fe administration, additional supplementation with folate, mode of supplement delivery (either supervised or unsupervised), and the presence of Hb(AE) were studied. The frequency and severity of side effects were also recorded. Fe administration resulted in an increase in hemoglobin concentration in all anemic individuals but approximately 20% failed to reach normality. The length of administration and the dose influenced the results. Frequency and severity of side effects increased with the dose of Fe administered. Folate supplementation did not affect the results. It appears possible to integrate a program of prevention and treatment of Fe deficiency anemia in a primary health-care system but the constraints and limitations of achievable results should be recognized.", "The need for prophylactic iron during pregnancy is uncertain.\n We tested the hypothesis that administration of a daily iron supplement from enrollment to 28 wk of gestation to initially iron-replete, nonanemic pregnant women would reduce the prevalence of anemia at 28 wk and increase birth weight.\n Between June 1995 and September 1998, 513 low-income pregnant women in Cleveland were enrolled in the study before 20 wk of gestation. Of these, 275 had a hemoglobin concentration >/= 110 g/L and a ferritin concentration >/= 20 micro g/L and were randomly assigned to receive a monthly supply of capsules containing either 30 mg Fe as ferrous sulfate or placebo until 28 wk of gestation. At 28 and 38 wk of gestation, women with a ferritin concentration of 12 to < 20 micro g/L or < 12 micro g/L received 30 and 60 mg Fe/d, respectively, regardless of initial assignment. Almost all the women received some supplemental iron during pregnancy. We obtained infant birth weight and gestational age at delivery for 117 and 96 of the 146 and 129 women randomly assigned to receive iron and placebo, respectively.\n Compared with placebo, iron supplementation from enrollment to 28 wk of gestation did not significantly affect the overall prevalence of anemia or the incidence of preterm births but led to a significantly higher mean (+/- SD) birth weight (206 +/- 565 g; P = 0.010), a significantly lower incidence of low-birth-weight infants (4% compared with 17%; P = 0.003), and a significantly lower incidence of preterm low-birth-weight infants (3% compared with 10%; P = 0.017).\n Prenatal prophylactic iron supplementation deserves further examination as a measure to improve birth weight and potentially reduce health care costs.", "nan", "Blood manganese levels and iron status indices were determined each trimester in 66 healthy pregnant women. Twenty-five were randomly assigned to iron supplementation, 19 to placebo and 22 received dietary advise aimed at increasing their dietary intake of fibre. Iron supplemented women had significantly higher levels of blood haemoglobin compared to the levels of the two other groups, and higher serum ferritin levels compared to the placebo group. No significant difference in blood manganese levels was observed among the three groups of women. There was a significant increase in blood manganese levels from one trimester to the next, which was slightly more pronounced in non supplemented women. The median values in the three trimesters were 154 (range 79-360) nmol/L, 190 (range 98-408) nmol/L, and 230 (range 133-481) nmol/L, respectively. Pregnancy seems to change manganese status or otherwise influence manganese metabolism irrespective of iron status and iron supplementation.", "Iron is important general well being, to prevent or treat anemia, and is a cofactor of many enzymes in the anti-oxidant process. Effect of sodium iron ethylenediaminetetraacetate (NaFeEDTA) and ferrous sulfate on iron bioavailability and oxidative stress in anemic pregnant women was evaluated. A 2-month randomized controlled trial was conducted on 153 anemic pregnant women, with 80 <= Hb <110 g/L. They were randomly allocated to three groups: group C (n=51) was the placebo control group, group I (n=51) was supplemented daily with 60 mg iron as ferrous sulfate, and group IE (n=51) with 60 mg iron as NaFeEDTA. Blood samples were collected before and at the end of the intervention for measurements of hematological indices and oxidative stress parameters. Considerable increases of hematologic indicators were observed: 20.5 and 21.8 g/L for Hb (both p values <0.001); 4.81 and 7.19 μmol/L for plasma iron (both p values <0.001), 2.63 and 8.99 μg /L for ferritin (both p values <0.05) in I and IE groups, respectively, compared with the control group. Glutathione peroxidase (GSH-Px) activities increased by 32.6 and 75.3 IU/ml, and malondialdehyde (MDA) levels decreased by 0.70 and 1.12 μmol/L in I and IE groups, compared with the C group (p values <0.05). Moreover, differences of plasma iron, ferritin and GSH-Px activity were 2.38 μmol/L, 6.36 μg /L and 42.7 IU/ml were also significantly greater in the IE group than in the I group. Moderate iron supplementation may be beneficial to improving iron deficiency and oxidative stress, and NaFeEDTA is better than ferrous sulfate.", "The iron stores of 32 healthy pregnant women were evaluated longitudinally during pregnancy and 6 months post partum by serum ferritin assay and by bone marrow iron content. Half of the women were receiving oral iron while the others were not given iron supplementation. Women receiving iron could maintain their iron stores throughout the pregnancy. By contrast, women without iron therapy had low serum ferritin values, pointing to the absence of iron stores during the last trimester, and 6 of these 16 women developed anemia. This was confirmed by estimation of the quantity of stainable iron in the bone marrow. In addition serum iron, transferrin and red cell MCV values indicated iron deficient erythropoesis. During a 6-month period after pregnancy the women receiving supplemental iron during pregnancy had a significant increase in their serum ferritin concentrations, indicating restoration of iron stores. Women not receiving iron during pregnancy had exhausted iron stores at term and serum ferritin values stayed low even at 6 months after delivery. If iron therapy was instituted after parturition, serum ferritin assays indicated restoration of iron stores within the ensuing 6 month. To prevent iron deficiency anemia during pregnancy supplemental iron is advisable for all pregnant women in our country.", "The iron status of two groups of pregnant women was investigated. One group did not receive iron (group B), the other erceived 100 mg iron/day (group A). 1. In all individuals concentrations of hemoglobin, serum iron, transferrin and serum ferritin were determined at regular intervals from the third month until delivery and at 3 months after delivery. The same determinations were performed in cord blood. 2. Changes in iron status appeared to be less in individuals with iron supplement than in those without iron supplement. A fall in Hb, serum iron and serum ferritin is observed in all individuals. 3. Three months after delivery the Hb concentration has generally returned to the normal female value, but the serum ferritin concentration is still very low. 4. The fetus does not discriminate as to the iron status of the mother. In both groups (A and B) cord blood values appeard to be not significantly different.", "Iron deficiency anemia (IDA) is common in pregnant women, but previous trials aimed at preventing IDA used high-dose iron supplements that are known to cause gastrointestinal side effects.\n The objective was to assess the effect on maternal IDA and iron deficiency (ID, without anemia) of supplementing pregnant women with a low dosage (20 mg/d) of iron. Effects on iron status were assessed at the time of delivery and at 6 mo postpartum. Gastrointestinal side effects were assessed at 24 and 36 wk of gestation.\n This was a randomized, double-blind, placebo-controlled trial of a 20-mg daily iron supplement (ferrous sulfate) given from 20 wk of gestation until delivery.\n A total of 430 women were enrolled, and 386 (89.7%) completed the follow-up to 6 mo postpartum. At delivery, fewer women from the iron-supplemented group than from the placebo group had IDA [6/198, or 3%, compared with 20/185, or 11%; relative risk (RR): 0.28; 95% CI: 0.12, 0.68; P < 0.005], and fewer women from the iron-supplemented group had ID (65/186, or 35%, compared with 102/176, or 58%; RR: 0.60; 95% CI: 0.48, 0.76; P < 0.001). There was no significant difference in gastrointestinal side effects between groups. At 6 mo postpartum, fewer women from the iron-supplemented group had ID (31/190, or 16%, compared with 51/177, or 29%; RR: 0.57; 95% CI: 0.38, 0.84; P < 0.005). The rate of IDA between the groups did not differ significantly at 6 mo postpartum.\n Supplementing the diet of women with 20 mg Fe/d from week 20 of pregnancy until delivery is an effective strategy for preventing IDA and ID without side effects.", "Hemoglobin (Hb) concentration, serum iron level, iron binding capacity and blood folate (Lactobacillus casei) activity were determined in 310 unselected pregnant Burmese women. Hb concentration was less than 11 g/dl in 72% of the women; the serum iron level was less than 50 mug/dl in 33%; serum folate activity was less than 3ng/ml in 13%; and red cell folate activity was less than 100 ng/ml in 17% of the women. Ninety-six of the women in our study were randomly divided into four groups, treated from the 22nd to the 25th week of pregnancy until full term with either ferrous sulfate containing 60 mg elemental iron twice daily, 5 mg folic acid twice daily, a combination of both, or a placebo only. At full term, Hb concentration fell in the groups given placebo or folic acid. On the other hand, in the groups given iron alone or iron plus folic acid there was an increase in Hb of 0.4 and 0.7 g/dl, respectively (intergroup difference not statistically significant). Serum iron and blood folate levels fell in the groups not receiving the appropriate hematinic. In spite of deficient serum and red cell folate levels in 30 and 40%, respectively, of the group on iron alone, the mean Hb concentration increased at full term and none of the women had a Hb concentration lower than 10 g/dl. Blood folate levels were lower in the iron-supplemented group than in the placebo group, indicating that iron deficiency does not aggravate the folate nutritional status.", "Iron absorption, bone-marrow smears and haematological parameters were repeatedly studied during pregnancy in 50 women. The same studies were repeated two months after delivery. The material was randomly divided into two groups. Twenty-four women were treated with 200 mg of ferrous iron daily while 26 were given placebo. The iron absorption was measured from radioiron-labelled test doses of 100 mg ferrous iron in a whole-body counter with high sensitivity. In the placebo group the iron absorption increased throughout pregnancy from an average of 6.5 % at the 12th week to 14.3 % at the 35th week of gestation. Two months after delivery the absorption was higher than initially. In the iron-treated group the absorption increased between the 24th and 35th week of gestation from 6.0 to 8.6 %. After delivery 5.5 % of the test dose was absorbed. The haemosiderin iron in the bone-marrow was mobilized during pregnancy. In the placebo group no woman had more than trace of haemosiderin in the bone-marrow smears at the 35th week of gestation. In the iron-treated group 65 % had the same bone-marrow findings. The amount of bone-marrow haemosiderin at term seems not to have the same significance for the diagnosis of iron deficiency in pregnancy as in non-pregnant subjects. Two months after delivery about 50 % of the women in the placebo group had restored their iron deposits. In the iron-group the haemosiderin content in the bone-marrow smears was enhanced in most women compared to early pregnancy. In the placebo group haematological data indicated a high frequency of iron deficiency in late pregnancy while in the iron-treated group iron deficiency was prevented.", "nan", "A randomized, double-blind, placebo-controlled community-based trial of oral iron supplementation (200 mg ferrous sulphate daily) administered to multigravid pregnant women by traditional birth attendants (TBAs) was carried out in a rural area of The Gambia. Iron supplementation led to a significant reduction in the prevalence of anaemia and of iron deficiency. Iron supplementation was not accompanied by increased susceptibility to malaria infection; there was no difference in the prevalence and severity of peripheral blood or placental malaria infection between the 2 groups of women. The birth weight of children born to women who received iron prophylaxis was increased by an average of 56 g. It is concluded that oral iron prophylaxis can be successfully delivered through TBAs integrated into a primary health care programme. This simple intervention can produce significant beneficial effects on the health of the mother without inducing increased susceptibility to malaria and has the potential for reducing perinatal mortality by increasing birth weight.", "To measure levels of markers of anemia before and after delivery in women who had high hemoglobin levels during the early stage of the second trimester of pregnancy and did not receive iron supplementation during their pregnancies.\n In a randomized, double-blind, placebo-controlled trial 244 women who had a hemoglobin concentration of 13.2 g/dL or greater and a serum ferritin level higher than 15 microg/L between the 13th and 18th week of pregnancy took either one 150-mg tablet of ferrous sulfate daily or placebo during their pregnancies. Markers of anemia were measured at the time of delivery and 6 weeks postpartum.\n There were statistically significant differences between the 2 groups in hematocrit as well as hemoglobin and ferritin levels both at the time of delivery and 6 weeks postpartum (P<0.05), but these differences were not clinically significant.\n Not using iron supplementation did not cause a considerable decrease in markers of anemia in women with a hemoglobin concentration of 13.2 g/dL or greater in the second trimester of pregnancy.", "Haematological parameters were determined in 146 pregnant patients seen before 20 weeks' gestation. Eighteen per cent had both reduced serum ferritin and raised serum transferrin values without significant anaemia, suggesting covert iron-storage deficiency. One group then received 120 mg elemental iron daily and the other no iron supplementation. Repeat haematological assessment 20 weeks later indicated that in 48% of patients a significant decrease in haemoglobin concentration occurred if no iron was given. Supplementary iron prevented this decrease from occurring in patients with iron stores, but was insufficient to restore depleted stores or to prevent depletion of iron stores in 34% of patients with adequate stores. It is suggested that patients with depleted iron stores require therapeutic doses of iron, whereas those with adequate stores require little or no iron supplementation.", "nan", "To assess the impact on birth size and risk of low birth weight of alternative combinations of micronutrients given to pregnant women.\n Double blind cluster randomised controlled trial.\n Rural community in south eastern Nepal.\n 4926 pregnant women and 4130 live born infants.\n 426 communities were randomised to five regimens in which pregnant women received daily supplements of folic acid, folic acid-iron, folic acid-iron-zinc, or multiple micronutrients all given with vitamin A, or vitamin A alone (control).\n Birth weight, length, and head and chest circumference assessed within 72 hours of birth. Low birth weight was defined <2500 g.\n Supplementation with maternal folic acid alone had no effect on birth size. Folic acid-iron increased mean birth weight by 37 g (95% confidence interval -16 g to 90 g) and reduced the percentage of low birthweight babies (<2500 g) from 43% to 34% (16%; relative risk=0.84, 0.72 to 0.99). Folic acid-iron-zinc had no effect on birth size compared with controls. Multiple micronutrient supplementation increased birth weight by 64 g (12 g to 115 g) and reduced the percentage of low birthweight babies by 14% (0.86, 0.74 to 0.99). None of the supplement combinations reduced the incidence of preterm births. Folic acid-iron and multiple micronutrients increased head and chest circumference of babies, but not length.\n Antenatal folic acid-iron supplements modestly reduce the risk of low birth weight. Multiple micronutrients confer no additional benefit over folic acid-iron in reducing this risk.", "Our purpose was to study the effect of hematinic supplementation on the maternal erythropoietin response during singleton pregnancy.\n In a randomized, double-blind trial 97 patients with a first-trimester hemoglobin level > or = 14.0 gm/dl received either iron and folic acid (hematinic group, n = 53) or a placebo (n = 44). Serial hemoglobin, hematocrit, and serum erythropoietin were recorded from maternal blood and from cord blood on delivery. Serum ferritin was measured in the first trimester, at 36 weeks' gestation, and in cord blood.\n In both groups (1) the mean hemoglobin was lower (p < 0.01) at 40 weeks' gestation than when first examined and (2) the mean serum erythropoietin was higher (p < 0.01). The mean serum ferritin was lower (p < 0.001) in both groups at 36 weeks' gestation than at presentation but higher (p = 0.04) in the hematinic group than in the placebo group. The mean hemoglobin and hematocrit were similar in the two groups until the third trimester but thereafter were higher (p < 0.05) in the hematinic group. The mean maternal serum erythropoietin was higher (p < 0.05) in the placebo group than in the hematinic group after 24 weeks' gestation. The mean cord blood hematologic values were similar in the two groups.\n Maternal serum erythropoietin increased during pregnancy, but this response was reduced in the third trimester in the hematinic-supplemented group.", "To study the effect of iron supplementation on pregnancy outcome in pregnant women with haemoglobin (Hb) > or = 13.2 g/dl.\n A randomised, double-blind, placebo-controlled trial.\n Routine health services.\n Seven hundred and twenty-seven pregnant women with Hb > or = 13.2 g/dl in the early stage of the second trimester.\n Each woman took one ferrous sulphate [DOSAGE ERROR CORRECTED] tablet (150 g tablet, containing 50 mg of elemental iron) [DOSAGE ERROR CORRECTED] daily in the case group (n = 370) or placebo in the control group (n = 357) throughout pregnancy.\n Pregnancy outcome.\n While there were no significant differences in demographic and obstetric characteristics between the two groups before any intervention, small-for-gestational-age birth rate and the number of women with hypertension disorder increased significantly in the case group in comparison with the control group (57 [15.7%] versus 36 [10.3%], P = 0.035, 10 [2.7%] versus 3 [8%], P = 0.05, respectively).\n Our finding proves that routine iron supplementation in nonanaemic women is not rational and may be harmful.", "nan", "Women have an increased risk of iron deficiency during pregnancy because of the demands of the developing fetus. Iron supplements are commonly advocated as a prophylactic treatment and are generally taken with meals to reduce side effects, but iron can interfere with the absorption of zinc.\n The aim was to determine the effect of consuming an iron supplement (100 mg Fe/d as ferrous gluconate) with meals from 16 wk gestation to term on zinc status and absorption.\n Stable-isotope techniques were used to measure zinc status (exchangeable zinc pool, EZP) and fractional zinc absorption (FZA) in early and late pregnancy from a meal consumed at a different time from that of iron supplement or placebo consumption in 6 women given iron supplements and 7 given a placebo.\n FZA increased during pregnancy, independent of iron supplementation. FZA was significantly higher (P < 0.001) at week 34 than at weeks 16 and 24, and urinary zinc excretion was higher at week 34 than at week 16 (P = 0.02). The size of the EZP remained unchanged throughout pregnancy and was unaffected by iron supplementation. The iron status of iron-supplemented women was higher than that of the placebo group.\n In iron-replete pregnant women who consumed a Western diet, no detectable adverse effects on zinc metabolism were observed after ingestion of 100 mg Fe/d. An increase in the efficiency of zinc absorption was observed during late pregnancy.", "nan", "The use of hemoglobin as a predictor of response to iron therapy, for screening, and for prevalence estimates was studied. An Fe supplementation trial was performed in Quito, Ecuador, in which 412 pregnant women were randomly assigned to treatment and control groups. Women in the treatment group received 390 mg ferrous sulfate/d for 2 mo. The prevalence of Fe deficiency as defined by response to therapy was found to be 60.8%. Sensitivity and specificity were calculated at various cutoff points of hemoglobin. The estimates of sensitivity and specificity allow for the use of hemoglobin in screening for Fe deficiency anemia and in the estimation of the prevalence in populations with characteristics similar to those found in the sample of pregnant women in Quito. Hemoglobin was shown to be a good predictor of response to Fe treatment and a good estimate of prevalence of Fe deficiency when prevalence is high.", "An iron supplementation trial versus placebo was performed in double blind on 191 attending at 3 month the antenatal clinic of Poissy maternity. Iron status of mothers and newborns was assessed at 3, 5, 7 month, during the delivery and 2 months after the delivery, using biochemical indicators (hemoglobin level, serum ferritin). The compliance was good in 165 pregnant women (86% of the initial sample): 81 in the iron group, 84 in the placebo group. Among the placebo group, anemia (Hb less than 11 g/dl) was observed at the end of the pregnancy in 30% of women. Depletion of iron stores started at 5 month. In the iron group, hemoglobin level increased significantly during the pregnancy and anemia was observed only in 3% of women at the delivery. Iron status of newborns and two months after delivery was related to mothers iron status at delivery and particularly at the 7th month of pregnancy.", "The effect of iron supplementation, 66 mg elemental iron daily, from the 16th week of gestation to delivery, on iron status markers during uncomplicated pregnancies was assessed in a randomised, double-blind, placebo controlled study of 207 healthy women (100 iron treated, 107 placebo treated) and their newborn babies. Haemoglobin (Hb) and serum (S-) human placental lactogen (HPL) were measured in all 207 females, while transferrin saturation, S-ferritin and S-erythropoietin (EPO) were measured in 120 females at monthly intervals. Hb: from 27th week of gestation to eight weeks post partum, the placebo treated group had significantly lower Hb levels than the iron treated group (p less than 0.001). Iron status markers: in the placebo group (n = 57), 92% developed exhausted iron stores (i.e. S-ferritin less than or equal to 20 micrograms/l), 65% latent iron deficiency (i.e. S-ferritin less than or equal to 20 micrograms/l and transferrin saturation less than 15%), and 18% iron deficiency anaemia (i.e. S-ferritin less than or equal to 20 micrograms/l, transferrin saturation less than 15% and Hb less than 110 g/l). In the iron treated group (n = 63), 54% developed exhausted iron stores, 6% latent iron deficiency, and none iron deficiency anaemia. S-EPO: the placebo group had significantly higher values than the iron treated group from the 27th week of gestation to one week post partum (p less than 0.01). S-HPL: levels were identical in placebo and iron treated females. Babies of iron treated mothers had higher S-ferritin than babies of placebo treated mothers (p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)", "Iron and vitamin A deficiencies impact anemia and the immune system.\n to investigate the effect of iron combined with retinol supplementation on iron status, IL-2 level and lymphocyte proliferation.\n a double-blind randomized trial conducted over 2 months. We randomly allocated 186 anemic pregnant women with 80 ≤ Hb 0 < 110 g/L into four groups. Group I (n=47) was supplemented daily with 60 mg iron as ferrous sulfate, IF (n=46) with 60 mg iron and 0.4 mg folic acid, IR (n=46) with 60 mg iron, 2.0 mg retinol and 0.4 mg folic acid and C (n=47) was the placebo group,.\n after the 2 months trial, there were considerable increases of iron status in Hb, plasma iron and ferritin in the I, IF and IR groups compared with Group C. Increases in plasma iron and ferritin in the IR group were also significantly greater than in Groups I and IF. Compared with group C, increases of IL-2 levels were 119, 184 and 206 ng/L; and lymphocyte proliferation increased by 0.095, 0.112 and 0.219 in Groups I, IF and IR, respectively. Increases of IL-2 were 65.3 ng/L and 87.5 ng/L in Groups IF and IR, greater than in Group I (both p values <0.01); and lymphocyte proliferation in Group IR were 0.124 and 0.107, also greater than in Groups I and IF, respectively.\n iron combined retinol supplementation was more beneficial to improving iron status and lymphocyte proliferation during pregnancy than iron alone.", "To test the hypothesis that iron supplement from early pregnancy would increase the risk of gestational diabetes mellitus (GDM).\n Randomised placebo-controlled trial.\n A university teaching hospital in Hong Kong.\n One thousand one hundred sixty-four women with singleton pregnancy at less than 16 weeks of gestation with haemoglobin (Hb) level between 8 and 14 g/dl and no pre-existing diabetes or haemoglobinopathies.\n Women were randomly allocated to receive 60 mg of iron supplement daily (n= 565) or placebo (n= 599). Oral glucose tolerance tests (OGTTs) were performed at 28 and 36 weeks. Women were followed up until delivery.\n The primary outcome was development of GDM at 28 weeks. The secondary outcomes were 2-hour post-OGTT glucose levels, development of GDM at 36 weeks and delivery and infant outcomes.\n There was no significant difference in the incidence of GDM in the iron supplement and placebo groups at 28 weeks (OR: 1.04, 95% confidence interval [CI]: 0.7-1.53 at 90% power) or 36 weeks. Maternal Hb and ferritin levels were higher in the iron supplement group at delivery (P < 0.001 and P= 0.003, respectively). Elective caesarean section rate was lower in the iron supplement group (OR: 0.58, 95% CI: 0.37-0.89). Infant birthweight was heavier (P= 0.001), and there were fewer small-for-gestational-age babies in the iron supplement group (OR: 0.46, 95% CI: 0.24-0.85).\n Iron supplement from early pregnancy does not increase the risk of GDM. It may have benefits in terms of pregnancy outcomes.", "A randomized polycentric study was programmed to establish the effects of daily administration of ferritin iron from early pregnancy to puerperium. 254 women with normal iron balance at the beginning of their pregnancy were randomized receiving no supplements or 40 mg iron daily. At the end of pregnancy iron balance was still normal only in one third of the pregnant women of the first group versus two third of the second group. 204 women who were iron-deficient received daily 40 or 120 mg of iron; in this group anemia developed less frequently (13% versus 29%) and iron balance normalized in one subject on four; the great majority of these women remained iron-deficient. Unwanted effects of minimal or mild relevance, and almost always sporadic were observed in 6.5% of cases and with the reduction or withdraw of the treatment in only 1.4% of cases. These results showed that daily administration of ferritin iron during pregnancy is effective and well tolerated; furthermore they suggest that the treatment must be done with at least 60 mg daily in women with normal iron balance and protracted also after the puerperium in iron deficient subjects.", "We studied the effect of iron supplementation on the iron status of mothers and on biochemical iron status and clinical and anthropometric measures in their infants. The subjects were 197 pregnant women selected at 28 wk +/- 21 d of gestation at a mother-and-child health center in Niamey, Niger. Ninety-nine women received 100 mg elemental Fe/d throughout the remainder of their pregnancies and 98 received placebo. The prevalence of anemia and iron deficiency decreased markedly during the last trimester of pregnancy in the iron-supplemented group but remained constant in the placebo group. Three months after delivery, the prevalence of anemia was significantly higher in the placebo group. At delivery, there were no differences between the two groups in cord blood iron variables. Three months after delivery, serum ferritin concentrations were significantly higher in infants of women in the iron-supplemented group. Mean length and Apgar scores were significantly higher in infants with mothers in the iron group than in those with mothers in the placebo group.", "Pregnancy is a condition exhibiting increased susceptibility to oxidative stress, and Fe plays a central role in generating harmful oxygen species. The objective of the present study is to investigate the changes in haematological status, oxidative stress and erythrocyte membrane fluidity in anaemic pregnant women after Fe supplementation with and without combined vitamins. The study was a 2 months double-blind, randomised trial. Pregnant women (n 164) were allocated to four groups: group C was the placebo control group; group I was supplemented daily with 60 mg Fe (ferrous sulphate) daily; group IF was supplemented daily with Fe plus 400 μg folic acid; group IM was supplemented daily with Fe plus 2 mg retinol and 1 mg riboflavin, respectively. After the 2-month trial, Hb significantly increased by 15.8, 17.3 and 21.8 g/l, and ferritin by 2.8, 3.6 and 11.0 μg/l, in the I, IF and IM groups compared with placebo. Polarisation (ρ) and microviscosity (η) decreased significantly in other groups compared with placebo, indicating an increase in membrane fluidity. Significant decreases of ρ and η values compared with group C were 0.033 and 0.959 for group I, 0.037 and 1.074 for group IF and 0.064 and 1.865 for group IM, respectively. In addition, significant increases of glutathione peroxidase activities and decreases of malondialdehyde were shown in all treated groups, as well as increases of plasma retinol and urine riboflavin in group IM. The findings show that supplementation with Fe and particularly in combination with vitamins could improve the haematological status as well as oxidative stress and erythrocyte membrane fluidity.", "Recent studies suggest that infant behavior and psychological test performance are impaired by iron deficiency and may be improved by iron. Comparable studies have not been performed in older populations. Young women early in pregnancy whose nutritional intake may be impaired by poverty constitute a high-risk population. Women aged 14-24 years coming for prenatal care at or before 16 weeks gestation whose hematocrits were greater than or equal to 31% were randomized in a double-blind trial to receive vitamins supplemented with iron (experimental group) or vitamins alone (controls). Hematologic status and tests of short-term memory and attention span were assessed at entry and conclusion of the one-month treatment period. The experimental group showed significant improvement on the most sensitive measure of short-term memory and three subtests. On comparison of the change between initial and final scores, the experimental group showed significant or borderline greater improvement than controls on three tests. These results indicated a beneficial effect of iron therapy on psychometric test-score performance.", "Two hundred Hausa primigravidae at Zaria were divided into five groups in a randomized double-blind trial of antenatal oral antimalarial prophylaxis, and haematinic supplements. Group 1 received no active treatment. Groups 2 to 5 were given chloroquine 600 mg base once, followed by proguanil 100 mg per day. In addition, group 3 received iron 60 mg daily, group 4 folic acid 1 mg daily, and group 5 iron plus folic acid. Forty-five percent were anaemic (haemoglobin (Hb) less than 11.0 g dl-1) at first attendance before 24 weeks of gestation, and malaria parasitaemia (predominantly Plasmodium falciparum) was seen in 27%, of whom 60% were anaemic. The mean Hb fell during pregnancy in group 1, and seven patients in this group had to be removed from the trial and treated for severe anaemia (packed cell volume (PCV) less than 0.26). Only five patients in the other groups developed severe anaemia (P = 0.006), two of whom had malaria following failure to take treatment. Patients in group 1 had the lowest mean Hb at 28 and 36 weeks of gestation, and patients receiving antimalarials and iron (groups 3 and 5) had the highest Hb at 28 weeks, but differences were not significant, possibly due to removal from the trial of patients with severe anaemia. Anaemia (Hb less than 12.0 g dl-1) at six weeks after delivery was observed in 61% of those not receiving active treatment (group 1), in 39% of those protected against malaria but not receiving iron supplements (groups 2 and 4) and in only 18% of patients receiving both antimalarials and iron (groups 3 and 5). Folic acid had no significant effect on mean Hb. Proguanil was confirmed to be a highly effective causal prophylaxis. Prevention of malaria, without folic acid supplements, reduced the frequency of megaloblastic erythropoiesis from 56% to 25%. Folic acid supplements abolished megaloblastosis, except in three patients who were apparently not taking the treatment prescribed. Red cell folate (RCF) concentrations were higher in subjects with malaria, probably due to intracellular synthesis by plasmodia. Infants of mothers not receiving antimalarials appeared to have an erythroid hyperplasia. Maternal folate supplements raised infants' serum folate and RCF. Fourteen per cent had low birth weight (less than 2500 g), and the perinatal death rate was 11%; the greatest number were in group 1, but not significantly. A regime is proposed for the prevention of malaria, iron deficiency, folate deficiency and anaemia in pregnancy in the guinea savanna of Nigeria.", "The known increased need for iron during pregnancy appears to be met only in part by increased iron absorption and amenorrhea. Considerable demands are made on maternal iron stores and, since many women lack sufficient storage iron, pregnancy may be expected to cause iron deficiency. This may lead to anemia in pregnancy and post partum and could also have a bearing on the iron status of the fetus and the neonate. Based on these considerations, prophylactic supplementation of dietary iron is advocated but remains a disputed issue. In the present controlled, prospective and longitudinal study changes in hematologic status, and in particular in iron stores, during pregnancy were investigated in 44 healthy Caucasian women with uncomplicated pregnancies and deliveries. They were randomly assigned to a study group (n = 21) receiving oral iron supplements from the 16th week of amenorrhea until 6 weeks post partum, and a control group (n = 23) without iron supplementation. Maternal concentrations of hemoglobin, serum iron, serum transferrin and serum ferritin were determined at 16, 28 and 36 weeks of amenorrhea, at delivery, and 6 and 12 weeks post partum. The same variables were determined in cord blood. Iron supplementation appeared to prevent the physiologic fall in hemoglobin and serum iron concentrations which occurred in the control group, but had little influence on the observed rise in transferrin concentrations. Ferritin levels in serum, which are known to reflect mobilisable iron stores, fell to 30% of the initial values in the control group and to 70% in the study group. Six and 12 weeks post partum ferritin levels were still low in the nonsupplemented group (Tab. I).(ABSTRACT TRUNCATED AT 250 WORDS)", "In Korea, it is customary to prescribe iron and folic acid supplements to pregnant women after the 20th wk of gestation; however, little evidence exists to support this practice.\n The objective was to determine the effects of time of initiation and dose of prenatal iron and folic acid supplementation on the iron and folate nutriture of Korean women during pregnancy.\n A total of 131 pregnant women were placed into 1 of 5 experimental groups, either the control group or 1 of 4 supplemented groups. The supplemented groups varied by time of initiation, which was either during the first trimester or at week 20 of gestation, and by dose of iron and folic acid supplements provided, which consisted of either 30 mg Fe plus 175 microg folic acid or 60 mg Fe plus 350 microg folic acid. All supplemented groups continued supplementation until delivery.\n Improvements in iron and folate nutriture were highly dependent on when the supplement program was initiated, but both supplement doses were equally effective. In contrast, the influence of folic acid supplementation on maternal folate status was not as pronounced as was the influence of iron supplementation on iron status.\n In pregnant Korean women, initiating iron and folic acid supplementation earlier during pregnancy may prevent the deterioration of iron and folate nutriture more than does increasing supplement doses in later stages of pregnancy.", "Serum iron, serum iron-binding capacity, serum ferritin and erythrocyte protoporphyrin were determined during uncomplicated pregnancy in 45 healthy women; 22 were given oral iron while the others were given a placebo. When iron was not given, 15 out of 23 women had exhausted iron stores and iron deficiency at term, as judged from low serum ferritin, low serum transferrin saturation and high erythrocyte protoporphyrin values. Only seven of them had a haemoglobin concentration between 10 and 11 g/dl at term but none had values less than 10 g/dl. In the iron-treated group (n = 22) none of the women developed iron deficiency. Serum ferritin was the most sensitive and specific test of iron deficiency. A practical procedure to detect iron deficiency and to control iron supplementation in pregnancy is suggested.", "This trial compares routine and selective iron supplementation during pregnancy to determine whether routine supplementation adversely affects fetal growth, increases infections and subjective adverse effects, and/or delays birth. At their first prenatal visit, 2912 pregnant women were randomized into two groups (2694 gave birth). Compliance was satisfactory as measured by self-reports by mothers and hematocrit values in the third trimester. More women in the routinely supplemented group had subjected adverse effects. The groups were similar in regard to most of the other outcomes. In the selectively supplemented group, there was weak evidence for increase in sick-days, referrals to hospital outpatient clinic, cesarean section, blood transfusions, and infants who were diagnosed as having hyperviscosity. In the routine group, there were somewhat more women with gestations greater than or equal to 41 weeks and more dead infants. The subgroup analyses suggest that some of the apparently worse outcomes in the selective group were due to reactions of midwives and physicians to low hematocrit values.", "Anemia is still the major nutritional problem among pregnant women in Southeast Asia. The objective of this study was to measure hemoglobin status and reduction of underweight in a group of pregnant women who received iron-fortified or nonfortified milk, and another group who received iron supplements (tablets) or placebo. The 44 women in the iron-fortified milk group received 15 mg of iron per day per 400 ml of milk, and 41 women received placebo. The 40 women in the iron supplement group received 60 mg of iron per day, and 43 women received nonfortified milk. During this intervention trial, all women were supervised from the 14th to the 18th week of gestation until delivery. Blood was sampled at 0, 5, 10, and 16 weeks of intervention. After the 16th week of intervention, the changes in hemoglobin (deltaHb) concentrations in both treatment groups (the iron-fortified milk and the iron tablet groups) were not significantly different (deltaHb: -0.5+/-0.9 and -0.3+/-0.9 g/L, respectively), but the changes were significantly greater in the nonfortified milk and placebo groups (deltaHb: -1.2+/-0.9 and -1.1+/-0.8 g/L, respectively; p < .01). The change in transferrin saturation (deltaTS) in the iron-fortified milk group (deltaTS: 3.4+/-12.9%) was greater than that in the placebo and nonfortified milk groups (deltaTS: -10.1+/-9.8% and -11.6+/-10.7 %, respectively) (p < .01). The weight gain of the subjects during intervention did not differ significantly in the fortified and nonfortified milk groups (delta weight: 5.0+/-2.0 and 5.8+/-2.1 kg, respectively), but was higher than in the iron tablet group (delta weight: 4.6+/-3.1 kg; p < .05) and the placebo group (delta weight: 3.8+/-2.5 kg; p < .001). Iron supplementation and fortification were seen to be effective in promoting weight gain in pregnant Vietnamese women. For women who are underweight, the administration of iron-fortified milk has additional benefits to those of supplementation, most likely due to additional energy and nutrient inputs.", "nan", "The present investigation was undertaken to assess the efficacy of oral iron supplementation during pregnancy by using a gastric delivery system (GDS). Three hundred seventy-six pregnant women between 16 and 35 y of age and 14 and 22 wk gestation were selected if mild anemia was present (hemoglobin concentration 80-110 g/L). The participants were randomly assigned to one of three study groups given no iron, two FeSO4 tablets (100 mg Fe) daily, or one GDS capsule (50 mg Fe) daily. Blood was obtained initially and after 6 and 12 wk for measurement of red blood cell and iron indexes, including serum transferrin receptor. There was a significant and comparable improvement in hematologic and iron-status measurements in the two groups of women given iron whereas iron deficiency evolved in women given no iron supplement. We conclude that by eliminating gastrointestinal side effects and reducing the administration frequency of an iron supplement to once daily, a GDS offers significant advantages for iron supplementation of pregnant women.", "Serum ferritin, total plasma ferritin and haematological indices were determined during and for 6 months after normal pregnancy in 45 healthy women, 21 of whom took oral iron supplements. The physiological effect of pregnancy was to markedly depress serum ferritin concentration. During unsupplemented pregnancy median serum ferritin concentration decreased to approx. 6.0 micrograms/l by 28 weeks gestation, this concentration was maintained until term and was associated with the appearance of erythrocyte microcytosis during the third trimester. At 6 months postpartum, individual and average serum and total plasma ferritin values showed a deficit compared with the values recorded at the beginning of pregnancy. Oral iron supplementation during pregnancy modified the fall in serum ferritin, median serum ferritin concentrations remained about 14.0 micrograms/l after 28 weeks gestation; normocytic erythropoiesis was maintained throughout the third trimester and no deficit in serum and total plasma ferritin occurred as a result of pregnancy. It is concluded that routine oral iron administration should be recommended during pregnancy, certainly after 28 weeks gestation.", "The hypothesis that daily use of a prenatal supplement with iron from enrollment to third trimester to initially iron-replete, nonanemic pregnant women would reduce third-trimester anemia and improve birth outcomes was tested.\n Eight hundred sixty-seven women in Raleigh, North Carolina, who were at < 20 weeks of gestation were enrolled; 429 of these women had hemoglobin levels of > or = 110 g/L and ferritin levels of > or = 40 microg/L and were assigned randomly to receive prenatal supplements with 30 mg of iron as ferrous sulfate (n = 218 women) or 0 mg of iron (n = 211 women) until 26 to 29 weeks of gestation. Intent-to-treat analysis was used for the outcomes of third-trimester iron status, birth weight, preterm birth, and small-for-gestational age.\n Mean birth weight was higher by 108 g (P = .03), and the incidence of preterm delivery was lower (8% vs 14%; P = .05) in the 30-mg group compared with the control group, respectively. Iron supplementation did not affect the prevalence of small-for-gestational age infants or third-trimester iron status.\n Prophylactic iron supplementation that is begun early in pregnancy among low income women in the United States may have benefits beyond the reduction of iron deficiency anemia during pregnancy." ]

[ "9627664" ]

[ "Prospective randomized comparison of external dacryocystorhinostomy and endonasal laser dacryocystorhinostomy." ]

[ "The introduction of endonasal laser dacryocystorhinostomy (ENL-DCR) in the early 1990s showed great promise of changing dacryocystorhinostomy into an elegant, minimally invasive procedure from the traditional external dacryocystorhinostomy (EXT-DCR). This prospective, randomized study compares these two operations, their success rates, surgical durations, and postoperative symptoms.\n A total of 64 cases in 61 patients with primary acquired nasolacrimal sac or duct obstruction were divided into 2 subgroups by symptoms (simple epiphora and chronic dacryocystitis). These patients were randomized within both subgroups into 2 operation groups with 32 cases in each group.\n Altogether, 32 EXT-DCRs and 32 ENL-DCRs were performed. The silicone tube was removed at 6 months after surgery. The final follow-up visit was at 1 year after surgery. The patency of the lacrimal passage was investigated by irrigation, and patients were questioned about their symptoms.\n The patency of the lacrimal passage to irrigation and the duration of surgery were measured.\n The success rate at 1 year after surgery was 91% for EXT-DCR and 63% for ENL-DCR after primary surgery. The difference was statistically significant (P = 0.016). The surgical duration for ENL-DCR was three times shorter than for EXT-DCR, the average duration being 23 minutes and 78 minutes, respectively (P < 0.0001).\n The EXT-DCR, when compared with ENL-DCR, seems to provide superior operation results in primary acquired nasolacrimal duct obstruction." ]

[ "7993958", "3110848", "14310348", "2615928" ]

[ "Acute d-amphetamine challenge in schizophrenia: effects on cerebral glucose utilization and clinical symptomatology.", "Effects of amphetamine on local cerebral metabolism in normal and schizophrenic subjects as determined by positron emission tomography.", "FAILURE OF DEXTROAMPHETAMINE SULFATE TO INFLUENCE EATING AND SLEEPING PATTERNS IN OBESE SCHIZOPHRENIC PATIENTS: CLINICAL AND PHARMACOLOGICAL SIGNIFICANCE.", "Changes in cerebral blood flow and mental state after amphetamine challenge in schizophrenic patients." ]

[ "The effects of d-amphetamine (0.5 mg/kg orally) on regional cerebral glucose utilization were measured with positron emission tomography (PET) in 17 schizophrenics (along with a placebo-control group of an additional six schizophrenic patients). The acute d-amphetamine challenge tended to decrease glucose utilization throughout much of the brain, with a regional effect that was statistically significant in the left temporal cortex. There was no apparent relationship between the effects of amphetamine-induced changes in regional cerebral metabolism and psychotic symptom exacerbation. An exploratory analysis suggested that features characteristic of Crow's type II syndrome were significant predictors of cerebral hyporesponsivity to stimulant challenge, however.", "The effects of d-amphetamine (0.5 mg/kg PO) on regional cerebral glucose utilization were measured with Positron Emission Tomography (PET). Subjects included ten chronic schizophrenics and six controls who received amphetamine, and six chronic schizophrenics and nine controls who received placebo or no treatment. Amphetamine decreased glucose metabolism in all regions studied (frontal, temporal, and striatal) in normal and schizophrenic subjects. The metabolic effects of amphetamine were correlated with plasma level of the drug. Cortical atrophy was associated with a blunted metabolic response.", "nan", "Changes in regional cerebral blood flow and behavioral and physiological indices were monitored after intravenous administration of d-amphetamine sulfate and placebo in groups of patients with schizophrenia and normal volunteers. Amphetamine administration was associated with decreased anxiety, emotional withdrawal, depressed mood, blunted affect and increased excitement in the patients. Subjects who received amphetamine showed significant increases in systolic and diastolic blood pressure and reduction in end-tidal carbon dioxide. Post-amphetamine cerebral blood flow was decreased equally in both patients and controls. The blood flow change, however, did not show any regional variations." ]

[ "12946968", "12588583", "15527668", "17907147", "17559610", "10219009", "10767816", "16734904", "12966613", "17387227", "10457579", "2148221", "15006216", "17013851", "11409662", "8444627", "15836934", "17650736", "17250965", "16139778", "11142075", "16448828", "8863761", "12833248", "16084806", "17139639", "17768009", "15285783", "9596385", "17443749", "16365466", "12759322", "6223946", "16426449", "9228140", "11240079", "10990236", "8980206", "4004977", "15075418", "16096246" ]

[ "Effectiveness of dynamic muscle training, relaxation training, or ordinary activity for chronic neck pain: randomised controlled trial.", "A home-based pedometer-driven walking program to increase physical activity in older adults with osteoarthritis of the knee: a preliminary study.", "Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and health economic analysis.", "Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial.", "Effects of a self-management arthritis programme with an added exercise component for osteoarthritic knee: randomized controlled trial.", "The effects of high-intensity and low-intensity cycle ergometry in older adults with knee osteoarthritis.", "Active treatment of chronic neck pain: a prospective randomized intervention.", "Behavior change following a self-management intervention for housebound older adults with arthritis: an experimental study.", "Effects of tai chi exercise on pain, balance, muscle strength, and perceived difficulties in physical functioning in older women with osteoarthritis: a randomized clinical trial.", "Effects of a self-efficacy intervention on initiation of recommended exercises in patients with spondylosis.", "The effect of a Mensendieck exercise program as secondary prophylaxis for recurrent low back pain. A randomized, controlled trial with 12-month follow-up.", "A controlled study on the outcome of inpatient and outpatient treatment of low back pain. Part III. Long-term follow-up of pain, disability, and compliance.", "A pilot study of health education via a nurse-run telephone self-management programme for elderly people with osteoarthritis.", "Effects of strength training on the incidence and progression of knee osteoarthritis.", "Primary care-based physical activity programs: effectiveness in sedentary older patients with osteoarthritis symptoms.", "Exercise maintenance of persons with arthritis after participation in a class experience.", "Supplementation of general endurance exercise with stabilisation training versus general exercise only. Physiological and functional outcomes of a randomised controlled trial of patients with recurrent low back pain.", "Cognitive behavioural components in physiotherapy management of chronic whiplash associated disorders (WAD)--a randomised group study.", "Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial.", "Individually tailored treatment targeting activity, motor behavior, and cognition reduces pain-related disability: a randomized controlled trial in patients with musculoskeletal pain.", "A randomized controlled study of the Arthritis Self-Management Programme in the UK.", "TTM-based counselling in physiotherapy does not contribute to an increase of adherence to activity recommendations in older adults with chronic low back pain--a randomised controlled trial.", "The effect of brochure use versus therapist teaching on patients performing therapeutic exercise and on changes in impairment status.", "A comparison of various therapeutic exercises on the functional status of patients with knee osteoarthritis.", "Use of ultrasound to increase effectiveness of isokinetic exercise for knee osteoarthritis.", "Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: A randomized clinical trial.", "The effectiveness of a work style intervention and a lifestyle physical activity intervention on the recovery from neck and upper limb symptoms in computer workers.", "Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548].", "Combined exercise and motivation program: effect on the compliance and level of disability of patients with chronic low back pain: a randomized controlled trial.", "Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.", "Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial.", "Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial.", "Group outpatient physical and behavioral therapy for chronic low back pain.", "Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229].", "Patient education in arthritis: randomized controlled trial of a mail-delivered program.", "A randomized controlled component analysis of a behavioral medicine rehabilitation program for chronic spinal pain: are the effects dependent on gender?", "Home based exercise therapy for older patients with knee osteoarthritis: a randomized clinical trial.", "A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST).", "Outcomes of self-help education for patients with arthritis.", "Impact of the fit and strong intervention on older adults with osteoarthritis.", "A randomized trial comparing a group exercise programme for back pain patients with individual physiotherapy in a severely deprived area." ]

[ "To determine the effectiveness of dynamic muscle training and relaxation training for chronic neck pain.\n Randomised controlled trial.\n Five occupational healthcare centres, Tampere, Finland.\n 393 female office workers (mean age 45 years) with chronic non-specific neck pain randomly assigned to 12 weeks of dynamic muscle training (n = 135) or relaxation training (n = 128), plus one week of reinforcement training six months after baseline; or ordinary activity (control group; n = 130).\n Change in intensity of neck pain at three, six, and 12 months.\n No significant difference was found in neck pain between the groups at follow up. However, the range of motion for cervical rotation and lateral flexion increased more in the training groups than in the control group.\n Dynamic muscle training and relaxation training do not lead to better improvements in neck pain compared with ordinary activity.", "To determine whether a home-based pedometer-driven walking program with arthritis self-management education (Walk +) would increase physical activity, muscle strength, and functional performance in older adults with osteoarthritis (OA) of the knee as opposed to arthritis self-management education alone (EDU).\n A randomized two-by-three (group-by-time) design with participants assigned to Walk + (n = 17, mean age +/- standard deviation = 69.6 +/- 6.7) or EDU (n = 17, age = 70.8 +/- 4.7).\n Community located in the Baltimore-Washington area.\n Thirty-four community-dwelling adults, aged 60 and older with symptomatic knee OA and self-reported functional impairment.\n Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks. In addition, the Walk + group received individualized instruction in the use of a pedometer, with the goal of increasing their step count by 30% of their baseline step count.\n The outcome measures were physical activity (daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer), quadriceps femoris strength (isometric peak torque), and functional performance tasks (100-foot walk-turn-walk, timed stair climb, timed chair rise, and pain status).\n Daily steps walked showed a significant group-by-time interaction (P =.04) after controlling for age. From baseline to completion of training, a 23% increase in daily steps occurred in the Walk + group and a 15% decrease in the EDU group. Although steps increased in the Walk + group, total activity vector magnitude was maintained, suggesting a more efficient gait. The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk (P =.04). An isometric strength gain of 21% postintervention was seen in the Walk + group, compared with a loss of 3.5% in the EDU group.\n In older adults with symptomatic knee OA, Walk + appears to increase walking, with improvements in muscle strength and walking performance. The use of a home-based pedometer-driven program to increase physical activity, strength, and function in this population warrants further research.", "To establish the relative effectiveness and cost of providing a home-based exercise programme versus home-based exercise supplemented with an 8-week class-based exercise programme.\n The trial was a pragmatic, single-blind randomised clinical trial accompanied by a full economic evaluation.\n Patients were randomly allocated to either home-based exercise or home exercise supplemented with class exercise programmes.\n A total of 214 patients, meeting the American College of Rheumatology's classification of knee osteoarthritis, were selected from referrals from the primary and secondary care settings.\n Both groups were given a home exercise programme aimed at increasing lower limb strength, and endurance, and improving balance. The supplemented group also attended 8 weeks of twice-weekly knee classes run by a physiotherapist. Classes represented typical knee class provision in the UK.\n Assessments of locomotor function, using a timed score of three locomotor activities, walking pain and self-reported disability with the Western Ontario and McMaster's Universities osteoarthritis index (WOMAC) were made. General health, lower limb strength, range of movement and compliance with exercise were also measured. Patients were assessed before and after treatment, and also at 6- and 12-month follow-ups. The economic evaluation looked at health service resource use and assessed cost-effectiveness by relating differential costs to differences in quality-adjusted life-years (QALYs) based on patients' responses to the EuroQol-5 Dimensions. Data were obtained at baseline, 1 month, 6 months and 12 months through face-to-face interviews and, where appropriate, examination of hospital medical records.\n Patients from the supplemented group demonstrated significantly greater improvement in locomotor function and decrease in pain while walking at all follow-ups. The supplemented group also demonstrated smaller but significant improvements in balance, strength, WOMAC score, and the physical function and pain dimensions of the Short Form-36. However, not all of these improvements were maintained over the 12-month follow-up period. There was no evidence that compliance with the home exercise programme was different or that total costs or mean QALY gains were significantly different between the groups. However, costs were slightly lower and QALY gains slightly higher in the group with the supplementary class-based programme. The economic evaluation suggests that supplemented programmes are likely to be considered cost-effective, although there is uncertainty around this estimate, with approximately 30--35% probability that the intervention would not be cost-effective.\n The supplementation of a home-based exercise programme with a class-based exercise programme led to superior improvement in the supplemented group. These differential improvements were still evident at review 12 months after treatment had ceased. The additional cost of the supplemented group was offset by reductions in resource use elsewhere in the system. Compliance with the home exercise programme did not differ between the groups. Based on this evidence, the supplementation of a home-based exercise programme with an 8-week class-based exercise programme can be confidently expected to produce small improvements in locomotor function and clinically important reductions in pain. It is recommended that future research investigates methods of increasing compliance with home exercise programmes and evaluates the impact of these interventions in the primary care setting, where most patients with knee osteoarthritis are managed.", "Chronic knee pain is a major cause of disability and health care expenditure, but there are concerns about efficacy, cost, and side effects associated with usual primary care. Conservative rehabilitation may offer a safe, effective, affordable alternative. We compared the effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies (Enabling Self-management and Coping with Arthritic Knee Pain through Exercise [ESCAPE-knee pain]) with usual primary care in improving functioning in persons with chronic knee pain.\n We conducted a single-blind, pragmatic, cluster randomized controlled trial. Participants age >/=50 years, reporting knee pain for >6 months, were recruited from 54 inner-city primary care practices. Primary care practices were randomized to continued usual primary care (i.e., whatever intervention a participant's primary care physician deemed appropriate), usual primary care plus the rehabilitation program delivered to individual participants, or usual primary care plus the rehabilitation program delivered to groups of 8 participants. The primary outcome was self-reported functioning (Western Ontario and McMaster Universities Osteoarthritis Index physical functioning [WOMAC-func]) 6 months after completing rehabilitation.\n A total of 418 participants were recruited; 76 (18%) withdrew, only 5 (1%) due to adverse events. Rehabilitated participants had better functioning than participants continuing usual primary care (-3.33 difference in WOMAC-func score; 95% confidence interval [95% CI] -5.88, -0.78; P = 0.01). Improvements were similar whether participants received individual rehabilitation (-3.53; 95% CI -6.52, -0.55) or group rehabilitation (-3.16; 95% CI -6.55, -0.12).\n ESCAPE-knee pain provides a safe, relatively brief intervention for chronic knee pain that is equally effective whether delivered to individuals or groups of participants.", "This paper is a report of a study to assess the effect of an adapted arthritis self-management programme with an added focus on exercise practice among osteoarthritic knee sufferers.\n Osteoarthritis of the knee is a major source of loss of function in older people. Previous studies have found self-management programmes to be effective in increasing arthritis self-efficacy and in mastery of self-management practice.\n A randomized control trial was carried out from December 2002 to May 2003 and 120 participants (65.9%, including 67 in intervention group and 53 in control group) completed the 16-week postintervention assessments. Outcome measures included arthritis self-efficacy, use of self-management techniques, pain intensity and daily activity.\n At 16 weeks, there was a 'statistically' significant improvement in the arthritis self-efficacy level (P <or= 0.001), in most of the self-management skills, i.e. use of cold and hot compresses, in two of three joint protective practices (P <or= 0.001; P = 0.01), an increase in the duration of light exercise practice (P <or= 0.001), reduction of current arthritis pain (P <or= 0.001) and in the ability to perform daily activities (P <or= 0.001) among the intervention group but not for the control group (P-range from 0.04 to 0.95). One joint protective practice showed a statistically significant increase in both groups (P <or= 0.001).\n Our findings add to evidence showing short-term beneficial effects of self-efficacy theory in education programmes. Self-efficacy theory has great potential for empowering sufferers of chronic conditions to live with their illness.", "People with osteoarthritis (OA) of the knee experience pain and deconditioning that lead to disability. This study challenged the clinical belief that repetitive lower extremity exercise is not indicated in persons with knee OA. The effects of high-intensity and low-intensity stationary cycling on functional status, gait, overall and acute pain, and aerobic capacity were examined.\n Thirty-nine adults (71+/-6.9 years old) with complaints of knee pain and diagnosis of OA were randomized to either a high-intensity (70% heart rate reserve [HRR]) or low-intensity (40% HRR) exercise group for 10 weeks of stationary cycling. Participants cycled for 25 minutes, 3 times per week. Before and after the exercise intervention they completed the Arthritis Impact Measurement Scale 2 for overall pain assessment, underwent timed chair rise, 6-minute walk test, gait, and graded exercise treadmill tests. Acute pain was reported daily with a visual analog scale and the Western Ontario and McMaster Universities Osteoarthritis Index scale.\n Analysis of variance revealed that participants in both groups significantly improved in the timed chair rise, in the 6-minute walk test, in the range of walking speeds, in the amount of overall pain relief, and in aerobic capacity. No differences between groups were found. Daily pain reports suggested that cycling did not increase acute pain in either group.\n Cycling may be considered as an alternative exercise modality for patients with knee OA. Low-intensity cycling was as effective as high-intensity cycling in improving function and gait, decreasing pain, and increasing aerobic capacity.", "A randomized comparative study with single-blind outcome assessments.\n To compare the efficacy of a multimodal treatment emphasizing proprioceptive training (ACTIVE) with activated home exercises (HOME) and recommendation of exercise (CONTROL) in patients with nonspecific chronic neck pain.\n The efficacy of active exercises and passive physiotherapy for neck trouble has been somewhat disappointing in the previous few studies.\n Seventy-six patients (22 men, 54 women) with chronic, nonspecific neck pain participated. Sixty-two participated the 1-year follow-up. Subjective pain and disability, cervical ranges of motion, and pressure pain threshold in the shoulder region were measured at baseline, at 3 months, and at 12 months. The ACTIVE treatment consisted of 24 sessions of proprioceptive exercises, relaxation, and behavioral support. The HOME regimen included a neck lecture and two sessions of practical training for home exercises and instructions for maintaining a diary of progress. The CONTROL treatment included a lecture regarding care of the neck with a recommendation to exercise.\n The average self-experienced total benefit was highest in the ACTIVE group, and the HOME group rated over the CONTROL group (P < 0.001). Differences between the groups in favor of the ACTIVE treatment were recorded in reduction of neck symptoms and improvements in general health and self-experienced working ability (P < 0.01-0.03). Changes in measures of mobility and pressure pain threshold were minor.\n Regarding self-experienced benefit, the multimodal treatment was more efficacious than activated home exercises that were clearly more efficacious than just advising. No major differences were noted in objective measurements of cervical function between the groups, but the content validity of these assessments in chronic neck trouble can be questioned.", "This study examined the impact of a home-based self-management intervention for housebound older adults with arthritis on the adoption of health behaviors. The moderating role of socio-demographic, psychological, and physical characteristics in the process of behavior change was also investigated.\n Participants were 113 older adult women (n = 102) and men (n = 11) with osteoarthritis (OA) or rheumatoid arthritis (RA) who were randomly assigned to experimental (n = 68) or wait list control (n = 45) groups. Participants were interviewed using standardized questionnaires at baseline, pre-intervention, and post-intervention.\n Adjusted multilevel modeling analyses indicated that from pre to post intervention, experimental participants significantly increased their weekly frequency of exercise and relaxation activities. Socioeconomic status and depression played a moderating role in this change for exercise with larger effects occurring among more privileged, non-depressed participants.\n We conclude that a self-management intervention can successfully improve involvement in exercise and relaxation among housebound older adults with arthritis.", "Twelve forms of Sun-style tai chi exercise have been developed specifically to reduce the symptoms and improve the physical functioning of arthritic patients, and this randomized study examined the changes in symptoms and physical characteristics in older women with osteoarthritis (OA) at the completion of a 12-week tai chi exercise program.\n Seventy-two patients with OA were randomly assigned into 2 groups. Due to a 41% overall dropout rate, 22 experimental subjects and 21 controls completed pre- and post-test measures over a 12 week interval. Outcome variables were physical symptoms and fitness, body mass index, cardiovascular functioning, and perceived difficulties in physical functioning. The independent t test was used to examine group differences.\n The homogeneity test confirmed that there were no significant group differences in demographic data and pretest measures. Mean comparisons of the change scores revealed that the experimental group perceived significantly less pain (t = -2.19, p = 0.034) and stiffness (t = -2.13, p = 0.039) in their joints, and reported fewer perceived difficulties in physical functioning (t = -2.81, p = 0.008), while the control group showed no change or even deterioration in physical functioning after 12 weeks. In the physical fitness test, there were significant improvements in balance (t = 3.34, p = 0.002) and abdominal muscle strength (t = 2.74, p = 0.009) for the tai chi exercise group. No significant group differences were found in flexibility and upper-body or knee muscle strength in the post-test scores.\n Older women with OA were able to safely perform the 12 forms of Sun-style tai chi exercise for 12 weeks, and this was effective in improving their arthritic symptoms, balance, and physical functioning. A longitudinal study with a larger sample size is now needed to confirm the potential use of tai chi exercise in arthritis management.", "An intervention designed to enhance preaction self-efficacy beliefs (i.e., beliefs about ability to initiate behavior despite anticipated barriers during the initiation period) was tested in patients with spondylosis in relation to initiation of exercises recommended by a consultant in orthopedic rehabilitation. Sixty patients (age 28-83 years; 44% men) with spondylosis who had not previously performed exercises recommended for degenerative spine diseases were randomly assigned to a control (education session) or intervention group. Three weeks later, intervention patients performed recommended exercises more frequently than controls. Regression analysis for all patients showed that preintervention, preaction self-efficacy predicted exercise. Age and preintervention self-efficacy moderated the intervention effects. Among older patients, only those with weak preintervention, preaction self-efficacy beliefs benefited from the intervention, whereas among younger patients, only those with strong preintervention, preaction self-efficacy beliefs benefited from the intervention.", "A prospective, randomized, controlled trial with a stratification block design in which a Mensendieck exercise program was compared with the experience of a control group.\n To evaluate the effect of a Mensendieck program on the incidence of recurrent episodes of low back pain in patients with a history of the condition who currently are working.\n One episode of low back pain increases the risk of further episodes of the condition. The Mensendieck approach combines education and exercise. This approach has been used for many years in Scandinavia and the Netherlands. However, the effects on low back pain have not been evaluated previously in a randomized, controlled trial.\n A total of 77 men and women, mean age 39.6 years (range, 21.2-49.8 years), who had finished treatment for a low back pain episode, were stratified according to incidence of low back pain episodes and symptoms of sciatica over the preceding 3 years. The patients were assigned at random to either the Mensendieck program or a control group. The Mensendieck group received 20 group sessions of exercises and ergonomic education in 13 weeks. At 5- and 12-month follow-up examinations, the patients were assessed for recurrence of low back pain, days of sick leave, low back pain, and functional scores.\n After 12 months, there was a significant reduction in recurrent low back pain episodes in the Mensendieck group compared with the control group (P < 0.05). There was a trend toward fewer days of sick leave because of low back pain in the Mensendieck group, but no significant differences between the groups. There was reduction in pain and improvement in function in both groups, with no significant differences between the groups.\n A secondary prophylaxis Mensendieck exercise program of 20 group sessions significantly reduced the incidence of low back pain recurrences in a population with history of the condition. However, there were no differences between the groups with regard to days of sick leave, low back pain, and function.", "The long-term outcome results of inpatient and outpatient treatment of low back pain (LBP) were studied in 476 subjects (aged 35-54, 63% men) randomly assigned to three study groups: inpatients (n = 157), outpatients (n = 159), and controls (n = 160). The study included changes in the severity of low back pain, grade and disability, compliance with self-care, data on disability pensions, and days of sickness allowance during a 2.5-year follow-up period. These variables were used as outcome criteria. Pain and disability had decreased significantly in the two treated groups up to the 3-month follow-up. LBP was still a little slighter in the inpatients at the 1.5-year and 22-month follow-ups, but there were no significant differences between the groups in disability caused by LBP. The refresher programme carried out 1.5 years after the first one did not bring about as clear short-term improvement in pain and disability as the first treatment. During the whole 2.5-year follow-up compliance with self-care was better in the two treated groups, especially in the inpatients. Days of sickness allowance had increased somewhat more in the controls than in the inpatients during the follow-up. No differences between the groups were found in the number of disability pensions granted.", "We conducted a pilot study of a nurse-run telephone self-management programme for elderly people with osteoarthritis (OA). Thirty-two subjects, aged 60 years or more, with a diagnosis of OA were recruited from two hospital rheumatology clinics and were randomized to a control or intervention group. The intervention group received six weekly mailings of OA health education modules, a relaxation audio-tape and six weekly 45 min follow-up telephone self-management sessions. There was a 100% compliance rate in the intervention group, and all subjects completed baseline and three-month interviews; one subject in each group was lost to six-month follow-up. There were no significant differences in self-management between the control and intervention groups. However, at three months there were improvements in the intervention group (relative to baseline) on some outcome measures. The results suggest that the telephone may be a useful tool for reinforcing health-promoting activities for patients.", "Quadriceps weakness is a risk factor for incident knee osteoarthritis (OA). We describe a randomized controlled trial of effects of lower-extremity strength training on incidence and progression of knee OA.\n A total of 221 older adults (mean age 69 years) were stratified by sex, presence of radiographic knee OA, and severity of knee pain, and were randomized to strength training (ST) or range-of-motion (ROM) exercises. Subjects exercised 3 times per week (twice at a fitness facility, once at home) for 12 weeks, followed by transition to home-based exercise after 12 months. Assessments of isokinetic lower-extremity strength and highly standardized knee radiographs were obtained at baseline and 30 months.\n Subjects in both groups lost lower-extremity strength over 30 months; however, the rate of loss was slower with ST than with ROM. Compared with ROM, ST decreased the mean rate of joint space narrowing (JSN) in osteoarthritic knees by 26% (P = not significant). However, the difference between ST and ROM groups with respect to frequency of knee OA progression in JSN consensus ratings was marginally significant (18% versus 28%; P = 0.094). In knees that were radiographically normal at baseline, JSN >0.50 mm was more common in ST than in ROM (34% versus 19%; P = 0.038). Incident JSN was unrelated to exercise adherence or changes in quadriceps strength or knee pain.\n The ST group retained more strength and exhibited less frequent progressive JSN over 30 months than the ROM group. The increase in incident JSN >0.50 mm in ST is unexplained and requires confirmation.", "This study examined, in a group of older patients, (a) the effectiveness of an invitation to participate in a program providing individualized physical activity advice in a primary care setting and (b) the changes in self-reported physical activity and symptoms in patients with osteoarthritis (OA).\n Healthy, sedentary community-dwelling men and women aged 60 years or more were invited to participate. Following random allocation, the intervention group received individualized physical activity advice at baseline and at 3, 6, and 12 months followup.\n Of the 299 people who satisfied the study's inclusion criteria, a subgroup of 69 people reported pain and stiffness of the hip or knee at baseline. These patients reported increases in frequency and time of walking and vigorous exercise (all P < 0.001), with no change to OA symptom scores (pain and stiffness), and a small decline in physical functioning was reported at 12 months followup in the control group only (P = 0.027). At the 12-month followup more intervention participants than control participants (P = 0.013) reported a greater intention to exercise.\n An offer of primary care-based physical activity advice, with an emphasis on the benefits for general health (rather than \"treatment\" for OA), will attract individuals with OA symptoms. Although the present study was unable to demonstrate intervention-control group differences for the majority of outcomes, intention to exercise did appear to be positively influenced.", "This study investigated factors related to an initial exercise experience to explain exercise maintenance in 120 adults with rheumatoid arthritis or osteoarthritis. Integral secondary analysis was used to incorporate data from a prospective, controlled trial of exercise (Minor et al.: Arthritis Rheum 32:1396, 1989) with data collected at 18 months follow-up. The dependent variable was self-directed exercise (min/wk) reported at 3, 9, and 18 or more months after exercise class participation. Predictor variables included physical, psychosocial, disease, and programmatic factors. The all possible regressions search procedure resulted in three explanatory models (p = .0001). At 3 months the model (R2 = .45) included initial aerobic capacity, depression, and anxiety; and changes in depression and social activity. The 9-month model (R2 = .35) consisted of initial anxiety and physical activity, change in depression, support of friends for exercise, and exercise behavior at prior assessment. At 18 or more months (R2 = .42), model variables were initial aerobic capacity, change in pain, and exercise behavior at the two prior assessments. Neither disease nor program factors appeared as significant. This limited study indicates that factors associated with exercise behavior in this sample are similar to those in the general population; explanatory factors change over time, and changes ascribed to a trial behavior may influence subsequent decision making.", "Determination of the mode of action of new exercise techniques in different back pain populations is lacking. The effectiveness of supplementing an exercise programme with stabilisation exercises concerning physiological and functional parameters in non-specific back pain patients is unknown.\n Randomised controlled trial, comparing a general trunk muscle endurance exercise approach enhanced with specific muscle stabilisation exercises (S&G group) with a general exercise approach only (G group). 55 patients with recurrent back pain were randomised in S&G group (n=29) and G group (n=26). Both groups received an 8-week exercise intervention and written advice. Paraspinal muscle strength and electromyographic fatigue of the erector spinae and multifidus were measured. Additionally, 3 functional speed tests were assessed. Outcomes were collected pre- and post-intervention.\n No differences were detected for any of the paraspinal fatigue characteristics either within or between groups, apart from a significant decrease in normalised median frequency slope of the erector spinae for the G group. Paraspinal muscle strength and all functional tests have demonstrated significant within-group improvements for both groups, without any between-group differences.\n An 8-week stabilisation exercise-enhanced approach presented equal benefits to a general endurance-based exercise programme for patients with recurrent non-specific back pain. A slightly steeper slope for the erector spinae in the G group was the only electromyographic fatigue alteration noted. Concomitant strength improvement probably reflects neural input changes rather than histochemical muscle changes. Physical exercise alone and not the exercise type was the key determinant for improvement in this patient group.", "Different types of integrated management programmes have lately been introduced in the treatment of Whiplash Associated Disorders (WAD). In this study regular primary care physiotherapy and physiotherapy management with integrated components of cognitive-behavioural origin was compared in an experimental group study. The predictive value of self-efficacy was also addressed. In all thirty-three patients with chronic WAD were included in the trial. Results revealed no significant differences between groups in self-ratings of disability or pain intensity. However, among the self-reported benefits of treatment, patients in the experimental group reported significantly less pain than did the comparison group. At three months follow-up the experimental group also reported better performance of daily activities. Between group differences in the coping repertoire were found at pre-, post-and three-month follow-up. Generally, patients with high self-efficacy reported less use of 'maladaptive' and passive coping style than less self-efficient subjects at all times. In conclusion cognitive behavioural components can be useful in physiotherapy treatment for patients with chronic WAD, but their contributions are not yet fully understood. Self-efficacy is related to patients' use of different coping styles. Positive long-term outcomes in WAD-patients could therefore be improved by boosting self-efficacy and by teaching patients to use active, adaptive coping strategies.", "Practice guidelines recommend various types of exercise and manipulative therapy for chronic back pain but there have been few head-to-head comparisons of these interventions. We conducted a randomized controlled trial to compare effects of general exercise, motor control exercise and manipulative therapy on function and perceived effect of intervention in patients with chronic back pain. Two hundred and forty adults with non-specific low back pain 3months were allocated to groups that received 8weeks of general exercise, motor control exercise or spinal manipulative therapy. General exercise included strengthening, stretching and aerobic exercises. Motor control exercise involved retraining specific trunk muscles using ultrasound feedback. Spinal manipulative therapy included joint mobilization and manipulation. Primary outcomes were patient-specific function (PSFS, 3-30) and global perceived effect (GPE, -5 to 5) at 8weeks. These outcomes were also measured at 6 and 12months. Follow-up was 93% at 8weeks and 88% at 6 and 12months. The motor control exercise group had slightly better outcomes than the general exercise group at 8weeks (between-group difference: PSFS 2.9, 95% CI: 0.9-4.8; GPE 1.7, 95% CI: 0.9-2.4), as did the spinal manipulative therapy group (PSFS 2.3, 95% CI: 0.4-4.2; GPE 1.2, 95% CI: 0.4-2.0). The groups had similar outcomes at 6 and 12months. Motor control exercise and spinal manipulative therapy produce slightly better short-term function and perceptions of effect than general exercise, but not better medium or long-term effects, in patients with chronic non-specific back pain.", "This study compares the outcomes of an individually tailored behavioral medicine intervention (experimental) with physical exercise therapy (control). The experimental intervention was systematically individualized according to each participant's behavioral treatment goals and functional behavioral analyses. One hundred twenty-two patients seeking care at 3 primary health care clinics because of musculoskeletal pain were randomized. Ninety-seven completed the trial. Data were collected at baseline, immediately after treatment, and at a 3-month follow-up. Analyses of data from completers, as well as intention-to-treat analyses, showed that the experimental group experienced lower levels of disability (P = .01), lower maximum pain intensity (P = .02), higher levels of pain control (P = .001), and lower fear of movement (P = .022) as a result of treatment condition. Self-efficacy (P = .0001) and physical performance (P = .0001) increased over time for both groups. Participants in the experimental group generally reported more positive effects after treatment. Treatment fidelity was maintained during the course of the study. Activity can be resumed and pain might be managed by the patients themselves if treatment incorporates the biopsychosocial explanatory model of pain and strategies are tailored according to individual's priorities of everyday life activities and empirically derived determinants of pain-related disability.\n This study shows that the biomedical and the psychosocial perspectives of the experiences and consequences of pain complement rather than contradict each other. Primary health care patients with persistent musculoskeletal pain benefit more from a systematic tailoring of treatments according to biopsychosocial factors than from a physically based exercise intervention.", "The objective of this study was to determine whether the Arthritis Self-Management Programme (ASMP) improves perceptions of control, health behaviours and health status, and changes use of health care resources. The design was a pragmatic randomized controlled study; participants were allocated to ASMP (Intervention Group) or a 4-month waiting-list Control Group. The Intervention Group completed a 12-month follow-up. In total, 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group. Main outcome measures included: arthritis self-efficacy, health behaviours (exercise, cognitive symptom management, diet and relaxation) and health status (pain, fatigue, anxiety, depression and positive affect). At 4 months follow-up, the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales. Performance of a range of health behaviours (cognitive symptom management, communication with physicians, dietary habit, exercise and relaxation) was significantly greater among the Intervention Group. The Intervention Group were significantly less depressed and had greater positive mood. In addition, trends towards decreases on fatigue and anxiety were noted. Physical functioning, pain and GP visits remained stable at 4 months. A similar pattern of findings was found at 12 months follow-up for the Intervention Group. Furthermore, a significant improvement was found on pain and visits to GPs had decreased. Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months, all effects were independent of the type of arthritis. The findings suggest that the ASMP is effective in promoting improvements in perception of control, health behaviours and health status, when delivered in UK settings.", "The present study examines the outcome of counselling in physiotherapy based on the Transtheoretical Model (TTM) in a sample of elderly individuals with chronic low back pain.\n In a prospective randomised trial with concealed assignment, elderly individuals with chronic low back pain were allocated to two treatment conditions. Both contained 10 sessions of physiotherapy, each of 20min duration. In addition, the experimental group (EG) received 10min counselling prior to every session based on the TTM, also provided by the physiotherapist, and the control group (CG) underwent a placebo ultrasound treatment with an inactivated device to control for the additional attention given to the EG. Assessments took place prior to the treatment (t1), immediately after termination of the treatment (t2), and at a 6-months follow-up. Outcome measures were physical activity calculated from one-week activity diaries, self-reported functional capacity, and range of motion measured by ultrasound topometry.\n A total of 170 individuals (64% female) with a mean age of 70.3 years (SD=4.4, range 65-84) participated in the study. The retention rate was 90%. At t3, both EG and CG showed increased physical activity and functional capacity, but no change in range of motion. Effect sizes were large. Contrary to our hypothesis, however, motivational training did not result in a better outcome compared with placebo treatment.\n The study does not provide evidence that a short TTM-based motivation programme is superior to placebo treatment regarding adherence to activity recommendations.", "The purpose of this study was to investigate whether the mode of teaching exercises (use of brochures versus therapist teaching) affects whether patients correctly perform the exercises and whether it affects changes in impairment.\n Eighty-seven patients (33 women, 54 men) with neck pain and low back pain were examined. The average age was 48 years (SD = 12.7, range = 21-67).\n Two groups of patients were analyzed. The supervised (physical therapist-instructed) group (n = 47) exercised under the supervision of a physical therapist, whereas the brochure group (n = 40) received their instructions only from one of three brochures. A rating scale was used to assess the correctness of exercise performance. Muscle status was registered using a standardized procedure for determination of muscle force and length. Pain severity was determined by means of a visual analogue scale.\n On the rating scale evaluating the correctness of exercise performance at follow-up, the patients in the supervised group performed better than the patients in the brochure group. In addition, there was a strong correlation between the quality of exercise performance and decrease in pain.\n Exercises learned only from a brochure without being monitored by a physical therapist were done properly by only about half of the patients and appeared to result in fewer improvements in impairments.", "To investigate the therapeutic effects of different muscle-strengthening exercises on the functional status of patients with knee osteoarthritis (OA).\n One hundred thirty-two patients with bilateral knee OA (Altman Grade II) were sequentially divided into 4 random groups (GI to GIV). The patients in group I received isokinetic muscle-strengthening exercise, group II received isotonic muscle-strengthening exercise, group III received isometric muscle-strengthening exercise, and group IV acted as controls. The changes of muscle power of leg flexion and extension were measured with a Kinetic Communicator dynamometer, and patients' functional status was evaluated by visual analogue scale, ambulation speed, and Lequesne index before and after treatment, and at the follow-up 1 year later.\n The results showed that the patients with OA in each treated group had significant improvement in pain reduction, disability reduction, and in walking speed after treatment and at follow-up when compared with their initial status. Isotonic exercise had the greatest effect on pain reduction after treatment, and fewer participants discontinued the treatment because of exercise knee pain. Isokinetic exercise caused the greatest increase of walking speed and decrease of disability after treatment and at follow-up. The greatest muscle-strength gain in 60 degrees /second angular velocity peak torques was found in the isokinetic and isotonic exercise groups. A significant muscle-strength gain in 180 degrees /second angular velocity peak torques was found only in the isokinetic group after treatment.\n Isotonic exercise is suggested for initial strengthening in patients with OA with exercise knee pain, and isokinetic exercise is suggested for improving joint stability or walking endurance at a later time.\n Copyright 2003 Elsevier Inc. All rights reserved.", "To investigate the effects of ultrasound (US) in isokinetic muscle strengthening exercises on functional status of patients with knee osteoarthritis (OA).\n Effectiveness of isokinetic muscle strengthening exercises for treatment of periarticular soft tissue disorders was compared with and without pulsed and continuous US.\n Outpatient exercise program in a Taiwan medical university hospital.\n One hundred twenty subjects with bilateral knee OA (Altman grade II).\n Subjects were randomized sequentially into 1 of 4 groups. Group I received isokinetic muscular strengthening exercises, group II received isokinetic exercise and continuous US, group III received isokinetic exercise and pulsed US treatment, and group IV was the control group.\n Therapeutic effects of isokinetic exercise were evaluated by changes in ambulation speed and the Lequesne index. In addition, changes in knee range of motion (ROM), visual analog scale for pain, and muscle peak torques during knee flexion and extension were compared. Compliance in each group was recorded.\n Each treated group had increased muscle peak torques and significantly reduced pain and disability after treatment and at follow-up. However, only patients in groups II and III had significant improvement in ROM and ambulation speed after treatment. Fewer participants in group III discontinued treatment due to knee pain during exercise. Patients in group III also showed the greatest increase in walking speed and decrease in disability after treatment and at follow-up. Gains in muscular strength in 60 degrees /s angular velocity peak torques were also noted in groups II and III. However, group III showed the greatest muscular strength gains with 180 degrees /s angular velocity peak torques after treatment and follow-up.\n US treatment could increase the effectiveness of isokinetic exercise for functional improvement of knee OA, and pulsed ultrasound has a greater effect than continuous US.", "To determine the effectiveness of a behavioral graded activity program (BGA) compared with usual care (UC; exercise therapy and advice) according to the Dutch guidelines for physiotherapy in patients with osteoarthritis (OA) of the hip and/or knee. The BGA intervention is intended to increase activity in the long term and consists of an exercise program with booster sessions, using operant treatment principles.\n We conducted a cluster randomized trial involving 200 patients with hip and/or knee OA. Primary outcome measures were pain (visual analog scale [VAS] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), physical function (WOMAC), and patient global assessment, assessed at weeks 0, 13, 39, and 65. Secondary outcome measures comprised tiredness (VAS), patient-oriented physical function (McMaster Toronto Arthritis Patient Preference Disability Questionnaire [MACTAR]), 5-meter walking time, muscle strength, and range of motion. Data were analyzed according to intent-to-treat principle.\n Both treatments showed short-term and long-term beneficial within-group effects. The mean differences between the 2 groups for pain and functional status were not statistically significant. Significant differences in favor of BGA were found for the MACTAR functional scale and 5-meter walking test at week 65.\n Because both interventions resulted in beneficial long-term effects, the superiority of BGA over UC has not been demonstrated. Therefore, BGA seems to be an acceptable method to treat patients with hip and/or knee OA, with equivalent results compared with UC.", "This study assessed the effectiveness of a single intervention targeting work style and a combined intervention targeting work style and physical activity on the recovery from neck and upper limb symptoms. Computer workers with frequent or long-term neck and upper limb symptoms were randomised into the work style group (WS, n=152), work style and physical activity group (WSPA, n=156), or usual care group (n=158). The WS and WSPA group attended six group meetings. All meetings focused on behavioural change with regard to body posture, workplace adjustment, breaks and coping with high work demands (WS and WSPA group) and physical activity (WSPA group). Pain, disability at work, days with symptoms and months without symptoms were measured at baseline and after 6 (T1) and 12 months (T2). Self-reported recovery was assessed at T1/T2. Both interventions were ineffective in improving recovery. The work style intervention but not the combined intervention was effective in reducing all pain measures. These effects were present in the neck/shoulder, not in the arm/wrist/hand. For the neck/shoulder, the work style intervention group also showed an increased recovery-rate. Total physical activity increased in all study groups but no differences between groups were observed. To conclude, a group-based work style intervention focused on behavioural change was effective in improving recovery from neck/shoulder symptoms and reducing pain on the long-term. The combined intervention was ineffective in increasing total physical activity. Therefore we cannot draw conclusions on the effect of increasing physical activity on the recovery from neck and upper limb symptoms.", "Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples.\n This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of.50 for the primary outcome.\n Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range.", "To assess the effect of a combined exercise and motivation program on the compliance and level of disability of patients with chronic and recurrent low back pain.\n A double-blind prospective randomized controlled trial.\n Physical therapy outpatient department, tertiary care.\n Ninety-three low back pain patients were randomly assigned to either a standard exercise program (n = 49) or a combined exercise and motivation program (n = 44).\n Patients were prescribed 10 physical therapy sessions and were advised to continue exercising after treatment termination. The motivation program consisted of five compliance-enhancing interventions. Follow-up assessments were performed at 3 1/2 weeks, 4 months, and 12 months.\n Disability (low back outcome score), pain intensity, physical impairment (modified Waddell score, fingertip-to-floor distance, abdominal muscle strength), working ability, motivation, and compliance.\n The patients in the motivation group were significantly more likely to attend their exercise therapy appointments (p = .0005). Four and 12 months after study entry there was a significant difference in favor of the motivation group with regard to the disability score (p = .004) and pain intensity (p < or = .026). At 4 months, there was a significant advantage for the motivation group in the fingertip-to-floor distance (p = .01) and in abdominal muscle strength (p = .018). No significant differences were found in motivation scores, self-reported compliance with long-term exercise, and modified Waddell score. In terms of working ability, there was a trend favoring the combined exercise and motivation program.\n The combined exercise and motivation program increased the rate of attendance at scheduled physical therapy sessions, ie, short-term compliance, and reduced disability and pain levels by the 12-month follow-up. However, there was no difference between the motivation and control groups with regard to long-term exercise compliance.", "To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits.\n A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb).\n At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi.\n Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.", "Chronic low back pain is a common problem that has only modestly effective treatment options.\n To determine whether yoga is more effective than conventional therapeutic exercise or a self-care book for patients with chronic low back pain.\n Randomized, controlled trial.\n A nonprofit, integrated health care system.\n 101 adults with chronic low back pain.\n 12-week sessions of yoga or conventional therapeutic exercise classes or a self-care book.\n Primary outcomes were back-related functional status (modified 24-point Roland Disability Scale) and \"bothersomeness\" of pain (11-point numerical scale). The primary time point was 12 weeks. Clinically significant change was considered to be 2.5 points on the functional status scale and 1.5 points on the bothersomeness scale. Secondary outcomes were days of restricted activity, general health status, and medication use.\n After adjustment for baseline values, back-related function in the yoga group was superior to the book and exercise groups at 12 weeks (yoga vs. book: mean difference, -3.4 [95% CI, -5.1 to - 1.6] [P < 0.001]; yoga vs. exercise: mean difference, -1.8 [CI, -3.5 to - 0.1] [P = 0.034]). No significant differences in symptom bothersomeness were found between any 2 groups at 12 weeks; at 26 weeks, the yoga group was superior to the book group with respect to this measure (mean difference, -2.2 [CI, -3.2 to - 1.2]; P < 0.001). At 26 weeks, back-related function in the yoga group was superior to the book group (mean difference, -3.6 [CI, -5.4 to - 1.8]; P < 0.001).\n Participants in this study were followed for only 26 weeks after randomization. Only 1 instructor delivered each intervention.\n Yoga was more effective than a self-care book for improving function and reducing chronic low back pain, and the benefits persisted for at least several months.", "Active physical training is commonly recommended for patients with chronic neck pain; however, its efficacy has not been demonstrated in randomized studies.\n To evaluate the efficacy of intensive isometric neck strength training and lighter endurance training of neck muscles on pain and disability in women with chronic, nonspecific neck pain.\n Examiner-blinded randomized controlled trial conducted between February 2000 and March 2002.\n Participants were recruited from occupational health care systems in southern and eastern Finland.\n A total of 180 female office workers between the ages of 25 and 53 years with chronic, nonspecific neck pain.\n Patients were randomly assigned to either 2 training groups or to a control group, with 60 patients in each group. The endurance training group performed dynamic neck exercises, which included lifting the head up from the supine and prone positions. The strength training group performed high-intensity isometric neck strengthening and stabilization exercises with an elastic band. Both training groups performed dynamic exercises for the shoulders and upper extremities with dumbbells. All groups were advised to do aerobic and stretching exercises regularly 3 times a week.\n Neck pain and disability were assessed by a visual analog scale, the neck and shoulder pain and disability index, and the Vernon neck disability index. Intermediate outcome measures included mood assessed by a short depression inventory and by maximal isometric neck strength and range of motion measures.\n At the 12-month follow-up visit, both neck pain and disability had decreased in both training groups compared with the control group (P<.001). Maximal isometric neck strength had improved flexion by 110%, rotation by 76%, and extension by 69% in the strength training group. The respective improvements in the endurance training group were 28%, 29%, and 16% and in the control group were 10%, 10%, and 7%. Range of motion had also improved statistically significantly in both training groups compared with the control group in rotation, but only the strength training group had statistically significant improvements in lateral flexion and in flexion and extension.\n Both strength and endurance training for 12 months were effective methods for decreasing pain and disability in women with chronic, nonspecific neck pain. Stretching and fitness training are commonly advised for patients with chronic neck pain, but stretching and aerobic exercising alone proved to be a much less effective form of training than strength training.", "Conducted a treatment-outcome study to investigate the effectiveness of behavioral (BT) or physical therapy (PT) for treating chronic low back pain (CLBP). Thirteen patients received BT; 12 patients received PT. All patients had at least a 6-month history of seeking treatment of CLBP. Prior to treatment patients were assessed in four principal areas of functioning: (1) physical abilities; (2) current physical functioning; (3) psychological and psychosocial functioning; and (4) pain intensity and pain perception. Treatments were conducted in a group (5-8 patients) outpatient setting. Both BT and PT met for 10 weekly 2-hour sessions. BT was designed to address the environmental, social, and emotional influences of the pain experience, depression, and decreased activity from CLBP. PT was based upon traditional rehabilitation theory and was designed to improve low back function. The posttreatment results showed general improvement for patients in both groups, but few treatment-specific differences in outcome measures.", "The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model. There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment, but information is lacking about the differential effectiveness of different kinds of rehabilitation. A direct comparison of a physical, a cognitive-behavioral treatment and a combination of both has never been carried out so far.\n The effectiveness of active physical, cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a randomized controlled trial in three rehabilitation centers. Two hundred and twenty three patients were randomized, using concealed block randomization to one of the following treatments, which they attended three times a week for 10 weeks: Active Physical Treatment (APT), Cognitive-Behavioral Treatment (CBT), Combined Treatment of APT and CBT (CT), or Waiting List (WL). The outcome variables were self-reported functional limitations, patient's main complaints, pain, mood, self-rated treatment effectiveness, treatment satisfaction and physical performance including walking, standing up, reaching forward, stair climbing and lifting. Assessments were carried out by blinded research assistants at baseline and immediately post-treatment. The data were analyzed using the intention-to-treat principle.\n For 212 patients, data were available for analysis. After treatment, significant reductions were observed in functional limitations, patient's main complaints and pain intensity for all three active treatments compared to the WL. Also, the self-rated treatment effectiveness and satisfaction appeared to be higher in the three active treatments. Several physical performance tasks improved in APT and CT but not in CBT. No clinically relevant differences were found between the CT and APT, or between CT and CBT.\n All three active treatments were effective in comparison to no treatment, but no clinically relevant differences between the combined and the single component treatments were found.", "Self-management courses in arthritis have been shown to improve outcomes and to decrease medical resource utilization. We studied the effectiveness of a mail-delivered arthritis self-management program with the potential for extending these effects more broadly.\n Randomized controlled trial of 375 program participants and 434 controls over a 6 month period. Baseline and 6 month data were analyzed for each group and between groups by paired 2 sample t test. The intervention consists of health assessment questionnaires at 3 month intervals, with computer processed recommendation letters and reports individualized to age, diagnosis, education level, disability, pain, medication, and other patient-specific variables.\n At 6 months, outcomes of function (4.7%; 95% confidence limits 2.7, 6.7), decreased pain (9%; 2.8, 15.2), global vitality (7%; 2.8, 11.2), and joint count (28%; 20, 36) were improved in the program group compared with controls (p < 0.01). Exercise (35%; 26, 44) and self-efficacy (14.7%; 9, 20) were increased in the program group but not controls (p < 0.001). Doctor visits/year were decreased by 16% (3, 29) in the program group compared with controls (p < 0.05) and days missed work or confined to home decreased by 52% (-3, 107) in the program group compared with controls (p = 0.06). At one year, patients in the original program group continued to improve, and the control group, provided with the program in the second 6 months, showed improvement similar to the first 6 months of the original program group.\n A mail-delivered arthritis self-management program can positively affect patient outcomes and can decrease medical resource utilization.", "The aim of the present study was to evaluate the outcome of a behavioral medicine (BM) rehabilitation program and the outcome of its two main components, compared to a 'treatment-as-usual' control group (CG). The study employed a 4x4 repeated-measures design with four groups and four assessment periods (pre-treatment, post-treatment, 6-month follow-up, and 18-month follow-up). The group studied consisted of subjects on sick leave identified in a nationwide health insurance scheme in Sweden. After inclusion, the subjects were randomized to one of four conditions, which were: (1) behavior-oriented physical therapy (PT); (2) cognitive behavioral therapy (CBT); (3) BM rehabilitation consisting of PT+CBT (BM); (4) a 'treatment-as-usual' CG. The treatments were given over a period of 4 weeks, PT and CBT on a part-time basis and BM on a full-time basis. Outcome variables were sick leave, early retirement, and health-related quality of life (measured using the Short Form Health Survey, SF-36). The results showed that the risk of being granted full-time early retirement was significantly lower for females in PT and CBT compared to the CG during the 18-month follow-up period. However, the total absence from work (sick listing plus early retirement) in days over the 18-month follow-up period was not significantly different in the CG compared to the treatments. On the SF-36, women in CBT and BM reported a significantly better health-related quality of life than women in the CG at the 18-month follow-up. No significant differences for men were found on the SF-36 scales. In conclusion, the results revealed gender differences in the outcome of the treatments and that the components of this BM program yielded as good results as the whole program.", "This 8 week randomized, double blind clinical trial compared the effect of a combined home based progressive exercise program and treatment with the nonsteroidal medication oxaprozin to treatment with oxaprozin alone on pain and physical functioning in older community dwelling patients with unilateral knee osteoarthritis (OA).\n Efficacy variables measured before and after 8 weeks included (1) pain using the Western Ontario McMaster (WOMAC) pain, physical disability, and stiffness subscales and a 10 point visual analog scale (VAS) before and after self-paced walking (SPW) and stepping (SPS) functional tasks; (2) physical function using the time to complete a self-paced 40 m walk (SPW) and 20 cycles of 2 steps (SPS): (3) physical activity level using the Physical Activity Scale for Elderly (PASE); (4) clinical measures of knee functioning (range of motion). One hundred seventy-nine men and women (mean age 74 +/- 6 yrs) with radiographic evidence of mild/moderate medial compartment OA were randomized to either a progressive home based knee exercise program (n = 88) or a control program (n = 89). All patients were given oxaprozin 1,200 mg per os daily.\n We observed significant reduction from baseline in activity related pain (VAS); and improvement in SPW and SPS test time, passive range of motion, and PASE after 8 weeks in both groups. These changes were significantly greater (p < 0.05) in the exercise versus sham group.\n Addition of a progressive exercise program to nonsteroidal antiinflammatory therapy in patients with knee OA can improve measures of activity and activity related pain more than medication alone.", "To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis.\n A randomized, single-blind clinical trial lasting 18 months conducted at 2 academic medical centers.\n A total of 439 community-dwelling adults, aged 60 years or older, with radiographically evident knee osteoarthritis, pain, and self-reported physical disability.\n An aerobic exercise program, a resistance exercise program, and a health education program.\n The primary outcome was self-reported disability score (range, 1-5). The secondary outcomes were knee pain score (range, 1-6), performance measures of physical function, x-ray score, aerobic capacity, and knee muscle strength.\n A total of 365 (83%) participants completed the trial. Overall compliance with the exercise prescription was 68% in the aerobic training group and 70% in the resistance training group. Postrandomization, participants in the aerobic exercise group had a 10% lower adjusted mean (+/- SE) score on the physical disability questionnaire (1.71 +/- 0.03 vs 1.90 +/- 0.04 units; P<.001), a 12% lower score on the knee pain questionnaire (2.1 +/- 0.05 vs 2.4 +/- 0.05 units; P=.001), and performed better (mean [+/- SE]) on the 6-minute walk test (1507 +/- 16 vs 1349 +/- 16 ft; P<.001), mean (+/-SE) time to climb and descend stairs (12.7 +/- 0.4 vs 13.9 +/- 0.4 seconds; P=.05), time to lift and carry 10 pounds (9.1 +/- 0.2 vs 10.0 +/- 0.1 seconds; P<.001), and mean (+/-SE) time to get in and out of a car (8.7 +/- 0.3 vs 10.6 +/- 0.3 seconds; P<.001) than the health education group. The resistance exercise group had an 8% lower score on the physical disability questionnaire (1.74 +/- 0.04 vs 1.90 +/- 0.03 units; P=.003), 8% lower pain score (2.2 +/- 0.06 vs 2.4 +/- 0.05 units; P=.02), greater distance on the 6-minute walk (1406 +/- 17 vs 1349 +/- 16 ft; P=.02), faster times on the lifting and carrying task (9.3 +/- 0.1 vs 10.0 +/- 0.16 seconds; P=.001), and the car task (9.0 +/- 0.3 vs 10.6 +/- 0.3 seconds; P=.003) than the health education group. There were no differences in x-ray scores between either exercise group and the health education group.\n Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability, physical performance, and pain from participating in either an aerobic or a resistance exercise program. These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis.", "Behavioral and health status outcomes of an unreinforced, self-help education program for arthritis patients taught by lay persons were examined in 2 ways: a 4-month randomized experiment and a 20-month longitudinal study. At 4 months, experimental subjects significantly exceeded control subjects in knowledge, recommended behaviors, and in lessened pain. These changes remained significant at 20 months. The course was inexpensive and well-accepted by patients, physicians, and other health professionals.", "This study assessed the impact of a low cost, multicomponent physical activity intervention for older adults with lower extremity osteoarthritis.\n A randomized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence (n = 80) to a wait list control group (n = 70). Assessments were conducted at baseline and at 2 and 6 months following randomization. The training program consisted of range of motion, resistance training, aerobic walking, and education-group problem solving regarding self-efficacy for exercise and exercise adherence. All training group participants developed individualized plans for posttraining adherence.\n Relative to the persons in the control group, individuals who participated in the exercise program experienced a statistically significant improvement in exercise efficacy, a 48.5% increase in exercise adherence, and a 13.3% increase in 6-min distance walk that were accompanied by significant decreases in lower extremity stiffness at 2 and 6 months. Program participants also experienced a significant decrease in lower extremity pain and a borderline significant improvement in efficacy to adhere to exercise over time at 6 months (p =.052). In contrast, persons in the control group deteriorated over time on the efficacy and adherence measures and showed no change on the other measures. No adverse health effects were encountered.\n These benefits indicate that this low-cost intervention may hold great promise as one of a growing number of public health intervention strategies for older adults in the United States with osteoarthritis.", "To compare a group exercise programme known as the Back to Fitness programme with individual physiotherapy for patients with non-specific low back pain from a materially deprived area.\n This was a randomized controlled trial including 237 physiotherapy patients with back pain lasting more than six weeks. Participants were allocated to either the Back to Fitness programme or to individual physiotherapy, and followed up at three months and 12 months after randomization. The main outcome measure was the Roland Disability Questionnaire. Secondary measures were: SF12, EQ5D, Pain Self-Efficacy Scale. Health care diaries recording patients' use of health care resources were also collected over a 12-month period.\n There were no statistically significant differences in change scores between groups on the primary outcome measure at three months (CI - 2.24 to 0.49) and at 12 months (CI - 1.68 to 1.39). Only minor improvements in disability scores were observed in the Back to Fitness group at three months and 12 months respectively (mean change scores; - 0.89, - 0.77) and in the individual physiotherapy arm (mean change scores; - 0.02, - 0.63). Further analysis showed that patients from the most severely deprived areas were marginally worse at three month follow-up whereas those from more affluent areas tended to improve (CI 0.43 to 3.15)." ]

[ "12208905", "12860546", "15800520", "15466722", "16909301", "12531752", "16923826", "8666597", "11341418", "8198189", "11357697", "11734484", "11394593", "1962713", "11912091", "16282583", "12531751", "17218661", "15650664" ]

[ "Anterior cruciate ligament replacement: comparison of bone-patellar tendon-bone grafts with two-strand hamstring grafts. A prospective, randomized study.", "A randomized comparison of patellar tendon and hamstring tendon anterior cruciate ligament reconstruction.", "Clinical evaluation of arthroscopically assisted anterior cruciate ligament reconstruction: patellar tendon versus gracilis and semitendinosus autograft.", "Anterior cruciate ligament reconstruction: bone-patellar tendon-bone compared with double semitendinosus and gracilis tendon grafts. A prospective, randomized clinical trial.", "Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up.", "Patellar tendon or semitendinosus tendon autografts for anterior cruciate ligament reconstruction? A prospective randomized study with a two-year follow-up.", "A prospective, randomized comparison of semitendinosus and gracilis tendon versus patellar tendon autografts for anterior cruciate ligament reconstruction: five-year follow-up.", "Arthroscopically assisted reconstruction of the anterior cruciate ligament. A prospective randomized analysis of three techniques.", "A comparison of quadruple semitendinosus and patellar tendon grafts in reconstruction of the anterior cruciate ligament.", "Patellar tendon versus doubled semitendinosus and gracilis tendons for anterior cruciate ligament reconstruction.", "[Semitendinosus tendon vs. patellar ligament. Results of a prospective randomized study after anterior cruciate ligament reconstruction].", "Four-strand hamstring tendon autograft compared with patellar tendon-bone autograft for anterior cruciate ligament reconstruction. A randomized study with two-year follow-up.", "Anterior cruciate ligament reconstruction. A prospective randomized study of three surgical methods.", "Prospective evaluation of arthroscopically assisted anterior cruciate ligament reconstruction. Patellar tendon versus semitendinosus and gracilis tendons.", "A prospective randomized comparison of patellar tendon versus semitendinosus and gracilis tendon autografts for anterior cruciate ligament reconstruction.", "A comparison of bone-patellar tendon-bone and bone-hamstring tendon-bone autografts for anterior cruciate ligament reconstruction.", "A prospective randomized study of patellar versus hamstring tendon autografts for anterior cruciate ligament reconstruction.", "A prospective randomized study of anterior cruciate ligament reconstruction: a comparison of patellar tendon and quadruple-strand semitendinosus/gracilis tendons fixed with bioabsorbable interference screws.", "A prospective randomized comparison of bone-patellar tendon-bone and hamstring grafts for anterior cruciate ligament reconstruction." ]

[ "The purpose of this investigation was to evaluate replacement of a torn anterior cruciate ligament with either a bone-patellar tendon-bone autograft or a two-strand semitendinosus-gracilis autograft to compare the results of clinical testing, patient satisfaction, activity level, functional status, and muscle strength.\n Fifty-six patients with a torn anterior cruciate ligament were enrolled in a prospective, randomized, controlled study. Twenty-eight underwent reconstruction with a bone-patellar tendon-bone autograft, and twenty-eight were treated with a two-strand semitendinosus-gracilis autograft. Patients were followed for an average of thirty-nine months (range, thirty-six to fifty-seven months). At the time of final follow-up, twenty-two patients in each group were evaluated in terms of clinical test findings, patient satisfaction, activity level, functional status, and isokinetic muscle strength.\n The objective outcome of replacement of the torn anterior cruciate ligament with a bone-patellar tendon-bone graft was superior to that obtained with a two-strand semitendinosus-gracilis graft. At the three-year follow-up interval, the patients in whom a hamstring graft had been used had an average of 4.4 mm of increased anterior knee laxity compared with the laxity of the contralateral, normal knee, whereas the patients in whom a bone-patellar tendon-bone graft had been used had an average of 1.1 mm of increased knee laxity. Fourteen percent (three) of the twenty-two patients with a hamstring graft had a mild pivot shift, and 27% (six) had a moderate pivot shift. Only 14% (three) of the twenty-two patients with a bone-patellar tendon-bone graft had a mild pivot shift, and none had a moderate pivot shift. At the same follow-up interval, the patients in whom a hamstring graft had been used had significantly lower peak knee-flexion strength than those who had a bone-patellar tendon-bone graft (p = 0.039). In contrast, the two treatments produced similar outcomes in terms of patient satisfaction, activity level, and knee function (ability to perform a one-legged hop, bear weight, squat, climb stairs, run in place, and duckwalk).\n After three years of follow-up, the objective results of anterior cruciate ligament replacement with a bone-patellar tendon-bone autograft were superior to those of replacement with a two-strand semitendinosus-gracilis graft with regard to knee laxity, pivot-shift grade, and strength of the knee flexor muscles. However, the two groups had comparable results in terms of patient satisfaction, activity level, and knee function.", "Patellar and hamstring tendon autografts are the most frequently used graft types for anterior cruciate ligament reconstruction, but few direct comparisons of outcomes have been published.\n There is no difference in outcome between the two types of reconstruction.\n Prospective randomized clinical trial.\n After isolated anterior cruciate ligament rupture, 65 patients were randomized to receive either a patellar tendon or a four-strand hamstring tendon graft reconstruction, and results were reviewed at 4, 8, 12, 24, and 36 months.\n Pain on kneeling was more common and extension deficits were greater in the patellar tendon group. There were greater quadriceps peak torque deficits in the patellar tendon group at 4 and 8 months but not thereafter. In the hamstring tendon group, active flexion deficits were greater from 8 to 24 months, and KT-1000 arthrometer side-to-side differences in anterior knee laxity at 134 N were greater. Cincinnati knee scores, International Knee Documentation Committee ratings, and rates of return to preinjury activity levels were not significantly different between the two groups.\n Both grafts resulted in satisfactory functional outcomes but with increased morbidity in the patellar tendon group and increased knee laxity and radiographic femoral tunnel widening in the hamstring tendon group.", "To evaluate the clinical results of anterior cruciate ligament (ACL) reconstruction in patients with ACL-deficient knee in 2 similar groups of patients.\n A prospective randomized comparison of patellar tendon (PT) versus semitendinosus and gracilis tendon (STG) autografts for ACL reconstruction.\n Between 1994 and 1996, 85 consecutive male patients with chronic ACL-deficient knees underwent arthroscopically assisted reconstruction with either autologous PT or double-loop STG (4-strand) graft. PT grafts were used in patients with even-numbered birth dates and STG grafts for those with odd-numbered birth dates. Preoperatively, no significant differences between the 2 groups were noted with respect to age, level of activity, and degree of laxity (chi-square analysis). A standardized rehabilitation program was used for both groups postoperatively that included immediate active extension and early weight bearing and gradual flexion. Return to sports was permitted 8 months postoperatively. Assessment of the patients was carried out using a questionnaire, clinical assessment, Lysholm knee scores, the International Knee Documentation Committee scale, and radiological examination.\n At a mean follow-up of 81 months, there was no significant difference between the 2 groups with respect to subjective complaints (recurrent giving way, functional level) or objective laxity evaluation, including KT-1000 measurement or return to sports. Loss of extension of < or =5 degrees was greater in the PT group (12 patients, 30 %) than in the STG group (8 patients, 17 %). There was loss of flexion of < or =15 degrees in 5 patients (12 %) in the PT group and 1 patient (2.2 %) in the STG group. Anterior knee pain was recorded in 10 patients (24 %) in the PT group and 3 patients (5 %) in the STG group. The Lysholm knee score was 91.6 and 92.7 for the PT and STG groups, respectively, and the Tegner activity score decreased from 8.9 preoperatively for both groups to 7.9 for the PT group and 7.8 for the STG group.\n In this study, the 2 groups had comparable results in terms of patient satisfaction, activity level, and knee function. Our study showed that patellofemoral problems and loss of knee motion are more frequent in patients with PT grafts than in those with STG grafts.\n Level I, Randomized Controlled Trial.", "The choice of graft for anterior cruciate ligament reconstruction is a matter of debate, with patellar and hamstring tendons being the two most popular autologous graft options. The objective of this study was to determine in a prospective, randomized clinical trial whether two grafts (bone-patellar tendon-bone or doubled hamstring tendons) fixed with modern devices affect the two-year minimum clinical and radiographic outcomes of anterior cruciate ligament reconstruction.\n One hundred and twenty patients with a chronic unilateral rupture of the anterior cruciate ligament underwent arthroscopically assisted reconstruction with use of either autologous bone-patellar tendon-bone or doubled hamstring tendon grafts, in a strictly alternating manner. Both groups were comparable with regard to demographic data, preoperative activity level, mechanism of injury, interval between the injury and the operation, and the amount of knee laxity present preoperatively. The same well-proven surgical technique and aggressive controlled rehabilitation was used. An independent observer, who was blinded with regard to the involved leg and the type of graft, performed the outcome assessment with use of a visual analog scale, the new International Knee Documentation Committee form, the Knee Injury and Osteoarthritis Outcome Score, the Functional Knee Score for Anterior Knee Pain, and an arthrometric and an isokinetic dynamometric evaluation. Radiographs were also made.\n At the two-year follow-up evaluation, no differences were found in terms of the visual analog score, the Knee Injury and Osteoarthritis Outcome Score, the new International Knee Documentation Committee subjective and objective evaluation scores, the KT-1000 side-to-side laxity measurements, the Functional Knee Score for Anterior Knee Pain, muscle strength recovery, or return to sports activities. In the bone-patellar tendon-bone group, we found a higher prevalence of postoperative kneeling discomfort (p < 0.01) and an increased area of decreased skin sensitivity (p < 0.001). In the hamstring tendon group, we recorded a higher prevalence of femoral tunnel widening (p < 0.01). In this group, a correlation was also found between medial meniscectomy and an increased prevalence of pivot-shift glide (p = 0.035).\n We believe that, with use of accurate and proven surgical and rehabilitation techniques, both grafts are an equivalent option for anterior cruciate ligament reconstruction.", "A variety of graft sources have been used for ACL reconstruction to improve functions and kinematics in ACL deficient knees. The two most commonly used autogenous grafts are the central third of the patellar tendon and the hamstring tendon constructs. The choice of different grafts and different construct influence the final clinical outcome of ACL reconstruction. The 3 groups, of 25 patients each, were generated by choosing the technique (PT tendon, 4 strand hamstring, and single hamstring plus extraarticular plasty) to utilize and followed for 5 years, with an alternate systematic sampling. Our comparison has shown significant kneeling pain in the patellar tendon with respect to the groups with hamstrings techniques. Single hamstring plus extraarticular plasty achieved subjective score significantly higher with respect to the other two groups as well as for the time to resume sport. The study confirms that patellar tendon and hamstring can be equivalent options for ACL reconstruction. This study demonstrated that a superior outcome as far as subjective clinical findings were concerned, was obtained in group III. Patients in the latter group were also able to return to sports sooner than those in the bone-patellar tendon graft group and the four-strand hamstring group.", "There are well-known problems with the use of bone-patellar tendon-bone autografts for anterior cruciate ligament reconstruction, especially in terms of donor site morbidity. Hamstring tendon grafts have been increasingly used as an alternative, but there are very few controlled studies comparing the methods.\n Use of semitendinosus tendon grafts will cause less donor site morbidity and result in better knee-walking ability.\n Prospective randomized clinical trial.\n Seventy-one patients who had a unilateral anterior cruciate ligament rupture underwent arthroscopic reconstruction with interference screw fixation and use of either bone-patellar tendon-bone or semitendinosus tendon graft. Outcome assessment was performed by physiotherapists not involved in the patients' care.\n At the 2-year follow-up, no differences were found in terms of the Lysholm score, Tegner activity level, KT-1000 arthrometer side-to-side laxity measurement, single-legged hop test, or International Knee Documentation Committee classification results. The knee-walking test was rated difficult or impossible to perform by 53% of the bone-patellar tendon-bone group and by only 23% of the semitendinosus graft patients, a significant difference.\n The semitendinosus tendon graft is at least an equivalent option to the bone-patellar tendon-bone graft for anterior cruciate ligament reconstruction, and we recommend its use.\n Copyright 2003 American Orthopaedic Society for Sports Medicine", "There are still controversies about graft selection for primary anterior cruciate ligament reconstruction. Prospective randomized long-term studies are needed to determine the differences between the materials.\n Five years after anterior cruciate ligament reconstruction, there is a difference between hamstring and patellar tendon grafts in development of degenerative knee joint disease.\n Randomized controlled trial; Level of evidence, 1.\n From June 1999 to March 2000, 64 patients were included in this prospective study. A single surgeon performed primary arthroscopically assisted anterior cruciate ligament reconstruction in an alternating sequence. In 32 patients, anterior cruciate ligament reconstruction was performed with hamstring tendon autograft, whereas in the other 32 patients, anterior cruciate ligament reconstruction was performed with patellar tendon autograft.\n At the 5-year follow-up, no statistically significant differences were seen with respect to the Lysholm score, clinical and KT-2000 arthrometer laxity testing, anterior knee pain, single-legged hop test, or International Knee Documentation Committee classification results; 23 patients (82%) in the hamstring tendon group and 23 patients (88%) in the patellar tendon group returned to their preinjury activity levels. Graft rupture occurred in 2 patients from the hamstring tendon group (7%) and in 2 patients from the patellar tendon group (8%). Grade B abnormal radiographic findings were seen in 50% (13/26) of patients in the patellar tendon group and in 17% (5/28) of patients in the hamstring tendon group (P = .012).\n Both hamstring and patellar tendon grafts provided good subjective outcomes and objective stability at 5 years. No significant differences in the rate of graft failure were identified. Patients with patellar tendon grafts had a greater prevalence of osteoarthritis at 5 years after surgery.", "One hundred and twenty-seven patients who had a rupture of the anterior cruciate ligament agreed to participate in a prospective, randomized study of three arthroscopically assisted reconstruction techniques. One hundred and twenty-five patients (125 reconstructions) were evaluated after a mean duration of follow-up of forty-two months (range, two to five years). Group I included forty patients who had a two-incision reconstruction with use of an autogenous semitendinosus-gracilis graft, group II consisted of forty patients who had a two-incision reconstruction with use of an autogenous patellar-ligament graft, and group III included forty-five patients who had a single-incision reconstruction (endoscopic technique) with use of an autogenous patellar-ligament graft. The male-female ratio, age range, level of athletic activity, interval between the injury and the reconstruction, previous operative procedures, and associated injuries were similar in all three groups. The same postoperative rehabilitation protocol was followed for all patients. Testing with a KT-2000 arthrometer at maximum manual force was done at the follow-up evaluation; the difference in laxity between the involved knee and the contralateral knee was three millimeters or less in thirty-three patients (83 per cent) in group I, thirty-seven patients (93 per cent) in group II, and thirty-nine patients (87 per cent) in group III. A difference of two millimeters or less was found in thirty patients (75 per cent) in group I, thirty-one patients (78 per cent) in group II, and thirty-five patients (78 per cent) in group III. Thirty-five patients (88 per cent) in group I, thirty-eight patients (95 per cent) in group II, and forty patients (89 per cent) in group III returned to at least the same level of athletic activity. Four grafts (two in group I and two in group II) failed as a result of trauma. There was one additional failure in groups I and III, as evidenced by a difference of nine and seven millimeters, respectively, on instrumented testing of laxity. The significant findings were that no knee was rated D according to the system of the International Knee Documentation Committee (p < 0.002, 94 per cent confidence level) and that fewer additional operative procedures were done on patients in group III (p < 0.08). Also, it was found that the patients in group II returned to a greater level of athletic activity (p < 0.02) and that a higher percentage of the patients in this group had a difference of three millimeters or less on testing with the KT-2000 arthrometer than in the other two groups (p < 0.08). However, with the numbers available, there were no significant differences in the over-all outcome among the three groups (p > 0.1). Importantly, the rate of failure was not greater and the outcomes were not less satisfactory for the late reconstructions than they were for the acute reconstructions (those performed less than three weeks after the injury), including those done with an autogenous semitendinosus-gracilis graft in a chronically unstable knee.", "In a two-centre study, 164 patients with unilateral instability of the anterior cruciate ligament were prospectively randomised to arthroscopic reconstruction with either a patellar tendon graft using interference screw fixation or a quadruple semitendinosus graft using an endobutton fixation technique. The same postoperative rehabilitation protocol was used for all patients and follow-up at a median of 31 months (24 to 59) was carried out by independent observers. Four patients (2%) were lost to follow-up. No significant differences were found between the groups regarding the Stryker laxity test, one-leg hop test, Tegner activity level, Lysholm score, patellofemoral pain score, International Knee Documentation Committee (IKDC) score or visual analogue scale, reflecting patient satisfaction and knee function. Slightly decreased extension, compared with the non-operated side, was found in the patellar tendon group (p < 0.05). Patients with associated meniscal injuries had lower IKDC, visual analogue (p < 0.01) and Lysholm scores (p < 0.05) than those without such injuries. Patients in whom reconstruction had been carried out less than five months after the injury had better final IKDC scores than the more chronic cases (p < 0.05). We conclude that patellar tendon and quadruple semitendinous tendon grafts have similar outcomes in the medium term. Associated meniscal pathology significantly affects the final outcome and early reconstruction seems to be beneficial.", "The results of intraarticular anterior cruciate ligament reconstruction with either the patellar tendon or the semitendinosus and gracilis tendons (four strands) were prospectively compared in a consecutive series of 60 patients with chronic injuries. A single surgeon performed arthroscopically assisted reconstructions in an alternating sequence. Preoperative and operative data revealed no significant differences between the two groups. After 28 months of followup there were no significant differences in the incidence of symptoms, and recurrent giving way was present in only one knee with semitendinosus and gracilis tendon graft. Return to sport participation was more frequent in the patellar tendon group (80% versus 43%, P < 0.01). A minor extension loss (< or = 3 degrees) was more frequent in the patellar tendon group (47% versus 3%, P < 0.001). Other differences between the two groups were not significant. KT-2000 arthrometer side-to-side difference of anterior displacement > 5 mm at 30 pounds was present in 13% of the knees with patellar tendon grafts and in 20% of those with semitendinosus and gracilis; a patellofemoral crepitation developed in 17% and 3% of the two groups, respectively. Based on these data we routinely use patellar tendon grafts. Semitendinosus and gracilis tendons are preferred in selected cases: older patients, patients with preexisting patellofemoral problems, and those with failed patellar tendon grafts.", "The aim of our prospective randomised study was to evaluate the clinical results after arthroscopical reconstruction of the ACL using the midthird patellar ligament or semitendinosus tendon.\n Forty patients were followed up two years postoperatively. Twenty of them received either a patellar ligament graft (BTB-group) or doubled semiteninosus tendon (SET-group). The clinical evaluation included the preoperative and two years postoperative assessment, based on the IKDC-Score, Tegener-Score and Mc-Carroll-Score. The a.p.-translation was evaluated using the KT-1000.\n Sixteen (80%) patients of the SET-group and 10 (50%) patients of the BTB-group showed good and excellent results in the over all assessment with the IKDC-Score. The mean side to side KT-1000 difference yielded 1.6 mm (-2-4 mm) in the BTB-group and 2.7 mm (0-7 mm) in the SET-group (p < 0.05). The retropatellar pain syndrome based on the Mc-Caroll-Score showed 17.4 points in the BTB-group in comparison to 19.5 points in the SET-group (p < 0.05). The level of activity using the Tegner-score showed preoperatively for both the SET- and BTB-group 6.9 points and postoperatively for the SET-group 6.7 points and for the BTB-group 5.6 points.\n Despite the inferior a.p.-stability for the patients who received doubled semitendinosus tendon grafts they presented clinically superior results compared to the BTB-group. Therefore this technique seems to be the alternative method. In order to improve the stability we recommend the usage of three or four stranded grafts and an improved fixation technique.", "Seventy-two patients with subacute or chronic rupture of the anterior cruciate ligament were randomly assigned to autograft reconstruction with four-strand gracilis and semitendinosus tendon (N = 37) or with patellar tendon-bone (N = 35) from the ipsilateral side. The groups were similar in terms of age, sex, level of activity, degree of laxity, meniscal lesions found surgically, and rehabilitation program. The follow-up was performed at another hospital by independent observers after 6, 12, and 24 months. Sixty-one patients (32 with hamstring tendon grafts and 29 with patellar tendon grafts) complied with the follow-up routine for the full 24 months. No differences were found between the groups with respect to Cincinnati functional score, KT-1000 arthrometer measurements, or stairs hopple test results. The subjective result and the single-legged hop test result were better for the hamstring tendon group after 6 and 12 months, but no differences were found after 24 months. The hamstring tendon group showed better isokinetic knee extension strength than did the patellar tendon group after 6 months, but not after 12 and 24 months. There was a significant weakness in isokinetic knee flexion strength among the hamstring tendon group. Anterior knee pain was not significantly different between the groups, but kneeling pain was significantly less common in the hamstring tendon group after 24 months.", "A prospective randomized study was performed to determine the differences in results between three methods of anterior cruciate ligament reconstruction: autogenous bone-patellar tendon-bone graft (group 1), semitendinosus and gracilis tendon graft reconstruction combined with an extraarticular procedure (group 2), and semitendinosus and gracilis tendon graft reconstruction alone (group 3). Preoperatively, there were no significant differences between groups. At a mean of 35.4 +/- 11.6 months postoperatively, 102 patients returned for evaluation. International Knee Documentation Committee knee evaluation revealed no significant differences in symptoms, function, return to pre-injury activity, harvest site abnormalities, or limitation of motion between groups 1 and 3. Patients in group 2 had a higher incidence of patellofemoral crepitation and loss of motion than did patients in group 3. The mean manual maximum KT-1000 arthrometer side-to-side difference was 2.1 +/- 2.0 mm in group 1, which was statistically significantly better than the difference in group 3 (3.1 +/- 2.3 mm). Final knee rating showed that 34 of 35 patients in group 1, 23 of 34 patients in group 2, and 26 of 33 patients in group 3 had a normal or nearly normal overall knee rating. Anterior cruciate ligament reconstruction with a semitendinosus and gracilis or a patellar tendon autograft may yield similar subjective results; however, the patellar tendon autograft may provide better objective stability in the long term. In addition, there appears to be no benefit to combining an intraarticular anterior cruciate ligament reconstruction with an extraarticular procedure.", "Eighty consecutive patients with chronic laxity due to a torn ACL underwent arthroscopically assisted reconstruction with either autogenous patellar tendon or doubled semitendinosus and gracilis tendons. Reconstructions were performed on a one-to-one alternating basis. Preoperatively, no significant differences between the two groups were noted with respect to age, sex, level of activity, and degree of laxity (chi square analysis). A standard rehabilitation regimen was used for all patients after surgery including immediate passive knee extension, early stationary cycling, protected weightbearing for 6 weeks, avoidance of resisted terminal knee extension until 6 months, and return to activity at 10 to 12 months postoperatively. Seventy-two patients were evaluated at a minimum of 24 months postoperatively (range, 24 to 40 months). No significant differences were noted between groups with respect to subjective complaints, functional level, or objective laxity evaluation, including KT-1000 measurements. Seventeen of 72 patients (24%) experienced anterior knee pain after ACL reconstruction. Overall, 46 of 72 patients (64%) returned to their preinjury level of activity. Mean KT-1000 scores were 1.6 +/- 1.4 mm for the patellar tendon group and 1.9 +/- 1.3 mm for the semitendinosus and gracilis tendons group. This study did find a statistically significant weakness in peak hamstrings torque at 60 deg/sec when reconstruction was performed with double-looped semitendinosus and gracilis tendons.", "Seventy patients with patellar tendon or hamstring tendon autografts for single-incision anterior cruciate ligament reconstruction were evaluated at least 2 years after surgery. All reconstructions were performed by the same surgeon, and metal interference screws were used for fixation of all grafts. No significant differences were noted between groups for Lysholm score, reduction in activity, KT-1000 arthrometer findings, quadriceps muscle size, return to sports, or ability to jump and do hard cuts and pivots. Significantly more patients in the patellar tendon group had patellofemoral pain at 6 months after surgery than did the hamstring tendon patients (48% versus 20%), and at last follow-up the incidence of patellofemoral pain was 42% and 20%, respectively. Fourteen patients in the patellar tendon group and seven in the hamstring tendon group had loss of motion (approximately 5 degrees ). Four patients (two in each group) had treatment failures and their results were not included in the clinical examination data. At 2 years' follow-up, 97% of patients with patellar tendon grafts and 100% of patients with hamstring tendon grafts rated their results as good or excellent. We found that hamstring tendon grafts performed similarly to patellar tendon grafts, although fewer patients in the hamstring tendon group had patellofemoral pain and loss of motion.", "Most of the previous comparative studies between patellar tendon and hamstring tendon anterior cruciate ligament grafts compared grafts of different constructs fixed with different methods.\n To compare patellar tendon and hamstring tendon grafts with the same fixation method used to reconstruct the anterior cruciate ligament.\n Randomized controlled trial; Level of evidence, 1.\n During the reconstructive procedure, the hamstring tendon graft was prepared as a bone-hamstring-bone graft; both bone-patellar tendon-bone and bone-hamstring-bone grafts were fixed with interference screws. Eighty consecutive patients who underwent anterior cruciate ligament reconstruction were randomly assigned to either bone-patellar tendon-bone or bone-hamstring-bone groups. Follow-up examinations were performed for at least 5 years postoperatively. Seventy-two of the 80 patients (37 patients in the bone-patellar tendon-bone group and 35 in the bone-hamstring-bone group) were evaluated, with a mean follow-up period of 87.0 and 80.8 months, respectively. Follow-up examinations were performed using the International Knee Documentation Committee knee ligament standard and subjective knee forms.\n The mean KT-1000 arthrometer evaluation results showed no significant difference between the bone-patellar tendon-bone and bone-hamstring-bone groups (1.2 +/- 2.1 mm and 1.7 +/- 1.4 mm, respectively; P = .24). However, symptoms related to graft harvest (anterior kneeling pain) were more frequently observed in the bone-patellar tendon-bone group, and unsatisfactory results were correlated with severe kneeling pain in 3 patients from this group (P = .0056). Significant hamstring muscle weakness without complaint of functional deficit was found in the bone-hamstring-bone group (P = .0045).\n Bone-hamstring-bone grafts were shown to reduce the risk of problems at the graft harvest site compared to bone-patellar tendon-bone grafts, with comparable results in the remaining clinical parameters tested.", "Bone-patellar tendon-bone graft has been the most commonly used graft material in anterior cruciate reconstructions, but there has been increasing use of hamstring tendon grafts. However, no existing clinical studies show adequate support for the choice of one graft over the other.\n Hamstring tendons are equally as good as patellar tendon in anterior cruciate ligament reconstructions.\n Prospective randomized clinical trial.\n Ninety-nine patients with laxity caused by a torn anterior cruciate ligament underwent arthroscopically assisted reconstruction with graft randomization according to their birth year. Grafts were either bone-patellar tendon-bone with metal interference screw fixation or double-looped hamstring tendons with metal plate fixation. There were no significant differences between the two groups preoperatively or at operation. Standard rehabilitation included immediate postoperative mobilization without a knee brace, protected weightbearing for 2 weeks, and return to full activity at 6 to 12 months.\n Forty-three patients in the patellar tendon group and 46 patients in the hamstring tendon group were available for clinical evaluation at a minimum of 21 months after surgery. No statistically significant differences were seen with respect to clinical and instrumented laxity testing, International Knee Documentation Committee Score ratings, isokinetic muscle torque measurements, and Kujala patellofemoral, Lysholm, and Tegner scores.\n Equal results were seen for patellar and hamstring tendon autograft anterior cruciate ligament reconstructions at 2 years after surgery. Both techniques seem to improve patients' performance.\n Copyright 2003 American Orthopaedic Society for Sports Medicine", "Debate exists regarding the optimal graft for anterior cruciate ligament reconstruction. Few studies have compared the differences in outcome after reconstruction using similar fixation methods.\n Similar outcomes will be seen after anterior cruciate ligament reconstruction with bone-patellar tendon-bone or quadruple-strand semitendinosus/gracilis tendons fixed with bioabsorbable interference screws.\n Randomized controlled trial; Level of evidence, 1.\n Ninety-nine patients were prospectively randomized to bone-patellar tendon-bone (46 patients) or quadruple-strand semitendinosus/gracilis (53 patients) reconstruction groups. The bone-patellar tendon-bone group had slightly lower preinjury Tegner scores (6.7 vs 7.1, P = .03); otherwise, the groups were similar. All surgeries were performed by a single surgeon using an endoscopic technique with bioabsorbable interference screw fixation. Patients were evaluated at 3, 6, 12, and 24 months.\n Forty-six bone-patellar tendon-bone and 50 quadruple-strand semitendinosus/gracilis patients were available at 24 months (97%). No differences in International Knee Documentation Committee grade, Lysholm score, Tegner activity level, range of motion, single-legged hop test, KT-1000 arthrometer manual maximum difference, Short Form-36, or patient knee rating were found. The bone-patellar tendon-bone group had better flexion strength in the operated leg than in the nonoperated leg (102% vs 90%, P = .0001), fewer patients complaining of difficulty jumping (3% vs 17%, P = .03), and a greater number of patients returning to preinjury Tegner level (51% vs 26%, P = .01). The quadruple-strand semitendinosus/gracilis group had better extension strength in the operated leg than in the nonoperated leg (92% vs 85%, P = .04), fewer patients with sensory deficits (14% vs 83%, P = .0001), and fewer patients with difficulty kneeling (6% vs 20%, P = .04). Both groups showed significant improvement in KT-1000 arthrometer manual maximum difference, Lysholm score, Tegner activity level, International Knee Documentation Committee grade, and patient knee rating score.\n Good outcomes were seen in both the bone-patellar tendon-bone and quadruple-strand semitendinosus/gracilis groups. Subtle differences were noted between the groups, which may help guide optimal graft choice.", "The aim of this study was to compare the results after arthroscopic anterior cruciate ligament (ACL) reconstruction using central-third, bone-patellar tendon-bone (BPTB group), 3-strand semitendinosus (ST group), or 4-strand semitendinosus/gracilis (ST/G group) autografts.\n Prospective randomized trial.\n A randomized series of 134 patients, all with unilateral ACL rupture was included in the study. In all 3 groups, interference screw fixation of the graft was used at both ends and 125 of 134 (93%) of the patients returned for the follow-up examination after 26 months (range, 20 to 43 months). The preoperative assessments in all 3 groups were similar in terms of gender, Tegner activity level, Lysholm score, KT-1000 measurements, 1-leg hop test, and the knee-walking test.\n At follow-up, the knee-walking test was significantly worse in the BPTB group than in the ST group (P = .0004) and ST/G group (P < .0001). Furthermore, the knee-walking test was significantly worse at follow-up than preoperatively in the BPTB group (P < .0001). The corresponding findings were not made in the other 2 groups. A significant reduction in knee laxity and an increase in activity level compared with the preoperative assessments were found in all 3 groups, without any significant differences between the groups.\n Two years after ACL reconstruction, the use of ST and ST/G autografts rendered significantly less discomfort during the knee-walking test than the use of BPTB autografts. However, in terms of functional outcome and knee laxity, the groups displayed no significant differences.\n Level I." ]

[ "12716329", "15830647", "19053918", "11966929", "9310876", "15212355", "19186961", "15058375", "10959787", "11846197", "11156038", "20467617", "10599912" ]

[ "Comparison of infrabony defects treated with enamel matrix derivative versus guided tissue regeneration with a nonresorbable membrane.", "Clinical and radiographic effects of enamel matrix derivative in the treatment of intrabony periodontal defects: a 12-month longitudinal placebo-controlled clinical trial in adult periodontitis patients.", "Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative: a 3-year prospective randomized clinical study.", "Enamel matrix proteins in the regenerative therapy of deep intrabony defects.", "Enamel matrix derivative (EMDOGAIN) in the treatment of intrabony periodontal defects.", "Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter practice-based clinical trial.", "Enamel matrix derivative versus bioactive ceramic filler in the treatment of intrabony defects: 12-month results.", "Enamel matrix proteins in the treatment of intra-bony defects. A prospective 24-month clinical trial.", "Comparison of treatments of infrabony defects with enamel matrix derivative, guided tissue regeneration with a nonresorbable membrane and Widman modified flap. A pilot study.", "Enamel matrix proteins and guided tissue regeneration with titanium-reinforced expanded polytetrafluoroethylene membranes in the treatment of infrabony defects: a comparative controlled clinical trial.", "Enamel matrix derivative in the treatment of human intrabony osseous defects.", "The efficacy of enamel matrix derivative (Emdogain) for the treatment of deep infrabony periodontal defects: a placebo-controlled randomised clinical trial.", "The use of barrier membranes and enamel matrix proteins in the treatment of angular bone defects. A prospective controlled clinical study." ]

[ "The purpose of the present multicenter clinical trial was to compare the efficacy of two different procedures in the treatment of infrabony defects: guided tissue regeneration (GTR) with nonresorbable membranes and enamel matrix derivative (EMD).\n Six centers participated in this study. Ninety-eight patients with an interproximal infrabony defect were selected. All patients were treated with an initial phase of scaling and root planing, and at the study's baseline the selected defects presented a value of probing depth (PD) > or =6 mm with an infrabony component > or =4 mm. Forty-nine patients were treated with GTR procedures (using ePTFE membranes (Gore-Tex W.L. Gore and Associates, Flagstaff, AZ, USA)) and forty-nine with EMDs (Emdogain (U Biora AB Malm, Sweden)). The efficacy of each treatment modality was investigated through covariance analysis.\n The patients were reevaluated at one year postop. Probing attachment level (PAL) gain and PD reduction were analyzed. In the Emdogain group the PAL before surgery (PAL 0) and the PD before surgery (PD 0) were respectively 9.9+/-1.4 and 8.5+/-1.6 mm. The PAL gain and the PD reduction at 1 year postsurgery were respectively 4.1+/-1.8 and 5.3+/-1.9 mm. The group of patients treated with membranes showed that PAL 0 and PD 0 were respectively 8.9+/-1.9 and 8.1+/-1.9. The PAL gain was 4.3+/-1.9 mm and the PD reduction was 5.6+/-1.5 mm. The mean PAL gain expressed by percentage (PAL gain/PAL 0) for the group treated with EMD was 41%, while it was 48% for the group treated with GTR. Results from our analysis suggest that there is no statistically significant difference between GTR and EMD treatments in terms of PAL gain, PD reduction and recession variation. Applying the regression model to a group of patients with a PAL 0 > or =8 mm, we observed a better clinical outcome in terms of PAL gain (difference of 0.3 mm) in patients treated with the GTR procedure compared to those treated with EMD. Covariance analysis showed a strong correlation in both groups of patients between PAL gain and full mouth bleeding score, and between PAL gain and defect morphology and depth.", "This randomized, double-masked, placebo-controlled clinical trial evaluated the effect of enamel matrix derivative (EMD) on clinical and radiographic parameters of periodontal intrabony defects.\n A split-mouth design was used in 16 chronic periodontitis patients who had similar defects (> or =6 mm of probing depth). Both groups underwent scaling and root planing and were acid-etched with EDTA. The test sites received the EMD solution and the controls a placebo. Clinical examinations of all 16 patients and radiographs of 14 patients were available at baseline and 6 and 12 months after surgery. Clinical outcomes included probing depth (PD) and clinical attachment level (CAL); radiographic analysis was performed using computerized linear measurements. Intergroup comparisons were performed by paired samples t test, and over time comparisons were made by general linear model (alpha = 0.05).\n A statistically significant improvement over time for PD and CAL and a decrease of the vertical component of the defect was detected in both groups. Comparisons between groups revealed at baseline a mean+/-SD value of CAL of 12.93+/-2.00 and 13.47+/-2.93 for test and control groups, respectively. These values decreased to 10.92+/-1.92 and 11.31+/-1.86 after 12 months for test and control. No statistically significant differences could be observed between groups. PD displayed similar results from 7.57+/-1.02 and 7.38+/-1.16 for test and control groups at baseline to 3.40+/-1.82 and 2.99+/-1.07 after 12 months. If the data are divided into smokers and non-smokers, no differences are observed.\n Use of EMD did not result in more improvement in clinical and radiographic parameters compared to the placebo.", "The aim of this randomized, controlled, prospective clinical study was to compare guided tissue regeneration (GTR) to enamel matrix derivative (EMD) for the treatment of intrabony defects in patients with chronic advanced periodontitis.\n Forty (39 evaluable) 3-wall intrabony defects, each with a depth > or = 4 mm measured from the crest of the bony defect, were treated in 40 subjects with advanced chronic periodontitis. Regeneration of angular bone defects was induced using non-resorbable membranes (GTR group; n = 20) or EMD (EMD group; evaluable n = 19). Clinical parameters, including probing depth (PD), clinical attachment level (CAL), gingival recession, radiographic measurement of the defect depth, plaque index, and bleeding on probing, were measured at baseline and at 12 and 36 months following surgery.\n Twelve months after surgery, sites treated with GTR demonstrated a mean CAL gain of 2.5 +/- 1.2 mm and a mean reduction in PD of 3.5 +/- 1.2 mm compared to baseline. The corresponding outcomes at 36 months were 2.0 +/- 1.1 mm (CAL) and 3.2 +/- 1.1 mm (PD). Sites treated with EMD demonstrated a mean CAL gain of 2.9 +/- 1.4 mm and a mean reduction in PD of 3.5 +/- 1.4 mm at 12 months, with a mean CAL gain of 2.4 +/- 1.2 mm and a mean PD reduction of 3.1 +/- 1.4 mm at 36 months. The differences in PD reduction and CAL gain were statistically significant between the groups and for each time point compared to baseline. Attachment loss was seen in both groups between the 12- and 36-month observations. Measured radiographic bone fill was 57.0% +/- 21% at 12 months and 53.7% +/- 14.3% at 36 months in the GTR group compared to 50.5% +/- 19% at 12 months and 58.8% +/- 14.9% at 36 months in the EMD group.\n The treatment of intrabony defects in patients with chronic advanced periodontitis using GTR or EMD led to significantly improved clinical parameters. Tests of statistical significance demonstrated better results with EMD, although the absolute differences between treatment modalities was small. Further studies with a larger number of treated defects are necessary to verify these findings.", "This prospective multicentre randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins (EMD).\n 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries. All patients had at least one intrabony defect of > or =3mm. Heavy smokers (> or =20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, roots were conditioned for 2 min with a gel containing 24% EDTA. EMD was applied in the test subjects, and omitted in the controls. Postsurgically, a strict plaque control protocol was followed. At baseline and 1 year following the interventions, clinical attachment levels (CAL), pocket probing depths (PPD), recession (REC), full-mouth plaque scores and full-mouth bleeding scores were assessed. A total of 166 patients were available for the 1-year follow-up.\n At baseline, 86 test and 86 control patients presented with similar subject and defect characteristics. On average, the test defects gained 3.1+/-1.5 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm. Pocket reduction was also significantly higher in the test group (3.9+/-1.7 mm) when compared to the controls (3.3+/-1.7 mm). A multivariate analysis indicated that the treatment, the clinical centers, cigarette smoking, baseline PPD, and defect corticalisation significantly influenced CAL gains. A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinically significant results (CAL gains > or =4 mm) and decreased the probability of obtaining negligible or no gains in CAL (CAL gains <2 mm).\n The results of this trial indicated that regenerative periodontal surgery with EMD offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.", "The aim of the present clinical trial was to compare the long-term effect of EMDOGAIN treatment as an adjunct to modified widman flap (MWF) surgery with the effect of MWF and placebo treatment. The investigation was a placebo-controlled, randomized multicenter trial involving 33 subjects with 34 paired test and control sites. The protocol required 2 interproximal sites, appropriately separated, in the same jaw with probing pocket depths > or = 6 mm and an associated intrabony defect with a depth of > or = 4 mm and a width of > or = 2 mm as measured on a radiograph. Only predominantly 1- and 2-wall defects were included. Clinical attachment gain and radiographic bone gain were used as primary outcome variables. Assessments were made at baseline, 8, 16 and 36 months. Mean values for clinical attachment level gain in test and control sites at 8 months were 2.1 mm and 1.5 mm, respectively; at 16 months, 2.3 mm and 1.7 mm, respectively; and at 36 months 2.2 mm and 1.7 mm, respectively; and the differences were statistically significantly different at each time point (p < 0.01). The radiographic bone level continued to increase over the 36 months at the EMDOGAIN-treated sites, while it remained close to the baseline level at the control sites. The statistically significant (p < 0.001) radiographic bone gain at 36 months of 2.6 mm at EMDOGAIN-treated sites corresponded to 36% gain of initial bone loss or 66% defect fill. The present trial has demonstrated that topical application of EMDOGAIN onto diseased root surfaces associated with intrabony defects during MWF periodontal surgery will promote an increased gain of radiographic bone and clinical attachment compared to control (placebo application) surgery in the same patient. There was no evidence to indicate any clinical adverse effects from application of EMDOGAIN conjunction with periodontal surgery.", "This prospective multicenter, randomized, controlled clinical trial compared the clinical outcomes of enamel matrix proteins (EMD) versus placement of a bioabsorbable membrane in conjunction with guided tissue regeneration (GTR).\n Seventy-five patients with advanced chronic periodontitis were recruited in seven centers in three countries. All patients had at least one intrabony defect of > or = 3 mm. Heavy smokers (> or = 20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using the simplified papilla preservation flap and either the application of EMD or the placement of a GTR membrane. At baseline and 1 year following the interventions, clinical attachment levels (CAL), probing depths (PD), recession (REC), full-mouth plaque scores, and full-mouth bleeding scores were assessed. A total of 67 patients completed the study.\n At 1 year, the EMD defects gained 3.1 +/- 1.8 mm of CAL, versus 2.5 +/- 1.9 mm for GTR defects. Probing depth reduction was 3.8 +/- 1.5 mm and 3.3 +/- 1.5 mm, respectively. A multivariate analysis indicated that the differences between EMD and GTR treatments were not significant while a center effect and baseline PD significantly influenced CAL gains. No significant differences in terms of frequency distribution of the outcomes were observed. All cases treated with GTR presented at least one surgical complication, mostly membrane exposure, while only 6% of EMD treated sites displayed complications (P < 0.0001).\n The results of this trial failed to demonstrate superiority of one treatment modality over the other. GTR outcomes in this trial were lower than anticipated based on previous evidence. This was attributed to the high prevalence of post-surgical complications in the GTR group.", "This study examined the clinical efficacy of enamel matrix derivative (EMD) and bioactive ceramic filler (BCF) in the treatment of intrabony periodontal defects and evaluated factors influencing the treatment outcome.\n Thirteen chronic periodontitis patients, 41 to 74 years of age, who had two proximal intrabony defects in different jaw quadrants with > or =3 mm vertical radiographic bone loss were selected for this study. After initial therapy, the sites in each patient were randomly assigned to EMD or BCF treatment. Clinical attachment level (CAL), probing depth (PD), tooth mobility (TM), gingival recession (GR), bleeding on probing, and dental plaque were recorded at baseline and at 6 and 12 months. At surgery, the intrabony component was characterized by recording the number of bony walls, distance in millimeters from the buccal crest (BC) to the most apical point of the defect, distance from the cemento-enamel junction (CEJ) to the BC, and the mesio-distal width of the defect at the level of the bony crest.\n BCF treatment resulted in a significant gain in proximal CAL (P = 0.005) and a reduction in proximal PD at 6 months (P <0.001), but there was no further improvement from 6 to 12 months. Paired comparisons by time for the EMD group revealed a significant reduction in proximal PD at 12 months (P = 0.001), whereas the gain in proximal CAL approached significance (P = 0.056). Mean GR increased significantly from baseline to 6 months in both groups (P = 0.001). Regression analysis revealed that within the EMD group, smoking and TM negatively influenced the gain of attachment, whereas within the BCF group, gingival recession increased with age, increasing CEJ to BC distance, and increasing mesial-distal width of the defect.\n The gain in proximal attachment after treating intrabony defects by flap surgery with BCF was significant (P = 0.004) and twice that following treatment with EMD (P = 0.056). Patient and site variables affected the clinical outcome differently.", "A growing flow of recent evidence indicates enamel matrix derivative (EMD, Emdogain) as a useful tool for the regeneration of periodontal tissues. This prospective clinical study aimed to evaluate the efficacy of EMD combined with surgical treatment of periodontal intra-bony defects, as compared with surgery alone, up to 24 months of follow-up.\n Twenty-four intra-bony defects were treated in 24 patients in a single clinical centre. Each defect had intra-bony depth (IBD) > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients were randomly assigned to either test or control group. Plaque index (PI), gingival index (GI), PPD and periodontal attachment level (PAL) were assessed at baseline pre-surgical examination at the site to be treated. Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) were also evaluated. Twelve patients were treated by simplified papilla preservation flap technique (control group), while 12 patients were treated with the same surgical technique plus EMD after ethylenediamine tetraacetic acid root conditioning (test group). Any probing at the involved sites was avoided in the first year post-surgery. Radiographs were taken at baseline, 12 and 24 months after surgery using customized bite blocks. Intra-bony defect depth (IBD) and angle (IBA) were measured from X-rays by a computer-aided technique. At 12 and 24 months post-surgery, FMPS, FMBS, PI, GI, PPD, PAL and radiographic IBD and IBA were assessed. The difference between each follow-up and baseline, and between groups at each follow-up was evaluated for the above parameters by standard statistical methods.\n In both groups, clinical and radiographic parameters were improved at either 12 or 24 months when compared with baseline. The test group displayed better outcomes when compared with the control group for IBD, PPD, and PAL gain at 12 months, and only for PAL and IBD gain at 24 months. No adverse event related to the use of EMD was reported.\n The surgical procedure used in the present study, aiming for maximum preservation of the regenerative potential of periodontal tissues, showed per se excellent results. The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects possibly enhances periodontal regeneration rate.", "The purpose of the present study was to compare the efficacy of 3 different surgical procedures in the treatment of infrabony defects: guided tissue regeneration (GTR) with non-resorbable membranes, Widman modified flap (WMF) and enamel matrix derivative (EMD).\n 30 patients with an infrabony component > or = 4 mm were selected. 10 were treated with expanded polytetrafluorethylene (ePTFE (Gore - Tex W. L. Gore and Associates, Flagstaff, AZ, USA)) membranes, 10 with WMF and 10 with enamel matrix derivatives (Emdogain (U Biora AB Malm, Sweden)). The efficacy of each treatment modality was investigated through regression analysis. Probing attachment level (PAL) gain, probing depth (PD) reduction and gingival recession (REC) variation were analyzed.\n Both Emdogain (enamel matrix derivative) and ePTFE treatment show significant better results as compared to the WMF procedure in which there were no significant changes in PAL gain and PD reduction at baseline and 1 year after surgery.\n Results from our analysis suggest that there is no statistically significant difference in PAL gain between GTR and EMD. The clinical outcomes of this pilot study may be of little significance, considering the small number of patients, but it has provided an important base for a controlled clinical trial (with a larger number of patients) which is currently in progress.", "Several studies have documented the clinical efficacy of guided tissue regeneration (GTR) with non-resorbable expanded polytetrafluoroethylene (ePTFE) membranes and enamel matrix proteins (EMP) in the treatment of infrabony defects. The objective of this controlled clinical study was to compare the clinical outcomes of 3 surgical modalities in the treatment of deep interproximal infrabony defects.\n Ninety (90) defects in 90 healthy subjects affected by chronic periodontitis were assigned to 1 of 3 treatment groups by blocking to prognostic variables. The test group was treated with the application of EMP and the simplified papilla preservation (SPP) technique; the second group was treated with titanium-reinforced ePFTE membranes and the SPP technique; and the third group was treated with the SPP technique used as access flap control procedure. No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups, indicating that the blocking approach was effective. A stringent infection control program was adopted for 1 year.\n The 1-year results indicated that: 1) all treatment modalities resulted in clinically significant improvements in clinical attachment levels (CAL) and reduction in probing depth (PD); 2) a statistically significant treatment effect was demonstrated comparing the EMP test, the membrane control, and the flap control groups in terms of CAL gains; 3) both the EMP test and the membrane control groups showed significant CAL gains compared to the flap control group; 4) a statistically significantly greater amount of CAL gain was demonstrated in GTR-treated compared to EMP-treated patients; 5) deeper residual probing depths but smaller increases in gingival recession were demonstrated following EMP therapy; and 6) smoking habits reduced the clinical outcomes of both regenerative procedures.\n The use of a regenerative procedure is indicated in the treatment of deep vertical bony defects since both the regenerative techniques (GTR and EMD) in the present study resulted in clinically and statistically significant improvements in clinical parameters compared to the access flap procedure. The use of EMP can be helpful in esthetically-sensitive sites and in reducing patient morbidity.", "There is limited information available from clinical trials regarding the performance of enamel matrix derivative (EMD) in the treatment of periodontal intrabony defects. This randomized, double-blind, placebo-controlled, split-mouth study was designed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects.\n Sixteen patients were included, each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch. Thirty-six intrabony defects were randomly assigned treatment with flap surgery plus EMD or flap surgery plus placebo. At baseline and at the 12-month follow-up evaluation visit, clinical and radiographic measurements were determined. Data were statistically analyzed using the Wilcoxon-signed rank test (alpha = 0.05).\n At the 12-month visit, bleeding on probing for the EMD group was 0.11 +/- 0.32 compared to the placebo group, 0.61 +/- 0.50 (P <0.05). Probing depth reduction was greater in the EMD group (3.00 +/- 0.97 mm) compared to the placebo group (2.22 +/- 0.81 mm) (P <0.05). Mean values for clinical attachment gain in the EMD and the placebo groups were 1.72 +/- 1.07 mm and 0.83 +/- 0.86 mm, respectively (P <0.05). Vertical relative attachment gain was 38.5 +/- 22.6% in the EMD group and 21.4 +/- 25.2% in the placebo group (P<0.05). Radiographic bone density gain was greater in the EMD (20.2 +/- 16.6%) compared to the placebo group (-3.94 +/- 23.3%) (P<0.01).\n Treatment with flap surgery and EMD, compared to flap surgery with placebo, produced a significantly more favorable clinical improvement in intrabony periodontal defects.", "To evaluate the efficacy of Emdogain versus placebo (its carrier) for the treatment of deep infrabony defects.\n Thirty patients with an infrabony defect of at least 4 mm deep and at least 2 mm wide were randomly allocated for treatment with either Emdogain or placebo (the Emdogain carrier). The treating clinician was completely blinded to the therapy provided and performed all evaluations blindly up to the third year of follow-up. Outcome measures were tooth loss, complications, post-operative healing, patient's satisfaction with treatment and aesthetics, changes in probing attachment levels (PAL), probing pocket depths (PPD), gingival recessions (REC) and radiographic bone levels (RAD).\n One year after treatment, both therapies had significantly improved clinical outcome measures: placebo group PAL gain = 3.3 mm, PPD reduction = 3.9 mm, and RAD gain = 2.5 mm; Emdogain group PAL gain = 3.4 mm, PPD reduction = 4.2 mm, and RAD gain = 2.5 mm. Both therapies induced statistically significant gingival recession (0.6 mm in the placebo and 0.8 mm in the Emdogain group). There were no statistically significant differences between groups for any of the outcomes tested. No teeth had to be extracted up to 3 years after treatment.\n There does not appear to be any clinical advantage when using Emdogain over its carrier (placebo) in the treatment of deep and wide infrabony defects.", "In the present prospective clinical trial, the effect of various regenerative procedures performed at sites with angular bone defects were evaluated. The main outcome variable was probing attachment alteration.\n 40 subjects, aged 32-61 years participated. They met the following inclusion criteria: (i) presence of generalized, advanced periodontal tissue destruction; (ii) presence of 2 similar, contralateral, angular bone defects (experimental sites) located in either the maxilla or the mandible; (iii) the defect site must exhibit a probing pocket depth (PPD) of > or = 6 mm, a probing attachment level (PAL) of > or = 7 mm, and a depth of the intrabony component of > or = 3 mm. All subjects had a good oral hygiene standard, were in good general health and did not use any medication. Prior to the start of the study, all subjects received non-surgical treatment for periodontal disease. Baseline clinical measurements (plaque, gingivitis, PPD, PAL and soft tissue recession) of the selected experimental sites were obtained 6 months after the completion of basic therapy. The 40 subjects were randomly divided into 4 treatment groups including 10 subjects each: 3 membrane groups and one Emdogain group. 1 h before surgery, the patients were given 3 g of Amoxicillin. No other antibiotics were prescribed. The test and control sites were treated during the same surgical session. Full thickness flaps were elevated and the exposed root surfaces were planed. Membrane placement: The root surface was rinsed with saline. A barrier membrane (Guidor or Resolut or Periodontal (e-PTFE) material) was positioned to cover the defect and the adjacent 2-3 mm of bone tissue. The control treatment was identical to the test treatment with the exception of barrier placement. Emdogain placement: The exposed root surfaces at both the test and control sites were, during a 2-min period, conditioned with a 24% EDTA gel. Emdogain was applied to the exposed root surface of the test site. In the control site, the vehicle, the PGA gel, was used as placebo control. The flaps were closed and sutured to obtain a complete coverage of the intrabony defect.\n Re-examinations, which were performed 12 months after surgery, disclosed that regenerative therapy, including either the use of barrier membranes or application of enamel matrix proteins to an instrumented root surface in an angular, intrabony defect, enhanced outcome variables such as probing pocket depth and probing attachment gain. It was furthermore demonstrated that clinical improvements were better at sites with deep, than at sites with shallow, intrabony defects.\n The 4 regenerative modalities tested appeared to be equally effective in terms of PPD reduction and PAL gain, and superior to open flap curettage alone." ]

[ "18424099", "10758778" ]

[ "Artichoke leaf extract (Cynara scolymus) reduces plasma cholesterol in otherwise healthy hypercholesterolemic adults: a randomized, double blind placebo controlled trial.", "Efficacy of Artichoke dry extract in patients with hyperlipoproteinemia." ]

[ "Cardiovascular diseases are the chief causes of death in the UK, and are associated with high circulating levels of total cholesterol in the plasma. Artichoke leaf extracts (ALEs) have been reported to reduce plasma lipids levels, including total cholesterol, although high quality data is lacking. The objective of this trial was to assess the effect of ALE on plasma lipid levels and general well-being in otherwise healthy adults with mild to moderate hypercholesterolemia. 131 adults were screened for total plasma cholesterol in the range 6.0-8.0 mmol/l, with 75 suitable volunteers randomised onto the trial. Volunteers consumed 1280 mg of a standardised ALE, or matched placebo, daily for 12 weeks. Plasma total cholesterol decreased in the treatment group by an average of 4.2% (from 7.16 (SD 0.62) mmol/l to 6.86 (SD 0.68) mmol/l) and increased in the control group by an average of 1.9% (6.90 (SD 0.49) mmol/l to 7.03 (0.61) mmol/l), the difference between groups being statistically significant (p=0.025). No significant differences between groups were observed for LDL cholesterol, HDL cholesterol or triglyceride levels. General well-being improved significantly in both the treatment (11%) and control groups (9%) with no significant differences between groups. In conclusion, ALE consumption resulted in a modest but favourable statistically significant difference in total cholesterol after 12 weeks. In comparison with a previous trial, it is suggested that the apparent positive health status of the study population may have contributed to the modesty of the observed response.", "Efficacy and tolerability of artichoke dry extract (drug/extract ratio 25-35:1, aquous extract, CY450) as coated tablets containing 450 mg extract (tradename: Valverde Artischocke bei Verdauungsbeschwerden) was investigated in the treatment of hyperlipoproteinemia and compared with placebo. 143 adult patients with initial total cholesterol of > 7.3 mmol/l (> 280 mg/dl) were included in a double blind, randomized, placebo controlled, multi-center clinical trial. Patients received 1,800 mg artichoke dry extract per day or placebo over 6 weeks. Changes of total cholesterol and LDL-cholesterol from baseline to the end of treatment showed a statistically significant superiority (p = 0.0001) of artichoke dry extract over placebo. The decrease of total cholesterol in the CY450 group was 18.5% compared to 8.6% in the placebo group. LDL-cholesterol decrease in the CY450 group was 22.9% and 6.3% for placebo. LDL/HDL ratio showed a decrease of 20.2% in the CY450 group and 7.2% in the placebo group. There were no drug related adverse events during this study indicating an excellent tolerability of artichoke dry extract. This prospective study could contribute clear evidence to recommend artichoke dry extract CY450 for treating hyperlipoproteinemia and, thus, prevention of atherosclerosis and coronary heart disease." ]

[ "19165109", "17989948", "19562446", "15729064", "2405749", "347099", "7050403", "16881426", "1779005", "9625243", "8150836", "19892627", "3411648", "4884240", "7035687", "9710723", "9715201", "2878088", "10425589", "2243846", "9882058", "9261702", "10626971", "11451595", "17667837", "10323611", "16679897", "11549952" ]

[ "Randomized clinical study of SilvaSorb gel in comparison to Silvadene silver sulfadiazine cream in the management of partial-thickness burns.", "[Local therapy of grade IIa burns: efficacy and tolerability of a new hydrosome wound gel for the local treatment of grade IIa burns as compared with silver sulfadiazine ointment].", "Aloe versus silver sulfadiazine creams for second-degree burns: a randomized controlled study.", "Survival benefit in critically ill burned patients receiving selective decontamination of the digestive tract: a randomized, placebo-controlled, double-blind trial.", "Outpatient management of partial-thickness burns: Biobrane versus 1% silver sulfadiazine.", "Prospective trials of dexamethasone and aerosolized gentamicin in the treatment of inhalation injury in the burned patient.", "Prophylactic antibiotics as an adjunct for skin grafting in clean reconstructive surgery following burn injury.", "Comparison of efficacy of 1% silver sulfadiazine and Acticoat for treatment of partial-thickness burn wounds.", "The role of gentamicin iontophoresis in the treatment of burned ears.", "A prospective randomised clinical and histological study of superficial burn wound healing with honey and silver sulfadiazine.", "Collagenase ointment and polymyxin B sulfate/bacitracin spray versus silver sulfadiazine cream in partial-thickness burns: a pilot study.", "Xenoderm versus 1% silver sulfadiazine in partial-thickness burns.", "Biosynthetic skin substitute vs. 1% silver sulfadiazine for treatment of inpatient partial-thickness thermal burns.", "A blind trial of two aerosol sprays in the exposure treatment of burns.", "A prospective study of prophylactic penicillin in acutely burned hospitalized patients.", "Prospective, randomized study of the efficacy of Mepitel on children with partial-thickness scalds.", "Trimethoprim-sulfamethoxazole for the prevention of methicillin-resistant Staphylococcus aureus pneumonia in severely burned patients.", "Reversal of postburn immunosuppression with low-dose polymyxin B.", "Safety and efficacy of TransCyte for the treatment of partial-thickness burns.", "A randomized prospective study of topical antimicrobial agents on skin grafts after thermal injury.", "A silicone-coated nylon dressing reduces healing time in burned paediatric patients in comparison with standard sulfadiazine treatment: a prospective randomized trial.", "Study of antibiotic prophylaxis during burn wound debridement in children.", "Biobrane versus 1% silver sulfadiazine in second-degree pediatric burns.", "Selective decontamination of the digestive tract in severely burned pediatric patients.", "A silver-coated antimicrobial barrier dressing used postoperatively on meshed autografts: a dressing comparison study.", "Management of partial thickness facial burns (comparison of topical antibiotics and bio-engineered skin substitutes).", "Randomized clinical study of Hydrofiber dressing with silver or silver sulfadiazine in the management of partial-thickness burns.", "Evaluating the role of alternative therapy in burn wound management: randomized trial comparing moist exposed burn ointment with conventional methods in the management of patients with second-degree burns." ]

[ "This prospective, randomized study assessed the clinical, microbiological, and patient comfort characteristics of two silver-based topical agents in the management of partial-thickness burn wounds. Pediatric patients were randomly assigned to treatment with either SilvaSorb Gel (Medline Industries, Munedelein, IL) or Silvadene silver sulfadiazine cream (King Pharmaceuticals, Bristol, TN) for up to 21 days or to the point of full reepithelialization of the wound. Inclusion criteria were patients ranging in age from 2 months to 18 years with TBSA ranging from 1 up to 40%. A total of 24 patients were enrolled and completed the study. Findings demonstrated that the use of SilvaSorb Gel was associated with less pain and greater patient satisfaction when compared with Silvadene. No statistically significant differences were found when assessing the rate of infection, time to reepithelialization, or the number of dressings changes required during treatment. The reduction of pain and improved overall patient satisfaction with the use of SilvaSorb Gel compared with Silvadene indicates an important role for SilvaSorb Gel in treatment of partial-thickness burns in a pediatric population.", "A new hydrosome wound gel is based on a new mechanism of action. It contains hydrosomes that penetrate to the wound bed and supply the wound with phospholipids, which are identical to membrane phospholipids of human cells. In this manner it supports the proliferative processes during wound healing.\n In a randomized, controlled, intraindividual comparative study of 47 patients with grade IIa burns, the hydrosome wound gel was tested against silver sulfadiazine cream. Digital pictures of the burn wounds were taken daily, and the wounds were analyzed in terms of their reepithelization rate.\n Wounds receiving the hydrosome wound gel healed 1.5-2 days faster than wounds treated with sulfadiazine cream (9.9+/-4.5 days vs. 11.3+/-4.9 days, p=0.015). In 66% of the patients, faster epithelization was observed with the hydrosome wound gel treatment. The hydrosome gel guaranteed secure prophylaxis against infection, and it was well tolerated and easy to apply.\n In this study, the treatment of grade IIa burn wounds with hydrosome wound gel led to faster wound closure compared with treatment with sulfadiazine cream. Therefore, hydrosome gel represents a good alternative to sulfadiazine cream.", "Burn injury is associated with a high incidence of death and disability; yet its management remains problematic and costly. We conducted this clinical study to evaluate the efficacy of aloe vera cream for partial thickness burn wounds and compare its results with those of silver sulfadiazine (SSD).\n Thirty patients with similar types of second-degree burns at two sites on different parts of the body were included in this study. Each patient had one burn treated with topical SSD and one treated with aloe cream, randomly.\n The rate of re-epithelialization and healing of the partial thickness burns was significantly faster in the site treated with aloe than in the site treated with SSD (15.9 +/- 2 vs 18.73 +/- 2.65 days, respectively; P < 0.0001). The sites treated with aloe were completely healed in less than 16 days vs 19 days for the sites treated with SSD.\n These results clearly demonstrated the greater efficacy of aloe cream over SSD cream for treating second-degree burns.", "To evaluate whether selective digestive decontamination (SDD) reduces mortality from any cause, and the incidence of pneumonia among patients with severe burns.\n SDD is a prophylactic strategy to reduce infectious morbidity and mortality in critically ill patients. Two meta-analyses and a recent randomized controlled trial demonstrated a mortality reduction varying between 20% and 40%. But this technique has never been properly evaluated in severely burned patients.\n The design of this single-center trial was randomized, double blind, placebo controlled. Patients with burns > or =20% of total body surface and/or suspected inhalation injury were enrolled and assigned to receive SDD or placebo for the total duration of treatment in the burn intensive care unit (ICU).\n One hundred seventeen patients were randomized and 107 were analyzed (53 in the SDD group and 54 in the placebo group). The ICU mortality was 27.8% in the placebo group and 9.4% in the SDD group in the burn ICU. Treatment with SDD was associated with a significant reduction in mortality both in the burn ICU (risk ratio 0.25; 95% CI 0.08 to 0.76) and in the hospital (risk ratio 0.28; 95% CI 0.10 to 0.80), following adjustment for predicted mortality. The incidence of pneumonia was significantly higher in the placebo group: 30.8 and 17.0 pneumonias per 1000 ventilation days (P = 0.03) in placebo and SDD group, respectively.\n Treatment with SDD reduces mortality and pneumonia incidence in patients with severe burns.", "A randomized, prospective study comparing the use of Biobrane (group 1) with the use of 1% silver sulfadiazine (group 2) in treating 56 partial-thickness burn wounds was carried out in 52 outpatients with burns that comprised less than 10% of their total body surface area. The two groups were similar in age, gender, race, and extent of burn. Wounds of patients in group 1 (30) were compared with those of group 2 (26) for healing time, pain, compliance with scheduled visits, and costs. Infected and skin-grafted wounds were excluded from healing time analysis. Infection rates of the two groups were similar (three of 30 vs two of 26). One patient in each group underwent skin grafting. Healing times of group 1 wounds were significantly less than those of group 2 (10.6 +/- 0.8 vs 15.0 +/- 1.2 days, P less than .01). Using a pain scale of 1 to 5, Biobrane-treated patients averaged lower pain scores at 24 hours after the burn (1.6 +/- 0.8 vs 3.6 +/- 1.3 P less than .001) and used less pain medication. Compliance with scheduled outpatient visits was also improved in the Biobrane-treated group (88.6% vs 63.2% attendance, P less than .001). Idealized total treatment costs averaged $434 for patients in group 1 compared with $504 for patients in group 2. We conclude that when used on properly selected wounds, Biobrane therapy can significantly decrease pain and total healing time without increasing the cost of outpatient burn care. Improved patient compliance may be an added benefit.", "The addition of an inhalation injury to a cutaneous burn results in a significant increase in patient mortality rates, both from early pulmonary edema and, later, Gram-negative pneumonitis. Steroids have been shown to decrease mortality in an inhalation injury model. Aerosolization of gentamicin has been used successfully to treat severe bronchial infections. Therefore, a prospective, randomized trial was undertaken to evaluate both these drugs. Sixty burned patients, with inhalation injury confirmed by bronchoscopy and 133Xenon scan, were studied: 30 patients received either dexamethasone or saline placebo for 3 days; serial pulmonary functions were measured on those able to cooperate; another 30 patients received either aerosolized gentamicin or placebo for 10 days. Both drug-treated groups were comparable to their controls in age and mean burn size. Results of the steroid trial showed no major differences in mortality, pulmonary complications, or changes in pulmonary functions. Results of the gentamicin trial showed no major differences in mortality, time of death, or pulmonary and septic complications between treated and control groups.", "A randomized prospective double-blind trial was conducted to determine the effectiveness of cephalothin vs. placebo given perioperatively for prevention of infections associated with operations using skin grafts for clean reconstructive surgery following burn injury. The antibiotic was effective in reducing infection (0.8% vs. 5.7%, p less than 0.03), reducing graft loss (p less than 0.2), and shortening hospital stay (12.38 days vs. 13.66 days, p = 0.02). Factors not associated with greater graft infection included the operating surgeon, the use or nonuse of a tie-on stent, graft thickness, large size of graft, and patient age.", "Acticoat (Smith & Nephew, Hull, UK) is a silver-coated dressing reported to reduce infection and exhibit antimicrobial activity in wounds.\n The purpose of the present study was to compare the efficacy ofacticoat and 1% silver sulfadiazine (1% AgSD) for treatment of partial thickness burn wounds.\n The authors reviewed 50 patients who had partial thickness burn wounds less than 25% admitted to Siriraj Burn Unit from May 2002 to September 2005. All patients were divided into 2 groups: the acticoat treated group (25 patients) and the 1% silver sulfadiazine treated group (25 patients). The 2 groups were compared for the etiology of burn wound, demographic data including age, sex, % Total Body Surface Area burn (TBSA%), cultured organisms, wound infection and outcome of Length Of hospital Stay (LOS) and level of pain.\n The authors found no significant differences in age, TBSA (%) between both groups. 7 patients (28%) developed wound infection. There were no differences in wound infection and LOS between both groups (p > 0.05). All of the patients who developed wound infection responded well to targeted topical and systemic antibiotic treatment. The 1% AgSD treated group (6 of 25, 24%) obtained more split thickness skin graft to close the granulation defects compared to patients who were treated with acticoat (4 of 25, 16%) but no statistical significance, p = 0.32). Average pain scores in the acticoat treated groups were significantly lower than the 1% AgSD treated group (4 +/- 0.6 versus 5 +/- 0.7, respectively).\n The present study confirms the efficacy of acticoat treatment in partial thickness burn wound. The authors conclude that acticoat has an advantage of limiting the frequency of replacement of the dressing and provides a less painful alternative to wound care with 1% AgSD with comparable incidence of burn wound infection. This is due to its long wear time and the ease of application and removal.", "Ear cartilage heals slowly, and limited vascularity in cartilage precludes use of systemic antibiotics. Iontophoresis electrically induces drugs in solution to migrate into target tissues. Fifteen patients were randomized to receive gentamicin iontophoresis (n = 7) plus dressing changes every 6 hours and cleaning or routine care alone (n = 8) for treatment of ear burns. There were no differences between the groups in incidence of chondritis (43% vs 50%) or cartilage loss (11% vs 16%). However, gentamicin-resistant organisms developed in 29% of the patients who received iontophoresis, but in none of the patients in the control group (p less than 0.05). To identify the etiology of the resistant organisms, 10 New Zealand white rabbits receive 7 cm2 contact burns to each ear. Gentamicin iontophoresis was performed on one ear, and the other ear served as the control. Serum gentamicin levels were always subtherapeutic. Additionally, gentamicin tissue levels in both the treated and control ears were subtherapeutic. Gentamicin iontophoresis appears to offer no additional salutary effects beyond those that are provided by routine care and may encourage the development of antibiotic resistance.", "Histological and clinical studies of wound healing have been made on comparable fresh partial thickness burns with honey dressing or silver sulfadiazine (SSD) in two groups of 25 randomly allocated patients. Of the wounds treated with honey 84 per cent showed satisfactory epithelialization by the 7th day, and in 100 per cent of the patients by the 21st day. In wounds treated with silver sulfadiazine, epithelialization occurred by the 7th day in 72 per cent of the patients and in 84 per cent of patients by 21 days. Histological evidence of reparative activity was seen in 80 per cent of wounds treated with the honey dressing by the 7th day with minimal inflammation. Fifty two per cent of the silver sulfadiazine treated wounds showed reparative activity with inflammatory changes by the 7th day. Reparative activity reached 100 per cent by 21 days with the honey dressing and 84 per cent with SSD. Thus in honey dressed wounds, early subsidence of acute inflammatory changes, better control of infection and quicker wound healing was observed while in the SSD treated wounds sustained inflammatory reaction was noted even on epithelialization.", "A multifaceted approach that involves early debridement and control of infection is critical to successful and rapid burn wound healing. This pilot study was conducted in 15 adult patients with burns to assess the usefulness of early enzymatic debridement with a combination of collagenase ointment and polymyxin B sulfate/bacitracin spray versus silver sulfadiazine cream in partial-thickness burns. Combination treatment with collagenase and polymyxin B sulfate/bacitracin resulted in significantly shorter time to achieve a clean wound bed than silver sulfadiazine (median 6 vs 12 days; p = 0.0012) and significantly more rapid wound healing than silver sulfadiazine (median 10 vs 15 days; p = 0.0007). These results are encouraging and justify implementation of a larger, multicenter, comparative study.", "The aim of this clinical trial was to evaluate the effectiveness of using lyophilised porcine skin (Xenoderm) compared with 1% silver sulfadiazine (SSD) in partial-thickness burns with regard to wound infection, length of hospital stay, number of dressings and doses of analgesics used (oral and injection).\n A total of 78 burns patients were included in this randomised study; their burns were caused by scalds or flames. They had second degree burns and had a burn area of 1060% of total body surface area (TBSA). Thirty-seven patients were treated with daily washing, followed by topical application of SSD dressing (the SSD group) and 39 with a biological dressing, i.e. Xenoderm (the Xenoderm group). The differences were evaluated using unpaired Student's t-test, Mann-Whitney U test and Chi-square test.\n There were no significant differences between the two groups with respect to age, gender, TBSA, cause of burn, and thickness of the burn or burn site. But there were significant differences regarding degree of wound infection, length of hospital stay, number of used dressings and given doses of analgesics.\n Xenoderm seems to be more effective than SSD dressing in terms of pain control, degree of wound infection, used wound dressings and length of hospital stay for partial-thickness burns. Prospective randomised studies are now necessary to compare possible reductions in the use of split thickness skin grafts and re-epithelialisation times.", "When used appropriately on superficial or moderate-depth partial-thickness burns, Biobrane significantly decreased total healing time to complete reepithelialization, reduced pain, and was associated with decreased nursing time and costs when compared to 1% silver sulfadiazine cream. Care must be used in selecting wounds for Biobrane therapy. They must be fresh, noninfected, and free of eschar and debris with a moist, sensate surface that demonstrates capillary blanching and refill. Wounds must be inspected regularly for nonadherence and signs of infection. Early fluid accumulation requires prompt aspiration. Biobrane should be removed if fluid reaccumulates or the Biobrane becomes nonadherent at any time after 48 hours. When used appropriately, Biobrane offers significant advantages over conventional therapy of acute partial-thickness burns.", "nan", "The use of prophylactic low-dose penicillin acutely burned, hospitalized patients remains controversial. Fifty-one adult patients with burns of 1% to 91% total body surface area were prospectively studied to determine the efficacy of prophylactic penicillin in the prevention of wound cellulitis and burn wound sepsis, and to examine the influence of prophylactic penicillin on the emergence of antibiotic resistant microorganisms. In 25 patients given a 5-day course of penicillin prophylactically, 11 developed cellulitis and two had burn wound sepsis. A similar group of patients given placebo developed seven cases of cellulitis and three cases of burn wound sepsis (p = 0.340). No patient in either group developed gentamicin-resistant Gram-negative organisms, although the gastrointestinal tracts of two patients in the penicillin group showed new colonization by yeast. We conclude that the routine administration of prophylactic penicillin neither protects against cellulitis and burn wound sepsis, nor promotes selection of antibiotic-resistant bacteria in hospitalized patients with acute thermal injury.", "We performed a randomized clinical trial in which children with partial-thickness scald burns of less than 15% total body surface area were assigned treatment with either Mepitel (Mölnlycke Health Care) or silver sulfadiazine. Data were collected on time to wound healing, pain at dressing change, infection, and resource use. Student's t and chi-square tests were used to determine differences in the two groups. Healing times were compared using Kaplan-Meier survival curves. Wounds of children treated with Mepitel healed significantly faster than did controls' (p < 0.001), exhibited less eschar formation (p < 0.05), and experienced less pain at dressing change (p < 0.05). They also had significantly lower mean daily hospital charges ($1937 vs $2316; p = 0.025); as well as significantly lower charges for dressing changes and narcotics. There was no significant difference in wound infection. We believe the use of Mepitel represents a significant advance in the treatment of partial-thickness scald wounds in children.", "Patients with severe burns are at increased risk of developing methicillin-resistant Staphylococcus aureus (MRSA) ventilator-associated pneumonia. This study was designed to determine whether MRSA pneumonia can be prevented by prophylactic administration of trimethoprim-sulfamethoxazole (TMP-SMX).\n We conducted a prospective, randomized, placebo-controlled study in patients with severe burns (> or = 20%), who required ventilator support. Prophylaxis was done with oral TMP-SMX (80 mg/400 mg) three times daily for 10 days from 4 to 6 days after burn injury. The incidence of MRSA pneumonia and the side effects were evaluated during the administration period.\n Twenty-one patients were assigned to receive TMP-SMX, and 19 patients to receive placebo. The incidence of MRSA pneumonia was 4.8% in the TMP-SMX group and 36.8% in the placebo group, showing a significant difference (p = 0.017). No major side effects of therapy were seen in the TMP-SMX group.\n Prophylactic treatment with TMP-SMX can prevent MRSA pneumonia in severely burned patients.", "In a randomized study of 28 patients with thermal injury, polymyxin B was administered intravenously in small doses to attempt to block the immunosuppressive effects of endotoxin. When compared with controls, treated patients showed a reduction in septic complications and death, but this reduction is not statistically significant at this time. In vitro measurements of lymphocyte function, however, indicate a statistically significant improvement in the T helper to suppressor ratio, and in the lymphocyte responsiveness to a number of bacterial antigens.", "Standard treatment for extensive partial-thickness burns in the United States and in much of the world involves the application of topical antimicrobial agents and repetitive wound débridements and dressing changes. We evaluated a new biologic wound covering, TransCyte (Advanced Tissue Sciences, La Jolla, Calif, formerly marketed as Dermagraft-Transitional Covering), for the treatment of partial-thickness burns. This material is composed of human newborn fibroblasts which are then cultured on the nylon mesh of Biobrane (Dow B. Hickam, Inc, Sugarland, Tex); the thin silicone membrane bonded to the mesh provides a moisture vapor barrier for the wound. A prospective, randomized, comparison study of silver sulfadiazine and TransCyte was performed with the use of paired wound sites on 14 patients. Wounds treated with TransCyte healed more quickly (mean 11.14 days to 90% epithelialization vs 18.14 days, P = .002). A noncomparison evaluation was then done for an additional 18 patients, and it confirmed excellent wound healing and an absence of infections. There were no infections in the 32 wound sites treated with TransCyte. In the first study group, late wound evaluations (3, 6, and 12 months postburn) were performed with use of the Vancouver Scar Scale. The results indicated that wound sites treated with TransCyte healed with less hypertrophic scarring than sites treated with silver sulfadiazine (P < .001 at 3 and 6 months, P = .006 at 12 months).", "We prospectively studied 52 consecutive patients who were treated by early tangential excision and grafting following thermal injury. The usefulness of two topical antimicrobial agents--0.5% silver nitrate (Ag) and neomycin (1 gm/liter) plus bacitracin (50,000 units/liter) (NB)--was compared with the effectiveness of Ringer's lactate (RL) for prevention of autogenous skin-graft loss due to infection. Graft loss of 10 percent or more occurred in 17 patients (33 percent)--due to infection in 16. Skin-graft loss was a minor problem in patients with less than 20 percent total body surface area (TBSA) burn (Ag: 0 of 6, NB: 1 of 6, RL: 1 of 5). The use of either antimicrobial (Ag or NB) resulted in less graft loss (1 of 14) than RL (4 of 6; p less than 0.05) in the 20 to 40 percent TBSA burn group. Large burns (greater than 40 percent) had a very high incidence of at least 10 percent graft loss (67 percent) regardless of treatment. Infection in the area of graft loss was caused by antibiotic-resistant organisms or yeast in 50 percent of the Ringer's lactate group and the entire neomycin plus bacitracin group. No graft infections were caused by resistant organisms or yeast in the silver nitrate group. This study demonstrates that topical antimicrobial agents reduce infection-related skin-graft loss in patients with medium-sized (20 to 40 percent TBSA) burns and that neomycin plus bacitracin is associated with rapid emergence of drug-resistant organisms whereas silver nitrate is not.", "Mepitel is a new grid like silicone coated nylon dressing containing no additional biological compounds. We describe a prospective randomized pilot study comparing Mepitel to the standard silver sulfadiazine cream (Flamazine) dressing for the topical treatment of paediatric burns. Seventy-six children presenting within 24 h of injury with a non previously treated burn were randomly assigned to Mepitel treatment (group M) or Flamazine treatment (group F). Age, sex, surface area of burn and causal agent were noted at admission. The depth of the burn, cumulative number of dressings, presence or absence of a complete epithelial cover, infection, bleeding and allergy were noted at each dressing change. There were 41 children in group M and 35 children in group F. Five children were subsequently withdrawn from each group because they required skin grafting. Analysis of the above mentioned criteria showed no statistical difference between the two groups except for the healing time (group M: 7.58+/-3.12, group F: 11.26+/-6.02, p < 0.01) and the number of dressings (group M: 3.64+/-1.5, group F: 5.13+/-2.9, p < 0.05). Mepitel has proved to be an easy-to-remove dressing, adhering only to intact skin. The faster healing time found in the Mepitel group may be related to a direct effect of silicone on epithelial growth or to a decrease in surface-cell damage compared to the silver sulfadiazine group. This attractive product will be further assessed on a larger scale trial to confirm our observations.", "Twenty-three children completed a randomized, prospective, partially blinded study performed to assess the need and effectiveness of antibiotic prophylaxis at the time of burn wound debridement and grafting. Patients with a total body surface area (TBSA) burn less than 35% were randomized to receive cefazolin or placebo. Patients with burns of 35% or more TBSA were randomized to receive cefazolin or targeted antibiotics based on surveillance cultures. Blood cultures were obtained at commencement, immediately after, and 24 hours after surgical debridement. Quantitative cultures and histologic examination of biopsied burn wounds were performed. Burn wound infection occurred in three patients with burns of less than 35% TBSA, two in the cefazolin group and one in the placebo group. Quantitative tissue cultures and histologic examination did not predict either infection. During the four procedures in three patients with 35% or more TBSA, three were randomized to receive cefazolin, and one targeted antibiotics. All receiving cefazolin developed burn wound infection. Quantitative tissue culture was more than 10(5) colony-forming units per gram in all, whereas histologic examination was positive in one. In our patients with less than 35% burn, cefazolin was not necessary, and in those with 35% or more burn, it was not effective.", "Partial-thickness burns in children have been treated for many years by daily, painful tubbing, washing, and cleansing of the burn wound, followed by topical application of antimicrobial creams. Pain and impaired wound healing are the main problems. We hypothesized that the treatment of second-degree burns with Biobrane is superior to topical treatment. Twenty pediatric patients were prospectively randomized in two groups to compare the efficacy of Biobrane versus 1% silver sulfadiazine. The rest of the routine clinical protocols were followed in both groups. Demographic data, wound healing time, length of hospital stay, pain assessments and pain medication requirements, and infection were analyzed and compared. Main outcome measures included pain, pain medication requirements, wound healing time, length of hospital stay, and infection. The application of Biobrane to partial-thickness burns proved to be superior to the topical treatment. Patients included in the biosynthetic temporary cover group presented with less pain and required less pain medication. Length of hospital stay and wound healing time were also significantly shorter in the Biobrane group. None of the patients in either group presented with wound infection or needed skin autografting. In conclusion, the treatment of partial-thickness burns with Biobrane is superior to topical therapy with 1% silver sulfadiazine. Pain, pain medication requirements, wound healing time, and length of hospital stay are significantly reduced.", "Infection is still one of the leading causes of morbidity and mortality in severely burned patients. Evidence suggests that many of the responsible organisms are endogenous. Systemic antibiotic prophylaxis is not effective, and produces resistant strains of microorganisms. SDD has been postulated to be beneficial for controlling and decreasing infections in critically ill patients. Its efficacy in severely burned patients, however, remains controversial. In order to analyze the efficacy of selective decontamination of the digestive (SDD) tract, to decrease the bacterial colonization of the aerodigestive tract and burn wounds, and the incidence of septic complications in severely burned children, 23 pediatric patients affected of severe burns were prospectively randomized in a double-blinded study. Eleven patients received SDD (Polymyxin E, Tobramycin, and Amphotericin B), and 12 placebo. Demographics, hospital course, microbiology results, complications, infectious episodes, and serum levels of IL-1beta, IL-6, IL-10, and TNF-alpha were compared to determine the efficacy of SDD. Colonization rates to the wound, sputum, nasogastric aspirates, and feces were similar. Pneumonia, sepsis and other complications had similar incidence in both groups. Serum levels of all cytokines studied were also comparable, suggesting a similar inflammatory status in all patients, regardless of the treatment received. Patients in the SDD group, however, had a significantly higher incidence of diarrhea (P=0.003). We can conclude that selective decontamination of the digestive tract with Polymixin E, Tobramycin and Amphotericin B is not effective to decrease bacterial colonization and infectious episodes in severely burned pediatric patients.", "In an effort to optimize the management of freshly grafted burn wounds, a silver-coated, low-adherence dressing, Acticoat (Smith & Nephew Inc., Largo, FL), was compared with 5% sulfamylon-soaked Exu-Dry burn wound dressings. Twenty subjects admitted to the Loyola University Medical Center were randomized to either Acticoat dressings or 5% sulfamylon-soaked burn wound dressings. Dressings were applied immediately after grafting in the operating room. Acticoat dressings were left in place for 3 days and then changed every 3 days thereafter. Sulfamylon-soaked dressings were changed at 48 hours and then every day. Subjects continued to have dressing changes on a twice-daily basis to wounds that were not grafted managed. Subjects were assessed for graft take, time to wound healing, and the number of dressings required until healing. Hospital charges and labor costs were retrospectively tabulated, yielding an expense estimate for each group. There were no significant differences between the two groups with respect to age, %TBSA, %TBSA of the grafted test sites, graft take, time to graft healing, or infectious complications. The median number of dressing changes to the test site was significantly less in the Acticoat group (P < .05). The average expense per dressing change was not significantly different between the two groups; however, the average total expense per patient was significantly lower for the Acticoat group because of the reduced number of dressing changes. Acticoat and 5% sulfamylon-soaked burn wound dressings were equivalent with respect to wound healing and infectious complications. The use of Acticoat was found to be a safe alternative to the use of 5% sulfamylon as a postsurgical dressing in this group of subjects. Because of the reduced number of dressing changes, the use of Acticoat was a less expensive alternative to 5% sulfamylon dressing changes in this study.", "This study compared the effect of standard topical antibiotic management versus a biological skin substitute wound closure for mid-partial thickness burns of the face. Adult patients with mid-dermal facial burns produced by flash flames or flame exposure were studied using a randomized prospective study design. Total daily burn care time, pain (0-10 scale) and healing time were monitored. Immediately after partial thickness debridement, the entire face burn, including ears, was closed with a bioengineered skin substitute coated with fibronectin (TransCyte) or treated by the open technique using bacitracin ointment applied 2-3 times daily. 21 patients were studied, with 10 patients in the skin substitute group. We found a significant decrease in wound care time 0.35 +/- 0.1 versus 1.9 +/- 0.5 h, decrease in pain of 2 +/- 1 versus 4 +/- 2 and re-epithelialization time 7 +/- 2 versus 13 +/- 4 days in the skin substitute group compared to topical antibiotics. We can conclude that a bioengineered skin substitute significantly improves the management and healing rate of partial thickness facial burns, compared to the standard open topical ointment technique.", "This prospective, randomized study compared protocols of care using either AQUACEL Ag Hydrofiber (ConvaTec, a Bristol-Myers Squibb company, Skillman, NJ) dressing with silver (n = 42) or silver sulfadiazine (n = 42) for up to 21 days in the management of partial-thickness burns covering 5% to 40% body surface area (BSA). AQUACEL Ag dressing was associated with less pain and anxiety during dressing changes, less burning and stinging during wear, fewer dressing changes, less nursing time, and fewer procedural medications. Silver sulfadiazine was associated with greater flexibility and ease of movement. Adverse events, including infection, were comparable between treatment groups. The AQUACEL Ag dressing protocol tended to have lower total treatment costs (Dollars 1040 vs. Dollars 1180) and a greater rate of re-epithelialization (73.8% vs 60.0%), resulting in cost-effectiveness per burn healed of Dollars 1,409.06 for AQUACEL Ag dressing and Dollars 1,967.95 for silver sulfadiazine. A protocol of care with AQUACEL(R) Ag provided clinical and economic benefits compared with silver sulfadiazine in patients with partial-thickness burns.", "Moist exposed burn ointment (MEBO), from China, has been said to revolutionize burn management.\n Our study was conducted to compare MEBO with conventional management (C) with respect to the rate of wound healing, antibacterial and analgesic effect, and hospital costs.\n This is a prospective, randomized, controlled clinical trial conducted between 1 March 1997 and 24 October 1998.\n The trial was conducted in a specialized burn facility located in a tertiary referral hospital in a developed and industrialized island-state in Southeast Asia.\n We randomly assigned 115 consecutive patients between the ages of 12 and 80 who had partial-thickness thermal burns covering less than 40% of body surface area (BSA) to receive either MEBO or C. Fifty-seven patients were assigned to MEBO and 58 patients to C. The latter group received twice-daily dressing changes; MEBO patients received MEBO every 4 hours.\n Patients were hospitalized until 75% BSA had healed. BSA was determined by visual inspection and charted on Lund and Browder charts regularly. Wound healing rate, bacterial infection rate, pain score, and hospitalization costs were recorded.\n The median time to 75% healing was 17.0 and 20.0 days with MEBO and C, respectively (HR = 0.67, 95% CI = 0.41-1.11, P =.11), suggesting similar efficacy between the 2 modalities. Bacterial infection rates were similar between the 2 groups (HR = 1.10, 95% CI = 0.59-2.03, P =.76). MEBO imparted a greater analgesic effect in the first 5 days of therapy and reduced hospital costs by 8%.\n MEBO is as effective as conventional management but is not the panacea for all burn wounds. The use of MEBO eases the management of face and neck burns and facilitates early institution of occupational therapy in hand burns. It confers better pain relief such that fewer opiates are used during the first 5 days after burn injury." ]

[ "4982076", "2260182", "18205977", "2143854", "13465958", "9264751" ]

[ "Effect of improved sanitary facilities on infant diarrhea in a Hopi village.", "Reduction in diarrhoeal diseases in children in rural Bangladesh by environmental and behavioural modifications.", "Diarrhoea prevention in a high-risk rural Kenyan population through point-of-use chlorination, safe water storage, sanitation, and rainwater harvesting.", "The Imo State (Nigeria) Drinking Water Supply and Sanitation Project, 2. Impact on dracunculiasis, diarrhoea and nutritional status.", "Diarrheal disease control by improved human excreta disposal.", "[Effect of hygiene measures, water sanitation and oral rehydration therapy on diarrhea in children less than five years old in the south of Ivory Coast]." ]

[ "nan", "The impact of a water, sanitation and hygiene education intervention project on diarrhoeal morbidity in children under 5 years old was evaluated in a rural area of Bangladesh. Data were collected throughout 1984-1987, covering both pre- and post-intervention periods, from an intervention and a control area. The 2 areas were similar with respect to most socio-economic characteristics and baseline levels of diarrhoeal morbidity. The project showed a striking impact on the incidence of all cases of diarrhoea, including dysentery and persistent diarrhoea. By the end of the study period, children in the intervention area were experiencing 25% fewer episodes of diarrhoea than those in the control area. This impact was evident throughout the year, but particularly in the monsoon season, and in all age groups except those less than 6 months old. Within the intervention area, children from households living closer to handpumps or where better sanitation habits were practised experienced lower rates of diarrhoea. These results suggest that an integrated approach to environmental interventions can have a significant impact on diarrhoeal morbidity.", "Lack of access to safe water and sanitation contributes to diarrhoea moribidity and mortality in developing countries. We evaluated the impact of household water treatment, latrines, shallow wells, and rainwater harvesting on diarrhoea incidence in rural Kenyan children. We compared diarrhoea rates in 960 children aged <5 years in 556 households in 12 randomly selected intervention villages and six randomly selected comparison villages during weekly home visits over an 8-week period. On multivariate analysis, chlorinating stored water [relative risk (RR) 0.44, 95% confidence interval (CI) 0.28-0.69], latrine presence (RR 0.71, 95% CI 0.54-0.92), rainwater use (RR 0.70, 95% CI 0.52-0.95), and living in an intervention village (RR 0.31, 95% CI 0.23-0.41), were independently associated with lower diarrhoea risk. Diarrhoea risk was higher among shallow well users (RR 1.78, 95% CI 1.12-2.83). Chlorinating stored water, latrines, and rainwater use all decreased diarrhoea risk; combined interventions may have increased health impact.", "Morbidity due to dracunculiasis (guinea worm disease) and diarrhoea in persons of all ages, and nutritional status of young children, were used as health impact indicators in the evaluation of the Imo State Drinking Water Supply and Sanitation Project in south-eastern Nigeria. Data were collected using repeated cross-sectional surveys and longitudinal follow-up. The study area was found to have a low level of endemicity of dracunculiasis. While no impact could be demonstrated on overall period or point prevalence rates in the cross-sectional surveys, a prospective longitudinal survey showed a significant reduction in the percentage of person-fortnights positive for dracunculiasis in areas served by the project, while the control areas showed no such change. In the cross-sectional surveys it was found that, in the project villages, those persons drinking only borehole water had significantly lower period prevalence rates one year later than others. Moreover, those living further from the nearest borehole had higher rates of dracunculiasis. An impact of the project on diarrhoea morbidity was found only in limited sub-groups of the population. A greater association with water availability rather than quality was suggested for rates in young children. The prevalence of wasting (less than 80% weight-for-height) among children aged less than 3 years decreased significantly over time in all 3 intervention villages; there was no such decline in the control villages.", "nan", "The purpose is to assess the impact of compliance with measures of hygiene and water supply and oral rehydration on the diarrhoea with under 5 years of age in four villages of southern Côte d'Ivoire. The method used is to compare morbidity and mortality of children, firstly between two groups of villages without such measures, secondly in two villages before and after implementing them. Initially, an exhaustive survey has determined the incidence rate of diarrhoea, the proportion of deaths resulting from such diarrhoea as well as the mortality rate 1988. Two similar survey were made in 1990 and 1992. The results show a 50% reduction of the incidence rate of diarrhoea and a 85% reduction of the proportion of deaths related to diarrhoea in the villages with intervention. The mortality rate to diarrhoea was likewise reduced by 85%. These results show the importance of the improvement and accessibility to drinkable water and hygiene in the prevention of diarrhoea in areas children." ]

[ "12161042", "16257151", "12724018", "9464712", "16321485", "11379373", "12113884", "11907915", "11910617", "12738504", "15243277", "12851275", "11910671", "10914616", "15613422", "12218721", "16837885", "18257146", "16513301", "11910672", "11864664", "16373244", "12627040", "15917152", "12895690", "12851519" ]

[ "Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared with placebo.", "Randomized clinical trial comparing conjugated equine estrogens and isoflavones in postmenopausal women: a pilot study.", "Effects of genistein on the endometrium: ultrasonographic evaluation.", "The effect of dietary soy supplementation on hot flushes.", "A first prospective, randomized, double-blind, placebo-controlled study on the use of a standardized hop extract to alleviate menopausal discomforts.", "Effects on menopausal symptoms and acceptability of isoflavone-containing soy powder dietary supplementation.", "A pilot study of the effects of phytoestrogen supplementation on postmenopausal endometrium.", "Effects of dietary phytoestrogens in postmenopausal women.", "The effects of soy protein containing phytoestrogens on menopausal symptoms in postmenopausal women.", "Effect of soy-derived isoflavones on hot flushes, endometrial thickness, and the pulsatility index of the uterine and cerebral arteries.", "Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebo-controlled study.", "Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial.", "The effect of Promensil, an isoflavone extract, on menopausal symptoms.", "Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study.", "The effects of flaxseed dietary supplement on lipid profile, bone mineral density, and symptoms in menopausal women: a randomized, double-blind, wheat germ placebo-controlled clinical trial.", "Effects of a standardized soy extract on hot flushes: a multicenter, double-blind, randomized, placebo-controlled study.", "A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause.", "Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women.", "Effects of a red clover extract (MF11RCE) on endometrium and sex hormones in postmenopausal women.", "Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women.", "Benefits of soy isoflavone therapeutic regimen on menopausal symptoms.", "The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study.", "Soy protein and isoflavone effects on vasomotor symptoms in peri- and postmenopausal women: the Soy Estrogen Alternative Study.", "Polyunsaturated fatty acids (PUFAs) might reduce hot flushes: an indication from two controlled trials on soy isoflavones alone and with a PUFA supplement.", "Improved cognitive function in postmenopausal women after 12 weeks of consumption of a soya extract containing isoflavones.", "Comparison of Pueraria lobata with hormone replacement therapy in treating the adverse health consequences of menopause." ]

[ "To investigate the effectiveness and safety of a red clover isoflavone dietary supplement (Promensil, Novogen Ltd., Australia) versus placebo on the change in hot flush frequency in postmenopausal women.\n In this randomized, double blind, placebo-controlled trial 30 women with more than 12 months amenorrhoea and experiencing more than five flushes per day were enrolled. All received single blind placebo tablets for 4 weeks and were subsequently randomized to either placebo or 80 mg isoflavones for a further 12 weeks. Efficacy was measured by the decrease in number of hot flushes per day and changes in Greene Climacteric Scale Score.\n During the first 4 weeks of placebo the frequency of hot flushes decreased by 16%. During the subsequent double blind phase, a further, statistically significant decrease of 44% was seen in isoflavones group (P<0.01), whereas no further reduction occurred within the placebo group. The Greene score decreased in the active group by 13% and remained unchanged in the placebo group.\n In this study, treatment with 80 mg isoflavones (Promensil) per day resulted in a significant reduction in hot flushes from baseline. At the end of the study there was a significant decrease in hot flushes of 44% between the active and placebo group, demonstrating the effectiveness of Promensil in the management of hot flushes.", "The aim of this study was to evaluate the effects of isoflavone on the climacteric symptoms (Kupperman Menopausal index), vaginal pH, vaginal cytology (vaginal maturation index) and endometrium (evaluated by ultrasound and biopsy) in postmenopausal women.\n It was a single-center, 6-month, randomized, double-blind, estrogen-controlled trial. Seventy-nine women were randomly assigned to one of the two treatment groups: isoflavone (n=40): 300 mg of the standardized soy extract with a medium dose of 120 mg isoflavones/day as glycoside and aglycone (60 mg twice a day), or estrogen (n=39): one capsule of 0.625 mg conjugated equine estrogens and other capsule with glucose 0.625 mg (placebo).\n After treatment, there was a decrease in the symptomatology in both estrogen and isoflavone groups. There was a significant decrease in vaginal pH, an increase in superficial vaginal cells and endometrium proliferation after 3 and 6 months of treatment in the estrogen group, but no differences were observed in the isoflavone group for these variables.\n We concluded that the daily standardized soy extract with 120 mg isoflavones' effect on symptoms was similar to that from estrogen. Soy isoflavone has no effect on endometrium and vaginal mucosa during the treatment.", "The aim of our study was to evaluate the effects of isoflavones on climacteric-related symptoms and on the endometrium in postmenopausal women, in a prospective, open, randomized, clinical trial performed at the Menopause Clinic of our Department. Seventy postmenopausal women were randomly assigned to two treatment groups receiving 12 cycles of treatment with genistein (group A) or calcium (group B). In all patients ultrasonographic endometrial thickness and Kupperman Index (KI) were evaluated at baseline and after 6 and 12 cycles of treatment. At baseline no significant difference was detected in endometrial thickness and in KI between groups A and B. After 6 and 12 cycles of treatment, no significant difference was observed in endometrial thickness between or within groups. Endometrial thickness was lower than 5 mm in all cases before and during treatment except in two cases in group B and in one case in group A after 12 months. At 6 and 12 months, the KI was significantly (p < 0.05) lower in group A in comparison with baseline values and group B. We conclude that genistein administration reduces climacteric symptoms in postmenopausal women and does not increase endometrial thickness.", "To assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in postmenopausal women.\n We carried out a double-blind, parallel, multicenter, randomized placebo-controlled trial of 104 postmenopausal women. Fifty-one patients (age range 48-61 years) took 60 g of products containing 40 g of isolated soy protein [corrected] daily and 53 patients (age range 45-62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment.\n Soy was significantly superior to placebo (P < .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P < .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P < .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study: 11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group).\n Soy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.", "To examine the efficacy of a hop extract enriched in 8-prenylnaringenin (8-PN, the phytoestrogen in hops, Humulus lupulus L.) on relief of menopausal discomforts.\n A prospective, randomized, double-blind, placebo-controlled study over 12 weeks with 67 menopausal women, who were administered a hop extract standardized on 8-PN (100 or 250 microg). The responses were determined by means of a modified Kupperman index (KI) and a patients' questionnaire.\n All groups, including placebo, showed a significant reduction of the KI both after 6 weeks and after 12 weeks. The hop extract at 100 microg 8-PN was significantly superior to placebo after 6 weeks (P=0.023) but not after 12 weeks (P=0.086). No dose-response relationship could be established, as the higher dose (250 microg) was less active than the lower dose both after 6 weeks and after 12 weeks. Still, a trend for a more rapid decrease of KI was noticed for both active groups as compared to placebo. In particular, the decrease in hot flush score (isolated from the KI) was found significant for both treatment groups after 6 weeks (P<0.01) with respect to placebo. Results of the patients' questionnaire were consistent with those of the KI, with the most pronounced effects being observed for the 100-microg treatment.\n Daily intake of a hop extract, standardized on 8-PN as a potent phytoestrogen, exerted favorable effects on vasomotor symptoms and other menopausal discomforts. Hop-derived prenylated flavonoids may provide an attractive addition to the alternative treatments available for relief of hot flushes and other menopausal discomforts.", "To assess the acceptability of the delivery of an isoflavone supplementation in the form of a powdered drink, and whether the supplementation of dietary isoflavones in this manner decreased the incidence of menopausal flushes. The secondary aims included assessment of other symptoms or parameters of estrogen deficiency and responses to isoflavones.\n A randomized, double-blind, placebo-controlled, parallel-group trial comprising 24 postmenopausal women with symptoms of estrogen deficiency was performed over a 12-week period. The women were randomized to receive a dietary beverage containing isoflavones or an isoflavone-free, isocaloric placebo preparation.\n Although there was a high compliance rate among individual patients, there was a 25% withdrawal rate from the study in the active group. The incidence of complaints of bad taste tended to be higher in the active group (p = 0.07), and the total number of adverse events was significantly higher in this group (p < 0.001). There was no statistically significant difference in the incidence of flushes between the groups. There was no difference between the groups in Greene Menopause Symptom Scores, vaginal maturation value, levels of follicle stimulating hormone (FSH) or sex hormone-binding globulin (SHBG), or bone turnover markers.\n Powdered energy drinks are not commonly consumed in Australia and were poorly tolerated in this study. The high withdrawal rate and reporting of side-effects suggests that other methods of isoflavone delivery may be more appropriate in this culture, in future trials. At the dose used no benefit was seen in relief from menopausal symptoms, although for the sample size, the study could only have been expected to detect major differences between the groups.", "This study was designed to assess endometrial histology in postmenopausal women not taking hormone replacement therapy, to evaluate side effects and efficacy of phytoestrogens in treating menopause-associated symptoms, and to determine whether 6 months of phytoestrogen supplementation altered endometrial histology.\n We performed a prospective, double-blinded, randomized, placebo-controlled trial comparing the effects of 6 months of dietary phytoestrogen supplementation versus placebo in postmenopausal women. Baseline endometrial biopsies were performed and, if adequate, nonhyperplastic, noncancerous, and nonovulatory, subjects were randomly assigned to receive daily placebo or soy cereal supplementation for 6 months. Study subjects completed baseline and weekly dietary, symptom, and side effect logs. Repeat endometrial biopsies were obtained at 6 months.\n Subjects were recruited from January 1998 through June 2000. Twenty-seven subjects were randomized, and 19 completed the study. One (3.7%) baseline endometrial sample was weakly proliferative. All other baseline and final biopsies were consistent with atrophic, inactive endometrium. The maximum risk of endometrial stimulation with phytoestrogens is 35%. Hot flushes, night sweats, and vaginal dryness were significantly less severe at the final week of the study compared with baseline in the placebo group. Insomnia was more common in the treated group. There were no other statistically significant differences in symptoms or side effects.\n Phytoestrogens did not cause stimulation of the endometrium. Insomnia was more frequent over the 6-month study in the soy group, whereas hot flushes, night sweats, and vaginal dryness improved from baseline in the placebo group but not in the soy group.", "The aim of this study was to test the hypothesis that increased dietary intake of phytoestrogens reduces the health impact of the menopause. To test this hypothesis, a double-blind, randomized, entry-exit, cross-over study was conducted to assess the effects of three dietary manipulations--soy and linseed diets (high in phytoestrogens) and a wheat diet (low in phytoestrogens). Postmenopausal women were recruited and randomly assigned to one of the three dietary regimens. Urinary phytoestrogen concentrations, hot flush rate, vaginal smears, bone mineral density and bone mineral content were assessed for two 12-week periods. Comparative analysis showed no significant differences, but, when analyzed separately, groups consuming high phytoestrogen diets had between 10 and 30 times higher urinary excretion of phytoestrogens compared to those consuming the low phytoestrogen diet (p < 0.01). Study participants consuming soy, linseed and wheat diets had a 22% (not significant, n.s.), 41% (p < 0.009) and 51% (p < 0.001) reduction in hot flush rate; a 103% (p < 0.04), 5.5% (n.s.) and 11% (n.s.) increase in vaginal cytology maturation index; and a 5.2% (p < 0.04), 5.2% (n.s.) and 3.8% (n.s.) increase in bone mineral content, respectively. No changes were detected in bone mineral density. The differential effects of high phytoestrogen dietary manipulations on outcomes may represent tissue-specific responses to isoflavones and lignans contained in soy and linseed, respectively. Whilst health outcome measures were not significantly different between groups, the data obtained from separate analysis suggest that phytoestrogens in soy and linseed may be of use in ameliorating some of the symptoms of menopause. Furthermore, the significant decrease in hot flush rate in the wheat group cannot be attributable to phytoestrogens measured in this study. Due to subject variability, larger studies are still needed to evaluate population benefit.", "To analyze the impact of soy protein dietary supplements containing phytoestrogens on menopausal symptoms in healthy postmenopausal women.\n A double-blind, placebo-controlled trial was conducted in 94 healthy postmenopausal women aged 50-75 years, with 44 randomized to soy supplements containing 118 mg of isoflavones (daidzein, genistein, glycitein and their respective glycosides), and 50 to an identically presented casein placebo. A validated questionnaire on menopausal symptoms was administered at baseline and at 3 months of treatment. Compliance was assessed by high-performance liquid chromatography assay of urinary phytoestrogens. Statistical analysis was completed using non-parametric statistical methods and multivariate analysis.\n At baseline 80% of women recruited were experiencing menopausal symptoms, although symptom severity was mild. Those consuming phytoestrogen supplements had 13- and 17-fold increases in urinary excretion of genistein and daidzein, respectively, with no change in the placebo group. Active soy supplements did not significantly alter either individual symptoms or specific symptom category scores when compared to placebo. Within-group comparisons revealed that the active group reported a significant improvement in vaginal dryness (p = 0.01), libido (p = 0.009), facial hair (p = 0.04) and dry skin (p = 0.027). However, similarly, those on placebo reported an improvement in libido (p = 0.015), facial hair (p = 0.014) and dry skin (p = 0.011) but not vaginal dryness.\n In this group of 94 older postmenopausal women with a high frequency of mild menopausal symptoms, 3 months of soy supplements containing phytoestrogens did not provide symptomatic relief compared with placebo.", "To determine the effect of soy-derived isoflavones on hot flushes, endometrial thickness, and the vascular reactivity of uterine and cerebral arteries.\n Double-blind, randomized, placebo-controlled trial.\n Healthy volunteers in an academic research environment.\n Sixty-two postmenopausal women aged 45-60 years attending the Outpatient Menopause Clinic of our gynecological departments.\n The patients were administered 72 mg of soy-derived isoflavones or placebo under double-blind conditions. The daily number of hot flushes was recorded in a diary. Endometrial thickness was measured by means of transvaginal ultrasound; the uterine, internal carotid, and middle cerebral arteries were evaluated using Doppler ultrasound.\n The daily number of hot flushes, endometrial thickness, and arterial pulsatility index (PI).\n Both treatments led to a 40% reduction in the number of hot flushes. Soy-derived isoflavones had no effect on endometrial thickness or the PI of the uterine and cerebral arteries.\n The daily administration of 72 mg of soy-derived isoflavones is no more effective than placebo in reducing hot flushes in postmenopausal women. It also has no effect on endometrial thickness or the PI of the uterine and cerebral arteries.", "We evaluated and compared the effects of the phytoestrogen genistein, estrogen-progestogen therapy (EPT), and placebo on hot flushes and endometrial thickness in postmenopausal women.\n Ninety healthy, postmenopausal women, 47 to 57 years of age, were randomly assigned to receive for 1 year continuous EPT (n = 30; 1 mg 17beta-estradiol combined with 0.5 mg norethisterone acetate), the phytoestrogen genistein (n = 30; 54 mg/day), or placebo (n = 30). Endometrial safety was evaluated by intravaginal ultrasounds at baseline, 6 and 12 months.\n By comparison with placebo, daily flushes reduced significantly by a mean of 22% (95% CI: -38 to -6.2; P < 0.01) after 3 months, by a mean of 29% (95% CI: -45 to -13; P < 0.001) after 6 months, and by a mean of 24% (95% CI: -43 to -5; P < 0.01) after 12 months of genistein treatment. Flush score decreased by a mean of 53% (95% CI: -79 to -26; P < 0.001) after 3 months, by a mean of 56% (95% CI: -83 to -28; P < 0.001) after 6 months, and by a mean of 54% (95% CI: -74 to -33; P < 0.001) after 12 months of EPT, as compared with placebo. No side effect was observed on the uterus of the participants.\n The present study confirms that genistein might have positive effects on hot flushes without a negative impact on endometrial thickness and suggests a future role of this phytoestrogen as a strategically therapeutic alternative in the management of postmenopausal symptoms.", "Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have increased interest in other therapies for menopausal symptoms. Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies for hot flashes, but there is a paucity of data supporting their efficacy.\n To compare the efficacy and safety of 2 dietary supplements derived from red clover with placebo in symptomatic menopausal women.\n Randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week. The study was conducted between November 1999 and March 2001 at 3 US medical centers and included women who were recently postmenopausal (mean [SD], 3.3 [4.5] years since menopause) experiencing 8.1 hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week, or took medications affecting isoflavone absorption.\n After a 2-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day), or an identical placebo, and followed-up for 12 weeks.\n The primary outcome measure was the change in frequency of hot flashes measured by participant daily diaries. Secondary outcome measures included changes in quality of life and adverse events.\n Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil (5.1), Rimostil (5.4), and placebo (5.0) groups. In comparison with the placebo group, participants in the Promensil group (41%; 95% confidence interval [CI], 29%-51%; P =.03), but not in the Rimostil group (34%; 95% CI, 22%-46%; P =.74) reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the 3 groups.\n Although the study provides some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause.", "The primary aim was to assess whether the use of an isoflavone extract containing 40 mg or 160 mg of total isoflavones affects the frequency of menopausal flushes and other symptoms. The secondary aims were assessments of possible effects on menopause symptom scores and biological measures of estrogen activity.\n A randomized, double-blind, placebo-controlled prospective trial of 37 postmenopausal women with symptoms of estrogen deficiency was performed over a 12-week period. The women were randomized to three treatment groups: placebo, 40 mg or 160 mg, delivered in tablet form.\n There was no significant difference in the incidence of flushes between the three groups at trial conclusion. There was no difference between the groups in Greene Menopause Symptom Scores, vaginal pH, levels of follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG) or total cholesterol, liver function or blood parameters. A statistically significant increase in high-density lipoprotein (HDL) cholesterol of 18.1% (p = 0.038) occurred in the 40-mg group.\n A large placebo response and inadvertent use of dietary isoflavones in the placebo group may have obscured a significant change in flushing frequency. Previous uncontrolled studies claiming a beneficial effect of foods with a high isoflavone content on menopausal symptoms may have been confounded by a large placebo response.", "To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes.\n This was a double-blind, randomized, parallel group, outpatient, multicenter (15 sites) study. A total of 177 postmenopausal women (mean age = 55 years) who were experiencing five or more hot flushes per day were randomized to receive either soy isoflavone extract (total of 50 mg genistin and daidzin per day) or placebo. Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion. Body weight, symptoms, and safety were evaluated at all visits.\n Relief of vasomotor symptoms was observed in both groups. Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group, whereas the placebo group experienced no relief for the first 4 weeks. Differences between evaluable subjects in both groups were statistically significant over 6 weeks (p = 0.03). Over 12 weeks, between-group differences approached significance (p = 0.08). Endometrial thickness evaluated by ultrasound, lipoproteins, bone markers, sex hormone-binding globulin and follicle-stimulating hormone, and vaginal cytology did not change in either group.\n Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium. Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes.", "Phytoestrogens are increasingly incorporated into the diet of menopausal women. However, there are limited data on the efficacy of flaxseed on the consequences of estrogen deficiency in menopausal women. The purpose of the study was to assess the effects of flaxseed incorporation into the diet of healthy menopausal women. One hundred and ninety-nine menopausal women were randomly assigned to consume 40 g flaxseed/d (n = 101) or wheat germ placebo (n = 98) for 12 months. At baseline and at month 12, serum levels of lipids, bone mineral density (BMD), and menopausal symptoms were evaluated. Statistical analysis was performed under the intention to treat principle. Flaxseed reduced serum total (-0.20 +/- 0.51 mmol/liter; P = 0.012) and high-density lipoprotein (-0.08 +/- 0.24 mmol/liter; P = 0.031) cholesterol concentrations compared with wheat germ placebo. BMD did not differ significantly between the two arms. Both flaxseed and wheat germ reduced (P < 0.0001) the severity scores of menopausal symptoms, but no statistical difference was found between the two arms. Our findings suggest that 1-yr incorporation of flaxseed into the diet produced a favorable, but not clinically significant, effect on blood cholesterol and caused no significant change in BMD or symptoms in healthy menopausal women.", "To investigate the effect of an oral soy isoflavone extract (Phytosoya) on hot flushes in menopausal women.\n The study was conducted on outpatients according to a multicenter, randomized, double-blind, placebo-controlled, parallel-group design. A total of 75 patients in natural or surgical menopause suffering from at least seven hot flushes per day were randomized to receive during 4 months either soy isoflavone extract (total of 70 mg genistin and daidzin per day) or placebo.\n There is evidence to suggest that 16 weeks of treatment with soy extract can help reduce the mean number of hot flushes per 24 hours in menopausal women. Withdrawals during this trial made it difficult to obtain an unbiased estimate of the true treatment effect, but numerous sensitivity analyses lend support to the suggestion that taking soy extract can be beneficial in the treatment of hot flushes. In particular, women taking soy extract had a 38% reduction in the mean number of hot flushes by week 4 and a 51% reduction by week 8. By the end of week 16, patients taking soy extract had a 61% reduction in their daily hot flushes versus a 21% reduction obtained with the placebo. \"Responders\" (defined as patients whose hot flushes were reduced by at least 50% at the end of treatment period) were 65.8% in the soy extract group and 34.2% in the placebo group ( < 0.005).\n Soy isoflavone extract may help to reduce the frequency of hot flushes in climacteric women and provides an attractive addition to the choices available for relief of hot flushes.", "To compare the effects of daily ingestion of soy flour (S), ground flaxseed (F), or wheat flour (W) muffins, on quality of life and hot flash frequency and severity in postmenopausal women.\n This was a double-blind, randomized, controlled, intention-to-treat trial. Ninety-nine women, 1 to 8 years after menopause, ingested muffins with 25 g of flaxseed (50 mg of lignans), 25 g of soy (42 mg of isoflavones), or wheat (control) daily for 16 weeks. Subjects completed the Menopause-specific Quality of Life instrument monthly along with daily hot flash frequency and severity diaries. Compliance measures included a 3-day food diary and urinary isoflavone and lignan analyses at weeks 0 and 16 and returned muffin counts monthly.\n Eighty-seven women (28, ground flaxseed muffins; 31, soy flour muffins; and 28, wheat flour muffins) completed the trial. Multivariate analysis of variance of all quality-of-life domains yielded an insignificant treatment x time interaction (F46,122 = 0.92, P = 0.62) but a significant time main effect (P <.0001). Repeated-measures analyses of covariance controlling for body mass index showed no significant group x time interaction nor time nor group differences on all quality-of-life domains and hot flash measures except severity. Hot flashes were less severe with flaxseed (P = 0.001) compared to placebo; however, the group x by time interaction was not significant. Phytoestrogen excretion analysis showed treatment group exposure as allocated and no contamination.\n Neither dietary flaxseed nor soy flour significantly affected menopause-specific quality of life or hot flash symptoms in this study.", "The aim of this study was to determine the effect of DRIs on hot flash symptoms in menopausal women.\n This was a randomized, double-blind, placebo-controlled trial of menopausal women, aged 38 to 60 years, who experienced 4 to 14 hot flashes per day. After a 1-week run-in period, a total of 190 menopausal women were randomized to receive a placebo or 40 or 60 mg/day of a DRI for 12 weeks. The primary outcome was the mean changes from baseline to week 12 in the frequency of hot flashes recorded in the participant diary. The secondary outcomes included changes in quality of life and hormonal profiles.\n A total of 147 women (77%) completed the study. It was found that 40 and 60 mg of DRI improved hot flash frequency and severity equally. At 8 weeks hot flash frequency was reduced by 43% in the 40-mg DRI group and by 41% in the 60-mg DRI group, compared with 32% in the placebo group (P = not significant vs placebo). The corresponding numbers for 12 weeks were 52%, 51%, and 39%, respectively (P = 0.07 and 0.09 vs placebo). When comparing the two treatment groups with the placebo group, there were significant reductions in mean daily hot flash frequency. The supplement (either 40 or 60 mg) reduced hot flash frequency by 43% at 8 weeks (P = 0.1) and 52% at 12 weeks (P = 0.048) but did not cause any significant changes in endogenous sex hormones or thyroid hormones. Menopausal quality of life improved in all three groups, although there were no statistically significant differences between groups.\n DRI supplementation may be an effective and acceptable alternative to hormone treatment for menopausal hot flashes.", "To evaluate the effects of a non-prescription red clover extract (MF11 RCE, Melbrosin International, Vienna, Austria) on selected sex hormones and endometrium in postmenopausal women.\n One-hundred and nine postmenopausal women with an age > or =40 years were randomly assigned to one of two groups either two capsules of MF11RCE (80mg isoflavone) per day for a 90 day period, or placebo of equal design. After a 7 day washout period, medication was crossed-over for another 90 days.\n Combined evaluation demonstrated that supplementation with MF11RCE (verum), in contrast to placebo, significantly increased plasma testosterone levels and decreased endometrial thickness.\n MF11RCE exerts a moderate effect on testosterone levels in postmenopausal women, while estradiol levels remained unchanged. The observed reduction of endometrial thickness provides further support for a safe role for isoflavones in terms of endometrial hyperplasia.", "To test the hypothesis that increasing the intake of isoflavones by dietary supplementation may produce a therapeutic effect in reducing the incidence and severity of hot flushes in menopausal women.\n Fifty-one postmenopausal women were randomized to placebo and active (one tablet per day of a 40-mg isoflavone supplement) groups in a cross-over design trial. After a 1-week run-in period, subjects were commenced on a 12-week period of treatment (active or placebo), followed by a 1-month placebo wash-out period, then crossed over to the alternative treatment regimen for a further 14 weeks. Symptom diaries were maintained throughout the trial and at the start and end of treatment. Plasma sex hormone binding globulin (SHBG) assay, full blood count, biochemical profiles, vaginal swabs and vaginal ultrasound scans were performed and isoflavones determined in 24-h urine collections by high-pressure liquid chromatography (HPLC) analysis.\n There was no significant difference between active and placebo groups in the reduction in hot flushes between start and finish time-points. Analysis performed on interim data time-points revealed a substantially greater reduction in flushing in the active group than placebo at 4 and 8 weeks after commencement of treatment, but this was not statistically significant. There were no significant differences between groups for Greene scores or in SHBG levels, hematological or biochemical parameters and vaginal swab or ultrasound findings. The combined values for all subjects, regardless of treatment group, revealed a strong negative correlation between the level of urinary isoflavone excretion and the incidence of hot flushes.\n These data do not indicate a therapeutic benefit from dietary supplementation with isoflavones in women experiencing menopausal symptoms, but do indicate that the apparent placebo effect in many studies of menopausal symptoms may be attributable to dietary sources of isoflavones. The study also demonstrates that 3 months of isoflavone supplementation did not cause adverse events or endometrial changes.", "To examine the change in menopausal symptoms and cardiovascular risk factors in response to 4 months of daily 100-mg soy isoflavone in postmenopausal women.\n In this double-blind, placebo-controlled study, 80 women were randomly assigned to isoflavone (n = 40) and placebo (n = 40) treatment. The menopausal Kupperman index was used to assess change in menopausal symptoms at baseline and after 4 months of treatment. Cardiovascular risk factors were assessed by evaluating plasma lipid levels, body mass index, blood pressure, and glucose levels in the participants. To examine the effects of this regime on endogenous hormone levels, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and 17 beta-estradiol were measured. Transvaginal sonography was performed to quantify endometrial thickness.\n The data showed a decrease in menopausal symptoms (P <.01, paired t test, two-tailed, between baseline and isoflavone groups, and P <.01, unpaired t test, between placebo and isoflavone groups). Total cholesterol and low-density lipoprotein decreased significantly in the isoflavone group compared with the baseline or placebo group (P <.001, paired t test, two-tailed, between baseline and isoflavone groups, and P <.01, unpaired t test, between placebo and isoflavone groups). The isoflavone treatment appeared to have no effect on blood pressure, plasma glucose, and high-density lipoprotein and triglyceride levels.\n This study suggests that isoflavone 100-mg regime treatment may be a safe and effective alternative therapy for menopausal symptoms and may offer a benefit to the cardiovascular system.", "Background: The unexpected results of the Women's Health Initiative study have decreased the use of conventional hormone therapy (HT), changing physicians' and patients' attitudes towards HT and increasing their interest in alternative options.\n The present study aimed to evaluate the effect of isoflavones contained in red clover extracts (Trifolium pratense) on menopausal symptoms, lipids and vaginal cytology in menopausal women.\n Sixty postmenopausal women aged >40 years, non-users of HT, with Kupperman index score 15, were double-blindly randomized to receive either a commercially available red clover isoflavone supplement (80 mg/day) or placebo for 90 days. Subsequently, after a 7-day washout period, subjects switched to receive the opposite treatment for a further 90 days. Kupperman index score was determined and fasting blood and vaginal cytologic sampling performed at baseline, 90 and 180 days.\n Fifty-three women (88.3%) completed the trial. Mean age was 51.3 +/- 3.5 years, 69.7% of the women were aged 50 years or more. There was no significant effect on body mass index, weight or blood pressure after either treatment phase. Baseline Kupperman index score decreased significantly after each treatment phase, with the decrease more pronounced after the isoflavone phase (baseline: 27.2 +/- 7.7; after isoflavone: 5.9 +/- 3.9; after placebo: 20.9 +/- 5.3, p < 0.05). Red clover isoflavone supplementation significantly decreased the rate of menopausal symptoms and had a positive effect on vaginal cytology as expressed by improvement in karyopyknotic, cornification and basal cell maturation indices. Mean total cholesterol, low-density lipoprotein-cholesterol and triglyceride levels also decreased; however, only the latter was significantly lower compared with placebo.\n Compared with placebo, red clover isoflavone supplementation in postmenopausal women significantly decreased menopausal symptoms and had a positive effect on vaginal cytology and triglyceride levels.", "To investigate the efficacy of dietary soy proteins containing differing amounts of isoflavones on the number and severity of vasomotor symptoms (hot flashes and night sweats) in peri- and postmenopausal women.\n A double-masked, randomized, controlled, clinical trial was conducted. A total of 241 community-dwelling women reporting vasomotor symptoms at baseline were randomized into one of three groups. In all groups, participants consumed a daily supplement containing 25 g of soy protein and were randomly assigned to one of three groups: (a) isoflavone extracted soy protein (control), (b) soy protein with a medium dose of isoflavones (42 mg/day), or (c) soy protein with a higher dose of isoflavones (58 mg/day). The primary outcome measure in this trial was change in reported vasomotor symptoms.\n A reduction in the number and severity of vasomotor symptoms was observed in all three treatment groups. No significant differences in the number and severity of vasomotor symptoms were observed among the high isoflavone, middle isoflavone, or control groups. The lack of a between-treatment group effect was observed even after stratified by number of baseline symptoms and use of traditional hormone replacement therapy.\n These data suggest that soy protein containing 42 or 58 mg of isoflavones is no more effective than isoflavone-extracted soy protein for improving the number and severity of vasomotor symptoms in peri- and postmenopausal women.", "To investigate the effect on hot flushes of a soy isoflavone extract alone (Study A) and with the addition of a supplement of polyunsaturated fatty acids, PUFAs (Study B).\n Subjects were postmenopausal women (29 in Study A, 28 in Study B) with more than five troublesome hot flushes per day. Both studies were double-blind randomized placebo-controlled trials with cross-over design, of 24-week duration. After a 2-week observation period, they were randomized to receive two capsules per day providing 60mg of isoflavones or placebo for 12 weeks; thereafter, women who had taken isoflavones were given placebo for a second 12-week period, and vice-versa. Women in the Study B were given also two capsules per day containing a PUFA supplement for the entire 24-week test period.\n Both studies showed the isoflavone extract to have no greater efficacy on hot flushes than the placebo. During the 24 weeks of the Study B there was a progressive and highly significant reduction in the number of hot flushes, independent of whether the women had begun with isoflavones or with placebo.\n In these two trials the isoflavone extract did not show greater efficacy on the hot flushes than the placebo. The reduction of hot flushes observed in the Study B might be due to the PUFA supplement. PUFAs, particularly Omega (Omega) 3-fatty acids, could reduce hot flushes through their influence on neuronal membranes and/or the modulation of the neurotransmitter function and the serotoninergic system. Studies specifically designed to document the action of PUFAs on hot flushes would be welcome.", "We previously reported that a high soya diet improved memory and frontal lobe function in young volunteers, and since soya isoflavones are agonists at oestrogen receptors, they may improve these functions in postmenopausal women. Thirty-three postmenopausal women (50-65 years) not receiving conventional hormone replacement therapy (HRT) were randomly allocated in a double-blind parallel study to receive a soya supplement (60 mg total isoflavone equivalents/day) or placebo for 12 weeks. They received a battery of cognitive tests and completed analogue rating scales of mood and sleepiness, and a menopausal symptoms questionnaire before the start of treatment and then after 12 weeks of treatment. Those receiving the isoflavone supplement showed significantly greater improvements in recall of pictures and in a sustained attention task. The groups did not differ in their ability to learn rules, but the isoflavone supplement group showed significantly greater improvements in learning rule reversals. They also showed significantly greater improvement in a planning task. There was no effect of treatment on menopausal symptoms, self-ratings of mood, bodily symptoms or sleepiness. Thus, significant cognitive improvements in postmenopausal women can be gained from 12 weeks of consumption of a supplement containing soya isoflavones that are independent of any changes in menopausal symptoms, mood or sleepiness.", "Pueraria lobata (PL) is used as a traditional Chinese herbal remedy for menopausal symptoms, as well as an ingredient in preparations for conditions affecting menopausal women, such as osteoporosis, coronary heart disease, and some hormone-dependent cancers. The scientific basis for its action may be its action as a phytoestrogen.\n To examine the effects of PL in comparison with hormone replacement therapy (HRT) on lipid profile, sex hormone levels, bone turnover markers, and indices of cognitive function. For the study, 127 community-living, postmenopausal women aged 50 to 65 years were randomized to receive HRT (n = 43), PL (equivalent to 100 mg isoflavone; n = 45), or no treatment (n = 39) for 3 months. The following measurements were carried out at baseline and after 3 months for all participants: menopausal symptoms questionnaire; neuropsychological tests covering memory, attention, motor speed, and word-finding ability; quality of life (SF36); lipid profile; urinary deoxypyridinoline; dietary phytoestrogen intake and urinary phytoestrogen; estradiol; follicle-stimulating hormone; and luteinizing hormone.\n Only participants in the HRT group showed a mean reduction in cholesterol and low-density lipoprotein cholesterol that was significantly different from that of the control group. No significant changes in lipid profile or follicle-stimulating hormone and luteinizing hormone were observed in the PL group compared with the controls. However, both the HRT and PL groups showed an improvement in Mini-Mental State Examination score and attention span compared with the case of participants receiving no treatment. HRT and PL had different effects on cognitive function; HRT improved delayed recall, whereas flexible thinking seemed improved in the PL group.\n This study was unable to demonstrate a scientific basis for the use of PL for improving the health of postmenopausal women in general. However, the effect of PL on cognitive function deserves further study." ]

[ "2107056", "11849631", "22678035", "9071516", "19442776", "8536454", "8585885", "15451329", "22067763" ]

[ "Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. III. The relationship between pregnancy rate and body weight. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation.", "Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data.", "Contraceptive failure rates of etonogestrel subdermal implants in overweight and obese women.", "Levonorgestrel concentrations during use of levonorgestrel rod (LNG ROD) implants.", "Association between efficacy and body weight or body mass index for two low-dose oral contraceptives.", "Effectiveness of Norplant implants through seven years: a large-scale study in China.", "Pre-introductory clinical trials of Norplant implants: a comparison of seventeen countries' experience.", "Contraceptive efficacy and safety of DMPA-SC.", "Body weight does not impact pregnancy rates during use of a low-dose extended-regimen 91-day oral contraceptive." ]

[ "This paper investigates the relationship between pregnancy rates and body weight of 1005 women using a vaginal ring releasing 20 micrograms levonorgestrel per 24 hours. While the overall pregnancy rate at one year was 3.7%, it was found that women have an increasing risk of pregnancy with increasing body weight. For example, a woman of 40 kg has an estimated pregnancy rate of 1.7% in contrast to 9.8% for a woman of 80 kg weight.", "To present efficacy and cycle control data pooled from three pivotal studies of the contraceptive patch (Ortho Evra/Evra).\n Three multicenter, open-label, contraceptive studies that included up to 13 treatment cycles.Setting: 183 centers.\n 3,319 women.Intervention(s): Three consecutive 7-day patches (21 days) with 1 patch-free week per cycle.\n Contraceptive efficacy and cycle control.\n Overall and method failure life-table estimates of contraceptive failure through 13 cycles were 0.8% (95% CI, 0.3%-1.3%) and 0.6% (95% CI, 0.2%-0.9%), respectively. Corresponding Pearl indices were 0.88 (95% CI, 0.44-1.33) and 0.7 (95% CI, 0.31-1.10). Contraceptive failure among women with a body weight < 90 kg (<198 lb) was low and uniformly distributed across the weight range. A subgroup of women with body weight > or = 90 kg (> or = 198 lb) may have increased risk of pregnancy. The incidence of breakthrough bleeding was low and decreased over time.\n In contraceptive patch users, the overall annual probability of pregnancy was 0.8% and the method failure probability was 0.6%. The efficacy of the patch was high and similar across age and racial groups. Among women < 90 kg (<198 lb), contraceptive failure was low and uniformly distributed across the range of body weights. In women > or = 90 kg (> or = 198 lb), contraceptive failures may be increased. Efficacy and cycle control have been shown to be comparable to an established oral contraceptive.", "To estimate the contraceptive failure rates of the etonogestrel subdermal contraceptive implant in overweight and obese women and compare failure rates with women of normal weight and women using intrauterine devices (IUDs).\n The Contraceptive CHOICE Project is a large prospective cohort study designed to promote the use of long-acting reversible contraceptive methods to reduce unintended pregnancies in the St Louis region. Participants are provided reversible contraception of their choice at no cost. We collected baseline height and weight of each participant. During each survey, participants were asked about missed menses and possible pregnancies. Any participant who suspected a pregnancy was asked to come in for urine pregnancy testing. Analysis includes the first 8,445 participants enrolled in CHOICE of which 1,168 chose the implant and 4,200 chose the IUD. Student's t test, χ test, and Kaplan-Meier survival curves were used to perform statistical analyses to estimate failure rates in overweight and obese women using the implant and IUDs.\n Of the women choosing the implant, 28% were overweight and 35% were obese. Of the women who chose an IUD, 27% were overweight and 35% were obese. The 3-year cumulative failure rates for implant and IUD users were less than one per 100 women-years and did not vary by body mass index.\n We found no decrease in the effectiveness of the implant in overweight or obese women. The implant may be offered as a first-line contraceptive method to any woman seeking a reversible and reliable birth control method.", "In a three-year randomized trial that included 398 women, blood samples were collected for the purpose of assaying levonorgestrel concentrations in women using a new two-rod contraceptive implant system or an earlier implant formulation, Norplant-2 implants. Sample collection was at 1, 3, 6, 9, and 12 months after placement and semiannually thereafter through three years. Resulting assays and analyses showed that levonorgestrel concentrations of each implant formulation decreased significantly with time after placement, with increasing body weight, and with ponderal index. In the third year, several measures indicated that concentrations of the contraceptive drug were higher in women using the LNG ROD implants than in users of the original formulation. No pregnancies occurred among women in either group in the three years. This study provides evidence that the minimum levonorgestrel concentration needed to protect against pregnancy is below 200 pg/ml, and possibly is below 175 pg/ml.", "This analysis investigated the association of oral contraceptive efficacy with body weight and body mass index (BMI) for hypothesis-generating purposes.\n Data were from a randomized, parallel-group trial of 180/215/250 mcg of norgestimate (NGM)/25 mcg of ethinyl estradiol (EE) (given to 1671 women) and 1 mg of norethindrone acetate (NETA)/20 mcg of EE (given to 1139 women). Pregnancies were evaluated across BMI deciles and by BMI and body weight dichotomies. A Pearl index was calculated for each treatment group. The relative risk (RR) of pregnancy was calculated with a Cox proportional hazards model.\n The Pearl index for women who received NGM/EE was 2.36 [95% confidence interval (CI)=1.33-3.40]; for those who received NETA/EE, the Pearl index was 3.29 (95% CI=1.81-4.77). Consistent, weak positive associations between weight and pregnancy risk were found. Overall, for women with a BMI >or=25 kg/m(2) (compared with women with a BMI <25 kg/m(2)), the RR of pregnancy was 1.84 (95% CI=0.98-3.45); that for women who received NGM/EE was 1.39 (95% CI=0.57-3.40), whereas that for women who received NETA/EE was 2.49 (95% CI=1.01-6.13). For women with a body weight >or=70 kg (compared with women with a body weight <70 kg), the RR was 1.25 (95% CI=0.63-2.46); that for women who received NGM/EE was 1.41 (95% CI=0.56-3.54), whereas that for women who received NETA/EE was 1.12 (95% CI=0.40-3.12).\n Women in the higher body weight or BMI category showed a small increase in the risk of pregnancy with these oral contraceptives, but this increase was not statistically significant overall or for either formulation studied.", "The effectiveness of Norplant implants over a seven year period of continuous use was studied in a multicenter trial. Pregnancy rates were 0.4 per 100 in both year six and year seven. More than 3,600 women completed 6 years and more than 2,400 women completed 7 years. Pregnancy rates increased with weight (p < .05) and decreased with age, but in years 6 and 7 combined, the pregnancy rate neither reached nor exceeded 1 per 100 woman years in any 5 year age group or in any 10 kg weight group.", "This report summarizes the data collected in pre-introductory Norplant implants clinical trials in 17 countries in Latin America, Asia and Africa that were coordinated by either the Population Council or Family Health International (FHI) between 1984 and 1991. A total of 16,282 women between the ages of 18 and 40 years participated in the studies with semi-annual or annual follow-up visits for up to 5 years. Gross cumulative pregnancy rates were < 0.6 per 100 women in the first year and < 1.5 in the second year in all countries. Significant differences in cumulative 5-year pregnancy rates were observed between weight groups 40-49 and 50-59 kg and between 50-59 and 60-69 kg body weight but not between 60-69 kg and those > or = 70 kg. Total cumulative discontinuation rates after five years of Norplant implants use ranged from 35.8 to 60.0 per 100 women. Younger age and low parity were associated with a higher discontinuation rate. Cumulative discontinuation rates for menstrual reasons more than doubled between the end of the first year and second year of use in 13 of 17 countries. This analysis and one previous review provide the only comparison of Norplant contraceptive system study results across a wide diversity of countries; thus allowing an appreciation of the range of clinical experience with Norplant implants and the regional differences in that experience.", "DMPA-SC 104 mg/0.65 mL is a new, low-dose subcutaneous (SC) formulation of Depo-Provera contraceptive injection (150 mg/mL medroxyprogesterone acetate injectable suspension) that provides efficacy, safety and immediacy of onset equivalent to Depo-Provera intramuscular (IM) injection. Two large, open-label, Phase 3 studies assessed the 1-year contraceptive efficacy, safety and patient satisfaction with DMPA-SC administered every 3 months (12-13 weeks). Zero pregnancies were reported in both studies, which included a total of 16,023 woman-cycles of exposure to DMPA-SC and substantial numbers of overweight or obese women. DMPA-SC was well-tolerated and adverse events were similar to those reported previously with Depo-Provera IM. Thus, DMPA-SC offers women a new, highly effective and convenient long-acting contraceptive option.\n Copyright 2004 Elsevier Inc.", "This study evaluated the impact of weight on efficacy during use of an extended oral contraceptive (OC).\n Data were from a Phase 3 clinical trial evaluating the efficacy of a low-dose 91-day extended regimen of 100 mcg levonorgestrel/20 mcg ethinyl estradiol (LNG/EE; 84 days)+10 mcg EE (7 days) for the prevention of pregnancy. Crude pregnancy rates were calculated for weight and body mass index (BMI) deciles.\n Of the 1736 women in this analysis, 878 (50.6%) had a BMI greater than 25 kg/m2, and 770 (44.4%) were heavier than 70 kg. Pregnancies occurred in 36 women. Crude pregnancy rates were similar across weight and BMI deciles, with no discernable differences observed between deciles using either classification criterion.\n No evidence of any reduction in the level of contraceptive efficacy was observed with this low-dose extended OC regimen in overweight and obese women.\n Copyright © 2012. Published by Elsevier Inc." ]

[ "7589382", "14684561", "7503821", "11684212", "12746252", "8317790", "8874241", "8100928", "8665055", "11743506", "8564129" ]

[ "Recombinant human DNase I in cystic fibrosis patients with severe pulmonary disease: a short-term, double-blind study followed by six months open-label treatment.", "Effect of treatment with dornase alpha on airway inflammation in patients with cystic fibrosis.", "Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group.", "Comparison of hypertonic saline and alternate-day or daily recombinant human deoxyribonuclease in children with cystic fibrosis: a randomised trial.", "Composite spirometric-computed tomography outcome measure in early cystic fibrosis lung disease.", "Efficacy and safety of short-term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis.", "Effects of 12-week administration of dornase alfa in patients with advanced cystic fibrosis lung disease. Pulmozyme Study Group.", "Efficacy and safety of short-term administration of aerosolised recombinant human DNase I in adults with stable stage cystic fibrosis.", "Aerosolized recombinant human DNase in hospitalized cystic fibrosis patients with acute pulmonary exacerbations.", "A two-year randomized, placebo-controlled trial of dornase alfa in young patients with cystic fibrosis with mild lung function abnormalities.", "Effect of rhDNase on airflow obstruction and mucociliary clearance in cystic fibrosis." ]

[ "Chronic pulmonary infection is the major cause of morbidity and mortality in cystic fibrosis (CF). Recombinant human deoxyribonuclease (rhDNase) in vitro has been shown to dramatically reduce the viscoelasticity of the sputum from CF patients. Phase II and III clinical trials have shown the drug to be safe, and that patients with a forced vital capacity (FVC) of > 40% predicted show an improvement in pulmonary function when receiving rhDNase. The current study evaluates the safety and efficacy of rhDNase in the most severly ill CF patients (FVC < 40% predicted). A double-blind, randomized, placebo-controlled trial in which patients received either 2.5 mg rhDNase twice daily or placebo for a period of 14 days followed by a 6 month open extension period (OEP) is reported. Seventy patients were recruited for the double-blind study, and 64 entered the OEP of whom 38 completed. During the OEP, all patients received 2.5 mg rhDNase twice daily. In both the double-blind period and the OEP the drug appeared to be safe. During the double-blind study, forced expiratory volume in one second (FEV1) and FVC improved in both groups but there was no statistically significant difference between the groups. In the OEP, there was mean improvement in percentage predicted FEV1 and FVC, 9 and 18%, respectively, for all patients participating. In conclusion, DNase is safe when administered in conjunction with a rigorous regimen of chest physiotherapy to severely ill patients (FVC < 40% predicted) with CF. The double-blind, 14 day study showed no significant improvement in pulmonary function but some patients may have improved after longer administration of rhDNase.", "Recombinant human deoxyribonuclease (rhDNase) has been shown to improve lung function and reduce the number of pulmonary exacerbations in patients with cystic fibrosis (CF), but its long-term effect on airway inflammation remains unknown. In this study, we used bronchoalveolar lavage (BAL) to investigate the long-term effect of rhDNase on inflammation in patients with CF having mild lung disease. A total of 105 patients with CF (> or =5 years of age) having normal lung function were randomized to receive rhDNase (2.5 mg/day) or no rhDNase. Patients with a normal percentage of neutrophils in BAL fluid at baseline were not randomized and served as the control group. The percentage of neutrophils in the pooled BAL sample was similar in both randomized groups at baseline. A significant increase in neutrophils was observed over the 3-year study period in both untreated patients and control subjects, whereas neutrophils remained unchanged in patients treated with rhDNase. Elastase activities and interleukin-8 concentrations also increased in untreated patients and remained stable in patients on rhDNase. We conclude that in patients with CF, an increase in neutrophilic airway inflammation is found that is positively influenced by rhDNase treatment.", "Respiratory disease in patients with cystic fibrosis is characterized by airway obstruction caused by the accumulation of thick, purulent secretions, which results in recurrent, symptomatic exacerbations. The viscoelasticity of the secretions can be reduced in vitro by recombinant human deoxyribonuclease I (rhDNase), a bioengineered copy of the human enzyme.\n We performed a randomized, double-blind, placebo-controlled study to determine the effects of once-daily and twice-daily administration of rhDNase on exacerbations of respiratory symptoms requiring parenteral antibiotics and on pulmonary function. A total of 968 adults and children with cystic fibrosis were treated for 24 weeks as outpatients.\n One or more exacerbations occurred in 27 percent of the patients given placebo, 22 percent of those treated with rhDNase once daily, and 19 percent of those treated with rhDNase twice daily. As compared with placebo, the administration of rhDNase once daily and twice daily reduced the age-adjusted risk of respiratory exacerbations by 28 percent (P = 0.04) and 37 percent (P < 0.01), respectively. The administration of rhDNase once daily and twice daily improved forced expiratory volume in one second during the study by a mean (+/- SD) of 5.8 +/- 0.7 and 5.6 +/- 0.7 percent, respectively. None of the patients had anaphylaxis. Voice alteration and laryngitis were more frequent in the rhDNase-treated patients than in those receiving placebo but were rarely severe and resolved within 21 days of onset.\n In patients with cystic fibrosis, the administration of rhDNase reduced but did not eliminate exacerbations of respiratory symptoms, resulted in slight improvement in pulmonary function, and was well tolerated.", "Daily recombinant human deoxyribonuclease (rhDNase) is an established but expensive treatment in cystic fibrosis. Alternate-day treatment, if equally effective, would reduce the drug cost. Hypertonic saline improved lung function to the same degree as rhDNase in short-term studies. We compared the effectiveness of daily rhDNase, hypertonic saline, and alternate-day rhDNase in children with cystic fibrosis.\n In an open cross-over trial, 48 children were allocated in random order to 12 weeks of once-daily rhDNase (2.5 mg), alternate-day rhDNase (2.5 mg), and twice-daily 5 mL 7% hypertonic saline. The primary outcome was forced expiratory volume in 1 s (FEV(1)). Secondary outcomes were forced vital capacity, number of pulmonary exacerbations, weight gain, quality of life, exercise tolerance, and the total costs of hospital and community care.\n Mean FEV(1) increased by 16% (SD 25%), 14% (22%), and 3% (21%) with daily rhDNase, alternate-day rhDNase, and hypertonic saline, respectively. There was no difference between daily and alternate-day rhDNase (2% [95% CI -4 to 9], p=0.55). However, daily rhDNase showed a significantly greater increase in FEV(1) than hypertonic saline (8% [2 to 14], p=0.01). The average difference in 12-week cost between daily and alternate-day rhDNase was pound513 (95% CI -546 to 1510) and that between daily rhDNase and hypertonic saline was pound1409 (440 to 2318). None of the secondary clinical outcomes showed significant differences between treatments.\n Hypertonic saline, delivered by jet nebuliser, is not as effective as daily rhDNase, although there is variation in individual response. There is no evidence of a difference between daily and alternate-day rhDNase.", "With the advent of therapies aimed at young patients with cystic fibrosis, who have mildly reduced pulmonary function, the need for improved outcome measures that discriminate treatment effects has become important. Pulmonary function measurements or chest high-resolution computed tomography (HRCT) scores have been separately used to assess interventions. We evaluated these modalities separately and together during a treatment study to develop a more sensitive outcome measure. In a 1-year trial, 25 children randomized either to daily Pulmozyme or to normal saline aerosol were evaluated at randomization and at 3 and 12 months. Outcome variables were pulmonary function test (PFT) results, a global HRCT score, and a composite score incorporating PFTs and HRCT scoring. Regression analyses with generalized estimating equations permitted estimation of the difference in treatment effect between groups over time for each outcome. The largest difference in treatment effects observed at 12 months, measured by the percentage change from baseline, were with the composite total and maximal CT/PFT scores (35.4 and 30.4%), compared with mean forced expiratory flow during the middle half of the FVC (FEF25-75%) (13.0%) and total and maximal global HRCT scores (6.2%, 7.2%). The composite total and maximal CT/PFT scores were the most sensitive outcome measures for discriminating a treatment effect in children with cystic fibrosis with normal or mildly reduced pulmonary function during a 1-year trial of Pulmozyme.", "Chronic endobronchial bacterial infection evokes purulent airway secretions in patients with CF. The viscoelastic properties of these secretions is primarily due to the presence of polymerized DNA from degenerating leukocytes. Recombinant human DNase I (rhDNase) reduces the viscosity of CF sputum in vitro. To test the hypothesis that rhDNase would improve pulmonary function in children and adults with CF, we compared the efficacy and safety of 10-day administration of three doses of aerosolized rhDNase (0.6, 2.5, or 10.0 mg twice daily) in 181 outpatients using a randomized, placebo-controlled parallel design. Forced vital capacity (FVC) improved 10 to 12% (p < 0.05 to 0.001), and forced expiratory volume in one second (FEV1) improved 10 to 15% (p < 0.001) across all doses of rhDNase compared with placebo. The magnitude of effect was dose dependent for both FVC and FEV1 through study Day 21 (p < 0.001). rhDNase was associated with a decreased perception of dyspnea and an improved perception of well-being. No patients developed detectable anti-rhDNase antibodies or bronchial reactivity to rhDNase. Some patients experienced mild upper airway irritation, but no major adverse events were reported. Administration for 10 days of aerosolized rhDNase to pediatric and adult outpatients with CF improves lung function and is well tolerated. Although all three doses were efficacious, the greatest improvement in FEV1 and FEV1/FVC ratio was demonstrated in the 2.5 and 10.0 mg rhDNase treatment groups.", "The 12-week efficacy and safety of aerosolized recombinant human DNase (dornase alfa) were evaluated in previously untreated patients with cystic fibrosis (CF) with advanced lung disease.\n In this multicenter, double-blind, placebo-controlled study, CF patients with advanced lung disease were randomized to receive either dornase alfa or placebo once a day for 12 weeks.\n A total of 320 patients in clinically stable condition with documented CF and an FVC less than 40% of predicted were recruited from 65 CF Foundation care centers in the United States. The dornase alfa and placebo groups were comparable with respect to age (range, 7 to 57 years), height, and weight. Male subjects outnumbered female subjects (55% vs 45%) and few subjects were younger than 17 years of age (15%). The percentages of predicted FEV1 and FVC were significantly lower in the dornase alfa group at baseline (p < or = 0.05).\n Patients were randomly assigned to receive either 2.5 mg dornase alfa once daily (n = 158) or placebo once daily (n = 162). All patients continued to receive standard medications and treatments administered for CF.\n Dornase alfa improved the mean percent change in FEV1 from baseline by 9.4% compared with 2.1% for placebo (p < 0.001). The actively treated group showed a 12.4% improvement in FVC compared with 7.3% for placebo (p < 0.01). There were no differences between the treatment groups in dyspnea score number of days receiving i.v. antibiotics, or length of hospital stay; the overall incidence of adverse events was comparable between treatment groups. Fifteen patients died: 9 in the dornase alfa group and 6 in the placebo group; no differentiating clinical characteristics were demonstrated.\n Pulmonary function as measured by FEV1 and FVC improved significantly in the dornase alfa-treated patients. Dornase alfa was found to be safe and well tolerated over the 12-week study period.", "Chronic pulmonary infection is the major cause of morbidity and mortality in cystic fibrosis. High levels of DNA in the sputum make the sputum viscous and difficult to expectorate. Recombinant human deoxyribonuclease (rhDNase) in vitro has been shown to reduce the viscoelasticity of the sputum from CF patients. We have done a phase II double-blind randomised placebo-controlled trial in which patients received either 2.5 mg rhDNase twice daily or placebo for 10 days. All patients had forced vital capacity (FVC) above 40% predicted and were clinically stable. Patients were followed up for 42 days from the start of drug/placebo administration. All 71 randomised patients, aged 16-55, completed every aspect of the study and baseline characteristics were similar in the two groups. Baseline forced expiratory volume in one second (FEV1) was 46% of predicted for patients randomised to rhDNase, and 48% for those randomised to placebo; and baseline FVC was 76% of predicted for both groups. The mean percentage change in FEV1 from baseline was a 13.3% rise on rhDNase and a 0.2% fall on placebo (p < 0.001). FVC rose 7.2% in the rhDNase group and 2.3% in the placebo group (not significant). There were no life-threatening adverse events and no anaphylactic reactions. There was no significant difference in side-effects between the groups. This study confirms that short-term administration of rhDNase in stable patients with cystic fibrosis is safe and improves lung function.", "The goal of this study was to evaluate the safety and efficacy of recombinant human DNase (rhDNase) in hospitalized patients with cystic fibrosis (CF) experiencing acute pulmonary exacerbations. Eighty patients with documented CF were enrolled at 11 CF centers when admitted for antibiotic therapy. Patients were at least 5 yr old with a forced vital capacity (FVC) > or = 35% of predicted and an oxygen saturation > or = 90% on a fraction of inspired oxygen (FIO2) < 0.5. Patients were randomized to receive rhDNase 2.5 mg in 2.5 ml excipient twice a day (n = 43) or 2.5 ml excipient alone twice daily (n = 37) along with conventional treatment for exacerbations. Administration of rhDNase was not associated with acute adverse events or deaths, and no patients experienced allergic or anaphylactic reactions. Although forced expiratory volume in one second (FEV1) and FVC improved in both treatment groups during the double-blind period, there were no statistically significant differences in the mean change from baseline in FEV1 or FVC between the two groups. rhDNase therapy is safe and well tolerated in CF patients with acute exacerbations requiring hospitalization, but the study did not demonstrate a statistically significant therapeutic effect of rhDNase when added to a regimen of antibiotics and chest physical therapy.", "Our objective was to determine whether long-term treatment of young patients with cystic fibrosis (CF) with dornase alfa maintains lung function and reduces respiratory tract exacerbations.\n This was a 96-week, randomized, double-blind, placebo-controlled trial involving 49 CF centers. Inclusion criteria were age 6 to 10 years and forced vital capacity > or = 85% predicted. Patients were excluded for hospitalization for complications of CF within 2 months and use of dornase alfa within 6 months. Patients were treated with dornase alfa 2.5 mg or placebo once daily with a jet nebulizer and a compressor.\n Patients were randomized, 239 to dornase alfa and 235 to placebo. At baseline the mean age was 8.4 years, the mean forced expiratory volume in 1 second 95% predicted, the mean forced expiratory flow, midexpiratory phase 85% predicted, and the mean forced vital capacity 102% predicted. At 96 weeks the treatment benefit for dornase alfa compared with placebo in percent predicted (mean +/- SE) was 3.2 +/- 1.2 for forced expiratory volume in 1 second (P =.006), 7.9 +/- 2.3 for forced expiratory flow between 25% and 75% of vital capacity (P =.0008), and 0.7 +/- 1.0 for forced vital capacity (P =.51). The risk of respiratory tract exacerbation was reduced by 34% in patients who received dornase alfa (relative risk 0.66, P =.048). There was no statistically significant difference between the groups in changes in weight-for-age percentile. Adverse event profiles for the treatment groups were similar.\n Treatment of young patients with CF with dornase alfa maintains lung function and reduces the risk of exacerbations over a 96-week period.", "We tested the hypothesis that recombinant human deoxyribonuclease 1 (rhDNase) reduces airflow obstruction and improves mucociliary clearance in patients with cystic fibrosis (CF), and that improvements seen in FEV1 and FVC after rhDNase treatment are independent of chest physical therapy (CPT). CF patients inhaled placebo (10 patients) or 2.5 mg rhDNAse aerosol (10 patients) twice a day for six consecutive days. Compared with baseline, there were no statistically significant differences between the two study groups by Day 6 for indices of airflow obstruction obtained from gamma-camera images of the right lung following inhalation of 99mTc aerosol, or for mucociliary clearance or the rate of clearance of the radioaerosol, quantified over a 6-h period. By Day 6, FEV1 and FVC were significantly higher in the rhDNase-treated group than in the placebo group, increasing by an average of 9.4 +/- 3.5% and 12.7 +/- 2.6%, respectively, as compared with a decrease of 1.8 +/- 1.7% and an increase of 0.4 +/- 1.1%, respectively (p < 0.05). There was no significant change in the FEV1/FVC ratio on Day 6 (0.68 +/- 0.05) compared with baseline (0.70 +/- 0.05) in the rhDNase group. On Day 6, FEV1 and FVC decreased after CPT in both study groups, but the decreases were not significant. Our results indicate that aerosolized rhDNase improves FEV1 and FVC independent of CPT. We were unable to demonstrate that rhDNase reduces airflow obstruction or improves mucociliary clearance." ]

[ "18595959", "11391326" ]

[ "Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome.", "Efficacy of fluticasone nasal spray for pediatric obstructive sleep apnea." ]

[ "Intranasal corticosteroids have been advanced as a nonsurgical therapeutic alternative for pediatric obstructive sleep apnea syndrome, particularly for patients with mild disease, and aims at reducing the size of hypertrophic adenotonsillar tissue.\n Of 71 possible candidates, 62 children with polysomnographically diagnosed mild obstructive sleep apnea syndrome were recruited onto a double-blind, randomized, crossover trial of intranasal budesonide (32 microg per nostril at bedtime) or placebo for 6 weeks followed by an additional 6-week treatment in the alternative treatment arm after allowing for a 2-week washout period. Polysomnographic assessment and radiographs for assessment of adenoid size were performed after completion of each phase.\n There were significant improvements in both polysomnographic measures (sleep latency, slow-wave sleep, and rapid-eye-movement sleep), in the magnitude of respiratory disturbance (apnea/hypopnea index, nadir pulse oxygen saturation), and in adenoid size among the 48 children who completed the treatment phase compared with 32 children who received placebo in their initial arm, with normalization of sleep measures in 54.1% of the treated children. Furthermore, discontinuation of treatment for 8 weeks for 25 children revealed a sustained duration of the initial treatment effect.\n A 6-week treatment with intranasal budesonide effectively reduced the severity of mild obstructive sleep apnea syndrome and the magnitude of the underlying adenoidal hypertrophy, and this effect persisted for at least 8 weeks after cessation of therapy. These findings justify the use of topical steroids as the initial therapeutic option in otherwise healthy children with mild obstructive sleep apnea.", "We tested the hypothesis that a 6-week course of a nasal glucocorticoid spray would decrease the severity of obstructive sleep apnea in children with adenotonsillar hypertrophy.\n We conducted a randomized, triple-blind, placebocontrolled, parallel-group trial of nasal fluticasone propionate versus placebo in 25 children aged 1 to 10 years with obstructive sleep apnea proven on polysomnography. The primary outcome was the change from baseline in the frequency of mixed and obstructive apneas and hypopneas.\n Thirteen children received fluticasone, and 12 received placebo. The mixed/obstructive apnea/hypopnea index decreased from 10.7 +/- 2.6 (SE) to 5.8 +/- 2.2 in the fluticasone group but increased from 10.9 +/- 2.3 to 13.1 +/- 3.6 in the placebo group, P =.04. The mixed/obstructive apnea/hypopnea index decreased in 12 of 13 subjects treated with fluticasone versus 6 of 12 treated with placebo, P =.03. The frequencies of hemoglobin desaturation and respiratory movement/arousals also decreased more in the fluticasone group. Changes from baseline in tonsillar size, adenoidal size, and symptom score were not significantly different between groups.\n Nasal fluticasone decreased the frequency of mixed and obstructive apneas and hypopneas, suggesting that topical corticosteroids may be helpful in ameliorating pediatric obstructive sleep apnea." ]

[ "11182878", "9825420" ]

[ "A randomized controlled trial of a smoking cessation intervention based in community pharmacies.", "Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomised controlled trial in Scotland." ]

[ "To evaluate whether a structured community pharmacy-based smoking cessation programme (the PAS model) would give rise to a higher smoking cessation rate compared with ad hoc advice from pharmacists.\n A randomized controlled trial comparing a structured intervention with usual care.\n One hundred pharmacists working in community pharmacies in N. Ireland and 24 in London took part in the study and were each asked to enroll 12 smokers; 44% of pharmacists who were trained managed to recruit one or more smokers during the recruitment period of approximately 1 year.\n A total of 484 smokers were enrolled by the pharmacists and individually randomized into the PAS intervention group (N = 265) or the control group (N = 219).\n The PAS intervention involved a structured counselling programme, an information leaflet and a follow-up weekly for the first 4 weeks then monthly as needed.\n The primary outcome measure of this study was self-reported smoking cessation for 12 months with cotinine validation at the 12-month follow-up.\n Of smokers in the PAS group, 14.3% (38) were abstinent up to 12 months compared with 2.7% (6) in the control group (p < 0.001 for the difference).\n The community pharmacy-based PAS smoking cessation service can be an effective method of helping people stop smoking when delivered by pharmacists willing to adopt this approach.", "To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model.\n A randomised controlled trial of community pharmacies and pharmacy customers.\n All 76 non-city community pharmacies registered in Grampian, Scotland, were invited to participate. Sixty-two pharmacies (82%) were recruited.\n All the intervention pharmacy personnel were invited to attend the training; 40 pharmacists and 54 assistants attended. A total of 492 customers who smoked (224 intervention, 268 controls) were recruited during the 12-month recruitment period (overall recruitment rate 63%).\n The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one, four, and nine months.\n The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel, 85% (113) compared with 62% (99) of the controls (p < 0.001). The former also rated their discussion more highly; 34% (45) of the intervention customers compared with 16% (25) of the controls rated it as \"very useful\" (p = 0.048). Assuming non-responders had lapsed, one-month point prevalence of abstinence was claimed by 30% of intervention customers and 24% of controls (p = 0.12); four months' continuous abstinence was claimed by 16% of intervention customers and 11% of controls (p = 0.094); and nine months' continuous abstinence was claimed by 12% of intervention customers and 7% of controls (p = 0.089). These trends in outcome were not affected by potential confounders (sex, age, socioeconomic status, nicotine dependence, and type of nicotine replacement product used) or adjustment for clustering.\n The intervention was associated with increased and more highly rated counselling, and a trend toward higher smoking cessation rates, indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets." ]

[ "434024", "7729737" ]

[ "An alternate approach to early cancer of the vulva.", "Surgical therapy of T1 and T2 vulvar carcinoma: further experience with radical wide excision and selective inguinal lymphadenectomy." ]

[ "Early invasive squamous cell carcinoma of the vulva has emerged as a controversial issue in recent literature. Reports illustrating metastatic disease in the inguinal lymph nodes have conflicted with other reports suggesting local treatment only. The morbidity produced by radical vulvectomy to both body image and sexual function make this issue worthy of serious consideration. This report deals with an alternate approach to this disease entity which attempts to preserve vulvar tissue without sacrificing curability where possible metastatic disease exists. The concept is proposed of utilizing the superficial inguinal nodes as sentinel nodes in the treatment planning. The results of 20 patients treated in this manner are presented.", "Radical wide excision and selective inguinal node dissection provide a more conservative and less morbid surgical option for women with vulvar carcinoma than en bloc radical vulvectomy with bilateral inguinofemoral lymphadenectomy. We have expanded our initial experience with this approach to 76 patients with T1 (n = 33) and T2 (n = 43) squamous carcinomas with invasion > 1 mm and clinically negative groin nodes treated between 1978 and 1994. Lateral tumors (n = 53) were more frequent than midline lesions (n = 23). Tumors were excised with a measured gross margin of 2 cm, and dissection was carried to the deep perineal fascia. The mean largest tumor dimension was 26 mm; the mean depth of invasion was 4.4 mm. Superficial inguinal lymphadenectomy, unilateral or bilateral depending on lesion location, was performed. Perioperative complications occurred on the vulva in 8% of cases and in the groin in 11%. Delayed complications, all related to groin treatment, were seen in 29%. The median follow-up interval was 38 months. Seven patients (9%) had inguinal lymph node metastases identified at their primary operation. Most received additional therapy; one has died of disease. Nine women (12%) developed recurrent disease in the vulva: all were controlled by additional resection. Four (5%) developed recurrence in a previously negative groin: three of these are dead of disease. Actuarial 4-year survival is 81%. Radical wide excision and selective inguinal lymphadenectomy can be safely offered to women with T1 and T2 vulvar cancers. Patients with known positive nodes or vulvar failure can be salvaged by further therapy. Women with unanticipated groin failure usually die of disease. These experiences are similar to those observed in more radically resected patients." ]

[ "1547016", "1547009", "16236232" ]

[ "Safety effects of 30 Km/H zones in The Netherlands.", "Safety effects of speed reducing measures in Danish residential areas.", "Safety impact of engineering treatments on undivided rural roads." ]

[ "Since 1983, Dutch municipal authorities can institute a maximum speed of 30 km/h on roads or in zones within built-up areas. The safety effects of 30 km/h zones are supposed to be positive. In order to be sure about this, the Ministry of Transport has stimulated 15 municipalities to implement a 30 km/h zone and set up an evaluation of the safety effects of these zones. The evaluation research is coordinated by the Institute for Road Safety Research (SWOV). The evaluation concerns the changes in traffic flows, opinions of residents, conflicts, and accidents. This paper gives the results of the evaluation.", "On May 1, 1977 a new code was introduced into the Danish Road Traffic Act. The result was a change in layout and speed limits in a great number of residential streets; in most cases the streets were transformed into 30 km/h streets and in few cases into 15 km/h streets. In addition to speed signs, both types of streets were equipped with speed reducing measures. Based on experiences from a selection of experimental streets, mostly 30 km/h streets, different, but very positive effects were found. Overall there was a reduction in the mean speed in these areas of 11 km/h. On the 223 km, 30 km/h streets there was a reduction of 77 accidents and 88 casualties within a period of three years. These reductions were caused by the implementation of speed signs, speed reducing measures, and a reduction in traffic. On the basis of 44 experimental streets, where traffic was recorded both before and after the changes, the reduction in risk of casualties, i.e. the number of casualties per road user km, was 72%, while the risk of accidents seemed to be unchanged. Considering serious injuries alone, a very high reduction of 78% was found. Accidents included in the study consist of all police reported accidents, i.e. accidents with personal injury as well as damage only accidents.", "This article presents an evaluation of the safety impacts of four engineering treatments implemented in the Autonomous Community of Madrid (Spain): highway upgrading; updating and improvement of traffic signing; repainting of pavement markings and pavement resurfacings. This evaluation was carried out using the Empirical Bayes method with a comparison group. The functioning of a methodology to test the significance of the safety impact is described. The results show that highway upgrading has a positive and significant safety impact, while the updating and improvement of traffic signing, the repainting of road markings and pavement resurfacings do not exhibit a significant impact on safety." ]

[ "8797464", "2555713", "19722254", "10680790" ]

[ "Effects of intravenous immunoglobulin on muscle weakness and calcium-channel autoantibodies in the Lambert-Eaton myasthenic syndrome.", "3,4-Diaminopyridine in the treatment of Lambert-Eaton myasthenic syndrome.", "3,4-Diaminopyridine is more effective than placebo in a randomized, double-blind, cross-over drug study in LEMS.", "A randomized trial of 3,4-diaminopyridine in Lambert-Eaton myasthenic syndrome." ]

[ "Intravenous immunoglobulin improves many antibody-mediated autoimmune disorders, but its mode of action is unknown. We investigated its effects on muscle strength and on the serum titer of the calcium-channel autoantibodies that are likely to be pathogenic in the Lambert-Eaton myasthenic syndrome (LEMS). In a randomized, double-blind, placebo-controlled crossover trial, serial indices of limb, respiratory, and bulbar muscle strength and the serum titer of calcium-channel antibodies in nine patients were compared over an 8-week period, using the area-under-the-curve approach, following infusion on two consecutive days of immunoglobulin at 1 g/kg body weight/day (total dose 2.0 g/kg body weight) or placebo (equivalent volume of 0.3% albumin). Calcium-channel antibodies were measured by radioimmunoassay using 125I-omega-conotoxin MVIIC. Direct anti-idiotypic actions of immunoglobulin were tested in this assay. Immunoglobulin infusion was followed by significant improvements in the three strength measures (p = 0.017 to 0.038) associated with a significant decline in serum calcium-channel antibody titers (p = 0.028). Improvement peaked at 2 to 4 weeks and was declining by 8 weeks. Mean serum titers were unchanged at 1 week, however, and direct anti-idiotypic neutralization by immunoglobulin was not demonstrable in vitro. We conclude that immunoglobulin causes a short-term improvement in muscle strength in LEMS that probably results from the induced reduction in calcium-channel autoantibodies. The reduction is not due to a direct neutralizing action of the immunoglobulin, but a delayed anti-idiotypic action cannot be excluded. Improvement following intravenous immunoglobulin in other autoantibody-mediated disorders may similarly be associated with decline in levels of pathogenic autoantibodies.", "Lambert-Eaton myasthenic syndrome is characterized by muscle weakness, hyporeflexia, and autonomic dysfunction, which result from impaired release of acetylcholine from cholinergic nerve terminals. It is frequently associated with cancer, it is autoimmune-mediated, and treatment has been unsatisfactory. 3,4-Diaminopyridine enhances the release of acetylcholine. In this prospective, double-blind, placebo-controlled crossover study of 12 patients with Lambert-Eaton myasthenic syndrome (7 of whom had cancer), 3,4-diaminopyridine in doses up to 100 mg per day was effective in treating both the motor and the autonomic deficits of the syndrome. Muscle strength increased from an average of 70 percent of normal to 81 percent of normal in the upper extremities, and from 45 to 65 percent of normal in the lower extremities. The amplitudes of compound-muscle-action potentials nearly doubled, increasing from an average of 2.9 mV to 5.0 mV in the arm and from 1.6 mV to 3.1 mV in the leg. Autonomic symptoms were relieved. One patient had a seizure after 10 months of treatment, but other side effects from the drug were minimal and dose-related. We conclude that 3,4-diaminopyridine, either alone or in conjunction with other therapies, may be useful in the treatment of Lambert-Eaton myasthenic syndrome.", "The purpose of this study was to investigate the clinical and electrophysiological efficacy of 3,4-diaminopyridine (DAP) in patients with Lambert-Eaton myasthenic syndrome (LEMS) in a randomized, double-blind, cross-over drug trial. The diagnosis of LEMS was made based on the combination of fluctuating muscle weakness, diminished or absent reflexes, and more than 60% increment of the compound muscle action potential (CMAP) amplitude after brief exercise or 50-HZ stimulation on a repetitive nerve stimulation (RNS) test. Evaluations were done at baseline, with placebo, and with 3,4-DAP (up to 75-80 mg/day). Assignment of placebo or 3,4-DAP was done in a double-blinded manner. Measurements included subjective symptoms score, objective clinical measurements [LEMS classification, muscle strength score, quantitative myasthenia gravis (QMG) score] and RNS test and single-fiber electromyography (SFEMG). The differences between placebo and baseline values (placebo change) were compared with the differences between 3,4-DAP and baseline or placebo values (DAP change). Seven patients with LEMS (QMG score >9) participated in the study. One patient had major side-effects with 3,4-DAP and withdrew from the study. Statistically significant efficacy was noted with DAP change (N = 13) compared with placebo change (N = 7) according to the subjective symptoms score (P = 0.01), LEMS classification (P < 0.001), muscle strength score (P < 0.006), QMG score (P = 0.02), and CMAP (P = 0.03). For long-term treatment, 2 patients preferred 3,4-DAP, 1 chose guanidine hydrochloride, 1 preferred pyridostigmine, and 2 chose no treatment. A randomized, double-blind, cross-over drug trial of 3,4-DAP showed significant efficacy over placebo in patients with LEMS. As a long-term treatment, however, not all patients preferred this drug.", "The authors report the results of a prospective, placebo-controlled, randomized study to evaluate the effectiveness of 3,4-diaminopyridine (DAP) in patients with Lambert-Eaton myasthenic syndrome (LEMS) and to determine the acute and long-term side effects of DAP.\n Twenty-six patients with LEMS completed a two-arm parallel treatment protocol in which DAP, 20 mg three times daily, or placebo was given blindly for 6 days, and a quantitative examination of muscle strength (the quantitative myasthenia gravis [QMG] score) was used as the primary measure of efficacy. After the blinded study, patients were given open-label DAP and monitored for side effects as long as there was symptomatic improvement.\n Twelve patients took DAP, and 14 took placebo. There was no difference in the age of LEMS onset, gender distribution, incidence of lung cancer, or baseline muscle strength between the patients who were randomly assigned to receive placebo and those randomly assigned to DAP. Statistical analysis using the Wilcoxon's rank sum test demonstrated that patients who received DAP had a significantly greater improvement in the QMG score and in the summated amplitude of compound muscle action potentials recorded from three sentinel limb muscles. All but one LEMS patient had significant symptomatic improvement from subsequent open-label DAP. Side effects of DAP were negligible, consisting of perioral and digital paresthesia. Laboratory measurements demonstrated no evidence of toxicity affecting liver, renal, hematologic, endocrinologic, encephalographic, or electrocardiologic function acutely or after 6 months of open-label DAP.\n This study corroborates previous studies and many years of clinical experience showing that DAP is an effective and safe treatment for LEMS." ]

[ "17990229", "12230222" ]

[ "An open-label comparative pilot study of oral voriconazole and itraconazole for long-term treatment of paracoccidioidomycosis.", "Randomized trial with itraconazole, ketoconazole and sulfadiazine in paracoccidioidomycosis." ]

[ "In previous studies, itraconazole was revealed to be an effective therapy and was considered to be the gold standard treatment for mild-to-moderate acute and chronic clinical forms of paracoccidioidomycosis. A pilot study was conducted to investigate the efficacy, safety, and tolerability of voriconazole for the long-term treatment of acute or chronic paracoccidioidomycosis, with itraconazole as the control treatment.\n A randomized, open-label study was conducted at 3 Brazilian tertiary care hospitals. Patients were randomized (at a 2 : 1 ratio) to receive oral therapy with voriconazole or itraconazole for 6 months. Patients receiving >or=1 dose of study drug were evaluated for safety; patients with confirmed paracoccidioidomycosis who completed >or=6 months of therapy (treatment-evaluable patients) were evaluated for treatment efficacy. Satisfactory global response was assessed at the end of treatment.\n Fifty-three patients were evaluated for treatment safety (35 received voriconazole, and 18 received itraconazole). Both drugs were well tolerated. The most common treatment-related adverse events in the voriconazole group included abnormal vision, chromatopsia, rash, and headache; the most common treatment-related adverse events in the itraconazole group included bradycardia, diarrhea, and headache. Liver function test values were slightly higher in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values. In the intent-to-treat populations, the satisfactory response rate (i.e., complete or partial global response) was 88.6% among the voriconazole group and 94.4% among the itraconazole group. The response rate among treatment-evaluable patients was 100% for both treatment groups; no relapses were observed after 8 weeks of follow-up.\n This is, to our knowledge, the first study to demonstrate that voriconazole is as well tolerated and effective as itraconazole for the long-term treatment of paracoccidioidomycosis.", "Forty-two patients with active paracoccidioidomycosis were randomized to receive itraconazole (50-100 mg d(-1)), ketoconazole (200-400 mg d(-1)) or sulfadiazine (100-150 mg kg d(-1) up to 6 g d(-1)) for 4-6 months, followed by slow release sulfa until negativity of serological tests. All 14 patients in itraconazole and sulfadiazine groups and 13 in the ketoconazole group showed an adequate clinical response to the chemotherapy. One patient in the latter group showed treatment failure according to clinical and mycological criteria. The test of the hypothesis that the drugs reduced antibody levels up to ten months of treatment showed a p value equal to 0.0001 for itraconazole, 0.017 for ketoconazole and 0.0012 for sulfadiazine; this reduction was similar for the three groups. In this first randomized study for the treatment of paracoccidioidomycosis we could not show superiority of any one regimen over the others in the clinical and serological responses of patients with the moderately severe form of the disease." ]

[ "9647058", "9305202", "8239794", "7955261", "8664018", "8311588", "7495583", "9270646", "8043290", "8787461", "7818312", "8873731", "8975854", "8037558", "9240302", "10421111" ]

[ "Intermittent antegrade tepid versus cold blood cardioplegia in elective myocardial revascularization.", "Influence of normothermic systemic perfusion during coronary artery bypass operations: a randomized prospective study.", "Which techniques of cardioplegia prevent ischemia?", "Cardiopulmonary bypass, temperature, and central nervous system dysfunction.", "Randomized trial comparing intermittent antegrade warm blood cardioplegia with multidose cold blood cardioplegia for coronary artery bypass.", "Prospective, randomized trial of retrograde warm blood cardioplegia: myocardial benefit and neurologic threat.", "Continuous warm versus intermittent cold blood cardioplegia for coronary bypass surgery in patients with left ventricular dysfunction.", "Cerebral dysfunction after coronary artery bypass grafting done with mild or moderate hypothermia.", "A prospective randomised study of continuous warm versus intermittent cold blood cardioplegia for coronary artery surgery: preliminary report.", "Cardiopulmonary bypass temperature, hematocrit, and cerebral oxygen delivery in humans.", "Normothermia versus hypothermia during cardiopulmonary bypass: a randomized, controlled trial.", "The effects of cardiopulmonary bypass temperature on neuropsychologic outcome after coronary artery operations: a prospective randomized trial.", "What is the best perfusion temperature for coronary revascularization?", "Intermittent antegrade warm versus cold blood cardioplegia: a prospective, randomized study.", "Temperature during cardiopulmonary bypass for coronary artery operations does not influence postoperative cognitive function: a prospective, randomized trial.", "Effects of hypothermic and normothermic cardiopulmonary bypass on brain oxygenation." ]

[ "The ideal temperature for blood cardioplegia administration remains controversial.\n Fifty-two patients who required elective myocardial revascularization were prospectively randomized to receive intermittent antegrade tepid (29 degrees C; group T, 25 patients) or cold (4 degrees C; group C, 27 patients) blood cardioplegia.\n The two cohorts were similar with respect to all preoperative and intraoperative variables. The mean septal temperature was higher in group T (T, 29.6 degrees +/- 1.1 degrees C versus 17.5 degrees +/- 3.0 degrees C; p < 0.0001). After reperfusion, group T exhibited significantly greater lactate and acid release despite similar levels of oxygen extraction (p < 0.05). The creatine kinase-MB isoenzyme release was significantly lower in group T (764 +/- 89 versus 1,120 +/- 141 U x h/L; p < 0.04). Hearts protected with tepid cardioplegia demonstrated significantly increased ejection fraction with volume loading, improvement in left ventricular function at 12 hours, and decreased need for postoperative inotropic support (p < 0.05). The frequency of ventricular defibrillation after cross-clamp removal was lower in this cohort (p < 0.05). There were no hospital deaths, and both groups had similar postoperative courses.\n Intermittent antegrade tepid blood cardioplegia is a safe and efficacious method of myocardial protection and demonstrates advantages when compared with cold blood cardioplegia in elective myocardial revascularization.", "Normothermic cardiopulmonary bypass has been proposed as a more physiologic technique than hypothermic bypass for the maintenance of the body during cardiac surgery. The aims of this study were to investigate the effects of systemic perfusion temperature on clinical outcome after coronary revascularization.\n Three hundred patients (mean age 60 +/- 9 years, 88% male) were prospectively randomized into three groups: hypothermia (28 degrees C, n = 100), moderate hypothermia (32 degrees C, n = 100), and normothermia (37 degrees C, n = 100). All patients received cold antegrade St. Thomas' Hospital crystalloid cardioplegic solution, and patients in the normothermic group were actively rewarmed during cardiopulmonary bypass (nasopharyngeal temperature 37 degrees C).\n No differences were found between groups with respect to mortality (1%), intraaortic balloon pump use, perioperative infarction rates, focal neurologic deficits (1%), intubation time, intensive care unit stay, and postoperative hospital stay. Further stepwise regression analysis identified age and intensive care unit stay as important predictors of the variability in postoperative stay (both R2 = 0.114; p < 0.001), whereas perfusion temperature remained a nonsignificant explanator. Normothermic perfusion necessitated larger doses of phenylephrine to maintain arterial pressure above 50 mm Hg during cardiopulmonary bypass (p < 0.0001 vs 28 degrees C, p < 0.01 vs 32 degrees C) but less requirement for electrical defibrillation during reperfusion (p < 0.05 vs 32 degrees C, p < 0.01 vs 28 degrees C). Total chest drainage was not different between groups, but patients undergoing normothermic cardiopulmonary bypass required less transfusion of blood (p < 0.05 vs 28 degrees C and 32 degrees C) and platelets (p < 0.04 vs 32 degrees C, p < 0.001 vs 28 degrees C) in the postoperative period.\n Cardiopulmonary bypass temperature did not influence early clinical outcome after routine coronary artery bypass operations. Normothermic systemic perfusion was associated with an increased requirement for vasoconstrictors and reduced requirements for electrical defibrillation and transfusion of blood products.", "One hundred seven patients undergoing coronary artery bypass grafting were randomized to receive warm antegrade (n = 21), warm retrograde (n = 22), cold antegrade (n = 20), cold retrograde (n = 22), or intermittent cold antegrade (n = 22) blood cardioplegia. Myocardial oxygen consumption and lactate production, adenine nucleotides, and adenine nucleotide degradation products were measured during the operation, and creatine kinase-MB release was assessed postoperatively. Warm cardioplegia resulted in greater myocardial lactate production than cold cardioplegia (p = 0.048). Retrograde cardioplegia was associated with greater lactate production than antegrade cardioplegia (p = 0.015). Adenosine triphosphate depletion was similar among groups. However, poorly diffusible metabolites of adenosine triphosphate accumulated to the greatest extent in the intermittent cold group. Levels of hypoxanthine were highest after warm retrograde cardioplegia. Operative mortality and morbidity were low and were not different among groups. In summary, none of the five techniques of cardioplegia evaluated in this study was able to completely prevent myocardial ischemia. Anaerobic lactate production was minimized with cold cardioplegia and with antegrade cardioplegic delivery. Hypothermia may have impaired regeneration of adenosine triphosphate, however, particularly in association with inadequate or intermittent cardioplegic flow.", "Neurological injury is an important cause of morbidity and mortality after cardiac surgery. With the advent of warm heart surgery, the neuroprotective role of hypothermic cardiopulmonary bypass (CPB) has come under increasing scrutiny. Preliminary work by us in the area found no increased risk of neurological morbidity with normothermic CPB in a small group of patients and suggested a possible benefit. The purpose of the present study is to compare the incidence of neurological and neuropsychological dysfunction in a larger number of patients randomized to warm or cold aortocoronary bypass surgery.\n With the approval of the institutional research ethics committee, 201 aortocoronary bypass patients were randomized to normothermic or moderate hypothermic CPB and subjected to neurological and neuropsychological evaluation. These subjects were a subset of patients enrolled in a large multicenter trial comparing warm versus cold heart surgery. The examinations took place preoperatively, 5 days after operation, and a 3-month follow-up. The examination consisted of a clinical neurological examination and a brief neuropsychological test battery. The neuropsychological tests included the Buschke selective reminding procedure, the Wechsler memory scale-revised visual reproduction subtest, the trial making test (parts A and B), the Wechsler adult intelligence scale-revised digit symbol subtest, and the grooved pegboard test. The examiner and subjects were unaware of the CPB temperature allocation (warm, > 34 degrees C; cold, < or = 28 degrees C). Statistical analysis was performed using the SAS statistical software package. Two hundred one patients were enrolled in the study. Of these, 155 patients completed the entire protocol and were included in the final analysis (warm group, n = 78; cold group, n = 77). One patient in the warm group died perioperatively from a massive hemispheric stroke. Another warm group patient was unable to complete neuropsychological evaluation because of a perioperative stroke. Thus, 153 patients completed the entire series of neuropsychological tests. A total of 6 patients (warm group, n = 2; cold group, n = 4; P = NS) suffered from perioperative focal neurological deficits. There was a consistent deterioration in scores from tests of psychomotor speed/coordination (trial making, digit symbol, pegboard) in the early postoperative period, which resolved by the 3-month follow-up. Tests of memory (Buschke, Wechsler memory scale) showed no evidence of patient deterioration in the postoperative period. No difference was seen between the warm and cold groups.\n In this randomized trial of normothermic versus hypothermic CPB, we found deterioration in scores of tests of psychomotor speed but not of memory in the early postoperative period. We were unable to demonstrate any neuroprotective effect from moderate hypothermia in this patient population.", "Forty patients were randomized to receive antegrade multidose warm (WBC) or cold blood cardioplegia (CBC) during coronary artery bypass. Cardioplegia was infused at a predetermined dose every 10 min during cardioplegia arrest and core temperature was maintained at 37 degrees C in both groups during extracorporeal circulation. Patient profiles were similar in the two groups. Cardiac index, left ventricular stroke work index, and myocardial oxygen consumption were measured before bypass and during the first 7 h of reperfusion. There was no significant difference in myocardial metabolic and function recovery, the incidence of myocardial infarction, low cardiac output or death. Our data suggests that similar protection is provided with the two techniques of myocardial protection.", "From March 1991 through July 1992, 1,001 patients having elective coronary artery bypass grafting were randomized to receive either continuous warm (> or = 35 degrees C) blood cardioplegia with systemic normothermia (> or = 35 degrees C) or intermittent cold (< or = 8 degrees C) oxygenated crystalloid cardioplegia and moderate systemic hypothermia (< or = 28 degrees C). Preoperative variables including age, sex, prior coronary bypass grafting, hypertension, prior myocardial infarction, diabetes, angina class, and preoperative heart failure class were similar in both groups, as were the intraoperative variables of number of coronary grafts, mammary artery use, and cardiopulmonary bypass time. Aortic cross-clamp time was significantly longer in the warm group (46 +/- 23 minutes versus 40 +/- 21 minutes). Most postoperative variables including mortality (warm, 1.0%, and cold, 1.6%), Q wave infarction (warm, 1.4%, and cold, 0.8%), and need of an intraaortic balloon pump (warm, 1.4%, and cold, 2.0%) were similar between groups. Total neurologic events (warm, 4.5%, and cold, 1.4%; p < 0.005) and perioperative strokes (warm, 3.1%, and cold, 1.0%; p < or = 0.02) were significantly higher in the warm group. Neurologic events included perioperative stroke (warm, 15 patients, and cold, 5 patients; p < 0.02), perioperative encephalopathy (warm, 2 patients, and cold, 1 patient), and delayed (> or = 3 in-hospital days) stroke (warm, 5 patients, and cold, 1 patient). All patients experiencing a stroke had a persistent neurologic deficit at the time of discharge. Encephalopathy resolved completely in all instances.(ABSTRACT TRUNCATED AT 250 WORDS)", "Between October 1991 and March 1994, 108 consecutive patients with moderate to severe left ventricular dysfunction underwent non-emergency isolated coronary artery surgery under the care of one surgeon (A.R.). They were prospectively randomised to receiving either intermittent cold (Group 1-50 patients) or continuous warm (Group 2-58 patients) blood cardioplegia for myocardial protection. There were no significant differences in clinical outcome between the two groups, as judged by operative mortality, rates of perioperative myocardial infarction, the serum CKMB isoenzyme level at 2 and 18 h after operation, need for circulatory support, postoperative neurological deficit, or duration of hospital stay. Group 2 patients required significantly more potassium (68 vs 29 mmol, P < 0.001) to maintain diastolic arrest and also had higher serum potassium levels after removal of the cross-clamp (P < 0.001). However, sinus rhythm returned spontaneously with greater frequency (91.2% vs 45.8%, P < 0.001) in Group 2 patients. In conclusion this report suggests that retrograde continuous warm blood cardioplegia provides comparable myocardial protection to that achieved with retrograde intermittent cold blood cardioplegia in patients with moderate to severe left ventricular dysfunction undergoing isolated coronary artery surgery.", "Ninety-nine patients undergoing elective coronary artery bypass grafting were enrolled in a prospective, randomized study to evaluate the incidence of cerebral dysfunction after \"mild\" or \"moderate\" hypothermia during cardiopulmonary bypass.\n Patients were evaluated before and after operation before hospital discharge and in some cases at follow-up at least 6 weeks later with a complete neurologic examination (85 patients) and a battery of standard neuropsychometric tests (86 patients).\n Postoperative changes detected by neurologic examination consisted of the appearance of new primitive reflexes in both groups. No statistically significant differences in incidence were found. The neuropsychometric performances of the two groups were statistically similar by either event-rate or group-rate analysis.\n There is no detectable difference in postoperative cerebral dysfunction in patients undergoing coronary artery bypass grafting who are supported by cardiopulmonary bypass with either mild or moderate hypothermia.", "Between October 1991 and March 1993, 281 consecutive patients underwent non-emergency isolated coronary artery surgery under the care of one surgeon (A.R.). They were prospectively randomised to receive either intermittent cold (Group I-144 patients) or continuous warm (Group II-137 patients) blood cardioplegia for myocardial protection. There were no significant differences in clinical outcome between the two groups, as judged by operative mortality, rates of peri-operative myocardial infarction, blood loss, need for circulatory support, post-operative neurological deficit, or duration of intensive care or hospital stay. However, sinus rhythm returned spontaneously with greater frequency (91.2% vs 45.8%, P < 0.001) in Group II patients. There was greater transmyocardial oxidative stress in Group I patients, as evidenced by a significant rise in oxidised glutathione in coronary sinus blood on myocardial reperfusion. Also, the serum CKMb isoenzyme level 2 h post-operatively was significantly raised in Group I patients, although this difference had disappeared by the day after surgery. In conclusion this preliminary report suggests that continuous warm blood cardioplegia provides comparable myocardial protection to that achieved with standard hypothermic techniques in patients undergoing coronary artery surgery.", "The neurologic effects of warm heart operations is a subject of popular interest. The purpose of this study was to examine the adequacy of cerebral oxygenation during normothermic cardiopulmonary bypass and better define the relationship between hematocrit, temperature, and brain oxygen delivery.\n Cerebral blood flow, metabolic rate, and oxygen delivery were measured in 60 patients randomized to normothermic (37 degrees C) or hypothermic (27 degrees C) cardiopulmonary bypass. The nitrous oxide saturation technique of Kety and Schmidt was used for cerebral blood flow determinations. Both temperature groups underwent moderate (31%) hemodilution.\n During normothermic cardiopulmonary bypass, cerebral blood flow increased secondary to hemodilution and decreased cerebral vascular resistance; a normal matching of oxygen demand and delivery was maintained. During hypothermic bypass, hemodilution and hypothermia had essentially equal, opposing effects on cerebral vascular resistance and blood flow. With hypothermia, brain oxygen demand and delivery were both reduced but not closely coupled.\n From the standpoint of global cerebral perfusion and oxygenation, our data support the practice of \"warm\" heart operations. It clarifies the marked influence of hematocrit on cerebral blood flow and delineates the interaction of temperature and hematocrit on cerebral oxygen delivery. It also suggests that additional investigation to better define \"temperature-appropriate\" hemodilution during cardiopulmonary bypass is indicated.", "To evaluate the influence of perfusion temperature on systemic effects of cardiopulmonary bypass (CPB), 30 patients undergoing elective coronary artery bypass grafting were randomly assigned to either normothermic (warm, n = 14, 36 degrees C) or hypothermic (cold, n = 16, 28 degrees C) CPB. Serial hemodynamic measurements and blood samples were obtained before, during and after the CPB procedure. During CPB, there were no differences between both groups in the need for vasopressors (norepinephrine, phenylephrine), urinary output, or fluid balance. In the early postoperative period, normothermic CPB patients had significantly lower systemic vascular resistance and higher cardiac index measurements (mean +/- standard error: systemic vascular resistance, 880 +/- 27 versus 1,060 +/- 57 dyne.s.cm-5, p = 0.025; cardiac index, 3.6 +/- 0.1 versus 2.9 +/- 0.1 L.min-1.m-2, p = 0.01) without differences in the administration of vasoactive drugs. Blood loss was significantly higher in patients after hypothermic CPB (median [range] body surface area: 370 [180-560] versus 490 [280-2,120] mL/m2, p = 0.0006), with a greater need for transfusion of erythrocytes and fresh frozen plasma. Plasma levels of tumor necrosis factor and soluble tumor necrosis factor receptors increased during and after CPB, independent of perfusion temperature. This study suggests a significant influence of CPB temperature and respective perfusion management on postoperative hemodynamics and blood loss. Normothermic CPB is not associated with additional systemic adverse effects.", "The effect of systemic perfusion temperature on postoperative cognitive function was investigated in 96 adult patients undergoing elective coronary revascularization with cardiopulmonary bypass at 28 degrees C, 32 degrees C, or 37 degrees C. Neuropsychologic performance was assessed 1 day before the operation and 6 weeks after the operation. Five tests were adapted from the Wechsler Adult Intelligence Scale and two from the Wechsler Memory Scale.\n No patients had major neurologic complications. Ninety-three patients completed the five Wechsler Adult Intelligence Scale tests, but only 70 went on to complete the Wechsler Memory Scale tests as well. In these, there was an effect of cardiopulmonary bypass temperature on the number of neuropsychologic tests in which there was a preoperative to postoperative deterioration (p = 0.021), the number with bypass at 37 degrees C being significantly greater than the number with bypass at 32 degrees C (p = 0.015). Subsidiary analyses using a multivariate linear model examined the effect of cardiopulmonary bypass temperature on the magnitude of change, with or without allowing for other possible confounding influences. There was an adverse effect of normothermic (37 degrees C) versus moderately hypothermic (32 degrees C) perfusion---more convincingly displayed in the analyses of all seven scores rather than just the Wechsler Adult Intelligence Scale scores. Further cooling to 28 degrees C conferred no additional benefit in terms of cognitive function. The importance of the deterioration is open to question.", "[corrected] A National Institutes of Health-funded clinical trial of patients undergoing coronary artery bypass randomized perfusate and myocardial preservation to cold, tepid, or warm temperatures. The goal of the trial was to evaluate neurologic function before and after operation (4 days and 1 month after operation) and to measure hematologic data for fibrinolytic potential.\n The three groups comprised 116 patients who completed neurologic evaluation by means of the Mathew scale out of 130 entered into the trial (37 cold group, 50 tepid, and 43 warm). Twenty-five patients had complete hematologic studies done. All three groups were comparable before operation. The myocardial preservation protocol used blood cardioplegic solution at cold (8 degrees to 10 degrees C), tepid (32 degrees C), or warm (37 degrees C) temperature and the systemic perfusate temperature during cardiopulmonary bypass was 20 degrees (cold), 32 degrees C (tepid), or 37 degrees (warm).\n Patients in the cold group had a longer duration of intubation and postoperative hospitalization and a slightly but significantly higher peak postoperative creatine kinase MB level than patients in the warm group. There were no deaths. There was deterioration in Mathew scale findings in all three groups, and no distinction could be made between groups. However, a significantly higher number in the cold group had an abnormal postoperative neurologic examination result that prompted computed tomographic scanning (18.9% cold, 2% tepid, 9.3% warm). A cerebrovascular accident was documented by computed tomographic scanning in 8.1%, 0%, and 4.7% of patients in the cold, tepid, and warm groups, respectively (not significant). Hematologic data documented significantly increased fibrinolytic potential in the warm group.\n Perfusion temperature is a factor in recovery from cardiopulmonary bypass. Cold has more adverse neurologic sequelae that prompt computed tomographic scanning whereas warm has more activation of fibrinolytic potential. Tepid is the best temperature for optimizing recovery from cardiopulmonary bypass.", "A prospective, randomized study was performed in 200 patients undergoing coronary artery bypass grafting to compare the myocardial protection obtained with intermittent antegrade warm versus cold blood cardioplegia. Preoperative and surgical characteristics of the two cohorts were similar. Intermittent antegrade infusion of warm blood cardioplegia failed to achieve sustained electromechanical arrest of the heart in 13%. The only difference in clinical outcomes was the more frequent spontaneous return to sinus rhythm after the unclamping of the aorta in the warm group (88% versus 70%, p = 0.002). Mortality (1% each) and myocardial infarction (2% and 4%) rates were similar. Rates of increase in serum activity of the isoenzyme of creatine kinase (CK-MB), CK-MB mass concentration, and cardiac troponin-T level as well as total release of troponin T were significantly lower in the warm group, and fewer patients in this group had a clinically significant increase in serum CK-MB mass (20% versus 39%, p = 0.005) and troponin T (20% versus 56%, p = 0.00001). Thus, intermittent antegrade warm blood cardioplegia is appropriate and clinically safe; the lower release of biochemical markers of myocardial damage suggests improved protection during first-time coronary artery bypass grafting.", "The objective was to examine the effect of temperature (28 degrees vs 36 degrees C) during cardiopulmonary bypass on postoperative cognitive functions in a prospective, double-blind, and randomized manner.\n Sixty-two patients scheduled for coronary operations were randomized to warm or cold cardiopulmonary bypass. Preoperative and postoperative (7 days) neuropsychologic evaluations were performed by an observer unaware of cardiopulmonary bypass temperature.\n Fifty-four patients completed the study (cold bypass, n = 24; warm bypass, n = 30). Significant (p < 0.01) postoperative deterioration for tests of psychomotor coordination and verbal memory was noted in both warm and cold groups, but no differences were observed between groups.\n Temperature during cardiopulmonary bypass for coronary operations does not influence postoperative cognitive function.", "In this study, we assessed the effects of normothermia and hypothermia during cardiopulmonary bypass (CPB) both on internal jugular venous oxygen saturation (SjvO2) and the regional cerebral oxygenation state (rSO2) estimated by near infrared spectroscopy (NIRS).\n Thirty patients scheduled for elective coronary artery bypass graft surgery (CABG) were randomly divided into two groups. Group 1 (n = 15) underwent surgery for normothermic (> 35 degrees C) CPB, and group 2 (n = 15) underwent surgery for hypothermic (30 degrees C) CPB, and alpha-stat regulation was applied. A 4.0-French fiberoptic oximetry oxygen saturation catheter was inserted into the right jugular bulb to continuously monitor the SjvO2 value. To estimate the rSO2 state, a spectrophotometer probe was attached to the mid-forehead. SjvO2 and rSO2 values were then collected simultaneously using a computer.\n Neither the cerebral desaturation time (duration during SjvO2 value below 50%), nor the ratio of the cerebral desaturation time to the total CPB time significantly differed (normothermic group: 18+/-6 min, 15+/-6%; hypothermic group: 17+/-6 min, 13+/-6%, respectively). The rSO2 value in the normothermic group decreased during the CPB period compared with the pre-CPB period. The rSO2 value in the hypothermic group did not change throughout the perioperative period.\n These findings suggest that near infrared spectroscopy might be sensitive enough to detect subtle changes in regional cerebral oxygenation." ]

[ "2301521", "15515199", "9849757", "9550207", "11574936", "10024253", "11893948", "17034605" ]

[ "The conservative management of patients with symptoms of stress incontinence: a randomized, prospective study comparing weighted vaginal cones and interferential therapy.", "A randomized prospective study comparing new vaginal cone and FES-Biofeedback.", "A randomized controlled trial of pelvic floor muscle exercises to treat postnatal urinary incontinence.", "Pelvic floor exercises versus vaginal weight cones in genuine stress incontinence.", "Effectiveness of two conservative modes of physical therapy in women with urinary stress incontinence.", "Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women.", "Pelvic floor reeducation for stress incontinence: comparing three methods.", "A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence." ]

[ "Sixty-nine female patients with symptoms of stress urinary incontinence were randomized to treatment with either interferential therapy or weighted vaginal cones. Fifty-four patients completed treatment (interferential therapy, 30 patients; weighted vaginal cones, 24 patients). Patients were assessed by subjective response, pad testing, continence charts, and the maximum weight of cone that could be held actively and passively. Forty-seven patients were reassessed at 6 months (19 cones; 28 interferential), five patients (9.26%) required surgery, and two patients (3.7%) could not be reassessed. Subjective response to treatment was good, with 80% to 90% of patients cured or improved after treatment. After 6 months, 41.67% in the cone group and 40% in the interferential group were subjectively cured, with improvement in 50% and 30%, respectively. Of those patients initially referred for treatment, greater than 30% in each group were cured of symptoms. There was an objective improvement in both groups. In the cone group 50% had improved after treatment and greater than 60% had improved at 6 months as assessed by pad testing, while in the interferential group 76% had improved after treatment and 73% had improved at 6 months. There was no significant difference in improvement between the two groups in any of the methods of assessment. However, the cones require less supervision by trained staff and can be used at home by the patient. Their use results in a savings in time for the physiotherapy department. The use of the cones is recommended as a cost-effective method of treatment that can be added to the present therapy options available to the physiotherapist.", "Several different methods of enhancing pelvic floor functions have been developed and modified. The aim of this study was to compare the efficacy of a new vaginal cone with conventional FES-Biofeedback therapy for female urinary incontinence, with respect to pelvic floor rehabilitation. One hundred and twenty patients, who required a non-surgical treatment for urinary incontinence, were divided randomly into two groups; (1) the Functional Electrical Stimulation (FES)- Biofeedback group (or BFB group) and (2) the new vaginal cone group (or cone group). For a period of six weeks, two training sessions each week were carried out on the BFB group. The new 150-gram dumbbell-shaped vaginal cone, made of fine ceramic material, was developed domestically. A therapist instructed patients in the cone group upon its use for pelvic floor exercise, and directed the exercise to be repeated at home daily; these patients had follow-up visits every week. Objective improvements were obvious in both groups. 88.3% and 91.6% of the cone and BFB groups showed an improvement after treatment, respectively. There was no significant difference in the improvement or dissatisfaction scores of the two groups. In conclusion, no significant differences in the therapeutic effects were observed between the FES- Biofeedback and the new vaginal cone groups. Considering improvements in the quality of life and objective symptoms, the therapeutic effects of the two techniques showed no significant differences. The new vaginal cone is relatively easy to use at home and aids in pelvic floor muscle exercises. Consequently, the new vaginal cone could be used as an alternative non-surgical treatment modality in female stress urinary incontinence.", "A randomized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises (PFME) reduces urinary incontinence 1 year after delivery. Two hundred and thirty women who were incontinent 3 months postpartum were randomized to either a control group doing standard postnatal pelvic floor muscle exercises (n = 117) or to an intervention group (n = 113) who saw a physiotherapist for instruction at approximately 3, 4, 6 and 9 months postpartum. Results collected 12 months after delivery included prevalence and frequency of incontinence and PFME, sexual satisfaction, perineometry measurements and pad tests. Twenty-six (22%) of the control group and 59 (52%) of the intervention group withdrew before the final assessment. The prevalence of incontinence was significantly less in the intervention group than in the control group (50% versus 76%, P=0.0003), and this group also did significantly more PFME. There were no significant differences between the groups as regards sexual satisfaction, perineometry measurements or pad test results.", "To compare pelvic floor exercises and vaginal weight cones in the treatment of genuine stress incontinence.\n Randomised controlled trial.\n Sixty ambulatory and fit white women (mean age 56 years) with urinary stress incontinence, treated by a single physiotherapist as outpatients during twelve weeks. Thirty women were allocated to a weekly session of pelvic floor exercises. Thirty were allocated to using cones, they were seen every two weeks.\n Objective: stress test, vaginal squeezing capacity. Subjective: urinary diary, visual analogue scales.\n Characteristics of both study groups were comparable. Unfortunately, there was an early withdrawal of fourteen (47%) women in the group treated with cones, and none in the other group. Therefore the pelvic floor exercise group was compared not only with the group intended to be treated with cones, but also with the selected group that only received cone therapy. No statistically significantly differences in outcome measures were found between the groups: 53% in the group assigned to pelvic floor exercises and 57% into the group assigned to cones, of which 50% in the group actually treated with cones, considered themselves as cured or improved to a significant degree. Long-term follow-up was not possible as all cone users refused continued exercises with cones once the twelve weeks had ended.\n Pelvic floor exercises and cones are equally effective in the treatment of genuine stress incontinence. Cones are cost and time saving. However, the low patient compliance with the cones importantly limits its clinical applicability, especially in the long run. Therefore, we do not recommend the use of cones.", "Stress incontinence is the most prevalent form of female urinary incontinence and it affects approximately 5% of younger women to nearly 50% of elderly women. Women have traditionally been treated with pelvic floor muscle exercises alone or with the use of vaginal cones. A new treatment mode, vaginal balls, has been developed. The aim of this study was to compare pelvic floor muscle training with and without vaginal balls and to collect information on women's subjective feelings about the two training modes. The study was carried out as a prospective randomized clinical trial. Thirty-seven women aged 25-65 were assigned either to a pelvic floor muscle training program or to a training program using weighted vaginal balls for 4 months. Treatment outcomes were assessed by a pad-test with a standardized bladder volume, vaginal palpation, and by women's self-reported perceptions. The sense of coherence score was compared with the score for a normal population. Ninety-three percent of the women completed the study. Both training modes were effective in reducing urinary leakage: with vaginal balls (P < 0.0001) and without (P < 0.019); and increasing pelvic floor muscle strength: with vaginal balls (P < 0.0039) and without (P < 0.0002). However, the reduction of urinary leakage after four months of exercise in the training group with vaginal balls was significantly better (P < 0.03) than the results in the group training with pelvic floor muscle exercises alone. The study found the weighted vaginal balls to be a good alternative for training pelvic floor muscles in women with stress urinary incontinence.\n Copyright 2001 Wiley-Liss, Inc.", "To compare the effect of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment for genuine stress incontinence.\n Stratified, single blind, randomised controlled trial.\n Multicentre.\n 107 women with clinically and urodynamically proved genuine stress incontinence. Mean (range) age was 49.5 (24-70) years, and mean (range) duration of symptoms 10.8 (1-45) years.\n Pelvic floor exercise (n=25) comprised 8-12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week. The electrical stimulation group (n=25) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day. The vaginal cones group (n=27) used cones for 20 minutes a day. The untreated control group (n=30) was offered the use of a continence guard. Muscle strength was measured by vaginal squeeze pressure once a month.\n Pad test with standardised bladder volume, and self report of severity.\n Improvement in muscle strength was significantly greater (P=0.03) after pelvic floor exercises (11.0 cm H2O (95% confidence interval 7.7 to 14.3) before v 19.2 cm H2O (15.3 to 23.1) after) than either electrical stimulation (14.8 cm H2O (10. 9 to 18.7) v 18.6 cm H2O (13.3 to 23.9)) or vaginal cones (11.8 cm H2O (8.5 to 15.1) v 15.4 cm H2O (11.1 to 19.7)). Reduction in leakage on pad test was greater in the exercise group (-30.2 g; -43. 3 to 16.9) than in the electrical stimulation group (-7.4 g; -20.9 to 6.1) and the vaginal cones group (-14.7 g; -27.6 to -1.8). On completion of the trial one participant in the control group, 14 in the pelvic floor exercise group, three in the electrical stimulation group, and two in the vaginal cones group no longer considered themselves as having a problem. Conclusion: Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence.", "Stress urinary incontinence is a common problem among women of all ages but may resolve with pelvic floor reeducation in many cases. Compliance to a regimen of pelvic floor muscle exercises is poor and many devices have been produced to make exercising these muscles more effective and interesting. This article describes a study in which two such devices -- vaginal cones and pressure biofeedback -- were compared with pelvic floor exercises alone. The results show that there is no statistically significant difference between the three modalities; all treatments produced significant improvement in symptoms and quality of life scores.", "To assess the efficacy and cost-effectiveness of pelvic floor muscle therapies (PFMT) in women aged > or = 40 years with urodynamic stress incontinence (USI) and mixed UI.\n In a three-arm randomized controlled trial in Leicestershire and Rutland UK, 238 community-dwelling women aged > or = 40 years with USI in whom previous primary behavioural intervention had failed were randomized to receive either intensive PFMT (79), vaginal cone therapy (80) or to continue with primary behavioural intervention (79) for 3 months. The main outcome measure was the frequency of primary UI episodes, and secondary measures were pad-test urine loss, patient perception of problem, assessment of PF function, voiding frequency, and pad usage. Validated scales for urinary dysfunction, and impact on quality of life and satisfaction were collected at an independent interview.\n All three groups had a moderate reduction in UI episodes after intervention but there was no statistically significant difference among the groups. There were marginal improvements in voiding frequency for all groups, with no statistically significant difference among them.\n In women who have already had simple behavioural therapies (including advice on PFM exercises) for urinary dysfunction, the continuation of these behavioural therapies can lead to further improvement. The addition of vaginal cone therapy or intensive PFMT does not seem to contribute to further improvement. The improvement in pelvic floor function was significantly greater in the PFMT arm than in the control arm although this did not translate into changes in urinary symptoms." ]

[ "3351688", "10333394", "7932931", "10617696" ]

[ "Need for endotracheal intubation and suction in meconium-stained neonates.", "The need for delivery room intubation of thin meconium in the low-risk newborn: a clinical trial.", "Tracheal suction in meconium stained infants: a randomized controlled study.", "Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial." ]

[ "In a prospective study, we determined whether routine immediate tracheal aspiration at birth is necessary in meconium-stained but otherwise normal infants delivered vaginally and having a 1-minute Apgar score greater than 8. A total of 572 newborn infants who met these criteria were randomly allocated to one of two groups. All infants underwent oropharyngeal suctioning with a DeLee catheter while the head was still on the perineum. In group I (n = 308) suctioning of the trachea under direct vision was performed instantly at birth; in group II (n = 264) this procedure was not done. There was no mortality among infants in the study, but morbidity, mainly pulmonary and laryngeal disorders, occurred in six of 308 group I infants and in none of the group II infants (P less than 0.025). Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with meconium-stained amniotic fluid.", "The delivery room management of meconium-stained amniotic fluid remains controversial. We attempted to determine if intubation of the low-risk newborn with thin meconium affects the incidence of respiratory symptoms. Exclusion criterion included moderate or thick meconium, fetal distress, neonatal depression, or prematurity. Eligible infants were randomized to either an intubation (group I) or to a nonintubation group (group II). The outcome was the presence of respiratory symptoms. Patients were studied from May 1994 to June 1997. There were 8967 births during this period: 7.9% (708/8967) were delivered through meconium. Thin meconium was noted in 50.3% (356/708) of all births. 24/356 infants with thin meconium were excluded for medical criterion. One hundred sixty-three infants were medically eligible but could not be randomized due to lack of consent, late arrival of the team, or obstetrician request. These were placed into intubation (group I B) and nonintubation (group II B) groups. Seventy-seven infants were randomized into group I and 92 infants into group II. From the intubation groups I and I B, one required supplemental oxygen and was weaned to room air in 7 hr. From the nonintubation groups II and II B, two infants required oxygen, weaning to room air in 11 and 46 hr. Comparing birth weight, gestational age, sex, mode of delivery and 5-min Apgar, there were no significant differences. However, the intubation groups had significantly lower 1-min Apgar scores. There was no airway morbidity reported in the intubation groups. In the infant with thin meconium and an otherwise low-risk pregnancy, we were unable to demonstrate a difference in respiratory symptoms with intubation and intratracheal suctioning.", "We performed a randomized controlled study of the mortality and morbidity of 49 babies born with thick meconium staining of amniotic fluid. These unasphyxiated babies were consecutively born and were admitted to the intensive care unit for observation as routine. The groups were comparable in regard to sex, birth weight, gestational age, maternal factors like anaemia, toxaemia, antepartum haemorrhage, prolonged rupture of membranes, presentation, and interventions including caesarian section. The control group, comprising 26 babies received only oropharyngeal suction, while the intervention group, comprising 23 babies, underwent oropharyngeal suction followed by tracheal suction. There was no significant difference in the mortality or morbidity in form of evidence of air leak or hypoxic ischaemic encephalopathy.", "Disagreement exists concerning the appropriate delivery room management of the airway of vigorous meconium-stained infants. Some suggest a universal approach to intubation and suctioning of the airway in all such neonates, whereas others advocate a selective approach. We performed this investigation: 1) to assess whether intubation and suctioning of apparently vigorous, meconium-stained neonates would reduce the incidence of meconium aspiration syndrome (MAS); and 2) to determine the frequency of complications from delivery room intubation and suctioning of such infants.\n Inclusion criteria included: 1) gestational age >/=37 weeks; 2) birth through meconium-stained amniotic fluid of any consistency; and 3) apparent vigor immediately after birth. Subjects were randomized to be intubated and suctioned (INT) or to expectant management (EXP). Primary outcome measures included: 1) the incidence of respiratory distress, including MAS, and 2) the incidence of complications from intubation.\n A total of 2094 neonates were enrolled from 12 participating centers (1051 INT and 1043 EXP). Meconium-stained amniotic fluid consistency was similar in both groups. Of the 149 (7.1%) infants that subsequently demonstrated respiratory distress, 62 (3.0%) had MAS and 87 (4.2%) had findings attributed to other disorders. There were no significant differences between groups in the occurrence of MAS (INT = 3.2%; EXP = 2.7%) or in the development of other respiratory disorders (INT = 3.8%; EXP = 4.5%). Of 1098 successfully intubated infants, 42 (3.8%) had a total of 51 complications of the procedure. In all cases, the complications were mild and transient in nature.\n Compared with expectant management, intubation and suctioning of the apparently vigorous meconium-stained infant does not result in a decreased incidence of MAS or other respiratory disorders. Complications of intubation are infrequent and short-lived." ]

[ "15967914", "6395773", "8304707", "8420491", "17121036", "19177141", "8002646", "18087004" ]

[ "Prediction of survival for patients with bullous pemphigoid: a prospective study.", "[Treatment of bullous pemphigoid with prednisolone only: 0.75 mg/kg/day versus 1.25 mg/kg/day. A multicenter randomized study].", "[Methylprednisolone versus prednisolone methylsulfobenzoate in pemphigoid: a comparative multicenter study].", "Controlled trial of azathioprine and plasma exchange in addition to prednisolone in the treatment of bullous pemphigoid.", "[Effects of jingui shenqi pill combined prednisone on expression of glucocorticoid receptor and its clinical effect in treating bullous pemphigoid patients].", "A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study.", "Nicotinamide and tetracycline therapy of bullous pemphigoid.", "A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid." ]

[ "To identify the prognostic factors of bullous pemphigoid (BP).\n Prospective study of patients with BP included in a randomized, controlled trial.\n Twenty dermatology departments in France. Patients One hundred seventy patients with BP initially treated with a 40-g/d dosage of clobetasol propionate cream (testing sample) and 171 patients initially treated with oral corticosteroids at a dosage of 0.5 or of 1.0 mg/kg per day, depending on the extent of BP (validation samples).\n The end point was overall survival during the first year after BP diagnosis. From the testing sample, associations of clinical and biological variables with overall survival were assessed using univariate and multivariate analyses. Selected predictors were included in a prognostic model. To verify that these predictors were not dependent on the treatment used, the model was then validated independently on the 2 series of BP patients treated with oral corticosteroids.\n Median age of the BP patients included in the testing sample was 83 years. The 1-year Kaplan-Meier survival rate was 74%. From univariate analysis, the main deleterious predictors were demographic factors (ie, older age and female sex), associated medical conditions (ie, cardiac insufficiency, history of stroke, and dementia), and low Karnofsky score, which is a measure of the patient's general condition. No factors directly related to BP, in particular extent of cutaneous lesions, were shown to be related to the patients' prognosis. From multivariate analysis, only older age (P = .02) and low Karnofsky score (P<.001) appeared independently predictive of death. From the Cox model including these 2 predictors, the predicted 1-year survival rates were 90% (95% confidence interval [CI], 85%-96%) for patients 83 years or younger with Karnofsky score greater than 40, 79% (95% CI, 69%-90%) for patients older than 83 years with Karnofsky score greater than 40, 65% (95% CI, 50%-86%) for patients 83 years or younger with Karnofsky score of 40 or less, and 38% (95% CI, 26%-57%) for patients older than 83 years with Karnofsky score of 40 or less. Kaplan-Meier survival distributions of patients from the validation samples appeared clearly separated according to these 4 categories and were in close agreement with corresponding predicted 1-year survival rates obtained from the testing sample.\n The prognosis of patients with BP is influenced by age and Karnofsky score. These predictors are easy to use and should facilitate the management of BP.", "Systemic corticosteroids for the treatment of bullous pemphigoid are an accepted therapeutic measure among dermatologists. Nevertheless, the best initial dosage is still unknown. The purpose of the present study was to compare the efficacy and safety of two dosages of prednisolone used as a single therapeutic agent: 0.75 mg/kg/day versus 1.25 mg/kg/day for three weeks. Fifty patients with bullous pemphigoid confirmed by direct cutaneous immunofluorescence were included in this study in different centers. They were randomly assigned to one of two groups: 24 patients were treated with prednisolone 0.75 mg/kg/day (group I) and 22 patients were treated with 1.25 mg/kg/day (group II). Four patients had to be excluded from this study. The low and high dosage prednisolone groups do not show a statistically significant difference from each other after 51 days. At day 21, 58 p. 100 of the patients in group I were disease-free, and 64 p. 100 in group II. At day 51, after a slow decrease of prednisolone therapy (half of the initial dosage per day), 33 p. 100 of the patients in group I were still free of skin lesions, and 55 p. 100 in group II.", "Bullous pemphigoid is a bullous skin disease associated with basal membrane antibodies. At present, the first treatment of these lesions is with corticosteroids. In this randomized study we compared the clinical results obtained with methylprednisolone (MePr) in 28 patients and with prednisolone methylsulfobenzoate (MsPr) in 29 patients. Both drugs were administered orally in daily doses of 1 to 1.5 mg/kg bodyweight. Three clinical data were examined: the number of bullous lesions, the intensity of pruritus and the extent of erythema after 5 then 10 days of treatment. After 10 days, the number of bullous lesions had decreased by 83 p. 100 with MePr and by 78 p. 100 with MsPr, and the decrease of pruritus had been significantly more pronounced in the MePr group than in the Ms group (p < 0.05). There had been no difference between treatments in the regression of erythema. Altogether, good results were obtained in 22/28 patients under MsPr (78.6 p. 100) and 18/29 patients under MePr (62.1 p. 100). This raises the question of the value of pharmacokinetic studies not only with these two corticosteroids, but also with prednisone which seems to be better absorbed.", "Bullous pemphigoid is usually treated with systemic corticosteroids. Side effects are common in elderly patients, justifying the search for adjuvant therapy. This randomized, multicentric unblind study was designed to assess the efficacy of azathioprine or plasma exchange when added to conventional doses of prednisolone. One hundred patients with active disease entered the study. They were randomly allocated to receive 28 days of treatment with oral prednisolone sodium metasulfobenzoate (1 mg/kg per day) either alone or in combination with oral azathioprine (100 to 150 mg/d) or four large-volume plasma exchanges. After 28 days, the prednisolone doses were progressively decreased according to the same strict regimen in the three groups (in combination with oral azathioprine in group 2).\n The clinical results were evaluable in 98 of the 100 patients included in the study. There was no appreciable difference in the percentages of complete remission of the disease in the three therapeutic groups at 28 days (71%, 80%, and 71%, respectively) or at 6 months (42%, 39%, and 29%, respectively). Severe complications were more often observed among patients receiving azathioprine. At 6 months, 14 of 98 patients had died, without any differences noted among the three study groups.\n We conclude that neither azathioprine nor plasma exchange is effective enough to be used routinely as an adjuvant to corticosteroids in the management of bullous pemphigoid.", "To investigate the effect of Jingui Shenqi Pill (JSP) on the expression of glucocorticoid receptor (GR) in the skin lesion and its clinical effect in treating bullous pemphigoid (BP) patients.\n Thirty BP patients were randomly divided into the treatment group (n=15) treated with JSP plus prednisone and the prednisone group (n=15) with prednisone alone both for 4 weeks. And a normal control group was set up also. Expressions of GR-alpha and GR-beta in the skin lesion of BP patients and the normal skin of the normal control were detected by immunohistochemical assay. Results The total effective rate was 93.33% in the treatment group, significantly higher than that in the prednisone group which was 73.33% (P < 0.05); GR-alpha expression was higher in the treatment group than that in other two groups (P < 0.01), while GR-beta expression in the treatment group was lower than that in the prednisone group (P < 0.01).\n JSP could increase GR-alpha expression and decrease GR-beta expression in the skin lesion of BP patients, so as to improve sensitivity of skin to glucocorticoid.", "Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients' survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n=134) or extensive (n=178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40 g per day initially, with CS tapering over 12 months) or the mild regimen (10-30 g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P=0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P=0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio=0.54; 95% confidence interval, 0.30-0.97; P=0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients' outcome.", "The combination of nicotinamide and tetracycline has been anecdotally reported to be effective in the treatment of bullous pemphigoid. We conducted a randomized, open-labeled trial comparing the combination of 500 mg of nicotinamide, three times daily, and 500 mg of tetracycline four times daily, with prednisone therapy in 20 patients with bullous pemphigoid. The study was divided between an 8-week acute phase with fixed drug dosages and a 10-month follow-up phase in which study medications were tapered based on patient response.\n Eighteen of 20 patients enrolled in the study were treated, two patients were unavailable for follow-up. Twelve patients were treated with the combination of nicotinamide and tetracycline and six patients were treated with prednisone. There were five complete responses, five partial responses, one nonresponder, and one patient with disease progression in the nicotinamide and tetracycline group compared with one complete response and five partial responses in the prednisone group. There were no statistically significant differences in response parameters between the two groups. All five patients in the nicotinamide and tetracycline group receiving long-term follow-up remained disease free during medication tapering, while three patients in the prednisone group had repeated disease flare-ups with steroid tapering. Adverse effects in the nicotinamide and tetracycline group included gastrointestinal upset (two patients) and transient renal failure (one patient). In the prednisone group, there was one occurrence each of hypertension, erosive gastritis, multiple decubitus ulcers, osteomyelitis, deep venous thrombosis, and death related to sepsis. Two patients required insulin therapy for hyperglycemia.\n The combination of nicotinamide and tetracycline appears to be a useful alternative to systemic steroids in the treatment of bullous pemphigoid.", "To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of bullous pemphigoid.\n A prospective, multicenter, randomized, nonblinded clinical trial to compare 2 parallel groups of patients with bullous pemphigoid undergoing different treatments.\n Thirteen departments of dermatology in Germany.\n Patients with bullous pemphigoid (n = 73) as evidenced by clinical lesions suggestive of bullous pemphigoid, signs of subepidermal blistering on histologic analysis of skin biopsy specimens, linear deposition of IgG and C3 along the dermoepidermal junction, and deposition of autoantibodies at the blister roof in split-skin analysis.\n Treatment with oral methylprednisolone plus azathioprine (azathioprine group) or oral methylprednisolone plus mycophenolate mofetil (mycophenolate mofetil group).\n The cumulative total methylprednisolone doses and rates of remission. Secondary outcome measures were safety profiles and duration of remission.\n In 38 of 38 patients in the azathioprine group (100%), complete remission was achieved after a mean +/- SD of 23.8 +/- 18.9 days vs 42.0 +/- 55.3 days for 35 of 35 patients in the mycophenolate mofetil group (100%). In the azathioprine group, the median +/- SD total cumulative methylprednisolone dose used was 4967.0 +/- 12 190.7 mg vs 5754.0 +/- 9692.8 mg in the mycophenolate mofetil group. Nine of 38 patients in the azathioprine group (24%) experienced grade 3 or 4 adverse effects vs 6 of 35 patients in the mycophenolate mofetil group (17%). Azathioprine therapy induced significantly elevated liver function test results compared with mycophenolate mofetil (P < .001). Importantly, patients in the azathioprine group showed significantly higher toxicity grades for aspartate aminotransferase (P = .03), alanine aminotransferase (P = .03), and gamma-glutamyltransferase (P = .01) than did those in the mycophenolate mofetil group.\n Mycophenolate mofetil or azathioprine demonstrate similar efficacy during treatment of bullous pemphigoid, and similar cumulative corticosteroid doses were given in both treatment arms to control disease. However, mycophenolate mofetil showed a significantly lower liver toxicity profile than azathioprine therapy." ]

[ "11468047", "6866594", "6907868", "7715976", "10368917", "15748130", "6912894", "7869147", "16000966", "6566129", "3639536", "9549449", "6903906", "1556284", "7088627", "17273449", "17252892", "7075329", "16938002", "3176449" ]

[ "Use of a behavioural programme in the first 3 months to prevent infant crying and sleeping problems.", "Enhancing infant development and parent-practitioner interaction with the Brazelton Neonatal Assessment Scale.", "Enhancing reciprocity between mother and neonate.", "Patient education: effects of two teaching methods upon parental retention of infant feeding practices.", "The role of an early intervention on enhancing the quality of mother-infant interaction.", "Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial.", "Effectiveness of prenatal and postnatal instruction in postpartum care.", "Effectiveness of postpartum education received by certified nurse-midwives' clients at a university hospital.", "An intervention program for families with irritable infants.", "Promoting awareness: the mother and her baby.", "Effect of early postpartum teaching on primiparas' knowledge of infant behavior and degree of confidence.", "The effects of postnatal health education for mothers on infant care and family planning practices in Nepal: a randomised controlled trial.", "Effect of teaching on primiparas' perceptions of their newborn.", "Effects of parent training on infant sleeping patterns, parents' stress, and perceived parental competence.", "Increasing the protection of newborn infants in cars.", "First-time mothers' selection of infant supine sleep positioning.", "A behavioral-educational intervention to promote maternal and infant sleep: a pilot randomized, controlled trial.", "Early intervention using Brazelton training with middle-class mothers and fathers of newborns.", "An intervention to increase father involvement and skills with infants during the transition to parenthood.", "Maternal role competence." ]

[ "To assess the effectiveness of a behavioural programme introduced in the first 3 months of age in preventing infant crying and sleeping problems. Two issues were addressed: (i) which elements of the behavioural programme would parents implement; and (ii) whether the behavioural programme was more effective in reducing infant crying and encouraging night-time sleeping than an educational intervention or the routine services.\n Mothers and newborns were assigned at random to the behavioural programme (n = 205), educational intervention (n = 202), or control (n = 203) group. Behaviour diaries kept before randomization and at 3, 6, 9 and 12 weeks of age were used to measure implementation of the interventions and infant behaviour, including crying and sleeping. Crying and sleeping problems were followed up using questionnaire measures at 9 months of age.\n The educational intervention did not change parental care behaviour. One element of the behavioural programme, a focal feed between 10 PM and midnight, was not implemented. A second element, stretching of interfeed intervals after 3 weeks of age, was implemented initially, but not maintained at older ages. The third element, which asked parents to emphasise day and night differences in the environment, and to settle their babies in the cot and minimise interaction at night, was carried out by more parents in the behavioural group than in the other groups. This led to an increase of around 10% in the number of babies who slept for 5 or more hours at night (a definition of sleeping through the night) at 12 weeks of age. Fewer behavioural programme parents sought help for crying and sleeping problems between 3 and 9 months of age.\n The behavioural programme produced a modest increase in the number of infants who slept through the night by 12 weeks of age. The results are discussed in relation to other findings, which bear on the programme's adoption for routine health-care policy and practice.", "Studies performed in low socioeconomic populations have shown that the demonstration of a newborn's developmental capacity to his mother during the first few days post partum enhances subsequent mother-infant interactions. This study was undertaken to determine whether demonstrating the Brazelton Neonatal Assessment Scale to white middle-class mothers would result in similar outcomes. Mothers of 75 neonates were randomly assigned to either an experimental group or to one of two control groups. Direct observation, subjective assessment of mother-infant interactions, and maternal questionnaires were used 1 and 3 months later to assess outcomes on several dimensions. Mothers in the experimental group spent more time playing with, talking to, and looking at their infants than did those in either control group, and were less likely to use feeding as a method of interacting with their infants. Experimental group mothers also were more likely to ask developmentally related questions. However, no differences were found in most indices of maternal-infant interaction used. The results of this study and a review of the literature indicate that the recommendation that such a demonstration be performed with all neonates must be weighed against the other methods available for enhancing infant development and healthy parent-child interaction.", "Thirty mothers of newborn infants were assigned to one of three equal-sized treatment groups to assess the effects on maternal responsiveness of an early intervention designed to familiarize mothers with the capabilities and individual characteristics of their infants. Mothers in one treatment group observed the administration of the Brazelton Neonatal Behavior Assessment Scale to their infants, were given an explanation of each item on the scale, and were told their infants' responses. Mothers in a second group were given the same individualized explanations about the scale items and their infants' responses, but did not observe the events. A third group of mothers, which served as control group, received individual instruction on infant furnishings. Maternal responsiveness was enhanced significantly in the \"show-and-tell\" group but not in the \"tell-only\" group. Parallel effects on infant responsiveness were also observed. '", "The purpose of this study was to test a strategy for improving patient's retention of discharge teaching.\n A pretest-posttest experimental design was used. Forty postpartum women were randomly assigned to a group. All subjects received infant feeding instruction until they reached criterion on the Infant Feeding Questionnaire. The experimental group received additional instruction on the same material (overlearning). The two groups were compared 2 weeks later on the same questionnaire. Mean scores were compared by a t-test, demographic variables were correlated to outcomes, and effect of race or culture was analyzed by ANOVA.\n The pretest showed no significant difference between the groups. Posttest scores were significantly higher for the experimental group. The mother's education was the only demographic variable that was correlated to the results.\n Mothers who receive overlearning beyond the mastery level retain significantly more of the material.", "The study examines an intervention designed to influence mothers' sensitive responsiveness toward their infant by presenting information about the newborn's competence to interact and promoting affectionate handling and interaction with the infant. Thirty-six primiparous mothers and their newborn infants participated in the study. On day 2/3 after delivery, mother-infant dyads were assigned to either: (1) an experimental group that received an intervention program designed to enhance mother-infant interaction; or (2) a control group that was presented with an intervention that emphasized basic caregiving skills. One month later an observation was undertaken in the home to assess mother-infant synchronous and asynchronous co-occurrences during free-play and infant bathing. The enhancement group showed a reliably greater frequency of co-occurrences involving vocal exchanges, looking to the partner, and physical contact. There also were differences in mothers' responsiveness to infant crying and involuntary responses. The findings show that even a modest videotaped early intervention can enhance mothers' sensitive responsiveness to the infant.", "To evaluate the effect of a behaviour modification program, taught to parents in a single visit to a trained nurse, in improving sleep performance in newborn infants, Australia.\n Randomised controlled trial.\n 268 families with normal newborn infants in the community, recruited between October 1996 and March 1997 from birth notices published in a South Australian daily newspaper.\n A 45-minute consultation with a nurse 2-3 weeks after the birth, including a tutorial discussion on normal sleep patterns in newborn infants, supported by retained written material and, for infants with weight gain < 30 g daily, referral to their usual postnatal care provider.\n Hours of daytime sleep (0600-1800), night sleep (1800-0600) and total sleep per 24 h; and number of daily records with total sleep >/= 15 h per 24 h, assessed by 7-day sleep diary at ages 6 and 12 weeks.\n 268 families returned at least one sleep diary (137/171 intervention, 131/175 control), recording 3273 days. Two intervention infants were referred for low weight gain. Total sleep time was 15 h or more per 24 h on 62% of recorded days in the intervention group, compared with 36% in the control group (P < 0.001). At 6 weeks of age, intervention infants slept a mean 1.3 h per day more than control infants (95% CI, 0.95-1.65), comprising a mean 0.5 h more night sleep (95% CI, 0.32-0.69) and 0.8 h more daytime sleep (95% CI, 0.56-1.07). At 12 weeks, intervention infants slept a mean 1.2 h per day more (95% CI, 0.94-2.14), comprising 0.64 h more night sleep (95% CI, 0.19-0.89) and 0.58 h more daytime sleep (95% CI, 0.39-1.03). There was no significant difference in crying time between the groups.\n A single consultation supported by written material in the first 3 weeks of a child's life improves sleep performance at 6 weeks of age. This improvement is maintained at 3 months.", "nan", "This pilot study's objective was to determine the effectiveness of postpartum education received by midwifery clients at the University of New Mexico Hospital. The authors of the study randomized 100 women following delivery to two groups. Group one, n = 55, received written postpartum instructions only. Group two, n = 45, received oral instructions by the certified nurse-midwife in addition to the written instructions. Both groups answered a written questionnaire after the teaching. Analyses were carried out on 100 posttest scores. Mean test scores for group one was 17.9 out of a possible score of 20. Mean score for group two was 18.3. No significant difference was detected between these two mean scores. A 95% confidence interval for the difference between mean scores was -1.9 to 1.1 (P > .05). Reliability of instrument was established via the Kuder-Richardson formula 21. This conservative estimate of internal consistency yielded r = .50. The authors found that oral instructions by the certified nurse-midwife did not significantly increase the knowledge of primiparas as evidenced by posttest results. However, results must be interpreted cautiously for three reasons: low reliability of the instrument, the small difference between groups, and the sample size. The need to determine how best to approach postpartum education is imperative in this era of early hospital discharge. A certified nurse-midwife's time may be better spent focusing on individual concerns rather than on a set teaching agenda. Alternative opportunities such as postpartum home visits need to be explored as a means of providing support and guidance to new mothers.", "To describe and evaluate a home-based nursing intervention program, the REST routine, which incorporates the use of infant behavior assessment, pattern recognition, individualized infant schedules, specific management strategies, and parent education and support.\n A two-site clinical trial was conducted on 164 healthy full-term infants with excessive unexplained irritability or colic. Infants between the ages of 2 to 6 weeks were randomized to routine care or a home-based intervention program (n = 121). A third group (n = 43) of infants too old at entry for randomization (mean age = 10.4 weeks) were entered into a posttest-only group.\n Infants in the REST routine treatment group cried 1.3 hours per day on average following the intervention program as compared to the control group crying 3 hours per day (p = .02). Infant irritability was resolved (< 1 hour) in 62% of the treatment group while only in 29% of the control group at the time of the 8-week follow-up visit (p = .04).\n Families in both the treatment and control groups reported benefiting from a nurse visiting in their home to inquire about their infant and their well-being. Options for individualizing the program for those most in need of intensive home visiting and other delivery modes for the intervention are areas for further investigation.", "This study considered the problem of how to increase a mother's awareness of her infant's behavior and her own behavior as a beginning step toward the promotion of quality interaction between mother and infant. The impact of informing 108 mothers of term infants and 32 mothers of preterm infants about: (a) neonatal interactive, motoric, state control, and response to stress behavior patterns; and (b) maternal behaviors to enhance and support infant behavior was tested with four groups. In describing the behavior that occurred during a feeding session, mothers in two treatment groups reported significantly more of their own behavior than that of their neonate. They more closely resembled the trained observers' report of the behavior than did mothers in two control groups. Recommendations include incorporating an educative treatment in plans of nursing care for mothers and infants and further research to determine the optimal timing and long-term effects of such an intervention.", "The purpose of this experimental study was to determine the effectiveness of teaching primiparous mothers about infant behavior. Experimental mothers (n = 17) received a teaching intervention representative of the Brazelton Neonatal Behavioral Assessment Scale when their infants were 2 weeks old; contrast mothers (n = 16) completed a Newborn Information Checklist about infant behavior at home two weeks postnatally; control mothers (n = 13) received neither teaching nor a checklist. At a 4-week postnatal office visit, experimental mothers had more knowledge about infant behavior than either the contrast or control mothers. There was no difference among the groups regarding maternal confidence in interpreting behavioral cues of their own infant. Contrast mothers reported wanting information about topics included in the teaching intervention.", "To evaluate impact of postnatal health education for mothers on infant care and postnatal family planning practices in Nepal.\n Randomised controlled trial with community follow up at 3 and 6 months post partum by interview. Initial household survey of study areas to identify all pregnant women to facilitate follow up.\n Main maternity hospital in Kathmandu, Nepal. Follow up in urban Kathmandu and a periurban area southwest of the city.\n 540 mothers randomly allocated to one of four groups: health education immediately after birth and three months later (group A), at birth only (group B), at three months only (group C), or none (group D).\n Structured baseline household questionnaire; 20 minute, one to one health education at birth and three months later.\n Duration of exclusive breast feeding, appropriate immunisation of infant, knowledge of oral rehydration solution and need to continue breast feeding in diarrhoea, knowledge of infant signs suggesting pneumonia, uptake of postnatal family planning.\n Mothers in groups A and B (received health education at birth) were slightly more likely to use contraception at six months after birth compared with mothers in groups C and D (no health education at birth) (odds ratio 1.62, 95% confidence interval 1.06 to 2.5). There were no other significant differences between groups with regards to infant feeding, infant care, or immunisation.\n Our findings suggest that the recommended practice of individual health education for postnatal mothers in poor communities has no impact on infant feeding, care, or immunisation, although uptake of family planning may be slightly enhanced.", "To determine if a relationship exists between structured, informative in-home teaching concerning infant behavior and primiparous mothers' perceptions of their newborn, 30 primiparas completed Broussard's Neonatal Perception Inventories I and II. The sample--30 women between the ages of 18 and 30 who had had no chronic disorders and had experienced normal pregnancy, labor, delivery, and postpartal course--was deliberately selected from a 489-bed community teaching hospital; 15 women were assigned randomly to a control group and 15 to an experimental group. All participants completed NPI I on their first or second postpartum day. Experimental participants received structured, informative teaching concerning infant behavior two to four days after discharge. All subjects were again visited at one month to complete NPI II. Data were analyzed by t test; significance was set at p = .05. No significant difference was found between the groups in NPI I perceptions. On NPI II a significantly positive change in perception was found for the experimental group, but not for the control group.", "First-time parent couples from childbirth classes were randomly assigned to a four-session training group (n = 29) or a control group (n = 31). Members of the training group were taught behavioral strategies to promote healthy, self-sufficient sleep patterns in their infants, whereas the control group received the same amount of personal contact without the behavioral training. Six sleep variables were derived from a daily infant sleep diary completed by parents at two time points. Results show that at age 6-9 weeks, infants in the training group displayed significantly better sleeping patterns than did control infants. Training group parents awakened and responded less often to infant signaling and reported greater parental competence. By contrast, control group parents indicated increased stress over time.", "Recently the American Academy of Pediatrics instituted a major campaign (\"The First Ride--A Safe Ride\") in order to encourage all parents to use an infant restraint seat for their newborn's first ride in an automobile--the ride home from the hospital. In the present study the effect of the behavior of the hospital staff on parents' use of infant restraint seats was examined. This study involved 30 mother-infant pairs who were selected sequentially from an obstetrics unit and randomly assigned to two groups. A control group was discharged from the obstetrics unit with no particular emphasis on car safety and no loaner restraint seat available. An experimental group was offered a loaner restraint seat at the time of discharge, with a staff person demonstrating how to put the infant into the restraint seat, how to carry the infant in the seat out to the car, and how to fasten the restraint seat in the automobile with the auto lap belt. Correct use of the loaner restraint seat on the first ride home was observed in 67% of the experimental mothers and in none (0%) of the control mothers. Although this difference was no longer significant at four- to six-week follow-up this study points out the short-term impact that hospital staff can have on the parents' use of restraint seats. Additional techniques are needed to maintain parents' use of restraint seats throughout childhood.", "The incidence of Sudden Infant Death Syndrome (SIDS) has decreased dramatically since the inception of the \"Back to Sleep\" campaign initiated by the American Academy of Pediatrics in 1992. However, that decrease has leveled off and many new parents cease to follow the recommendation to place their infants in the supine position for sleep between 1 and 3 months of age, the peak age for the incidence of SIDS. Shortened hospital stays for new mothers and the overwhelming amount of required patient teaching dictate the need to find the best method of instruction. The purpose of this study was to determine if a one-on-one teaching intervention improved the effectiveness of patient education and led to an increase in the desired behavior of placing the infant to sleep in the supine position. A quantitative experimental approach was used to examine the difference in compliance of supine infant positioning. Participants were drawn from a convenience sample of 61 primiparous women between the ages of 18 and 35 years with random assignment to either the experimental or control group. Compared to mothers in the control group, mothers in the experimental group demonstrated greater compliance in selecting supine sleep position in the first week home from the hospital and on the day of follow-up 6 weeks later. However, no difference in \"usual position\" was reported at 6 weeks and for the night previous to follow-up.", "Maternal and infant sleep are significant health concerns for postpartum families. The results of previously published studies have indicated that behavioral-educational strategies promote infant sleep, but these reports relied on parental report and did not include maternal sleep. This pilot study of a maternal-infant sleep intervention evaluated feasibility, acceptability, and effects on sleep and other outcomes in the early postpartum period.\n Randomized controlled trial with concealed-group allocation.\n Hospital postpartum unit with home follow-up.\n First-time mothers and their infants randomly assigned to sleep intervention (n = 15) or control group (n = 15).\n The sleep intervention included a 45-minute meeting with a nurse to discuss sleep information and strategies, an 11-page booklet, and weekly phone contact to reinforce information and problem solve. The control group received a 10-minute meeting during which only maternal sleep hygiene and basic information about infant sleep were discussed, a 1-page pamphlet, and calls at weeks 3 and 5 to maintain contact without provision of advice.\n Questionnaires were completed at baseline and 6 weeks; sleep diaries and mother and infant actigraphy were completed at 6 weeks. The mothers in the sleep intervention group averaged 57 minutes more nighttime sleep, and fewer rated their sleep as a problem, as compared with the mothers in the control group. Infants in the sleep intervention group had fewer nighttime awakenings and had maximum lengths of nighttime sleep that were, on average, 46 minutes longer than those in the control group.\n A behavioral-educational intervention with first-time mothers in the early postpartum period promotes maternal and infant sleep. Further evaluation of the intervention in a larger, more diverse sample is needed.", "The purpose of this study was to test the effectiveness of the Brazelton exam as a parent education tool for mothers and fathers. 42 middle-class families with firstborn, healthy, full-term infants were randomly assigned to one of three groups: father treatment, mother treatment, and control. The target parents in the treatment groups were taught to perform the Brazelton exam on their own infant, with attention being drawn to the infant's most positive interactive and physical abilities. Questionnaire and observational data were collected in the hospital and at 4 weeks postpartum. These included measures of knowledge of infant behavior, confidence in parenting ability, satisfaction with the infant, and behavior with the infant. The results showed that treatment parents scored higher in knowledge about infants, at both the early and the 4-week periods. Also, treatment fathers were more involved in caretaking with their infants at 4 weeks than were control fathers. More modest treatment effects were shown for confidence and satisfaction measures. No behavioral treatment effects were found during a 10-min observation of parent-infant interaction.", "This study examined whether a group educational intervention during the transition to parenthood can enhance the quality of father-child interaction and increase father involvement with their children. A randomized experimental design was used to evaluate an 8-session program with 165 couples who were first-time parents, beginning during the second trimester of pregnancy and ending at 5 months postpartum. Outcomes were assessed with time diaries, coded observations of parent-child play, and self-reports of fathers and mothers. The intervention had positive effects on fathers' skills in interacting with their babies and their involvement on work days but not home days. It is concluded that a relatively brief intervention during the transition to parenthood can improve fathering, and possible reasons for differential effects on areas of parenting are explored.\n Copyright (c) 2006 APA, all rights reserved.", "nan" ]

[ "7546114", "7982015" ]

[ "The effects of non-thermal pulsed electromagnetic energy on wound healing of pressure ulcers in spinal cord-injured patients: a randomized, double-blind study.", "The effect of diapulse therapy on the healing of decubitus ulcer." ]

[ "The objective of this randomized, double-blind study was to determine if non-thermal pulsed electromagnetic energy treatment significantly increases the healing rate of pressure ulcers in patients with spinal cord injuries. Subjects included volunteers admitted to a Veteran's Administration Hospital in New York over a 2 year period and consisted of 30 male spinal cord-injured patients, 20 with Stage II and 10 with Stage III pressure ulcers. Subjects were given non-thermal pulsed high-frequency electromagnetic energy treatment for 30 minutes twice daily for 12 weeks or until healed. The percentage of pressure ulcers healed was measured at one week. Of the 20 patients with Stage II pressure ulcers, the active group had a significantly increased rate of healing with a greater percentage of the ulcer healed at one week than the control group. After controlling for the baseline status of the pressure ulcer, active treatment was independently associated with a significantly shorter median time to complete healing of the ulcer. Stage III pressure ulcers healed faster in the treatment group but the sample size was limited. For spinal cord-injured men with Stage II pressure ulcers, active non-thermal pulsed electromagnetic energy treatment significantly improved healing.", "The effect of pulsed high peak power electromagnetic field (Diapulse) on treatment of pressure ulcers is under investigation. 20 elderly patients, aged from 60 to 84, hospitalized with chronic conditions and bearing long-standing pressure ulcers, are subjected to Diapulse sessions (1-2 daily), parallel to conventional treatment. 5 patients undergo conventional therapy, serving as control and 5 others follow conventional+placebo Diapulse treatment. All patients were daily monitored, concerning their clinical status and ulcers' healing. After a maximum 2-weeks treatment, bulge healing rate was, as follows: 85% excellent and 15% very good healing under Diapulse therapy; in the placebo group, 80% patients show no improvement and 20% poor improvement; in the control group, 60% patients show no improvement and 40% poor improvement of ulcers. This investigation strongly advises for Diapulse treatment as a modern, uninvasive therapy of great efficiency and low social costs in resolving a serious, widespread medical problem." ]

[ "11036894", "11082090", "10591717", "16138795", "10078179", "11842709", "16053592", "15207444", "15604157" ]

[ "Alternative strategies for stroke care: a prospective randomised controlled trial.", "\"Hospital at home\" versus hospital care in patients with exacerbations of chronic obstructive pulmonary disease: prospective randomised controlled trial.", "Randomised controlled trial of effectiveness of Leicester hospital at home scheme compared with hospital care.", "Home management of mild to moderately severe community-acquired pneumonia: a randomised controlled trial.", "Hospital in the home: a randomised controlled trial.", "Cost comparison of hospital- and home-based treatment models for acute chronic obstructive pulmonary disease.", "The effectiveness, acceptability and costs of a hospital-at-home service compared with acute hospital care: a randomized controlled trial.", "A randomized controlled trial of a home hospital intervention for frail elderly demented patients: behavioral disturbances and caregiver's stress.", "Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital." ]

[ "Organised specialist care for stroke improves outcome, but the merits of different methods of organisation are in doubt. This study compares the efficacy of stroke unit with stroke team or domiciliary care.\n A single-blind, randomised, controlled trial was undertaken in 457 acute-stroke patients (average age 76 years, 48% women) randomly assigned to stroke unit, general wards with stroke team support, or domiciliary stroke care, within 72 h of stroke onset. Outcome was assessed at 3, 6, and 12 months. The primary outcome measure was death or institutionalisation at 12 months. Analyses were by intention to treat.\n 152 patients were allocated to the stroke unit, 152 to stroke team, and 153 to domiciliary stroke care. 51 (34%) patients in the domiciliary group were admitted to hospital after randomisation. Mortality or institutionalisation at 1 year were lower in patients on a stroke unit than for those receiving care from a stroke team (21/152 [14%] vs 45/149 [30%]; p<0.001) or domiciliary care (21/152 [14%] vs 34/144 [24%]; p=0.03), mainly as a result of reduction in mortality. The proportion of patients alive without severe disability at 1 year was also significantly higher on the stroke unit compared with stroke team (129/152 [85%] vs 99/149 [66%]; p<0.001) or domiciliary care (129/152 [85%] vs 102/144 [71%]; p=0.002). These differences were present at 3 and 6 months after stroke.\n Stroke units are more effective than a specialist stroke team or specialist domiciliary care in reducing mortality, institutionalisation, and dependence after stroke.", "To compare \"hospital at home\" and hospital care as an inpatient in acute exacerbations of chronic obstructive pulmonary disease.\n Prospective randomised controlled trial with three months' follow up.\n University teaching hospital offering secondary care service to 350 000 patients.\n Selected patients with an exacerbation of chronic obstructive pulmonary disease where hospital admission had been recommended after medical assessment. Interventions: Nurse administered home care was provided as an alternative to inpatient admission.\n Readmission rates at two weeks and three months, changes in forced expiratory volume in one second (FEV(1)) from baseline at these times and mortality.\n 583 patients with chronic obstructive pulmonary disease referred for admission were assessed. 192 met the criteria for home care, and 42 refused to enter the trial. 100 were randomised to home care and 50 to hospital care. On admission, FEV(1) after use of a bronchodilator was 36.1% (95% confidence interval 2.4% to 69.8%) predicted in home care and 35.1% (6.3% to 63. 9%) predicted in hospital care. No significant difference was found in FEV(1 )after use of a bronchodilator at two weeks (42.6%, 3.4% to 81.8% versus 42.1%, 5.1% to 79.1%) or three months (41.5%, 8.2% to 74.8% versus 41.9%, 6.2% to 77.6%) between the groups. 37% of patients receiving home care and 34% receiving hospital care were readmitted at three months. No significant difference was found in mortality between the groups at three months (9% versus 8%).\n Hospital at home care is a practical alternative to emergency admission in selected patients with exacerbations of chronic obstructive pulmonary disease.", "To compare effectiveness of patient care in hospital at home scheme with hospital care.\n Pragmatic randomised controlled trial.\n Leicester hospital at home scheme and the city's three acute hospitals.\n 199 consecutive patients referred to hospital at home by their general practitioner and assessed as being suitable for admission. Six of 102 patients randomised to hospital at home refused admission, as did 23 of 97 allocated to hospital.\n Hospital at home or hospital inpatient care.\n Mortality and change in health status (Barthel index, sickness impact profile 68, EuroQol, Philadelphia geriatric morale scale) assessed at 2 weeks and 3 months after randomisation. The main process measures were service inputs, discharge destination, readmission rates, length of initial stay, and total days of care.\n Hospital at home group and hospital group showed no significant differences in health status (median scores on sickness impact profile 68 were 29 and 30 respectively at 2 weeks, and 24 and 26 at 3 months) or in dependency (Barthel scores 15 and 14 at 2 weeks and 16 for both groups at 3 months). At 3 months' follow up, 26 (25%) of hospital at home group had died compared with 30 (31%) of hospital group (relative risk 0. 82 (95% confidence interval 0.52 to 1.28)). Hospital at home group required fewer days of treatment than hospital group, both in terms of initial stay (median 8 days v 14.5 days, P=0.026) and total days of care at 3 months (median 9 days v 16 days, P=0.031).\n Hospital at home scheme delivered care as effectively as hospital, with no clinically important differences in health status. Hospital at home resulted in significantly shorter lengths of stay, which did not lead to a higher rate of subsequent admission.", "To determine whether community management of mild to moderate community-acquired pneumonia (CAP) is as effective and acceptable as standard hospital management of CAP.\n Randomised controlled trial.\n Christchurch, New Zealand, primary and secondary care.\n 55 patients presenting or referred to the emergency department at Christchurch Hospital with mild to moderately severe pneumonia, assessed using a validated pneumonia severity assessment score, from July 2002 to October 2003.\n Hospital treatment as usual or comprehensive care in the home delivered by primary care teams.\n Primary: days to discharge, days on intravenous (IV) antibiotics, patient-rated symptom scores. Secondary: health status measured using level of functioning at 2 and 6 weeks, patient satisfaction.\n The median number of days to discharge was higher in the home care group (4 days; range, 1-14) than in the hospital groups (2 days; range, 0-10; P = 0.004). There was no difference in the number of days on IV antibiotics or on subsequent oral antibiotics. Patient-rated symptom scores at 2 and 6 weeks, median change in symptom severity from baseline to 6 weeks, and general functioning at 2 and 6 weeks did not differ between the groups. Patients in both groups were satisfied with their treatment, with a clear preference for community treatment (P < 0.001).\n Mild to moderately severe CAP can be managed effectively in the community by primary care teams. This model of comprehensive care at home can be implemented by primary care teams with suitable funding structures.", "To compare treatment of acute illness at home and in hospital, assessing safety, effect on geriatric complications, and patient/carer satisfaction.\n Randomised controlled trial.\n A tertiary referral hospital affiliated with the University of New South Wales.\n 100 patients (69% older than 65 years) with a variety of acute conditions, who were assessed in the emergency department as requiring admission to hospital.\n Patients were allocated at random to be treated by a hospital-in-the-home (HIH) service in their usual residence or to be admitted to hospital.\n Geriatric complications (confusion, falls, urinary incontinence or retention, faecal incontinence or constipation, phlebitis and pressure areas), patient/carer satisfaction, adverse events, and death.\n There was a lower incidence of confusion (0 v. 20.4% [95% CI, 9.1%-31.7%]; P = 0.0005), urinary complications (incontinence or retention) (2.0% [95% CI, -1.8%, 5.8%] v. 16.3% [95% CI, 6.0%, 26.6%]; P = 0.01), and bowel complications (incontinence or constipation) (0 v. 22.5% [95% CI, 10.7%, 34.1%]; P = 0.0003) among HIH-treated patients. No significant difference in number of adverse events and deaths (to 28 days after discharge) in the two groups was found (although numbers were small). Patient and carer satisfaction was significantly higher in the HIH group.\n Home treatment appears to provide a safe alternative to hospitalisation for selected patients, and may be preferable for some older patients. We found high levels of both patient and carer satisfaction with home treatment.", "This trial compared the cost of an integrated home-based care model with traditional inpatient care for acute chronic obstructive pulmonary disease (COPD). 25 patients with acute COPD were randomised to either home or hospital management following request for hospital admission. The acute care at home group costs per separation ($745, CI95% $595-$895, n = 13) were significantly lower (p < 0.01) than the hospital group ($2543, CI95% $1766-$3321, n = 12). There was an improvement in lung function in the hospital-managed group at the Outpatient Department review, decreased anxiety in the Emergency Department in the home-managed group and equal patient satisfaction with care delivery. Acute care at home schemes can substitute for usual hospital care for some patients without adverse effects, and potentially release resources. A funding model that allows adequate resource delivery to the community will be needed if there is a move to devolve acute care to community providers.", "To compare the safety, effectiveness, acceptability and costs of a hospital-at-home programme with usual acute hospital inpatient care.\n Patients aged 55 years or over being treated for an acute medical problem were randomized to receive either standard inpatient hospital care or hospital-at-home care. Follow-up was for 90 days after randomization. Health outcome measures included physical and mental function, self-rated recovery, health status as assessed by the SF-36, adverse events and readmissions to hospital. Acceptability was assessed using satisfaction surveys and the Carer Strain Index. Costs comprised hospital care, care in the home, community services, general practitioner services and personal health care expenses.\n In all, 285 people were randomized with a mean age of 80 years. There were no significant differences in health outcome measures between the two randomized groups. Significantly more patients receiving care at home reported high levels of satisfaction, as did more of their relatives. Relatives of the care-at-home group also reported significantly lower scores on the Carer Strain Index. However, the mean cost per patient was almost twice for patients treated at home (NZ 6524 dollars) as for standard hospital care (NZ 3525 dollars). A sensitivity analysis indicated that, if the service providing care in the home had been operating at full capacity, the mean cost per patient episode would have been similar for both modes of care.\n This hospital-at-home programme was found to be more acceptable and as effective and safe as inpatient care. While caring for patients at home was significantly more costly than standard inpatient care, this was largely due to the hospital-at-home programme not operating at full capacity.", "A Geriatric Home Hospitalization Service (GHHS) has been operating in Torino at S. Giovanni Battista Hospital since 1985. GHHS allows us to perform diagnostic and therapeutic interventions, which are usually made in hospital, also at home. GHHS team includes geriatricians, nurses, physiotherapists, social workers and counselors. Between February 1999 and April 2002, the GHH Service conducted a randomized controlled trial on 109 elderly, demented patients requiring admission to the Hospital Emergency Department (ED)for acute illnesses. Objective of the study was to identify the benefits of the care in a GHHScompared to a general medical ward (GMW) in reducing behavioral disturbances in elderly patients with advanced dementia and in lowering caregiver's stress. Patients were randomly assigned to GHHS (56 patients) or to GMW (53 patients). Both groups were examined using the same protocol and were evaluated on admission and on discharge. All patients had a severe form of dementia as shown by the clinical dementia rating (CDR) scale mean value (3.7 +/- 0.9) with an important functional impairment and a relevant degree of comorbidity.The main reasons for hospitalization were infections, cerebrovascular accidents and malnutrition. Mortality of total sample was 19.3 %, without significant differences in the two settings of care. On discharge, in GHHS patients there was a significant reduction of behavioral disturbances. The use of anti-psychotic drugs was significantly lower in GHHS patients compared to the GMW group (p < 0.001). The stress of caregivers on discharge was reduced only in GHHS group and not in the control ones. In conclusion, we can say that a GHHS continuous support allows us to reduce the family caregiver's stress. When treated at home, demented patients do not have to change their environment or routine and it is possible to have a better control on behavioral disturbances.", "To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital.\n Prospective randomised controlled trial.\n Christchurch, New Zealand.\n 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital.\n Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded.\n The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home.\n Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment." ]

[ "18684735", "15126522", "19684043", "20483664" ]

[ "A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation.", "Induction of multiple follicular development by a single dose of long-acting recombinant follicle-Stimulating hormone (FSH-CTP, corifollitropin alfa) for controlled ovarian stimulation before in vitro fertilization.", "A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol.", "Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women." ]

[ "This study primarily investigated the dose-response relationship of corifollitropin alfa to initiate multifollicular development for the first 7 days of controlled ovarian stimulation (COS).\n Women aged 20-39 years undergoing COS for in vitro fertilization or intracytoplasmic sperm injection were randomized to a single dose of corifollitropin alfa 60, 120 or 180 microg, or daily injections of 150 IU recombinant follicle-stimulating hormone (rFSH). Patients treated with corifollitropin alfa started fixed daily treatment with 150 IU rFSH on stimulation Day 8. Patients received a GnRH antagonist (ganirelix 0.25 mg/day) from stimulation Day 5 until the day of human chorionic gonadotrophin.\n Pharmacokinetics of corifollitropin alfa were dose-proportional. The main reason for not having embryo transfer was insufficient ovarian response in 30.8, 2.6, 3.8 and 7.4% of patients in the corifollitropin alfa 60, 120, 180 microg and rFSH groups, respectively. On Day 8, the mean (standard deviation) number of follicles >or=11 mm was 6.8 (4.4), 10.1 (6.1) and 12.8 (7.5), respectively. The number of cumulus-oocyte complexes retrieved showed a clear dose-response relationship (P < 0.0001), being 5.2 (5.5), 10.3 (6.3) and 12.5 (8.0) in the three dose groups, respectively.\n A single injection of corifollitropin alfa induces dose-related increase in multifollicular development and in the number of retrieved oocytes. The optimal dose for a 1-week interval is higher than 60 microg and lower than 180 microg and will be selected based on modelling and simulation taking into account insufficient stimulation as well as overstimulation. Clinical Trials gov: NCT00598208.", "In a first feasibility study, the efficacy and safety of a single dose of recombinant long-acting FSH (FSH-CTP) were investigated in in vitro fertilization (IVF) patients undergoing controlled ovarian stimulation with a flexible GnRH antagonist protocol. Eligible subjects were randomized to receive a single dose of 120 micro g (n = 25), 180 microg (n = 24), or 240 microg (n = 25) corifollitropin alfa (FSH-CTP) or to start daily fixed doses of 150 IU recombinant FSH (rFSH) (n = 24, reference). Subjects who received a single dose of FSH-CTP continued 1 wk after injection (treatment d 8) with fixed daily doses of 150 IU rFSH (Puregon/Follistim) until the day of triggering final oocyte maturation. The terminal half-life of FSH-CTP was, on average, 65 h and dose independent. Cycle cancellation before human chorionic gonadotropin (hCG) administration occurred in only three subjects treated with FSH-CTP. The median duration of stimulation was 10.0 d in each FSH-CTP group and 9.0 d in the daily rFSH group. The total number of follicles at least 11 mm at stimulation d 8 and at the day of hCG administration tended to increase with dose of FSH-CTP, although a significant dose-response relationship was revealed only for the number of follicles at least 15 mm on the day of hCG (P = 0.03). Serum estradiol levels and inhibin-B levels were not significantly different between the four groups on d 8 and on the day of hCG. In total, 12 subjects (17.6%) in the FSH-CTP groups and two subjects (8.3%) in the rFSH group experienced a premature LH rise (defined as LH >or= 10 IU/liter) before the start of the GnRH antagonist (P value not significant between groups). This relatively high incidence of women demonstrating an early LH rise in the FSH-CTP groups may be related to the higher initial rises of serum estradiol and the use of a flexible GnRH antagonist protocol. The mean number of oocytes recovered per started cycle was higher in FSH-CTP-treated subjects compared with rFSH-treated subjects (significant at P = 0.03 for the 240- microg FSH-CTP group), but no difference could be noted between the number of good quality embryos (range of means, 3.8-4.8 per attempt), and equal numbers of embryos were available for embryo transfer. In summary, FSH-CTP appeared to be a potent inducer of multiple follicular growth; additional research will be needed to select the optimal FSH-CTP dose and treatment time interval.", "Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation.\n In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 microg corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol.\n The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1% for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): -3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulus-oocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively P = 0.15).\n Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.", "In this double-blind, double-dummy, randomized, equivalence trial (Ensure), 396 women weighing 60kg or less who underwent controlled ovarian stimulation prior to IVF or intracytoplasmic sperm injection were randomized in a 2:1 ratio to a single dose of 100mug corifollitropin alfa or daily 150IU recombinant FSH (rFSH) for the first 7days of stimulation in a gonadotrophin-releasing hormone antagonist protocol. The mean +/- SD number of oocytes retrieved per started cycle was 13.3 +/- 7.3 for corifollitropin alfa versus 10.6 +/- 5.9 for rFSH. The estimated treatment difference of +2.5 oocytes (95% CI 1.2-3.9) in favour of corifollitropin alfa (P<0.001) was well within the predefined equivalence margin. The median (range) duration of stimulation was 9 (6-15) days in both groups. In 32.8% of the patients, one injection of corifollitropin alfa was sufficient to reach the human chorionic gonadotrophin criterion. The incidence of moderate and severe ovarian hyperstimulation syndrome was 3.4% for corifollitropin alfa and 1.6% for rFSH. A dose of 100mug corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight.\n 2010 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved." ]

[ "9431382", "12922087", "17532669", "15370670", "12718838", "11457553", "17961876", "19467896", "11732460", "12424582", "16640847", "12431356", "10772563", "10969252", "11144372", "11906779", "11144370", "19333002", "11228385" ]

[ "Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine.", "Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age.", "Immunogenicity and Reactogenicity following Primary Immunisation with a Combined DTaP-HBV Vaccine and a Haemophilus influenzae Type B Vaccine Administered by Separate or Mixed Injection.", "Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age.", "Immunogenicity and reactogenicity of combined versus separately administered DTPw-HBV and Hib vaccines given to healthy infants at 2, 4 and 6 months of age, with a booster at 18 months.", "Reactogenicity of DTPa-HBV/Hib vaccine administered as a single injection vs DTPa-HBV and Hib vaccines administered simultaneously at separate sites, to infants at 2, 4 and 6 months of age.", "The immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 combination vaccine: results from four phase III multicenter trials across three continents.", "Primary and booster immunization with a diphtheria, tetanus, acellular pertussis, hepatitis B (DTPa-HBV) and Haemophilus influenzae type b (Hib) vaccine administered separately or together is safe and immunogenic.", "A new combined DTP-HBV-Hib vaccine--strategy for incorporation of Hib vaccination into childhood immunisation programmes.", "Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule.", "A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America.", "Primary and booster vaccination with DTPw-HB/Hib pentavalent vaccine in Costa Rican children who had received a birth dose of hepatitis B vaccine.", "The new DTPw-HBV-Hib combination vaccine can be used at the who schedule with a monovalent dose of hepatitis B vaccine at birth.", "Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B virus- inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections.", "Immunogenicity of a Haemophilus influenzae type b-tetanus toxoid conjugate vaccine when mixed with a diphtheria-tetanus-acellular pertussis-hepatitis B combination vaccine.", "DTPw-HB and Hib primary and booster vaccination: combined versus separate administration to Latin American children.", "Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants.", "A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (liq) and TritanrixHB + Hiberix (lyo) in Indian infants administered according to the EPI schedule.", "A combined liquid Hib (PRP-OMPC), hepatitis B, diphtheria, tetanus and whole-cell pertussis vaccine: controlled studies of immunogenicity and reactogenicity." ]

[ "We compared antibody levels following separate but simultaneous administration of diphtheria and tetanus toxoids with acellular pertussis vaccine (DTaP) containing pertussis toxoid, filamentous hemagglutinin, and pertactin (PRN); hepatitis B vaccine; and Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate; PRP) vaccine conjugated to tetanus toxoid (PRP-T) with those following administration of a combination of a DTaP-hepatitis B vaccine-PRP-T to infants at 2, 4, and 6 months of age. The antibody response to a booster dose of PRP conjugate vaccine (CRM197-OS) in infants with low (< 1 microgram/mL) or undetectable (< 0.10 microgram/mL) postpriming levels of antibody to PRP was also studied. Antibody levels were quantitated before and after dose 3 by enzyme-linked immunosorbent assay, radioimmunoassay, or neutralization assay. Seroresponse rates were not different between the two vaccine groups except for rates of response to PRP. There was a trend that levels of antibody to all the antigens included in the combination vaccine were lower than those of antibody to antigens in separate vaccines; for levels of antibody to diphtheria toxoid (P = .001), PRN (P < .0001), and PRP (P < .0001), the differences were significant. Despite low or undetectable postpriming levels of antibody to PRP, high-titered (geometric mean concentration, 9.02 micrograms/mL; range, 1.0-81.5 micrograms/mL), immunoglobulin G-predominant antibody to PRP was produced following a booster dose of CRM197-OS, a finding consistent with a memory response.", "An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age. A total of 235 completed the study, 120 from Group 1 and 115 from Group 2. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1: 40; Group 2: 31) to assess the immune response to vaccination. Local and general solicited symptoms were recorded by parents on diary cards. Seven hundred and five diary cards (Group 1: 360; Group 2: 345) were collected. The clinically relevant and most commonly reported local reaction was pain (infant cried when the limb was moved) in 2.5% (Group 1) and 1.2% (Group 2) of diary cards. Fever was more frequently reported in Group 1 (21% of diary cards) than in Group 2 (12% of diary cards). However only 3 and 2% of doses in Groups 1 and 2, respectively, were responsible for a rectal temperature between 38.6 and 39.5 degrees C and only one case (Group 2) had > or =39.5 degrees C. Other clinically relevant general symptoms were rarely recorded: irritability (2-2.8%), loss of appetite (0.3-0.6%) and drowsiness (0.3-0.3%). All subjects included in the immunogenicity analysis had seroprotective titres to diphtheria, tetanus, polio virus types 1 and 3, Hib. Almost all subjects were seroprotected for anti-polio type 2 and hepatitis B (with the exception of 1 subject in Group 1 for each antigen). The vaccines response rates to pertussis antigens were over 97 and 90% in Groups 1 and 2, respectively. This study shows that, from a clinical perspective, the DTPa-HBV-IPV/Hib vaccine given in a single injection has a similar reactogenicity and safety profile to that of two licensed vaccines (DTPa-IPV/Hib, HBV) given in two simultaneous injections to infants at 2, 4 and 6 months of age. This is a valuable advantage, since in some countries, such as Spain and the UK, an additional injection (for the administration of meningococcal C conjugate vaccine) has been recently included in the infants' vaccination calendars.", "The aim of this open, randomised, multicentre trial was to evaluate the immunogenicity and reactogenicity of the tetravalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTaP-HBV) vaccine when given either as a mixed or as a separate concomitant injection with the Haemophilus influenzae type b (Hib) vaccine at 3, 5 and 11 months of age.\n Antibody against diphtheria, tetanus, pertussis (ELISA), hepatitis B (radioimmunoassay) and Hib polyribosylribitol phosphate (PRP) [radiolabeled antigen binding assay] was determined. Solicited local and systemic adverse events were evaluated on the day of each vaccination and for three subsequent days. Follow-up of unsolicited and serious adverse events was conducted for 30 days following each vaccination.\n A total of 360 subjects were enrolled in the study. After completion of the three-dose vaccination course, seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, together with a pertussis vaccine response, were seen in almost all subjects with immunogenicity results (n = 336). All subjects had post-vaccination Hib anti-PRP antibody concentrations of at least 0.15 mug/mL, and 97.0% and 99.4%, respectively, of the subjects receiving a single or separate injections had Hib anti-PRP antibody concentrations >/=1.0 mug/mL. Addition of the Hib vaccine to the tetravalent DTaP-HBV vaccine did not increase the incidence of local or systemic reactions.\n Combination of DTaP-HBV and Hib vaccines in a single injection is safe, immunogenic and well tolerated, and thus has the potential to simplify the childhood immunisation schedule in Italy.", "A combined DTPa-HBV-IPV/Hib vaccine containing diphtheria (D), tetanus (T), acellular pertussis (Pa), hepatitis B (HBV) and types 1, 2 and 3 inactivated polioviruses (IPV) extemporaneously mixed with a conjugated Haemophilus influenzae type b (Hib) vaccine (Group 1) was compared to the DTPa-HBV-IPV and Hib vaccines (Group 2) administered separately at 3, 5 and 11 months of age (n = 440). A microneutralization assay was used to detect antibodies against the 3 polio virus types (cut-off 1:8 dil), RIA for anti-HBs antibodies (cut-off 10 mIU/ml) and ELISA for antibodies against all other vaccine antigens (cut-off: 0.1 IU/ml for anti-tetanus and anti-diphtheria antibodies; 5 El.U/ml for antibodies against each of the 3 acellular pertussis antigens and 0.15 microg/ml for anti-PRP antibodies). Similar immune responses were observed in both groups 1 month after dose 2 as well as after dose 3. Six months after dose 2 however, the proportion of subjects maintaining an anti-tetanus antibody concentration > or = 0.1 IU/ml was lower in Group 2 and a slight group difference in favour of Group 1 was also observed for anti-PRP, anti-diphtheria and anti-polio type 1 antibody persistence prior to the third dose. The overall incidence of local and general solicited symptoms was similar in both groups. One subject discontinued study vaccination following an SAE considered to be related to vaccination. The DTPa-HBV-IPV/Hib combined vaccine is immunogenic and well tolerated when administered according to a 3, 5 and 11 month vaccination schedule and can therefore be considered as a feasible alternative to the separate administration of the pentavalent DTPa-HBV-IPV and the monovalent Hib vaccines.", "To determine the immunogenicity and reactogenicity of a combined DTPw-HBV/Hib vaccine, in comparison with DTPw-HBV and Hib vaccines given as separate concomitant injections.\n In an open, randomized study, healthy infants were injected with either DTPw-HBV/Hib vaccine or separate DTPw-HBV and Hib vaccines at 2, 4 and 6 months of age, with a booster at 18 months.\n Both vaccination regimens were immunogenic, with seropositivity rates of 100% after the booster vaccination for all vaccine components. Even as early as 2 months after the second dose of the primary vaccination, most patients had seroprotective antibody titers, the proportion of seropositive subjects approaching 100% for tetanus, hepatitis B, and Hib. Post-primary and post-booster geometric mean titers (GMTs) were well above seroprotective thresholds for each vaccine antigen in both groups, with no clinically relevant differences in the groups. The separate and combined administrations showed comparable reactogenicity profiles, and neither showed a significant increase in reactogenicity with successive doses.\n The results of this study support the combination of Hib and DTPw-HBV vaccination in routine infant immunization at 2, 4 and 6 months of age with a booster at 18 months. Maximum benefit is obtained from compliance with the full course, but substantial benefit is likely to be achieved even in partially compliant patients, provided they receive at least two doses. Furthermore, these results demonstrate the tolerability of a fourth (booster) administration, where the addition of the Hib vaccine to DTPw-HBV did not lead to an increase in the overall reactogenicity.", "An open, randomised, multicentre trial was performed to assess the reactogenicity and safety profile of the administration of a candidate Haemophilus influenzae type b (Hib) conjugate vaccine with a quadrivalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTPa-HBV) vaccine as a single injection (Group 1) versus the simultaneous administration of the latter vaccine (DTPa-HBV) and an available Hib conjugate vaccine (Group 2) in opposite thighs, as a primary vaccination course to healthy infants at 2, 4 and 6 months of age. Eight hundred and eighty five infants (9.3+/-1.4 weeks old) were randomly allocated to Group 1 (n=665) and Group 2 (n=221). Oral polio vaccine was given concomitantly to all subjects. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1, 73; Group 2, 22) for serological determinations. Local and general symptoms were recorded by parents on diary cards. 2614 diary cards (Group 1, 1966; Group 2, 648) were collected. There were no statistically significant differences in the incidence of local and general symptoms between groups. Pain such that the infant cried when limb was moved was reported in 0.6 and 0.2% in groups 1 and 2, respectively. Redness and swelling (>20 mm in diameter) were recorded between 2.1 and 3% in both groups. Fussiness preventing normal activities was the most frequently reported general symptom in both groups (1.6 and 1.9% in groups 1 and 2, respectively). Fever (rectal temperature >39.5 degrees C) was reported in 0.4% (Group 1) and 0.3% (Group 2). All subjects included in the immunogenicity analysis had seroprotective or seropositive titres to the diphtheria, tetanus, hepatitis B and pertussis components of the vaccines. About 99 and 100% of infants had anti-PRP titres > or =0.15 mcg/ml in groups 1 and 2, respectively. This study indicates that DTPa-HBV vaccine given in a single injection with a candidate Hib conjugate vaccine has a similar reactogenicity profile to that of two commercially available vaccines (DTPa-HBV, Hib) given in two simultaneous injections to infants 2, 4 and 6 months of age.", "This paper presents the results of four separate phase III trials, which assessed the immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 in comparison with licensed Tritanrix-Hep B (GlaxoSmithKline Biologicals) and Hiberix (10 microg PRP), given as separate or mixed injections (3 trials) or with or without hepatitis B vaccine at birth (1 trial). The immunogenicity of DTPw-HBV/Hib 2.5 was non-inferior to the reference vaccine regimen in terms of seropositivity rates. The overall reactogenicity profile of DTPw-HBV/Hib 2.5 was also similar to that of the reference vaccine regimen. These results confirm the previously established immunogenicity and safety of reduced dose PRP conjugated vaccine regimens.", "The aim of this study was to evaluate the safety and immunogenicity of DTPa-HBV and Hib vaccines given mixed or separately to 360 healthy infants at 2, 4, and 6 months of age.\n Immune memory was assessed in lower responders (post-primary anti-PRP <0.545 microg/ml), through administration of plain polyribosylribitol phosphate (PRP) at 12-15 months. All subjects received a DTPa-HBV/Hib booster at 18-19 months.\n One month after primary vaccination, 98% had seroprotective antibody levels against HBV and 94-97% against Hib (anti-PRP> or =0.15microg/ml). A statistically significant difference between groups was observed in the proportion of subjects who achieved anti-PRP antibodies > or =1.0microg/ml post-primary vaccination; 68.1% for DTPa-HBV/Hib and 84.5% for DTPa-HBV and Hib. PRP administered to lower responders produced a 7-fold increase in anti-PRP antibodies, indicative of immunological memory. After DTPa-HBV/Hib booster vaccination, 96-100% of subjects had seroprotective antibody concentrations against Hib, hepatitis B, tetanus, and diphtheria and high vaccine response rates against pertussis toxoid, filamentous hemagglutinin, and pertactin.\n A robust and protective Hib response was demonstrated following plain PRP and/or a booster conjugate Hib vaccine in both lower and higher Hib responders.\n Copyright 2009 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.", "To evaluate the immunogenicity and reactogenicity of a pentavalent vaccine prepared by extemporaneously mixing diphtheria-tetanus pertussis-hepatitis B vaccine (DTP-HBV) and lyophilised Haemophilus influenzae type B (Hib)-tetanus conjugate vaccines in the same syringe, compared with the same vaccines given as separate, concomitant administrations.\n Open, randomised comparative study.\n Durban, South Africa.\n A total of 120 healthy male and female infants were enrolled in the trial and randomised into two groups; group 1 received the combined administration (DTP-HBV-Hib), and group 2 received separate administrations of DTP-HBV and Hib vaccines. Vaccines were given as a three-dose primary vaccination course at 2, 4 and 6 months [corrected] of age.\n Antibody levels were measured using standard techniques and local and general solicited symptoms were recorded using diary cards.\n All subjects had seroprotective titres against diphtheria and tetanus; and antipolyribose-ribitol phosphate (PRP) titres > or = 0.15 microgram/ml 1 month after the final dose. A vaccine response (defined as post-vaccination titres > or = 15 ELISA (EL).U/ml in initially seronegative subjects; and as post-vaccination titres > or = pre-vaccination titres in initially seropositive subjects) against the pertussis component was seen in 83% and 85% of subjects in the groups receiving combined and separate administration. No differences were seen in any of the geometric mean titres (GMTs) between the two administrations either 2 months after the second dose or 1 month after the final dose. There was no observed increase in reactogenicity in the group receiving the mixed administration.\n The results demonstrate that combined DTP-HBV-Hib vaccine is well tolerated and immunogenic.", "In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b (DTPa-HBV-IPV/Hib) vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib vaccine was at least as immunogenic as the comparator vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no vaccine-related serious adverse events occurred.\n the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator vaccines thus providing an effective and more comfortable option for this infant vaccination schedule.", "In 1998 the World Health Organization (WHO) recommended the inclusion of Haemophilus influenza type B (Hib) conjugate vaccines in infant immunization programs, whenever in accordance with national priorities. GlaxoSmithKline Biologicals has developed a new pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B/Hib (DTPw-HB/Hib) vaccine containing 5 microg of polyribosylribitol phosphate (PRP), and we assessed the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with this new vaccine compared with a reference regimen consisting of the licensed DTPw-HB (Tritanrix) and Hib (Hiberix) vaccines given as simultaneous concomitant injections.\n We performed a randomized, double-blind study from September 1998 to August 1999 to establish the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with the new pentavalent combined DTPw-HB/Hib vaccine given as a single injection, compared with the reference regimen.\n Both vaccination regimens elicited excellent immune responses, with all subjects in both groups achieving seroprotective anti-PRP antibody concentrations of > or = 0.15 microg/mL one month after primary vaccination. The combined DTPw-HB/Hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components. Persistence of antibodies against all study vaccine antigens up to the time of booster vaccination was comparable between groups, and a marked increase of all antibody concentrations was observed after the booster dose. Both vaccine regimens were similar in terms of their overall reactogenicity profiles.\n Our results indicate that the new DTPw-HB/Hib pentavalent combination vaccine provides an efficient and reliable way of implementing WHO recommendations for controlling hepatitis B and Hib infections on a worldwide basis.", "The DTPw-HB/Hib pentavalent combination vaccine has been developed following recommendations of the World Health Organization for the introduction of hepatitis B (HB) and Haemophilus influenzae type b (Hib) vaccines into routine childhood vaccination programs. The objectives of this study were to: 1) analyze the immunogenicity and the reactogenicity of the DTPw-HB/Hib pentavalent combination vaccine in comparison to separate injections of DTPw-HB and Hib vaccines as primary vaccination in a group of children who had received a dose of HB vaccine at birth and 2) in the second year of life to assess the antibody persistence as well as the response to a DTPw-HB/Hib or DTPw/Hib booster.\n In the first part of the study (primary-vaccination stage), conducted in 1998-1999, we analyzed the immunogenicity and reactogenicity of the DTPw-HB/Hib combination vaccine in comparison to separate injections of DTPw-HB and Hib vaccines as primary vaccination at 2, 4, and 6 months of age in 207 Costa Rican children who had received a dose of HB vaccine at birth. Later, in the booster-vaccination stage of the study, in 1999-2000, in a subset of the children (69 toddlers, now 15-18 months old), antibody persistence was measured, and response to a DTPw-HB/Hib or DTPw/Hib booster was also assessed.\n In both primary-vaccination groups, at least 97.5% of the infants reached protective levels of antibodies (seropositivity) against the antigens employed in the vaccines. The DTPw-HB/Hib pentavalent combination vaccine did not result in more local reactions than did the DTPw-HB vaccine alone, and, in terms of general reactions, there was no clinically significant difference between the combination or separate injections, and with the pentavalent vaccine having the benefit of needing one less injection. Nine months after the third dose of the primary-vaccination course, antibody persistence was similar in both groups, with over 93% of children still having protective/seropositive titers for Hib, HB, and tetanus and about 50% for diphtheria and Bordetella pertussis. At 15 months of age, virtually all the toddlers responded with a strong boost response to all the vaccine antigens, whether they received the DTPw-HB/Hib pentavalent vaccine or the DTPw/Hib vaccine as a booster. Both booster regimens were equally well tolerated, indicating that up to five doses of the HB vaccine can be given without impact on safety.\n Our study confirms that the DTPw-HB/Hib pentavalent vaccine is highly immunogenic as a primary vaccination in children who received an HB vaccine at birth, with the pentavalent combination inducing both persisting immunity and boostable memory. The pentavalent vaccine was safe both for primary and booster vaccinations. Thus, this study in Costa Rican infants supports the routine use of the pentavalent DTPw-HB/Hib vaccine as part of childhood vaccination programs in Latin America and the Caribbean.", "An open, randomized, clinical trial was conducted in order to assess the reactogenicity and immunogenicity of DTPw-HBV and Haemophilus influenzae type b (Hib) vaccines when given either as a mixed administration or as separate concomitant injections using the WHO schedule at 6, 10 and 14 weeks of age, following a dose of HBV at birth. There were no clinically relevant differences in the immune response to any component between the mixed and separate administrations. In fact the anti-tetanus GMTs were significantly higher (p=0.002) in mixed administration (3.9 IU/ml) compared with the separate administration (1.9 IU/ml). However although all subjects achieved anti-PRP titers > or = 0.15 microg/ml, higher anti-PRP GMTs were seen in the group receiving the separate administration. Importantly, the addition of Hib did not adversely alter the reactogenicity profile of DTPw-HBV. This report which demonstrates that this novel combination can be used in WHO recommended schedule.", "The aim of this open, multicenter, randomized trial was to evaluate the immunogenicity and reactogenicity of a candidate combined diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus (DTaP-HBV-IPV) vaccine when given as either a mixed or as separate concomitant injections with Haemophilus influenzae type b (Hib) vaccine.\n A total of 359 subjects were randomized to receive either DTaP-HBV-IPV/Hib (mixed administration - 180 subjects) or DTaP-HBV-IPV + Hib (separate administration in opposite limbs - 179 subjects) at 2, 3, and 4 months of age.\n After vaccination, seroprotective antibody concentrations against diphtheria, tetanus, hepatitis B, and polio viruses and a high (> or = 97%) pertussis vaccine response were seen in almost all study participants. All subjects except one in the mixed administration group had postvaccination Hib anti-PRP antibody concentrations > or = 0.15 microg/mL. Of subjects in the mixed and separate group, 77.2% (geometric mean antibody concentration, 2. 62 microg/mL) and 88.6% (geometric mean antibody concentration, 4.45 microg/mL) had Hib anti-PRP concentrations > or = 1 microg/mL, respectively. The addition of the Hib component to the 5-component vaccine did not increase the incidence of local or general reactions.\n Both administrations of the candidate vaccine were found to be safe, immunogenic, and well tolerated. Although anti-PRP geometric mean antibody concentrations and the percent of subjects achieving the 1 microg/mL seroprotective level were lower after the mixed administration, they were in the range seen with monovalent Hib vaccines or with other DTaP-based/Hib combinations licensed in some European countries. Therefore both administrations have the potential to simplify childhood immunization.", "Combination vaccines are urgently needed to reduce the number of injections given to young children. The aim of the study was to evaluate the safety and immunogenicity of a combination vaccine that contains diphtheria and tetanus toxoids and acellular pertussis antigens (DTaP), recombinant hepatitis B surface antigen (HepB) and Haemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus toxoid (PRP-T).\n Four hundred five infants were randomized equally to three groups and immunized at 2, 4 and 6 months of age with: (1) DTaP/HepB vaccine used to reconstitute lyophilized PRP-T vaccine and administered as a single injection; (2) DTaP/HepB vaccine and PRP-T vaccine administered as two separate injections; or (3) DTaP, HepB and PRP-T vaccines administered as three separate injections. Safety was closely monitored, and blood specimens were obtained to assess antibody responses to each vaccine antigen.\n All study vaccines were well-tolerated, and the rates of systemic and injection site reactions were similar between groups. After the third dose the geometric mean antibody concentrations to Hib were significantly lower in subjects in Group 1 (1.63 microg/ml) compared with subjects in Groups 2 and 3 (6.26 and 6.15 microg/ml, respectively; P < 0.0001). Subjects with antibody concentrations <1.0 microg/ml after the third dose responded well to a booster dose of Hib conjugate vaccine given at 11 to 15 months of age (41 of 44 with anti-PRP > or = 1.0 microg/ml). Differences between groups for antibody responses to the other vaccine components were not clinically significant.\n Infants given a combined DTaP/ HepB/PRP-T vaccine experienced a significantly lower antibody response to the PRP-T component than infants given PRP-T vaccine as a separate injection. However, the immune response to a booster dose of Hib conjugate vaccine indicated the presence of immunologic memory.", "This multicentre study was designed to establish the reactogenicity and immunogenicity profiles of primary and booster vaccination with diphtheria, tetanus, and pertussis whole-cell-hepatitis B/Haemophilus influenzae type-b (DTPw-HB/Hib) administered as either a syringe mix or as separate injections in 400 Latin American children. Both vaccine regimens were equally well tolerated and elicited post-primary excellent seropositivity rates at or close to 100% for all five component antigens. With regard to HB, 100% of subjects in the combined vaccination group, and 98.8% subjects in the separate injection vaccination group reached seroprotective antibody concentrations (>or=10 mIU/ml) 1 month after the primary vaccination course. Equally high anti-PRP antibody concentrations were reached 1 month after vaccination, with 100% of seroprotected subjects in the combined vaccination group (antibody concentrations >or=0.15 microg/ml), against 99.4% in the separate injection vaccination group. Seroprotective anti-HBs and anti-PRP antibody concentration levels persisted approximately 1 year after the primary vaccination course, just prior to booster vaccination. Finally, a significant increase of all antibody concentrations could be observed after the booster vaccination, since all but one subject in the separate injection vaccination group had protective levels of anti-HBs and anti-PRP antibodies 1 month after the booster dose. These results suggest that the combination of DTPw-HB and Hib vaccines provides an effective means for increasing vaccine coverage in childhood vaccination programmes.", "The immunogenicity and safety of a new liquid hexavalent vaccine (diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-hepatitis B-polyribosyl ribitol phosphate conjugated to tetanus protein; Hexavac; Aventis Pasteur MSD, Lyon, France) are compared with those of reference vaccines [diphtheria-tetanus-acellular pertussis-inactivated polio vaccine reconstituting lyophilized purified Haemophilus influenzae polysaccharide conjugated to tetanus protein vaccine (Pentavac; Aventis Pasteur MSD) and hepatitis B vaccine (H-B-Vax II; Aventis Pasteur MSD)] injected separately at the same visit in a prospective multicenter, comparative, open label trial.\n Infants were randomized to receive Hexavac (n = 423) or Pentavac and H-B-Vax II (n = 425) as a primary immunization series at 2, 4 and 6 months of age. Seroprotection and seroconversion rates against all antigens at 1 month after the primary series were compared between the two vaccine groups with 95% confidence intervals (CI0.95) and were considered clinically equivalent (not inferior) when the upper limit of the 95% confidence interval on the difference (reference, hexavalent) was below predefined differences.\n Hexavac met and surpassed the pre-defined criteria for clinical equivalence to Pentavac and H-B-Vax II given concomitantly. It elicited similar seroprotection and seroconversion rates against all antigens. Seroprotection and seroconversion rates obtained 1 month after the third dose of Hexavac were >90% for all antigens. The postimmunization antibody geometric mean titers (GMT) for hepatitis B and purified Haemophilus influenzae polysaccharide were about 2-fold higher in infants who received the reference vaccines than in infants who had received Hexavac. GMTs for poliovirus antibodies tended to be enhanced in infants vaccinated with Hexavac. GMTs for all other antigens were very similar among both groups. Hexavac was generally well-tolerated. At least one local reaction was reported in 20.3% of Hexavac injections compared with 15.8% at the Pentavac injections site and 3.8% at the H-B-Vax II injections site. These reactions were generally mild and transient. At least one systemic adverse event was reported in 45.7% of Hexavac injections compared with 42.2% of Pentavac and H-B-Vax II injections (mild fever, irritability and drowsiness were most frequently reported). The frequency of adverse events was not significantly different between groups. No vaccine-related serious adverse event occurred during the study.\n This liquid hexavalent vaccine was generally well-tolerated and provided immune responses adequate to be protective against six infectious diseases with a single injection, given at 2, 4 and 6 months of age.", "The study was planned to assess and compare the immune response and safety of an indigenous DTPwHB-Hib pentavalent liquid combination vaccine (Shan 5) with Easyfive and TritanrixHB+ Hiberix, the two available pentavalent combination vaccines. Four hundred infants were randomized to receive three doses of either Shan 5 or one of the two comparators. Antibody analysis was performed prior to and four to six weeks post third vaccine dose. Solicited local and systemic events upto three days and unsolicited adverse events in the 30 days follow up period after each dose were recorded. A total of 365 subjects completed the study. Four to six weeks after third dose, 98.32% of the subjects in Shan 5 group had seroprotective Anti PRP-T IgG antibody concentrations (> or =0.15 microg/mL) as compared to 100% and 98.94% subjects in TritanrixHB + Hiberix and Easyfive groups respectively. Seroprotective levels for Anti-HBs (> or =10 mIU/mL) were observed in 97.77%, 97.83% and 98.94% subjects in Shan 5, TritanrixHB + Hiberix and Easyfive groups respectively. Comparable immune responses were observed for the three other components (D, T and P) in all the groups. Four Serious Adverse Events (SAEs) were reported (three with Shan 5 and one with Easyfive), all unrelated to the respective vaccines. Most commonly reported adverse events in all the groups were pain at injection site, mild fever (<103 degrees F) and minor swelling at injection site. The study proved that Shan 5 was safe and immunogenic compared to the two other licensed vaccines.", "We evaluated the immunogenicity and reactogenicity of a new liquid pentavalent combination vaccine, which incorporates a diphtheria, tetanus and whole-cell pertussis vaccine (DTP) with Hib (PRP-OMPC) and hepatitis B vaccine (HB), in a series of three studies involving 2156 infants. The vaccination schedule was 2, 4, 6 and 18 months for all studies. In addition, subjects in the third study also received a dose of monovalent hepatitis B vaccine at birth. The principal study was a randomised double blind trial of two separate, but concurrently administered vaccines in each of three groups: pentavalent vaccine [DTP-Hib-HB] plus placebo (Group A, n=619); quadrivalent vaccine [DTP-HB] plus Hib vaccine (Group B, n=620); and bivalent vaccine [Hib-HB] plus DTP (Group C, n=226). The second study (Group D, n=231) was an open trial of three separate, but concurrently administered licensed control vaccines (DTP, Hib and HB). The third study (Group E, n=460) administered a dose of monovalent hepatitis B vaccine at birth followed by pentavalent vaccine as for Group A. Subjects were bled prior to the 2- and 18-month vaccinations, and a month after the 6- and 18-month vaccinations. A diary card was used to record subject temperatures and other systemic and local clinical signs for 7 days after each vaccination. The pentavalent vaccine, whether or not preceded by a birth dose of hepatitis B vaccine, was generally well tolerated at all administration times, and had a reactogenicity profile similar to that observed for licensed vaccine controls. Diphtheria and tetanus antibody levels were substantially above protective levels in all study groups. The anti-HBs responses (% > or = 10 mIU/ml) following the 6-month dose of vaccines were, respectively, for Groups A-E: 83.2, 91.7, 96.5, 98.8 and 93.9%, and following the 18-month doses: 87.9, 97.5, 98.8, 98.8 and 92.8%. Anti-PRP responses (% > or = 1.0 microg/ml) following the 6-month dose for Groups A-D were 86.0, 90.5, 91.2, and 74.4%, and after the 18-month dose for Groups A-E were 97.3, 98.3, 98.1, 97.0, and 99.5%. Consistently higher geometric mean titres (GMTs) for pertussis antibodies to agglutinogens (Agg2, Agg3) and pertactin were recorded for the pentavalent vaccine compared to the licensed control vaccine, though they were somewhat lower for pertussigen (PT). Except for the hepatitis B response, antibody responses induced by the pentavalent vaccine to all antigens with a schedule commencing at 2 months of age and completed at 18 months were equivalent to responses to the same antigens induced by the separate, but concurrently administered licensed control vaccines. A regimen of a birth dose of hepatitis B vaccine followed by pentavalent vaccine at 2, 4, 6 and 18 months was not countered by any clinically significant decrease in seroresponses." ]

[ "9804219", "12009350", "16984757", "15016780", "7989521" ]

[ "Transfer of frozen-thawed embryos in artificially prepared cycles with and without prior gonadotrophin-releasing hormone agonist suppression: a prospective randomized study.", "Endometrial preparation for frozen-thawed embryo transfer with or without pretreatment with gonadotropin-releasing hormone agonist.", "Artificial versus stimulated cycles for endometrial preparation prior to frozen-thawed embryo transfer.", "Pituitary suppression in ultrasound-monitored frozen embryo replacement cycles. A randomised study.", "Human menopausal gonadotrophin increases pregnancy rate in comparison with clomiphene citrate during replacement cycles of frozen/thawed pronucleate ova." ]

[ "Transfer of frozen-thawed embryos is usually carried out in a natural cycle or in a programmed cycle in which the endometrium is exogenously stimulated following down-regulation of the hypophysis. To analyse the possibility that the programmed cycle for embryo transfer can still be hormonally manipulated without the use of gonadotrophin-releasing hormone agonist (GnRHa) we have conducted a prospective randomized study that compared the outcome of frozen-thawed embryo transfer cycles using micronized 17beta-oestradiol and micronized progesterone preparations with and without the concomitant use of GnRHa. One hundred and six patients were randomly divided into two groups. In group A (53 patients) 4 mg/day of micronized 17beta-oestradiol was initiated following down-regulation of hypophysis. In group B (53 patients) oestrogen stimulation started on day 1 of the cycle without prior pituitary down-regulation using a dose of 6 mg/day for 7 days. In both groups, micronized progesterone in a dose of 900 mg/day was administered vaginally after at least 12 days of oestrogen stimulation. Embryo transfer embryo transfer took place 48-72 h thereafter according to the cryopreserved embryonic stage. Overall, none of the patients had any follicular development and only one cycle in group B had to be cancelled because of premature progesterone secretion. The two groups did not differ in age (31+/-5.6 and 31+/-5.0 years), number of embryos transferred per patient (3.4+/-1.2 and 3.3+/-1.0), and day of progesterone initiation (15+/-2.2 and 15+/-1.9 for groups A and B respectively). The endometrial thickness on the day of progesterone initiation was comparable in both groups (11 +/-1.6 and 10+/-1.6 mm for groups A and B respectively). Similarly, the pregnancy rate per embryo transfer and implantation rate in group A (26.4% and 9.5%) were comparable to those of group B (21.1% and 9%). These results indicate that programmed cycles can be successfully applied by administering a high dose of micronized 17beta-oestradiol starting on day 1 of the cycle. Compared to GnRHa programmed cycles, this approach is simpler, more convenient for both the patient and medical staff, and results in a similar success rate at a lower cost.", "To test the efficacy of endometrial preparation with exogenous steroids, without pretreatment with gonadotropin-releasing hormone (GnRH) agonist, in women with normal ovarian function.\n Prospective randomized study.\n Private outpatient infertility clinic.\n Two hundred ninety-six women undergoing frozen-thawed embryo transfer.\n In group 1 (146 patients), depot GnRH agonist was administered in the luteal phase; treatment with 17beta-estradiol transdermal patches at steadily increasing dosage from 100 to 300 microg was then given for at least 12 days. In group 2 (150 patients), endometrial preparation began on day 1 of menstrual cycle. The starting dose was 200 microg; this was increased to 300 microg after 7 days.\n Pregnancy, abortion, implantation and cancellation rates.\n In group 2, six cycles (4%) were cancelled due to evidence of ovulation. Groups were similar in the percentage of embryos that survived freezing-thawing (77.1% in group 1 and 76.6% in group 2) and in the number of embryos transferred per patient (2.1 +/- 0.6 and 2.1 +/- 0.7, respectively). Groups 1 and 2 did not differ significantly in rates of pregnancy (19.7% and 24.1%), abortion (17.8% and 11.7%), and implantation (10.4% and 11.9%).\n Endometrial preparation for frozen-thawed embryo transfer based exclusively on steroid administration appears to be as effective as the more conventional protocol involving preliminary desensitization with a GnRH agonist. This simplified protocol reduces costs, minimizes pharmacologic treatment, and increases patient compliance.", "The objective of this study was to compare the implantation rate, pregnancy rate and endometrial thickness of frozen-thawed embryo transfers using endometrial preparation with either an artificial cycle or stimulated cycle. This was a prospective randomized trial at a single academic IVF centre. Seventy-seven patients undergoing artificial cycles received oral oestradiol; patients with endometrium < 7 mm on day 9-10 were switched to vaginal oestradiol. Eighty-six patients undergoing stimulated cycles received recombinant FSH followed by human gonadotrophin hormone injection. Vaginal progesterone was begun 2 or 3 days prior to embryo transfer. There was no difference in implantation rate (8.5% versus 7.3%), pregnancy rate (16% versus 13%), cancellation rate (both 23%) or endometrium thickness (8.7 +/- 1.1 mm versus 8.7 +/- 1.0 mm) between artificial and stimulated cycles. Stimulated cycles had a higher incidence of thin endometrium (27% versus 5%, P < 0.01). In artificial cycles, patients switched to vaginal oestradiol had improved pregnancy rate (31%) versus patients who received oral oestradiol alone (13%) (P = 0.05). It is concluded that artificial and stimulated cycles produce comparable pregnancy rates, implantation rates, cancellation rates and endometrial thickness, although stimulated cycles have a higher incidence of thin endometrium. Vaginal oestradiol supplementation improved implantation rates.", "This study was designed to assess the value of using a gonadotrophin-releasing hormone (GnRH) agonist prior to exogenous steroid supplementation for endometrial preparation in frozen-thawed embryo replacement (FER) cycles.\n A prospective randomized trial of 234 patients undergoing FER cycles was conducted. The study population was randomly divided into two groups according to a computer-generated list. In group A (n = 117), a daily dose of 6 mg of oral estradiol valerate was initiated on menstrual day 1 following pituitary suppression using 400 mcg buserelin acetate daily. In group B (n = 117), the same dose of estradiol valerate was initiated on day 1 of bleeding without prior GnRH agonist therapy. In both groups, ovulation monitoring was not undertaken and progesterone pessaries (800 mg daily) were administrated when the endometrial thickness had reached 8 mm or more with embryo transfer taking place 2 days later.\n The two groups were comparable with respect to cause of infertility, age at stimulation (32.8 +/- 4 vs 33.2 +/- 3.9 years, P = 0.4), basal FSH level (6.3 +/- 1.7 vs 6.4 +/- 2 IU/l, P = 0.5), number of oocytes collected (16.9 +/- 7.3 vs 16.5 +/- 7.4, P = 0.7) and fertilized normally in the retrieval cycle (11.5 +/- 4.9 vs 11 +/- 4.9, P = 0.4) and number of embryos cryopreserved (6.6 +/- 3.6 vs 6.2 +/- 3.6, P = 0.3). There was no significant difference between the two groups in age at frozen replacement (33.6 +/- 4.2 vs 34 +/- 3.9 years, P = 0.4), duration of the proliferative phase (20.7 +/- 8.6 vs 21 +/- 9.2 days, P = 0.7) and number of thawed embryos replaced (2.3 +/- 0.6 vs 2.2 +/- 0.6, P = 0.2). However, compared with group B, group A achieved significantly higher pregnancy (37.6% vs 24%, OR 1.8, 95%CI 1.1-3.4), clinical pregnancy (24% vs 11.3%, OR 2.5, 95%CI 1.2-5.5) and live birth rates (20% vs 8.5%, OR 2.9, 95%CI 1.2-8).\n Medicated frozen embryo replacement cycles timed by endometrial thickness measurement alone without monitoring or suppression of ovarian activity are associated with reduced outcome.", "In a prospective randomized study, the effect of two ovulation induction regimens on implantation rate of frozen/thawed pronucleate ova was investigated. Patients received either human menopausal gonadotrophin (HMG) or clomiphene/HMG. Ovulation induction was done on an individual basis using ultrasound and plasma 17 beta-oestradiol concentrations. Ovulation was induced with human chorionic gonadotrophin (HCG) when the leading follicle reached a diameter of 18 mm. Pronucleate ova had been frozen using the slow-freezing method of Lassalle et al. (1985) (Fertil. Steril., 44, 645-651) and were thawed in synchrony with the age of the endometrium. Both groups of patients were comparable for age, indication for in-vitro fertilization, pre-ovulatory 17 beta-oestradiol concentration, number of large follicles and number and quality of embryos transferred. The only difference found was that HCG was administered 1 day earlier in the HMG group compared to the clomiphene/HMG group (P < 0.01). Using univariate analysis, the pregnancy rate was higher in patients stimulated with HMG alone compared to those stimulated with clomiphene/HMG (27 versus 15% respectively; P < 0.03), when HCG was administered later in the menstrual cycle (P < 0.01) and when more and better quality embryos were transferred (P < 0.01). Using multivariate regression analysis, the influence of the stimulation on pregnancy rate was even more pronounced (P < 0.01) when the day of HCG administration and the number and quality embryos transferred were taken into account. Therefore, we conclude that HMG alone increases pregnancy rate compared to clomiphene/HMG during replacement cycles of frozen/thawed pronucleate ova. These data suggest that HMG results in a better endometrium receptivity for embryos.(ABSTRACT TRUNCATED AT 250 WORDS)" ]

[ "10527076", "15537991", "17537090", "19704158", "18176736", "4682697", "9756581", "11823669", "17979080", "11239307", "3703931", "15105515", "18955423", "14606739", "17008338", "17613581", "18613281", "19969159", "12235606", "12920254", "18212034", "8503751", "15473116", "19109444", "7839377", "15083439", "15817001", "18955431", "17903837", "19910547" ]

[ "Muscle strengthening and physical conditioning to reduce impairment and disability in chronic stroke survivors.", "The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial.", "Stroke: a randomized trial of exercise or relaxation.", "Efficacy of functional strength training on restoration of lower-limb motor function early after stroke: phase I randomized controlled trial.", "Progressive resistance training after stroke: effects on muscle strength, muscle tone, gait performance and perceived participation.", "Effectiveness of functional training, active exercise, and resistive exercise for patients with hemiplegia.", "A randomized, controlled pilot study of a home-based exercise program for individuals with mild and moderate stroke.", "Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial.", "[A study on the quality of life in ischaemic vascular accidents and its relation to physical activity].", "The effect of aerobic training on rehabilitation outcomes after recent severe brain injury: a randomized controlled evaluation.", "Effects of isokinetic training on the rate of movement during ambulation in hemiparetic patients.", "High-intensity resistance training improves muscle strength, self-reported function, and disability in long-term stroke survivors.", "Does functional strength training of the leg in subacute stroke improve physical performance? A pilot randomized controlled trial.", "The effect of early aerobic training on independence six months post stroke.", "Task-oriented progressive resistance strength training improves muscle strength and functional performance in individuals with stroke.", "Stroke patients and long-term training: is it worthwhile? A randomized comparison of two different training strategies after rehabilitation.", "Regenerate: assessing the feasibility of a strength-training program to enhance the physical and mental health of chronic post stroke patients with depression.", "Circuit-based rehabilitation improves gait endurance but not usual walking activity in chronic stroke: a randomized controlled trial.", "Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study.", "Randomized clinical trial of therapeutic exercise in subacute stroke.", "A pilot randomized controlled trial to evaluate the benefit of the cardiac rehabilitation paradigm for the non-acute ischaemic stroke population.", "Task-specific physical therapy for optimization of gait recovery in acute stroke patients.", "Aerobic treadmill plus Bobath walking training improves walking in subacute stroke: a randomized controlled trial.", "Effects of conventional physical therapy and functional strength training on upper limb motor recovery after stroke: a randomized phase II study.", "Physiological outcomes of aerobic exercise training in hemiparetic stroke patients.", "A randomized controlled comparison of upper-extremity rehabilitation strategies in acute stroke: A pilot study of immediate and long-term outcomes.", "The effect of a task-oriented walking intervention on improving balance self-efficacy poststroke: a randomized, controlled trial.", "Treadmill training post stroke: are there any secondary benefits? A pilot study.", "Effects of isokinetic strength training on walking in persons with stroke: a double-blind controlled pilot study.", "Locomotor training improves daily stepping activity and gait efficiency in individuals poststroke who have reached a \"plateau\" in recovery." ]

[ "To evaluate the impact of a program of muscle strengthening and physical conditioning on impairment and disability in chronic stroke subjects.\n A randomized pretest and posttest control group, followed by a single-group pretest and posttest design.\n Thirteen community-dwelling stroke survivors of at least 9 months.\n A 10-week (3 days/week) program consisting of a warm-up, aerobic exercises, lower extremity muscle strengthening, and a cool-down.\n Peak isokinetic torque of the major muscle groups of the affected lower limb, quadriceps and ankle plantarflexor spasticity, gait speed, rate of stair climbing, the Human Activity Profile (HAP), and the Nottingham Health Profile (NHP) were recorded twice for the treatment group and three times for the control group.\n Significant improvements were found for all the selected outcome measures (HAP, NHP, and gait speed) for the treatment group (p < .001). In terms of overall training effects, the 13 subjects demonstrated increases in strength of the affected major muscle groups, in HAP and NHP profiles, and in gait speed and rate of stair climbing without concomitant increases in either quadriceps or ankle plantarflexor spasticity.\n The 10-week combined program of muscle strengthening and physical conditioning resulted in gains in all measures of impairment and disability. These gains were not associated with measurable changes of spasticity in either quadriceps or ankle plantarflexors.", "This trial compares the effects of task-oriented physical therapy (PT) provided with and without the use of rehabilitation technology on locomotor recovery in 63 persons with subacute stroke. Participants in the experimental (EXP) group used a treadmill, a Kinetron isokinetic exerciser, and a limb-load monitor, whereas those in the control (CTL) group did not while engaging in PT 1 h per day, 5 days per week for 2 months. Locomotor recovery was assessed by clinical (gait speed, Fugl Meyer motor leg and arm subscores, the Balance Scale, the Timed Up and Go, and the Barthel ambulation subscore) and laboratory outcomes (gait kinematics and kinetics) pre- and posttherapy and 3 months later. Within groups, gait speed (P < 0.01) and all secondary measures improved posttherapy (P < 0.01-0.05), and improvements in clinical measures were maintained at follow-up, but there was no difference between groups (P > 0.05). When the groups were pooled, the increase in gait speed was associated (r = 0.52, P = 0.003) with an increase in ankle power generation of the affected leg. The results demonstrate that the efficacy of the task-oriented approach is not dependent on rehabilitation technology.", "To determine the feasibility and effect of exercise training after stroke.\n Randomized exploratory trial comparing exercise training (including progressive endurance and resistance training) with relaxation (attention control).\n Interventions were performed in a rehabilitation hospital.\n Sixty-six independently ambulatory patients (mean age 72, 36 men) without significant dysphasia, confusion, or medical contraindications to exercise training who had completed their usual rehabilitation and had been discharged from hospital.\n Both interventions were held three times a week for 12 weeks. Up to seven patients attended each session.\n The Functional Independence Measure; Nottingham Extended Activities of Daily Living; Rivermead Mobility Index; functional reach; sit-to-stand; elderly mobility score; timed up-and-go; Medical Outcomes Study 36-Item Short Form Questionnaire, version 2 (SF-36); Hospital Anxiety and Depression Score; aspects of physical fitness (comfortable walking speed, walking economy, and explosive leg extensor power) were measured at baseline, immediately after interventions (3 months), and 7 months after baseline.\n The median number of intervention sessions attended was 36 (interquartile range (IQR) 30.00-36.75) for exercise and 36 (IQR 30.50-37.00) for relaxation. Adherence to the individual exercises ranged from 94% to 99%. At 3 months, role-physical (an item in SF-36), timed up-and-go, and walking economy were significantly better in the exercise group (analysis of covariance). At 7 months, role-physical was the only significant difference between groups.\n Exercise training for ambulatory stroke patients was feasible and led to significantly greater benefits in aspects of physical function and perceived effect of physical health on daily life.", "After stroke, physiotherapy can promote brain reorganization and motor recovery. Combining muscle strength and functional training (functional strength training, FST) may be beneficial. The aim of the authors was to compare FST with conventional physiotherapy (CPT) while controlling for the potential confounder of therapy intensity in a multicenter, randomized controlled observer-blind trial. The mean age of the participants was 68.3 (standard deviation [SD] = 12.03) years at a mean of 34 (SD = 20) days after stroke, with mean peak paretic knee extension torque (torque) of 22 (SD = 25) Nm. The estimated sample size was 102 to detect a between-group difference of 0.2 m/s in walking speed. After baseline measures, participants were allocated randomly to CPT or CPT + CPT or CPT + FST for 6 weeks. Additional experimental therapy was provided for up to 1 hour a day, 4 times each week. Outcomes were measured 6 weeks after baseline and at follow-up 12 weeks thereafter.\n included walking speed, knee extensor torque, and functional mobility (Rivermead). At outcome, both extraintensity groups showed greater increases in walking speed than the CPT group, but this reached significance only for the CPT + CPT group (P = .031). The CPT + CPT group also had a greater number of participants who walked at 0.8 m/s or above. No significant differences were observed for torque about the knee or for the Rivermead score. At follow-up, no significant differences were observed. These phase I results justify a subsequent trial of CPT + CPT versus CPT + FST.", "To evaluate the effects of progressive resistance training on muscle strength, muscle tone, gait performance and perceived participation after stroke.\n A randomized controlled trial.\n Twenty-four subjects (mean age 61 years (standard deviation 5)) 6-48 months post-stroke.\n The training group (n = 15) participated in supervised progressive resistance training of the knee muscles (80% of maximum) twice weekly for 10 weeks, and the control group (n = 9) continued their usual daily activities. Both groups were assessed before and after the intervention and at follow-up after 5 months. Muscle strength was evaluated dynamically and isokinetically (60 degrees /sec) and muscle tone by the Modified Ashworth Scale. Gait performance was evaluated by Timed \"Up & Go\", Fast Gait Speed and 6-Minute Walk tests, and perceived participation by Stroke Impact Scale.\n Muscle strength increased significantly after progressive resistance training with no increase in muscle tone and improvements were maintained at follow-up. Both groups improved in gait performance, but at follow-up only Timed \"Up & Go\" and perceived participation were significantly better for the training group.\n Progressive resistance training is an effective intervention to improve muscle strength in chronic stroke. There appear to be long-term benefits, but further studies are needed to clarify the effects, specifically of progressive resistance training on gait performance and participation.", "nan", "BACKGROUND and\n Many stroke survivors have minimal to moderate neurological deficits but are physically deconditioned and have a high prevalence of cardiovascular problems; all of these are potentially modifiable with exercise. The purposes of this randomized, controlled pilot study were (1) to develop a home-based balance, strength, and endurance program; (2) to evaluate the ability to recruit and retain stroke subjects; and (3) to assess the effects of the interventions used.\n Twenty minimally and moderately impaired stroke patients who had completed inpatient rehabilitation and who were 30 to 90 days after stroke onset were randomized to a control group or to an experimental group that received a therapist-supervised, 8-week, 3-times-per-week, home-based exercise program. The control group received usual care as prescribed by the patients' physicians. Baseline and postintervention assessments included the Fugl-Meyer Motor Assessment, the Barthel Index of Activities of Daily Living (ADL), the Lawton Scale of Instrumental ADL, and the Medical Outcomes Study-36 Health Status Measurement. Functional assessments of balance and gait included a 10-m walk, 6-Minute Walk, and the Berg Balance Scale. Upper extremity function was evaluated by the Jebsen Test of Hand Function.\n Of 22 patients who met study criteria, 20 completed the study and 2 refused to participate. The experimental group tended to improve more than the control group in motor function (Fugl-Meyer Upper Extremity: mean change in score, 8. 4 versus 2.2; Fugl-Meyer Lower Extremity: 4.7 versus -0.9; gait velocity: median change, 0.25 versus .09 m/s; 6-Minute Walk: 195 versus 114 ft; Berg Balance Score: 7.8 versus 5; and Medical Outcomes Study-36 Health Status Measurement of Physical Function: 15. 5 versus 9). There were no trends in differences in change scores by the Jebsen Test of Hand Function, Barthel Index, and Lawton Instrumental ADL Scale.\n This study demonstrated that a randomized, controlled clinical trial of a poststroke exercise program is feasible. Measures of neurological impairments and lower extremity function showed the most benefit. Effects of the intervention on upper extremity dexterity and functional health status were equivocal. The lasting effects of the intervention were not assessed.", "A new gait training strategy for patients with stroke seeks to increase walking speed through treadmill training. This study compares the effects of structured speed-dependent treadmill training (STT) (with the use of an interval paradigm to increase the treadmill speed stepwise according to principles of sport physiology) with limited progressive treadmill training (LTT) and conventional gait training (CGT) on clinical outcome measures for patients with hemiparesis.\n Sixty ambulatory poststroke patients were each randomly selected to receive 1 of the 3 different gait therapies: 20 subjects were treated with STT, 20 subjects were trained to walk on a treadmill with a 20% increase of belt speed over the treatment period (LTT), and 20 subjects were treated with CGT. Treatment outcomes were assessed on the basis of overground walking speed, cadence, stride length, and Functional Ambulation Category scores.\n After a 4-week training period, the STT group scored significantly higher than the LTT and CGT groups for overground walking speed (STT versus LTT, P<0.001; STT versus CGT, P<0.001), cadence (STT versus LTT, P=0.007; STT versus CGT, P<0.001), stride length (STT versus LTT, P<0.001; STT versus CGT, P<0.001), and Functional Ambulation Category scores (STT versus LTT, P=0.007; STT versus CGT, P<0.001).\n Structured STT in poststroke patients resulted in better walking abilities than LTT or CGT. This gait training strategy provides a dynamic and integrative approach for the treatment of gait dysfunction after stroke.", "Cerebrovascular accidents (CVA) are the third most common cause of death and are the main cause of permanent disability in the western world, where they also rank first as regards the loss of years of disability-adapted independent life. Ischaemic CVAs tend to present irreversible sequelae, which reduces the patient's quality of life.\n To analyse the effect of a series of exercises carried out in water on the quality of life of patients who have had an ischaemic CVA.\n Two groups were studied: an experimental group made up of 15 subjects aged 50.3 +/- 9.1 years, and a control group consisting of 13 subjects aged 52.5 +/- 7.7 years. The experimental group followed a 12-week programme of aquatic physical exercises. The two groups were evaluated in a pre- and post-treatment and then results from both groups were compared. Data were collected by administering a generic health-related quality of life survey (SF-36).\n Significant differences were found between the pre- and post-treatment in the experimental group. In the between-groups evaluation, significant differences were recorded with regard to functional capacity, physical aspects, pain, general state of health, vitality, social aspects and mental health.\n Doing physical exercises in water tends to improve motor behaviour, with a greater degree of independence, significant improvements in functional capacity and other aspects linked to physical aptitude. As a result, the level of quality of life of individuals affected by ischaemic CVA is enhanced.", "To examine the impact of fitness training with recently brain-injured inpatients on exercise capacity and functional and psychologic outcome measures.\n A randomized controlled trial of exercise versus relaxation training for 3 months. Blind assessments were conducted before and after the end of a 12-week training program, as well as at follow-up assessment 12 weeks posttraining.\n Four regional neurologic inpatient rehabilitation units.\n Of 157 patients recruited 24 +/- 14 weeks after single-incident brain injury, 142 patients were assessed at week 12, and 128 patients at follow-up.\n Patients were randomized between cycle ergometer aerobic training and a relaxation training control condition, which was theoretically inert with respect to cardiovascular fitness.\n Validation of exercise training (peak work rate, peak heart rate, body mass index); mobility and physical function (modified Ashworth scale, Berg balance scale, Rivermead Mobility Index, 10-m walk velocity); disability and dependency (Barthel index, FIMtrade mark instrument, Nottingham Extended Activities of Daily Living); and psychologic function (fatigue questionnaire, Hospital Anxiety and Depression Scale).\n Significant improvements in exercise capacity (p <.05) in the exercise training group (n = 70) relative to the control group (n = 72) were not matched by greater improvements in functional independence, mobility, or psychologic function, at either 12 weeks or follow-up.\n The benefits of improved cardiovascular fitness did not appear to extend to measurable change in function or psychologic state.", "The purpose of this study was to determine the effects of isokinetic training on the rate of movement during ambulation in hemiparetic patients. Ten male and 10 female subjects, aged 40 to 75 years, participated in the study. The 20 hemiparetic subjects were assigned randomly to either a control group or an experimental group. All of the subjects participated in a conventional therapeutic exercise program and gait training. The experimental group also received isokinetic training on the Kinetron exercise machine as part of their program. Functional ambulation profile tests were administered to each subject before and after the five-week experimental period. All of the subjects showed improvement in the rate of ambulation and in overall ambulation performance. The differences in ambulation times and functional ambulation profile scores between the two groups were shown to be insignificant.", "To evaluate the efficacy of supervised high-intensity progressive resistance training (PRT) on lower extremity strength, function, and disability in older, long-term stroke survivors.\n Forty-two volunteers aged 50 years and above, 6 months to 6 years after a single mild to moderate stroke, were randomized into either a control group of upper extremity stretching or a PRT group that received a 12-week supervised high-intensity resistance training program consisting of bilateral leg press (LP), unilateral paretic and nonparetic knee extension (KE), ankle dorsiflexion (DF), and plantarflexion (PF) exercises. Functional performance was assessed using the 6-minute walk, stair-climb time, repeated chair-rise time, and habitual and maximal gait velocities. Self-reported changes in function and disability were evaluated using the Late Life Function and Disability Instrument (LLFDI).\n Single-repetition maximum strength significantly improved in the PRT group for LP (16.2%), paretic KE (31.4%), and nonparetic KE (38.2%) with no change in the control group. Paretic ankle DF (66.7% versus -24.0%), paretic ankle PF (35.5% versus -20.3%), and nonparetic ankle PF (14.7% versus -13.8%) significantly improved in the PRT group compared with the control. The PRT group showed significant improvement in self-reported function and disability with no change in the control. There was no significant difference between groups for any performance-based measure of function.\n High-intensity PRT improves both paretic and nonparetic lower extremity strength after stroke, and results in reductions in functional limitations and disability.", "To examine the effect of functional strength training in subacute stroke.\n A single-blinded randomized controlled trial.\n Two rehabilitation units.\n Eighteen patients in the subacute phase post stroke, randomly allocated to a functional strength training (intervention) group (n = 8) and a training-as-usual (comparison) group (n = 10).\n The functional strength training group participated in functional progressive strength training of the affected lower extremity. The training-as-usual group had traditional training, excessive muscle power being avoided to prevent associated reactions. All trained 50 minutes five days a week for four weeks.\n Maximum weight-bearing in standing (primary outcome), isometric muscle strength, gait speed and items of Motor Assessment Scale.\n Maximum weight-bearing on the affected leg improved more in the functional strength training group (mean 17.4% of body weight) than in the training-as-usual group (mean 5.6% of body weight), but taking test data at inclusion into consideration, the difference in change was not statistically significant (P = 0.056). More patients in the functional strength training group (57%) could weight-bear on the affected leg while stepping forward, than in the training-as-usual group (17%). Improvement was clinically significant in 7 of 9 outcome measures in the functional strength training group (effect size > or = 0.80, large), but in only 3 of 9 in the training-as-usual group. All patients in the functional strength training group and 70% of the patients in the training-as-usual group rated their overall status as 'much' or 'very much' improved.\n This pilot study indicates that functional strength training of lower extremities improves physical performance more than traditional training.", "To investigate whether early aerobic training has a beneficial effect on stroke patients' independence in daily and social activities six months after the event.\n Randomized clinical trial.\n Rehabilitation unit.\n Ninety-two patients after a first stroke.\n Forty-six patients participated in an eight-week programme of aerobic training, using a leg cycle ergometer.\n Frenchay Activities Index (FAI) measured twice, at entry to programme (pre-event score) and six months after the onset of the event.\n Despite the significant improvement of study group patients' functional abilities immediately after the intervention compared with controls, no significant difference was found in FAI mean score between groups six months post event. An interaction effect was noted between event severity, intervention and FAI total score. Mean FAI score declined significantly less in the less severely impaired study group patients.\n Early, moderately intense aerobic training has no direct impact on independence in daily and social activities as measured by FAI total score six months after a stroke.", "To examine the effectiveness of task-oriented progressive resistance strength training on lower extremity strength and functional performance in chronic stroke subjects.\n Single-blind, randomized controlled trial.\n Medical centre and district hospital.\n Forty-eight subjects at least one year post stroke.\n Participants randomly allocated to two groups, control (n-/24) and experimental (n-/24). Subjects in the control group did not receive any rehabilitation training. Subjects in the experimental group were put on a four-week task-oriented progressive resistance strength training.\n Lower extremity muscle strength, gait velocity, cadence, stride length, six-minute walk test, step test, and timed up and go test.\n Muscle strength significantly improved in the experimental group for strong side muscle groups (ranged from 23.9% to 36.5%) and paretic side muscle groups (ranged from 10.1% to 77.9%). In the control group muscle strength changes ranged from 6.7% gain to 11.2% decline. The experimental group showed significant improvement in all selected measures of functional performance except for the step test. In the control group, the number of repetitions of the step test significantly decreased (-20.3%) with no change in other functional tests. There was a significant difference between groups for muscle strength and all functional measures. The strength gain was significantly associated with gain in the functional tests.\n The task-oriented progressive resistance strength training programme could improve lower extremity muscle strength in individuals with chronic stroke and could carry over into improvement in functional abilities.", "To find out if there were any differences in improvement and maintenance of motor function, activity of daily living and grip strength between patients with first-ever stroke receiving two different strategies of physical exercise during the first year after stroke.\n A longitudinal randomized controlled stratified trial.\n Rehabilitation institutions, community, patients' homes and nursing homes.\n Seventy-five male and female first-time-ever stroke patients: 35 in an intensive exercise group and 40 in a regular exercise group.\n The intensive exercise group received physiotherapy with focus on intensive exercises in four periods during the first year after stroke. The regular exercise group patients were followed up according to their subjective needs during the corresponding year.\n Motor Assessment Scale, Barthel Index of Activities of Daily Living, and grip strength.\n Both groups improved significantly up to six months when function stabilized. The groups did not differ significantly on any test occasions. The difference of improvement from admission to discharge was significant in favour of the intensive exercise group, in the Motor Assessment Scale total score (intensive exercise group 7.5; regular exercise group 1.7, P = 0.01), and in the Barthel Index of Activities of Daily Living total score (17.4 versus 8.9, P = 0.04).\n Motor function, activities of daily living functions and grip strength improved initially and were maintained during the first year after stroke in all patients irrespective of exercise regime. This indicates the importance of motivation for regular exercise in the first year following stroke, achieved by regular check-ups.", "The Regenerate pilot study explored whether a 10-week, community-based progressive resistance training (PRT) program could reduce depressive symptoms in depressed chronic stroke survivors.\n Participants were screened for depressive status using the PHQ-9 and confirmed by psychiatric assessment. Eligible people (n = 45) were randomised to PRT or a waiting-list comparison group. The PRT program included two high intensity sessions/week for 10 weeks at a community-based gymnasium. Depressive status, physical and mental health and quality of life were measured at baseline, 10 weeks and 6 months. Muscle strength was assessed using 1 repetition maximum (1-RM) for upper and lower limbs.\n The participants' median age was 69 years: 27 were male. The intervention group had lower depression scores than the comparison group at all time points. At 6-month follow-up, there was a trend for PRT participants to be more likely to be no longer depressed than the comparison group, but the difference was not significant after adjusting for baseline scores. There were modest improvements in health and wellbeing over time, but many scores were lower than reported in non-depressed people. Intervention participants demonstrated significant improvements in strength. Program adherence was good: on average 75% of the 10-week program was completed.\n The intervention appeared to be feasible within a community-based setting. To optimize stroke recovery and improve the quality of life of stroke survivors, health professionals should continue to focus on helping survivors' mental health recovery as well their physical rehabilitation.\n (c) 2008 John Wiley & Sons, Ltd.", "Mudge S, Barber PA, Stott NS. Circuit-based rehabilitation improves gait endurance but not usual walking activity in chronic stroke: a randomized controlled trial.\n To determine whether circuit-based rehabilitation would increase the amount and rate that individuals with stroke walk in their usual environments.\n Single-blind randomized controlled trial.\n Rehabilitation clinic.\n Sixty participants with a residual gait deficit at least 6 months after stroke originally enrolled in the study. Two withdrew in the initial phase, leaving 58 participants (median age, 71.5y; range, 39.0-89.0y) who were randomized to the 2 intervention groups.\n The exercise group had 12 sessions of clinic-based rehabilitation delivered in a circuit class designed to improve walking. The control group received a comparable duration of group social and educational classes.\n Usual walking performance was assessed using the StepWatch Activity Monitor. Clinical tests were gait speed (timed 10-meter walk) and endurance (six-minute walk test [6MWT]), confidence (Activities-Based Confidence Scale), self-reported mobility (Rivermead Mobility Index [RMI]), and self-reported physical activity (Physical Activity and Disability Scale).\n Intention-to-treat analysis revealed that the exercise group showed a significantly greater distance for the 6MWT than the control group immediately after the intervention (P=.030) but that this effect was not retained 3 months later. There were no changes in the StepWatch measures of usual walking performance for either group. The exercise and control groups had significantly different gait speed (P=.038) and scores on the RMI (P=.025) at the 3-month follow-up. These differences represented a greater decline in the control group compared with the exercise group for both outcome measures.\n Circuit-based rehabilitation leads to improvements in gait endurance but does not change the amount or rate of walking performance in usual environments. Clinical gains made by the exercise group were lost 3 months later. Future studies should consider whether rehabilitation needs to occur in usual environments to improve walking performance.", "To investigate gait outcomes with supported treadmill ambulation training (STAT) associated with regular rehabilitation in acute stroke survivors.\n Randomized controlled trial, pilot study.\n Rehabilitation medicine service at a Veterans Affairs medical center.\n Seven acute stroke survivors assigned to regular intervention group and 6 patients assigned to STAT intervention.\n Regular intervention consisted of 3 hours daily of physical therapy, kinesiotherapy, and occupational therapy. STAT group received regular rehabilitation with STAT substituted for usual gait training. Participants were tested at baseline, treated for an average of 3 weeks, and retested on discharge. The analysis of covariance procedure was used to test for differences between the 2 approaches.\n Functional Ambulation Category Scale, gait speed, walking distance, gait energy expenditure, and gait energy cost.\n The small sample size did not generate enough power to detect significant differences in any variable. However, medium to large effect sizes of 0.7 and 1.16 standard deviation units were observed for gait energy cost and walk distance, respectively.\n This pilot study indicated that STAT is a safe, feasible, and promising intervention for acute stroke survivors. A larger trial is warranted for statistical relevance.", "Rehabilitation care after stroke is highly variable and increasingly shorter in duration. The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear. The objective of this study was to determine whether a structured, progressive, physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care.\n This randomized, controlled, single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions. We included persons with stroke who were living in the community. One hundred patients (mean age, 70 years; mean Orpington score, 3.4) consented and were randomized from a screened sample of 582. Ninety-two subjects completed the trial. Intervention was a structured, progressive, physiologically based, therapist-supervised, in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility, strength, balance, endurance, and upper-extremity function. Main outcome measures were postintervention strength (ankle and knee isometric peak torque, grip strength), upper- and lower-extremity motor control (Fugl Meyer), balance (Berg and functional reach), endurance (peak aerobic capacity and exercise duration), upper-extremity function (Wolf Motor Function Test), and mobility (timed 10-m walk and 6-minute walk distance).\n In the intention-to-treat multivariate analysis of variance testing the overall effect, the intervention produced greater gains than usual care (Wilk's lambda=0.64, P=0.0056). Both intervention and usual care groups improved in strength, balance, upper- and lower-extremity motor control, upper-extremity function, and gait velocity. Gains for the intervention group exceeded those in the usual care group in balance, endurance, peak aerobic capacity, and mobility. Upper-extremity gains exceeded those in the usual care group only in patients with higher baseline function.\n This structured, progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance, balance, and mobility beyond those attributable to spontaneous recovery and usual care.", "To evaluate risk factor reduction and health-related quality of life following a 10-week cardiac rehabilitation programme in non-acute ischaemic stroke subjects.\n Single-blinded randomized control trial.\n Outpatient rehabilitation.\n Forty-eight community-dwelling ischaemic stroke patients (38 independently mobile, 9 requiring assistance, 1 non-ambulatory) were randomly assigned to intervention or control groups by concealed allocation.\n The trial consisted of a 10-week schedule with measures taken at weeks 1 and 10. Both groups continued usual care (excluding aerobic exercise); intervention subjects attended 16 cycle ergometry sessions of aerobic-training intensity and two stress-management classes.\n Cardiac risk score (CRS); VO(2) (mL O(2)/kg per minute) and Borg Rate of Perceived Exertion (RPE) assessed during a standardized ergometry test; Hospital Anxiety and Depression Scale (HADS); Frenchay Activity Index; Fasting Lipid Profiles and Resting Blood Pressure.\n Group comparison with independent t-tests showed significantly greater improvement at follow-up by intervention subjects than controls in VO(2) (intervention 10.6 +/-1.6 to 12.0 +/- 2.2, control 11.1 +/-1.8 to 11.1 +/-1.9 t=4.734, P<0.001) and CRS (intervention 13.4 +/-10.1 to 12.4 +/-10.5, control 9.4 +/-6.7 to 15.0 +/-6.1 t=-2.537, P<0.05). RPE rating decreased in intervention subjects (13.4 +/-12.2 to 12.4 +/-2.0) and increased in controls (13.8 +/-1.8 to 14.4 +/-1.6); Mann-Whitney U (U = 173.5, P<0.05). Within-group comparison showed significant decrease in the HADS depression subscale in the intervention group alone (5.1 +/-3.4 to 3.0 +/-2.8) (Wilcoxon signed ranks test Z=-3.278, P<0.001).\n Preliminary findings suggest non-acute ischaemic stroke patients can improve their cardiovascular fitness and reduce their CRS with a cardiac rehabilitation programme. The intervention was associated with improvement in self-reported depression.", "A randomized controlled pilot trial was conducted to estimate the effects of early, intensive, gait-focused physical therapy on ambulatory ability in acute, stroke patients. Twenty-seven patients with middle cerebral artery infarct of thromboembolic origin confirmed by computed axial tomography scan were stratified and randomly assigned to the experimental group, to a control group that received early, intensive and conventional therapy, or to a group receiving routine conventional therapy that started later and was not intense. Assessments at entry, six weeks, and three and six months by independent evaluators permitted comparisons with reference to clinical measures of motor performance, balance, and functional capacity, and laboratory measures of gait movements. Group results at six weeks demonstrated that gait velocity was similar in the two conventional groups thereby eliminating the timing of the interventions as an important factor. At that point, gait velocity was faster in the experimental group. The difference translated into a moderate effect size of 0.58. The time dedicated to gait training but not to total therapy time was correlated (rs = 0.63) to gait velocity. This effect disappeared at three and six months after stroke. These pilot results justify planning a large trial to test the effectiveness of a therapeutic protocol that focuses on early and intense gait therapy in an effort to facilitate early ambulation following stroke.", "To evaluate the immediate and long-term effects of aerobic treadmill plus Bobath walking training in subacute stroke survivors compared with Bobath walking training alone.\n Randomized controlled trial.\n Rehabilitation unit.\n Fifty patients, first-time supratentorial stroke, stroke interval less than six weeks, Barthel Index (0-100) from 50 to 80, able to walk a minimum distance of 12 m with either intermittent help or stand-by while walking, cardiovascular stable, minimum 50 W in the bicycle ergometry, randomly allocated to two groups, A and B.\n Group A 30 min of treadmill training, harness secured and minimally supported according to patients' needs, and 30 min of physiotherapy, every workday for six weeks, speed and inclination of the treadmill were adjusted to achieve a heart rate of HR: (Hrmax-HRrest)*0.6+HRrest; in group B 60 min of daily physiotherapy for six weeks.\n Primary outcome variables were the absolute improvement of walking velocity (m/s) and capacity (m), secondary were gross motor function including walking ability (score out of 13) and walking quality (score out of 41), blindly assessed before and after the intervention, and at follow-up three months later.\n Patients tolerated the aerobic training well with no side-effects, significantly greater improvement of walking velocity and capacity both at study end (p =0.001 versus p =0.002) and at follow-up (p <0.001 versus p <0.001) in the experimental group. Between weeks 0 and 6, the experimental group improved walking speed and capacity by a mean of.31 m/s and 91 m, the control group by a mean of 0.16 m/s and 56 m. Between weeks 0 and 18, the experimental group improved walking speed and capacity by a mean of 0.36 m/s and 111 m, the control group by a mean of 0.15 m/s and 57 m. Gross motor function and walking quality did not differ at any time.\n Aerobic treadmill plus Bobath walking training in moderately affected stroke patients was better than Bobath walking training alone with respect to the improvement of walking velocity and capacity. The treatment approach is recommended in patients meeting the inclusion criteria. A multicentre trial should follow to strengthen the evidence.", "Functional training and muscle strength training may improve upper limb motor recovery after stroke. Combining these as functional strength training (FST) might enhance the benefit, but it is unclear whether this is better than conventional physical therapy (CPT). Comparing FST with CPT is not straightforward.\n This study aimed at assessing the feasibility of conducting a phase III trial comparing CPT with FST for upper limb recovery.\n Randomized, observer-blind, phase II trial. Subjects had upper limb weakness within 3 months of anterior circulation infarction. Subjects were randomized to CPT (no extra therapy), CPT + CPT, and CPT + FST. Intervention lasted 6 weeks. Primary outcome measure was the Action Research Arm Test (ARAT). Measurements were taken before treatment began, after 6 weeks of intervention, and 12 weeks thereafter. Attrition rate was calculated and differences between groups were interpreted using descriptive statistics. ARAT data were used to inform a power calculation.\n Thirty subjects were recruited (8% of people screened). Attrition rate was 6.7% at outcome and 40% at follow-up. At outcome the CPT + FST group showed the largest increase in ARAT score and this was above the clinically important level of 5.7 points. Median (interquartile range) increases were 11.5 (21.0) for CPT; 8.0 (13.3) for CPT + CPT; and 19.5 (22.0) for CPT + FST. The estimated sample size for an adequately powered subsequent phase III trial was 279 subjects at outcome.\n Further work toward a phase III clinical trial appears justifiable.", "In hemiparetic individuals, low endurance to exercise may compound the increased energy cost of movement and contribute to poor rehabilitation outcomes. The purpose of this investigation was to describe how hemiparetic stroke patients responded to intense exercise and aerobic training.\n Forty-two subjects were randomly assigned to an exercise training group or to a control group. Treatments were given three times per week for 10 weeks in similar laboratory settings. Baseline and posttest measurements were made of maximal oxygen consumption, heart rate, workload, exercise time, resting and submaximal blood pressures, and sensorimotor function.\n Only experimental subjects showed significant improvement in maximal oxygen consumption, workload, and exercise time. Improvement in sensorimotor function was significantly related to the improvement in aerobic capacity. After treatment, experimental subjects showed significantly lower systolic blood pressure at submaximal workloads during the graded exercise test.\n We conclude that hemiparetic stroke patients may improve their aerobic capacity and submaximal exercise systolic blood pressure response with training. Sensorimotor improvement is related to the improvement in aerobic capacity.", "To evaluate the immediate and long-term effects of 2 upper-extremity rehabilitation approaches for stroke compared with standard care in participants stratified by stroke severity.\n Nonblinded, randomized controlled trial (baseline, postintervention, 9mo) design.\n Inpatient rehabilitation hospital and outpatient clinic.\n Sixty-four patients with recent stroke admitted for inpatient rehabilitation were randomized within severity strata (Orpington Prognostic Scale) into 1 of 3 intervention groups. Forty-four patients completed the 9-month follow-up.\n Standard care (SC), functional task practice (FT), and strength training (ST). The FT and ST groups received 20 additional hours of upper-extremity therapy beyond standard care distributed over a 4- to 6-week period.\n Performance measures of impairment (Fugl-Meyer Assessment), strength (isometric torque), and function (Functional Test of the Hemiparetic Upper Extremity [FTHUE]).\n Compared with SC participants, those in the FT and ST groups had significantly greater increases in Fugl-Meyer motor scores (P=.04) and isometric torque (P=.02) posttreatment. Treatment benefit was primarily in the less severe participants, where improvement in FT and ST group Fugl-Meyer motor scores more than doubled that of the SC group. Similar results were found for the FTHEU and isometric torque. During the long term, at 9 months, the less severe FT group continued to make gains in isometric muscle torque, significantly exceeding those of the ST group (P<.05).\n Task specificity and stroke severity are important factors for rehabilitation of arm use in acute stroke. Twenty hours of upper extremity-specific therapy over 4 to 6 weeks significantly affected functional outcomes. The immediate benefits of a functional task approach were similar to those of a resistance-strength approach, however, the former was more beneficial in the long-term.", "To evaluate the efficacy of a task-oriented walking intervention in improving balance self-efficacy in persons with stroke and to determine whether effects were task-specific, influenced by baseline level of self-efficacy and associated with changes in walking and balance capacity.\n Secondary analysis of a two-center, observer-blinded, randomized, controlled trial.\n General community.\n Ninety-one individuals with a residual walking deficit within 1 year of a first or recurrent stroke.\n Task-oriented interventions targeting walking or upper extremity (UE) function were provided three times a week for 6 weeks.\n Activities-specific Balance Confidence Scale, Six-Minute Walk Test, 5-m walk, Berg Balance Scale, and Timed \"Up and Go\" administered at baseline and postintervention.\n The walking intervention was associated with a significantly greater average proportional change in balance self-efficacy than the UE intervention. Treatment effects were largest in persons with low self-efficacy at baseline and for activities relating to tasks practiced. In the walking group, change in balance self-efficacy correlated with change in functional walking capacity (correlation coefficient=0.45, 95% confidence interval=0.16-0.68). Results of multivariable modeling suggested effect modification by the baseline level of depressive symptoms and a prognostic influence of age, sex, comorbidity, time poststroke, and functional mobility on change in self-efficacy.\n Task-oriented walking retraining enhances balance self-efficacy in community-dwelling individuals with chronic stroke. Benefits may be partially the result of improvement in walking capacity. The influence of baseline level of self-efficacy, depressive symptoms, and prognostic variables on treatment effects are of clinical importance and must be verified in future studies.", "To explore the secondary benefits of treadmill training for people in the chronic stage of recovery from stroke.\n Modified random assignment, matched-pair control group design with repeated measures.\n Outpatient stroke centre.\n Twenty individuals post first stroke who acknowledged walking slower than pre stroke. Participants matched by side of hemiparesis and motor impairment.\n Twelve 20-minute sessions of walking on a treadmill or weekly phone call.\n Depression (Beck Depression Index), mobility and social participation (Stroke Impact Scale 3.0 subscales) were assessed initially, at the end of 12 treatments (four weeks) and six weeks later.\n No significant difference was found between groups for any dependent measure. The ANOVA to investigate main effects in each group found no significant findings in the control group; however in the treatment group significant improvements over time for depression (P = 0.005, P < 0.001), mobility (P = 0.008) and social participation (P = 0.004) were demonstrated.\n A task-specific intervention designed to improve gait speed may potentially provide secondary benefits by positively impacting depression, mobility and social participation for people post stroke.", "The goal most often stated by persons with stroke is improved walking function. The purpose of this study was to determine the effects of isokinetic strength training on walking performance, muscle strength, and health-related quality of life in survivors of chronic stroke.\n Twenty participants (age, 61.2 +/- 8.4 years) with chronic stroke were randomized into 2 groups. The experimental group undertook maximal concentric isokinetic strength training, whereas the control group received passive range of motion of the paretic lower extremity 3 times a week for 6 weeks. The Kin-Com Isokinetic Dynamometer (Chattanooga Group Inc., TN) was used for both the strengthening and passive range of motion exercises. The Mann-Whitney U test was used to compare the changes in scores (postintervention minus baseline) between the control and experimental groups for a composite lower extremity strength score, walking speed (level-walking and stair-walking) and health-related quality of life measure (36-Item Short Form Health Survey [SF-36]).\n Both the experimental and control groups increased their strength and walking speed postintervention; however, there were no differences in the changes in walking speed between the groups. There was a trend (P = .06) toward greater strength improvement in the experimental group compared with the control group. No changes in SF-36 scores were found in either group.\n Intervention aimed at increasing strength did not result in improvements in walking. The results of this study stress the importance of controlled clinical trials in determining the effect of specific treatment approaches. Strength training in conjunction with other task-related training may be indicated.", "Individuals with chronic stroke often demonstrate a \"plateau,\" or deceleration of motor recovery, which may lead to discharge from physical therapy (PT). However, numerous studies report improvements in motor function when individuals are provided intensive practice of motor tasks. We suggest that reduced task-specific walking practice during clinical PT contributes to limited gains in ambulatory function in those with a perceived plateau poststroke, and suggest that further gains can be realized if intensive stepping, or locomotor training (LT) is provided after discharge.\n Twenty subjects with chronic stroke completed a repeated baseline measures, randomized crossover trial in which walking performance was assessed during the last 4 weeks of clinical PT before discharge secondary to reaching a plateau, followed by 4 weeks of intensive LT and 4 weeks of no intervention. Outcome measures included clinical and physiological (metabolic) measures of walking overground and on a treadmill, and measures of daily stepping activity in the home and community, including during clinical PT and subsequent LT sessions.\n Stepping practice was more than 4-fold higher during LT versus clinical PT sessions, with significant improvements in daily stepping and gait efficiency only after LT. Changes in daily stepping after clinical PT and intensive LT were correlated (P<0.001) with the amount of stepping practice received during these interventions.\n Intensive LT results in improved daily stepping in individuals poststroke who have been discharged from PT because of a perceived plateau in motor function. These improvements may be related to the amount and intensity of stepping practice." ]

[ "18315511", "17722829", "17926617", "20804366", "20806998", "19606510" ]

[ "Scalp acupuncture effect on language development in children with autism: a pilot study.", "[Effect of acupuncture on rehabilitation training of child's autism].", "[Effects of electroacupuncture combined with behavior therapy on intelligence and behavior of children of autism].", "Randomized controlled trial of acupuncture versus sham acupuncture in autism spectrum disorder.", "Randomized controlled trial of electro-acupuncture for autism spectrum disorder.", "Seven-star needle stimulation improves language and social interaction of children with autistic spectrum disorders." ]

[ "Autism is a neurodevelopmental disorder that manifests in delays in social interaction, language used in social communication, and symbolic or imaginative play, with an onset prior to age 3 years. Language therapy (LT) for children with autism is the main form of rehabilitation, because it emphasizes its major presenting symptom (i.e., language impairment). Scalp acupuncture (scalp AP) is a modality based on the physiologic function of different brain areas, where different scalp zones are stimulated with needles so as to stimulate the reflexively related nervous tissue. This study aimed to evaluate the role of scalp AP as a complementary modality to LT in rehabilitation of children with autism.\n The study involved 20 children (divided into 2 equal groups: A and B), diagnosed as autistic according to DSM IV classification. Their ages ranged between 4 and 7 years old. All subjects underwent LT twice weekly, aiming at stimulation of cognitive and verbal abilities. Group B only was subjected to scalp AP sessions--twice weekly--as a rehabilitation complementary tool during the 9-month period of the study. The acupoints used were: Du 20, 26, GV17; three temple needles; and Yamamoto's New Scalp Acupuncture cerebrum and aphasia points (acupuncture needles 0.3 x 30 mm). A language test was performed before and after therapy to monitor cognition and expression (an Arabic test was included).\n Both groups, whose mean age range was 5.5 years+/-1.22 years, showed a significant improvement in cognitive and expressive language skills pre- and post-therapy, which was highly significant among group B children treated with scalp AP (attention 2.8+/-0.8 in group A versus 3.5+/-0.8 in group B; receptive semantics were 7+/-3.8 in group A versus 9.4+/-3.1 in group B). Expressive semantics significantly improved in both groups.\n Scalp AP is a safe complementary modality when combined with LT and has a significantly positive effect on language development in children with autism.", "To observe the effect of acupuncture on rehabilitation training for children's autism.\n Forty autistic children receiving rehabilitation training were divided into a control group and a treatment group, 20 cases in each group. The control group received rehabilitation training including ABA training, the Conductive Education Approach and the training of sensory integration, about 90 sessions for each training; the treatment group received acupuncture treatment for 60-90 sessions after the rehabilitation training. Their results were detected by the revised Chinese version of Psycho-Educational Profile for autistic and developmentally disabled children (C-PEP).\n The markedly effective rate was 55.0% in the treatment group and 15.0% in the control group with a very significant difference between the two groups (P < 0.01); the differences before and after training in some projects such as the total score of development, imitation, oral cognition in the treatment group were very significantly different from those in the control group (P < 0.01).\n Acupuncture combined with scientific and effective rehabilitation training has a better therapeutic effect than that of the simple rehabilitation training for child's autism.", "To find out an effective therapy for autism.\n Sixty children of autism were randomly divided into an electroacupuncture (EA) plus behavior therapy group and a behavior therapy group, 30 cases in each group. The patients in the two groups were treated with routine behavior, with EA at Baihui (GV 20), Sishencong (EX-HN 1), Shenting (GV 24), Benshen (GB 13), Yintang (EX-HN 3), Naohu (GV 17), Naokong (GB 19), Neiguan (PC 6) and scalp acupuncture at Speech Areas I, II, III added for the EA plus behavior therapy group. Their therapeutic effects were observed, and the picture and vocabulary scale (PPVT) and behavior ability were detected.\n The total effective rate was 86.7% in the EA plus behavior therapy group which was better than 56.7% of the behavior therapy group, and had significant enhancement in sensation, association, body, and ability of self-care (P < 0.05) and was better than the behavior therapy group in sensation, body and self-care factors, with no significantly improvement in the scores of PPVT in the two groups (P > 0.05).\n EA combined with behavior therapy can significantly improve clinical symptoms of autism, but does not improve intelligence.", "We aim to study the efficacy of acupuncture versus sham acupuncture in children with autism spectrum disorder.\n A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to the treatment group with tongue acupuncture (40 sessions over 8 weeks) or the control group (sham tongue acupuncture to nonacupoints in the tongue).\n There was improvement in both the treatment and control groups in all assessed measures but more so in the treatment than in the control group: (1) eye-hand coordination, performance, and practical reasoning of Griffiths Mental Developmental Scale; (2) sensory-motor, social, affectual, language, and total score of Ritvo-Freeman Real Life Scale; (3) Comprehension Language age in the Reynell Language Developmental Scale; and (4) Total Score and Mental Age in Symbolic Play Test. The only statistically significant improvement in the treatment as compared to the control group was seen in self-care and cognition domains of the Functional Independence Measure for children.\n We had demonstrated that a short course of acupuncture had efficacy in improving various developmental and behavioral aspects of children with autism. The long-term efficacy in functional gain needs to be further explored.", "To study the efficacy, safety, and compliance of short-term electro-acupuncture for children with autism spectrum disorder (ASD).\n Randomized, double-blind, sham-controlled, clinical trial.\n Children with ASD were randomly assigned to an electro-acupuncture (EA) group (n=30) or a sham electro-acupuncture (SEA) group (n=25) matched by age and severity of autism. The EA group received electro-acupuncture for selected acupoints while the SEA group received sham electro-acupuncture to sham acupoints. A total of 12 EA and SEA sessions over four weeks were given. Primary outcome measures included Functional Independence Measure for Children (WeeFIM), Pediatric Evaluation of Disability Inventory (PEDI), Leiter International Performance Scale-Revised (Leiter-R), and Clinical Global Impression-Improvement (CGI-I) scale. Secondary outcome measures consisted of Aberrant Behavior Checklist (ABC), Ritvo-Freeman Real Life Scale (RFRLS), Reynell Developmental Language Scale (RDLS), and a standardized parental report. Data were analyzed by the Mann-Whitney test.\n There were significant improvements in the language comprehension domain of WeeFIM (p=0.02), self-care caregiver assistant domain of PEDI (p=0.028), and CGI-I (p=0.003) in the EA group compared to the SEA group. As for the parental report, the EA group also showed significantly better social initiation (p=0.01), receptive language (p=0.006), motor skills (p=0.034), coordination (p=0.07), and attention span (p=0.003). More than 70 percent of children with ASD adapted to acupuncture easily, while eight percent had poor acupuncture compliance. Mild side effects of minor superficial bleeding or irritability during acupuncture were observed.\n A short, four-week (12 sessions) course of electro-acupuncture is useful to improve specific functions in children with ASD, especially for language comprehension and self-care ability.", "This is a randomized controlled trial that aimed to evaluate the effect of the Seven-star Needle Stimulation treatment on children with Autistic Spectrum Disorders (ASD). Thirty-two children with ASD were assigned randomly into the treatment and control groups. Children in the treatment group underwent 30 sessions of stimulation over 6 weeks, while children in the control group were on a waiting list and did not receive treatment during this period of time. Intervention consisted of a treatment regime comprising of 30 sessions of Seven-star Needle Stimulation, delivered over 6 weeks. Each session lasted 5 to 10 min, children in the treatment group were stimulated at the front and back sides of their body and the head by using Seven-star Needles. The change in the children's behavior was evaluated using parents' report and neurophysiological changes were measured by quantitative EEG (qEEG). Results showed that the treatment group demonstrated significant improvement in language and social interaction, but not in stereotyped behavior or motor function, compared to the control group. qEEG spectral amplitudes in the treatment, but not in the control group, were also reduced significantly. The results suggested that Seven-star Needle Stimulation might be an effective intervention to improve language and social functioning of children with ASD." ]

[ "10327093", "3102375", "323842", "375521" ]

[ "Randomized controlled study of ultrasound therapy in the management of acute lateral ligament sprains of the ankle joint.", "Ultrasound in the treatment of ankle sprains.", "Ultrasound in the treatment of sprained ankles.", "[Evaluation of ultrasonics and electric stimulation in the treatment of sprained ankles. A controlled study]." ]

[ "To determine the efficacy of a fixed dose of ultrasound energy to treat acute lateral ligament sprains of the ankle joint.\n Double-blind randomised controlled trial.\n Accident and Emergency department of University Teaching Hospital.\n Patients presenting at Accident and Emergency with ankle injuries.\n Ultrasound or placebo, and Tubigrip.\n Pain measured with visual analogue scales, swelling using a tape measure, range of movement using a fluid-filled goniometer, and weight bearing using two scales simultaneously.\n Patients in both groups improved symptomatically. There were no statistically significant differences between groups in any outcome measure. Within groups, statistically significant differences were detected in pain perceived, and range of movement (dorsiflexion).\n At the dose and duration used, ultrasound therapy is no better than placebo in the management of lateral ligament injuries.", "Ultrasound is commonly used in association with other forms of treatment in the management of sprains of the lateral ligament of the ankle. Despite its widespread use there is little scientific evidence to support its role in the management of sprained ankles. We have conducted a prospective, randomized, double-blind trial to compare the results of physiotherapy for sprains of the lateral ligament of the ankle without the use of ultrasound with physiotherapy which included ultrasound. The results in the 154 patients who entered the trial demonstrate that there was no significant difference between the results achieved by the group treated with ultrasound and by those managed without.", "nan", "nan" ]

[ "8120709", "16325968", "8102430", "20639712" ]

[ "Oral absorption of omega-3 fatty acids in patients with cystic fibrosis who have pancreatic insufficiency and in healthy control subjects.", "Biological effects of a dietary omega-3 polyunsaturated fatty acids supplementation in cystic fibrosis patients: a randomized, crossover placebo-controlled trial.", "Eicosapentaenoic acid in cystic fibrosis: evidence of a pathogenetic role for leukotriene B4.", "Supplementation with fatty acids influences the airway nitric oxide and inflammatory markers in patients with cystic fibrosis." ]

[ "Dietary supplementation with fish oils high in the omega-3 fatty acids, eicosapentaenoic acid and docosahexaenoic acid, may have an antiinflammatory effect. We determined whether patients with cystic fibrosis (CF) could incorporate omega-3 fatty acids into their plasma and cell membrane phospholipids without adverse effects. In this double-blind study, 12 patients with pancreatic insufficiency who have CF (mean age, 12.2 +/- 5.4 (SD) years) and 13 subjects without CF (mean age, 13.4 +/- 6.3 (SD) years) were randomly assigned to ingest 8 gm daily of either encapsulated fish oil (3.2 gm of eicosapentaenoic acid and 2.2 gm of docosahexaenoic acid daily) or olive oil ethyl esters for 6 weeks. Two of seven and two of five patients with CF who received fish and olive oils, respectively, and one of eight and none of five subjects without CF discontinued taking the capsules before 6 weeks because of eructation or diarrhea. Significant incorporation of omega-3 fatty acids into plasma and erythrocyte membrane phospholipids was observed in subjects with and those without CF randomly assigned to the fish oil treatment. For example, in subjects randomly assigned to receive fish oil, the eicosapentaenoic acid/arachidonic acid ratio in plasma increased 9.8-fold, from 0.04 +/- 0.02 (mean +/- SEM) to 0.39 +/- 0.11 (p = 0.02), in the patients with CF (n = 7) and 23.0-fold, from 0.04 +/- 0.01 to 0.92 +/- 0.17 (p = 0.001), in the subjects without CF (n = 8) who received fish oil (p = 0.02, patients with CF vs subjects without CF at 6 weeks). No clinically or statistically significant changes from baseline were observed in platelet aggregation or levels of vitamin E or A in subjects who received fish oil. Future studies are indicated to determine whether omega-3 fatty acid enrichment provides a clinically beneficial antiinflammatory effect in patients with CF.", "Various anti-inflammatory therapies, including dietary omega-3 polyunsaturated fatty acids (PUFA) supplementation, have been investigated in cystic fibrosis (CF) patients. To further explore this nutritional approach, biological effects of an omega-3 PUFA oral liquid supplementation were measured in 17 CF patients in a double-blind, randomized, crossover without a washout period and placebo-controlled study.\n CF patients (age: 18+/-9 year; weight: 43+/-13 kg) received a liquid dietary supplementation either enriched or not in omega-3 PUFA (390-1170 mg/day according to patient weight) during two 6-month periods.\n Increase in eicosapentaenoic acid was observed in neutrophil membrane following omega-3 PUFA dietary supplementation (from 0.7+/-0.6 to 1.6+/-0.6 micromol%, P<0.01). The leukotriene B(4) (LTB(4))/leukotriene B(5) (LTB(5)) ratio was decreased (from 72+/-27 to 24+/-7, P<0.001) in CF patients taking omega-3 PUFA supplements. In contrast, omega-3 PUFA supplementation affected neither internalization of IL-8 receptors following IL-8 exposure, nor IL-8-induced neutrophil chemotaxis.\n Our results show that omega-3 PUFA are incorporated in neutrophil membranes. The subsequent decrease in LTB(4)/LTB(5) ratio suggests that, in such conditions, neutrophils may produce less pro-inflammatory mediators from the acid arachidonic pathway. These data indicate that omega-3 PUFA intake may have anti-inflammatory effect that still need to be assessed by long-term studies following large groups of patients.", "Much of the lung damage that limits the life of young adults with cystic fibrosis is due to proteases and oxygen metabolites generated by neutrophils, which are recruited into the airway by the interaction between Pseudomonas aeruginosa and pulmonary macrophages. Leukotriene B4 (LTB4) has been proposed as a local mediator of this process; its production is susceptible to specific modulation with dietary eicosapentaenoic acid (EPA). We carried out a placebo-controlled trial of EPA (2.7 g daily for 6 weeks) to assess its effects on markers of clinical state, peripheral neutrophil function, and lung inflammation in sixteen patients with cystic fibrosis colonised with P aeruginosa. EPA was well tolerated and resulted in a significant reduction in sputum volume (median change with EPA -10 mL/day, placebo 0; p = 0.015), and improvements in Schwachman score (EPA 5%, placebo 0; p = 0.034), forced expiratory volume in 1 s (EPA 0.25 L, placebo -0.1 L; p = 0.006), and vital capacity (EPA 0.6 L, placebo 0; p = 0.011). Relative chemotaxis of circulating neutrophils to LTB4 increased from a subnormal baseline of 4 (median; range 0-10) microns/30 min before treatment, to a near normal value of 11 (5-18) microns/30 min after EPA. Relative chemotaxis to LTB4 of patients taking placebo did not change: the difference in response was highly significant (p = 0.001). Specific reduction of neutrophil chemotaxis to LTB4 is a sensitive assay of chronic in-vivo exposure to LTB4. Our results suggest that LTB4 has a pathogenetic role in the lung damage of cystic fibrosis. Longer-term clinical trials of EPA are warranted in a larger number of cystic fibrosis patients.", "To obtain a balance in the fatty acid (FA) metabolism is important for the inflammatory response and of special importance in cystic fibrosis (CF), which is characterized by impaired FA metabolism, chronic inflammation, and infection in the airways. Nitric oxide (NO) has antimicrobial properties and low nasal (nNO) and exhaled NO (FENO), commonly reported in CF that may affect bacterial status. The present study investigates the effect of different FA blends on nNO and FENO and immunological markers in patients with CF.\n Forty-three patients with CF and \"severe\" mutations were consecutively enrolled in a randomized double-blind placebo-controlled study with 3 FA blends containing mainly n-3 or n-6 FA or saturated FA acting as placebo. FENO, nNO, serum phospholipid concentrations of FA, and biomarkers of inflammation were measured before and after 3 months of supplementation.\n Thirty-five patients in clinically stable condition completed the study. The serum phospholipid FA pattern changed significantly in all 3 groups. An increase of the n-6 FA, arachidonic acid, was associated with a decrease of FENO and nNO. The inflammatory biomarkers, erythrocyte sedimentation rate, and interleukin-8 decreased after supplementation with n-3 FA and erythrocyte sedimentation rate increased after supplementation with n-6 FA.\n This small pilot study indicated that the composition of dietary n-3 and n-6 FA influenced the inflammatory markers in CF. FENO and nNO were influenced by changes in the arachidonic acid concentration, supporting previous studies suggesting that both the lipid abnormality and the colonization with Pseudomonas influenced NO in the airways." ]

[ "10625096", "3761107", "2709252", "2726319", "3625417", "10565448", "3373407", "9497191", "7974045", "2375291", "8694013", "3578162" ]

[ "Diet and bone mineral content at term in premature infants.", "Growth, biochemical status, and mineral metabolism in very-low-birth-weight infants receiving fortified preterm human milk.", "Bone mineralization and mineral homeostasis in very low-birth-weight infants fed either human milk or fortified human milk.", "Growth of very low birth weight infants on varying amounts of human milk protein.", "Bone mineralization in preterm infants fed human milk with and without mineral supplementation.", "Changes in growth and metabolism in very low birthweight infants fed with fortified breast milk.", "Improved bone mineralization and growth in premature infants fed fortified own mother's milk.", "Moderate nutrient supplementation of mother's milk for preterm infants supports adequate bone mass and short-term growth: a randomized, controlled trial.", "Rickets in very-low-birth-weight infants born at Baragwanath Hospital.", "Growth, nutrient retention, and metabolic response of low-birth-weight infants fed supplemented and unsupplemented preterm human milk.", "Randomized outcome trial of human milk fortification and developmental outcome in preterm infants.", "Growth and phosphorus metabolism in premature infants fed human milk, fortified human milk, or special premature formula. Use of serum procollagen as a marker of growth." ]

[ "Premature infants are at risk of developing metabolic bone disease mainly because of low calcium and phosphorus intake. We have examined the effect of different mineral supplements on bone mineral content at term in 127 premature infants with gestational age <32 wk in a double-blinded randomized trial. We used either phosphate supplementation of human milk as recommended by the European Society of Pediatric Gastroenterology and Nutrition or fortified supplementation with protein, calcium, and phosphorus or preterm formula as recommended by the American Academy of Pediatrics. The intervention period was from 1 week old until 36 wk of gestational age, and the infants were fed approximately 200 mL x kg(-1) x d(-1). Bone mineral content was measured at term by dual-energy x-ray absorptiometry scan. Surprisingly, neither phosphate, fortifier, nor preterm formula supplementation had any significant effect on bone mineral content at term compared with infants fed their own mother's milk only. There was a tendency to higher total bone mineral content in infants fed preterm formula compared with infants fed their own mother's milk only (p = 0.05), but when the bone mineral content was corrected for the size of the infant, there was no difference (p = 0.68). Infants fed preterm formula had a significantly higher weight at term compared with infants fed their own mother's milk only (p = 0.02), but did not differ significantly in length or head circumference. In a regression analysis, the amount of supplemented phosphorus was significantly associated with weight at term (p = 0.008). We conclude that when feeding 200 mL x kg(-1) x d(-1), mineral supplementation of human milk or use of preterm formula does not significantly improve bone mineralization outcome at term.", "We compared the growth, biochemical status, and mineral status of 30 very-low-birth-weight infants randomly assigned to receive preterm human milk (Group I, 10 infants) from their own mothers, fortified preterm human milk (Group II, 8 infants), or a high-caloric-density premature formula (Group III, 12 infants). Added to the infant's own mother's milk, a human milk fortifier at full strength provided additional protein (60:40 whey/casein, 0.7 g/dl), calories (4 kcal/oz), and minerals. Volume of intake, feeding tolerance, and complications were similar in the three groups. Infants receiving fortified preterm human milk showed growth, biochemical status, and mineral status similar to those receiving high-caloric-density formula, but infants receiving fortified preterm human milk grew faster (12.0 +/- 3.2 vs. 8.9 +/- 1.1 days/300 g, p less than 0.05), had higher serum protein (4.6 +/- 0.5 vs. 4.2 +/- 0.2 g/dl, p less than 0.05), and tended to have better mineral status (higher serum calcium, lower alkaline phosphatase, and higher serum phosphorus, none individually significant) than infants receiving preterm human milk alone. This study supports previous observations that fortified preterm human milk provides nutritional advantages for very-low-birth-weight infants.", "Abnormalities in bone mineral metabolism are frequently found in very low-birth-weight infants, especially if fed breast milk. To assess the efficacy of a breast-milk fortifier in the feeding of these very small infants, very low-birth-weight babies (between 1,000 g-1,500 g at birth) were randomly assigned to one of two groups on day 4 of life. The fortified group received the fortifier mixed in equal proportions with their own mother's milk, while the breast-milk group received only their own mother's milk. All infants received an oral vitamin D supplement of 750 IU/day. The study was continued until the infants weighed 1,800 g, at which stage breast feeding was encouraged. Thirty infants in the breast-milk group and 29 in the fortified group completed the study. Infants in the fortified group had significantly lower alkaline phosphatase values, a greater bone mineral content (BMC) and BMC/bone width ratio, and lower urinary calcium excretion than the breast-milk group at a weight of 1,800 g. At follow-up study 3 months after delivery, when most of the infants in both groups had been breast fed for at least 6 weeks, the breast-milk group's biochemical and BMC abnormalities were almost totally corrected and were now similar to those of the fortified group. Thus, the addition of the fortifier to breast milk during the first 4-6 weeks of life decreased the biochemical evidence of abnormal bone mineral homeostasis and increased BMC in very low-birth-weight infants. By 3 months of age, however, the breast-milk group had almost totally corrected its abnormalities.", "In a double-blind, randomized study, 28 healthy, growing very low birth wt, appropriate-for-gestational-age infants were fed human milk, preferably mother's own, fortified daily with human milk protein and/or human milk fat. The infants entered the study when they were stable on complete enteral intakes of 170 mL/kg/d (mean age = 19 d). The study lasted for a mean of 4 wk. Samples from all the milks were collected daily, and intakes of protein, fat, carbohydrates, energy, and electrolytes were calculated weekly during the whole study period. Protein intakes ranged from 1.7 to 3.9 g/kg/d, and energy intakes from 100 to 150 kcal/kg/d. Wt and length gain in the nonprotein-enriched groups were 15.6 +/- 2.7 g/kg/d (mean +/- SD) and 0.88 +/- 0.17 cm/wk; the corresponding figures for the protein-enriched groups were 20.2 +/- 2.1 g/kg/d and 1.24 +/- 0.14 cm/wk. There was a strong correlation between protein intake and growth in wt and length up to an intake of about 3 g/kg/d; more protein did not result in increased growth. The same was true for energy intake, with a maximal growth rate at an intake of about 120 kcal/kg/d. A protein intake of more than 3 g/kg/d resulted in a growth rate equal to or higher than the estimated intrauterine growth rate. Some infants fed mature banked human milk alone had a poor growth. Sodium intake was low, ranging from 1.5 to 2.6 mmol/kg/d. No correlation was found between sodium intake and growth rates.", "The bone mineral status of healthy preterm infants fed maternal milk was compared with that of similar infants fed maternal milk with mineral supplementation. Fifty infants with birth weight less than 1600 g were fed human milk for 1 week until reaching an intake of 120 kcal/kg/d. Thereafter, infants were assigned randomly to one of three diets: (1) continued unsupplemented human milk, providing an intake of 40 to 50 mg/kg/d calcium and 23 to 30 mg/kg/d phosphorus; (2) human milk mixed with a high mineral containing formula, providing total intakes of 130 mg/kg/d calcium and 68 mg/kg/d phosphorus; or (3) human milk alone for 1 additional week, followed by human milk mixed with a powdered fortifier, providing total intakes of 160 mg/kg/d calcium and 90 mg/kg/d phosphorus. Infants fed human milk with formula supplementation, but not those fed human milk with fortifier, had significantly higher serum phosphorus concentrations and significantly lower serum alkaline phosphatase concentrations than did those fed unsupplemented human milk (P less than 0.01). Bone mineral content of the humerus, determined by photon absorptiometry, however, was similar in all three groups; values averaged 0.104 g/cm at the beginning of the study, and remained unchanged irrespective of mineral supplementation. Shortly before hospital discharge, study diets were discontinued and infants were fed standard proprietary formula or were nursed by their mothers. At 44 weeks postconceptional age (7 to 10 weeks after change in diet), infants were reexamined. Serum phosphorus concentrations increased, serum alkaline phosphatase concentrations decreased, and bone mineral content more than doubled to values comparable with those in term infants. Results at follow-up were comparable for all three initial diet groups and for infants who were formula-fed or breast-fed after hospital discharge. The lack of any significant effect of early maternal milk supplementation on bone mineralization by 44 weeks postconceptional age suggests that these methods of supplementation of maternal milk may not be warranted for healthy preterm infants.", "Human milk is often inadequate nutritionally for preterm infants. We investigated the effect of adding a commercially prepared milk fortifier to human (maternal or bank) milk and measured changes in lower leg length velocity (LLLvel) using knemometry, weight gain and biochemical indices of nutrition. Babies were allocated to one of three feed groups, in a semi-randomized fashion, to receive human milk alone (group I), fortified human milk (group II) or a preterm formula (group III). The birthweights (median and R) and birth gestations (median and R) of the three groups were as follows: group I 1099 g (654-1248 g) and 28 wk (26-32 wk); group II 838 g (742-1340g) and 31 wk (28-36); group III 1136g (624-1552g) and 32 wk (27-36 wk). All babies who received fortified milk either showed significant (p = 0.0004) acceleration in LLLvel during the period studied, or maintained their pre-study period velocity. This increase in LLLvel was comparable to that achieved by a group of babies given a standard preterm infant formula (p < 0.001). By comparison, the control group's change in LLLvel was more modest (p = 0.04). Babies who received human milk with the fortifier added had the lowest serum levels of alkaline phosphatase at the end of the study period when compared to the other two groups. Other biochemical indices were similar in the three feed groups. No adverse clinical events were encountered which could be attributed to the use of the breast milk fortifier.", "\"Preterm\" human milk fortified with protein (0.85 gm/dL), calcium (90 mg/dL), and phosphorus (45 mg/dL) was compared with unfortified preterm human milk as a feeding for low birth weight infants. Additionally, a special formula for low birth weight infants (Similac Special Care (SC), 20 cal/oz), was compared with a standard 20 cal/oz formula (Similac). Bone mineral content (BMC), as measured by photon absorptiometry, improved in the study groups fed fortified human milk and Similac SC formula during the first 6 weeks of full oral feedings. Even though the intakes of calcium in the groups fed fortified human milk and Similac SC formula approached the intrauterine requirement for Ca during the third trimester of pregnancy (150 mg/kg/d), the values for BMC in these two groups (37 to 39 mg/cm) at the completion of the study were still considerably less than the intrauterine values for radial BMC at 36 to 37 weeks gestational age (72.6 +/- 14.1 mg/cm). Furthermore, the relative phosphorus deficiency (as determined by increased urinary Ca excretion and increased renal tubular reabsorption of phosphate) in the human milk groups occurred with or without supplements of Ca and P. Rate of weight gain in the fortified human milk group was greater than that of the unfortified human milk group and was comparable to that of infants fed Similac SC formula. Rate of weight gain for the unfortified human milk group was similar to that of infants fed Similac formula containing 20 cal/oz. However, none of the four feeding groups exceeded the 50th percentile for weight at the time of discharge (36 to 37 weeks postconceptional age). The results suggest that fortifying preterm human milk with Ca, P, and protein for low birth weight infants will improve bone mineralization and rate of growth to levels comparable to those achieved with a special formula containing high amounts of protein, Ca, and P.", "Our objectives were 1) to determine whether moderate nutrient supplementation of mother's milk (MM) for preterm infants, in the form of a new multinutrient fortifier (MNF), would improve short-term growth and bone mineral content (BMC) when compared with supplementation with calcium and phosphorus alone; and 2) to investigate whether moderate calcium and phosphorus intakes, in the form of calcium glycerophosphate (CaGP), resulted in a BMC similar to that of term corrected infants. Twenty-five preterm infants fed MM were randomly assigned to receive either MM+MNF or MM+CaGP. A third group of infants fed preterm formula (PTF) served as a comparison group. Whole-body BMC and lean and fat mass were determined by dual-energy X-ray absorptiometry (DXA) at full-term age. Nitrogen retention and calcium, phosphorus, and zinc intakes were determined by using mass balance techniques. Nitrogen retention was significantly lower in the MM+CaGP group than in the PTF group as were both weight and length gain (weight gain: 16.6 +/- 1.6, 14.2 +/- 2.0, and 16.1 +/- 2.9 g x kg(-1) x d(-1); length gain: 1.1 +/- 0.2, 0.9 +/- 0.2, and 1.1 +/- 0.3 cm/wk for the MM+MNF, MM+CaGP, and PTF groups, respectively). Biochemical indexes of mineral status and bone turnover were normal. Conservative amounts of calcium and phosphorus, as CaGP, resulted in adequate BMC. Moderate amounts of protein, calcium, and phosphorus plus trace elements added to MM in the form of an MNF resulted in improved linear growth but did not provide any advantages to BMC when compared with supplementation with calcium and phosphorus alone.", "Disturbed mineral and bone metabolism has been reported to occur frequently in very-low-birth-weight infants fed breast-milk during the first 3 months of life. This study was designed to assess the prevalence of disturbed mineral homeostasis in a breast-milk-fed very-low-birth-weight population at Baragwanath Hospital and to determine whether the addition of a preterm infant formula to the feeds would reduce this prevalence and increase the rate of weight gain. Fifty-three neonates weighing less than 1 200 g at birth were monitored for weight gain, growth and biochemical and radiological evidence of metabolic bone disease at 2-weekly intervals during hospitalisation and for 18 weeks after discharge. The infants were randomised at 2 weeks of age to receive either breast-milk only, or a combination of breast-milk and a premature formula containing 550 mg calcium and 300 mg phosphorus. All infants received 800 IU vitamin D daily from day 14. Weight gain and growth were similar in both groups. Calcium and phosphorus intakes were higher in the mixed feeding group, but did not affect serum mineral levels. Radiological rickets was uncommon in both groups although periosteal reactions and osteopenia occurred frequently and with similar prevalences. Vitamin D deficiency was not found to be a problem. In conclusion, overt rickets is not a major problem in very-low-birth-weight infants born at Baragwanath Hospital, although biochemical abnormalities occur frequently.(ABSTRACT TRUNCATED AT 250 WORDS)", "Growth, nutrient retention, and metabolic response of low-birth-weight infants fed human milk provided by their mother; this milk supplemented with bovine milk protein, calcium, phosphorus, and sodium; or pasteurized term human milk with the same supplement were monitored from the time desired intake was tolerated until weight reached 2200 g. The supplement resulted in greater rates of weight gain (20.5 +/- 2.3 vs 16.4 +/- 2.2 g.kg-1.d-1) and nitrogen retention (353 +/- 76 vs 270 +/- 53 mg.kg-1.d-1), increase in plasma transthyretin (TTR) concentration (7 +/- 16 vs -3 +/- 9 mg.L-1.wk-1), a higher mean plasma albumin concentration (34 +/- 3 vs 32 +/- 4 g/L), and a higher plasma TTR concentration at discharge (100 +/- 22 vs 75 +/- 24 mg/L). All these variables correlated significantly with total nitrogen intake, suggesting that the differences are attributable to the protein content of the supplement. The supplement also resulted in greater rates of calcium and phosphorus accretion but the plasma alkaline phosphatase activity of the supplemented vs the unsupplemented groups did not differ.", "Despite potential benefits, human milk may fail to meet preterm infants' nutrient requirements. We tested the hypothesis that fortified breast milk, fed alone or with preterm formula, would improve neurodevelopment and growth at 18-mo follow-up without adverse short-term clinical or biochemical consequences. Two hundred seventy-five preterm infants from two medical centers (birth weight < 1850 g; mean gestation 29.8 +/- 2.7 wk) whose mothers chose to provide breast milk were randomly assigned to receive for a mean of 39 d a multinutrient fortifier or control supplement containing phosphate and vitamins. Breast milk comprised 47.6% and 46.4% of enteral intake in fortified and control groups, respectively; preterm formula supplements were used when insufficient breast milk was available. Overall, there were no significant growth advantages with fortification; although, when breast milk exceeded 50% of intake, fortification promoted faster weight gain (an advantage of 1.6 g.kg-1.d-1; 95% CI: 0.1, 3.1; P < 0.05). Compared with control infants, the fortified group showed 1) higher plasma urea from week 2 (P = 0.04), 2) higher plasma calcium (mean 2.34 +/- 0.01 compared with 2.27 +/- 0.02 mmol/L; P = 0.003), 3) a greater rise in alkaline phosphatase by week 6 (P = 0.04), 4) more clinical infections (suspected plus proven; 43% compared with 31%, P = 0.04), 5) a nonsignificantly increased incidence of necrotizing enterocolitis (5.8% compared with 2.2%, P = 0.12), and 6) higher white cell and platelet counts. Developmental scores at 18 mo were slightly but not significantly higher in the fortified group. This study confirmed that breast milk fortifiers can improve short-term growth (when breast milk intakes are high); but beneficial effects on long-term development remained unproven. Future research is required to evaluate potential adverse consequences and explore more optimal fortification strategies.", "Human milk promotes less than optimal growth and is associated with phosphorus deficiency and decreased bone mineralization in very-low-birth-weight (VLBW) infants. In this study, the effects of feeding premature infants either human milk (HM), fortified human milk (FHM), or special premature formula (Similac Special Care [SSC]) on growth, phosphorus metabolism, and serum type I procollagen (pColl-I-C) were evaluated. Infants fed FHM exhibited a rate of weight gain and an increase in head circumference comparable with infants fed SSC and significantly greater than infants fed HM, despite the fact that both the FHM group and the HM group demonstrated biochemical evidence of phosphorus deficiency. The pColl-I-C concentrations in VLBW infants were tenfold to 20-fold greater than concentrations in normal children older than 2 years of age. The pColl-I-C levels correlated positively with weight gain and were significantly greater in the FHM and SSC groups than in the HM group. By contrast, serum alkaline phosphatase levels did not correlate with weight gain and were significantly lower in the rapidly growing SSC group than in either of the two groups with phosphorus deficiency and presumed poor bone mineralization. We conclude that the serum pColl-I-C concentration is a biochemical marker of growth in VLBW infants and may prove useful as a predictor of growth responses to various nutritional and therapeutic interventions." ]

[ "11134918", "11680552", "11086269", "9624744", "11282864", "9400510", "7862598" ]

[ "A randomised controlled trial to evaluate the effectiveness and cost-effectiveness of counselling patients with chronic depression.", "A randomized trial of the effectiveness of cognitive-behavioral therapy and supportive counseling for anxiety symptoms in older adults.", "Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy and usual general practitioner care in the management of depression as well as mixed anxiety and depression in primary care.", "A randomized controlled trial and economic evaluation of counselling in primary care.", "Antidepressant drugs and generic counselling for treatment of major depression in primary care: randomised trial with patient preference arms.", "Randomised controlled assessment of non-directive psychotherapy versus routine general-practitioner care.", "Evaluation of the short-term impact of counseling in general practice." ]

[ "To examine the effectiveness and cost-effectiveness of short-term counselling in general practice for patients with chronic depression or combined depression and anxiety, compared with general practitioner (GP) care alone.\n A randomised controlled trial and economic evaluation with an initial assessment at randomisation and follow-ups at 6 and 12 months.\n Nine general practices that were well-established participants of the Derbyshire counselling in general practice scheme, and already had a counsellor in the practice team.\n Patients were screened at GP practices, and asked to participate if they scored >/= 14 on the Beck Depression Inventory (BDI), had suffered depression or depression/anxiety for 6 months or more, were aged 18-70 and had no history of drug or alcohol abuse, psychoses or suicidal tendencies.\n The experimental group received usual GP treatment and were also referred to an experienced, well-qualified counsellor attached to their general practice. Of the eight counsellors, two practiced cognitive behavioural therapy (CBT) and six had a psychodynamic approach. The controls were referred back to their GP for routine treatment. There were no restrictions regarding the treatment that could be used, except that GPs could not refer controls to practice counsellors.\n The main outcome measure was the BDI. Others included the Brief Symptom Inventory, the Inventory of Interpersonal Problems and the Social Adjustment Scale. All tests were given at initial, 6- and 12-month assessments. Comprehensive costs were also estimated, and combined with changes in outcomes to examine between-group differences and whether counselling was more cost-effective than standard GP care.\n The trial recruited 181 patients. There was an overall significant improvement in the actual scores over time but no difference between groups or between CBT and psychodynamic counselling approaches at either 6 or 12 months. However, fewer experimental group patients were still 'cases' on the BDI than controls. This difference was statistically significant at 12 months and neared significance at 6 months (using logistic regression with the initial score as a covariate). In addition, most patients were very positive about the counselling and considered it helpful. Visual inspection of the outcomes suggested that more patients with mild or moderate depression at study entry had improved and ceased to be cases, and that more of these patients had become 'non-cases' in the experimental than the control group. However, a multiple regression analysis indicated no significant interactions between group and initial severity of depression. This could be partly due to there being no difference in outcome between the experimental and control group patients who were initially severely depressed and few of these patients ceasing to be cases at follow-up. There were no significant differences in the mean total costs, aggregate costs of services, or any of the service-group costs, except for primary care, between the experimental and control groups over time. The cost-burden to GP practices was significantly higher in the experimental than the control group at 6 months.\n Although patients were generally appreciative of the counselling received, there was only limited evidence of improved outcomes in those referred to counselling. Stricter referral criteria to exclude the severely depressed may have yielded more conclusive results. It is also difficult to estimate the effect of recruitment by screening rather than GP referral, which may limit the applicability of the results to routine clinical practice, and may have interfered with the normal working alliance established between the GP, patient and counsellor. A patient preference trial may, therefore, have been more appropriate. The results indicated that there were similar improvements for both CBT and psychodynamic counselling, but a", "The authors used a randomized trial to compare cognitive-behavioral therapy (CBT) and supportive counseling (SC) in the treatment of anxiety symptoms in older adults who met Diagnostic and Statistical Manual of Mental Disorders (4th ed.: American Psychiatric Association, 1994) criteria for anxiety disorders. Both conditions had a 6-week baseline no-treatment phase. Treatment was delivered primarily in patients' own homes and in an individual format. Outcomes were assessed at posttreatment and at 3-, 6-, and 12-month follow-ups. There was no spontaneous improvement during the baseline phase. Both groups showed improvement on anxiety measures following treatment, with a better outcome for the CBT group on self-rating of anxiety and depression. Over the follow-up period, the CBT group maintained improvement and had significantly greater improvement than the SC group on anxiety and 1 depression measure. Treatment response for anxiety was also superior for the CBT group, although there was no difference between groups in endstate functioning.", "The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive-behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting.\n The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months.\n The study was conducted in 24 general practices in Greater Manchester and London.\n A total of 464 eligible patients, aged 18 years and over, were referred by 73 GPs and allocated to one of the psychological therapies or usual GP care for depressive symptoms.\n The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling. Cognitive-behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months. Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists.\n The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post.\n At 4 months, both psychological therapies had reduced depressive symptoms to a significantly greater extent than usual GP care. Patients in the psychological therapy groups exhibited mean scores on the Beck Depression Inventory that were 4-5 points lower than the mean score of patients in the usual GP care group, a difference that was also clinically significant. These differences did not generalize to other measures of outcome. There was no significant difference in outcome between the two psychological therapies when they were compared directly using all 260 patients randomised to a psychological therapy by either randomised allocation method. At 12 months, the patients in all three groups had improved to the same extent. The lack of a significant difference between the treatment groups at this point resulted from greater improvement of the patients in the GP care group between the 4- and 12-month follow-ups. At 4 months, patients in both psychological therapy groups were more satisfied with their treatment than those in the usual GP care group. However, by 12 months, patients who had received non-directive counselling were more satisfied than those in either of the other two groups. There were few differences in the baseline characteristics of patients who were randomised or expressed a treatment preference, and no differences in outcome between these patients. Similar outcomes were found for patients who chose either psychological therapy. Again, there were no significant differences between the two groups at 4 or 12 months. Patients who chose counselling were more satisfied with treatment than those who chose c", "Counselling in primary care settings remains largely unevaluated. Such evaluation has been strongly recommended.\n To determine the relative effectiveness and cost-effectiveness of generic counselling and usual general practitioner (GP) care for patients with minor mental health problems.\n A randomized controlled trial and health economic evaluation were carried out in nine general practices. Access to generic counselling (brief counselling, generally involving up to six 50-minute sessions) was compared with usual GP care. A total of 162 patients aged 16 years and over with diverse mental health problems (excluding phobic conditions and psychoses) were randomized. The Hospital Anxiety and Depression (HAD) scale, COOP/WONCA (World Organization of Family Doctors) functional health assessment charts, and the delighted-terrible faces scale were used to assess outcome four months after randomization.\n The two groups were similar at baseline. There were significant improvements in both groups between randomization and follow-up for most outcome measures, but no significant differences between the study arms. The 95% confidence limits were narrow and excluded clinically significant effects. Under various assumptions concerning the cost of secondary care referrals and of counselling time, no clear cost advantage was associated with either intervention.\n This pragmatic trial demonstrates no difference in functional or mental health outcome at four months between subjects offered access to counselling and those given usual care by their GP. There is no clear difference in the cost-effectiveness of the two interventions. Purchasers should take account of these findings in allocating resources within primary care.", "To compare the efficacy of antidepressant drugs and generic counselling for treating mild to moderate depression in general practice. To determine whether the outcomes were similar for patients with randomly allocated treatment and those expressing a treatment preference.\n Randomised controlled trial, with patient preference arms. Follow up at 8 weeks and 12 months and abstraction of GP case notes.\n 31 general practices in Trent region.\n Patients aged 18-70 who met research diagnostic criteria for major depression; 103 patients were randomised and 220 patients were recruited to the preference arms.\n Difference in mean Beck depression inventory score; time to remission; global outcome assessed by a psychiatrist using all data sources; and research diagnostic criteria.\n At 12 months there was no difference between the mean Beck scores in the randomised arms. Combining the randomised and patient preference groups, the difference in Beck scores was 0.4 (95% confidence interval -2.7 to 3.5). Patients choosing counselling did better than those randomised to it (mean difference in Beck score 4.6, 0.0 to 9.2). There was no difference in the psychiatrist's overall assessment of outcome between any of the groups. 221/265 (83%) of participants with a known outcome had a remission. Median time to remission was shorter in the group randomised to antidepressants than the other three groups (2 months v 3 months). 33/221 (15%) patients had a relapse.\n Generic counselling seems to be as effective as antidepressant treatment for mild to moderate depressive illness, although patients receiving antidepressants may recover more quickly. General practitioners should allow patients to have their preferred treatment.", "We compared the efficacy of and patients' satisfaction with general-practice-based psychotherapists with those of general practitioners in providing treatment to people with emotional difficulties.\n We carried out a prospective, randomised, controlled trial of brief, non-directive psychotherapy and routine general-practice care. Therapists adhered to a non-directive Rogerian model of psychotherapy. Between one and 12 sessions of psychotherapy were given over 12 weeks in 14 general practices in north London, UK. Of 136 patients with emotional difficulties, mainly depression, 70 patients were randomly assigned to the therapist and 66 to the general practitioner. Depression, anxiety, other mental-disorder symptoms, and social adjustment were measured by self-report at baseline, 3 months, and 9 months. Patients' satisfaction was also measured by self-report at 3 and 9 months.\n All patients improved significantly over time. There were no significant differences between the groups receiving brief psychotherapy and routine general-practitioner care. Patients assigned brief psychotherapy were more satisfied with the help they received than those assigned to the general practitioner at both 3 and 9 months' follow-up (mean scores on satisfaction scale 50.9 [SD 7.9] vs 44.4 [9.8] and 45.6 [9.4] vs 37.1 [11.2], respectively).\n General-practitioner care is as effective as brief psychotherapy for patients usually referred by doctors to practice-based psychotherapists. Patients with emotional difficulties prefer brief psychotherapy from a counsellor to care from their general practitioner.", "This paper describes the findings of a randomised controlled trial of the short-term impact of counseling in the general practice setting. Compared with patients who received usual advice from their general practitioner for acute problems such as relationship difficulties, anxiety and depression, those who received counseling from qualified counselors working within the primary health care context showed greater improvement in psychological health as measured by the General Health Questionnaire. Significantly fewer of those counselled were prescribed anti-depressant drugs by the general practitioners in the study, or were referred to psychiatrists or clinical psychologists for care. In addition those patients who attended sessions with the practice counselor were more likely to report that they were satisfied with their treatment and more expressed feelings of well-being." ]

[ "10999118", "2986562", "20071702", "6126752", "6372935", "7741850" ]

[ "Usefulness of percutaneous transhepatic biliary drainage in patients with surgical jaundice--a prospective randomised study.", "Does preoperative percutaneous biliary drainage reduce operative risk or increase hospital cost?", "Preoperative biliary drainage for cancer of the head of the pancreas.", "Preoperative external biliary drainage in obstructive jaundice. A prospective controlled clinical trial.", "Pre-operative percutaneous transhepatic biliary drainage: the results of a controlled trial.", "Preoperative endoscopic drainage for malignant obstructive jaundice." ]

[ "Patients with obstructive jaundice undergoing surgical procedures have a significant risk of morbidity and mortality. The role of preoperative percutaneous transhepatic biliary drainage (PTBD) was evaluated in a randomized trial.\n A total of 40 patients were assigned to either preoperative PTBD (n = 20), or surgery alone (n = 20). PTBD was performed under ultrasound guidance. There were no major complications related to the procedure.\n Ultrasound guided drainage was a successful and safe method of preoperative biliary decompression. There was a marked relief from pruritus and significant reduction of hyperbilirubinaemia from a mean of 386.48 mumol/L to 116.10 mumol/L (p < 0.001). Mean duration of drainage was 42.5 days. Postoperative complications occurred in five patients in PTBD group (25%) compared to 11 patients (55%) in the control group. One death (5%) occurred in PTBD group compared to four deaths (20%) in the control group (significant at 5% level with probability 0.2).\n Ultrasound guided drainage is a useful preoperative supportive measure in preparing deeply jaundiced patients for surgery and permits hepatic function to return to a near normal state preoperatively. The improved results in our study were due to longer duration of drainage.", "Despite recent advances in perioperative support care, surgery for obstructive jaundice is still associated with significant morbidity and mortality. For this reason, preoperative percutaneous transhepatic drainage (PTD) has been recommended for these patients. This method of management, however, has only been supported by retrospective and nonrandomized studies. Therefore, a prospective, randomized study was performed to determine the effect of preoperative PTD on operative mortality, morbidity, hospital stay, and hospital cost. Thirty-day mortality was 8.1% among 37 patients undergoing preoperative PTD, compared to 5.3% for 38 patients who went to surgery without preoperative drainage. Overall morbidity was also slightly, but not significantly, higher in patients who underwent preoperative PTD, (57% versus 53%). However, total hospital stay was significantly longer (p less than 0.005) in the PTD group (31.4 days versus 23.1 days). The cost of this excess hospitalization and the PTD procedure at our university medical center was over +8000 per patient. The authors conclude that preoperative PTD does not reduce operative risk but does increase hospital cost and, therefore, should not be performed routinely.", "The benefits of preoperative biliary drainage, which was introduced to improve the postoperative outcome in patients with obstructive jaundice caused by a tumor of the pancreatic head, are unclear.\n In this multicenter, randomized trial, we compared preoperative biliary drainage with surgery alone for patients with cancer of the pancreatic head. Patients with obstructive jaundice and a bilirubin level of 40 to 250 micromol per liter (2.3 to 14.6 mg per deciliter) were randomly assigned to undergo either preoperative biliary drainage for 4 to 6 weeks, followed by surgery, or surgery alone within 1 week after diagnosis. Preoperative biliary drainage was attempted primarily with the placement of an endoprosthesis by means of endoscopic retrograde cholangiopancreatography. The primary outcome was the rate of serious complications within 120 days after randomization.\n We enrolled 202 patients; 96 were assigned to undergo early surgery and 106 to undergo preoperative biliary drainage; 6 patients were excluded from the analysis. The rates of serious complications were 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group (relative risk in the early-surgery group, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). Preoperative biliary drainage was successful in 96 patients (94%) after one or more attempts, with complications in 47 patients (46%). Surgery-related complications occurred in 35 patients (37%) in the early-surgery group and in 48 patients (47%) in the biliary-drainage group (relative risk, 0.79; 95% CI, 0.57 to 1.11; P=0.14). Mortality and the length of hospital stay did not differ significantly between the two groups.\n Routine preoperative biliary drainage in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. (Current Controlled Trials number, ISRCTN31939699.)\n 2010 Massachusetts Medical Society", "57 patients with obstructive jaundice were randomly allocated to surgery with preoperative external biliary drainage (29 patients) and without preoperative external biliary drainage (28 patients). 22 patients ultimately underwent laparotomy after a mean of 11.7 days of drainage and 25 had surgery without preoperative drainage. The postoperative complication rate was low and similar in both groups but complications associated with the drainage procedure were substantial. Perioperative mortality was 4/28 (14%) in the drainage group and 4/27 (15%) in the non-drainage group. There seems to be no advantage associated with routine preoperative external biliary drainage before surgery for obstructive jaundice.", "The operative mortality for biliary tract obstruction due to malignancy is high. In 1981 a controlled clinical trial of pre-operative percutaneous drainage was started at the Royal Postgraduate Medical School. At the time of percutaneous transhepatic cholangiography patients were randomized either to laparotomy or to pre-operative percutaneous transhepatic biliary drainage ( PTBD ) followed by laparotomy. Only patients with malignant biliary tract obstruction and serum bilirubin greater than 100 mumol/l were included. Seventy patients entered the trial, and five were withdrawn. Of the 65 remaining, 31 underwent laparotomy and 34 had pre-operative PTBD followed by laparotomy. The median duration of drainage was 18 days and during this time the median bilirubin fell from 305 to 115 mumol/l. Five patients required early surgery for complications of PTBD and two died within 30 days of surgery. The mortality for laparotomy was 19 per cent (6/31) compared with 32 per cent (11/34) for drainage plus laparotomy. This trial highlights the hazards of PTBD in high risk patients and has failed to demonstrate a reduction in mortality with the use of pre-operative PTBD .", "The role of preoperative endoscopic drainage for patients with malignant obstructive jaundice was evaluated in a randomized controlled trial. A total of 87 patients were assigned to either early elective surgery (44 patients) or endoscopic biliary drainage followed by exploration (43). Thirty-seven patients underwent successful stent insertion and 25 had effective biliary drainage. Complications related to endoscopy occurred in 12 patients. After endoscopic drainage significant reductions of hyperbilirubinaemia, indocyanine green retention and serum albumin concentration were observed. Patients with hilar lesions had a significantly higher incidence of cholangitis and failed endoscopic drainage after stent placement. The overall morbidity rate (18 patients versus 16) and mortality rate (six patients in each group) were similar in the two treatment arms irrespective of the level of biliary obstruction. Despite the improvement of liver function, routine application of endoscopic drainage had no demonstrable benefit. Endoscopic drainage is indicated only when early surgery is not feasible, especially for patients with distal obstruction." ]

[ "17456571", "19079957" ]

[ "Dopamine agonist cabergoline reduces hemoconcentration and ascites in hyperstimulated women undergoing assisted reproduction.", "Cabergoline reduces the early onset of ovarian hyperstimulation syndrome: a prospective randomized study." ]

[ "Ovarian hyperstimulation syndrome (OHSS) results from increased vascular permeability (VP) caused by ovarian hypersecretion of vascular endothelial growth factor (VEGF), which activates its receptor-2. In animals, the dopamine receptor 2 agonist cabergoline (Cb2) inactivates VEGF receptor-2 and prevents increased VP.\n Our objective was to test whether Cb2 reduces VP and prevents OHSS in humans.\n We conducted a prospective, randomized, double-blind study on oocyte donors at risk of developing OHSS (>20 follicles, >12 mm developed, and >20 oocytes retrieved).\n Cb2 0.5 mg/d (n = 37) or a placebo (n = 32) was administered from the day of human chorionic gonadotropin (d 0) until d 8. Ascites (a pocket of peritoneal fluid > 9 cm(2) in lithotomy position), hemoconcentration, and serum prolactin were recorded. Pharmacokinetic studies with magnetic resonance employing the transfer constant rate (K(trans), measure of permeability) and the extravascular extracellular space (upsilon(e), marker of cellular leakage) were performed to measure VP objectively.\n Hematocrit (P < 0.01), hemoglobin (P = 0.003), and ascites (P = 0.005) were significantly lower on d 4 and 6 after treatment with Cb2 as compared with placebo. The incidence of moderate OHSS was 20.0 and 43.8%, respectively (P = 0.04). Magnetic resonance studies showed an increase in VP and extravascular leakage of fluid 5 d after human chorionic gonadotropin injection that was significantly prevented with Cb2 (K(trans) P = 0.04 and upsilon(e) P = 0.001, respectively).\n Given that Cb2 is a well-established and safe medication, this study provides proof of concept for the use of dopamine agonists in the prevention of OHSS in women undergoing assisted reproduction.", "Prophylactic use of cabergoline has been associated with a decrease in the severity of ovarian hyperstimulation syndrome (OHSS). A prospective randomized study was designed to evaluate the potential of cabergoline to decrease the incidence of OHSS in high-risk patients undergoing assisted reproductive technology treatment; 166 patients with oestradiol concentrations over 4000 pg/ml on the day of human chorionic gonadotrophin (HCG) administration were evaluated. They all received 20 g routine preventive intravenous human albumin on the day of oocyte retrieval. They were then randomized into two groups: group A (n = 83) received 0.5 mg oral cabergoline per day for 3 weeks beginning on the day after oocyte retrieval, and group B (n = 83) received no medication. 'Early' OHSS was defined as being when the onset of the syndrome was initiated during the first 9 days after HCG administration, and 'late' OHSS was defined as being when the onset of the syndrome was initiated from 10 days after HCG administration. In group A, no patients progressed to 'early' OHSS and nine patients (10.8%) developed 'late' OHSS; in group B, 12 patients (15.0%) progressed to 'early' OHSS and three (3.8%) to 'late' OHSS. Although the risk of 'early' OHSS decreased significantly (P < 0.001), the risk of 'late' onset OHSS did not. The two groups presented no changes in pregnancy, implantation or miscarriages rates." ]

[ "9621526", "8149802", "10195718", "9749850", "10023558", "8873520", "10069634", "9446392", "10715982", "9481395", "9198569" ]

[ "Prospective randomized controlled trial comparing Lichtenstein with modified Bassini repair of inguinal hernia.", "[Lichtenstein patch versus Shouldice technique in primary inguinal hernia with a high risk of recurrence].", "Pain after primary inguinal herniorrhaphy: influence of surgical technique.", "Prospective randomized comparison of the Shouldice and Lichtenstein hernia repair procedures.", "[Management of inguinal hernia--a comparison of current methods].", "The tension-free hernioplasty in a randomized trial.", "Randomised study of Lichtenstein compared with Shouldice inguinal hernia repair by surgeons in training.", "[Mesh-plug operation for treating inguinal hernia. Randomized studies].", "Lichtenstein patch or Perfix plug-and-patch in inguinal hernia: a prospective double-blind randomized controlled trial of short-term outcome.", "Short-term outcome after mesh or shouldice herniorrhaphy: a randomized, prospective study.", "[\"Tension-free technique\" in open inguinal hernia repair. A prospective, randomized study of postoperative pain perception (\"tension-free reconstruction\" vs. Shouldice technique)]." ]

[ "We present a prospective randomized study of 80 patients with inguinal hernia who underwent either a modified Bassini repair (n = 38) or a Lichtenstein mesh repair (n = 42). Treatment groups were matched for age, side of hernia, type of hernia and ASA grade. There was no difference in the time taken to perform the two operations: the mean time taken to perform Lichtenstein repair was 26.8 min (range 12 to 49), Bassini repair taking a mean of 27.5 min (range 9 to 51), P = 0.76. There was, however, a difference between the operating times with respect to the type of hernia present, direct hernias being the fastest to repair. Pain scores were assessed by a visual analogue scale, and there was significantly less pain in the Lichtenstein group, P = 0.028. Despite this, there was no difference between the analgesic requirements of the two groups, P = 0.073. In order to assess rehabilitation, lengths of time not working and not driving were assessed. There was no difference in either measurement, P = 0.335 and 0.467 respectively. Patients were followed up a mean of 7 weeks post-operatively (range 1 to 13 weeks). There was no significant difference between the two procedures with regard to post-operative urinary complications, wound infection or other complications. All measurements except the time taken to perform the operation were independent of the surgeon involved. The accuracy of the clinical diagnosis was also assessed, and found to be moderate, with 63% of diagnoses being correct.", "209 primary inguinal hernias in patients older than 60 years with high risk for recurrence and for surgery were randomly allocated to Shouldice repair (107 hernias) or Lichtenstein patch (102 hernias). Over a 30 months period there was one recurrence in the Lichtenstein group. The amount of local anesthetic and postoperative pain medication was significantly reduced in the Lichtenstein group, 9.8% of repairs requiring no pain medication at all, and 29.4% none on the first postoperative day. No other hernia repair is as painless, innocuous, and easily performed under local anesthesia as the Lichtenstein patch. Both, Lichtenstein and Shouldice, serve their purpose almost ideally when done correctly.", "Pain is an important problem after ambulatory hernia repair. To assess the influence of the surgical technique on postoperative pain, two separate randomized, patient-blinded, controlled trials were performed in men with an indirect inguinal hernia.\n In study A, 48 patients with an internal inguinal ring smaller than 1.5 cm were randomly allocated to either simple extirpation of the hernial sac or extirpation plus annulorrhaphy. In study B, 84 patients with an internal inguinal ring wider than 1.5 cm were randomly allocated to extirpation plus annulorrhaphy or extirpation plus Lichtenstein mesh repair (modified). All operations were performed under unmonitored local anesthesia with standardized perioperative analgesia using methadone and tenoxicam. Pain was scored daily for the first postoperative week and after 4 weeks on a four-point verbal-rank scale (no, light, moderate, or severe pain) during rest, while coughing, and during mobilization (rising to the sitting position). Use of supplementary analgesics (paracetamol) was recorded. Cumulative daily pain scores for the first postoperative week and the number of patients who used supplementary analgesics were the main outcome measures.\n There were no significant differences in cumulative pain scores or use of supplementary analgesics between the treatment groups in either study. Cumulative pain scores were significantly higher during coughing and mobilization than during rest in both studies.\n Choice of surgical technique for open repair of a primary indirect inguinal hernia has no influence on postoperative pain.", "To compare the Lichtenstein, tension-free mesh, and the Shouldice, 4-layer Bassini repair of the inguinal hernia.\n Prospective randomized clinical trial.\n A private suburban hernia center.\n Six hundred seventy-two men with inguinal hernias, aged 20 to 90 years, seen at the hernia center between January 1, 1990, and December 31, 1995.\n Slightly modified Shouldice and Lichtenstein repairs were used to repair primary and recurrent inguinal hernias.\n Recurrence rates, symptoms (including patient satisfaction), and infections.\n A total of 717 repairs in 672 patients, including 45 bilateral repairs, have been monitored to date. Recurrence of hernia occurred in 7 Shouldice repairs and 2 mesh repairs. Twelve superficial infections associated with Shouldice and 6 associated with mesh repairs were found.\n Both types of hernia repair are comparable and effective, but long-term results favor the Lichtenstein technique for reducing recurrences (to a P value of .10), ease of technical mastery, and application to the outpatient setting by use of a local anesthetic.", "Between July 1995 and June 1996, 280 patients were operated on for inguinal hernia within the scope of a prospective, randomized study. The aim of the study was to compare the Shouldice technique with tension-free hernioplasty (Lichtenstein, TAPP). The operation time was comparable in all three groups. There was less need for analgesics and postoperative morbidity was less after the tension-free technique. No severe complications such as deep wound infection or infection of the implant were seen in any of the groups. After a follow-up period of 18 months, we found two recurrences after the Shouldice operation and one recurrence in each of the tension-free groups. Treatment satisfaction after tension-free hernioplasty was high. One year after the Shouldice operation, about 10% of the patients were dissatisfied because of persistent discomfort and pain. Because of lower morbidity, less pain, and low recurrence rates after tension-free hernioplasty, we find the tension-free techniques to be superior to conventional hernioplasty.", "The tension-free hernioplasty as introduced by Lichtenstein has gained increasing acceptance during the last decade although the technique has not been evaluated in a randomized trial.\n This randomized study compares the 2-year follow-up results after 102 tension-free hernioplasties with implantation of a prolene mesh in all groin hernias to 53 Cooper ligament repairs in direct hernias and 53 abdominal ring repairs in indirect hernias.\n After tension-free repairs five hernias recurred (5%), and after either Cooper ligament or abdominal ring repair, 16 recurrences were found (15%) (P = 0.025). No indirect hernias recurred after a tension-free repair; 2 recurred after abdominal ring repair (4%; NS). The recurrence rate after tension-free repairs for primary direct inguinal hernias was 7% as compared with 30% after Cooper ligament repair (P = 0.0081). No difference in complication rate between the tested methods was found.\n Recurrence rate is reduced to one-third after tension-free herniotomies as compared with the conventionel herniotomies without increase in complication rate.", "To compare the outcome following Lichtenstein open mesh technique or Shouldice repair for inguinal hernia operated on by surgeons in training.\n Prospective, randomised, trial.\n District hospital, Sweden.\n 200 men with primary inguinal hernias.\n Lichtenstein mesh repair or Shouldice repair.\n Duration of operation, postoperative pain assessed by visual analogue scale (VAS), complications within 30 days, duration of sick leave, and recurrence within one year.\n 178 patients were available for evaluation (n = 89 in each group). There were no significant differences in duration of operation, pain score, or incidence of postoperative complications. Patients in the mesh group took significantly less sick leave (mean 18.2 days) than those in the Shouldice group (23.8 days, p<0.05). The number of recurrences differed significantly between the groups with 9 in the Shouldice group and none in the mesh group (p<0.01).\n For surgeons in training the Lichtenstein open mesh technique is a better method of inguinal hernia repair than the Shouldice technique. The outcome is better for the patients and it is more cost-effective.", "In the period from October 1996 to April 1997 a prospective randomized study of one hundred patients with inguinal hernia was performed. 50 patients underwent the Bassini procedure (group I) and others tension-free mesh-plug repair (Lichtenstein in Rutkow's modification) (group II). The type of hernia was classified according to Gilbert's classification in Rutkow's modification. We used t- Student test and Mann-Whitney's test to evaluate significant differences. There was no significant difference in patients' age, types of hernia or the type of anesthesia between to groups. The time of operation was significantly shorter in group II (median 51.8 min) than in group I (median 63 min). During the post operative period more patients from group I required narcotic analgetics (64% versus 22%). The rate of complications was similar (8% and 6% respectively). Hospital stay was significantly shorter in group II-median 4 days versus 6 days in group I. Rehabilitation to normal activity and return to work was also shorter in group II-median 2 weeks versus 3 weeks (not statistically significant). During the follow up period 1-17 months no recurrences were observed.", "Open mesh used in anterior inguinal hernia repair can be configured as a flat patch (Lichtenstein operation) or as a cone-shaped preformed plug and supplementary patch (plug-and-patch operation; Perfix Plug; Davol Inc, Cranston, RI).\n One hundred forty-one patients were randomly allocated and blinded to receive either a Lichtenstein patch or a Perfix plug-and-patch. Information before the operation and on postoperative days 3 and 14 was recorded by an independent blinded observer to include operating time, postoperative pain, analgesic medication, return to activity and work, and quality of life assessment.\n Operating time (32 vs 37.6 minutes) was significantly shorter in the plug-and-patch group (P = .01). During days 1 through 8, patients who had undergone the plug-and-patch operation experienced less pain, and their physical functioning on day 3 was significantly better (P = .013). Days of analgesic medication (4.0 vs 4.6 days), return to normal activity (2.8 vs 3.6 days), return to work (17.0 vs 20.8 days), and total days of work missed (14.3 vs 16.1 days) were similar in both groups (P = NS for all comparisons).\n Compared with patients who received the Lichtenstein patch for ambulatory inguinal hernia repair, patients who underwent the Perfix plug-and-patch operation experienced less postoperative pain in the first 8 days after the operation but consumed similar postoperative analgesic medication. The rate of return to normal activity and work is similar in both groups, which indicates no superiority for the plug-and-patch operation in overall rehabilitation and societal costs. Overall hospital costs are greater for the plug-and-patch operation ($120 [US]) compared with the Lichtenstein patch ($20 [US]), with a negligible (5.6 minutes) saving of operating room time for the plug-and-patch operation.", "Retrospective analyses have shown that long-term recurrence rates after Lichtenstein mesh and Shouldice herniorrhaphies are low. Therefore differences in short-term outcome may be important determinants of one's choice of repair. Although proponents of the mesh repair claim that their methods is less morbid, to our knowledge no prospective comparative studies of short-term morbidity have been reported.\n One hundred five adult patients were randomized to undergo either a mesh or Shouldice inguinal hernia repair. Postoperative pain, narcotic use, and time to resumption of usual activities and employment were recorded. Patients were blinded to the type of repair received until all data were collected.\n There was no difference between the herniorrhaphy methods with respect to postoperative pain, duration of narcotic use, and time to resumption of usual activity and employment. Recovery was rapid for both groups of patients. By 3 days after operation, 50% of patients rated their pain as very mild or less and no longer required narcotic analgesics. Patients in both groups returned to usual activity and work by a median of 9 days after operation.\n Both of these well-established methods can be used to repair inguinal hernias with local anesthetics in an outpatient setting with minimal morbidity. Despite the \"tension-free\" design of the mesh repair, short-term outcomes of mesh and Shouldice repairs of inguinal hernias do not differ.", "A prospective randomized study was performed on 64 patients suffering from primary inguinal hernia. Two groups were formed, each consisting of 32 patients. The patients either underwent tension-free surgical treatment or Shouldice herniorraphy. The aim of the study was to determine if the tension-free operative technique on inguinal hernia patients reduces postoperative pain intensity by 2 days in comparison to the patients receiving Shouldice repair treatment. By using the VAS was shown that at no time was there any significant difference in the pain sensation levels between the two groups. The amount of pain tablets consumed among the patients was similar in each group. The number of complications in both groups was also comparable. During the postoperative follow-up of 6 days six patients in the tension-free surgical group and four patients in the Shouldice group developed uncomplicated hematomas on the 4th day, which were traced to the heparin medication. One patient from the Shouldice group suffered from temporary swelling of the scrotum. The advantage of open tension-free repair using extraperitoneally placed polypropylene mesh is that the technique is simple, size-adapted, and can be carried out easily and at any time under local anesthesia. With regard to the lower recurrence rate of hernia as published in the American literature, this can only be verified by randomized studies." ]

[ "3454792", "495249", "10243938", "832925", "83330", "6661146", "5421730", "5010650", "5734531", "8302982", "1159123", "7230259", "6379002", "993420", "6163329", "4688685", "7102445", "730881", "3741309" ]

[ "Effects of maintenance sessions on smoking relapse: delaying the inevitable?", "Partial component analysis of a comprehensive smoking program.", "Rapid puffing as a treatment component of a community smoking program.", "The effects of rapid smoking and hypnosis in the treatment of smoking behavior.", "Comparison of symbolic and overt aversion in the self-control of smoking.", "Aversive smoking therapies: a conditioning analysis of therapeutic effectiveness.", "Aversive and cognitive factors in the modification of smoking behaviour.", "Successful treatment of habitual smokers with warm, smoky air and rapid smoking.", "Behavior modification of smoking: the experimental investigation of diverse techniques.", "Nicotine fading and smokeholding methods to smoking cessation.", "A comparison of excessive and rapid smoking in the modification of chronic smoking behavior.", "Self-initiated, cue extinction, and covert sensitization procedures in smoking cessation.", "Preventing relapse to cigarette smoking by behavioral skill training.", "Effectiveness of negative practice and self-control techniques in the reduction of smoking behavior.", "Aversive smoking using printed instructions and audiotape adjuncts.", "Comparison of rapid smoking, warm, smoky air, and attention placebo in the modification of smoking behavior.", "A factorial analysis of preparation, aversion, and maintenance in the elimination of smoking.", "A multiple-component treatment approach to smoking reduction.", "Treatments for cigarette smoking: an evaluation of the contributions of aversion and counseling procedures." ]

[ "nan", "nan", "Twenty-six persons participated in a community smoking program, which required a $40 contribution to the sponsoring health organization and a $25 refundable deposit. Clients were assigned to one of two treatment groups; one involved group discussion and rapid puffing, and the other involved group discussion only. The number of cigarettes smoked before treatment and one week, two months, and five months after treatment were determined for each client. Smoking decreased substantially following treatment in both groups and did not differ significantly between the groups across the follow-up periods. Females, however, showed significantly greater relapse in smoking following treatment than did males. Overall, approximately 15% of the clients in each group were abstinent five months after treatment.", "nan", "nan", "nan", "nan", "nan", "nan", "We tested a multicomponent behavioural package to stop smoking that contained nicotine fading and smokeholding techniques. 73 smokers were randomly assigned to one of five treatment programmes: (1) nicotine fading and cigarette fading, (2) nicotine fading and concurrent smokeholding, (3) nicotine fading and subsequent smokeholding, (4) a nonintensive smokeholding programme, and (5) an intensive smokeholding programme (daily sessions). Common components of the programmes were self-monitoring, information on smoking, stimulus control, CO feedback, and strategies to avoid withdrawal symptoms. Each treatment was carried out during a total of 10 sessions over 4 weeks (Treatments 1-4) or 2 weeks (Treatment 5). End-of-treatment quit rates ranged from 85% to 91%. At 12-mo. follow-up, the most effective package proved to have been nicotine fading and cigarette fading, with an abstinence rate of 57% as against 25 to 37% for the other treatments.", "nan", "Two studies tested the utility of self-control procedures and covert sensitization as alternatives to rapid smokers in smoking cessation. Subjects were at least 21 years old and had smoked at least one pack per day for at least 5 years. Relaxation training and discussion of goals were given in three meetings per week for 2 weeks prior to subject-chosen quit dates. A total of 10 sessions was held during the 90 days following cessation. In Study I, both groups received self-control strategies. One group also received covert sensitization. At 3-month follow-up, 33% of those without and 27% of those with covert sensitization were abstinent. At 6-month follow-up these percentages were 33 and 13, respectively. Covert sensitization apparently added nothing to the effects of the self-control package. In Study II, one group received the same combination of self-control manual and the basic package as in Study I. A second group received the basic package with cue extinction procedures designed to extinguish associations between desires for cigarettes and cues paired with previous smoking. A third group received a combination of both sets of procedures. At 3-month follow-up, 71 and 60%, respectively, of the first two groups were abstinent, while only 31% of the combination group was abstinent. At 6-month follow-up, these percentages were 29, 27, and 8, respectively. The low abstinence rate for the combination group likely reflects problems associated with presenting too much material in the 2 weeks prior to cessation.", "nan", "nan", "nan", "nan", "The present investigation initiated a dismantling strategy in which subjects were assigned to treatment stages (preparation, aversion, maintenance) or to combinations of stages in a factorial design. It was hypothesized that multistage conditions would be superior to single stage conditions and that maintenance would retard relapse. Forty men and 33 women were randomly assigned to one of seven conditions. Results supported both hypotheses although significant effects were no longer evident at 12-month follow-up. Considerable relapse occurred in all conditions. Specific treatment components appeared to be of limited importance as indicated by generally very similar results for preparation and aversion. Booster sessions appeared to be ineffective. Interpretation of the findings is limited, however, by a relatively small subject enrollment in each condition. It was concluded that attempts to isolate extremely precise treatment elements are unlikely to be successful. Suggestions for further research included adoption of more structured maintenance strategies emphasizing coping skills and a more systematic focus upon potentially important process variables, notably group cohesiveness.", "nan", "nan" ]

[ "3884218", "3537593", "7199092", "342302", "6337322", "7035052", "19434268", "333341", "6378158", "6379082", "1683673", "335005", "6778329", "7028897", "3543180", "351537" ]

[ "The long-term outcome of nonsuppurative otitis media with effusion.", "[Effects and adverse effects of decongestants in otosalpingitis].", "Secretory otitis media, oral decongestant and antihistamine.", "Clinical trial with Lunerin mixture and Lunerin mite in children with secretory otitis media.", "Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion (\"secretory\" otitis media) in children. Results of a double-blind, randomized trial.", "Childhood serous otitis media: fifteen months' observations of children untreated compared with those receiving an antihistamine-adrenergic combination.", "Management for the children with otitis media with effusion in the tertiary hospital.", "Secretory otitis media. Aspects on treatment and control.", "Topical phenylephrine for the treatment of middle ear effusion.", "Management of middle-ear effusions in children.", "Antimicrobial therapy for otitis media with effusion ('secretory' otitis media).", "The medical treatment of secretory otitis media. A clinical trial of three commonly used regimes.", "Diagnostic and therapeutic studies in childhood serous otitis media. Results of treatment with an antihistamine-adrenergic combination.", "S-carboxymethylcysteine in otitis media with effusion. (A double-blind study).", "Efficacy of medical treatment as an adjunct to surgery in the treatment of secretory otitis media.", "Prevention and therapy of serous otitis media by oral decongestant: a double-blind study in pediatric practice." ]

[ "Seventy-four children were enrolled in a double-blind placebo-controlled study to define the outcome of nonsuppurative otitis media with effusion (OME) over a 12-week period. Participants were randomly assigned to one of three treatment groups: pseudoephedrine (4 mg/kg/day), chlorpheniramine (0.35 mg/kg/day), or placebo. The children were reexamined at 2, 4, 8, and 12 weeks after enrollment unless earlier dismissed from the study because OME resolved or acute suppurative otitis media developed. Of the 66 children completing the study protocol, 44 percent had resolved OME, 38 percent developed acute suppurative otitis media, 14 percent had unresolved OME, and 4 percent developed severe hearing loss or medication side effects by the end of 12 weeks. The greatest incidence of both suppurative otitis media and resolution of OME occurred by 2 weeks of follow-up. There was no significant difference in resolution of effusion between treatment groups. Children who were 18 months of age or older with unilateral effusion had the best likelihood of resolution.", "nan", "nan", "A double-blind comparison between a combined antihistaminc and vasoconstricting preparation (Lunerin Mixture, Lunerin Mite) and placebo was performed in children with secretory otitis media. It was shown that the children given the active drug reacted more favourably on every investigated parameter (hearing threshold, appearance and mobility of the ear drum, number of myringotomies and observation time) than the patients who were given placebo. The incidence of side-effects was low.", "In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion (\"secretory\" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children.", "Of 55 patients who had received, in a previously reported double-blind study, either an antihistamine-adrenergic combination or a placebo for three months for serous otitis media, 48 were followed without drug therapy for an additional year. During the follow-up period no differences were detected between the patients who had initially been treated with drugs and those who had received the placebo, as detected by audiometry, tympanometry, parental concern about hearing loss (as detected by the parents themselves or by their children's teachers or primary health care providers), school performance, or recurrences of serous otitis media.", "Recently, new evidence-based recommendations have been introduced for diagnosing and managing otitis media with effusion (OME) in children. However, there are some difficulties to follow the general guidelines in the tertiary hospitals. The purpose is to evaluate the efficiency of antibiotics or antihistamines for treatment of children with OME in the tertiary hospital with a randomized prospective clinical study.\n Eighty-four children with OME who had been diagnosed in the tertiary hospital were randomized to receive 5 different medications for 2 weeks. We prescribed antibiotics (amoxicillin-clavulanate syrup) in Group I (n=16), antibiotics/steroids (prednisolone) in Group II (n=18), antibiotics/antihistamines (ebastine) in Group III (n=15), antibiotics/steroids/antihistamines in Group IV (n=17), and mucolytics (ivy leaf extract) in Group V (n=17) for control. We followed-up children every 2 weeks and evaluated the state of OME at 3 months.\n Thirty six (42.9%) of 84 children were resolved within average 6.9 weeks after the treatments. Thirty-six (42.9%) were treated with ventilation tube insertion and 12 patients (14.3%) were observed. There was no difference in the resolution rates of OME among the five different protocols (P>0.05). There was no difference in the resolution rates among groups who used steroids, antihistamines, steroids and antihistamines, or other medications to manage 42 children with allergies (P>0.05).\n In the tertiary hospital, the cure rate of children with OME was not as high as well-known, and antibiotics or anti-allergic medications were not more effective than control. We may, therefore, need any other guidelines which are different from the previous evidence-based recommendations, including early operation in the tertiary hospitals.", "In a double-blind study, 228 secretory otitis media patients were evaluated according to mucolytic and decongestive treatment. No definite difference comparing with the placebo group was registered. About 50% of all patients were cured within 4 weeks after the diagnosis was established. Those patients who earlier had been treated with antibiotics because of a preceding acute otitis media had a better cure rate than the untreated group. Suggestions on treatment and control of secretory otitis media are given.", "One hundred fifty-two children were enrolled in a randomized, controlled clinical trial of the efficacy of phenylephrine hydrochloride nose drops or nasal spray in hastening the resolution of middle ear effusion. Children with persistent effusion were recruited for the study during a return visit two weeks after an episode of acute otitis media. Forty-six patients (30%) dropped out of the study, many because they failed to tolerate the medication, especially the nose drops. Another 27 (18%) had to be excluded because of intercurrent illness or systemic drug therapy. Among those children completing the study, rates of clinical and tympanometric cure during the following four weeks were similar in the drug and placebo groups. In view of the absence of documented clinical efficacy and the practical difficulties inherent in their administration, topical decongestants appear to have a limited role, if any, in treating children with persistent effusion.", "A double-blind placebo controlled trial of Mucodyne (carbocisteine, Berk Pharmaceuticals), Actifed (triprolidine HC1 and pseudoephedrine HC1, Wellcome) and combined Mucodyne and Actifed in the treatment of middle-ear effusions is reported. The trial was undertaken to assess whether either preparation, alone or in combination, would reduce the number of children requiring surgical treatment for this condition. No statistical difference between the various groups in avoiding surgical treatment was detected. In those patients undergoing surgery, pre-operative treatment with Mucodyne was associated with a significantly greater number of ears restored to a normal appearance and middle ear function as measured by tympanometry. All patients relapsing after surgery belonged to the groups receiving placebo, Actifed or the combination of Mucodyne and Actifed prior to the operation.", "To determine the effectiveness of antimicrobial treatment for otitis media with effusion (\"secretory\" otitis media) in children.\n We report the reexamination of a previously published study by Mandel et al that evaluated the efficacy of a 2-week course of antimicrobials (amoxicillin trihydrate) with and without a 4-week course of an oral decongestant-antihistamine combination in a double-blind, placebo-controlled, randomized trial involving 518 infants and children with otitis media with effusion.\n At 4 weeks, amoxicillin efficacy as determined by a tympanometric criterion (P = .121) or by a measure of improvement in hearing (P = .311) was insignificant. Only by otoscopic judgment, which is shown to contain a systematic bias as used in this clinical trial, could an argument be made for a marginal efficacy of amoxicillin at the 4-week end point. Logistic regression analyses of the combined effects of treatment and prognostic factors showed no significant differences between placebo- and antibiotic-treated groups for unilateral effusions and for bilateral effusions. When subjects with unilateral and bilateral effusions were combined, the estimated efficacy of antibiotic treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry (P = .171). We also demonstrate the sensitivity of outcome to diagnostic measures used and provide statistical evidence questioning the validity of otoscopic observations in this study. Six weeks after the termination of amoxicillin therapy, the recurrence of effusion was two to six times higher in the amoxicillin-treated children than in those treated with placebo (P = .001), and resolution of effusion was not significantly different among antibiotic and placebo groups (13.6% and 11.3%, respectively; P = .477).\n Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children.", "A clinical trial was undertaken to evaluate three medical treatments commonly used for chronic secretory otitis media. The treatments compared were Ephedrine nose drops, an oral antihistamine and decongestant (Dimotapp) and autoinflation of the middle ear. Changes in middle ear compliance and pressure were used as objective criteria of the efficacy of treatment in addition to changes in pure-tone threshold and to clinical assessment. Symptoms and abnormal signs tended to remit during the trial but there was no evidence from pure-tone audiometry and tympanometry that any of the treatments was beneficial. The period of observation enabled 28% of the children to avoid surgical treatment. Good and bad prognostic features are described which should help in deciding whether to manage a case conservatively or whether to proceed directly to surgery.", "Fifty-five children with their first recognized episodes of serous otitis media were followed over a three-month period. The efficacy of an antihistamine-adrenergic combination (diphenhydramine and pseudoephedrine), the comparative value of various diagnostic studies of middle ear function, and the prognostic importance of information obtained at the first visit were assessed. Compared double-blindly to a placebo, the pharmaceutical preparations did not appear to influence the clinical course, although more drug patients experienced lethargy or relief of symptoms not directly concerned with middle ear function (mainly upper respiratory congestion). The color and extent of motility of the tympanic membrane, but no other pneumatic otoscopic findings, were related to audiometry, whereas tympanometry correlated with the amount of motility and the presence or absence of visible fluid behind the membrane. The patients with the most severe hearing losses or with visible middle ear fluid at their initial visits improved the most, and those who began to be followed in the summer the least. The last finding may be due to a general but unexplained deterioration of childhood serous otitis media during the fall.", "S-carboxymethylcysteine syrup (SCMC); brompheniramine, phenylephrine with phenylpropanolamine elixir (BPP); and a placebo were compared in a double-blind trial in 58 children with otitis media with effusion (OME). All patients underwent myringotomies after an initial period of medical treatment. SCMC, but not BPP, was significantly better than the placebo in speeding up resolution of the effusion after surgery, as judged by pure tone audiometry, showing this drug to be a useful adjunct to the surgical management of OME. It should also be considered as an alternative to surgery.", "In a pilot controlled randomised trial of 38 children who had bilateral secretory otitis media, with effusion demonstrated at operation, we compared the efficacy of a six-week course of an oral decongestant--antihistamine combination and a mucolytic preparation with a control group in preventing the presence of middle-ear effusion six weeks after myringotomy and adenoidectomy. The mucolytic preparation decreased the presence of middle-ear effusion when compared to the decongestant-antihistamine combination and the control group (p = 0.06).", "We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no siginificant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM." ]

[ "9027779", "15836660", "15754269", "15843280", "11840368", "12147804", "15524059", "7813167", "17533020", "12046033", "16034009", "18000162", "18161210", "11918754" ]

[ "Effect of treatment with simvastatin on serum cholesteryl ester transfer in patients on dialysis. PERFECT Study Collaborative Group.", "Effects of atorvastatin and vitamin E on lipoproteins and oxidative stress in dialysis patients: a randomised-controlled trial.", "First United Kingdom Heart and Renal Protection (UK-HARP-I) study: biochemical efficacy and safety of simvastatin and safety of low-dose aspirin in chronic kidney disease.", "Effects of atorvastatin on low-density lipoprotein cholesterol phenotype and C-reactive protein levels in patients undergoing long-term dialysis.", "Safety and efficacy of simvastatin in hypercholesterolemic patients undergoing chronic renal dialysis.", "Fluvastatin prevents development of arterial stiffness in haemodialysis patients with type 2 diabetes mellitus.", "Lipid and apoprotein changes during atorvastatin up-titration in hemodialysis patients with hypercholesterolemia: a placebo-controlled study.", "Clinical investigation on the hypolipidemic effect of simvastatin versus probucol in hemodialysis patients.", "A randomized trial of the effect of statin and fibrate therapy on arterial function in CKD.", "Effects of simvastatin on high-sensitivity C-reactive protein and serum albumin in hemodialysis patients.", "Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis.", "Effects of atorvastatin on Lp(a) and lipoprotein profiles in hemodialysis patients.", "Low-dose atorvastatin in severe chronic kidney disease patients: a randomized, controlled endpoint study.", "A placebo-controlled trial examining atorvastatin in dyslipidemic patients undergoing CAPD." ]

[ "Plasma cholesteryl ester transfer activity is increased in patients with chronic renal failure on dialysis who have elevated levels of apolipoprotein B (apoB)-containing lipoproteins. Simvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor, reduces levels of these lipoproteins but the effect of treatment on cholesteryl ester transfer activity in patients on dialysis remains to be determined.\n We measured serum newly synthesized cholesteryl ester transfer (NCET) activity, lecithin:cholesterol acyltransferase (LCAT) activity and serum lipid, lipoprotein and apolipoprotein concentrations before and immediately after 6 months treatment with simvastatin (10 mg daily, n = 24) or placebo (n = 29) in 53 patients with chronic renal failure receiving haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).\n Simvastatin therapy significantly reduced serum cholesterol, LDL cholesterol, apoB concentrations, and both NCET (P = 0.001) and LCAT (P = 0.012) rates. The decrease in NCET activity was correlated significantly with the corresponding decrease in apoB concentration (r = 0.715, P < 0.001) and LCAT activity (r = 0.715, P < 0.001) during simvastatin therapy and was no longer significant when apoB concentration (P = 0.14) or LCAT activity (P = 0.07) were controlled.\n These data show that simvastatin therapy reduces serum NCET rates, and suggest that this may be linked to the concomitant decrease in levels of apoB-containing lipoproteins which are acceptors of transferred cholesteryl esters, and to the decrease in serum LCAT rates in patients with chronic renal failure with treatment.", "The objective of this study was to examine the effects of treatment with atorvastatin, alpha-tocopherol and the combination of both, on lipoproteins and oxidative stress in dialysis patients.\n This double-blind randomised placebo-controlled trial was performed at the dialysis department of a non-university hospital. SUBJECTS, INTERVENTION AND MEASUREMENTS: A total of 44 clinically stable, non-diabetic patients on dialysis therapy (23 on haemo- and 21 on peritoneal-dialysis) without manifest cardiovascular disease were included in this study. They were randomised for treatment during a period of 12 weeks with 40 mg atorvastatin + placebo alpha-tocopherol (group 1) once daily, 800 IU alpha-tocopherol + placebo atorvastatin once daily (group 2), 40 mg atorvastatin + 800 IU alpha-tocopherol once daily (group 3), or placebo atorvastatin + placebo alpha-tocopherol once daily (group 4). Assessment of lipid profile and oxidative stress was performed at the start of the study and after 12 weeks of treatment.\n Treatment with atorvastatin reduced total cholesterol, triglycerides (TG), low-density lipoprotein (LDL) cholesterol, apolipoprotein B (apoB) and levels of oxidised LDL (oxLDL) with 30-43%. It had no influence on LDL oxidisability. Additional supplementation with alpha-tocopherol had no effect on lipid profile and oxLDL levels but decreased in vitro LDL oxidisability. No side-effects were observed.\n Treatment with atorvastatin is effective in lowering plasma total cholesterol, TG, LDL, apoB and oxLDL in a population of stable dialysis patients and might therefore be an effective tool in improving the poor cardiovascular outcome in these patients. Supplementation of alpha-tocopherol to atorvastatin had beneficial effects on in vitro LDL oxidisability and might therefore be of additional value. Further research on the clinical effects of treatment with atorvastatin in combination with alpha-tocopherol is necessary.", "Patients with chronic kidney disease are at increased risk for cardiovascular disease, but the efficacy and safety of simvastatin and aspirin are unknown in this patient group.\n Patients were randomly assigned in a 2 x 2 factorial design to the administration of: (1) 20 mg of simvastatin daily versus matching placebo, and (2) 100 mg of modified-release aspirin daily versus matching placebo.\n Overall, 448 patients with chronic kidney disease were randomly assigned (242 predialysis patients with a creatinine level > or = 1.7 mg/dL [> or =150 micromol/L], 73 patients on dialysis therapy, and 133 patients with a functioning transplant). Compliance with study treatments was 80% at 12 months. Allocation to treatment with 100 mg of aspirin daily was not associated with an excess of major bleeds (aspirin, 4 of 225 patients [2%] versus placebo, 6 of 223 patients [3%]; P = not significant [NS]), although there was a 3-fold excess of minor bleeds (34 of 225 [15%] versus 12 of 223 patients [5%]; P = 0.001). Among those with predialysis renal failure or a functioning transplant at baseline, aspirin did not increase the number of patients who progressed to dialysis therapy (7 of 187 [4%] versus 6 of 188 patients [3%]; P = NS) or experienced a greater than 20% increase in creatinine level (63 of 187 patients [34%] versus 56 of 188 patients [30%]; P = NS). After 12 months of follow-up, allocation to 20 mg of simvastatin daily reduced nonfasting total cholesterol levels by 18% (simvastatin, 163 mg/dL [4.22 mmol/L] versus placebo, 196 mg/dL [5.08 mmol/L]; P < 0.0001), directly measured low-density lipoprotein cholesterol levels by 24% (89 mg/dL [2.31 mmol/L] versus 114 mg/dL [2.96 mmol/L]; P < 0.0001), and triglyceride levels by 13% (166 mg/dL [1.87 mmol/L] versus 186 mg/dL [2.10 mmol/L]; P < 0.01), but there was no significant effect on high-density lipoprotein cholesterol levels (2% increase; P = NS). Allocation to simvastatin therapy was not associated with excess risk for abnormal liver function test results or elevated creatine kinase levels.\n During a 1-year treatment period, simvastatin, 20 mg/d, produced a sustained reduction of approximately one quarter in low-density lipoprotein cholesterol levels, with no evidence of toxicity, and aspirin, 100 mg/d, did not substantially increase the risk for a major bleeding episode. Much larger trials are now needed to assess whether these treatments can prevent vascular events.", "To determine the effects of atorvastatin on low-density lipoprotein cholesterol (LDL) particle size and C-reactive protein (CRP) concentrations in patients undergoing long-term hemodialysis. Another objective was to compare the effects of atorvastatin on lipoprotein profiles as determined by direct versus indirect assessment of lipoprotein composition.\n Randomized, parallel-group substudy.\n Two university-affiliated outpatient hemodialysis centers.\n Nineteen patients with LDL levels above 100 mg/dl and with at least two cardiovascular risk factors.\n Patients were randomized in a 1:1 ratio to atorvastatin 10 mg/day or no treatment (control) for 20 weeks.\n We compared the differences between LDL particle size and CRP levels at baseline and 20 weeks in the atorvastatin versus control groups. Baseline demographic characteristics were similar between the two groups. Atorvastatin therapy was associated with no change in mean LDL particle size (p=0.23) and with a 90% decrease in mean CRP level (p=0.52). When evaluated by standard chemical analysis, atorvastatin therapy reduced total cholesterol levels by 29% (p=0.025) and resulted in nonsignificant reductions in LDL, high-density lipoprotein cholesterol, and triglyceride levels. Treatment with atorvastatin was not associated with significant changes in lipoprotein profile as determined by nuclear magnetic resonance (NMR) spectroscopy.\n Treatment with atorvastatin did not affect LDL particle size but was associated with a sizable, yet nonsignificant, reduction in CRP concentrations. The drug had variable effects on lipoprotein concentrations as determined by chemical and NMR analytical methods. A larger study is necessary to provide definitive information on the effects of atorvastatin on LDL phenotype and CRP in patients with kidney disease.", "Dyslipidemia is universal but hypercholesterolemia per se is present in around 50% of dialysis patients. Although dietary therapy is of benefit in some, the majority require drug therapy. We compared the efficacy and safety of simvastatin plus an optimized lipid-lowering dialysis diet with placebo plus diet in a randomized, double-blind trial stratified for dialysis modality. Patients treated with hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) for at least 9 months and with serum non-high-density lipoprotein (HDL) cholesterol greater than 135 mg/dL, low-density lipoprotein (LDL) greater than 116 mg/dL, and triglyceride less than 600 mg/dL after a 6-week dietary treatment phase and an 8-week diet plus placebo run-in phase, were enrolled in the 24-week double-blind treatment phase. Fifty-seven patients (16 men, 41 women, median age 63 years, range 22-75 yr) were randomized 2:1 to diet plus 5 mg/day simvastatin (n = 38: 22 HD, 16 CAPD) or diet plus placebo (n = 19: 12 HD, 7 CAPD) for 24 weeks. Dose was doubled bimonthly (maximum 20 mg/day) if non-HDL cholesterol was greater than 135 mg/dL. Forty-two patients (73.7%) completed the trial. Comparing baseline and 24 weeks, simvastatin (median 10 mg/day) was significantly more effective than placebo in reducing serum non-HDL cholesterol concentrations. For HD, the median percentage changes for total cholesterol (TC) (simvastatin versus placebo) were -21.4% and -12.1% (P = 0.011), respectively; for LDL cholesterol, -33.0% and -8.8% (P = 0.023); for non-HDL cholesterol, -25.2% and -14.0% (P = 0.008); and for TC:HDL, -17.65% and -1.67% (P = 0.008). For CAPD, changes for TC were -22.1% and -1.5% (P = 0.003), respectively; for LDL, -36.4% and 0.0% (P = 0.001); for non-HDL cholesterol, -24.9% and -3.6% (P = 0.002); and for TC:HDL ratio, -21.49% and +9.74% (P = 0.045). Changes with CAPD in apolipoprotein (Apo) A1 were -4.7% and +4.0% (P = 0.031); and for ApoB, -19.9% and +2.6%, respectively (P = 0.031). There were no significant changes in ApoA1 or ApoB with HD. Compared with placebo, triglyceride levels fell 10.2% with HD and 6.2% with CAPD. HDL cholesterol was unchanged with HD but rose 8.5% with CAPD. These trends, however, did not reach statistical significance (P > 0.05). There was no effect on Lp (a). The incidence of clinical and laboratory adverse experiences were not increased in the simvastatin-treated patients compared with placebo. Simvastatin appears to be a safe and effective treatment for the reduction of serum non-HDL cholesterol levels in both HD and, particularly, CAPD patients.\n Copyright 2002 by the National Kidney Foundation, Inc.", "Arterial stiffness assessed by pulse wave velocity (PWV) predicts all-cause and cardiovascular mortality in diabetic patients with end-stage renal disease. We studied the preventive effects of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, fluvastatin, on arterial PWV values in this population.\n Twenty-two patients with normal serum lipid levels received fluvastatin (20 mg/day p.o.) or a placebo for 6 months. Their serum lipid levels, serum levels of C-reactive protein (CRP), arterial PWV, and ankle brachial indexes (ABI) were determined before, and 3 and 6 months after taking the medication to evaluate arterial stiffness.\n At the beginning of the follow-up, there were no differences in age, blood pressure, body mass index, serum haemoglobin A1c level, serum CRP level, serum lipid levels, PWV or ABI between the placebo- (n=10) and the fluvastatin-treated patients (n=12). After 6 months, the PWV and the serum oxidized low-density lipoprotein cholesterol (LDL-C) level increased significantly (from 1969+/-140 to 2326+/-190 cm/s and 70.4+/-13.8 to 91.8+/-15.5 U/l, respectively) in the placebo-treated patients. However, the fluvastatin group had a significantly reduced PWV (from 1991+/-162 to 1709+/-134 cm/s), oxidized LDL-C serum levels (from 89.0+/-9.6 to 73.0+/-5.8 U/l) and CRP serum levels (from 0.97+/-0.32 to 0.26+/-0.16 mg/dl) compared with those in the placebo group.\n Long-term administration of fluvastatin prevents further worsening of arterial biomechanics in haemodialysis patients with type 2 diabetes mellitus, even in the presence of serum lipid levels in the normal range.", "Patients with end-stage renal disease commonly present with an atherogenic lipid profile characterized by the accumulation of triglyceride-rich, apoprotein B-containing \"remnant\" lipoproteins, small dense low-density lipoprotein, and low levels of high-density lipoprotein. They are at increased cardiovascular risk and may benefit from drastic lipid-lowering treatment with atorvastatin, a potent, broadacting lipid regulator. This study aims to assess the effects of atorvastatin on the lipid profile in hemodialysis patients, to determine wether atorvastatin is also effective at lowering lipid levels in this particular high-risk subgroup.\n In this randomized, placebo-controlled, double-blind study in hemodialysis patients with hypercholesterolemia (n = 42, mean total cholesterol 243 +/- 33 mg/dl (6.3 +/- 0.8 mmol/l)), the efficacy of 4-weekly increasing doses of atorvastatin (10 - 40 mg daily) was investigated. Lipids and apoproteins were measured in plasma and isolated lipoprotein fractions.\n Mean total cholesterol and low-density lipoprotein cholesterol progressively decreased with increasing doses of atorvastatin (total cholesterol -33%, low-density lipoprotein cholesterol -43% after 12 weeks), while high-density lipoprotein cholesterol remained unchanged. Plasma levels of apoprotein B and apoprotein E were also significantly reduced by atorvastatin 10 mg, while up-titration to 20 and 40 mg daily provided additional benefits by lowering triglycerides and apoprotein C-III. At week 12, the fraction of small dense low-density lipoprotein was significantly reduced from 23% - 18%, and apoprotein B-containing intermediate-density lipoproteins were no longer detectable.\n In conclusion, atorvastatin not only treated hypercholesterolemia but also favorably affected the uremic lipid profile in patients on hemodialysis. Atorvastatin 4-weekly dose escalation up to 40 mg daily was well-tolerated. Further prospective studies are needed to evaluate the impact of this improved lipid profile on morbidity and mortality.", "In chronic renal failure hypertriglyceridemia is a well-known complication that persists during hemodialysis treatment: it may be one of the major risk factor for cardiovascular death in these patients. We studied the effects of two lipid lowering drugs; simvastatin (20 mg/day for six months) and probucol (500 mg/day for six months), on lipid profile in 12 hemodialysis patients. Simvastatin therapy reduced plasma total cholesterol by 26% (p > 0.002), LDL-cholesterol by 36% (p > 0.002) and triglycerides by 28% (p > 0.05): plasma HDL-cholesterol and apo-A were raised, but not significantly. Probucol therapy decreased plasma triglycerides by 38% (p > 0.05), total cholesterol by 15% and LDL-cholesterol by 19%: plasma HDL-cholesterol and apo-A were decreased but not significantly. No side effects occurred with either drug. These data suggest that in hemodialysis patients both simvastatin and probucol profoundly affect the lipid profile, as well as the triglyceride levels.", "Although patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease (CVD), the roles of lipid-modifying therapies in decreasing CVD risk are unclear. Our aim is to compare the effects of statin and fibrate therapy on arterial function as a risk marker of CVD.\n Double-blind, randomized, placebo-controlled, parallel-group study.\n Ambulatory patients with stages 3 to 5 CKD.\n 6 weeks of atorvastatin, 40 mg/d, or gemfibrozil, 600 mg twice daily, with placebo.\n Primary outcome was arterial function assessed by means of endothelial-dependent flow-mediated dilatation (FMD) and small-artery compliance (C2). Secondary outcomes included endothelial-independent glyceryl trinitrate-mediated dilatation (GTNMD), large-artery compliance (C1), and levels of lipids, lipoproteins, and oxidized low-density lipoprotein, as well as markers of insulin resistance and inflammation.\n Compared with placebo, atorvastatin significantly decreased low-density lipoprotein (-52%), triglyceride (-30%), and oxidized low-density lipoprotein levels (-41%; P < 0.0001). Gemfibrozil significantly decreased triglyceride levels (-40%) and increased high-density lipoprotein levels (+20%; P < 0.0001). Neither atorvastatin nor gemfibrozil had a significant effect on markers of insulin resistance or inflammation. There was no significant change in FMD, GTNMD, or C1 with either atorvastatin or gemfibrozil. There was improvement in C2 with atorvastatin (+1.1 mL/mm Hg x 100) compared with placebo (P = 0.024), but not with gemfibrozil compared with placebo.\n Small sample size leading to inadequate power, short duration of therapy, and use of a heterogeneous group of patients with CKD and dialysis patients.\n In patients with advanced CKD, atorvastatin is associated with improvement in dyslipidemia and small-artery stiffness, but not endothelial function. Gemfibrozil improves dyslipidemia, but has no effect on arterial function.", "A 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is recommended in hemodialysis (HD) patients with hypercholesterolemia to improve their lipid profiles. We evaluated effects of simvastatin on markers for inflammation, oxidative stress, and coagulation in HD patients. Sixty-two maintenance HD patients with serum cholesterol levels of 200 mg/dL or greater were randomly assigned to the treatment group (n = 31; 8 men, 23 women; age, 63 +/- 11 years) and administered simvastatin, 20 mg/d, for 8 weeks or to the control group (n = 31; 10 men, 21 women; age, 60 +/- 12 years). We measured cholesterol, albumin, high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA; an index of lipid peroxidation), and D-dimer (a marker of intravascular coagulation) in blood at baseline and again at 8 weeks. Fifty-eight of 62 patients completed the study. In the control group, total cholesterol, serum albumin, hs-CRP, MDA, and D-dimer levels did not change. In the treatment group, simvastatin administration for 8 weeks significantly reduced total cholesterol levels from 232 +/- 25 to 165 +/- 39 mg/dL (P < 0.001) and hs-CRP levels from a median of 0.23 mg/dL (range, 0.05 to 1.63 mg/dL) to 0.12 mg/dL (range, <0.006 to 1.45 mg/dL; P < 0.01), whereas it increased serum albumin levels from 3.4 +/- 0.3 to 3.6 +/- 0.4 g/dL (P < 0.001). Administration of simvastatin did not affect MDA and D-dimer levels. These results suggest that in addition to the lipid-lowering effect, simvastatin had an antiinflammatory effect in HD patients. Considering that atherosclerosis is inflammation of the vascular wall, simvastatin may have a beneficial effect on cardiovascular disease, in part because it alleviates inflammation.\n Copyright 2002 by the National Kidney Foundation, Inc.", "Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.\n We conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.\n After four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).\n Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.", "Dialysis patients have many underlying traditional and nontraditional risk factors that may predispose them to a high prevalence of cardiovascular disease. The effects of statins (eg, atorvastatin) on altering nontraditional lipoprotein measures in dialysis patients have not been extensively investigated.\n To evaluate the efficacy of atorvastatin compared with a control group in inducing changes in lipoprotein(a) [Lp(a)], apolipoprotein (Apo) A-1, Apo-B, and fibrinogen levels, as well as the conventional lipoprotein profile, in hemodialysis patients over 36 weeks; secondary objectives were to assess changes in C-reactive protein, albumin, and safety measures.\n Forty-five hemodialysis patients with low-density lipoprotein cholesterol (LDL-C) levels greater than 100 mg/dL were randomized to parallel groups: atorvastatin (n = 19) or no treatment (n = 26). The atorvastatin dose was titrated from 10 mg to achieve an LDL-C goal of 100 mg/dL or less and therapy was continued for 36 weeks. Biochemical and lipoprotein laboratory tests for efficacy outcomes were obtained at baseline, 12 weeks, and 36 weeks.\n The atorvastatin group exhibited clinically significant reductions (mean +/- SD) compared with controls in total cholesterol (-21.7 +/- 41.7 vs -3.2 +/- 40.0 mg/dL, respectively; p = 0.017) and LDL-C (-13.1 +/- 32.0 vs -1.1 +/- 38.4 mg/dL, respectively; p = 0.058) levels, as well as Lp(a) (-10.6 +/- 27 vs 3.5 +/- 17.8 mg/dL, respectively; p = 0.046). Statistical analyses included analysis of variance on ranked measures for multivariable modeling and paired t-test to determine changes in efficacy measures between baseline and 36 weeks within groups.\n Atorvastatin was safe and effective in reducing Lp(a), total cholesterol, and LDL-C levels. Given the prevalence of atherosclerosis in hemodialysis patients, therapy aimed at reducing traditional and nontraditional risk factors may be beneficial.", "There have been no endpoint studies with statins for patients with severe renal failure. The purpose of this prospective, open, randomized, controlled study was to investigate whether atorvastatin (10 mg/day) would alter cardiovascular endpoints and the overall mortality rate of patients with chronic kidney disease stage 4 or 5 (creatinine clearance < 30 ml/min).\n The study subjects comprised 143 patients who were randomized either to placebo (controls; n=73; mean age 69.5 years) or to treatment with atorvastatin (n=70; mean age 67.9 years). The patients included were either non-dialysis (n=33), haemodialysis (n=97) or peritoneal dialysis (n=13) patients. Analysis focused on the primary endpoints of all-cause mortality, non-lethal acute myocardial infarction, coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty. Statistical analysis for endpoint data was mainly by intention-to-treat.\n Primary endpoints occurred in 74% of the subjects. There was no difference in outcome between the control and atorvastatin groups. The 5-year endpoint-free survival rate from study entry was 20%. Atorvastatin was withdrawn in 20% of patients due to unacceptable side-effects. In the atorvastatin group, low-density lipoprotein (LDL) cholesterol was reduced by 35% at 1 month and then sustained. The controls showed a progressive reduction in LDL cholesterol until 36 months.\n Although atorvastatin reduced total and LDL cholesterol effectively it was not beneficial regarding the long-term outcomes of cardiovascular endpoints or survival. In contrast to other patient groups, patients with severe chronic kidney disease, especially those on dialysis, seem to derive limited benefit from this lower dose of atorvastatin.", "Individuals with chronic renal disease are at high risk of cardiovascular morbidity and mortality, and therefore the management of dyslipidemia is particularly important in this patient population. This double-blind randomized study investigated the efficacy and safety of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, atorvastatin, in continuous ambulatory peritoneal dialysis (CAPD) patients with dyslipidemia.\n Following a two- to four-week baseline period, patients with low-density lipoprotein (LDL)-cholesterol > or =3.5 mmol/L (135 mg/dL) were randomized to receive either atorvastatin 10 mg (N = 82) or placebo (N = 95) for 16 weeks. If LDL-cholesterol remained > or =3.5 mmol/L, the dose of atorvastatin was titrated to 20 mg and 40 mg after four and eight weeks, respectively.\n After four weeks a significantly greater proportion of patients receiving atorvastatin 10 mg had achieved the LDL-cholesterol goal < or =3.5 mmol/L compared with patients receiving placebo (85.4% vs. 16.0%; P < or = 0.001). The statistically significant difference between the two groups was maintained at week 8 and week 16 (P < or = 0.001 at both time points). At week 16, patients receiving atorvastatin had significantly greater reductions from baseline in LDL-cholesterol, total cholesterol, triglycerides and total cholesterol:HDL-cholesterol ratio (all P = 0.0001), and a significantly greater increase from baseline in HDL-cholesterol (P = 0.001) than patients receiving placebo. The overall adverse event profile for atorvastatin was similar to that observed with placebo.\n Atorvastatin was effective in achieving target LDL-cholesterol levels in a high proportion of the dyslipidemic CAPD patients studied at doses that are well tolerated." ]

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[ "Double-blind controlled study of central nervous system side effects of amantadine, rimantadine, and chlorpheniramine.", "A controlled trial of amantadine and rimantadine in the prophylaxis of influenza A infection.", "[Controlled study of influenza prophylaxis by VUFB amantadin (author's transl)].", "Efficacy and safety of low dosage amantadine hydrochloride as prophylaxis for influenza A.", "A study of 1-adamantamine hydrochloride during the 1970 Hong Kong influenza epidemic.", "Therapeutic effectiveness of amantadine hydrochloride in influenza A2--double blind studies.", "Prevention of Russian influenza by amantadine.", "Therapeutic effect of 1-adamantanamine hydrochloride in naturally occurring influenza A 2 -Hong Kong infection. A controlled double-blind study.", "Influenza A prophylaxis with amantadine in a boarding school.", "Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults.", "Therapeutic effects of aerosolized amantadine in naturally acquired infection due to influenza A virus.", "Treatment of influenza. The therapeutic efficacy of rimantadine HC1 in a naturally occurring influenza A2 outbreak.", "Administration of amantadine for the prevention of Hong Kong influenza.", "Oral rimantadine hydrochloride therapy of influenza A virus H3N2 subtype infection in adults.", "Safety and prophylactic efficacy of low-dose rimantadine in adults during an influenza A epidemic.", "The prophylactic effectiveness of amantadine hydrochloride in an epidemic of Hong Kong influenza in Leningrad in 1969.", "Protection of man from natural infection with influenza A2 Hong Kong virus by amantadine: a controlled field trial.", "Therapeutic efficacy of amantadine HCl and rimantadine HCl in naturally occurring influenza A2 respiratory illness in man.", "Prophylactic use of amantadine during Hong Kong influenza epidemic.", "[Therapeutic efficacy of amantadine hydrochloride in patients with epidemic influenza A virus infection].", "Prevention of influenza A/USSR/77 (H1N1): an evaluation of the side effects and efficacy of amantadine in recruits at Fort Sam Houston.", "Comparison of amantadine and rimantadine for prevention of type A (Russian) influenza.", "Use and withdrawal of amantadine chemoprophylaxis during epidemic influenza A.", "Reduction in fever and symptoms in young adults with influenza A/Brazil/78 H1N1 infection after treatment with aspirin or amantadine.", "Amantadine therapy of epidemic influenza a(2) (Hong Kong).", "Therapeutic effectiveness of amantadine hydrochloride in naturally occurring Hong Kong influenza--double-blind studies.", "Evaluation of amantadine hydrochloride in the treatment of A2 influenzal disease.", "Trial of amantadine in epidemic influenza.", "Amantadine hydrochloride as a prophylactic in respiratory infections. A double-blind investigation of its clinical use and serology.", "Evaluation of amantadine in the prophylaxis of influenza A (H1N1) virus infection: a controlled field trial among young adults and high-risk patients.", "Successful treatment of naturally occurring influenza A/USSR/77 H1N1." ]

[ "A total of 52 healthy, adult volunteers were randomly assigned to five treatment groups to be treated twice daily for 4 days with 100 mg of amantadine, 100 mg of rimantadine, 4 mg of chlorpheniramine or placebo alone, or 100 mg of amantadine in combination with chlorpheniramine. The results of tests measuring performance on tasks of attention, reasoning, and memory were unaffected by treatment. Subjective side effects in recipients of amantadine, rimantadine, and chlorpheniramine were comparable and minimal. Side effects appeared to be enhanced in subjects receiving both amantadine and chlorpheniramine.", "Four hundred fifty volunteers participated in a placebo-controlled, double-blind, randomized trial of the prophylactic effects of rimantadine and amantadine during an outbreak of influenza A. The subjects received drugs orally at a dose of 100 mg twice a day for six weeks. Influenza-like illness occurred in 41 per cent of the subjects receiving placebo but in only 14 per cent of those receiving rimantadine and 9 per cent of these receiving amantadine (P less than 0.001 for either drug vs. placebo). Laboratory-documented influenza occurred in 21 per cent of placebo recipients, 3 per cent of rimantadine recipients, and 2 per cent of amantadine recipients (P less than 0.001). These findings represent efficacy rates of 85 per cent for rimantadine and 91 per cent for amantadine, as compared with placebo. More recipients of amantadine (13 per cent) than recipients of rimantadine (6 per cent; P less than 0.05) or placebo (4 per cent; P less than 0.01) withdrew from the study because of central-nervous-system side effects. On the basis of this study, rimantadine appears to be the drug of choice for the prophylaxis of influenza A.", "nan", "The efficacy and safety of prophylactic low dose amantadine hydrochloride was assessed in two double-blind, placebo-controlled, randomized studies. In a study of 476 subjects aged 18 to 55 years, adverse reactions were not significantly different between the group receiving 100 mg/day amantadine and the placebo group but significantly greater in the group given 200 mg/day (P less than 0.009). The influenza attack rate in this study was too low to assess efficacy. In an experimental challenge study of influenza A/Beth/1/85 in 78 subjects of similar age the prophylactic administration of 50 mg, 100 mg or 200 mg/day doses of amantadine were more effective than placebo in preventing influenza illness (P less than 0.02, 66, 74 and 82% protection, respectively), and in suppressing viral replication (P = 0.02). There was no significant difference between amantadine groups in influenza illness or viral shedding. Compared with the placebo group the 100 and 200 mg amantadine groups showed a significant decrease in infection rate (100 mg: 40% protection: P = 0.012; 200 mg: 32% protection: P = 0.045) whereas the 50 mg group did not (20% protection: P = 0.187). These results suggest that 100 mg/day of amantadine will reduce toxicity but maintain the prophylactic efficacy seen with 200 mg/day.", "nan", "nan", "We tested the effectiveness of amantadine hydrochloride in prevention of illness and infection caused by Russian (h1n1) influenza. The trial lasted seven weeks and was double-blind and placebo controlled. The dosage used was 200 mg daily. Efficacy in prevention of serologically confirmed clinical influenza was 70.7%. Efficacy in prevention of infection, symptomatic or asymptomatic, was 39.4%. Side effects seen were all mild, began within two days of the start of the trial, and terminated rapidly on cessation of prophylaxis. The withdrawal rate attributable to use of amantadine was 6.2%. Those who continued to receive prophylaxis for the remainder of the trial did not exhibit excess side effects. It is concluded that amantadine is safe and effective in prophylaxis of H1N1 strains, as has been shown previously for other subtypes of A influenza.", "nan", "In a boarding school for boys, where routine influenza vaccination is carried out annually, 267 boys were given amantadine (100 mg daily) and 269 received no specific treatment during an influenza A (H1N1) outbreak. 3 boys receiving amantadine and 29 boys receiving no medication had laboratory-proven influenza A. There are circumstances when the prophylactic use of amantadine may be justified for the control of influenza A outbreaks in boarding schools and other institutions where high attack-rates are experienced.", "The relative toxicities of amantadine and rimantadine were compared in a double-blind, placebo-controlled study involving healthy adults. In separate studies, drugs were administered at a dosage of 200 mg/day (52 volunteers) or 300 mg/day (196 volunteers) for 4.5 days. Both drugs were well tolerated at the lower dosage. At 300 mg/day amantadine recipients had a greater frequency and severity of central nervous system (nervousness, lightheadedness, difficulty concentrating) and sleep (insomnia, fatigue) complaints compared with rimantadine or placebo recipients. Amantadine recipients also performed less well on an objective test measuring sustained attention and problem-solving ability. Both amantadine and rimantadine recipients reported adverse gastrointestinal symptoms more often than placebo recipients. Because of better tolerance at higher dosage, rimantadine offers more promise than amantadine for treatment of influenza A virus infections.", "The effect of small-particle aerosol therapy with amantadine was assessed in a randomized, double-blind study of 20 patients with naturally acquired influenza A virus infection. Aerosol treatments of 20 min with either distilled water or with amantadine hydrochloride (1.0 g/100 ml of distilled water) were given three times a day for four days. The amantadine-treated patients experienced a significantly more rapid resolution of clinical signs and symptoms when compared with placebo-treated patients. The resolution of fever was similar for both groups. Aerosol delivery of amantadine did not affect the frequency of viral isolation from upper respiratory tract secretions but was associated with a trend toward reduced quantity of viral shedding. Serial pulmonary function tests found no important differences between the groups. Amantadine-treated patients experienced a greater frequency of mild local side effects (rhinorrhea, nasal irritation) during aerosol exposures, but aerosol treatments did not cause any apparent decline in pulmonary function.", "nan", "The prophylactic effectiveness of amantadine against A2/Hong Kong influenza was investigated in the course of a double-blind trial in Braşov, Romania, during an epidemic due to the Hong Kong virus that started there in March 1969.Altogether 215 subjects were included in the trial; 112 received 100 mg of amantadine twice daily for 20 days and the remaining 103 received inert placebo tablets. Of the amantadine-treated group, 2 had clinical symptoms diagnosed as influenza (1 of these was a doubtful diagnosis), whereas 20 (1 doubtful) of the placebo group had such symptoms. No case with both clinical symptoms and serologically confirmed influenza (>/=4-fold increase in haemagglutination-inhibition titre) occurred among 77 amantadine-treated subjects for whom paired sera were available but there were 13 such cases among the 74 placebo subjects with paired sera. These differences are statistically highly significant. No serious side-effects were recorded.The authors conclude that amantadine was highly effective in preventing overt disease and discuss indications that suggest that it did not interfere with the development of immunity in persons treated during the incubation period.", "In a randomized, double-blind trial involving patients with uncomplicated influenza A H3N2 subtype virus infection, rimantadine treatment (200 mg/day for 5 days) was associated with significant reductions in nasal secretion viral titers (days 2 through 4), maximal temperature (days 2 and 3), time until defervescence (mean, 37 h shorter), and systemic symptoms compared with placebo treatment.", "A placebo-controlled, double-blind study to evaluate the safety and prophylactic efficacy of a low dose (100 mg) of rimantadine hydrochloride against naturally occurring influenza in adults was conducted at two sites. After the onset of the influenza season, volunteers (ages, 18 to 55 years) were assigned randomly to receive rimantadine or placebo daily. Subjects were monitored for adverse effects and evidence of influenza virus infection weekly for six weeks. Only 10 (8.7%) of 114 rimantadine recipients and 5 (4.4%) of 114 placebo control recipients reported one or more mild to moderate adverse symptoms, most of which were related to the gastrointestinal or central nervous system. Compared with placebo, low-dose rimantadine was highly effective in the prevention of influenza A virus infection (20 of 110 versus 7 of 112 participants; P less than 0.01) and influenza illness (7 of 110 versus 1 of 112 participants; P = 0.04). Influenza A/Leningrad/87-like (H3N2) virus was recovered from the nasopharynxes of only five placebo recipients. These findings indicate that low-dose rimantadine is well tolerated and highly effective for the prevention of influenza A illness in healthy adults.", "The effectiveness of amantadine hydrochloride as a prophylactic against influenza was studied during an epidemic caused by viruses related to influenza A2/Hong Kong/1968 variants in Leningrad, USSR, early in 1969. In all, 8169 subjects, assigned to amantadine-dosed, placebo-dosed, internal control and external control groups, were assessed. The index of effectiveness of the prophylactic medication, based on clinical diagnosis, in subjects who took amantadine regularly was 1.95. When the clinical diagnoses were confirmed serologically the index of effectiveness for the amantadine compared with the placebo group increased to 2.7. A comparison of the medicated group with the non-medicated, non-isolated internal control group showed an index of effectiveness of 5.34. A daily dose of 100 mg of amantadine was associated with an increase of 1.14% in complaints of sleep disturbances but these had no effect on the working capacity of subjects.", "Prophylactic administration of amantadine in doses of 100 mg. twice a day offered statistically significant protection against influenza A2 infection in a double-blind field trial involving 391 medical student volunteers during the influenza A2 Hong Kong epidemic in Helsinki in the winter of 1969. Serologically verified influenza, as measured by complement fixation and/or haemagglutination inhibition, occurred in 27 out of 192 students in the amantadine group against 57 out of 199 in the placebo group, giving a protection rate of 52%.", "nan", "nan", "A virus infection was studied using half of the normal oral dose of amantadine hydrochloride-100 mg/d instead of 200 mg/d. The patients in this study, who visited the clinics during January and February 1999, were confirmed within 48 hours to have influenza A virus infections by the Directigen FluA test. Using a quasi-randomized controlled trial, 26 patients were treated with amantadine hydrochloride in addition to the usual medication, while 23 were treated with only the ordinary medication. There were no significant differences in the mean age, 35.6 years old, or in clinical features between the two groups. The period of fever over 38 degrees C in the amantadine treated group was 1 day while that in the control group was 1.7 days, which shows a significant difference (p = 0.049). There was no significant difference in the duration of aching, such as arthralgia, or of general fatigue. There was no significant difference in the appearance of subsequent new symptoms after the onset of influenza A virus infection. In conclusion, it is expected that oral amantadine hydrochloride, 100 mg/d, together with the ordinary medication, will reduce the duration of the period of fever over 38 degrees C.", "nan", "The efficacies of 200 mg of daily doses of amantadine and of rimantadine for prevention of infection and illness due to influenza A/USSR/77 (H1N1) virus were compared in a double-blind, placebo-controlled study on a college campus. Frequencies of symptoms that might have been side effects of the drugs were not significantly different from those in placebo recipients. Analyses indicated that the trial was initiated late in the epidemic and that an age-related protective effect against A/USSR virus existed; seroconversion frequencies were 52/139 (37%) among 18-19-year-olds, 33/130 (25%) among 20-21-year-olds, and 5/39 (12.8%) among 22-24-year-olds. Among initially antibody-negative (less than 1 : 4 in complement fixing and neutralizing tests and less than 1 : 8 in hemagglutination inhibition tests) 18-19-year-old students, amantadine was associated with significantly fewer seroconversions (P = 0.01) and both less infection and milder illness than occurred in placebo recipients (P less than 0.05). Although rimantadine was not accompanied by reduction in frequency of seroconversions in the same age group, illness frequency and severity among seroconverters were significantly reduced when compared to placebo recipients (P less than 0.01). Amantadine and rimantadine appear suitable for use in young adults. Although other studies have suggested greater effectiveness of rimantadine than of amantadine against influenza, no evidence for this was seen in the present study which used both drugs at the same dose.", "A controlled investigation of chemoprophylaxis with amantadine hydrochloride during an epidemic of influenza A was performed in nonimmune students. Illness was significantly decreased and serologic evidence of infection reduced by treatment. During the post-treatment period, while influenza was still prevalent, an accelerated rate of infection occurred among persons previously protected by chemotherapy. When used, chemoprophylaxis should be continued until influenza is no longer prevalent or, preferably, should be combined with vaccine administration to ensure protection after treatment.", "During an outbreak of influenza A/Brazil/78 H1N1 infection, 47 volunteers with clinical and virological influenza of less than 2 days duration were treated in a randomized double-blind fashion for 5 days with 100 or 200 mg of amantadine daily or with 3.25 g of aspirin daily. The aspirin treatment group defervesced more rapidly (10.3 h versus 21.5 h and 23.6 h; P less than 0.01), but by the second daily follow-up visit, both groups of amantadine recipients exhibited greater symptomatic improvement. Bothersome side effects resulted in discontinuation of therapy by 35% of the aspirin treatment group but only 3% of the amantadine treatment group (P less than 0.05). Individuals who present to a physician during an influenza A epidemic with characteristic symptoms will experience symptomatic benefit from amantadine treatment, with negligible toxicity.", "In a double-blind comparison of the therapeutic effect of amantadine in a natural outbreak of Hong Kong influenza in January 1969 near Houston, Texas, the decrease in titers of virus in throat swabs from 12 treated patients during the first 10 hr of treatment was appreciably greater than similar titers of virus from 16 untreated patients (P = 0.06). The titer of shed virus decreased significantly more rapidly (P < 0.05) among amantadine-treated patients ill more than 48 hr before treatment than among five control patients who had been ill more than 48 hr. Cough, sore throat, and nasal obstruction cleared more rapidly in treated patients (P < 0.05), and decline of fever in 6 treated patients sick for less than 48 hr before treatment was more rapid than among 13 untreated patients who had been ill for less than 48 hr. These findings are considered to be consistent with a limited therapeutic effect of the drug.", "nan", "Amantadine hydrochloride is the first drug to show promise as a practical anti-influenza agent. Several studies demonstrating a prophylactic effect in volunteers with induced A2 disease as well as in patients during A2 outbreaks have created the impetus for therapeutic trials. The widespread A2 influenza epidemic that occurred early in 1968 provided the opportunity for therapeutic evaluation in the USA.A total of 197 prison inmates with proven influenza agreed to participate in the 10-day double-blind evaluation of amantadine (100 mg, twice daily). Onset of therapy was approximately 20 hours after first subjective awareness of illness.Assessment of drug effectiveness was based on rapidity of resolution of illness. There was a significant increase in the number of drug-treated as against placebo patients in the \"rapid resolver\" group whereas individuals receiving placebo dominated the \"slow resolver\" group. Analysis of febrile responses indicated that amantadine-treated patients had significantly more rapid defervescence. Virus isolation studies revealed etiologically related virus in 90% of all volunteers during the first 5 days of therapy. It was apparent that clinical improvement was not correlated with disappearance of the virus. Nevertheless, the trials conducted during the influenza season of early 1968 indicated the therapeutic effect of amantadine hydrochloride. Administration of 100 mg, twice daily, for 10 days did not cause any adverse effects.", "nan", "nan", "The usefulness of amantadine in the protection of humans against influenza A (H1N1) virus was evaluated in a double-blind field trial with 555 volunteers in Finland in the winter of 1978. Three populations--patients in a general hospital, adults in a home for the aged, and two groups of military conscripts--were chosen. Epidemic influenza occurred only in the two groups of conscripts: the incidence of serologically verified influenza was 66% and 83% in the groups that received placebo and 43% and 51% in the groups that received amantadine, giving protection rates of 36% (P = 0.05) and 39% (P = 0.001). The evaluation of the effect of amantadine on the occurrence of illness was obscured by concomitant adenoviral infections that caused influenza-like symptoms. No clear difference in the occurrences of side effects was observed between the placebo and amantadine-treated groups; however, a significantly greater number of participants who took 200 mg of amantadine/day (16.9%) stopped medication during the trial as compared with the placebo groups (7.6%) (P < 0.02).", "Forty-five university students with proved influenza A/USSR/77 H1N1 infection were randomly treated with either amantadine hydrochloride (14 students), rimantadine hydrochloride (19 students), or placebo (12 students). By 48 hours after initiation of therapy, amantadine and rimantadine recipients had significantly less fever and greater improvement compared with subjects given the placebo. Minor reversible CNS side effects at the end of the five-day course of therapy were observed in one third of the amantadine-treated subjects. However, both amantadine and rimantadine recipients returned to classes earlier and shed smaller amounts of virus than placebo recipients. Thus, both drugs exerted a notable therapeutic effect. Hence, during an influenza outbreak, five days of empirical therapy with amantadine or rimantadine for persons with an influenza-like syndrome should ameliorate clinical symptoms and might decrease spread of virus." ]

[ "2665639", "16982486", "11073753", "1397668", "10929163", "18045283", "2820298", "9643859", "8678384", "18279051", "3307620", "3440773" ]

[ "Failure of zinc gluconate in treatment of acute upper respiratory tract infections.", "The prophylactic and therapeutic effectiveness of zinc sulphate on common cold in children.", "Effect of treatment with zinc gluconate or zinc acetate on experimental and natural colds.", "Zinc gluconate and the common cold: a controlled clinical study.", "Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial.", "Effect of zinc sulfate on common cold in children: randomized, double blind study.", "Two randomized controlled trials of zinc gluconate lozenge therapy of experimentally induced rhinovirus colds.", "Zinc gluconate lozenges for treating the common cold in children: a randomized controlled trial.", "Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study.", "Duration and severity of symptoms and levels of plasma interleukin-1 receptor antagonist, soluble tumor necrosis factor receptor, and adhesion molecules in patients with common cold treated with zinc acetate.", "Failure of effervescent zinc acetate lozenges to alter the course of upper respiratory tract infections in Australian adults.", "Prophylaxis and treatment of rhinovirus colds with zinc gluconate lozenges." ]

[ "Zinc is a trace metal with in vitro activity against rhinovirus, the major etiologic agent in acute upper respiratory tract infections (URIs). A previous trial of zinc gluconate supported its efficacy in treating URIs, but the effectiveness of blinding was uncertain. We conducted a prospective randomized trial of zinc gluconate versus a taste-matched placebo of sucrose octaacetate. Lozenges containing either 23 mg of elemental zinc or placebo were taken every 2 h. Eleven URI symptoms were rated daily on a scale of 0 (not present) to 3 (severe). Duration of illness, reflected in the proportion of subjects remaining symptomatic on each day, was not significantly reduced (maximum difference of 12.6% on day 7, P = 0.09; 95% confidence interval, -6 to 31%) by either treatment. Severity of illness, assessed by using a summed severity score, was reduced incrementally by 7 to 8% on days 5 to 7 (P = 0.02) in subjects taking zinc. Adverse effects, mostly nausea and altered taste, were reported by 50% of subjects taking zinc. We conclude that while zinc gluconate may produce a small reduction in overall severity of symptoms, this is not clinically significant. Given the additional high incidence of adverse effects, zinc gluconate cannot be recommended for use in the treatment of acute URIs.", "To determine the efficacy of prophylactic administration of zinc sulphate in reducing the occurrence of the common cold in children, and to evaluate the efficacy of zinc sulphate in reducing the duration and severity of cold symptoms.\n A total of 200 healthy children were randomly assigned to receive oral zinc sulphate (zinc group, n=100) or placebo (placebo group, n=100). Zinc sulphate (15 mg of zinc) or placebo syrup were administered for prophylaxis once daily during a 7-mo study period. The dose was increased to two times per day (30 mg of zinc) at the onset of cold, until symptoms resolved.\n The mean number of colds in the zinc group was significantly less than in the placebo group (1.2 vs 1.7 colds per child; p=0.003). The mean cold-related school absence was 0.9 d per child in the zinc group versus 1.3 d in the placebo group (p=0.04). Compared to the placebo group, the zinc group had shorter mean duration of cold symptoms and decreased total severity scores for cold symptoms (p<0.0001). Adverse effects were mild and similar in both groups.\n Zinc sulphate appears to be an easily administered, safe and well-tolerated alternative for the prevention and treatment of the common cold in children.", "Two clinical trials were conducted, one involving 273 subjects with experimental rhinovirus colds and the other involving 281 subjects with natural colds. Symptomatic volunteers were randomized to receive oral lozenges containing zinc gluconate (13.3 mg), zinc acetate (5 or 11.5 mg), or placebo. The median duration of illness in zinc gluconate recipients was 2.5 days, contrasted with 3.5 days in the placebo recipients (P=.035), in the experimental colds study. Zinc gluconate had no effect on symptom severity and zinc acetate had no effect on either duration or severity. Neither formulation had an effect on the duration or severity of natural cold symptoms. Evaluation of blinding, taste, and adverse events revealed no significant differences among the 4 treatment arms. Zinc compounds appear to have little utility for common-cold treatment.", "A report in 1984 on the success of zinc gluconate against common cold symptoms could not be confirmed in three subsequent studies, which are now known to have used formulations that inactivated zinc. A non-chelating formulation including glycine, which releases 93% of contained zinc into saliva, was tested in a randomized, placebo-controlled, double-blind trial in 73 young adults. Efficacy was recorded in symptom diaries using a symptom severity rating. Patients' symptoms first appeared 1.34 days prior to entry to the study in both groups. Disappearance of symptoms occurred after an additional 4.9 days for zinc-treated patients versus 6.1 days for placebo-treated patients. A difference was noted in the efficacy of treatment if it was started 1 day after symptom onset: cold duration was an additional 4.3 days in zinc-treated patients compared with 9.2 days for placebo-treated patients. Cough, nasal drainage and congestion were the symptoms most affected, and only mild side-effects were noted.", "Adults and children in the United States get two to six colds per year. Evidence that zinc is effective therapy for colds is inconsistent.\n To test the efficacy of zinc acetate lozenges in reducing the duration of symptoms of the common cold.\n Randomized, double-blind, placebo-controlled trial.\n Detroit Medical Center, Detroit, Michigan.\n 50 ambulatory volunteers recruited within 24 hours of developing symptoms of the common cold.\n Participants took one lozenge containing 12.8 mg of zinc acetate or placebo every 2 to 3 hours while awake as long as they had cold symptoms.\n Subjective symptom scores for sore throat, nasal discharge, nasal congestion, sneezing, cough, scratchy throat, hoarseness, muscle ache, fever, and headache were recorded daily for 12 days. Plasma zinc and proinflammatory cytokine levels were measured on day 1 and after participants were well.\n Forty-eight participants completed the study (25 in the zinc group and 23 in the placebo group). Compared with the placebo group, the zinc group had shorter mean overall duration of cold symptoms (4.5 vs. 8.1 days), cough (3.1 [95% CI, 2.1 to 4.1] vs. 6.3 [CI, 4.9 to 7.7] days), and nasal discharge (4.1 [CI, 3.3 to 4.9] vs. 5.8 [CI, 4.3 to 7.3] days) and decreased total severity scores for all symptoms (P < 0.002, test for treatment x time interaction). Mean changes in soluble interleukin-1 receptor antagonist level differed nonsignificantly between the zinc group and the placebo group (difference between changes, -89.4 pg/mL [CI, -243.6 to -64.8 pg/mL]).\n Administration of zinc lozenges was associated with reduced duration and severity of cold symptoms, especially cough. Improvement in clinical symptoms with zinc treatment may be related to a decrease in proinflammatory cytokine levels; however, in this study, the observed differences between changes in cytokine levels in zinc and placebo recipients were not significant.", "The aim of the present randomized, double-blind, placebo-controlled study was to determine the efficacy of zinc sulfate on the duration and severity of common cold in children.\n Children presenting at least two of 10 symptoms of common cold within the 24-48 h of the onset of illness were eligible for the study. Children were randomized to receive either oral zinc containing zinc sulfate or placebo. A diary was completed to record symptoms and adverse effects. Symptoms were scored as absent (0), mild (1), moderate (2), or severe (3).\n One hundred and fifty children participated in the study, and 120 children were included in the final analysis. The median duration of all cold symptoms was 6 days (P = 0.20), and the median duration of nasal symptoms was 5 days in both groups (P = 0.09). However, total symptom severity scores were significantly lower in the zinc group, starting from the second day of the study. The lower scores in the zinc group were largely due to improvement of nasal symptom scores. Adverse effects were similar in both groups.\n Zinc sulfate had no effect on the duration of cold symptoms. However, it appears to be effective in reducing the severity of the cold symptoms in healthy children.", "The therapeutic efficacy of zinc gluconate lozenge therapy in experimentally induced rhinovirus infection was assessed in two randomized controlled trials in susceptible adult volunteers. In trial 1, lozenges containing either zinc gluconate (23 mg of elemental zinc) or placebo were given 36 h after nasal inoculation of rhinovirus type 39 and administered eight times per day for 5 days. All of the volunteers had early cold symptoms at the time that treatment was begun. In trial 2, the same lozenge regimen was used, beginning 2 h after nasal inoculation with rhinovirus type 13, and continued for 7 days. Zinc therapy did not reduce the severity or duration of cold symptoms or the frequency or duration of viral shedding in either trial. Viral titers were measured in trial 2 and were shown to be unaffected by zinc therapy. Nasal mucus weights and the numbers of paper tissues used were slightly higher in zinc recipients. A statistically significant increase in levels of zinc in serum was documented in zinc recipients after 5 days of therapy. These data suggest that zinc gluconate lozenge therapy is not therapeutically useful in the treatment of rhinovirus colds.", "The common cold is one of the most frequently occurring illnesses and is responsible for substantial morbidity and economic loss. Biochemical evidence suggests that zinc may be an effective treatment, and zinc gluconate glycine (ZGG) lozenges have been shown to reduce the duration of cold symptoms in adults.\n To determine the efficacy of ZGG treatment of colds in children and adolescents.\n A randomized, double-masked, placebo-controlled study.\n Two suburban school districts in Cleveland, Ohio.\n A total of 249 students in grades 1 through 12 were enrolled within the first 24 hours of experiencing at least 2 of 9 symptoms of the common cold.\n Zinc lozenges, 10 mg, orally dissolved, 5 times a day (in grades 1-6) or 6 times a day (in grades 7-12).\n Time to resolution of cold symptoms based on subjective daily symptom scores for cough, headache, hoarseness, muscle ache, nasal congestion, nasal drainage, scratchy throat, sore throat, and sneezing.\n Time to resolution of all cold symptoms did not differ significantly between students receiving zinc (n = 124) and those receiving placebo (n = 125) (median, 9 days; 95% confidence interval [CI], 8-9 days; median, 9 days, 95% CI, 7-10 days, respectively; P=.71). There were no significant differences in the time to resolution of any of the 9 symptoms studied. Compared with controls, more students in the zinc group reported adverse effects (88.6% vs 79.8%; P=.06); bad taste (60.2% vs 37.9%; P=.001); nausea (29.3% vs 16.1%; P=.01); mouth, tongue, or throat discomfort (36.6% vs 24.2%; P=.03); and diarrhea (10.6% vs 4.0%; P=.05).\n In this community-based, randomized controlled trial, ZGG lozenges were not effective in treating cold symptoms in children and adolescents. Further studies with virologic testing are needed to clarify what role, if any, zinc may play in treating cold symptoms.", "The common cold is one of the most frequent human illnesses and is responsible for substantial morbidity and economic loss. No consistently effective therapy for the common cold has been well documented, but evidence suggests that several possible mechanisms may make zinc an effective treatment.\n To test the efficacy of zinc gluconate lozenges in reducing the duration of symptoms caused by the common cold.\n Randomized, double-blind, placebo-controlled study.\n Outpatient department of a large tertiary care center.\n 100 employees of the Cleveland Clinic who developed symptoms of the common cold within 24 hours before enrollment.\n Patients in the zinc group (n = 50) received lozenges (one lozenge every 2 hours while awake) containing 13.3 mg of zinc from zinc gluconate as long as they had cold symptoms. Patients in the placebo group (n = 50) received similarly administered lozenges that contained 5% calcium lactate pentahydrate instead of zinc gluconate.\n Subjective daily symptom scores for cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever (assessed by oral temperature).\n The time to complete resolution of symptoms was significantly shorter in the zinc group than in the placebo group (median, 4.4 days compared with 7.6 days; P < 0.001). The zinc group had significantly fewer days with coughing (median, 2.0 days compared with 4.5 days; P = 0.04), headache (2.0 days and 3.0 days; P = 0.02), hoarseness (2.0 days and 3.0 days; P = 0.02), nasal congestion (4.0 days and 6.0 days; P = 0.002), nasal drainage (4.0 days and 7.0 days; P < 0.001), and sore throat (1.0 day and 3.0 days; P < 0.001). The groups did not differ significantly in the resolution of fever, muscle ache, scratchy throat, or sneezing. More patients in the zinc group than in the placebo group had side effects (90% compared with 62%; P < 0.001), nausea (20% compared with 4%; P = 0.02), and bad-taste reactions (80% compared with 30%; P < 0.001),\n Zinc gluconate in the form and dosage studied significantly reduced the duration of symptoms of the common cold. The mechanism of action of this substance in treating the common cold remains unknown. Individual patients must decide whether the possible beneficial effects of zinc gluconate on cold symptoms outweigh the possible adverse effects.", "Zinc lozenges have been used for treatment of the common cold; however, the results remain controversial.\n Fifty ambulatory volunteers were recruited within 24 h of developing symptoms of the common cold for a randomized, double-blind, placebo-controlled trial of zinc. Participants took 1 lozenge containing 13.3 mg of zinc (as zinc acetate) or placebo every 2-3 h while awake. The subjective scores for common cold symptoms were recorded daily. Plasma zinc, soluble interleukin (IL)-1 receptor antagonist (sIL-1ra), soluble tumor necrosis factor receptor 1, soluble vascular endothelial cell adhesion molecule, and soluble intercellular adhesion molecule (sICAM)-1 were assayed on days 1 and 5.\n Compared with the placebo group, the zinc group had a shorter mean overall duration of cold (4.0 vs. 7.1 days; P < .0001) and shorter durations of cough (2.1 vs. 5.0 days; P < .0001) and nasal discharge (3.0 vs. 4.5 days, P = .02) Blinding of subjects was adequate, and adverse effects were comparable in the 2 groups. Symptom severity scores were decreased significantly in the zinc group. Mean changes in plasma levels of zinc, sIL-1ra, and ICAM-1 differed significantly between groups.\n Administration of zinc lozenges was associated with reduced duration and severity of cold symptoms. We related the improvement in cold symptoms to the antioxidant and anti-inflammatory properties of zinc.", "Effervescent lozenges containing 10 mg of zinc acetate were evaluated as a treatment of upper respiratory tract infections in a double-blind randomized trial by using a placebo which was indistinguishable to most observers in taste and appearance from the active material. Of the 70 treatment courses used by 55 individuals in 34 families, 63 (33 zinc and 30 placebo) were considered evaluable, in that the volunteer used the medication at least four times daily for at least 3 days, the average utilization being 5.4 days at an average dose of six lozenges daily. Six users of zinc reported nausea (versus no placebo users), and eight reported an unpleasant taste or aftertaste (versus one placebo user). No benefit was observed among the users of zinc acetate. The mean duration of symptoms in users of the zinc was 12.1 days, compared with 7.7 days in those who used the placebo. Nor was any beneficial effect of zinc evident among the four zinc-treated versus the two placebo-treated individuals from whom rhinovirus was grown.", "Following a tolerance study, double-blind placebo controlled trials were conducted to determine the prophylactic effect of zinc gluconate lozenges on rhinovirus challenge and, in a third study, their therapeutic efficacy when given at the start of colds caused by virus inoculation was tested. In the prophylaxis study a total of 57 volunteers received lozenges of either zinc gluconate (23 mg) (29 volunteers) or matched placebo (28 volunteers) every 2 h while awake during a period of four and a half days. They were challenged with 10(2) tissue culture infecting dose (TCID50) of human rhinovirus 2 (HRV-2) on the second day of medication, and were monitored daily for symptoms and signs of colds and laboratory evidence of infection. Zinc reduced the total mean clinical score from 8.2 in the placebo group to 5.7 and the reduction of the mean clinical score was statistically significant on the second day after virus challenge. In the therapeutic study 69 volunteers were inoculated with 10(2) TCID50 of HRV-2 and those who developed cold symptoms were randomly allocated to receive either zinc gluconate lozenges (six volunteers) or matched placebo lozenges (six volunteers) every two hours they were awake for six days. Treatment of colds with zinc reduced the mean daily clinical score and this was statistically significant on the fourth and fifth day of medication. Similarly, medication also reduced the mean daily nasal secretion weight and total tissue count and these reductions were statistically significant on days two and six for nasal secretion weights and days four to six of medication for tissue counts when compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)" ]

[ "8881815", "15704045", "17954953", "11156638", "9922309", "9692692", "8536887", "9616309", "10333200", "15709986", "15017504" ]

[ "Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo controlled one year study.", "Bone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn's disease.", "Maintenance treatment with budesonide 6 mg versus 9 mg once daily in patients with Crohn's disease in remission.", "Switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn's disease.", "Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group.", "Oral budesonide as maintenance therapy in Crohn's disease--results of a 12-month study. Global Budesonide Study Group.", "Oral budesonide as maintenance treatment for Crohn's disease: a placebo-controlled, dose-ranging study. Canadian Inflammatory Bowel Disease Study Group.", "Low dose oral pH modified release budesonide for maintenance of steroid induced remission in Crohn's disease. The Budesonide Study Group.", "Low-dose budesonide treatment for prevention of postoperative recurrence of Crohn's disease: a multicentre randomized placebo-controlled trial. German Budesonide Study Group.", "Budesonide as maintenance treatment in Crohn's disease: a placebo-controlled trial.", "Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn's disease." ]

[ "To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD).\n Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment.\n Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups.\n 6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.", "Osteoporosis frequently occurs in Crohn's disease, often because of corticosteroids. Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability. We investigated its effects on bone compared with prednisolone.\n In 34 international centers, 272 patients with Crohn's disease involving ileum and/or colon ascendens were randomized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity. One hundred eighty-one corticosteroid-free patients had active disease (98 had never received corticosteroids, corticosteroid naive; 83 had received corticosteroids previously, corticosteroid exposed), and 90 had quiescent disease, receiving long-term low doses of corticosteroids, corticosteroid-dependent; in 1 patient, no efficacy data were obtained. Bone mineral density and fractures were assessed in a double-blinded fashion; disease activity, side effects, and quality of life were monitored.\n Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone. However, corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone (mean, -1.04% vs -3.84%; P = .0084). Treatment-emergent corticosteroid side effects were less frequent with budesonide. Efficacy was similar in both groups.\n Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn's disease. In both the corticosteroid-free and corticosteroid-dependent groups, budesonide and prednisolone were equally effective for up to 2 years, but budesonide caused fewer corticosteroid side effects.", "In previous trials, budesonide 6 mg/day was able to prolong the time to relapse in patients with quiescent Crohn's disease and budesonide 9 mg/day was effective in active disease with limited side effects. The aim of this study was to compare the effectiveness of budesonide 9 mg vs 6 mg once daily on the maintenance of remission and occurrence of adverse events.\n Double-blind, randomised trial in patients with Crohn's disease in remission. Patients were randomised to receive 6 mg/day or 9 mg/day of budesonide (Budenofalk) without concomitant treatment for Crohn's disease. Endpoints were the time to relapse and relapse rates after one year.\n Seventy-six patients were randomised to 6 mg/day and 81 patients to 9 mg/day. Survival analysis showed no differences in the time to relapse. One-year relapse rates were not significantly different (6 mg group 24%; 9 mg group 19%). Any adverse event was reported in 61 and 68% of patients in the 6 mg and 9 mg groups, respectively; none of the 12 serious adverse events were drug related.\n The one-year relapse rates were low and not significantly different between the group of patients treated with budesonide 6 mg vs 9 mg/day. Also, time to relapse and the number of adverse events were similar in both treatment groups.", "Steroid dependent patients with Crohn's disease are at high risk of developing glucocorticosteroid induced side effects.\n We evaluated the possibility of switching from systemic steroids to budesonide (Entocort) in prednisolone/prednisone dependent patients with inactive Crohn's disease affecting the ileum and/or ascending colon.\n Steroid dependent patients with a Crohn's disease activity index </=200 were included.\n In a double blind multicentre trial, 120 patients were randomly assigned to receive budesonide 6 mg once daily or placebo. Prednisolone was tapered to zero during the first 4-10 weeks and budesonide or placebo was given concomitantly and for a further 12 weeks. Relapse was defined as an index >200 and an increase of 60 points from baseline or withdrawal due to disease deterioration.\n After one and 13 weeks without prednisolone, relapse rates were 17% and 32%, respectively, in the budesonide group, and 41% and 65% in the placebo group (95% confidence intervals for the difference in percentages -41%, -8% and -51%, -16%; p=0.004 and p<0.001, respectively). The number of glucocorticosteroid side effects was reduced by 50% by switching from prednisolone and was similar in the budesonide and placebo groups. Basal plasma cortisol increased in both groups.\n The majority of patients with steroid dependent ileocaecal Crohn's disease may be switched to budesonide controlled ileal release capsules 6 mg without relapse, resulting in a sharp decrease in glucocorticosteroid side effects similar to placebo, and with an increase in plasma cortisol levels.", "Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD.\n Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10).\n The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups.\n Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity.", "Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid inactivation. We have assessed the efficacy and safety of an oral controlled ileal release (CIR) preparation of budesonide for maintenance of remission in patients with ileal or ileocaecal Crohn's disease.\n In a double-blind, multicentre trial, 75 patients in clinical remission (Crohn's Disease Activity Index, CDAI, < or = 150) were randomly assigned to receive placebo, budesonide 3 mg or budesonide 6 mg daily for 12 months. Trial drugs were given at a fixed dose and without concomitant medication. The primary outcome measure was relapse, defined as a CDAI > 150 together with an increase of at least 60 units from entry. A patient was also considered to have a relapse if withdrawn from the study due to clinical deterioration, whether or not a CDAI value could be calculated at that time.\n There were no statistically significant differences in the relapse rate at any time-point throughout the study. By 12 months the proportion of patients having relapsed were 48, 46 and 60% in those patients treated with budesonide 6 mg, 3 mg and placebo, respectively (N.S.). Treatments were well tolerated, and the proportion of patients with suppressed adrenal function (according to predetermined criteria) were 50% (6 mg), 26% (3 mg) and 17% (placebo) (P = 0.096).\n In the present study, relapse rate and time to relapse were similar in the patients treated with budesonide CIR, 6 mg daily or 3 mg daily or with placebo, throughout 12 months. This is in contrast to the two previous trials with identical design, where a significant effect of budesonide CIR in prolonging the median time to relapse was found. Possible reasons for the negative results of the present study include small sample size, and the fact that there was a high placebo response.", "Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease.\n In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points.\n Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups.\n Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.", "The relapse rate after steroid induced remission in Crohn's disease is high.\n To test whether oral pH modified release budesonide (3 x 1 mg/day) reduces the relapse rate and to identify patient subgroups with an increased risk of relapse.\n In a multicentre, randomised, double blind study, 179 patients with steroid induced remission of Crohn's disease received either 3 x 1 mg budesonide (n = 84) or placebo (n = 95) for one year. The primary study aim was the maintenance of remission of Crohn's disease for one year.\n Patient characteristics at study entry were similar for both groups. The relapse rate was 67% (56/84) in the budesonide group and 65% (62/95) in the placebo group. The relapse curves in both groups were similar. The mean time to relapse was 93.5 days in the budesonide group and 67.0 days in the placebo group. No prognostic factors allowing prediction of an increased risk for relapse or definition of patient subgroups who derived benefit from low dose budesonide were found. Drug related side effects were mild and no different between the budesonide and the placebo group.\n Oral pH modified release budesonide at a dose of 3 x 1 mg/day is not effective for maintaining steroid induced remission in Crohn's disease.", "Endoscopic recurrence of Crohn's disease frequently occurs within weeks after 'curative' operation. Treatment with 3 x 1 mg oral pH-modified release budesonide was tried to prevent postoperative recurrence.\n A multicentre randomized double-blind placebo-controlled trial of 1 year duration was performed.\n Departments of surgery, endoscopy and pathology of three university hospitals participated in the trial.\n Patients with Crohn's disease who underwent ileal and/or colonic resection and whose anastomosis was accessible to colonoscopy were admitted to the study. Of the 88 randomized patients, 83 patients were included in the efficacy analysis (budesonide n = 43, placebo n = 40). Treatment was started within 2 weeks after surgery.\n Colonoscopy was performed 3 and 12 months postoperatively. The anastomosis and the adjacent bowel were evaluated by endoscopy and histology. For follow-up of the clinical course of the disease the Crohn's disease activity index (CDAI) was used.\n The primary outcome variable was recurrence of Crohn's disease based on endoscopic findings. Secondary efficacy variables were histology scores, CDAI, time-to-failure and global judgement of well-being of the patient.\n The recurrence rate after 1 year (endoscopic and/or clinical) was 57% (20/35) in the budesonide group and 70% (19/27) in the placebo group (n.s.). Mean time-to-failure was 196 days under budesonide and 154 days under placebo (n.s.). Median CDAI (relapse 19% vs. 28%) and global patients' judgement at the end of treatment (bad 5% vs. 15%) was slightly in favour of budesonide. One patient in each group discontinued the trial because of adverse events. Potentially steroid-related side effects were reported more frequently in the placebo than in the budesonide group (32% vs. 17%) (n.s.).\n Although the effect of budesonide was altogether positive in almost all variables studied in this trial (e.g. endoscopic and histopathological score, time-to-failure, CDAI, patients' global judgement and rate of side effects), this increase in efficacy was small and the power for detecting differences versus placebo was too low to be statistically significant. According to these results, low-dose oral budesonide cannot be recommended to be used for the prevention of postoperative relapse in Crohn's disease.", "To assess the efficacy and safety of budesonide capsules 6 mg daily for prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon.\n In a double-blind, placebo-controlled, multicentre trial, 110 patients with CD, who had previously achieved remission in a placebo-controlled trial of budesonide 9 mg daily, were randomly assigned to receive budesonide 6 mg once daily or placebo for 52 weeks. Primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration].\n Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients (P = 0.132). No significant differences were seen between groups in relapse rates at 1 year. Budesonide was safe and well tolerated, with a similar adverse events profile to placebo.\n Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower CDAI scores compared with patients treated with placebo, but relapse rates were not significantly different at the 1-year end point.", "To compare the efficacy of controlled-release budesonide capsules with that of mesalamine for maintaining remission and improving quality of life (QOL) in patients with steroid-dependent Crohn's disease.\n Fifty-seven patients (25 men; mean age, 32 +/- 10.1 yr) with quiescent steroid-dependent Crohn's ileitis, ileocolitis, or colitis (Crohn's disease activity index <150) entered a prospective, investigator-blind trial. Patients were eligible for treatment with azathioprine but had not consented or had developed side effects. Patients were randomized to receive budesonide 6 mg/day (n = 29) or mesalamine 1 g 3 times/day (n = 28). Follow-up assessments were made every 2 months for up to 1 year or until relapse. At each visit, quality of life (QOL) was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ).\n There were no significant differences in baseline clinical characteristics between the study groups. The 1-year relapse rate was significantly lower in the budesonide group than in the mesalamine group (55% vs. 82%; 95% confidence interval, 12.4%-41%; P = 0.045). Patients assigned to budesonide also remained in remission longer (241 +/- 114 days vs. 147 +/- 117 days; 95% confidence interval, 32.7-155.3 days; P = 0.003). Compared with mesalamine, budesonide treatment also was associated with a better QOL throughout the study (mean total IBDQ scores 165 +/- 36 vs. 182 +/- 28, respectively; 95% confidence interval, -0.4 to 34.4, P = 0.0001). This advantage was confirmed in patients' self-assessed QOL scores.\n Over a 1-year period, controlled-release budesonide was significantly more effective than mesalamine for maintaining remission and improving the QOL of patients with steroid-dependent Crohn's disease." ]

[ "10731173" ]

[ "Immediate and long term effects of weight reduction in obese people with asthma: randomised controlled study." ]

[ "To investigate the influence of weight reduction on obese patients with asthma. Design: Open study, two randomised parallel groups.\n Private outpatients centre, Helsinki, Finland.\n Two groups of 19 obese patients with asthma (body mass index (kg/m(2)) 30 to 42) recruited through newspaper advertisements.\n Supervised weight reduction programme including 8 week very low energy diet.\n Body weight, morning peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory volume in one second (FEV(1)); and also asthma symptoms, number of acute episodes, courses of oral steroids, health status (quality of life).\n At the end of the weight reducing programme, the participants in the treatment group had lost a mean of 14.5% of their pretreatment weight, the controls 0.3%. The corresponding figures after one year were 11.3% and a weight gain of 2.2%. After the 8 week dieting period the difference in changes in percentage of predicted FEV(1) from baseline in the treatment and control groups was 7.2% (95% confidence interval 1.9% to 12.5%, P=0. 009). The corresponding difference in the changes in FVC was 8.6% (4. 8% to 12.5%, P<0.0001). After one year the differences in the changes in the two groups were still significant: 7.6% for FEV(1) (1. 5% to 13.8%, P=0.02) and 7.6% for FVC (3.5% to 11.8%, P=0.001). By the end of the weight reduction programme, reduction in dyspnoea was 13 mm (on a visual analogue scale 0 mm to 100 mm) in the treatment group and 1 mm in the control group (P=0.02). The reduction of rescue medication was 1.2 and 0.1 doses respectively (P=0.03). After one year the differences in the changes between the two groups were -12 for symptom scores (range -1 to -22, P=0.04) and -10 for total scores (-18 to -1, P=0.02). The median number of exacerbations in the treatment group was 1 (0-4) and in the controls 4 (0-7), P=0.001.\n Weight reduction in obese patients with asthma improves lung function, symptoms, morbidity, and health status." ]

[ "21464374", "11230586", "15607598", "12878450", "20488453", "20855387", "12165594", "19797281", "16407967", "16221780", "15721471" ]

[ "Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial.", "Neurodevelopmental outcome of infants treated with head cooling and mild hypothermia after perinatal asphyxia.", "Moderate hypothermia in neonatal encephalopathy: efficacy outcomes.", "Selective head cooling with hypothermia suppresses the generation of platelet-activating factor in cerebrospinal fluid of newborn infants with perinatal asphyxia.", "Selective head cooling with mild systemic hypothermia after neonatal hypoxic-ischemic encephalopathy: a multicenter randomized controlled trial in China.", "Systemic hypothermia after neonatal encephalopathy: outcomes of neo.nEURO.network RCT.", "Whole-body hypothermia for neonatal encephalopathy: animal observations as a basis for a randomized, controlled pilot study in term infants.", "Moderate hypothermia to treat perinatal asphyxial encephalopathy.", "Mild hypothermia via selective head cooling as neuroprotective therapy in term neonates with perinatal asphyxia: an experience from a single neonatal intensive care unit.", "Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy.", "Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial." ]

[ "To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.\n Multicenter, international, randomized controlled trial.\n Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007.\n Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n = 110) or standard care (n = 111).\n Whole-body hypothermia to 33.5°C for 72 hours or standard care (37°C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33°C to 34°C.\n Death or major sensorineural disability at 2 years of age.\n Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P = .03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.\n Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.\n anzctr.org.au Identifier: ACTRN12606000036516.", "To determine the neurodevelopmental outcome of infants treated with head cooling with systemic hypothermia after hypoxic-ischemic encephalopathy.\n Infants >/=37 weeks' gestation, who had an umbilical artery pH </=7.09 or Apgar score </=6 at 5 minutes, plus clinical encephalopathy. Infants with major congenital abnormalities were excluded.\n Infants were allocated to either no cooling (rectal temperature = 37.0 +/- 0.2 degrees C, n = 15), or, sequentially, to head cooling accompanied by different levels of systemic hypothermia, including minimal cooling, rectal temperature 36.5 degrees C to 36 degrees C (n = 6), and mild cooling, to either 35.9 degrees C to 35.5 degrees C (n = 6), 35 +/- 0.5 degrees C (n = 6) or 34.5 +/- 0.5 degrees C (n = 7). Head cooling was accomplished by circulating cooled water through a coil of tubing wrapped around the head for up to 72 hours. Survivors were followed up with regular neurologic examination by a neonatologist until 18 months of age, then with blinded developmental testing using the revised Bayley Scales.\n A total of 40 term infants were enrolled from 2 to 5 hours after birth. The control and the cooled groups were not significantly different for gestation, birth weight, Apgar score, and initial pH. There were 6 early neonatal deaths (3 normothermic and 3 cooled), and 1 death in infancy associated with severe spastic cerebral palsy in a normothermic infant. Six normothermic, 1 minimally cooled, and 4 mildly cooled infants had early stage 1 encephalopathy; all but 1 had a good outcome. Among infants with early stage 2 or 3 encephalopathy, an adverse outcome was found in 4 of 9 normothermic infants (44%) and 4 of 5 minimally cooled infants (80%), whereas in the combined mildly cooled groups, an adverse outcome was found in 4 of 15 infants (26%, odds ratio 0.46 [0.08, 2.56] vs normothermia).\n The present study supports the safety of hypothermia, with no evidence of late adverse effects in any infant. Among infants with moderate to severe encephalopathy at enrollment, there was a tendency toward better outcome. These results emphasize the relatively wide range of outcomes using purely clinical criteria for enrollment. Therapeutic hypothermia should not be used outside of stringent, multicenter trials.", "Therapeutic hypothermia holds promise as a rescue neuroprotective strategy for hypoxic-ischemic injury, but the incidence of severe neurologic sequelae with hypothermia is unknown in encephalopathic neonates who present shortly after birth. This study reports a multicenter, randomized, controlled, pilot trial of moderate systemic hypothermia (33 degrees C) vs normothermia (37 degrees C) for 48 hours in neonates initiated within 6 hours of birth or hypoxic-ischemic event. The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. Thirty-two hypothermic and 33 normothermic neonates were enrolled. The entry criteria selected a severely affected group of neonates, with 77% Sarnat stage III. Ten hypothermia (10/32, 31%) and 14 normothermia (14/33, 42%) patients expired. Controlling for treatment group, outborn infants were significantly more likely to die than hypoxic-ischemic infants born in participating tertiary care centers (odds ratio 10.7, 95% confidence interval 1.3-90). Severely abnormal motor scores (Psychomotor Development Index < 70) were recorded in 64% of normothermia patients and in 24% of hypothermia patients. The combined outcome of death or severe motor scores yielded fewer bad outcomes in the hypothermia group (52%) than the normothermia group (84%) (P = 0.019). Although these results need to be validated in a large clinical trial, this pilot trial provides important data for clinical trial design of hypothermia treatment in neonatal hypoxic-ischemic injury.", "Hypoxic-ischemic encephalopathy (HIE) remains one of the most important neurologic complications in the newborn. Several experimental and clinical studies have shown that hypothermia is the most effective means known for protecting the brain against hypoxic-ischemic brain damage. Furthermore, recent data have suggested that platelet-activating factor (PAF) could play a pathophysiologically important role in the progression of hypoxic-ischemic brain injury. The aim of the present study was to investigate the role of head cooling combined with minimal hypothermia in short-term outcome of infants with perinatal asphyxia. In addition, we have examined the effect of head cooling combined with minimal hypothermia on PAF concentrations in cerebrospinal fluid (CSF) after hypoxic-ischemic brain injury. The group of asphyxiated infants (Group 1) consisted of 21 full-term (gestational age >37 weeks). These infants were randomized and divided into either a standard therapy group (Group 1a; n=10) or cooling group (Group 1b; n=11). Head cooling combined with minimal hypothermia (rectal temperature 36.5-36 degrees C) was started as soon as practicable after birth. The infants were cooled for 72h and then were rewarmed at 0.5 degrees C/h. The control group (Group 2) consisted of seven full-term infants and none of these infants showed any sign of asphyxia. To measure PAF concentration in CSF, CSF with lumbar puncture was collected into tubes immediately before the cooling (1-3h after birth) and again after 36h. We had no evidence of severe adverse events related to hypothermia. In Group 1a, two infants died after 72h of life; however, all newborn infants in Group 1b survived. Convulsion required treatment in three infants of standard therapy group (1a); none of the infants in Group 1b had clinical seizure activity. Abnormal EEG patterns were found in four infants of Group 1a; no EEG abnormalities were noted in Group 1b (P<0.05). On admission (before cooling), PAF concentration in CSF of asphyxiated infants was found to be significantly higher when compared with that of control (P<0.001). Mean PAF concentration before initiation of the study was similar in the two asphyxiated groups (Group 1a vs. 1b) (P>0.05). Obtained PAF level in CSF after 36h, showed a profound decline in cooling group of infants compared to Group 1a infants (P<0.01). In conclusion, the present study suggests that cerebral cooling with minimal hypothermia started soon after birth has no severe adverse effects during 72-h cooling period and that short-term outcome of infants are encouraging. Our results also support the hypothesis PAF an important mediator in hypoxic-ischemic brain injury and demonstrate that head cooling combined with minimal hypothermia reduces the normal increase in PAF following hypoxic-ischemic brain injury in full-term infants.", "To investigate the efficacy and safety of selective head cooling with mild systemic hypothermia in hypoxic-ischemic encephalopathy (HIE) in newborn infants.\n Infants with HIE were randomly assigned to the selective head cooling or control group. Selective head cooling was initiated within 6 hours after birth to a nasopharyngeal temperature of 34 degrees+/-0.2 degrees C and rectal temperature of 34.5 degrees to 35.0 degrees C for 72 hours. Rectal temperature was maintained at 36.0 degrees to 37.5 degrees C in the control group. Neurodevelopmental outcome was assessed at 18 months of age. The primary outcome was a combined end point of death and severe disability.\n One hundred ninety-four infants were available for analysis (100 and 94 infants in the selective head cooling and control group, respectively). For the selective head cooling and control groups, respectively, the combined outcome of death and severe disability was 31% and 49% (OR: 0.47; 95% CI: 0.26-0.84; P=.01), the mortality rate was 20% and 29% (OR:0.62; 95% CI: 0.32-1.20; P=.16), and the severe disability rate was 14% (11/80) and 28% (19/67) (OR: 0.40; 95% CI: 0.17-0.92; P=.01).\n Selective head cooling combined with mild systemic hypothermia for 72 hours may significantly decrease the combined outcome of severe disability and death, as well as severe disability.\n Copyright (c) 2010 Mosby, Inc. All rights reserved.", "Mild hypothermia after perinatal hypoxic-ischemic encephalopathy (HIE) reduces neurologic sequelae without significant adverse effects, but studies are needed to determine the most-efficacious methods.\n In the neo.nEURO.network trial, term neonates with clinical and electrophysiological evidence of HIE were assigned randomly to either a control group, with a rectal temperature of 37°C (range: 36.5-37.5°C), or a hypothermia group, cooled and maintained at a rectal temperature of 33.5°C (range: 33-34°C) with a cooling blanket for 72 hours, followed by slow rewarming. All infants received morphine (0.1 mg/kg) every 4 hours or an equivalent dose of fentanyl. Neurodevelopmental outcomes were assessed at the age of 18 to 21 months. The primary outcome was death or severe disability.\n A total of 129 newborn infants were enrolled, and 111 infants were evaluated at 18 to 21 months (53 in the hypothermia group and 58 in the normothermia group). The rates of death or severe disability were 51% in the hypothermia group and 83% in the normothermia group (P=.001; odds ratio: 0.21 [95% confidence interval [CI]: 0.09-0.54]; number needed to treat: 4 [95% CI: 3-9]). Hypothermia also had a statistically significant protective effect in the group with severe HIE (n=77; P=.005; odds ratio: 0.17 [95% CI: 0.05-0.57]). Rates of adverse events during the intervention were similar in the 2 groups except for fewer clinical seizures in the hypothermia group.\n Systemic hypothermia in the neo.nEURO.network trial showed a strong neuroprotective effect and was effective in the severe HIE group.", "Modest reduction in brain temperature is a promising therapy to reduce brain damage after neonatal encephalopathy as a result of acute perinatal asphyxia. The efficacy of modest hypothermia may in part be dependent on the stability of the desired brain temperature. The objective of this study was 1) to evaluate in newborn animals a commercially available cooling system (Blanketrol II Hyperthermia-Hypothermia system) to control brain temperature during whole-body hypothermia and 2) to use the results of the animal experiments to perform a pilot study evaluating the feasibility of whole-body hypothermia as a neuroprotective therapy for newborns with encephalopathy at birth.\n In the animal investigation, 3 miniature swine were instrumented and ventilated, and temperature probes were placed in the esophagus and the brain (1 cm and 2 cm beneath the parietal cortical surface and the dura). Body cooling was achieved using the automatic control mode (servo) of the cooling system. In the human investigation, 19 term infants with moderate or severe encephalopathy were randomized to either normothermia (n = 10) or hypothermia (n = 9) within 6 hours of birth. Whole-body hypothermia was achieved using the hyperthermia-hypothermia cooling system with servo control of esophageal temperature to 34.5 degrees C for 72 hours followed by slow rewarming.\n In the animal investigation, body cooling with the animal lying on a single blanket resulted in rapid cooling of the body within 90 minutes. Repetitive cyclical swings in esophageal temperature of 1.7 +/- 0.2 degrees C (mean +/- standard deviation) around the set point of 33.5 degrees C were reduced to 0.7 +/- 0.2 degrees C when a second, larger blanket was attached and suspended. Esophageal temperature was a good marker of deep brain temperature (esophageal to 2-cm brain difference: 0.1 +/- 0.3 degrees C). In the human investigation, the infants were randomized at 4.1 +/- 1.3 hours (mean +/- standard deviation) after birth. Age at randomization was similar in the 2 groups. Cooling was initiated at an average age of 5.3 hours. Target temperature of 34.5 degrees C was achieved within 30 minutes and remained constant throughout the intervention period. Heart rate decreased to 108 +/- 14 beats per minute (bpm) at 60 minutes and remained between 115 and 130 bpm for the duration of cooling compared with 130 to 145 bpm in the normothermia group. Blood pressure was similar in the 2 groups. No adverse events occurred during 72 hours of cooling. The mortality rate and frequency of persistent pulmonary hypertension, renal failure, hepatic dysfunction, and need for pressor support were similar in both groups.\n Animal studies showed that a simple modification of a commercially available cooling system (2 blankets attached, subject lying on 1 and the second hanging freely) results in stable core body and brain temperature when used in the automatic control mode. The pilot study in term infants with encephalopathy using this cooling system demonstrates feasibility of initiating whole-body hypothermia at <6 hours of age to a constant esophageal temperature using servo control and provides no evidence that hypothermia involved greater hazard than benefit.", "Whether hypothermic therapy improves neurodevelopmental outcomes in newborn infants with asphyxial encephalopathy is uncertain.\n We performed a randomized trial of infants who were less than 6 hours of age and had a gestational age of at least 36 weeks and perinatal asphyxial encephalopathy. We compared intensive care plus cooling of the body to 33.5 degrees C for 72 hours and intensive care alone. The primary outcome was death or severe disability at 18 months of age. Prespecified secondary outcomes included 12 neurologic outcomes and 14 other adverse outcomes.\n Of 325 infants enrolled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone. In the cooled group, 42 infants died and 32 survived but had severe neurodevelopmental disability, whereas in the noncooled group, 44 infants died and 42 had severe disability (relative risk for either outcome, 0.86; 95% confidence interval [CI], 0.68 to 1.07; P=0.17). Infants in the cooled group had an increased rate of survival without neurologic abnormality (relative risk, 1.57; 95% CI, 1.16 to 2.12; P=0.003). Among survivors, cooling resulted in reduced risks of cerebral palsy (relative risk, 0.67; 95% CI, 0.47 to 0.96; P=0.03) and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II (P=0.03 for each) and the Gross Motor Function Classification System (P=0.01). Improvements in other neurologic outcomes in the cooled group were not significant. Adverse events were mostly minor and not associated with cooling.\n Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571.)\n 2009 Massachusetts Medical Society", "The objective of this study was to determine the efficacy of mild hypothermia via selective head cooling as a neuroprotective therapy in term infants with perinatal asphyxia.\n Full-term newborns who had 5 min Apgar scores <6, first arterial blood gas pH<7.10 or BD>15 mEq/l, and with the clinical signs of encephalopathy were enrolled within 6 h after birth. Patients were randomized to receive mild hypothermia treatment via selective head cooling for a total of 72 h or receive routine treatment as a control. Brain hypoxic-ischemic injury was quantified based on the head computed tomographic scan (CT scan) at postnatal age 5-7 days and a Neonatal Behavioral Neurological Assessment (NBNA) score at 7-10 days of life.\n A total of 58 patients (30 hypothermia, 28 control) completed the study. Hypothermia was well tolerated in this study and attenuated the hypoxic-ischemic brain injury due to perinatal asphyxia. Head CT scan demonstrated moderate to severe hypoxic-ischemic changes in only 4/30 cases from the hypothermic group. In contrast, 18/28 cases in the control group showed moderate to severe hypoxic-ischemic changes (chi (2)=15.97, P<0.01). Brain hypothermia also significantly improved the NBNA score (32+/-2 in the hypothermic group vs 28+/-3 in the control group, P<0.01).\n Our results suggest that selective head cooling may be used as a neuroprotective therapy in term neonates with perinatal asphyxia. A long-term follow-up study is needed to further validate the results of this study.", "Hypothermia is protective against brain injury after asphyxiation in animal models. However, the safety and effectiveness of hypothermia in term infants with encephalopathy is uncertain.\n We conducted a randomized trial of hypothermia in infants with a gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age with either severe acidosis or perinatal complications and resuscitation at birth and who had moderate or severe encephalopathy. Infants were randomly assigned to usual care (control group) or whole-body cooling to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming (hypothermia group). Neurodevelopmental outcome was assessed at 18 to 22 months of age. The primary outcome was a combined end point of death or moderate or severe disability.\n Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia group and 38 (37 percent) in the control group died (risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05; P=0.08). There was no increase in major disability among survivors; the rate of cerebral palsy was 15 of 77 (19 percent) in the hypothermia group as compared with 19 of 64 (30 percent) in the control group (risk ratio, 0.68; 95 percent confidence interval, 0.38 to 1.22; P=0.20).\n Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.\n Copyright 2005 Massachusetts Medical Society.", "Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.\n 234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34-35 degrees C (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation--ie, severe loss of background amplitude, and seizures--and those with less severe changes.\n In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio 0.61; 95% CI 0.34-1.09, p=0.1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0.57 (0.32-1.01, p=0.05). No difference was noted in the frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1.8; 0.49-6.4, p=0.51), but was beneficial in infants with less severe aEEG changes (n=172, 0.42; 0.22-0.80, p=0.009).\n These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes." ]

[ "3986438", "10450619", "10448446", "12655910" ]

[ "Professional and non-professional intervention for highly anxious primiparous mothers.", "Professional and paraprofessional group treatments for depression: a comparison of cognitive-behavioral and mutual support interventions.", "Befriending as an intervention for chronic depression among women in an inner city. 1: Randomised controlled trial.", "The effect of peer support on postpartum depression: a pilot randomized controlled trial." ]

[ "Primiparous women (n = 627) were screened on state and trait anxiety measures in the post-partum period; sub-groups of highly anxious (n = 89), moderately anxious (n = 29), and minimally anxious (n = 29) mothers were derived and subsequently interviewed. The high-anxiety mothers were randomly assigned to a professional intervention, to a non-professional intervention, and to a control group, and their progress was reviewed over the following 12 months. Compliance, both in responding to progressive assessments and in accepting therapeutic intervention, was extremely high. Changes in anxiety levels for mothers not receiving an intervention were minimal over the study. In the high-anxiety sub-groups, there was a 19% reduction in state anxiety levels for those receiving a professional intervention, a 12% reduction for those receiving a non-professional intervention, and a 3% reduction in the controls. A planned contrast analysis determined that only professional intervention had a significant effect, intervention successfully lowering state anxiety levels to a value comparable with the moderately anxious mothers.", "The relative efficacy of professional and paraprofessional therapists in providing group cognitive-behavioral therapy (CBT) and mutual support group therapy (MSG) was examined. Depressed outpatients (N = 98) were randomly assigned to CBT or MSG led by either 2 professional or 2 paraprofessional therapists. Results suggest that nonprofessionals were as effective as professionals in reducing depressive symptoms and that clients in the CBT and MSG conditions improved equally. Clinically significant improvement was demonstrated for both conditions. However, following treatment, more patients in the professionally led CBT groups were classified as nondepressed and alleviated than in the paraprofessionally led CBT groups. Additionally, therapist adherence to manual-based treatments was associated with greater improvement in clinician-rated depressive symptoms in both conditions and skills in cognitive restructuring were associated with greater improvement among clients in CBT.", "Earlier work on the protective role of social support in onset and course of depressive disorder suggested that its provision might be relevant for outcome.\n To evaluate volunteer befriending as an intervention among women with chronic depression in inner London.\n A randomised controlled trial, with a waiting list control design, with outcome measured as Present State Examination (PSE)-based full or partial remission after one year.\n A statistically significant effect upon remission was found for befriending. Other treatments monitored naturalistically did not relate to remission, nor did initial duration of chronic episode or comorbidity, but there was an association with initial PSE score. The findings are discussed in relation to standard drug-trial results and to another befriending intervention with the elderly.\n The results are not unpromising. Additional trials with less restricted intake conditions, and in more naturalistic general practice settings, might confirm volunteer befriending as a useful adjunct to current treatments.", "To evaluate the effect of peer support (mother-to-mother) on depressive symptomatology among mothers identified as high-risk for postpartum depression (PPD).\n Forty-two mothers in British Columbia were identified as high-risk for PPD according to the Edinburgh Postnatal Depression Scale (EPDS) and randomly assigned to either a control group (that is, to standard community postpartum care) or an experimental group. The experimental group received standard care plus telephone-based peer support, initiated within 48 to 72 hours of randomization, from a mother who previously experienced PPD and attended a 4-hour training session. Research assistants blind to group allocation conducted follow-up assessments on diverse outcomes, including depressive symptomatology, at 4 and 8 weeks postrandomization.\n Significant group differences were found in probable major depressive symptomatology (EPDS > 12) at the 4-week (chi 2 = 5.18, df = 1; P = 0.02) and 8-week (chi 2 = 6.37, df = 1; P = 0.01) assessments. Specifically, at the 4-week assessment 40.9% (n = 9) of mothers in the control group scored > 12 on the EPDS, compared with only 10% (n = 2) in the experimental group. Similar findings were found at the 8-week assessment, when 52.4% (n = 11) of mothers in the control group scored > 12 on the EPDS, compared with 15% (n = 3) of mothers in the experimental group. Of the 16 mothers in the experimental group who evaluated the intervention, 87.5% were satisfied with their peer-support experience.\n Telephone-based peer support may effectively decrease depressive symptomatology among new mothers. The high maternal satisfaction with, and acceptance of, the intervention suggests that a larger trial is feasible." ]

[ "14341119", "15761580", "19538406", "20492051", "18396254", "15605131", "3635599" ]

[ "CLINICAL TRIAL OF AUDIO-ANALGESIA IN CHILDBIRTH.", "[The use of respiration and relaxation techniques for pain and anxiety relief in the parturition process].", "Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial.", "Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers.", "Yoga during pregnancy: effects on maternal comfort, labor pain and birth outcomes.", "The effect of breathing and skin stimulation techniques on labour pain perception of Turkish women.", "The effect of music as a conditioning aid in prepared childbirth education." ]

[ "nan", "This study aimed to evaluate the effect of respiration and relaxation techniques on pain and anxiety during labor. Seventeen parturients (Control Group--CG) received routine care and nineteen (Experimental Group--EG) were orientated and stimulated to perform respiration and relaxation techniques. Pain was evaluated by means of the visual analogy scale and anxiety by means of the anxiety inventories--trait and state. Pain intensity increased along with the evolution of the delivery for both groups. In the latent phase, anxiety levels were low for both groups; in the active phase, levels were average for CG and low for EG. In the transition phase, levels were average and, in the immediate post-labor phase, low for both groups. It was concluded that the techniques used did not reduce pain intensity, but provided EG with lower anxiety levels for a longer time during labor.", "To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers.\n Randomised controlled multicentre trial.\n Fifteen antenatal clinics in Sweden between January 2006 and May 2007.\n A total of 1087 nulliparous women and 1064 of their partners.\n Natural group: Antenatal education focussing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis). Standard care group: Standard antenatal education focussing on both childbirth and parenthood, without psychoprophylactic training. Both groups: Four 2-hour sessions in groups of 12 participants during third trimester of pregnancy and one follow-up after delivery.\n Epidural analgesia during labour, experience of childbirth as measured by the Wijma Delivery Experience Questionnaire (B), and parental stress measured by the Swedish Parenthood Stress Questionnaire.\n The epidural rate was 52% in both groups. There were no statistically significant differences in the experience of childbirth or parental stress between the randomised groups, either in women or men. Seventy percent of the women in the Natural group reported having used psychoprophylaxis during labour. A minority in the Standard care group (37%) had also used this method, but subgroup analysis where these women were excluded did not change the principal findings.\n Natural childbirth preparation including training in breathing and relaxation did not decrease the use of epidural analgesia during labour, nor did it improve the birth experience or affect parental stress in early parenthood in nulliparous women and men, compared with a standard form of antenatal education.", "The purpose of the study was to investigate the effects of music on pain reaction and anxiety during labour.\n Music therapy has been used on clinical medicine. Only few scientific studies validate the value on labour women.\n Randomised controlled trial.\n Sixty primiparas expected to have a normal spontaneous delivery were randomly assigned to either the experimental group (n = 30) or the control group (n = 30). The experimental group received routine care and music therapy, whereas the control group received routine care only. A self-report visual analogue scale for pain and a nurse-rated present behavioural intensity were used to measure labour pain. Anxiety was measured with a visual analogue scale for anxiety and finger temperature. Pain and anxiety between groups were compared during the latent phase (2-4 cm cervical dilation) and active phase (5-7 cm) separately.\n Our results revealed that compared with the control group, the experimental group had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labour. However, no significant differences were found between the two groups on all outcome measures during the active phase.\n This study provides evidence for the use of music as an empirically based intervention of women for labour pain and anxiety during the latent phase of labour.\n The findings support that music listening is an acceptable and non-medical coping strategy for labouring women. Especially, apply in reducing the pain and anxiety for women who are at the early phase of labour.", "This study examined the effects of a yoga program during pregnancy, on maternal comfort, labor pain, and birth outcomes. A randomized trial was conducted using 74-primigravid Thai women who were equally divided into two groups (experimental and control). The yoga program involved six, 1-h sessions at prescribed weeks of gestation. A variety of instruments were used to assess maternal comfort, labor pain and birth outcomes. The experimental group was found to have higher levels of maternal comfort during labor and 2h post-labor, and experienced less subject evaluated labor pain than the control group. In each group, pain increased and maternal comfort decreased as labor progressed. No differences were found, between the groups, regarding pethidine usage, labor augmentation or newborn Apgar scores at 1 and 5 min. The experimental group was found to have a shorter duration of the first stage of labor, as well as the total time of labor.", "To determine the effect of breathing techniques and nurse-administered massage on the pain perception of pregnant woman during labour.\n The present study was conducted among pregnant women (75% primiparous) admitted to the SSK Bakirkoy Women and Children's Hospital (Istanbul, Turkey) between January 1, and September 1, 2000. The patients were in their 38th to 42nd week of pregnancy, not at high risk and expected to have normal vaginal delivery. They were selected from volunteers by nonrandom sampling.\n The present study involved 40 cases, with 20 in the experimental group and 20 in the control group. Data were obtained through the visual analogue scale, inspection form, observation form and postnatal interview form. The study investigators provided information about labour, breathing techniques and massage to the pregnant women assigned to the experimental group at the beginning of labour (latent phase). A study investigator also accompanied them during labour. These women received nurse-administered massage and were encouraged to breathe and perform self-administered massage. They were also instructed to change their positions and to relax.\n Study results demonstrated that nursing support and patient-directed education concerning labour and nonpharmacological pain control methods (eg, breathing and cutaneous stimulation techniques) were effective in reducing the perception of pain by pregnant women (when provided in the latent labour phase before delivery), leading to a more satisfactory birth experience.", "The addition of self-selected music as a conditioning aid during prepared childbirth education and subsequent family performance in labor within a musical environment were examined. Thirty primigravida couples received the same psychoprophylactic instruction, with 15 randomly selected couples receiving the added musical conditioning aid. Medication use remained minimal, without significant difference, for couples who did and couples who did not use music. However, the value of music to both the family and the health care staff is felt to be of enough subjective significance to warrant its use as a normal component of prepared childbirth education." ]

[ "12878286", "10958880", "12201325", "1591918", "12636960", "10827335", "11257245", "10224546", "9561872" ]

[ "Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study.", "Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom.", "Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial.", "Condom performance during vaginal intercourse: comparison of Trojan-Enz and Tactylon condoms.", "Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.", "Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage.", "Randomized crossover trial comparing the eZ.on plastic condom and a latex condom.", "Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.", "Breakage and acceptability of a polyurethane condom: a randomized, controlled study." ]

[ "Although latex remains the primary material for male condoms, a number of condoms made from synthetic materials have appeared in commercial markets in recent years. Published data on the safety and efficacy of these condoms is still limited, but nevertheless synthetic condoms do offer the user a wider choice and may encourage greater use of condoms for contraception and sexual transmitted infection prophylaxis. This paper reports on a study carried out in the Paris region of France on a new, commercial polyurethane condom marketed in Japan as Sagami Original and in Europe as Protex Original. A standard latex condom complying with the European standard for condoms (EN 600:1996) from the same manufacturer was used as the control in the study. The clinical breakage rate for the polyurethane condom was 0.6% (95% confidence interval 0.2-1.4%) compared to 1.3% (95% confidence interval 0.6-2.2%) for the latex condom. The difference was not statistically significant (chi(2) = 1.9, p = 0.168). Clinically significant slippage (complete slippage of the condom off the penis) was 1.1% (95% confidence interval 0.5-1.9%) for the polyurethane condom, compared to 0.5% (95% confidence interval 0.2-1.2%) for the latex; a difference that again was not statistically significant (chi(2) = 1.783, p = 0.182). The polyurethane condom was therefore equivalent to the latex condom in terms of clinical failure rate.", "After more than a century of reliance on latex condoms, male condoms fabricated from new materials are finally becoming commercially available to consumers. This study was an open label acceptability study that compared three lubricated condom products during vaginal intercourse: a natural rubber latex condom, a polyurethane condom, and a new non-latex (styrene ethylene butylene styrene, SEBS) condom. Fifty-four couples who were using condoms for birth control were enrolled in this three-way crossover study. Each couple tested three condoms of each type in a randomized sequence. Couples reported condom performance after each use and rated condom acceptability after use of three condoms of each type. At the completion of the study, participants selected their preferred condom type for overall acceptability, sensitivity, ease of use, appearance, and comfort. All three condom types had low clinical breakage and slippage rates (</= 3.3%) although the polyurethane condom did not perform as well in other measures of performance including unrolling, discomfort, stretching, bunching, and sliding along the penis during intercourse. None of the condom types were statistically preferred overall [males: natural rubber latex 37%, polyurethane 24%, new non-latex (SEBS) 37%, no preference 2%; females: natural rubber latex 33%, polyurethane 27%, new non-latex 37%, no preference 2%]. A statistically higher proportion of couples preferred both the natural rubber latex condom and the new non-latex condom above the polyurethane condom for ease of unrolling, and the natural rubber latex condom above the other condom types for perceived safety. Approximately two-thirds of both male and female participants preferred one of the two condoms made of synthetic materials suggesting that consumers will appreciate the availability of these products.", "To assess the short-term acceptability and functionality of the eZ.on condom compared with currently marketed latex (Gossamer) and polyurethane (Avanti) condoms. Method Healthy, sexually active volunteers aged 18-50 years, self-selected from among the UK population, were enrolled in a randomized cross-over trial. Participants were required to test six of each of three condom variants. Data were collected on structured questionnaires by means of postal and telephone contacts. Main outcome measures were breakage and slippage rates, and short-term user acceptability based on participants' ratings documented in end-of-study questionnaires.\n Forty-three couples entered the study, of whom 37 tested the condoms on 512 occasions. There was no statistically significant difference in the clinical breakage rate between eZ.on (3.7%) and the comparator condoms (3.5% for Gossamer and 2.9% for Avanti). Complete slippage rates were similar for eZ.on (2.4%) and Avanti (2.9%). Gossamer had the lowest slippage rate (1.2%), but this difference was not statistically significant. User acceptability was similar for the three condom types; however, there was a trend for more participants to express dissatisfaction with eZ.on, including difficulties with putting on the condom.\n No firm conclusions can be drawn from this pilot study, but our observations suggest that eZ.on may be an acceptable option for some couples unwilling or unable to use a latex condom.", "Forty-nine mutually monogamous couples used a total of 478 condoms during vaginal intercourse in a prospective trial whose purpose was to discover whether the performance of a new non-latex hypoallergenic condom was substantially equivalent to that of a leading condom brand already being marketed. Of these 478 condoms, seven (1.46%) either broke or fell off the penis during intercourse. Two (0.42%) of the 471 condoms that did not break or fall off during intercourse fell off the penis when it was being withdrawn from the vagina. Altogether, 469 (98.1%) of the 478 condoms used for intercourse survived intact throughout intercourse and withdrawal. Differences in breakage and slippage rates for the two condom brands were statistically insignificant. The overall 98.1% success rate is much higher than the rate of success found in a previous condom trial with nearly identical research protocol. The reason for the difference is attributed to much more precise questioning of subjects in the current trial.", "To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.\n We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception. We tested for pregnancy at enrollment and at every scheduled follow-up visit (weeks 4, 10, 16, 22, and 30).\n The 6-month typical-use pregnancy probabilities were 9.0% (95% confidence interval [CI] 5.9, 12.2) for the polyurethane group and 5.4% (95% CI 2.9, 7.8) for the latex group; the hazard ratio was 1.7 (95% CI 1.1, 2.7), and we failed to reject the null hypothesis of our test of noninferiority. Females in the polyurethane group reported fewer genital irritations (hazard ratio 0.6; 95% CI 0.5, 0.8; P <.01), whereas males in both groups reported the same number of genital irritations (hazard ratio 1.0; 95% CI 0.7, 1.5; P =.94). Total clinical failures (breakage and slippage) were 8.4% for the polyurethane condom and 3.2% for the latex condom (difference 5.3%, 90% CI 2.8, 7.7). The risk of discontinuation did not differ between groups. Participants judged both condoms favorably in terms of the four primary acceptability outcomes (willingness to purchase, willingness to recommend, confidence in method, and general comfort).\n The polyurethane condom was not shown to be as effective as the latex comparator condom for pregnancy prevention. However, the risk of pregnancy in the polyurethane group falls in the range of other barrier methods. For people with latex sensitivity or who find latex condoms unacceptable, this polyurethane condom represents one of several synthetic male condom alternatives currently available on the US market.", "This study compared breakage and slippage rates of three male condom styles made of Tactylon(TM), a synthetic elastomer, to those of a marketed latex condom during vaginal intercourse. Safety and acceptability outcomes were also assessed. This two-center, prospective, crossover study enrolled 443 couples. Each couple was randomly assigned to use three condoms of each type in one of 24 use sequences. Couples completed questionnaires after using each condom, all of one condom type, and all four condom types. The percentage and standard error (SE, in parentheses) of latex condoms with clinical breakage was 0.86% (0.295). Percentages for Tactylon condoms were not equivalent to the latex study condom, ranging from 3.50% to 4.17%. The percentage and SE of latex condoms with complete slippage was 1.11% (0.328). Percentages for Tactylon condoms were equivalent to those for latex, ranging from 0.70% to 1.31%. The Low-Modulus Tactylon condom was the most preferred. Fewer medical events were reported with the Tactylon condoms than with the latex condom. It was concluded that Tactylon condoms were equivalent to the latex condom in terms of slippage but not breakage. However, safety and acceptability seemed to be better for Tactylon condoms. This may improve consistency of use and may attract new users.", "This randomized crossover trial compared the breakage and slippage rates, safety, and acceptability of the recently developed polyurethane bi-directional eZ.on condom with a marketed latex condom. Three hundred sixty couples were asked to use 4 eZ.on condoms and 4 latex condoms. Like several other non-latex condoms tested to date, the eZ.on condom had a higher clinical breakage rate than its latex comparator, while the slippage rates were similar. The clinical breakage rate for the eZ.on condom was 5.6%, compared with 0.9% for the latex condom (difference = 4.76%, with upper 95% confidence bound on the difference = 6.26%). Thus, based on an a priori definition of a 2% clinically acceptable difference, the study failed to conclude equivalence relative to clinical breakage. The complete slippage rate for eZ.on was 1.6%; compared to 0.7% for latex (difference = 0.87%, with upper 95% confidence bound = 1.55%). Thus, based on an a priori definition of a 2% difference we concluded equivalence relative to complete slippage. The safety profile of the eZ.on condom was good and similar to the latex condom. The eZ.on was also found to be easier to don and remove than the latex condom. Although no overall preference existed for either condom, nearly 30%women and men strongly preferred the eZ.on condom to the latex condom. The eZ.on condom may be an acceptable alternative for couples unable or unwilling to use latex condoms.", "Condoms made of latex are not comfortable or appropriate for all consumers. Polyurethane condoms may provide a needed alternative.\n In a double-masked study, 805 monogamous couples were randomized to use either the polyurethane condom or the latex condom for six months. Couples recorded the frequency of intercourse, of condom use and of breakage and slippage throughout the trial in coital diaries and in detailed reports on the first five uses. Breakage and slippage rates were determined, and typical-use and consistent-use pregnancy rates were calculated using life-table analysis, adjusted for use of emergency contraception.\n The six-month pregnancy rate during typical use (adjusted for use of emergency contraception) was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over six completed menstrual cycles--2.4% for the polyurethane condom and 1.1% for the latex condom--did not differ significantly. Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for the latex condom. In general, male participants were more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were users of polyurethane.\n Although polyurethane and latex condoms provide equivalent levels of contraceptive protection, the polyurethane condom's higher frequency of breakage and slippage suggests that this condom may confer less protection from sexually transmitted infections than does the latex condom.", "Although the first commercial polyurethane condom was approved for use several years ago, no U.S. clinical trial has compared its performance to that of the latex condom.\n In a masked crossover study, 360 couples were randomized to use three polyurethane condoms and three latex condoms. After each use, couples recorded condom breaks, condom slips and other aspects of performance. At completion of the study, couples compared the sensitivity, ease of use, fit and lubrication of the two types of condoms.\n The clinical breakage rate of the polyurethane condom was 7.2%, compared with 1.1% for the latex condom (relative risk of 6.6, 95% confidence interval of 3.5-12.3). The complete slippage rate (combining incidents during intercourse and withdrawal) of the polyurethane condom was 3.6%, compared with 0.6% for the latex condom (relative risk of 6.0, 95% confidence interval of 2.6-14.2). Most male users preferred the sensitivity provided by the polyurethane condom to that of the latex condom.\n The clinical breakage rate of the polyurethane condom is significantly higher than that of the latex condom. However, nearly half of the users preferred the polyurethane condom, which provides an option for couples who have rejected conventional condoms or who cannot use latex products." ]

[ "11401657", "18158074", "3898725", "21263010", "12817155", "21869697", "9547134", "3324648", "15526307", "12650745", "21206792", "17647298", "15812262", "20340011", "16633139", "11074227", "14980069", "8021437", "10565799", "9871816", "16555167", "16238906", "12000207", "3300171", "16782204", "3545354", "10767728" ]

[ "Citalopram versus nortriptyline in late-life depression: a 12-week randomized single-blind study.", "Efficacy and tolerability of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, prospective, randomized, double-blind, active-controlled study in adult outpatients.", "Citalopram versus mianserin. A controlled, double-blind trial in depressed patients.", "Polymorphism of the 5-HT transporter and response to antidepressants: randomised controlled trial.", "Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care.", "Faster onset of antidepressant effects of citalopram compared with sertraline in drug-naïve first-episode major depressive disorder in a Chinese population: a 6-week double-blind, randomized comparative study.", "A double-blind multicenter trial comparing sertraline and citalopram in patients with major depression treated in general practice.", "Citalopram versus maprotiline: a controlled, clinical multicentre trial in depressed patients.", "Efficacy and tolerability of venlafaxine in geriatric outpatients with major depression: a double-blind, randomised 6-month comparative trial with citalopram.", "Oral citalopram and reboxetine challenge tests before and after selective antidepressant treatment.", "Escitalopram Versus Citalopram and Sertraline: A Double-Blind Controlled, Multi-centric Trial in Indian Patients with Unipolar Major Depression.", "Effectiveness and acceptability of sertraline and citalopram in major depressive disorder: pragmatic randomized open-label comparison.", "Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.", "Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study.", "Efficacy and tolerability of reboxetine compared with citalopram: a double-blind study in patients with major depressive disorder.", "Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline.", "Oxidative damage and major depression: the potential antioxidant action of selective serotonin re-uptake inhibitors.", "Citalopram and imipramine in the treatment of depressive patients in general practice. A Nordic multicentre clinical study.", "Efficacy and tolerability of mirtazapine versus citalopram: a double-blind, randomized study in patients with major depressive disorder. Nordic Antidepressant Study Group.", "Comparison of the tolerability and efficacy of citalopram and amitriptyline in elderly depressed patients treated in general practice.", "Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study.", "A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder.", "Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients.", "A double-blind comparison of citalopram (Lu 10-171) and amitriptyline in depressed patients.", "Different gender response to serotonergic and noradrenergic antidepressants. A comparative study of the efficacy of citalopram and reboxetine.", "A comparison of the antidepressant action of citalopram and amitriptyline.", "A randomised, double-blind comparison of the efficacy and safety of citalopram compared to mianserin in elderly, depressed patients with or without mild to moderate dementia." ]

[ "The aim of this single-blind study was to examine the efficacy and tolerability of citalopram compared to nortriptyline in moderate to severe major depressive patients aged 60 years or over. Method: In- and out-patients (N=58) with unipolar major depression were randomized to 12-week flexible dose treatment with nortriptyline or citalopram.\n No significant differences between the number of drop-outs in either group were observed, but the autonomic side-effects were significantly higher for nortriptyline than for citalopram. A significantly higher remission rate to nortriptyline than to citalopram was demonstrated, particularly if severe patients (endogenous or psychotic patients) were assessed.\n The remission rate to a therapeutic plasma level of nortriptyline appears to be higher than the remission rate to a standard dose of citalopram in a group of elderly major depressed patients, especially those with endogenous or psychotic features. On the other hand, citalopram appears to be better tolerated.", "The S-enantiomer of citalopram (escitalopram) is the active moiety linked to the anti-depressant effects associated with citalopram (the racemate). For escitalopram to be approved for the treatment of depression in Europe, findings from clinical trials of escitalopram are required to match previous results from studies of the racemate, citalopram.\n The aim of this study was to compare the efficacy and tolerability of escitalopram and citalopram in outpatients with major depressive disorder (MDD).\n This prospective, randomized, double-blind, active-controlled study was conducted at 8 psychiatric outpatient clinics in the Federation of Russia. Adult outpatients aged 25 to 45 years with MDD and a total score > or =25 on the Montgomery-Asberg Depression Rating Scale (MADRS) were eligible. Patients were randomly assigned to receive 6 weeks of treatment with fixed daily doses of escitalopram 10 mg, citalopram 10 mg, or citalopram 20 mg. Efficacy assessments were made at weeks 0 (baseline), 1, 4, and 6 (study end or last observation carried forward). The primary efficacy parameter was the change from baseline in MADRS total score. Secondary measures were the change from baseline in MADRS total score in a subgroup of severely depressed patients (baseline MADRS total score, > or =35), MADRS core depression subscale score, and Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I) scores; and the proportions of patients classified as responders and remitters at study end. Tolerability was assessed using adverse events (AEs) recorded by the investigator.\n Of 330 assessable randomized patients, 8 withdrew, including 7 who withdrew consent and 1 who withdrew due to recurrence of a preexisting event. Thus, 322 patients were included in the assessment (mean age, 35 years; 41.6% male; all white; escitalopram 10 mg, 108 patients; citalopram 10 mg, 106; citalopram 20 mg, 108). At study end, the mean (SE) change from baseline in MADRS total score was significantly greater in the escitalopram arm than in the 10- and 20-rag citalopram arms (-28.70 [0.78] vs -20.11 [0.80] and -25.19 [0.78]; both, P < 0.001). Improvements were more marked in the severely depressed subgroup (-30.33 [0.95] vs -20.87 [0.99] and -26.34 [0.91]). Changes in the CGI-S and CGI-I scores and the rates of response and remission were significantly greater in the escitalopram group compared with those in the citalopram 10- and 20-mg groups (CGI-S: -2.60 [0.10] vs -1.61 [0.10] and -2.05 [0.10]; CGI-I: +1.58 [0.09] vs +2.35 [0.10] and +1.80 [0.09]; response: 95.4% vs 44.3% and 83.3%; remission: 89.8% vs 25.5% and 50.9% [all, P < 0.001]). Mean (SE) changes from baseline in core depression subscale score were -19.00 (0.59), -13.00 (0.60), and -16.52 (0.58) with escitalopram, citalopram 10 mg, and citalopram 20 mg, respectively. The prevalence of AEs was significantly lower in the escitalopram group (7) compared with the citalopram groups (16 and 19 in the 10- and 20-mg groups, respectively; both, P < 0.05). Nausea (2 [1.9%], 5 [4.7%], and 7 [6.5%] patients in the escitalopram and citalopram 10- and 20-mg groups, respectively) and headache (1 [0.9%], 2 [1.9%], and 4 [3.7%]) were the most frequently reported AEs.\n The results from this study suggest that escitalopram 10 mg was more effective than citalopram 10 and 20 mg at 6 weeks in these adult outpatients with MDD. All treatments were well tolerated.\n Copyright (c) 2007 Excerpta Medica, Inc.", "In a double-blind trial, comprising 60 endogenously depressed patients, citalopram was compared with mianserin. Fifty-eight patients completed the 6-week trial period with ratings and side effect recordings at weeks 0, 1, 2, 4, and 6. Both drugs were administered as a single evening dose, 20-80 mg (most frequently 40 mg) for citalopram and 60-120 mg (most frequently 90 mg) for mianserin. CPRS (Subscale for Depression) total scores showed a highly significant reduction in both groups with a significant difference in favour of citalopram after 1 and 2 weeks. Based on the Global Evaluation of the Severity of Illness there were 18 complete and three partial responders on citalopram and 13 complete and four partial responders on mianserin. Six patients on citalopram and one patient on mianserin showed mild or moderate side effects, but no cardiovascular side effects were recorded. The authors conclude that citalopram is a safe antidepressant drug, presumably better than mianserin.", "Antidepressants exhibit a variety of pharmacological actions including inhibition of the serotonin and noradrenaline transporters. We wished to investigate whether genetic variation could be used to target or personalise treatment, in a comparison of selective serotonin reuptake inhibitors (SSRIs) with noradrenaline reuptake inhibitors (NARIs).\n To test the hypothesis that patients homozygous for the long (insertion) polymorphism of the serotonin transporter (5-HTTLPR) have an increased response to SSRI antidepressants but not to NARI antidepressants.\n In an individually randomised, parallel-group controlled trial, people meeting criteria for a depressive episode who were referred by their general practitioner were randomised to receive either citalopram (an SSRI) or reboxetine (an NARI). Randomisation was by means of a remote automated system accessed by telephone. The main outcome was depressive symptoms, measured by Beck Depression Inventory (BDI) total score 6 weeks after randomisation. The trial was registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN31345163).\n Altogether 298 participants were randomised to receive citalopram and 303 were randomised to reboxetine. At 6 weeks follow-up, complete data were available for 258 participants taking citalopram and 262 taking reboxetine. We found no evidence to support an influence of 5-HTTLPR on outcome following antidepressant treatment. The interaction term for BDI score at 6 weeks was 0.50 (95% CI -2.04 to 3.03, P = 0.70), which indicated that responses to the SSRI and NARI were similar irrespective of 5-HTTLPR genotype.\n It is unlikely that the 5-HTTLPR polymorphism alone will be clinically useful in predicting response to antidepressants in people with depression.", "Escitalopram was compared to placebo in moderately to severely depressed patients in primary care with citalopram as the active reference. Patients were randomized to receive flexible doses of 10-20 mg/day escitalopram (n=155), 20-40 mg/day citalopram (n=160), or placebo (n=154) over an 8-week double-blind period. The primary efficacy parameter was the change from baseline to last assessment in the Montgomery-Asberg Depression Rating Scale total score. Escitalopram produced a statistically significant therapeutic difference of 2.9 points (P=0.002) compared to placebo, and escitalopram was consistently and statistically significantly more efficacious than placebo from week 1 onwards. Analysis of Clinical Global Impression-Severity and Clinical Global Impression-Improvement confirmed the primary efficacy results. By week 8, significantly more patients had responded to treatment with escitalopram than with citalopram (P=0.021) or placebo (P=0.009). Escitalopram was as well tolerated as citalopram and had a similar adverse event profile. Both escitalopram- and citalopram-treated patients had placebo-level adverse event withdrawal rates (3% and 4%, respectively). This study demonstrates the consistent antidepressant efficacy and excellent tolerability of escitalopram 10-20 mg/day in primary care patients with major depressive disorder.", "Several previous studies, including a meta-analysis, reported no significant differences between various selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder. However, because of the different chemical structure of SSRIs and the difference in the frequency of serotonin transporter polymorphisms between ethnic groups, a head-to-head comparative study between SSRIs in different populations may be enlightening. We compared the efficacy and adverse effect profiles of citalopram and sertraline in a double-blinded randomized clinical trial in a Chinese population of drug-naïve patients with first-episode major depressive disorder. Fifty-one patients were randomly assigned to citalopram or sertraline treatment. The Montgomery-Åsberg Depression Rating Scale (MADRS) was used as the primary outcome. Efficacy and adverse effects were analyzed in an intent-to-treat population. Efficacy was analyzed using a last-observation-carried-forward method for early terminators. There were no significant differences in demographic characteristics at baseline. No significant differences were found in MADRS scores between citalopram and sertraline at baseline (36.6 ± 5.5 vs 38.2 ± 4.9; P = 0.322) or at the end of treatment (week 6; 10.8 ± 10.0 vs 16.7 ± 11.3; P = 0.082). However, MADRS scores in the citalopram group were significantly lower at week 1 (25.2 ± 8.5 vs 30.4 ± 6.1; P = 0.029) and week 3 (15.9 ± 10.0 vs 22.1 ± 8.7; P = 0.037). Overall, treatment-emergent adverse effects were reported by 14.3% and 28.6% of patients in the citalopram and sertraline groups, respectively. In conclusion, citalopram and sertraline were both efficacious and well tolerated. However, citalopram exhibited a significantly faster onset than sertraline during the early weeks of treatment and tended to have a better efficacy in overall treatment, although the statistic was not significant.", "The purpose of this double-blind, multicenter trial was to compare the efficacy and safety of sertraline (50-150 mg/day) with those of citalopram (20-60 mg/day) in patients with major depression in general practice during 24 weeks of treatment. The patients were assessed using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impressions of severity and improvement scales. Observed and spontaneously reported adverse events were recorded and side-effects were assessed by means of the UKU Side-Effect Scale. Altogether 400 patients were randomized into the study. A total of 308 patients completed the 24-week study in accordance with the protocol. A significant reduction in the total Montgomery-Asberg Depression Rating Scale scores was observed in both treatment groups as early as 2 weeks, with no statistically significant differences between the drugs. In the intention to treat-last observation carried forward analysis 76% responded to treatment in the sertraline and 81% in the citalopram group. The final mean doses were 82 mg/day (64% higher than baseline) in the sertraline group and 34 mg/day (70% higher than baseline) in the citalopram group. The response rate in completers in accordance with protocol was 90% in the sertraline group and 93% in the citalopram group. The side-effects were those usually seen, and both sertraline and citalopram were considered to be well tolerated. It was concluded that patients with major depression in general practice respond well to 24 weeks of treatment with sertraline or citalopram. With regard to efficacy, no statistically significant differences were found between the drugs.", "In a double-blind trial, comprising 96 depressed patients, citalopram was compared with maprotiline. The trial period was 6 weeks with ratings (MADRS, CGI) and side effects recordings taking place at Weeks 0, 1, 2, 4, and 6. Both drugs were administered as a single evening dose, 40 or 60 mg for citalopram, and 75 or 150 mg for maprotiline. MADRS total scores and CGI scores showed a highly significant reduction in both groups with no significant difference between them, whether the groups were considered as a whole or whether they were subdivided into endogenously/non-endogenously depressed or melancholic/non-melancholic patients. Side effects were not significantly different, but the maprotiline group showed more anticholinergic side effects, whereas the citalopram group showed more nausea, increased sweating and headache. Two patients on maprotiline were withdrawn because of side effects (hypotension and somnolence in the one case; tremor and insomnia in the other). One patient in each group was withdrawn because of increased transaminases, the citalopram-treated patient having increased values, however, already at baseline. Apart from this, no cardiovascular side effects and no pathological laboratory values related to treatment were observed. The authors conclude that citalopram is a safe antidepressant drug and as effective as maprotiline.", "The objectives of the study were to compare efficacy and tolerability of venlafaxine ER 75-150 mg/day with that of citalopram 10-20 mg/day in elderly patients with major depression according to DSM-IV criteria.\n A randomised, double-blind, parallel group 6-month study. Efficacy was assessed by MADRS, CGI Global Improvement, CGI Severity of Illness and GDS-20 scores and safety by physical examinations, vital signs, adverse events and UKU side effect rating. Plasma levels of venlafaxine, its major metabolite O-desmethylvenlafaxine and citalopram were followed.\n One hundred and fifty-one male and female patients (64-89 years) were enrolled and 118 patients completed the study. Comparable improvements in MADRS, CGI Severity of Illness, CGI Global Improvement and GDS-20 were observed during venlafaxine and citalopram treatment. The MADRS remission rate was 19% for venlafaxine and 23% for citalopram. Side effects were common during both treatments but differed in tremor being more common during citalopram and nausea/vomiting during venlafaxine treatment. There were no clinically significant changes in blood pressure or body weight.\n The observed benefits of venlafaxine treatment in elderly patients with major depression were similar to those observed in younger adults as were reported adverse events and side effects. Treatment with venlafaxine ER was well tolerated and induced beneficial effects of similar magnitude as those of citalopram.\n Copyright (c) 2004 John Wiley & Sons, Ltd.", "nan", "The present randomized, double blind, parallel group, controlled, multi-centric trial was designed to evaluate the efficacy and tolerability of escitalopram in comparison with citalopram and sertraline in the treatment of major depressive disorder. Outpatients (N=214) with an ongoing/newly diagnosed ICD-10 major depressive episode and a Hamilton Rating Scale for Depression (HAM-D) score of > 18 were randomly assigned to citalopram, 20-40 mg/day (74 patients), escitalopram, 10-20 mg/day (69 patients) and sertraline, 50-150 mg/day (71 patients), for a 4-week double-blind treatment period, with dosage adjustment (after 2 weeks of treatment) according to the response to treatment. Clinical response was evaluated by the 17 items HAM-D and the Clinical Global Impression (CGI) scales, which were recorded at baseline and at weekly intervals. Tolerability was evaluated by observed/spontaneously reported adverse changes in laboratory parameters (baseline and after 4 weeks). Response rate was defined as a decrease in HAM-D score by 50% from baseline and remission rate was defined as a HAM-D score of < 8. Response rate at the end of two week were 58% for escitalopram (10mg/day), 49% for citalopram (20mg/day) and 52% for sertraline (50-100mg/day). Response rate at the end of four week were 90% for escitalopram (10-20mg/day), 86% for citalopram (20-40mg/day) and 97% for sertraline (100-150mg/day). The Remission rates at the end of four weeks were 74% for escitalopram, 65% for citalopram and 77% for sertraline. Adverse experiences were reported by 45% of patients in escitalopram group, 58% patients in citalopram and 56% patients in the sertraline group. Additionally, there were lesser dropouts and lesser requirement for dose escalation in escitalopram than in citalopram and sertraline group. In conclusion Escitalopram, the Senantiomer of the citalopram is a safe and effective antidepressant in the Indian population. It has potentially superior efficacy than citalopram and a comparable efficacy to sertraline with fewer side effects than both citalopram and sertraline.", "Citalopram and sertraline are widely prescribed selective serotonin reuptake inhibitors (SSRIs). There is no conclusive evidence to show superiority of citalopram or sertraline in terms of efficacy or tolerability. Hence this study was designed to compare short term efficacy and safety of citalopram and sertraline in major depressive disorder (MDD) in Indian patients.\n In an open, randomized study, 100 patients were divided into two groups. In Group A (n = 50) patients received citalopram (20-60 mg/day) for 6 weeks. In Group B (n = 50) patients received sertraline (50-150 mg/day) for 6 weeks. Patients were evaluated at baseline and then at 1, 2, 3, 4, 5, and 6 weeks.\n There was significant improvement in Hamilton depression rating scale (HDRS), Montgomery and Asberg depression rating scale (MADRS) and Amritsar depressive inventory (ADI) scores (p < 0.05) with both the drugs. However, the decrease in score was more with citalopram (p < 0.05). Onset of action of citalopram was earlier as compared to sertraline (p < 0.05). The number of responders and remitters was also more with citalopram (p < 0.05). No serious adverse event was reported in either of the groups.\n Citalopram had shown better efficacy, earlier onset of action and more number of responders and remitters as compared to sertraline in MDD in Indian patients.\n Copyright 2007 John Wiley & Sons, Ltd.", "Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.", "S-citalopram (escitalopram) is the very active moiety of citalopram. It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder (MDD).\n The aim of our study was to compare the efficacy and safety of escitalopram vs citalopram in Chinese MDD patients.\n In the double-blind study, 240 MDD patients were randomly assigned to treatment for 6 weeks either with escitalopram (10-20 mg/d) or citalopram (20-40 mg/d). The primary efficacy measurement was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the end of study. The secondary efficacy measurements were response and remission rates. The adverse events (AEs) were recorded by the investigator.\n Two hundred and three (85%) patients completed the trial. The average dose was 13.9 mg/d in the escitalopram group and 27.6 mg/d in the citalopram group. No significant differences were found between the two groups in the change in HAMD-17 total score, response, and remission rate. These results were similar in severe MDD patients. No significant differences were found between the two groups in AEs. No serious AEs were observed in this study.\n The study suggests that escitalopram 10-20 mg/d are as effective and safe as citalopram 20-40 mg/d in the short-term treatment for Chinese MDD patients.", "The objective of this study was to compare efficacy and tolerability of the selective noradrenaline reuptake inhibitor reboxetine with the selective serotonin reuptake inhibitor citalopram, in the treatment of major depressive disorder (MDD). In total, 357 outpatients with MDD were randomized to treatment with reboxetine 8-10 mg or citalopram 20-40 mg per day during 24 weeks. Primary end-point was change from baseline in the Hamilton Depression Rating Scale (HAM-D, 21 items). Sexual function/dysfunction was measured by the Sexual Function scale (SF). Observed case analysis showed that both treatments yielded a gradual reduction of HAM-D scores: reboxetine with -21.4 and citalopram with -22.1 points (NS). LOCF analysis showed a greater reduction of the HAM-D scores with citalopram compared with reboxetine (-19.6 vs. -17.8; P = 0.034). The response rate was 90.3% for reboxetine and 92.7% for citalopram (NS). The most common side effect in the reboxetine group was dry mouth, and in the citalopram group sexual dysfunction. At week 24, anorgasmia was reported by 5.9% of the sexually active women in the reboxetine group vs 39% in the citalopram group. The dropout number was 91 in the reboxetine group, and 54 in the citalopram group. To summarize, both treatments gave a satisfactory antidepressant effect. The side effect profile differed between the groups, with a notably high prevalence of sexual dysfunctions in the citalopram group. The high number of dropouts in the reboxetine group, is considered as a result of the non-titration starting dose of 8 mg reboxetine per day, which gave a high incidence of early side-effects.", "Previous comparative studies of the selective serotonin reuptake inhibitors (SSRIs) have rarely included a placebo control group and have rarely demonstrated significant between-group differences. The study reported on here was a placebo-controlled comparison of the antidepressant effects of two SSRIs, citalopram and sertraline.\n Three hundred twenty-three patients with DSM-IV-defined major depressive disorder were randomized to 24 weeks of double-blind treatment with citalopram (20-60 mg/day), sertraline (50-150 mg/day), or a placebo. The primary efficacy measure was the Hamilton Depression Rating Scale (HAMD) and the primary statistical analysis was an analysis of variance comparing the change from baseline to the last observation carried forward in each treatment group.\n Both citalopram and sertraline produced significantly greater improvement than placebo on the HAMD, the Montgomery-Asberg Depression Rating Scale, and the Clinical Global Impression Scale. Significant improvement was observed at earlier timepoints in the citalopram group than the sertraline group; however, sertraline treatment was associated with increased gastrointestinal side effects and a tendency toward early discontinuation, and analyses that excluded early dropouts revealed similar acute efficacy for the two active treatments. The Hamilton Anxiety Scale demonstrated a significant anxiolytic effect of citalopram, but not sertraline, relative to placebo.\n This study confirms the antidepressant efficacy of two SSRIs, citalopram and sertraline. It is hypothesized that the more consistent evidence of antidepressant activity that was observed early in treatment in the citalopram group was related to more pronounced antianxiety effects and better tolerability upon initiation of therapy.", "There is evidence of derangement of oxidant and antioxidant defense systems in depression. The present study examined the effects of fluoxetine and citalopram, standard selective serotonin re-uptake inhibitors, on lipid peroxidation, superoxide dismutase (SOD) activity and ascorbic acid concentrations. For this, a prospective open-labeled, randomized design was utilized. Patients with major depression (n = 62) were compared with age- and sex-matched healthy volunteers (n = 40). There was a significant increase in serum SOD, serum MDA and decrease in plasma ascorbic acid levels in patients of major depression as compared to control subjects. The trend reversed significantly after treatment with fluoxetine and citalopram. Results indicate a greater reduction in oxidative stress with citalopram than fluoxetine. The Hamilton Rating Scale for Depression (HRSD) score also improved with fluoxetine and citalopram treatment. These findings indicate that major depression is associated with increased levels of serum SOD, serum MDA and decreased levels of plasma ascorbic acid. Treatment with fluoxetine and citalopram reversed these biochemical parameters. This study can be used as a predictor of drug response by fluoxetine and citalopram in major depression.", "Two dose levels of citalopram, 10-30 mg and 20-60 mg, were compared with imipramine, 50-150 mg, in depressed patients treated in general practice. This was a multicentre study carried out in Denmark, Sweden, Norway, and Finland. The duration of treatment was 6 weeks with an optional continuation phase of a further 16 weeks. The patients were assessed by means of the Hamilton Rating Scale for Depression (HAMD), Clinical Global Impressions (CGI), and a visual analogue self-rating scale for depression. Observed and spontaneously reported adverse events were recorded. A total of 472 patients were entered into the study and 400 patients completed the 6 week trial period. A total of 297 patients completed the optional 22 week double-blind period. A clear reduction of the HAMD total scores was seen in all three treatment groups with no significant differences between groups. A reduction of the HAMD anxiety factor and sleep factor scores was also seen with no significant differences between treatments. The imipramine-treated patients showed a higher frequency of adverse events, especially the anticholinergic type, than citalopram-treated patients. Most patients entered into the continuation phase remained well.", "We aimed to compare the antidepressant and anxiolytic effects, tolerability and effects on quality of life of mirtazapine and citalopram in a randomized, double-blind, multicentre, 8-week study. Patients with a Major Depressive Episode (DSM-IV) and a baseline score of > or = 22 on the Montgomery-Asberg Depression Rating Scale (MADRS) were randomized to 8 weeks treatment with either mirtazapine (n = 137, 15-60 mg/day) or citalopram (n = 133, 20-60 mg/day). Efficacy was evaluated by the MADRS, Hamilton Anxiety Scale (HAM-A), Clinical Global Impression scales (CGI), the Leeds Sleep Evaluation Questionnaire (LSEQ) and Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). The efficacy analyses were performed on the Intent-To-Treat Group using the Last Observation Carried Forward method. Vital signs and laboratory variables are measured and adverse events recorded at each weekly visit. The magnitude of reduction from baseline in group mean MADRS scores was large in both groups, reaching after 8 weeks of treatment mean scores of 9.1 in the mirtazapine group and 8.9 in the citalopram group. Both treatments also resulted in a substantial improvement in anxiety symptoms, sleep disturbances and quality of life, and high percentage of responders. However, at day 14, statistically significantly larger magnitudes of change favouring mirtazapine were present in the group mean MADRS, HAM-A and CGI-Severity of illness and Quality of life scores. A difference of 2.3 points on MADRS favouring mirtazapine is considered indicative for a clinically relevant superiority between two proven antidepressants. Mirtazapine treatment was also related to faster improvement of sleep, quality of sleep and improved alertness following awakening, as shown by statistically significant differences on the self-rating LSEQ at various time points. There were no differences between two treatment groups on self-rating QLSEQ. Both drugs were well tolerated, with a low number of patients in either group prematurely terminating the study due to adverse events (mirtazapine: 3.6%, citalopram, 3.0%). Sweating and nausea were statistically significantly more frequent in the citalopram group and increased appetite and complaints of weight increase in the mirtazapine group. There were no clinically relevant changes in laboratory parameters and vital sign variables with either treatment, except for clinically relevant increase in body weight, occurring more frequently in mirtazapine patients. In this study, mirtazapine and citalopram were equally effective in reducing symptoms of depression and anxiety, and well tolerated. However, mirtazapine was significantly more effective than citalopram after 2 weeks of treatment on the MADRS, HAM-A and CGI Severity of illness and Quality of life scales. This finding, consistently present at all major efficacy variables, suggests potentially faster onset of efficacy of mirtazapine over citalopram.", "The enhanced sensitivity of the elderly to the side effects produced by tricyclic antidepressants (TCAs), and the frequency and type of adverse events, have made the treatment of depression in this group difficult. The selective serotonin reuptake inhibitors (SSRIs) have been reported to produce significantly fewer undesirable side effects and display better tolerance than TCAs. We compared the therapeutic actions and side effects produced by citalopram, the most selective SSRI available, with amitriptyline in a group of elderly patients (aged 65 and older) diagnosed with major depression. In a double-blind, double-dummy, parallel-group, multicenter comparison of citalopram (20 or 40 mg/day) and amitriptyline (50 or 100 mg/day), patients who did not respond to placebo during a 1-week single-blind phase were randomly assigned to receive citalopram or amitriptyline for 8 weeks. Efficacy measures included the Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Depression Scale (HAMD), and Clinical Global Impressions. Both drug treatments produced equivalent time-related declines in severity of depression, so that by 8 weeks slightly more than 50% of the patients in each group experienced marked recovery, defined as MADRS scores < or = 12. Amitriptyline produced a greater overall incidence of adverse events, including a significantly higher (P < 0.001) percentage of patients reporting dry mouth (34% vs. 7%), as well as a significantly higher (P < 0.02) incidence of somnolence. Constipation and fatigue also occurred more frequently in the amitriptyline than in the citalopram group. For only one event (nausea) did the citalopram group report a significantly greater (P = 0.012) incidence (12.8% vs. 4.8%). On the basis of these results, it was concluded that citalopram is as effective an antidepressant as amitriptyline in the treatment of the depressed elderly. Because of its low incidence and low magnitude of side effects, citalopram seems especially useful in private practice.", "The objective of this double-blind, randomised, placebo-controlled, multicentre clinical study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI in a once-daily dosage regime in the treatment of moderate depression. During the 6-week treatment phase, the course of depression was documented by use of HAMD (items 1-17), the von Zerssen's Adjective Mood Scale (BfS) and the CGI scales. The primary objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum extract STW3-VI (900 mg) to the SSRI citalopram (20 mg) and superiority of hypericum over placebo.\n Outpatients (N = 388) suffering from moderate depression were enrolled. The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI, the occurrence of adverse events and the investigation of laboratory parameters and vital signs.\n From almost identical baseline values of 21.9 +/- 1.2 points (hypericum extract), 21.8 +/- 1.2 points (citalopram) and 22.0 +/- 1.2 points (placebo), the HAMD score was reduced to 10.3 +/- 6.4 (hypericum extract), 10.3 +/- 6.4 (citalopram) and 13.0 +/- 6.9 (placebo), respectively. Based on this data, the statistical significant therapeutic equivalence of hypericum extract STW3-VI to citalopram (p < 0.0001) and the superiority of this hypericum extract over placebo (p < 0.0001) was demonstrated. At the end of treatment 54.2 % (hypericum extract), 55.9 % (citalopram) and 39.2 % (placebo) of the patients were assessed as therapy responders. The secondary efficacy parameters, change in BfS, CGI and amount of therapy responders showed that the hypericum group was not statistically different from the citalopram group, and significantly superior to the placebo group. Significantly more adverse events with \"certain\", \"probable\" or \"possible\" relation to study medication were documented in the citalopram group (hypericum: 17.2 %, citalopram: 53.2 %, placebo: 30 %). In most cases, the investigators assessed the tolerability of hypericum extract, citalopram and placebo as \"good\" or \"very good\".\n The non-inferiority of hypericum extract as compared to citalopram and the superiority of both active compounds to placebo were demonstrated, as well as a better safety and tolerability of hypericum extract in comparison to citalopram. These results revealed that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants in the treatment of outpatients with moderate depression.", "A randomized, double-blind, 24-week-fixed-dose study comparing the efficacy and safety of escitalopram to that of citalopram was safety was conducted in primary care patients with moderate to severe major depressive disorder (MDD).\n This was a randomized, double-blind, 24-week fixeddose study. Patients were randomly assigned to treatment with escitalopram 10 mg/day (n = 175) or citalopram 20 mg/day (n = 182). Clinical response was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI-S) scale. The prospectively defined primary parameter of antidepressant efficacy was the change from baseline in the mean MADRS total score during the 24 weeks of double-blind treatment, using a repeated measures analysis of variance to compare the treatment groups over all assessment points simultaneously.\n Based on the primary parameter, escitalopram was at least as efficacious as citalopram. Based on the prospectively defined secondary parameter, mean change from baseline in the CGI-S score, escitalopram was statistically significantly superior to citalopram at Week 24. The importance of long-term treatment could be demonstrated, in that more than half (55% and 51%) of the patients who had not responded by Week 8 achieved remission by Week 24. Both escitalopram and citalopram were safe and well tolerated in acute and long-term treatment, and the overall adverse event profiles for the two drugs were similar. For the intent-to-treat population, there were statistically significantly fewer withdrawals in the escitalopram group than in the citalopram group, particularly after Week 8.\n Patients with MDD responded well to long-term treatment with either escitalopram or citalopram. This study demonstrated the importance of extending treatment of depression beyond 8 weeks.", "Escitalopram is the single isomer responsible for the serotonin reuptake inhibition produced by the racemic antidepressant citalopram. The present randomized, double-blind, placebo-controlled, fixed-dose multicenter trial was designed to evaluate the efficacy and tolerability of escitalopram in the treatment of major depressive disorder.\n Outpatients with an ongoing DSM-IV major depressive episode (N = 491) were randomly assigned to placebo, escitalopram, 10 mg/day, escitalopram, 20 mg/day, or citalopram, 40 mg/day, and entered an 8-week double-blind treatment period following a 1-week single-blind placebo lead-in. Clinical response was evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS), the 24-item Hamilton Rating Scale for Depression (HAM-D), the Clinical Global Impressions (CGI) scales, the Hamilton Rating Scale for Anxiety (HAM-A), and patient-rated quality-of-life scales.\n Escitalopram, at both doses, produced significant improvement at study endpoint relative to placebo on all measures of depression; significant separation of escitalopram from placebo was observed within I week of double-blind treatment. Citalopram treatment also significantly improved depressive symptomatology compared with placebo; however, escitalopram, 10 mg/day, was at least as effective as citalopram, 40 mg/day, at endpoint. Anxiety symptoms and quality of life were also significantly improved by escitalopram compared with placebo. The incidence of discontinuations due to adverse events for the escitalopram 10 mg/day group was not different from the placebo group (4.2% vs. 2.5%; p = .50), and not different for the escitalopram 20 mg/day group and the citalopram 40 mg/day group (10.4% vs. 8.8%; p = .83).\n Escitalopram, a single isomer SSRI, is well-tolerated and has demonstrated antidepressant efficacy at a dose of 10 mg/day.", "In a controlled, clinical, multicentre trial comprising a total of 43 patients (17 men and 26 women) citalopram was compared double-blindly with amitriptyline. Nineteen patients of each group were classified as endogeneously depressed, whereas four patients of the citalopram group and one of the amitriptyline group were classified as non-endogenously depressed. The patients were seriously ill with a high frequency of previous depressive episodes and of mental disorders among their closest relatives. Thirteen of the patients in either group had received antidepressants without satisfactory effect before entry into the trial. Each patient was treated for a period of at least 3 weeks with daily citalopram doses of 30-60 mg or daily amitriptyline doses of 75-225 mg. A statistically significant reduction of MADRS scores (total scores as well as each of the 10 individual items) was recorded in both groups. The only difference between the groups was a trend towards a better effect on sleep disturbances in the amitriptyline group. Side-effects were recorded more frequently in the amitriptyline group than in the citalopram group, global assessment of side effects being significantly different in favour of citalopram. It is concluded that citalopram is an effective and safe drug in the treatment of endogenous depression - probably as efficacious as amitriptyline, but with fewer side effects.", "It is well established that depressive disorders are more prevalent in women; however gender differences in the pharmacological response to antidepressants are not a consistent finding in all reports. It is considered that this discrepancy can be explained by the fact that in most clinical trials drug use for comparative purposes is not completely different. In this study gender differences in antidepressant response with citalopram (CTP), a selective serotonin reuptake inhibitor and reboxetine (RBX), a selective noradrenaline reuptake inhibitor were evaluated in a group of young men and premenopausal women.\n Eighty-six depressed patients 18 to 40 years old participated in an 8-week double-blind clinical trial. Subjects were divided in four groups according to sex and treatment assignation: females treated with CTP (n = 25) or RBX (n = 23), and males treated with CTP (n = 19) or RBX (n = 19). Response was determined using HDRS and BDI.\n ANOVA analysis considering change in HDRS scores from baseline to last evaluation found a significant interaction between gender and type of treatment. Females treated with CTP showed a significantly greater response than females treated with RBX, while in men no differences were observed for both drugs.\n Replication using larger sample size and longer treatment periods is required.\n These results support previous findings which show that premenopausal women respond better than men to serotonergic antidepressants. They also support that a plausible interaction between gonadal hormones and serotonin may explain gender differences in antidepressant response.", "The response of patients with major depressive illness to citalopram of amitriptyline was compared in a double-blind multi-centre trial. No differences in efficacy were observed, but citalopram had less hypnotic effect, and a remarkably lower profile of side-effects.", "Depression is the most common psychiatric disorder among the elderly and in old age may interact with emotional and cognitive functioning. Depression in old age has been shown to be associated with degenerative changes in the brain. It is, therefore, important that in this patient population antidepressants with a favourable tolerability profile, such as the selective serotonin reuptake inhibitors (SSRIs), are examined for both antidepressant efficacy and effect on cognitive function and emotional impairment. This randomised, double-blind study compared the efficacy and tolerability of citalopram and mianserin in 336 elderly, depressed patients with or without dementia. Patients received either citalopram 20-40 mg/day or mianserin 30-60 mg/day for 12 weeks. The treatments were equivalent with respect to change in Montgomery-Asberg Depression Rating Scale (MADRS) total score; patients in both treatment groups responded well. Patients with dementia showed a smaller decrease in total MADRS score than patients without dementia. Both treatments were well tolerated with a relatively low incidence of adverse events. Fatigue and somnolence were more frequent with mianserin, while insomnia was more frequent with citalopram. Overall, this study showed that the two treatments were equivalent in efficacy, and that citalopram is an effective, well-tolerated and non-sedative treatment for elderly depressed patients with or without dementia.\n Copyright 2000 John Wiley & Sons, Ltd." ]

[ "10431879", "7760659", "15533144", "8763370", "8509691", "11589975", "15742266", "1734364", "1470454", "9048472", "17178938", "17316832", "14758376", "8745020" ]

[ "The effect of topical ciprofloxacin on postoperative otorrhea after tympanostomy tube insertion.", "Safety of ototopical antibiotics.", "The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.", "Per-operative antibiotic/steroid prophylaxis of tympanostomy tube otorrhoea: chemical or mechanical effect?", "The use of antibiotic/steroid ear drops to reduce post-operative otorrhoea and blockage of ventilation tubes. A prospective study.", "A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea.", "Preventive therapy for postoperative purulent otorrhea after ventilation tube insertion.", "Post-tympanostomy otorrhea: a randomized clinical trial of topical prophylaxis.", "Prevention of early otorrhea in ventilation tubes.", "Early otorrhea following ear tube insertion.", "Ofloxacin otic drops vs neomycin-polymyxin B otic drops as prophylaxis against early postoperative tympanostomy tube otorrhea.", "Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement.", "Prophylactic ciprofloxacin drops after tympanostomy tube insertion.", "Randomized trial of the efficacy of trimethoprim-sulfamethoxazole and prednisone in preventing post-tympanostomy tube morbidity." ]

[ "This study aimed to evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of otorrhea after tympanostomy tube insertion.\n The study design was a single-blind, randomized clinical trial.\n The study was conducted at a tertiary care referral center.\n One hundred fifty-four patients aged 6 months to 14 years undergoing tympanostomy tube insertion participated.\n For each subject, one ear was randomly assigned to receive topical ciprofloxacin, placed in the middle and external ear after surgery, while the contralateral ear served as a control.\n Posttympanostomy otorrhea occurring during the period from 24 hours after surgery until 2 weeks after surgery was measured.\n Topical ciprofloxacin application after tympanostomy tube insertion was associated with a significantly lower incidence of early posttympanostomy otorrhea. The rates of otorrhea for control and treatment ears were 9.1% and 3.9%, respectively (p = 0.029).\n The topical administration of a single dose of ciprofloxacin solution after surgery is an effective treatment for the prevention of early posttympanostomy otorrhea.", "A prospective randomized study analyzing the safety and efficacy of a single dose of ototopical antibiotics following human middle ear tympanostomy tube insertion was performed. Fifty children undergoing bilateral tympanostomy tube insertion were studied by the placement of 0.5 mL of Cortisporin Otic Suspension (COS; Burroughs Wellcome Co., Research Triangle Park, N.C.) to one middle ear space by random assignment. Preoperative and postoperative audiograms were obtained, and the presence of otorrhea was noted. In one patient sensorineural hearing loss of 6 dB developed bilaterally, which was symmetric in both the treated and the untreated ear. This preliminary study showed no statistical difference in hearing loss or postoperative otorrhea associated with a single application of Cortisporin to the middle ear space.", "Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.", "The per-operative instillation of ototopical antibiotic/steroid drops reduces the incidence of early otorrhoea after tympanostomy tube insertion. Whether this is due to the chemical properties of the antibiotic/steroid or simply the mechanical instillation of fluid is unclear. In this paired matched study of 161 subjects Gentisone HC was shown to significantly reduce the otorrhoea rate compared to normal saline (1.24 per cent compared with 9.32 per cent, p < 0.005, difference 8.07 per cent, 95 per cent confidence interval for difference 3.21 per cent to 12.93 per cent). Capillary viscosimetry proved Gentisone HC to be more viscous than normal saline. The benefits are due to Gentisone HC's chemical properties, and Gentisone HC rather than normal saline instillation per-operatively is recommended when tympanostomy tubes are inserted.", "This prospective randomized study investigates whether the use of antibiotic/steroid ear drops (Betnesol-N) is effective in reducing early post-operative otorrhoea and blockage of ventilation tubes (VTs). The study included 162 children who had bilateral VT insertion and used Betnesol-N ear drops in one ear only for three days after surgery, the other ear was left as control. These children were reviewed two weeks later and their ears were examined for VT patency, presence of blood or of mucopus. Statistical analysis of our results showed that the use of Betnesol-N ear drops has significantly reduced the incidence of post-operative otorrhoea within two weeks of VTs insertion (p < 0.01). However, these drops did not have a significant effect on the blockage rates of VTs with dried blood (p > 0.05).", "Myringotomy and tube insertion, a common pediatric surgical procedure, is frequently complicated by purulent otorrhea. Many otolaryngologists routinely use topical antibiotics as prophylaxis against post-tympanostomy otorrhea. The aminoglycosides (neomycin sulfate, tobramycin and gentamicin) contained in commonly used topical antibiotics as well as components of the solutions have been shown to be ototoxic in animal studies. Although little reported evidence of ototoxicity in humans exists, sporadic reports of sensorineural hearing loss linked to topical antibiotic use do exist, and the potential for sensorineural hearing loss must be considered. The purpose of this study is to compare the rate of post-tympanostomy otorrhea in a double-blinded randomized trial using either topical Ciprofloxacin, with no reported ototoxicity, or Cortisporin as prophylaxis. One hundred patients (200 ears) between ages 7 months and 11 years with a diagnosis of recurrent otitis media or chronic otitis media undergoing tympanostomy tube insertion were randomized into two equal groups. Three drops of either drop A or B were placed into each ear at the time of tube insertion and then three times daily for 3 days. Patients were examined at 3 weeks and details of otorrhea were obtained. The rate of otorrhea was analyzed using chi-square. The overall rate of otorrhea was 39 ears (19.5%), 17 (17%) ears for the Cortisporin group and 22 (22%) for the Ciprofloxacin group. The difference in rate of otorrhea was not statistically significant (P=0.372, 95% confidence interval equals -6-16%). Our data suggest that topical Cortisporin offers no benefit over Ciprofloxacin for post-operative otorrhea prophylaxis. Therefore we recommend topical quinolone prophylaxis, which should eliminate concerns about ototoxicity, without sacrificing efficacy.", "Treatment modalities which are intraoperative irrigation of the middle ear with isotonic saline, postoperative oral antibiotic treatment, and postoperative topical antibiotic use have been compared with each other and with control group regarding their efficiency in preventing postoperative purulent otorrhea after ventilation tube insertion. Moreover, the costs of the treatment modalities were analyzed.\n Each group consisted of 70 patients, and a total of 280 patients were followed up for purulent otorrhea 2 weeks after the surgery. The study was a single-blind randomized clinical trial.\n Ten (14.28%) patients in the oral antibiotic group, 11 (15.71%) patients in the isotonic saline irrigation group, 6 (8.57%) patients in the topical antibiotic drops group, and 21 (30%) patients in the control group had postoperative purulent otorrhea. Statistical analysis determined a significant difference between each treatment modalities and control group but did not show any significant difference between the treatment groups. When the treatment options were compared according to their cost, however, the cost per successfully treated patient was significantly lower in the saline irrigation group.\n Intraoperative saline irrigation of the middle ear provides an effective, easy, and cheap treatment in preventing postoperative purulent otorrhea.", "Myringotomy with the insertion of tympanostomy tubes has become the most frequently performed otolaryngologic procedure, and otorrhea is the most common post-tympanostomy complication. Many otolaryngologists routinely use prophylactic topical antibiotic solutions when performing tympanostomy tube placement. Relatively little has been written regarding early post-tympanostomy otorrhea and scarcely any examining the efficacy of such prophylaxis. The current study is a randomized clinical trial to critically evaluate the efficacy of prophylactic otic drops after tympanostomy tube placement. The ototoxic potential of these solutions, combined with constant pressures to decrease medication expenses and eliminate unnecessary use of antibiotics, makes determination of the shortest effective course of application paramount. Subjects were randomized at the time of surgery into one of three groups: one group received no prophylaxis, a second group received gentamicin otic drops immediately after tympanostomy tube placement in the operating room only, and the third group received an additional 48 hours of drops (4 drops in each ear, three times a day). All patients were seen within 2 weeks postoperatively. An overall early post-tympanostomy otorrhea incidence of 8.7% is documented with 12%, 8.8%, and 5.6% for each study group, respectively. While these findings may suggest possible efficacy of topical prophylaxis, a statistically significant difference between the treatment groups was not proved (p = 0.62). Further analysis by subdivision of the patients, on the basis of middle ear cavity finding at the time of surgery, reveals a highly significant statistical association of the occurrence of post-tympanostomy otorrhea in ears having mucoid effusions (p less than 0.001) as compared to ears without effusion or with serous effusions.(ABSTRACT TRUNCATED AT 250 WORDS)", "The incidence of early postoperative otorrhea after placement of ventilation tubes ranges from 12% to 40%. This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson tubes. Subjects were randomized into two groups--drops and no drops. Preoperative diagnosis and intraoperative findings were correlated with findings. The incidence of otorrhea among all patients was 11.9%. The use of sulfacetamide/prednisolone drops for 3 days after insertion of ventilation tubes failed to reduce the incidence of otorrhea in the overall study population. The drops did demonstrate a trend toward reducing the incidence of otorrhea in certain subpopulations, including children under 3 years of age, blood at the myringotomy site, and thick middle ear effusions. Subpopulations associated with a higher incidence of otorrhea were also identified.", "nan", "To evaluate the incidence of tympanostomy tube (TT) sequelae, tube otorrhea, and tube obstruction immediately postoperatively in patients receiving TT for otitis media and to compare patients receiving postoperative otic drops with controls.\n Blinded randomized control trial.\n A tertiary pediatric otolaryngology practice.\n The study population comprised 306 patients undergoing TT placement.\n The 306 patients were enrolled into the following 3 groups: (1) those receiving no postoperative otic drop prophylaxis (control group), (2) those receiving ofloxacin otic drops (FLOX group), and (3) those receiving neomycin sulfate-polymyxin B sulfate-hydrocortisone otic drops (COS group).\n Overall otorrhea rates postoperatively were 14.9% for the control group, 8.1% for the FLOX group, and 5.5% for the COS group. When controlling for disease severity, the rate of otorrhea was significantly higher for the control group than for both the FLOX (P = .04) and COS (P = .01) groups. Nonpatent, plugged, tube rates were added to otorrhea rates for a TT failure analysis postoperatively. The control group demonstrated a significantly greater failure rate (29.9%) than both the FLOX (12.1%) and COS (7.7%) groups. The only differences between the patients in the 2 groups receiving drops were that ofloxacin was more well liked by patients (P = .04) and caused less pain (P = .004).\n Nonpatency and otorrhea are the most frequent sequelae immediately following TT placement. Few studies have compared different treatment regimens in a randomized controlled trial. These results demonstrate that otic drops clearly provide benefit postoperatively in preventing TT plugging and otorrhea but primarily in patients who have middle ear fluid at the time of TT placement. In addition, consideration of drop choice should be based on patient tolerance and medication safety profiles.", "To evaluate ciprofloxacin 0.3%/dexamethasone 0.1% (CIPRODEX, Alcon, Ft. Worth, TX) for the prevention of early post-operative otorrhea following TT placement.\n This was a single-center, randomized, evaluator-blinded, parallel-group study. Two hundred children undergoing bilateral TT placement were categorized as having unilateral (\"wet/dry\"), bilateral (\"wet/wet\"), or no (\"dry/dry\") effusion at the time of surgery. All patients received Ciprodex or no treatment for 5 days post-operatively and returned at 2 weeks.\n Physician-observed otorrhea was reported in 5 (4.95%) patients receiving Ciprodex and 39 (39.39%) patients receiving no treatment (p<0.0001). Treatment decreased otorrhea in all groups, while the greatest benefit was observed in patients with bilateral effusion (93% reduction). Ciprodex treatment also decreased the rate of clinically diagnosed otitis media (OM) and effusion following TT placement (p< or =0.0006).\n Ciprodex reduced early post-operative otorrhea, clinically diagnosed OM and effusion following TT insertion. The greatest reduction in otorrhea was observed in patients with bilateral effusion at the time of surgery.", "To evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of post-tympanostomy otorrhea, and the relation between middle ear content and post-tympanostomy otorrhea.\n One hundred and fifty patients aged 3-14 years underwent tympanostomy and tube insertion at the Prince Rashid Ben Al-Hasan Hospital, Al-Husn, Jordan during the interval between February 2000 to January 2003. The patients were randomized into 3 groups: group 1 (control group) received no antibiotic drops, group 2 received a single dose of ciprofloxacin drops intraoperatively and group 3 received an intraoperative dose followed by 5-day postoperative course.\n Application of topical ciprofloxacin after tympanostomy tube insertion was associated with a significantly lower incidence of early post-tympanostomy otorrhea. The rate of otorrhea for the control group was 16.5% and the treatment groups were (group 1) 8.4%, (group 2) 8.2% and p=0.011. A single dose of antibiotics was effective when patient's middle ears were dry or had serous effusions. For those whose ears had mucoid or purulent content a 5-day course was indicated.\n Topical administration of a single dose of ototopical ciprofloxacin after surgery is an effective treatment for the prevention of early post-tympanostomy otorrhea, and a prolonged course (5 days) may be indicated for those whose ears had purulent or thick mucoid contents, and the content of middle ear are important in predicating postoperative otorrhea.", "This study was designed to determine whether treatment with prednisone and trimethoprim-sulfamethoxazole would reduce first year post-operative morbidity in children with chronic otitis media with effusion undergoing tympanostomy tube insertion (intubation). Eighty children ages 6 months to 8 years were enrolled at intubation and randomized from age strata to receive active drugs or placebos for 14 days after surgery. They were examined with pneumatic otoscopy and tympanometry preoperatively and at 3 weeks and 3, 6, 9 and 12 months after surgery. Active drug treatment significantly reduced tube obstruction or extrusion in the first 3 postoperative months compared with placebos (4% vs. 17%, P = .01). However, rates of repeat intubation, otorrhea and recurrence of otitis media did not differ significantly in the two groups. Children with chronic otitis media with effusion treated with intubation may benefit from a 2-week course of prednisone and trimethoprim-sulfamethoxazole at the time of surgery. However, there is no apparent long term benefit of this treatment." ]

[ "9924848", "8247194", "2441152", "8673775", "1968368", "10355071", "9681776", "10449212", "9310807", "3532693", "15080014", "3063797", "6132082" ]

[ "Nitrate therapy is an alternative to furosemide/morphine therapy in the management of acute cardiogenic pulmonary edema.", "Comparison of sublingual captopril, nifedipine and prazosin in hypertensive emergencies during hemodialysis.", "First-line treatment of left ventricular failure complicating acute myocardial infarction: a randomised evaluation of immediate effects of diuretic, venodilator, arteriodilator, and positive inotropic drugs on left ventricular function.", "Rapid improvement of acute pulmonary edema with sublingual captopril.", "Renal and hemodynamic effects of intravenous fenoldopam versus nitroprusside in severe hypertension.", "[Sublingual nitroglycerin or intravenous enalaprilat in preclinical treatment of hypertensive patients with pulmonary edema].", "The nitura study--effect of nitroglycerin or urapidil on hemodynamic, metabolic and respiratory parameters in hypertensive patients with pulmonary edema.", "Comparison between isosorbide dinitrate aerosol and nifedipine in the treatment of hypertensive emergencies.", "Safety and efficacy of urapidil and sodium nitroprusside in the treatment of hypertensive emergencies.", "Severe hypertension with cerebral symptoms treated with furosemide, fractionated diazoxide or dihydralazine. Danish Multicenter Study.", "Nicardipine versus nitroprusside infusion as antihypertensive therapy in hypertensive emergencies.", "Hypertensive emergencies in old age: effects of angiotensin converting enzyme inhibition.", "Haemodynamic advantages of isosorbide dinitrate over frusemide in acute heart-failure following myocardial infarction." ]

[ "Nitrates are superior to furosemide in the management of acute pulmonary edema associated with myocardial infarction; however, their role in the absence of infarction is unclear.\n A randomized comparison was undertaken of the relative effectiveness of primary therapy with either intravenous morphine/furosemide (men/women; n = 32) or nitroglycerin/N-acetylcysteine (NTG/NAC; n = 37) in consecutive patients with acute pulmonary edema. The primary end point was change in PaO2/FIO2 over the first 60 minutes of therapy. Secondary end points were needed for mechanical respiratory assistance (ie, continuous positive airway pressure via mask or intubation and ventilation) and changes in other gas exchange parameters. Both treatment groups showed improvement in oxygenation after 60 minutes of therapy; however, this reached statistical significance only with NTG/NAC therapy. There was no significant difference between groups in the assessed parameters (95% CI for differences in Pao2/FIO2: furosemide/morphine -12 to 23 and NTG/NAC 4 to 44), a finding also confirmed in 32 patients presenting with respiratory failure. Only 11% of the study group required mechanical ventilatory assistance (continuous positive airway pressure in 4 patients and intubation and ventilation in 3 patients).\n NTG/NAC therapy is as effective as furosemide/morphine in the initial management of acute pulmonary edema, regardless of the presence or absence of respiratory failure. The necessity for mechanical ventilatory assistance is infrequent in these patients, regardless of the initial medical treatment regimen.", "Hypertensive emergencies in hemodialysis require immediate therapy, usually by parenteral drug administration; however, sublingual medications may have potential in this special condition. Sublingual captopril (25 mg), nifedipine (10 mg) and prazosin (2 mg) were prescribed to determine the effectiveness and safety of each medication in the treatment of hypertensive emergencies during hemodialysis. Blood pressure and heart rate were measured continuously up to 120 min postdose. The response rates were 83% for captopril, 90% for nifedipine and 11% for prazosin. The significant hypotensive effects of both sublingual captopril and nifedipine occurred at 10 min and continued up to 120 min. The reduction of systolic blood pressure occurred earlier in nifedipine than captopril (10 vs. 15 min). No significant difference in heart rate between them was noted. There were no side effects in the captopril group but flushing, tachycardia and headache were observed in 4 patients of the nifedipine group. We concluded that sublingual captopril and nifedipine were effective but captopril seemed to have less side effects than nifedipine and may be an excellent alternative to sublingual nifedipine in the urgent treatment of hypertensive emergencies in hemodialysis. Prazosin was not recommended because of its low response rate.", "A prospective randomised trial compared the immediate haemodynamic effects of intravenous diuretic (frusemide), venodilator (isosorbide dinitrate), arteriolar dilator (hydralazine), and positive inotropic stimulation (prenalterol) as first-line therapy for acute left ventricular (LV) failure following myocardial infarction. Forty-eight patients with transmural myocardial infarction and a pulmonary artery occluded pressure (PAOP) of greater than 20 mm Hg were studied within 18 h of admission to a coronary care unit. Both frusemide (-4 mm Hg; p less than 0.01) and isosorbide dinitrate (-6 mm Hg; p less than 0.01) reduced LV filling pressure without change in cardiac index and heart rate. Although both hydralazine and prenalterol increased cardiac index (p less than 0.01), the reduction in LV filling pressure (-2 mm Hg; p less than 0.05) was less than with frusemide and isosorbide dinitrate, and was associated with an increased heart rate (+8 and +13 beats min-1; p less than 0.01). These data suggest that in acute heart failure following myocardial infarction the four treatment modalities could be ranked in descending order of potential benefit as follows: venodilatation (isosorbide dinitrate)--decrease of LV pressure/work; diuretic therapy (frusemide)--decrease of LV pressure/work offset by a transient pressor effect; arteriolar dilatation (hydralazine)--decrease of LV pressure/work and of PAOP, but offset by tachycardia; and positive inotropic therapy (beta 1-agonist prenalterol)--tachycardia and augmented LV afterload. Combination of the former and latter agents, because of their differing modes of action, should offer haemodynamic advantages over monotherapy and deserves further evaluation.", "To test the hypothesis that sublingual captopril produces a more rapid improvement of acute pulmonary edema (APE) than does placebo, when added to a standard regimen of O2, nitrates, morphine, and furosemide.\n Prospective, randomized, double-blind, placebo-controlled clinical trial in an urban teaching hospital ED. Adults brought to the ED with APE were given captopril or placebo sublingually. Every 5 minutes a clinical APE distress score (APEX) was obtained.\n Over the first 40 minutes of treatment, the mean APEXs were significantly better for the patients given captopril [p < 0.001, F = 14.5, one-way (repeated-measures) analysis of variance (ANOVA)]. At 30 minutes, the patients given captopril had a mean APEX improvement of 43% (i.e., to 57% of initial distress); the group given the current standard regimen plus placebo improved only 25% (i.e., to 75% of initial distress; p = 0.03, multiway ANOVA). In addition, there was less respiratory failure necessitating mechanical ventilation in the captopril patients (9%) vs the placebo patients (20%), which did not achieve significance (p = 0.10, Fisher's exact test).\n In APE, the addition of sublingual captopril to the standard regimen of O2, nitrates, morphine, and furosemide produces more rapid clinical improvement than does the standard regimen alone.", "The renal and hemodynamic effects of intravenously administered fenoldopam mesylate, a novel dopamine-1 receptor agonist, were compared with those of sodium nitroprusside in 28 patients (18 male; 26 black, two white; average age, 49 +/- 3 years) with an average blood pressure of 219/137 mm Hg, most of whom presented with acute target organ damage. Fenoldopam and nitroprusside lowered blood pressure safely to an average pressure of 176/105 mm Hg; highly significant dose-response relations were found for the 13 patients receiving fenoldopam and the 15 receiving nitroprusside. Volume and sodium, potassium, and creatinine concentrations were measured in freely voided urine specimens both before and during intravenous therapy. In the fenoldopam-treated patients, there were significant increases in urinary flow (92 +/- 21 to 168 +/- 37 ml/hr, p less than 0.003), sodium excretion (227 +/- 73 to 335 +/- 90 mu eq/min, p less than 0.001), and creatinine clearance (70 +/- 11 to 93 +/- 13 ml/hr, p less than 0.003). In the nitroprusside-treated group, however, all these parameters decreased, but not significantly. For direct comparison of the two agents, the increments in urinary flow rate (+76 +/- 20 vs. -16 +/- 15 ml/hr, fenoldopam vs. nitroprusside), sodium excretion (+109 +/- 28 vs. -39 +/- 28 mu eq/min), and creatinine clearance (+23 +/- 6 vs. -11 +/- 7 ml/min) were significantly greater (p less than 0.001 for each) in the fenoldopam-treated group. Significant differences were also obtained when these parameters were calculated as percentage increase over baseline. Fenoldopam and nitroprusside are effective therapies for severe, accelerated, or malignant hypertension, but fenoldopam had additional salutary renal effects in these patients.", "In a prospectively designed randomized study, we compared the efficacy of sublingual nitroglycerine and intravenous enalaprilat in the out-of-hospital treatment of 46 hypertensive patients with pulmonary edema (defined as rales over both lungs and systolic blood pressure > 200 mm Hg and diastolic blood pressure > 100 mg). The out-of-hospital treatment consists of oxygen (6 Ll/min) via a face mask, furosemide 80 mg i.v., opioids 10 mg s.c., and either sublingual nitroglycerine (n = 23; initial dose: 0.8 mg; repetitive application of 0.8 mg every 10 min until a cumulative dose of 3.2 mg) or intravenous enalaprilat (initial dose: 2.5 mg; repetitive application of 2.5 mg every 30 min until a cumulative dose of 10 mg). The aim of the antihypertensive treatment was a reduction of systolic blood pressure below 160 mm Hg and diastolic blood pressure below 90 mm Hg until admission to the emergency department. In the emergency room, an arterial and venous blood sample was taken to determine the respiratory (pO2, pCO2) and metabolic status (pH value; base-excess; serum lactate) of the patient. Successful antihypertensive treatment was observed in 13/23 (57%) patients of the enalaprilat group and 15/23 (65%) patients of the nitroglycerine group (p = 0.54). Systolic and diastolic blood pressure on admission were similar in both treatment groups (systolic RR: enalaprilat: 179 [31] mm Hg; nitroglycerine: 184 [38] mm Hg; p = 0.59; diastolic RR: enalaprilat: 96 [14] mm Hg; nitroglycerine: 101 [14] mm Hg; p = 0.12). No significant differences were observed between the enalaprilat and the nitroglycerine groups concerning respiratory and metabolic parameters on admission (pO2: 67 [15] vs. 64 [17] mm Hg; p = 0.50; pCO2: 46 [9] vs. 47 [13]; p = 0.75; pH value: 7.27 [0.12] vs. 7.27 [0.09]; p = 0.98; BE: -4.2 [3.7] vs. -5.7 [4.1]; p = 0.23; lactate: 4.2 [3.3] vs. 4.2 [2.7]; p = 0.98). Intravenous enalaprilat did not exhibit any advantage compared to nitroglycerine in terms of blood pressure reduction or respiratory and metabolic parameters on admission to the emergency room. We conclude that enalaprilat is no substitute for nitroglycerine in the out-of-hospital treatment of hypertensive patients with pulmonary edema.", "To assess the effects of nitroglycerin or urapidil on hemodynamic, respiratory and metabolic parameters in hypertensive patients with pulmonary edema.\n Open, randomized and prospective clinical study.\n Out-of-hospital setting and Emergency Department in a 2000-bed hospital.\n Hundred twelve patients with evidence of hypertensive crises with pulmonary edema (systolic blood pressure (SBP) > 200 mmHg and/or diastolic blood pressure (DBP) > 100 mm Hg and rales over both lungs) at the time when the emergency physician arrived.\n The out-of-hospital treatment consisted of oxygen via face mask, 80 mg furosemide i.v., 10 mg morphium s.c., and either nitroglycerin sublingually (initial dose: 0.8 mg; repetitive administration of 0.8 mg every 10 min to a cumulative dose of 3.2 mg) or urapidil (initial dose: 12.5 mg i.v.; repetitive administration every 15 min to a cumulative dose of 50 mg). If SBP was more than 180 mm Hg and/or DBP more than 90 mm Hg on admission, antihypertensive treatment was continued with nitroglycerin (0.3-3 mg/h) or urapidil (5-50 mg/h).\n Blood pressure (BP) was measured every 5 min with the use of an automatic oscillometric device. Serum lactate, PO2, pH value, and base excess (BE) were evaluated on admission and 6 h later. Blood pressure, serum lactate and BE on admission were significantly lower (SBP: 155 +/- 30 vs 179 +/- 33 mm Hg; p = 0.0002; DBP: 82 +/- 17 vs 93 +/- 19 mmHg; p = 0.001; lactate: 2.2 +/- 1.6 vs 3.9 +/- 2.7; p = 0.0001; BE: -1.9 +/- 3.9 vs -4.4 +/- 1.7; p = 0.0005) and PO2 and pH values were significantly higher in the urapidil group compared to the nitroglycerin group (PO2: 75 +/- 25 vs 66 +/- 17; p = 0.036; pH: 7.33 +/- 0.08 vs 7.29 +/- 0.09; p = 0.042). After 6 h no differences between the two groups were observed.\n The more pronounced BP reduction in the urapidil group was associated with an improved respiratory and metabolic situation in hypertensive patients with pulmonary edema. Therefore, urapidil is a valuable alternative to nitroglycerin in patients with pulmonary edema and systemic hypertension.", "Nitric oxide donors have been used in the management of hypertensive emergencies (HE). Isosorbide dinitrate aerosol (ISA) is a nitric oxide fast-acting donor. The aim of this study is to compare the efficacy of ISA and nifedipine in the treatment of HE.\n Sixty adult patients with an HE were randomised to receive either ISA (2.5 mg) or nifedipine (10 mg). Patients were given an electrocardiogram (ECG) immediately prior, and 30 min after administering the medication. Blood pressure (BP) was measured every 5 min for the first 30 min, and then every 30 min for a period of 6 h.\n Blood pressure values for all patients in the ISA group decreased significantly (187 +/- 13/121 +/- 6 to 153 +/- 15/92.3 +/- 7.6 mmHg, P < 0.005). Two of the patients in this group had angor pectoris with evidence of subepicardial ischaemia as seen in the first ECG, both of which disappeared with the drug. Heart rate decreased by 14%. Similarly, all patients in the nifedipine group had significant decreases in BP (190 +/- 23/115 +/- 7 to 153 +/- 26/86 +/- 6 mm Hg, P < 0.005). Their first ECG was normal. Two patients suffered angor pectoris after nifedipine, with subepicardial ischaemia registering in the second ECG. Heart rate increased 11.9% in this group. During the follow-up period, no clinically significant side effects or cases of rebound hypertension were observed in the ISA group, whereas in the nifedipine group, eight patients reported having headaches and four others rebound hypertension.\n Our results show a favourable effect of ISA in the treatment of HE.", "To assess the safety and efficacy of urapidil compared to sodium nitroprusside in the treatment of hypertensive emergencies.\n Randomized, prospective clinical study.\n Emergency department in a 2000-bed inner city hospital.\n Eighty-one patients with hypertensive emergencies defined as elevation of systolic blood pressure above 200 mmHg and/or diastolic blood pressure above 110 mmHg plus evidence of end-organ damage were included in the study protocol. The efficacy of therapy was defined as 1) blood pressure reduction below 180/95 mmHg within 90 min and 2) no re-elevation of blood pressure during a 4-h follow-up period in primary responders. The safety of both drugs was defined as the number of minor and major side effects during treatment.\n Patients received either sodium nitroprusside (n = 35; continuous intravenous administration with a starting dose of 0.5 microgram/kg per min; increase in increments of 0.5 microgram/kg per min every 15 min until response to treatment or a maximum of 3 micrograms/kg per min) or urapidil (n = 46; intravenous bolus; starting dose: 12.5 mg; repetitive administration of 12.5 mg every 15 min until response or a maximum dose of 75 mg).\n Blood pressure was measured every 2.5 min by using a non-invasive oscillometric blood pressure measurement unit. Response to treatment within 90 min was observed in 75 (93%) patients (urapidil: n = 41 [89%]; nitroprusside: n = 34 [97%]; p = 0.18). During the follow-up period 8/34 (24%) patients in the nitroprusside group and 1/41 (2%) patients in the urapidil group exhibited blood pressure re-elevation. Major side effects were observed in seven patients receiving nitroprusside and two patients in the urapidil group (p = 0.04).\n Urapidil is equally effective, compared to sodium nitroprusside, in the treatment of hypertensive emergencies. Due to a smaller number of adverse events, urapidil is a reasonable alternative to nitroprusside in the treatment of hypertensive emergencies.", "Emergency treatment of acute, severe hypertension defined as diastolic blood pressure (DBP) greater than or equal to 135 mmHg combined with cerebral symptoms was prospectively monitored in a randomized multicenter study including 64 patients. Treatment was divided into two periods. In the first hour the patients were observed in the supine position after being given 40 mg furosemide intravenously. If DBP remained greater than 125 mmHg (n = 52), the patients were put on fractionated diazoxide administered intravenously (n = 28) or dihydralazine administered intramuscularly (n = 24). Blood pressure (BP) decreased with diazoxide from an average of 241/149 mmHg to 180/111 mmHg after 5 hours and with dihydralazine from 237/149 to 161/101 mmHg. The inter-individual BP response varied considerably. A clear and identical regression in neurological symptoms was observed on both drug regimens. No new neurological symptoms were seen to develop. It is concluded that a gradual fall in BP can be obtained after fractionated dosage of diazoxide (i.v.) as well as after dihydralazine (i.m.). The indication of acute parenteral therapy compared to less aggressive oral treatment is discussed.", "This prospective study compared the efficacy of nicardipine and nitroprusside for treating hypertensive emergencies by measuring haemodynamic indices and serum catecholamine levels. Patients admitted to the emergency department with a hypertensive crisis and acute pulmonary oedema received intravenous infusions of nitroprusside (starting dose 1 microgram/kg per min, n = 20) or nicardipine (starting dose 3 micrograms/kg per min, n = 20). Both groups experienced significant declines in systolic and diastolic blood pressure after treatment, but there were no significant time-dependent differences between the groups. Heart rate decreased in the nicardipine group and increased in the nitroprusside group, but neither change was significant. Respiration rate decreased and capillary oxygen saturation rate increased after treatment in both groups. Adrenaline and noradrenaline levels decreased significantly after treatment in both groups; noradrenaline levels were significantly decreased in the nicardipine-treated group compared with the nitroprusside-treated group. Injectable nicardipine is easy to use and as effective as nitroprusside for treating hypertensive crisis with acute pulmonary oedema.", "Hypertensive emergencies, and to a certain extent their treatment, contribute to morbidity and mortality in elderly patients. We studied 22 hospitalized patients, aged 70-90 years, all of whom had moderate essential hypertensive. During acute hypertension, mean systolic and diastolic blood pressure rose to 230 +/- 24 and 120 +/- 22 mmHg, respectively. Symptoms of reduced tissue perfusion/oxygenation and/or organ failure occurred, forcing us to begin antihypertensive therapy. We administered 50 mg of the angiotensin converting enzyme (ACE) inhibitor captopril sublingually, and within 15 min, systolic blood pressure decreased by an average 60 +/- 16 mmHg and diastolic blood pressure by an average 25 +/- 14 mmHg. There was no significant change in the heart rate. In addition, we treated 22 comparable patients with 10 mg nifedipine sublingually and observed, in four cases, a greater fall in blood pressure (up to 90 mmHg) together with tachycardia. These results show the beneficial effects of captopril in the treatment of hypertensive emergencies in elderly patients. The absence of dangerous side effects indicates that ACE inhibitors can be used as first-choice drugs for the treatment of acute hypertensive crises, even in old age.", "The immediate haemodynamic effects of intravenous frusemide (1 mg/kg) and intravenous isosorbide dinitrate (50-200 micrograms/kg/h) were compared in a prospective, randomised, between-group study in 28 men with radiographic and haemodynamic evidence of left ventricular failure following acute myocardial infarction. The diuresis induced by frusemide reduced the left heart filling pressure and cardiac output and transiently raised systemic blood-pressure. In contrast, isosorbide dinitrate was accompanied by a reduction in systemic blood-pressure and peripheral resistance with the result that the cardiac output was not decreased despite a large fall in the pulmonary vascular and left heart filling pressures. These results indicate that reduction of excessive preload by venodilatation may be haemodynamically superior to that induced by diuresis in terms of both reducing myocardial oxygen consumption and maintaining peripheral perfusion. The influence of these contrasting treatments on the prognosis of these high-risk patients warrants further study." ]

[ "2529524", "11978282", "12421172", "12113971" ]

[ "[Comparative study of Pfannenstiel's incision and transverse abdominal incision in gynecologic and obstetric surgery].", "Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial.", "Joel-Cohen or Pfannenstiel incision at cesarean delivery: does it make a difference?", "Comparison of two transverse abdominal incisions for cesarean delivery." ]

[ "The ease of execution and the post-operative quality of 2 types of incision commonly performed in pelvic surgery were compared in a prospective randomised study: Pfannenstiel's incision was used in 59 patients and Mouchel's low transverse abdominal incision (LTA) in 60 patients. Results were evaluated 8 days and 3 months after the operation. There was no difference in immediate post-operative results between these two groups of patients. At the 3 month examination, hypoaesthesia of the skin was less frequent in patients who had been operated upon through the LTA incision. The authors conclude that the transmuscular incision is innocuous.", "To compare the Pfannenstiel incision with transverse muscle-cutting Maylard incision in women who had cesarean delivery.\n Patients were assigned randomly to a Pfannenstiel or Maylard incision. Postoperative treatment was similar for each group. Surgical characteristics, complications, postoperative pain (visual analog scale, analgesic use), and related quality of life (1- and 3-month self-administered questionnaires) were analyzed. Abdominal wall muscle recovery was compared objectively by dynamometer.\n Fifty-four women had a Pfannenstiel incision and 43 had the Maylard incision. There were no differences in intraoperative characteristics, postoperative morbidity, or pain. Women's responses to the Nottingham Health Profile questionnaire at 1 and 3 months postoperatively and clinical and isokinetic testing for abdominal wall strength were similar between the two groups.\n Transecting the rectus muscle was no more deleterious than the Pfannenstiel incision. There was no difference in objectively measured abdominal wall strength.", "To evaluate whether the technique to open the abdomen might influence the operative time and the maternal and neonatal outcome.\n All consecutive women who underwent a cesarean section at a gestational age greater than or equal to 32 weeks were randomly allocated to have either the Joel-Cohen or the Pfannenstiel incision. Exclusion criteria were two or more previous cesarean sections and previous longitudinal abdominal incision. During the study period 366 patients underwent a cesarean delivery. Of these patients, 56 did not meet the inclusion criteria. The remaining patients were allocated to the Joel-Cohen (n = 152) group and to the Pfannenstiel (n = 158) group. Extraction time was defined as the time interval from skin incision to the clamping of the umbilical cord.\n The total operative time was similar in both groups [Joel-Cohen 32 min (12-60) vs. Pfannenstiel 33 min (18-70)]. The extraction time was shorter in the Joel-Cohen group than in the Pfannenstiel group [190 s (60-600) vs. 240 s (50-600), p = 0.05]. This remained statistically significant after adjustment for confounding variables (Hazard = 1.26, p = 0.05). No difference was found between groups in terms of intraoperative and postoperative complications. No difference was found in the neonatal neurodevelopmental assessment at 6 months of age in relation to the abdominal incision performed.\n The Joel-Cohen method of opening the abdomen at cesarean delivery is faster then the Pfannenstiel technique at delivering the fetus. However, considering the absence of benefits to the mother and the fetus there is no clear indication for performing a Joel-Cohen incision.", "nan" ]

[ "18330955", "19053049", "19827166", "20664019", "19637289", "16630771" ]

[ "Effect of lifestyle intervention on non-alcoholic fatty liver disease in Chinese obese children.", "Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial.", "Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis.", "Effect of a 12-month intensive lifestyle intervention on hepatic steatosis in adults with type 2 diabetes.", "Aerobic exercise training reduces hepatic and visceral lipids in obese individuals without weight loss.", "A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease." ]

[ "To investigate the effect of lifestyle intervention on non-alcoholic fatty liver disease (NAFLD) in Chinese obese children.\n Seventy-six obese children aged from 10 to 17 years with NAFLD were enrolled for a one-month intervention and divided randomly into three groups. Group1, consisting of 38 obese children, was an untreated control group without any intervention. Group 2, consisting of 19 obese children in summer camp, was strictly controlled only by life style intervention. Group 3, consisting of 19 obese children, received oral vitamin E therapy at a dose of 100 mg/d. The height, weight, fasting blood glucose (FBG), fasting serum insulin (FINS), plasma alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglyceride (TG), total cholesterol (TCHO) and homeostasis model assent-insulin resistance (HOMA-IR) were measured at baseline and after one month. All patients were underwent to an ultrasonographic study of the liver performed by one operator who was blinded to the groups.\n The monitor indices of BMI, ALT, AST, TG, TCHO and HOMA-IR were successfully improved except in group 1. BMI and ALT in group 2 were reduced more significantly than in group 3 (2.44 +/- 0.82 vs 1.45 +/- 0.80, P = 0.001; 88.58 +/- 39.99 vs 63.69 +/- 27.05, P = 0.040, respectively).\n Both a short-term lifestyle intervention and vitamin E therapy have an effect on NAFLD in obese children. Compared with vitamin E, lifestyle intervention is more effective. Therefore, lifestyle intervention should represent the first step in the management of children with NAFLD.", "The aim of this study was to determine if orlistat, an inhibitor of fat absorption, combined with caloric restriction in overweight subjects with nonalcoholic steatohepatitis results in weight loss and improved liver histology. Fifty overweight subjects (body mass index = >or=27) with biopsy proven nonalcoholic steatohepatitis were randomized to receive a 1,400 Kcal/day diet plus vitamin E (800 IU) daily with or without orlistat (120 mg three times a day) for 36 weeks. Liver biopsies were repeated at week 36. Twenty-three subjects in the orlistat/diet/vitamin E group and 18 in the diet/vitamin E group completed the study. The mean age was 47 +/- 9.0 (standard deviation) years and mean body mass index was 36.4 +/- 6.3 kg/m(2). Four subjects were diabetic. The orlistat group lost a mean of 8.3% body weight compared to 6.0% in the diet plus vitamin E group (not significant). Both groups also had similarly improved serum aminotransferases, hepatic steatosis, necroinflammation, ballooning, and nonalcoholic fatty liver disease activity scores. Stratified according to weight loss instead of treatment group, a loss of >or=5% body weight (n = 24) compared to <5% body weight (n = 17) correlated with improvement in insulin sensitivity (P = 0.001) and steatosis (P = 0.015). Comparing subjects who lost >or=9% of body weight (n = 16), to those that did not (n = 25), improved insulin sensitivity (P < 0.001), adiponectin (P = 0.03), steatosis (P = 0.005), ballooning (P = 0.04), inflammation (P = 0.045), and nonalcoholic fatty liver disease activity score (P = 0.009) were seen. Increases in adiponectin strongly correlated with improved ballooning and nonalcoholic fatty liver disease activity score (P = 0.03). Orlistat did not enhance weight loss or improve liver enzymes, measures of insulin resistance, and histopathology. However, subjects who lost >or=5% of body weight over 9 months improved insulin resistance and steatosis, and those subjects who lost >or=9% also achieved improved hepatic histologic changes.", "Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25-40 kg/m(2)) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (>or=7%), compared with those who lost less than 7%, had significant improvements in steatosis (-1.36 versus -0.41, P < 0.001), lobular inflammation (-0.82 versus -0.24, P = 0.03), ballooning injury (-1.27 versus -0.53, P = 0.03) and NAS (-3.45 versus -1.18, P < 0.001).\n Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH.", "Weight loss through lifestyle changes is recommended for nonalcoholic fatty liver disease (NAFLD). However, its efficacy in patients with type 2 diabetes is unproven.\n Look AHEAD (Action for Health in Diabetes) is a 16-center clinical trial with 5,145 overweight or obese adults with type 2 diabetes, who were randomly assigned to an intensive lifestyle intervention (ILI) to induce a minimum weight loss of 7% or a control group who received diabetes support and education (DSE). In the Fatty Liver Ancillary Study, 96 participants completed proton magnetic resonance spectroscopy to quantify hepatic steatosis and tests to exclude other causes of liver disease at baseline and 12 months. We defined steatosis >5.5% as NAFLD.\n Participants were 49% women and 68% white. The mean age was 61 years, mean BMI was 35 kg/m(2), mean steatosis was 8.0%, and mean aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 20.5 and 24.2 units/l, respectively. After 12 months, participants assigned to ILI (n = 46) lost more weight (-8.5 vs. -0.05%; P < 0.01) than those assigned to DSE and had a greater decline in steatosis (-50.8 vs. -22.8%; P = 0.04) and in A1C (-0.7 vs. -0.2%; P = 0.04). There were no significant 12-month changes in AST or ALT levels. At 12 months, 26% of DSE participants and 3% (1 of 31) of ILI participants without NAFLD at baseline developed NAFLD (P < 0.05).\n A 12-month intensive lifestyle intervention in patients with type 2 diabetes reduces steatosis and incident NAFLD.", "Weight loss remains the most common therapy advocated for reducing hepatic lipid in obesity and nonalcoholic fatty liver disease. Yet, reduction of body weight by lifestyle intervention is often modest, and thus, therapies which effectively modulate the burden of fatty liver but are not contingent upon weight loss are of the highest practical significance. However, the effect of aerobic exercise on liver fat independent of weight loss has not been clarified. We assessed the effect of aerobic exercise training on hepatic, blood, abdominal and muscle lipids in 19 sedentary obese men and women using magnetic resonance imaging and proton magnetic resonance spectroscopy ((1)H-MRS). Four weeks of aerobic cycling exercise, in accordance with current physical activity guidelines, significantly reduced visceral adipose tissue volume by 12% (P < 0.01) and hepatic triglyceride concentration by 21% (P < 0.05). This was associated with a significant (14%) reduction in plasma free fatty acids (P < 0.05). Exercise training did not alter body weight, vastus lateralis intramyocellular triglyceride concentration, abdominal subcutaneous adipose tissue volume, (1)H-MRS-measured hepatic lipid saturation, or HOMA-IR (homeostasis model assessment of insulin resistance; P > 0.05).\n These data provide the first direct experimental evidence demonstrating that regular aerobic exercise reduces hepatic lipids in obesity even in the absence of body weight reduction. Physical activity should be strongly promoted for the management of fatty liver, the benefits of which are not exclusively contingent upon weight loss.", "Few controlled studies have addressed the issue of effective medical treatment for nonalcoholic fatty liver disease (NAFLD). We herein assessed the effect of orlistat in patients with NAFLD.\n We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD diagnosed by ultrasound (US) and confirmed by liver biopsy (40 patients). The patients were randomized to receive either orlistat (120 mg 3 times daily for 6 months) or placebo. All patients participated in an identical behavioral weight loss program. All patients underwent monthly evaluation by abdominal US; liver enzyme levels, lipid profiles, insulin levels, and anthropometric parameters were monitored, and all patients underwent nutritional follow-up evaluation. Twenty-two patients underwent a second liver biopsy examination at the end of the study.\n Fifty-two patients were recruited and 44 (mean age, 47.7 y; mean body mass index, 33) completed the study. Serum glucose and insulin levels (P<.03) were significantly higher in the orlistat group, which also presented a higher degree of fibrosis. Body mass index was reduced significantly in each group, with a nonsignificant difference between the groups. Serum alanine transaminase (ALT) levels decreased significantly in both groups, with an almost 2-fold reduction in the orlistat group (48% vs 26.4%). There was a statistically significant reversal of fatty liver by US only in the orlistat group (P<.05).\n Orlistat improves serum ALT levels and steatosis on US in NAFLD patients, beyond its effect on weight reduction." ]

[ "11237234", "10501359", "11313504", "16905564", "16106314" ]

[ "Efficacy of a home-made spacer with acute exacerbation of bronchial asthma: a randomized controlled trial.", "Home-made spacers for bronchodilator therapy in children with acute asthma: a randomised trial.", "Comparative efficiency of commercial and improvised spacer device in acute bronchial asthma.", "Randomised controlled trial of the efficacy of a metered dose inhaler with bottle spacer for bronchodilator treatment in acute lower airway obstruction.", "[Different inhaler devices in acute asthma attacks: a randomized, double-blind, placebo-controlled study]." ]

[ "Metered dose inhaler (MDI) with spacer is the preferred method for administration of aerosolized medications in pediatric asthma. The expense of commercial spacers limits their use and indigenous alternatives have therefore been developed. Information on the clinical efficacy of home-made spacers is limited. This study was conducted to compare the efficacy of a valve-less home-made spacer with a commercial spacer in delivering salbutamol via MDI in acute asthma. Asthmatic children aged 5-15 years who presented with an acute exacerbation to the pediatric chest clinic of a tertiary care hospital were enrolled in a single blinded randomized parallel group study. The study patients received 10 puffs of salbutamol (100 microg/puff) via MDI-home-made spacer or MDI-commercial spacer. Pre and post inhalation measurements of peak expiratory flow rate (PEFR), oxygen saturation (SaO2), respiratory rate (RR), pulse rate (PR) were made and compared. Sixty children were enrolled in the study, 31 were administered salbutamol via the home-made spacer and 29 via the commercial spacer. The median increase in PEFR was similar in both the groups (20.8% vs 22.2%, p=0.4), clinical improvement being satisfactory in all patients. The valve-less home-made spacer is equally efficacious and cheaper than the commercial spacer in administering bronchodilators in acute exacerbations of asthma. Further studies on the efficacy of home-made spacer in delivery of inhaled steroids are needed.", "A metered-dose inhaler (MDI) with spacer is the best way to deliver bronchodilator therapy for treatment of acute asthma. In developing countries, commercially produced spacers are generally unavailable or too costly. We tested the efficacy of home-made spacers (500 mL plastic bottle, polystyrene cup) compared with a conventional spacer for delivery of a beta2 agonist via MDI for children with acute asthma.\n We studied children aged 5 to 13 years with acute asthma, stratified into those with mild airways obstruction (peak expiratory flow [PEF] 60-79% of predicted value) or moderate to severe airways obstruction (PEF 20-59% of predicted value). A beta2 agonist (fenoterol hydrobromide) was given via MDI and one of four randomly assigned spacers (conventional spacer, sealed 500 mL plastic bottle, unsealed 500 mL bottle, 200 mL polystyrene cup). Clinical score, pulmonary function tests, and oximetry were recorded at baseline and 15 min after treatment. If a second bronchodilator treatment was needed, nebulised fenoterol was given and the assessment repeated 15 min later. Primary outcome measures were changes in clinical score and pulmonary function, and need for and response to nebulisation.\n 88 children were eligible for study. In 44 children with moderate to severe airways obstruction, a cup gave significantly less bronchodilation (median increase in: forced expiratory volume in 1 s [FEV1] 0%; PEF 12%) compared with the conventional spacer (37%; 59%), sealed bottle (33%; 36%), or unsealed bottle (18%; 21%, p<0.05 for difference between groups). Nebulisation was required by ten of 11 who had used a cup, nine of 11 who had used an unsealed bottle, eight of 11 who had used a sealed bottle, and only four of 11 who had used a conventional spacer. After nebulisation, improvement in FEV1 (15.5%) and PEF (26%) was more marked in children who had used a cup than in those who had used a conventional spacer (5.5% FEV1; 4% PEF), sealed bottle (3%; 0%), or unsealed bottle (7%; 9%). For 44 children with mild airways obstruction, response to bronchodilator was similar for all spacers and need for nebulisation was not associated with use of a particular spacer.\n A conventional spacer and sealed 500 mL plastic bottle produced similar bronchodilation, an unsealed bottle gave intermediate improvement in lung function, and a polystyrene cup was least effective as a spacer for children with moderate to severe airways obstruction. Use of bottle spacers should be incorporated into guidelines for asthma management in developing countries.", "To compare the efficacy of a commercial spacer device versus an improvised spacer device in delivering aerosolized beta-2 agonist through metered dose inhaler in an acute exacerbation of bronchial asthma.\n Randomized controlled trial.\n Urban tertiary care teaching hospital.\n 60 children between 1 to 12 years of age with acute asthma were prospectively enrolled and randomized into two groups. Detailed history, clinical evaluation and appropriate laboratory investigations were recorded on a pretested proforma. One group received inhaled salbutamol using metered dose inhaler via commercial spacer device (Group 1), while the other received it via improvised spacer device (Group II). The response was sequentially assessed after 20, 40 and 60 minutes of institution of therapy.\n The two groups were comparable with respect to various parameters at presentation (p > 0.05). All the outcome parameters showed a significant improvement with time in both groups (p < 0.05). There was no statistical difference between the response in the two groups (p< 0.05).\n Metered dose inhaler with improvised spacer device is equivalent in efficacy and a more cost effective alternative to metered dose inhaler with commercial spacer for administration of beta-2 agonist in acute asthma.", "Inhaled bronchodilator treatment given via a metered dose inhaler (MDI) and spacer is optimal for relief of bronchoconstriction. Conventional spacers are expensive or unavailable in developing countries, but there is little information on the efficacy of low-cost spacers in young children.\n To compare the response to bronchodilator treatment given via a conventional or a low-cost bottle spacer\n A randomised controlled trial of the efficacy of a conventional spacer compared with a bottle spacer for bronchodilator treatment in young children with acute lower airway obstruction. Bronchodilator treatment was given from an MDI via an Aerochamber or a bottle spacer. Clinical score and oximetry recording were carried out before and after 15 min of treatment. MDI-spacer treatment was repeated up to three times, depending on clinical response, after which nebulisation was used. The primary outcome was hospitalisation.\n 400 children, aged (median (25th-75th centile)) 12 (6-25) months, were enrolled. The number of children hospitalised (n = 60, 15%) was identical in the conventional and bottle spacer groups (n = 30, 15% in each). Secondary outcomes including change in clinical score (-2 (-3 to -1)), oxygen saturation (0 (-1 to 1)) and number of bronchodilator treatments (2 (1 to 3)) were similar in both groups. Oral corticosteroids, prescribed for 78 (19.5%) children, were given to a similar number in the conventional (37 (18.5%)) and bottle spacer groups (41 (20.5%)).\n A low-cost bottle spacer is as effective as a conventional spacer for bronchodilator treatment in young children with acute obstruction of the lower airways.", "To verify the efficacy, side effects, and cost of treatment of acute asthma attacks, using different inhaler devices.\n This is a randomized, double-blind, placebo-controlled study. Salbutamol was administered via a nebulizer, a metered-dose inhaler (attached to a commercially available spacer device), a homemade non-valved spacer device, or a dry powder inhaler. Assessments were made at zero, 20, 40 and 60 minutes, followed by the application of salbutamol and placebo with another device. Forty children (mean age of 11+/-3.5 years) with acute asthma attacks, were evaluated. Clinical score, forced expiratory volume in one second and side effects were analyzed. The costs for medication and spacer devices were calculated.\n There is no difference between groups regarding clinical score and variation of forced expiratory volume in one second. There was a major variation in the heart rate response to the nebulizer (35%) compared to the commercially available spacer and dry powder inhaler (15 and 17%) and between the homemade spacer and the commercially available spacer (28 and 15%) (p = 0.004). The nebulizer and homemade spacer caused more tremor (p = 0.02). The cost of treatment was higher for the nebulizer and commercially available spacer (p = 0.0001).\n The nebulizer was more expensive and used more medicine, showing the same efficiency. The homemade spacer was cheaper, but presented more side effects. The commercially available spacer was as expensive as the nebulizer, although safer. The dry powder inhaler was cheaper, but, just as the homemade spacer, it also caused tachycardia." ]

[ "10755239", "6363930", "9713140" ]

[ "Randomized controlled trial of doxycycline prophylaxis against leptospirosis in an endemic area.", "An efficacy trial of doxycycline chemoprophylaxis against leptospirosis.", "Use of doxycycline for leptospirosis after high-risk exposure in São Paulo, Brazil." ]

[ "Leptospirosis occurs as seasonal outbreaks, lasting for about 3 weeks during October-November in North Andaman. A randomized controlled trial was undertaken to assess the efficacy of doxycycline prophylaxis in the prevention of infection and clinical disease due to leptospires during the outbreak period. A sample population of 782 persons, randomized into two groups was given doxycycline 200 mg/week and a placebo. The microscopic agglutination test was done on blood samples collected on day zero, after 6 weeks and after 12 weeks. Infection rates and attack rates of clinical illness were calculated in the two groups based on the serological results. Statistically there was no difference in the infection rates among the two groups. However, a statistically significant difference was observed in the clinical disease attack rates (3.11 vs. 6.82%) between study group and control group. The results of the study indicate that doxycycline prophylaxis does not prevent leptospiral infection in an endemic area, but has a significant protective effect in reducing the morbidity and mortality during outbreaks.", "Because leptospirosis has been an important cause of morbidity in U.S. soldiers training in the Republic of Panama, we conducted a randomized, double-blind, placebo-controlled field trial during the fall of 1982 to determine whether doxycycline was an effective chemoprophylactic agent against this infection. Doxycycline (200 mg) or placebo was administered orally on a weekly basis and at the completion of training to 940 volunteers from two U.S. Army units deployed in Panama for approximately three weeks of jungle training. Twenty cases of leptospirosis occurred in the placebo group (an attack rate of 4.2 per cent), as compared with only one case in the doxycycline group (attack rate, 0.2 per cent, P less than 0.001), yielding an efficacy of 95.0 per cent. This study demonstrated the value of doxycycline as a prophylactic drug against leptospirosis.", "A clinical trial pilot study, double-blinded, randomized, and controlled with a placebo to assess the effectiveness of oral doxycycline (200 mg, single dose) in preventing leptospirosis after high exposure to potentially contaminated water was performed in São Paulo, SP, Brazil. Confirmed cases were defined as those with leptospira IgM antibody and symptoms; asymptomatic cases were those presenting with IgM antibodies but no symptoms; and suspected cases were individuals with symptoms but no IgM antibody. Forty subjects were given doxycycline and 42 were given placebo. In the drug-treated group there were 2 confirmed cases, 11 asymptomatic cases, and 6 suspected cases. In the placebo group there were 5 confirmed, 6 symptomatic, and 5 suspected cases. Even though we found a protective association of doxycycline for confirmed leptospirosis cases (RR = 2.3) and seroconversion only (RR = 2.0), the association was not statistically significant because of the small number of individuals enrolled in this pilot study. We observed that the 22% of the volunteers already had IgM antibodies to leptospirosis at the first sampling. Finally, the attack rate to confirmed, asymptomatic, and suspected cases of Leptospirosis was 8.5%, 22%, and 13%, respectively, in this population." ]

[ "7636912", "15163774", "2111981", "4749684", "6342554", "2013", "7223302", "9034259", "13679934", "419454", "16915107", "7119271", "1702977", "21615299", "15090958", "7087432", "449157", "436425", "16398734", "8110727", "6194934", "15667544", "1738219", "8143470", "7324819", "7324820", "367709", "7684579", "9934892", "8319421", "1154272", "9059186", "8466026", "907460", "8444226", "11801830", "8884861", "2409845", "4017661", "8239200", "3142719" ]

[ "Maintenance of serum albumin levels in pediatric burn patients: a prospective, randomized trial.", "A comparison of albumin and saline for fluid resuscitation in the intensive care unit.", "Albumin supplementation in the critically ill. A prospective, randomized trial.", "Early albumin infusion to infants at risk for respiratory distress.", "Randomized trial of efficacy of crystalloid and colloid resuscitation on hemodynamic response and lung water following thermal injury.", "Rapid infusion of sodium bicarbonate and albumin into high-risk premature infants soon after birth: a controlled, prospective trial.", "Is albumin therapy worthwhile in surgery for colorectal cancer?", "Randomized, double-blind study of intravenous human albumin in hypoalbuminemic patients receiving total parenteral nutrition.", "Randomized trial of normal saline versus 5% albumin for the treatment of neonatal hypotension.", "Crystalloid vs. colloid resuscitation: is one better? A randomized clinical study.", "Albumin administration improves organ function in critically ill hypoalbuminemic patients: A prospective, randomized, controlled, pilot study.", "The significance of colloid osmotic pressure measurement after crystalloid and colloid infusions.", "Effect of intraoperative fluid administration and colloid osmotic pressure on the formation of intestinal edema during gastrointestinal surgery.", "Mortality after fluid bolus in African children with severe infection.", "Albumin influences total plasma antioxidant capacity favorably in patients with acute lung injury.", "The effect of albumin resuscitation for shock on the immune response to tetanus toxoid.", "Shock and resuscitation. III. Accurate refractometric COP determinations in hypovolemia treated with HALFD.", "Crystalloid versus colloid in the etiology of pulmonary failure after trauma--a randomized trial in man.", "Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score.", "A prospective randomized trial evaluating colloid versus crystalloid resuscitation in the treatment of the vascular leak syndrome associated with interleukin-2 therapy.", "Fluid resuscitation in circulatory shock: a comparison of the cardiorespiratory effects of albumin, hetastarch, and saline solutions in patients with hypovolemic and septic shock.", "Pre-transfusion management of children with severe malarial anaemia: a randomised controlled trial of intravascular volume expansion.", "Concurrent administration of albumin with total parenteral nutrition in sick newborn infants.", "Efficacy of albumin supplementation in the surgical intensive care unit: a prospective, randomized study.", "Albumin treatment following major surgery. I. Effects on plasma oncotic pressure, renal function and peripheral oedema.", "Albumin treatment following major surgery. II. Effects on postoperative lung function and circulatory adaptation.", "Comparison of hemodynamic, pulmonary, and renal effects of use of three types of fluids after major surgical procedures on the abdominal aorta.", "Influence of different intravascular volume therapies on platelet function in patients undergoing cardiopulmonary bypass.", "Distribution of normal saline and 5% albumin infusions in septic patients.", "Effects of human albumin administration on visceral protein markers in patients receiving parenteral nutrition.", "Randomized trial of albumin vs. electrolyte solutions during abdominal aortic operations.", "Randomised controlled trial of colloid or crystalloid in hypotensive preterm infants.", "Evaluation of STAT-CRIT hematocrit determination in comparison to Coulter and centrifuge: the effects of isotonic hemodilution and albumin administration.", "Cardiac output and pulmonary wedge pressure. Use for evaluation of fluid replacement in trauma patients.", "Randomised controlled trial of albumin infusion in ill preterm infants.", "Distribution of normal saline and 5% albumin infusions in cardiac surgical patients.", "Complement activation during and after open-heart surgery is only marginally affected by the choice of fluid for volume replacement.", "Effects of colloid or crystalloid administration on pulmonary extravascular water in the postoperative period after coronary artery bypass grafting.", "Effects of maintaining normal plasma colloid osmotic pressure on renal function and excretion of sodium and water after major surgery. A randomized study.", "Oncotic pressure, albumin and ileus: the effect of albumin replacement on postoperative ileus.", "Effect of albumin supplementation during parenteral nutrition on hospital morbidity." ]

[ "A prospective, randomized trial was performed to determine whether maintaining serum albumin levels in burned pediatric patients had any effect on morbidity and mortality. Patients < 19 years of age with burns > 20% total body surface area were randomized to receive supplemental albumin to maintain levels 2.5 to 3.5 g/dL (\"High Albumin\") or were given albumin only if levels dropped < 1.5 g/dL (\"Low Albumin\") after completing burn shock resuscitation. The 36 patients in the Low Albumin group were well matched for age, burn size, depth of injury, and inhalation injury when compared with the High Albumin group (34 patients). As expected, serum albumin levels were significantly lower in the Low Albumin group when compared with the High Albumin group. No differences between groups were noted for resuscitation needs, maintenance fluid requirements, urine output, tube feedings received, days of antibiotic treatment, or ventilatory requirements. No differences in hematology, electrolytes, or nutritional laboratories were found. Finally, length of stay, complication rate, and mortality were not affected by albumin treatment. Albumin supplementation to maintain normal serum levels does not seem to be warranted in previously healthy children who suffer severe burns and who receive adequate nutrition.", "It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units (ICUs) affects survival. We conducted a multicenter, randomized, double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU.\n We randomly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days. The primary outcome measure was death from any cause during the 28-day period after randomization.\n Of the 6997 patients who underwent randomization, 3497 were assigned to receive albumin and 3500 to receive saline; the two groups had similar baseline characteristics. There were 726 deaths in the albumin group, as compared with 729 deaths in the saline group (relative risk of death, 0.99; 95 percent confidence interval, 0.91 to 1.09; P=0.87). The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups (P=0.85). There were no significant differences between the groups in the mean (+/-SD) numbers of days spent in the ICU (6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group, P=0.44), days spent in the hospital (15.3+/-9.6 and 15.6+/-9.6, respectively; P=0.30), days of mechanical ventilation (4.5+/-6.1 and 4.3+/-5.7, respectively; P=0.74), or days of renal-replacement therapy (0.5+/-2.3 and 0.4+/-2.0, respectively; P=0.41).\n In patients in the ICU, use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days.\n Copyright 2004 Massachusetts Medical Society", "Albumin replacement to correct hypoalbuminemia in critically ill patients has been controversial. This study was a prospective, randomized trial of 25% albumin administration in 40 hypoalbuminemic (serum albumin, less than 25 g/L [2.5 g/dL]), critically ill patients. The treatment group (18 patients) received 25% albumin supplementation to achieve and maintain serum albumin levels of 25 g/L (2.5 g/dL) or greater, while the nontreatment group (22 patients) received no concentrated albumin. There was no clinical benefit from albumin therapy when assessing mortality (39% vs 27%, treatment vs control) or major complication rate (89% vs 77% of patients). There were also no significant differences in length of hospital stay, intensive care unit stay, ventilator dependence, or tolerance of enteral feeding, despite significant elevations of albumin in the treatment group. The costly use of exogenous albumin as treatment for hypoalbuminemia in this patient population does not appear to be justified.", "nan", "To assess the effects of crystalloid and colloid resuscitation on hemodynamic response and on lung water following thermal injury, 79 patients were assigned randomly to receive lactated Ringer's solution or 2.5% albumin-lactated Ringer's solution. Crystalloid-treated patients required more fluid for successful resuscitation than did those receiving colloid solutions (3.81 vs. 2.98 ml/kg body weight/% body surface burn, p less than 0.01). In study phase 1 (29 patients), cardiac index and myocardial contractility (ejection fraction and mean rate of internal fiber shortening, Vcf) were determined by echocardiography during the first 48 hours postburn. Cardiac index was lower in the 12- to 24-hour postburn interval in the crystalloid group, but this difference between treatment groups had disappeared by 48 hours postburn. Ejection fractions were normal throughout the entire study, while Vcf was supranormal (p less than 0.01 vs. normals) and equal in the two resuscitation groups. In study phase 2 (50 patients), extravascular lung water and cardiac index were measured by a standard rebreathing technique at least daily for the first postburn week. Lung water remained unchanged in the crystalloid-treated patients (p greater than 0.10), but progressively increased in the colloid-treated patients over the seven day study (p less than 0.0001). The measured lung water in each treatment group was significantly different from one another (p less than 0.001). Cardiac index increased progressively and identically in both treatment groups over the study period (p less than 0.01). These data refute the existence of myocardial depression during postburn resuscitation and document hypercontractile left ventricular performance. The addition of colloid to crystalloid resuscitation fluids produces no long lasting benefit on total body blood flow, and promotes accumulation of lung water when edema fluid is being reabsorbed from the burn wound.", "We conducted a controlled, prospective trial to evaluate the effectiveness of rapidly infusing sodium bicarbonate (NaHCO3) and salt-poor albumin into high-risk, premature infants in the first 2 hours of life. Fifty-three infants, randomized into one of four treatment groups, received 8 ml. per kilogram of a solution containing either (A) glucose in water, (B) salt-poor albumin, (C) NaHCO3, or (D) a combination of albumin and NaHCO3. After the initial infusion, the babies received no colloid or alkali solutions until 4 hours of age. We managed them supportively with warmth, appropriate oxygen administration, isotonic fluid infusion, and close monitoring. Among the infants who received alkali, 14 of 26 acquired the respiratory distress syndrome (RDS), 11 died, and four had intracranial hemorrhage. Among babies who received no alkali, RDS occurred in 11 of 27, 5 died, and none had intracranial hemorrhage. These results do not support the common practice of rapidly infusing NaHCO3 into high-risk, premature infants, and they suggest that the early management of such infants needs renewed critical evaluation.", "Patients with colorectal cancer undergoing elective surgery with resection of the tumour and primary anastomosis were randomly allocated into two groups. 29 patients received a total of 60-75 g of albumin postoperatively, 30 patients received no albumin and served as controls. The two groups were comparable with respect to age and sex of the patients and stage of growth of the tumour. The patients who received albumin had a significantly lower preoperative serum albumin concentration. On day 4 after the operation the serum albumin concentrations of the control patients and the patients who received albumin were 20% and 5% lower, respectively, than the preoperative value. Eight patients of the albumin group and 5 of the control group developed postoperative complications. There was no significant difference in the postoperative clinical course between the two groups. Preoperative serum albumin levels did not differ between patients who developed postoperative complications and those who had an uneventful postoperative course whether or not they received albumin postoperatively. The present study does not confirm earlier results indicating that serum albumin alone is of prognostic value for the postoperative course following colorectal surgery. Furthermore, the postoperative course is not improved by addition of albumin postoperatively and hence albumin should be given in this situation only when its specific oncotic effect is required.", "To determine whether replacement of human albumin will improve a patient's prognosis.\n A randomized, double-blind, controlled study in which 25 g of human albumin vs. placebo was administered intravenously daily.\n A university-affiliated hospital.\n Thirty-six patients with hypoalbuminemia (serum albumin of <2.5 g/dL), receiving total parenteral nutrition. None of the patients had known cancer, cirrhosis, or nephrotic syndrome.\n Each patient received at least 6 days of therapy (6 to 24 days of albumin; 7 to 32 days of placebo). Four subjects were excluded from the study since they received therapy for <6 days. One patient was excluded from the study after nephrotic syndrome was identified. Albumin metabolic rates for those patients receiving albumin were estimated using the formula: Metabolism of albumin = 25 g/day + (albumin 1 - albumin 2)(Vd)/days, where albumin 1 and 2 are the serum albumin concentrations (g/L) at the beginning and end of the serum sampling intervals, respectively; Vd is the volume of distribution (L); and days relates to the number of days of the sampling interval.\n Sixteen patients received albumin; 15 patients received placebo. One patient receiving placebo and two patients receiving albumin died within 30 days. One patient who received placebo and three patients who received albumin developed sepsis or bacteremia; four patients who received placebo and seven patients who received albumin developed pneumonia during the study (NS). The serum albumin increased in all patients receiving intravenous albumin, but one patient received intravenous albumin for only 6 days. The mean serum albumin concentration increased by 1.42 g/dL in the albumin patients, and increased by 0.29 in the placebo patients (p < .0001 by unpaired t-test). Mean initial albumin metabolism was 17.4 g/day (0.3 g/kg/day). At the end of therapy, albumin metabolism was 20.5 g/day (0.36 g/kg/day) (paired t-test, p = .4, NS).\n a) The administration of intravenous albumin to hypoalbuminemic patients receiving total parenteral nutrition does not improve morbidity or mortality. b) Albumin metabolic rates, initially related to the catabolic state, are high; later, these rates are high related to filling of the albumin space and gluconeogenesis. c) On the basis of the high albumin catabolic rates at the end of the infusion, doses of albumin of <25 g/day might be sufficient to replace albumin stores.", "This study was designed to assess the comparative efficacy of normal saline (NS) and 5% albumin (ALB) for treatment of hypotension in the acutely ill newborn.\n Newborn infants who were < 24 hours old and were admitted to the Holden Neonatal Intensive Care Unit at the University of Michigan were randomized to receive one of the two solutions for volume expansion. Hypotension was defined as a sustained (> or =30 minutes) mean arterial pressure (MAP) of < 30 mmHg for infants weighing < or =2500 g, or a MAP of < 40 mmHg for those weighing > 2500 g. The short-term outcome measure was the resolution of hypotension defined as a MAP over the minimum limits set for birthweight sustained for > or =30 minutes.\n In total 41 infants met criteria and were entered. Of these, 21 infants received ALB and 20 received NS. Successful treatment was seen in 17/21 (81%) of infants in the ALB group and 17/20 (85%) of infants in the NS group. There was no statistically significant difference in response to treatment (p=0.30). In addition, there was no statistically significant difference in the magnitude of change in MAP between the two (p=0.41).\n NS was shown to be as effective as ALB for the correction of acute hypotension in the newborn infant. Given comparable efficacy of NS, along with its relatively low cost and availability, it should be considered the initial treatment of choice in this setting.", "The effects of hemodynamic resuscitation with protein-containing or balanced salt solution were studied prospectively in 29 patients undergoing abdominal aortic surgery. Blood loss was replaced with packed red cells and extracellular volume with either Ringer's Lactate (RL) or 5% albumin in Ringer's lactate (ALB). Fluids were given to maintain the pulmonary capillary wedge pressure (PCWP) equal to or within 5 torr above preoperative (PO) levels, the cardiac output (CO) equal to or greater than preoperative values, and the urine output at least 50 ml/hr. Serum colloid osmotic pressure (COP), CO, PCWP, the gradient between COP and PCWP (COP-PCWP), and intrapulmonary shunt (Qs/Qt) were measured PO, intraoperatively (IO), and daily for 3 days. The measured variables were similar PO in both groups. Operation time, estimated blood loss, and transfusions were similar. Total fluids received for resuscitation (day of operation) was 11.3 +/- 0.8 liters (RL) and 6.2 +/- 0.4 liters (ALB). Fluid balance at the end of resuscitation was 8.4 +/- 0.8 liters (RL) and 3.4 +/- 0.5 liters (ALB). Maximum decrease in COP was 40% (P less than 0.001) in the RL group and was insignificant in the ALB group. The COP-PCWP decreased from 11 +/- 1 to 2 +/- 1 in RL (P less than 0.001) and insignificantly in ALB. Qs/Qt increased slightly in both groups following operation but was not different between groups. Fluid balance, total fluid infused, sodium balance, total sodium infused, COP, or COP-PCWP did not significantly correlate with Qs/Qt. Two patients in the ALB group experienced pulmonary edema associated with normal COPs and elevated PCWPs. There were no cases of pulmonary edema associated with low COPs and normal PCWPs in the crystalloid group. These data seriously question the necessity to maintain COP by using protein-containing solutions during acute hemodynamic resuscitation. When titrated to physiological end points, even large volumes of balanced salt solutions are tolerated well.", "To test the hypothesis that administration of albumin to correct hypoalbuminemia might have beneficial effects on organ function in a mixed population of critically ill patients.\n : Prospective, controlled, randomized study.\n Thirty-one-bed, mixed medicosurgical department of intensive care.\n All adult patients with a serum albumin concentration < or =30 g/L were assessed for eligibility. Principal exclusion criteria were expected length of stay <72 hrs, life expectancy <3 months or a do-not-resuscitate order, albumin administration in the preceding 24 hrs, or evidence of fluid overload.\n The 100 patients were randomized to receive 300 mL of 20% albumin solution on the first day, then 200 mL/day provided their serum albumin concentration was <31 g/dL (albumin group), or to receive no albumin (control group).\n The primary outcome was the effect of albumin administration on organ function as assessed by a delta Sequential Organ Failure Assessment score from day 1 to day 7 (or the day of intensive care discharge or death, whichever came first). The two groups of 50 patients were comparable at baseline for age, gender, albumin concentration, and Acute Physiology and Chronic Health Evaluation II score. Albumin concentration did not change over time in the control group but increased consistently in the albumin group (p < .001). Organ function improved more in the albumin than in the control group (p = .026), mainly due to a difference in respiratory, cardiovascular, and central nervous system components of the Sequential Organ Failure Assessment score. Diuretic use was identical in both groups, but mean fluid gain was almost three times higher in the control group (1679 +/- 1156 vs. 658 +/- 1101 mL, p = .04). Median daily calorie intake was higher in the albumin than in the control group (1122 [935-1158] vs. 760 [571-1077] kcal, p = .05).\n Albumin administration may improve organ function in hypoalbuminemic critically ill patients. It results in a less positive fluid balance and a better tolerance to enteral feeding.", "Colloid osmotic pressure (COP) was followed postoperatively in 55 randomized patients. After minor operations and short-term infusion therapy only small changes of the COP could be observed and it was concluded that after such operations COP measurement is unnecessary. After major surgical interventions, however, COP measurement gave valuable hints. It was shown that even in the case of moderate blood loss replaced by crystalloids an abnormally low COP did not occur. The same applied also to preoperative hemodilution. It was unnecessary to substitute the withdrawn blood with a colloid solution. In addition, COP measurement helped to avoid expensive albumin administrations, and indicated colloid overload in cases of pulmonary edema.", "The effects of intraoperative changes in plasma colloid osmotic pressure (COP) on the formation of intestinal edema were studied in patients during modified Whipple's operation (hemipancreato-duodenectomy). Eighteen patients (ASA physical status I or II) were randomly assigned to one of three groups. They received either lactated Ringer's (RL group, n = 6), 10% hydroxyethyl starch (HES group, n = 6), or 20% human albumin (HA group, n = 6) as a volume replacement solution, which was given to maintain central venous pressure (CVP) at the preoperative level. Jejunal specimens were obtained after the first transsection of the jejunum and prior to the jejuno-jejunostomy. Their water fraction (g H2O/g tissue dry weight) was measured gravimetrically. COP was determined prior to induction of anesthesia and upon removal of the second jejunal sample. In the RL group, 3,850 +/- 584 ml (data are means +/- SEM) of volume replacement solution were infused from induction of anesthesia to removal of the second jejunal sample. In the HES group, 1,358 +/- 45 ml were infused, and in the HA group, 463 +/- 49 ml were infused. During this time, COP decreased from 20.3 +/- 0.5 mmHg to 14.1 +/- 0.6 mmHg in the RL group, remained at 22.0 +/- 0.9 mmHg in the HES group, and increased from 20.7 +/- 0.9 mmHg to 28.1 +/- 0.9 mmHg in the HA group.(ABSTRACT TRUNCATED AT 250 WORDS)", "The role of fluid resuscitation in the treatment of children with shock and life-threatening infections who live in resource-limited settings is not established.\n We randomly assigned children with severe febrile illness and impaired perfusion to receive boluses of 20 to 40 ml of 5% albumin solution (albumin-bolus group) or 0.9% saline solution (saline-bolus group) per kilogram of body weight or no bolus (control group) at the time of admission to a hospital in Uganda, Kenya, or Tanzania (stratum A); children with severe hypotension were randomly assigned to one of the bolus groups only (stratum B). All children received appropriate antimicrobial treatment, intravenous maintenance fluids, and supportive care, according to guidelines. Children with malnutrition or gastroenteritis were excluded. The primary end point was 48-hour mortality; secondary end points included pulmonary edema, increased intracranial pressure, and mortality or neurologic sequelae at 4 weeks.\n The data and safety monitoring committee recommended halting recruitment after 3141 of the projected 3600 children in stratum A were enrolled. Malaria status (57% overall) and clinical severity were similar across groups. The 48-hour mortality was 10.6% (111 of 1050 children), 10.5% (110 of 1047 children), and 7.3% (76 of 1044 children) in the albumin-bolus, saline-bolus, and control groups, respectively (relative risk for saline bolus vs. control, 1.44; 95% confidence interval [CI], 1.09 to 1.90; P=0.01; relative risk for albumin bolus vs. saline bolus, 1.01; 95% CI, 0.78 to 1.29; P=0.96; and relative risk for any bolus vs. control, 1.45; 95% CI, 1.13 to 1.86; P=0.003). The 4-week mortality was 12.2%, 12.0%, and 8.7% in the three groups, respectively (P=0.004 for the comparison of bolus with control). Neurologic sequelae occurred in 2.2%, 1.9%, and 2.0% of the children in the respective groups (P=0.92), and pulmonary edema or increased intracranial pressure occurred in 2.6%, 2.2%, and 1.7% (P=0.17), respectively. In stratum B, 69% of the children (9 of 13) in the albumin-bolus group and 56% (9 of 16) in the saline-bolus group died (P=0.45). The results were consistent across centers and across subgroups according to the severity of shock and status with respect to malaria, coma, sepsis, acidosis, and severe anemia.\n Fluid boluses significantly increased 48-hour mortality in critically ill children with impaired perfusion in these resource-limited settings in Africa. (Funded by the Medical Research Council, United Kingdom; FEAST Current Controlled Trials number, ISRCTN69856593.).", "To ascertain the influence of albumin on antioxidant status in patients with acute lung injury.\n Prospective, randomized, placebo-controlled study.\n Intensive care units, teaching hospitals.\n Twenty patients meeting the American European Consensus criteria for acute lung injury.\n Ten patients received albumin (25 g of a 25% solution every 8 hrs for a total of nine doses) and ten received placebo (normal saline administered in identical fashion and volume). All received supportive therapy appropriate for patients with acute lung injury. Plasma samples were obtained sequentially from all patients before, 30 mins after, and 4 hrs after albumin/placebo administration.\n Serum albumin and total protein, total antioxidant status, iron-binding antioxidant protection, iron-oxidizing antioxidant protection, lipid hydroperoxides, protein carbonyls, and plasma thiols were measured. Albumin administration increased plasma albumin concentrations (p <.05 compared with placebo) and decreased concentrations of protein carbonyls (p <.05 compared with placebo). By contrast, plasma lipid hydroperoxide concentrations were similar in both groups, both in absolute terms and relative to albumin content. For all other variables, no significant differences were apparent. For all patients, there was a positive correlation between albumin and plasma thiol concentrations (r =.983, p <.01) and albumin and antioxidant capacity (r =.885, p =.01). In the albumin treatment group, there was a strong correlation between thiols and antioxidant capacity (r =.876, p =.01). No such correlation was apparent in the placebo group. Plasma iron-binding antioxidant protection was negatively correlated (r = -.741, p <.05) with albumin content in the treatment group but not the placebo group.\n In patients with acute lung injury, albumin administration favorably influences plasma thiol-dependent antioxidant status as well as levels of protein oxidative damage.", "nan", "In 38 critically burned patients with symptomatic hypovolemia being treated by intravenous fluids, the accuracy of colloid oncotic pressure (COP) calculated from the refractometrically-determined serum total protein (TPRI) was compared with COP values determined by a commercially-available clinical oncometer. Sera were obtained randomly from seven patients receiving Ringer's lactate solution, five receiving a hypertonic solution (240 mOsm Na+) and 26 receiving a hypertonic solution containing albumin (12.5 gm/liter, HALFD method). There was poor correlation between COP measure and that calculated from RI in patients receiving colloid-free fluid, but high correlation (r = 0.925) in patients receiving HALFD. There was high correlation (r = 0.951) between measured COP and values calculated from TPRI in patients receiving hypertonic fluid, colloid containing hypertonic fluid, or no fluid:COP = 4.08 (TPRI)--4.61.", "nan", "The effect of 5 percent human albumin on multiple organ dysfunction was investigated during the first 14 days of treatment to determine whether albumin resuscitation might benefit adult burn patients.\n Multicenter unblinded controlled trial with stratified block (two patients per block) randomization by center and mortality prediction at enrollment (high-risk stratum [predicted mortality, 50%-90%] and low-risk stratum [predicted mortality, <50%]). The primary outcome was the worst multiple organ dysfunction score (MODS), excluding the cardiovascular component, to Day 14. Eligible adults (>15 years) suffering from thermal injury not more than 12 hours before enrollment received fluid resuscitation with Ringer's lactate (n=23) or 5 percent human albumin plus Ringer's lactate (n=19) by protocol to achieve recommended (American Burn Association) resuscitation endpoints.\n Forty-two patients were randomly assigned. There were no significant differences (median [95% confidence intervals]) in age (36 [24-45] vs. 31 [25-39] years), burn size (39 [32-53] vs. 32 [26-34] total body surface area percentage), inhalation injury (n=12/19 vs. n=11/23), or baseline MODS (3 [1-5] vs. 1.5 [0-2]) between the treatment and control groups. In an intention-to-treat analysis, there was no significant difference between the treatment and control group in the lowest MODS from Day 0 to Day 14 (analysis of covariance, p=0.73).\n Treatment with 5 percent albumin from Day 0 to Day 14 does not decrease the burden of MODS in adult burn patients.", "Interleukin-2 (IL-2)-based therapy induces a vascular leak syndrome (VLS), manifested by hypotension, tachycardia, and oliguria, as is also seen with septic shock. The optimal method for treating such VLS is not known. A prospective randomized trial was undertaken to compare crystalloid and colloid fluid resuscitation for patients receiving bolus IL-2-based therapy for metastatic cancer. All patients received maintenance crystalloid fluid administration and were randomized to receive crystalloid (0.9% normal saline) or colloid (5% human serum albumin) fluid boluses to maintain acceptable vital signs and urine output. Patients refractory to fluid boluses were given dopamine for oliguria and/or phenylephrine for hypotension. Of 107 patients who completed one cycle of therapy on study, 76 completed a full treatment course (two cycles) on study. The total number of saline and albumin fluid boluses given were 9.5 +/- 0.9 versus 7.7 +/- 0.7 (p = 0.36, n = 107) for the first cycle and 19.2 +/- 1.8 versus 16.1 +/- 1.6 (p = 0.33, n = 76) for a complete course, respectively. Although patients receiving saline boluses had significantly more oliguria during a course of therapy, weight gain, number of IL-2 doses, tachycardia, hypotension, vasopressor use, hospital stay, and clinical response rates did not significantly differ between arms. Changes in hematocrit, hemoglobin, protein, albumin, blood urea nitrogen (BUN), and creatinine were analyzed, and patients receiving crystalloid showed greater decreases in albumin (p < 0.0001) and total protein (p < 0.05) as expected. A 40-fold greater cost associated with albumin suggested that crystalloid resuscitation be used to treat the VLS associated with IL-2 therapy.(ABSTRACT TRUNCATED AT 250 WORDS)", "Twenty-six consecutive patients in hypovolemic shock were randomized to fluid challenge with 5% albumin (A), 6% hetastarch (H), or 0.9% saline (S) solutions. Fluid challenge consisted of 250 ml of test fluid every 15 min until the pulmonary artery wedge pressure (WP) reached 15 mm Hg. Thereafter, WP was maintained at 15 mm Hg for an additional 24 h with infusions of the same test fluid. Vital signs, hemodynamic and respiratory variables, as well as arterial lactate and colloid osmotic pressure (COP) were monitored according to protocol. Chest x-rays were performed by standardized technique before fluid challenge and at 12 and 24 h of maintenance fluid therapy and were evaluated for evidence of pulmonary edema. Cardiac function and hemodynamic stability were restored by fluid challenge with A, H, and S. Two to 4 times the volume of S as A or H was required to achieve similar hemodynamic endpoints. COP was increased by fluid challenge with A or H but was markedly reduced by fluid challenge with S and throughout the 24-h maintenance period. Fluid challenge resulted in reductions in COP-WP gradient of 62% in the A, 43% in the H, and 125% in the S groups. Resuscitation with S resulted in a significantly higher incidence of pulmonary edema (87.5%) than did resuscitation with A (22%) or H (22%). Urine output was not different among the groups at any time during the study. We conclude that 6% H performs as well as 5% A as a resuscitative fluid and that resuscitation with either of these colloids is associated with a lower incidence of pulmonary edema than is resuscitation with 0.9% S.", "Symptomatic severe malarial anaemia (SMA) has a high fatality rate of 30-40%; most deaths occur in children awaiting blood transfusion. Blood transfusion services in most of Africa are not capable of delivering adequate supplies of safe blood in a timely manner to critically ill children with SMA. Contrary to widely held belief, hypovolaemia, rather than heart failure, has emerged as a common complication in such children. We examined the safety of pre-transfusion management (PTM) by volume expansion, aimed at stabilizing children and obviating the urgency for blood transfusion. Kenyan children with severe falciparum anaemia (haemoglobin <5 g/dl) and respiratory distress were randomly assigned to 20 ml/kg of 4.5% albumin or 0.9% saline or maintenance only (control) while awaiting blood transfusion. PTM was apparently safe since it did not lead to the development of pulmonary oedema or other adverse events. There was no significant difference in the primary outcome [mean percentage reduction in base excess between admission and 8 h (95% confidence interval)] between the control group 42% (19-66%) albumin group 44% (32-57%) and saline group 36% (16-57%); adjusted analysis of variance F=0.31, P=0.7. However, the number of children requiring emergency interventions was significantly greater in the control group, four of 18 (22%) than the saline group 0 of 20 (P=0.03). We have established the safety of this PTM in children with SMA whilst awaiting blood transfusion at a hospital with an adequate blood-banking program. The impact on mortality should be assessed where blood transfusion services are unable to supply emergency transfusions.", "The effects of concurrent administration of albumin with total parenteral nutrition were studied in 12 premature newborns (birth weight 1.26 +/- 0.1 kg [mean +/- SEM] and gestational age 30 +/- 0.8 weeks [mean +/- SEM]) compared with a control group of 12 premature newborns (birth weight 1.17 +/- 0.2 kg and gestational age 29 +/- 0.1 weeks) who received total parenteral nutrition. All newborns had a plasma albumin level below 3 g/dL and were in cardiorespiratory distress requiring assisted ventilation. Albumin supplementation of total parenteral nutrition resulted in a sustained increase in serum albumin concentration as well as increased mean arterial blood pressures in the study group. Slow albumin infusion had no observed effect on the severity of respiratory distress. Study group infants regained birth weight earlier than control group infants. These data suggest that the concurrent administration of albumin may be clinically beneficial in critically ill newborn infants.", "To determine the efficacy of supplemental 25% albumin in reducing morbidity and mortality rates in the surgical intensive care unit (ICU).\n Prospective, randomized, unblinded clinical study.\n Surgical ICU in a community hospital.\n Two hundred nineteen patients with admission circulating albumin concentrations of < 3.0 g/dL (< 30 g/L). The groups were well matched regarding age, sex, Acute Physiology and Chronic Health Evaluation II scores and initial circulating albumin concentrations.\n The treatment group (n = 116) received 37.5 g/day of albumin until the circulating albumin concentration increased to > 3.0 g/dL (> 30 g/L). The control group (n = 103) received no supplemental albumin. Both groups received standard nutritional support.\n The complication rate was 44% in the albumin group vs. 36.9% in the controls (p = .29). The albumin patients had a mortality rate of 10.3% vs. 5.8% in the control group (p = .22). There were no significant differences between the groups in the number of days spent receiving mechanical ventilation or in the tolerance to tube feedings.\n Routine supplemental administration of 25% albumin is expensive and offers no apparent outcome advantage and should be abandoned in the treatment of patients in the surgical ICU.", "The effect of a 20% albumin solution on plasma oncotic pressure, renal function and peripheral oedema was investigated in 30 adult patients undergoing elective major abdominal surgery. Half of them received an average of 173 g of albumin between the end of the operation and the 5th postoperative day, in accordance with a standardized scheme. Otherwise the same schedules for fluid therapy and blood replacement were followed in all patients. Postoperatively, serum albumin and plasma oncotic pressure were fairly normal in the albumin group, but decreased by 28% and 24% in the control group. The difference between the groups was statistically significant during the first week, but disappeared during the second week. Arm and thigh circumferences increased postoperatively to a similar extent in both groups. There were no apparent differences in circulatory variables, alveolo-arterial oxygen tension difference, incidence of wound infection or postoperative restoration of intestinal activity between the groups. Although renal and thromboembolic complications occurred only in the control group, the material is too small to permit any conclusions to be drawn from the possible difference in renal function and morbidity between the groups. The limited availability and high cost of albumin require strict indications for its use. Our results so far have failed to justify routine administration of concentrated albumin postoperatively.", "The effects of i.v. infusion of 5% albumin and balanced salt solutions were investigated in a prospective study on 18 patients subjected to reconstruction of the abdominal aorta. The same schedules for blood replacement and intraoperative fluid therapy were followed for all patients. Postoperatively, the amounts of fluid administered were adjusted with the aim of keeping the mean pulmonary arterial occlusion pressure (MPAOP) close to the preoperative level. Immediately after operation, there was a decrease in cardiac filling pressures, indicating a blood volume deficit, in both groups. Less fluid was needed for adequate haemodynamic restitution in the albumin group. Postoperatively, the mean plasma oncotic pressure (POP) in the albumin-treated patients remained steady at 2.4-2.5 kPa (86-88% of preoperative value). In the control group, POP fell to a mean minimum of 1.8 kPa (64% of preoperative value) 8 h after operation. The difference between POP and MPAOP decreased significantly in both groups, but the difference between the groups was not significant at any time. There was no significant correlation between venous admixture, on the one hand, and POP, MPAOP, POP-MPAOP difference, total sodium intake or net supply of non-colloid fluids, on the other. No clinically important differences in haemodynamic or lung function variables were found between the groups.", "Hemodynamic, pulmonary, and renal variables were measured in 24 patients scheduled for major abdominal aortic operations. Control values were obtained before preoperative medications were given. All patients received 5% dextrose in Lactated Ringer's solution intraoperatively. Postoperatively, group 1 patients received 5% dextrose in water plus albumin, group 2 received 5% dextrose in 0.45 sodium chloride solution, and group 3 received 5% dextrose in lactated Ringer's solution. There were significant increases in Qs/Qt and AaDO2, 48 hours after operation in group 3. Oxygen consumption and cardiac output increased in all groups 24 hours after operation. Twenty-four hours later, these two variables returned to control values in group 1 but continued to rise in the other two groups. Significant diuresis occurred in group 1, 48 hours postoperatively, whereas the other two groups continued to retain water. Use of albumin and 5% dextrose in water in the postoperative period seemed to produce less deviations from control values of most measured variables, than the other two groups.", "The influence of four different kinds of intravascular volume replacement on platelet function was investigated in 60 patients undergoing elective aortocoronary bypass grafting using cardiopulmonary bypass (CPB). In a randomized sequence, high-molecular weight hydroxyethyl starch solution (HMW-HES, mean molecular weight [Mw] 450,000 d), low-molecular weight HES (LMW-HES, Mw 200,000 d), 3.5% gelatin or 5% albumin were infused preoperatively to double reduced filling pressure (pulmonary capillary wedge pressure [PCWP] < 5 mm Hg). Fifteen untreated patients served as a control. Platelet function was assessed by aggregometry using turbidometric technique (inductors: ADP, epinephrine, collagen). Maximum aggregation, maximum gradient of aggregation, and platelet volume were measured before, during, and after CPB until the first postoperative day. HMW-HES 840 +/- 90 mL, LMW 850 +/- 100 mL, gelatin 950 +/- 110 mL, and albumin 810 +/- 100 mL were given preoperatively. Maximum platelet aggregation (ranging from -23% to -44% relative from baseline value) and maximum gradient of platelet aggregation (ranging from -26% to -45% relative from baseline values) were reduced only in the HMW-HES patients. After CPB, aggregometry also was impaired most markedly in these patients. The other volume groups showed less reduction in platelet aggregation and were similar to the untreated control. On the first postoperative day, aggregation variables had returned almost to baseline in all patients. Platelet volume was the same among the groups within the investigation period. Postbypass blood loss was highest in the HMW-HES group (890 +/- 180 mL). There was significant (P < 0.04) correlation in this group between blood loss and change in platelet aggregation.(ABSTRACT TRUNCATED AT 250 WORDS)", "To determine the relative distribution of fluid within the extracellular fluid volume (ECFV) after infusing either normal saline or 5% albumin in septic, critically ill patients.\n Prospective, randomized, unblinded, interventional study.\n Intensive care unit in a 450-bed, tertiary care, teaching hospital.\n Septic, critically ill patients (n = 18).\n Infusion of either normal saline or 5% albumin to a hemodynamic end point determined by the patient's clinician.\n Plasma volume (PV), ECFV, cardiac index, and arterial oxygen content were measured immediately before (baseline) and after each fluid infusion. PV and ECFV were measured by dilution of 131I-albumin and 35S sodium sulfate, respectively. Interstitial fluid volume (ISFV) was calculated as ECFV - PV. Baseline values for PV, ISFV, ECFV, and oxygen delivery index did not differ between treatment groups. Infusion of normal saline increased the ECFV by approximately the volume infused, and the expansion of the PV to ISFV was in a ratio of 1:3. Infusion of 5% albumin increased the ECFV by double the volume infused, with both the PV and ISFV expanding by approximately equal amounts. Oxygen delivery index did not increase after either infusion due to the effect of hemodilution.\n Expansion of the ECFV in excess of the volume of 5% albumin infused suggests that fluid may move from the intracellular fluid volume to the ECFV in septic patients who receive this fluid.", "nan", "In a prospective randomized trial of 16 patients undergoing abdominal vascular reconstructive procedures, changes in plasma volume, serum oncotic pressure (pis), serum albumin and total protein concentration, alveolar to arterial oxygen tension differences (AaDO2, FIO2 = 1.0), creatinine clearance, body weight, and fluid and sodium intake were examined. By random assignment patients received either an albumin- or a sodium-rich intraoperative fluid regimen. Pulmonary arteriovenous admixture was significantly less in the albumin group (n = 7) than in the electrolyte group (n = 9) on the first postoperative day. The change in AaDO2 correlated positively with the total sodium intake in the electrolyte group. Despite the larger fluid load and significantly greater gain of body weight, patients in the electrolyte group had a postoperative plasma volume significantly lower than the preoperative value. Postoperative values of albumin concentration, circulating albumin mass and pis were significantly greater in the albumin group in comparison to the electrolyte group. Creatinine clearance values were not different between the two groups. The change in pis correlated significantly with sodium intake and circulating albumin mass. Pulmonary shunting and expansion of the extracellular fluid volume may be minimized without adverse effects on renal function by administration of fluids rich in albumin in preference to sodium.", "To compare the efficacy of a colloid (5% albumin) and a crystalloid (isotonic saline) solution for treating hypotension in mechanically ventilated preterm infants.\n Sixty three preterm infants weighing 540 to 1950 g at birth and with gestational ages of 23 to 34 weeks, who developed hypotension (mean arterial pressure < 25, 30, and 35 mm Hg for infants with birthweight < 1, 1-1.49, and 1.5-1.99 kg, respectively) within the first 2 hours of life, were randomly allocated to receive intravenous infusions at 10 ml/kg of either 5% albumin (group 1, n = 32) or isotonic (0.9%) saline (group 2, n = 31). Inotropic support with dopamine infusion was given if the infants remained hypotensive after a total of three infusions (30 ml/kg). Subsequent extra doses of volume expander in the form of 5% albumin was given, depending on the infant's blood pressure.\n There was no difference in the volume of the test solutions required between the two groups. Outcome, as assessed by the number of infants requiring inotropic support and death or chronic lung disease, did not differ between the groups. After inotropic support, however, group 1 required significantly more volume expander to maintain normal blood pressure (median: 27.5 ml/kg vs 10 ml/kg; P = 0.0187) and had a higher mean (SEM) percentage weight gain within the first 48 hours of life (at 24 hours: 6.3(1.3)% vs 3.3(0.8)%; P = 0.049; at 48 hours: 5.9(1.9)% vs 0.9(1.7)%; P = 0.045). The difference in weight gain was significant at 48 hours even when only those infants not requiring inotropic support or extra 5% albumin were compared (group 1: 1.5(1.5)%, group 2: -4.2(1.1)%; P = 0.027).\n Isotonic saline is as effective as 5% albumin for treating hypotension in preterm infants, and it has the additional advantage of causing less fluid retention in the first 48 hours.", "The accuracy of the STAT-CRIT hematocrit (hct) was compared to Coulter and centrifuge methods in this study of the interrelationship between non-red cell blood constituents and accuracy of conductivity-based hct measurements. In the first part of the study, blood samples from 31 patients undergoing elective cardiac procedures were analyzed at three times: before induction of anesthesia (Time 1), during the rewarming period of cardiopulmonary bypass (CPB) (Time 2), and after transfusion of all cell-saver blood available after termination of CPB (Time 3). Laboratory evaluation included hct using the Stat-Crit, Coulter, and centrifuge methods, and sodium (Na), potassium (K), chloride (Cl), white blood cell count, total protein (TP), and albumin. In the second part of the study, patients were randomized to receive either 5% albumin (n = 14) or isotonic crystalloid (n = 14) after termination of CPB to determine the effect of protein colloid replacement on conductivity-based hct measurements. Blood samples were obtained before and after fluid volume replacement for multivariate analysis. Correlation of Coulter hct (absolute) with microhematocrit by centrifuge at all times (n = 93) was 0.95 (R2) with a bias and precision of -0.26 +/- 1.7%. Blood variables having the most significant effect on the Coulter-Stat-Crit difference (bias) were protein, Cl, and Na. Single regression analysis indicated that a 1-g/dL decrease in TP resulted in an absolute decrease in the hct reading by 1 hct% units. A 10-mmol/L change in either Cl or Na concentration resulted in a change in Stat-Crit accuracy of 3.5% and 2.5%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)", "Cardiac output and pulmonary wedge pressure (PWP) were used to evaluate the end point of fluid resuscitation in 20 patients suffering from multiple trauma and shock. Eleven patients received crystalloid resuscitation and nine patients received colloid resuscitation. Fifteen of 20 patients had an adequate cardiac output at the termination of resuscitation, but but only six of these patients had a PWP above 10 mm Hg. There was no significant correlation between left ventricular stroke work index and PWP in these patients, either at the completion of resuscitation or during the following three days. Five patients did not achieve adequate cardiac output and four of these patients died, suggesting that cardiac output was the most important criterion for adequate resuscitation. If the goal of fluid resuscitation is to achieve an adequate cardiac output, then PWP was not a reliable guide. Furthermore, using both cardiac output and PWP as a guide to fluid resuscitation of our patients, we found that the type of fluid (crystalloid or colloid) for resuscitation did not influence the course of respiratory distress in these patients up to three days following resuscitation.", "We assessed the effect of albumin infusion on weight loss and ventilation requirement in sick premature infants. Thirty infants, median gestational age 29 weeks, were entered into a randomised controlled trial, at a median of 2 days of age. The infants, all with an albumin level < or = 30 g/l, received either 5 ml/kg of 20% albumin or 5 ml/kg of their maintenance fluids (placebo), both given as part of the total daily fluid requirement. The response to the infusion was assessed by comparing two periods; 12 h immediately prior to the infusion and 12-24 h after the infusion. Albumin infusion was associated with a significant increase in albumin level and a significant reduction in weight, but in the placebo group there was a significant increase in weight. There were, however, no significant changes in the peak inspiratory pressure in response to either infusion. There was only a modest reduction (< 15%) in the inspired oxygen concentration, which occurred in both groups, but reached statistical significance only following the albumin infusion. We conclude that our results suggest that albumin infusion in \"hypoalbuminaemic\" sick preterm infants is unlikely to alter their respiratory status.", "To determine the relative distribution of fluid within the extracellular fluid volume (ECFV) and the effect on oxygen delivery after infusing either normal saline or 5% albumin in cardiac surgical patients.\n Prospective, randomized, unblinded, interventional study.\n Cardiac surgical intensive care unit in a 450-bed teaching hospital.\n Postoperative cardiac surgical patients (n = 40).\n Infusion of either normal saline or 5% albumin to a hemodynamic end point determined by the patient's clinician.\n Plasma volume (PV), ECFV, cardiac index, and arterial oxygen content were measured immediately before (baseline) and after each fluid infusion. PV and ECFV were measured by dilution of (131)I-albumin and [(35)S]sodium sulfate, respectively. Interstitial fluid volume (ISFV) was calculated as ECFV - PV. Baseline values for PV, ISFV, ECFV, and oxygen delivery index did not differ between treatment groups. Infusion of normal saline and 5% albumin increased PV by 9 +/- 23% and 52 +/- 84% of the volume infused, respectively (p <.05), whereas there was no significant difference between saline and albumin in the change in ISFV per volume infused. Only 5% albumin significantly increased cardiac index, although oxygen delivery did not change significantly after either infusion.\n In postoperative cardiac surgical patients, infusion of 5% albumin is approximately five times as efficient as a PV expander but has comparable effects on changes in ISFV and oxygen delivery relative to normal saline.", "Forty patients undergoing CPB for coronary artery surgery, using a standardized technical setting, were randomized to receive either Ringer's acetate, dextran 70 (Macrodex), polygeline (Haemaccel) or albumin 4% for volume replacement during and after surgery. The choice of fluid did not affect early complement activation (C3 activation products). Higher values of the terminal complement complex (TCC) were found only at the end of the operation in patients receiving polygeline. There were no differences between any two of the four groups during the postoperative course. The use of blood transfusion or autotransfusion and the degree of haemodilution and hypothermia did not affect complement activation. We conclude that complement activation in association with open-heart surgery is only marginally affected by the choice of fluid for volume replacement.", "The effect of postoperative fluid management on pulmonary extravascular thermal volume (ETVL) as in index of pulmonary extravascular water after coronary artery bypass grafting was compared, using the thermal-dye technique, among five patients who received 5% albumin (group A), five patients who received 6% hydroxyethyl starch (group H), and five who received lactated Ringer's solution (group C). Intraoperatively, all patients received lactated Ringer's solution intravenously, and the cardiopulmonary bypass (CPB) circuit prime included 5% albumin. No statistically significant changes in ETVL occurred postoperatively in any group, nor did ETVL differ significantly between groups. After CPB, colloid osmotic pressure (COP) significantly decreased and pulmonary artery wedge pressure (WP) and the WP-COP gradient significantly increased in each group, implying an increase in transcapillary fluid flux. Cardiac index changed variably. Pulmonary shunt fraction (Qsp/Qt) did not change in groups A and C but decreased during CPB in group H (from 0.22 +/- 0.03 to 0.16 +/- 0.11). Postoperatively, patients in the three groups received similar volumes of fluids and had similar perioperative weight gains. By the next morning (AM1), COP increased in all groups, returning to levels noted before CPB in group C, and exceeding these levels in groups A and H. Wedge pressure was similar in all three groups on AM1. PaO2 decreased significantly, and alveolar-arterial oxygen partial pressure difference increased significantly in all groups on AM1. In Group H, Qsp/Qt returned to levels observed before CPB by AM1 (0.27 +/- 0.09). We conclude that in patients without postoperative increases in WP, ETVL changes minimally during CPB and is not influenced by the type of fluid administered as the primary volume replacement in the postoperative period.", "A prospective, randomized study of patients undergoing abdominal aortic surgery was undertaken to determine the effects of maintaining normal plasma colloid osmotic pressure (COPp) on postoperative renal function and excretion of water and electrolytes. Two groups of 13 patients were given whole blood transfusions to replace blood loss. One group (ALB) received 80 g albumin on the day of operation and 20 g albumin the following three days. The other group (NON-ALB) received no extra albumin. The glomerular filtration rate (GFR) did not change significantly from preoperative values on the first or fourth postoperative day in any of the groups. The differences between the groups were non-significant. COPp could not be correlated to either GFR or sodium or fluid balances. Postoperative sodium and water retention was found to depend on the amount of infused sodium. Unexplained fluid shifts to a \"third space\" did not occur. Administration of albumin in addition to quantitative blood loss replacement is unnecessary and expensive.", "The effect of decreased colloid oncotic pressure, as seen in hypoalbuminemia and hypoproteinemia, upon intestinal function has been well delineated in the surgical literature. Patients undergoing abdominal aortic aneurysm resection or aortoiliac or aortofemoral bypass grafts are almost uniformly hypoalbuminemic postoperatively; with these two facts in mind, a prospective, randomized clinical study was undertaken to identify the role of serum albumin concentration on the length of postoperative ileus in this population. The main hypothesis was that patients whose albumin levels dropped below 3.5 gm/dL would have a more prolonged postoperative hospital course as a result of delay in return of bowel function when compared with those patients in whom the low albumin levels were exogenously acutely replenished to > 3.5 gm/dL. Albumin was replaced to a level greater-than or equal to 3.5 g/dL in one group of 37 patients (AR), with a control group of 32 patients (NR) not receiving any albumin. Return of bowel function was measured by the postoperative day that flatus was documented, as well as the postoperative day oral intake was resumed. Mean values were determined for each group, and t tests did not reveal a significant difference in postoperative day of flatus (AR mean = 4.06 days, NR mean = 4.16 days) or postoperative day of oral intake (AR mean = 4.0, NR mean = 3.75). Additional comparisons between the groups involving the number of postoperative days until a regular diet was begun (AR mean = 6.06, NR mean = 5.48) and length of postoperative hospital stay (AR mean = 9.16, NR mean = 8.43) failed to reveal significant differences.(ABSTRACT TRUNCATED AT 250 WORDS)", "Because several studies have shown a significant inverse correlation between depressed serum concentrations of albumin and hospital morbidity, a study with central total parenteral nutrition (TPN) with normal serum albumin (NSA) in hypoalbuminemic patients was conducted. Sixty-one patients who required central TPN were randomized into one of two groups: group 1 (n = 31) received TPN plus NSA (25 to 37.5 g/day) until their measured serum albumin was greater than 3 g/dl, and group 2 (n = 30), who received TPN alone. All patients were followed for hospital complications until discharge or death. The groups were well matched for age, sex, major diagnoses, initial serum albumin concentrations, hospital complications before TPN, and number of operative procedures. Both groups received comparable doses of energy (37.2 +/- 89 vs. 3.30 +/- 6.2 kcal/kg.day) and protein (1.6 +/- 0.4 vs. 1.6 +/- 0.3 g/kg.day). After initiation of TPN, there were significantly more hospital complications in group 2 (1 = 1.1 +/- 1.4, n = 33; 2 = 2.6 +/- 3.0, n = 80, p less than .01). When complications in the patient groups were stratified, significantly more patients in group 2 developed pneumonia (18 vs. 9, p less than .05) and septicemia (11 vs. 2, p less than .05). Increasing serum albumin concentrations with NSA in hypoalbuminemic patients receiving central TPN appears to be associated with a reduction in hospital morbidity." ]

[ "17464583", "2317057", "10403865", "14693624", "11605924", "7073996", "9392696", "3796922", "12566183", "7362799", "9654537", "74569", "698606" ]

[ "Upright position during the first stage of labor: a randomised controlled trial.", "Maternal position, labor, and comfort.", "Effect of maternal ambulation on labour with low-dose combined spinal-epidural analgesia.", "The effects of prolonged ambulation on labor with epidural analgesia.", "Effect of epidural analgesia with ambulation on labor duration.", "An assessment of radiotelemetry in the monitoring of labour.", "Epidural analgesia compared with combined spinal-epidural analgesia during labor in nulliparous women.", "Effects of sitting position on uterine activity during labor.", "Ambulatory epidural anesthesia and the duration of labor.", "A study of the benefits and acceptability of ambulation in spontaneous labour.", "Lack of effect of walking on labor and delivery.", "Upright posture and the efficiency of labour.", "Ambulation in labour." ]

[ "Evaluation of the upright position during the first stage of labor on pain, patient satisfaction, obstetrical and perinatal outcomes in nullipara women.\n This prospective, randomised, controlled trial included a group of 54 women who were informed and encouraged to adopt the upright position, and a control group of 53 women who were not given this information. The difference between groups was evaluated using the chi2, Wilcoxon and Fisher's Exact tests. Significance was defined as p<0.05. Risk ratios and 95% confidence intervals were calculated.\n No statistically significant differences were found between the groups in baseline characteristics, obstetrical and perinatal outcomes; however, there was a preference among women in both groups for the upright position.\n The upright position during the first stage of labor did not contribute towards a shorter duration of labor; however, it proved to be a safe and well-accepted option for the women of this study.", "The purpose of this study was to determine if women who assumed upright positions during the phase of maximum slope would have a shorter phase of maximum slope in their labor and experience more comfort than women who assumed recumbent positions. Forty laboring women were randomly assigned to either an upright or recumbent position group. Subjects assumed the positions of their assigned group during the phase of maximum slope in their labor (cervical dilatation from 4 cm to 9 cm). Every hour during the phase of maximum slope, each subject was examined vaginally to determine her cervical dilatation and assessed for her level of comfort using the Maternal Comfort Assessment Tool. Women in the upright position group had a significantly shorter phase of maximum slope in labor, but did not significantly differ in comfort level from women in the recumbent group. Newborn Apgar scores were not significantly different between the two groups. Nurses need to be aware that the upright labor positions have the distinct advantages of facilitating efficient uterine contractions and reducing the duration of the phase of maximum slope in labor, with no increase in the discomfort experienced or adverse effect on newborn well-being.", "Two hundred and twenty-nine nulliparous women who requested regional analgesia during labour were given a combined spinal-epidural block. They were randomly allocated to stay in bed or spend at least 20 min of every hour out of bed. There was no significant difference in duration of labour, analgesia requirements, mode of delivery or condition of the baby between the groups. Ambulation appeared to be safe for the mother and baby. Maternal satisfaction with the low-dose combined spinal-epidural was high in both groups.", "Ambulation during labor is becoming more popular, although its impact on the progress of labor and on pain intensity remains unclear. We wondered whether prolonged ambulation with epidural analgesia had a possible effect on duration of labor and pain. In this prospective, randomized trial, 61 parturients with uncomplicated term pregnancies were allocated to be recumbent (n = 31) or to ambulate (n = 30). Epidural analgesia was provided with intermittent administrations of 0.08% bupivacaine-epinephrine plus 1 microg/mL of sufentanil. Of the 30 women assigned to the ambulatory group, 25 actually walked. Their ambulating time was 64 +/- 34 min (mean +/- SD), i.e., 29% +/- 16% of the first stage. There were no differences between the two groups in the length of labor and in pain visual analog scale scores. However, the ambulatory group received smaller doses of bupivacaine (6.4 +/- 2.2 mg/h versus 8.4 +/- 3.6 mg/h; P = 0.01) and of oxytocin (6.0 +/- 3.7 mUI/min versus 10.2 +/- 8.8 mUI/min; P < 0.05). A greater ability to void was also found in the ambulatory group (P < 0.01). Although the duration of labor and pain relief was unchanged, these findings support that ambulation during labor may be advantageous.\n This study compared the duration of labor and pain relief between parturients receiving epidural analgesia who were ambulated or were recumbent. Whereas walking had no impact on either duration of labor or pain relief, it was associated with a reduction in both bupivacaine and oxytocin requirements.", "Ambulatory epidural analgesia (AEA) is a popular choice for labor analgesia because ambulation reportedly increases maternal comfort, increases the intensity of uterine contractions, avoids inferior vena cava compression, facilitates fetal head descent, and relaxes the pelvic musculature, all of which can shorten labor. However, the preponderance of evidence suggests that ambulation during labor is not associated with these benefits. The purpose of this study is to determine whether ambulation with AEA decreases labor duration from the time of epidural insertion to complete cervical dilatation.\n In this prospective, randomized study, 160 nulliparous women with AFA were randomly assigned to one of two groups: AEA with ambulation and AEA without ambulation. AEA blocks were initiated with 15-20 ml ropivacaine (0.07%) plus 100 microg fentanyl, followed by a continuous infusion of 0.07% ropivacaine plus 2 microg/ml fentanyl at 15-20 ml/h. Maternal measured variables included ambulation time, time from epidural insertion to complete dilatation, stage II duration, pain Visual Analogue Scale scores, and mode of delivery. APGAR scores were recorded at 1 and 5 min. Results are expressed as mean +/- SD or median and analyzed using the t test, chi-square, or the Mann-Whitney test at P < or = 0.05.\n The ambulatory group walked 25.0 +/- 23.3 min, sat upright 40.3 +/- 29.7 min, or both. Time from epidural insertion to complete dilatation was 240.9 +/- 146.1 min in the ambulatory group and 211.9 +/- 133.9 min in the nonambulatory group (P = 0.206).\n Ambulatory epidural analgesia with walking or sitting does not shorten labor duration from the time of epidural insertion to complete cervical dilatation.", "Conventional and telemetric monitoring of labour were compared in a randomized study of 200 patients to assess the effect on the pattern of labour, outcome and attitude of the patients. All the telemetry patients had the option of mobility, but only 45% elected to get out of bed, and then often only for short periods. No clear physical benefits accrued from voluntary mobility. Ambulant patients who had spontaneous deliveries had a longer second stage and more of their babies were slow to establish regular respiration. Quantitative subjective assessments of pain, anxiety and comfort were made. Primigravidae with telemetric monitoring who chose to get out of bed had higher pain scores than primigravidae monitored conventionally, but anxiety scores were highest among primigravidae with telemetry who elected to stay in bed. There was a significant bias towards increased anxiety in the lower social classes. Primigravidae gained more reassurance from monitoring than did multigravidae, but there were no differences resulting from whether or not the recording apparatus was within the patients' view. Multigravidae who had experienced both forms of monitoring preferred telemetry because they felt less restricted and less anxious.", "Among nulliparous women, there appears to be an association between the use of epidural analgesia during labor and an increased risk of dystocia. We tested the hypothesis that combined spinal-epidural analgesia, which permits ambulation during labor, is associated with a lower incidence of dystocia than continuous lumbar epidural analgesia.\n Between July 1995 and September 1996, we randomly assigned 761 nulliparous women in spontaneous labor at term who requested epidural analgesia to receive either continuous lumbar epidural analgesia or a combination of spinal and epidural analgesia. Among the women who received combined spinal-epidural analgesia, some were discouraged from walking and others were encouraged to walk. Maternal and neonatal outcomes, the incidence of dystocia necessitating cesarean section, and measures of patients' satisfaction were compared in the two groups.\n There were no significant differences in the overall rate of cesarean section, the incidence of dystocia, the frequency of maternal or fetal complications, the patients' or nursing staff's assessment of the adequacy of analgesia, or the degree of overall satisfaction between the two groups. Significantly more women receiving combined spinal-epidural analgesia had pruritus (P<0.001) and requested additional epidural bolus doses of local anesthetic (P=0.01). For all the women, dystocia necessitating cesarean section was significantly more likely when analgesia was administered with the fetal vertex at a negative station (odds ratio, 2.5; P<0.001) or at less than 4 cm of cervical dilatation (odds ratio, 2.2; P<0.001).\n As compared with continuous lumbar epidural analgesia, the combination of spinal and epidural analgesia is not associated with an overall decrease in the incidence of cesarean delivery.", "To determine which components of uterine activity are affected by different positions of labor, 116 intrauterine pressure records in the sitting and supine positions were analyzed in order to measure resting, contraction, and bearing down pressures. The resting pressure in the sitting position showed consistent elevation compared to the supine position, while the contraction pressure did not differ strikingly in the two positions. The bearing down pressure in the sitting position for nulliparas during the second stage and for multiparas at the time of the 8- to 10-cm dilation was significantly higher than that in the supine position. Also, the sitting position led to a significantly shorter duration of the second stage in nulliparas and the 5- to 10-cm dilation period in multiparas. These findings suggest that the maternal position does not affect uterine contractility, that the increased resting pressure in the sitting position is of some importance in supplementing the downward delivery force, and that the increased bearing down pressure in the sitting position could help to significantly shorten the duration of labor.", "Ambulatory epidural analgesia has become a common option for women in labor in France. We tested the hypothesis that a method of epidural analgesia that allowed women to walk had specific advantages regarding mode of delivery, consumption of local anesthetic, oxytocin requirement, and labor duration.\n Two hundred and twenty-one women with uncomplicated pregnancies who presented in spontaneous labor between 36 and 42 weeks of gestation or who were scheduled for induced labor were randomly divided into two groups, ambulatory and non-ambulatory. All were given intermittent epidural injections of 0.1% ropivacaine with 0.6 microg/ml sufentanil for analgesia during labor (P<0.05 was considered significant). None of the women had previous cesarean delivery.\n There were no significant differences between the two groups in mode of delivery, consumption of local anesthetic, or oxytocin requirement. However, a significant difference was noted in labor duration (173.4+/-109.9 min vs. 236.4+/-130.6 min; P=0.001).\n Walking with ambulatory labor analgesia shortens labor duration but has no other effect on the progress and outcome of labor.", "A prospective study of 300 consecutive deliveries has been made to assess the benefits and acceptability of ambulation during spontaneous labour. Ambulation during the first stage occurred in 48 patients with 55 non-ambulant patients acting as controls. No difference in the length of first or second stage, incidence of fetal distress or mode of delivery was observed. In spite of the lack of apparent advantage to the fetal condition, ambulation was acceptable to both patients and nursing staff and should not be discouraged.", "Walking during labor may reduce patients' discomfort and improve outcomes. We conducted a randomized trial of walking during active labor to determine whether it altered the duration of labor or other maternal or fetal outcomes. Women with uncomplicated pregnancies between 36 and 41 weeks' gestation and in active labor were randomly assigned either to walking or to no walking (usual care). Pedometers were used to quantify walking, and the time spent walking was recorded.\n Of the 536 women assigned to the walking group, 380 actually walked. Their mean (+/-SD) walking time was 56+/-46 minutes. There were no significant differences between the women assigned to the walking group and the 531 women assigned to the usual-care group in the duration of the first stage of labor (6.1 hours in both groups, P=0.83), the need for labor augmentation with oxytocin (23 percent vs. 26 percent, P=0.25), and the use of analgesia (84 percent vs. 86 percent, P=0.59). Similarly, the percentages of women requiring delivery by forceps (4 percent vs. 3 percent, P=0.35) and cesarean section (4 percent vs. 6 percent, P=0.25) were not significantly different. These labor and delivery outcomes were unrelated to walking in both nulliparous and parous women. The infants' outcomes were also similar in the two study groups.\n Walking neither enhanced nor impaired active labor and was not harmful to the mothers or their infants.", "The claim that an upright maternal posture during labour improves the efficiency of the uterus to the benefit of both mother and fetus has been investigated in a randomised prospective study. 40 patients undergoing induction of labour were allocated to a recumbent group or an upright group. No differences were found between the groups in the length of labour, mode of delivery, requirements of oxytocic and analgesic drugs, or fetal and neonatal condition. Our data do not support calls to change conventional intrapartum nursing attitudes.", "In a randomised prospective study of 68 women in spontaneous labour half were allocated to an ambulant group and half to a recumbent group. The duration of labour was significantly shorter, the need for analgesia significantly less, and the incidence of fetal heart abnormalities significantly smaller in the ambulant group than in the recumbent group. Apgar scores at one and five minutes were also significantly greater in the ambulant group. More patients in the recumbent group required augmentations with oxytocic drugs. There was no statistically significant difference in the third stage loss in the two groups. Ambulation in labour should be encouraged: it may bring human benefits while allowing the advantages of hospital supervision." ]

[ "2720328", "3150063", "15227689" ]

[ "Thigh length versus knee length stockings in the prevention of deep vein thrombosis.", "Cost effectiveness and efficacy of below knee against above knee graduated compression stockings in the prevention of deep vein thrombosis.", "Randomized clinical trial of low molecular weight heparin with thigh-length or knee-length antiembolism stockings for patients undergoing surgery." ]

[ "Above-knee graduated compression stockings are effective in preventing postoperative deep vein thrombosis, but are more expensive and less acceptable than below-knee stockings. One hundred and fourteen patients undergoing major abdominal surgery were randomly allocated to wear above-knee or below-knee graduated compression stockings. Deep vein thromboses were diagnosed by isotope uptake in three of 56 patients (5.4 per cent) in the above-knee group and one of 58 patients (1.7 per cent) in the below-knee group. These differences are not statistically significant. Results suggest that below-knee stockings are as effective as above-knee in the prevention of postoperative deep vein thrombosis.", "nan", "This was a randomized clinical trial to determine the efficacy and safety of a 'blanket' protocol of low molecular weight heparin (LMWH) and the best length of antiembolism stocking, for every patient requiring surgery under general anaesthesia.\n Of 426 patients interviewed, 376 agreed to be randomized to receive one of three types of stocking: thigh-length Medi thrombexin climax (Medi UK, Hereford, UK), knee-length thrombexin climax and thigh-length Kendall T.E.D. (Tyco Healthcare UK, Redruth, UK). All patients received LMWH thromboprophylaxis. Duplex ultrasonography was used to assess the incidence of postoperative deep vein thrombosis (DVT).\n No postoperative DVT occurred in 85 patients at low or moderate risk. Nineteen DVTs occurred, all in the 291 high-risk patients: two with the Medi thigh-length stockings, 11 with the Medi knee-length stockings (odds ratio 0.18 (95 per cent confidence interval 0.04 to 0.82); P = 0.026) and six with the Kendall T.E.D. thigh-length stockings. No patient developed a pulmonary embolism. Stocking groups were similar for age, sex, thromboembolic risk, type of operation and compliance. One significant bleeding complication occurred.\n A single protocol comprising LMWH and thigh-length stockings abolished DVT in low- and moderate-risk patients, and reduced the rate of DVT to 2 per cent in high-risk patients.\n Copyright 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd." ]

[ "16099293", "17105795", "19433689" ]

[ "Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911).", "Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial.", "Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95." ]

[ "Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer.\n After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat.\n The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p<0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=0.0726).\n Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival.", "Despite a stage-shift to earlier cancer stages and lower tumor volumes for prostate cancer, pathologically advanced disease is detected at radical prostatectomy in 38% to 52% of patients. However, the optimal management of these patients after radical prostatectomy is unknown.\n To determine whether adjuvant radiotherapy improves metastasis-free survival in patients with stage pT3 N0 M0 prostate cancer.\n Randomized, prospective, multi-institutional, US clinical trial with enrollment between August 15, 1988, and January 1, 1997 (with database frozen for statistical analysis on September 21, 2005). Patients were 425 men with pathologically advanced prostate cancer who had undergone radical prostatectomy.\n Men were randomly assigned to receive 60 to 64 Gy of external beam radiotherapy delivered to the prostatic fossa (n = 214) or usual care plus observation (n = 211).\n Primary outcome was metastasis-free survival, defined as time to first occurrence of metastatic disease or death due to any cause. Secondary outcomes included prostate-specific antigen (PSA) relapse, recurrence-free survival, overall survival, freedom from hormonal therapy, and postoperative complications.\n Among the 425 men, median follow-up was 10.6 years (interquartile range, 9.2-12.7 years). For metastasis-free survival, 76 (35.5%) of 214 men in the adjuvant radiotherapy group were diagnosed with metastatic disease or died (median metastasis-free estimate, 14.7 years), compared with 91 (43.1%) of 211 (median metastasis-free estimate, 13.2 years) of those in the observation group (hazard ratio [HR], 0.75; 95% CI, 0.55-1.02; P = .06). There were no significant between-group differences for overall survival (71 deaths, median survival of 14.7 years for radiotherapy vs 83 deaths, median survival of 13.8 years for observation; HR, 0.80; 95% CI, 0.58-1.09; P = .16). PSA relapse (median PSA relapse-free survival, 10.3 years for radiotherapy vs 3.1 years for observation; HR, 0.43; 95% CI, 0.31-0.58; P<.001) and disease recurrence (median recurrence-free survival, 13.8 years for radiotherapy vs 9.9 years for observation; HR, 0.62; 95% CI, 0.46-0.82; P = .001) were both significantly reduced with radiotherapy. Adverse effects were more common with radiotherapy vs observation (23.8% vs 11.9%), including rectal complications (3.3% vs 0%), urethral strictures (17.8% vs 9.5%), and total urinary incontinence (6.5% vs 2.8%).\n In men who had undergone radical prostatectomy for pathologically advanced prostate cancer, adjuvant radiotherapy resulted in significantly reduced risk of PSA relapse and disease recurrence, although the improvements in metastasis-free survival and overall survival were not statistically significant. Trial Registration clinicaltrials.gov Identifier: NCT00394511.", "Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP.\n After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival.\n Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%.\n Adjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival." ]

[ "12683708" ]

[ "Role of gallium arsenide laser irradiation at 890 nm as an adjunctive to anti-tuberculosis drugs in the treatment of pulmonary tuberculosis." ]

[ "Tuberculosis is a global emergency with about nine million people developing disease every year. The long duration of treatment has emerged as a major obstacle in the control of tuberculosis. There is a need for development of new drugs and or shortened therapy.\n The present study was carried out to explore whether any benefit could be achieved by the addition of low level energy laser therapy (LLLT) to the conventional anti-tubercular chemotherapy. One-hundred-thirty new sputum smear positive patients of pulmonary tuberculosis were enrolled to evaluate the bio-stimulatory effects of Gallium Arsenide laser irradiation at 890 nm, as an adjuvant therapy. These patients were randomly divided into two groups to receive either LLLT or sham irradiation (control) concomitantly with anti-tuberculosis chemotherpy.\n The patients treated with semiconductor laser as an adjuvant therapy along with anti-tuberculosis drugs had a faster clearance of tubercle bacilli from the sputum as compared to the control group (P value at :45 days=0.1392, 60 days=0.0117, 75 days=0.00805, 90 days=0.00739).\n These findings provide preliminary evidence that low level laser therapy with Gallium Arsenide laser may be a promising adjunctive therapy for patients with tuberculosis. Faster conversion of sputum should prevent the development of resistant mutants." ]

[ "19216268", "17888016", "16672024", "20467621", "18757179", "17622003", "12656875", "15877756", "14731181", "20467615", "19681938", "17501979" ]

[ "Clinical and histologic evaluation of allogeneic bone matrix versus autogenous bone chips associated with titanium-reinforced e-PTFE membrane for vertical ridge augmentation: a prospective pilot study.", "Evaluation of aesthetics of implant-supported single-tooth replacements using different bone augmentation procedures: a prospective randomized clinical study.", "Resorbable screws for fixation of autologous bone grafts.", "Vertical ridge augmentation of the atrophic posterior mandible with interpositional block grafts: bone from the iliac crest versus bovine anorganic bone.", "The effect of ultrasound on osteogenesis in the vertically distracted edentulous mandible: a double-blind trial.", "Vertical ridge augmentation with autogenous bone grafts: resorbable barriers supported by ostheosynthesis plates versus titanium-reinforced barriers. A preliminary report of a blinded, randomized controlled clinical trial.", "Satisfaction and psychosocial aspects of patients with an extremely resorbed mandible treated with implant-retained overdentures. A prospective, comparative study.", "Does platelet-rich plasma promote remodeling of autologous bone grafts used for augmentation of the maxillary sinus floor?", "Alveolar distraction osteogenesis vs. vertical guided bone regeneration for the correction of vertically deficient edentulous ridges: a 1-3-year prospective study on humans.", "Vertical bone augmentation versus 7-mm-long implants in posterior atrophic mandibles. Results of a randomised controlled clinical trial of up to 4 months after loading.", "Inlay versus onlay iliac bone grafting in atrophic posterior mandible: a prospective controlled clinical trial for the comparison of two techniques.", "Autogenous onlay bone grafts vs. alveolar distraction osteogenesis for the correction of vertically deficient edentulous ridges: a 2-4-year prospective study on humans." ]

[ "To compare clinically and histologically an allogeneic bone matrix to autogenous bone chips in the vertical ridge augmentation technique using titanium-reinforced e-PTFE membranes.\n The study protocol was designed to include patients with bilateral posterior mandibular partial edentulism. Patients were treated with a split-mouth design approach: each side was randomly assigned to the test group (titanium-reinforced e-PTFE membrane and allogeneic bone matrix) or to the control group (titanium-reinforced e-PTFE membrane and autogenous bone chips). Different clinical parameters including the amount of vertically regenerated bone (DSB) and biologic complications were recorded. Histomorphometric analysis and the bone-implant contact percentage were performed.\n Five female patients were enrolled in the study. Ten edentulous sites were vertically augmented and 25 implants were inserted (13 test group, 12 control group) with a staged approach. In the test group no membrane was exposed. The mean bone regeneration was 4.70 mm (SD 0.48 mm). All 13 implants appeared clinically stable. In the control group, 1 membrane was exposed after 2 months. The mean crestal bone regeneration was 4.10 mm (SD 0.88 mm). All 12 implants were stable at the abutment connection. Nine biopsy specimens from the regenerated areas were evaluated. Vertical bone regeneration was evident in both groups since all the samples demonstrated trabecular bone with different degrees of maturation and mineralization in the regenerated area.\n Within the limits of this study based on 5 patients, it appears that the behavior of the allogeneic bone matrix is similar to that of autogenous bone chips when used for vertical ridge augmentation by means of guided bone regeneration techniques. Both grafts demonstrated analogous histologic characteristics. Nevertheless, long-term clinical studies are needed to confirm these preliminary results.", "The aim of this study was to evaluate the aesthetics of implant-supported single-tooth replacements using different augmentation procedures in a prospective study with the use of an objective rating index and with a subjective patient questionnaire, and to compare the results with each other.\n Ninety-three patients with a single-tooth gap in the anterior zone of the maxilla were selected for the study. All patients had a local bone defect that needed augmentation before placement of an endosseous implant with sufficient initial stability. Aesthetics of the implant-supported crown and adjacent mucosa was rated by a prosthodontist 1 year after placement of the porcelain crown. Aesthetics was rated using the Implant Crown Aesthetic Index. A subjective appreciation of the final result was assessed with a patient questionnaire.\n The Implant Crown Aesthetic Index reveals a mean overall score of 4.8, with an acceptable result in 66% of the cases. Results of the satisfaction questionnaire reveal a mean overall score of 8.5 with an acceptable result in 100% of the cases. There is no correlation between results of the Index and the questionnaire for the overall and the crown score. The patients' opinion and the professionals' opinion about the peri-implant mucosa do show a significant correlation.\n The peri-implant mucosa is rated as less satisfactory than the implant-supported crown by both the dental professional and patients. The dental professional was less satisfied with respect to the total result and results of the crown than the patients.", "The aim of this study was to evaluate the suitability of resorbable screws made of poly (D.L-lactide) acid (PDLLA) for fixation of autologous bone grafts related to graft regeneration and osseointegration of dental implants. In eight edentulous patients suffering from insufficient retention of their upper denture related to a severely resorbed maxilla, the floor of both maxillary sinus and width of the alveolar crest were augmented with an autologous bone graft from the iliac crest. Randomly, the bone graft used to augment the alveolar crest was fixed with two titanium screws on one side and two resorbable screws on the other side (split-mouth design). Three months after the reconstruction, a bone biopsy was taken with a trephine including one resorbable screw (N = 8). Subsequently, six implants were placed in the left and right posterior maxilla. Six months later, at the abutment connection, a bone biopsy was taken including the other resorbable screw (N = 8). The biopsies were processed for light microscopic examination. In addition, clinical parameters were scored. Wound healing was uneventful. Clinically no difference in wound healing was observed between sides treated with either a resorbable or titanium screw. No implants were lost. Six months after implantation, implant retained overdentures could be fabricated in all patients. All patients functioned well with their overdentures (follow-up 22.2 +/- 4.3 months). Three as well as 9 months after insertion (remnants of), the resorbable screws were still visible after reflecting the mucoperiosteum. Histological examination confirmed that a considerable quantity of remnants of the resorbable screws was still present, although areas with some fragmentation of the PDLLA were also observed. The screws were separated by a fibrous tissue layer containing many giant cells from the bone. Particles of PDLLA were observed within these giant cells. This study revealed that resorbable screws made of PDLLA can be used for fixation of bone grafts. The bulk of the PDLLA material is still present after 9 months.", "To compare the efficacy, complications and patient preference of two different techniques for vertical bone augmentation of the posterior mandible: bone blocks harvested from the iliac crest versus anorganic bovine bone blocks (Bio-Oss(R)) were used as inlays.\n Ten partially edentulous patients, requiring bilateral and vertical bone augmentation of the posterior mandible (having 5 to 7mm of residual crestal height and at least 5mm thickness above the mandibular canal to allow for implant placement) had their posterior mandibles randomly allocated to both interventions. Resorbable barriers were used to cover the grafts. After 4 months, implants were inserted, and after a further 4 months, provisional prostheses were inserted. Definitive prostheses were delivered 4 months later. Prosthesis and implant failures, the amount of vertically regenerated bone measured on computerised tomography (CT) scans, any complications, the time needed to fully recover mental nerve sensitivity and patient preference were all recorded. All patients were followed up for up to 1 month after the delivery of the final restorations.\n Up to 5 months post-loading no patients dropped out or were excluded. Both procedures obtained significant bone gain and achieved the desired results. Four months after grafting, autogenous bone loss was on average 1.1mm (P=0.088) and Bio-Oss 0.6mm (P=0.001). There were no statistically significant differences in bone gain and maintenance among the two procedures. The sides treated with Bio-Oss recovered their full mental nerve sensitivity significantly faster than those treated with autogenous bone (4 versus 6.3 days). Three complications occurred during graft healing; two in the autogenous bone group and one determining the complete failure of the augmentation procedure. No implants or prosthesis could be placed in the planed area. There was no statistically significant differences in the occurrence of complications between the procedures. After implant placement one complication occurred in the autogenous bone group (probably as a consequence of a previous complication). Patients significantly preferred the treatment with Bio-Oss: 3 weeks after augmentation seven patients preferred Bio-Oss and three patients found the treatments to be 'equally good' (odds ratio 0.045 [5% confidence interval (CI) 0.00 to 0.87], P=0.04). One month after delivery of the final prostheses, eight patients preferred Bio-Oss and two patients found the treatments to be 'equally good' (odds ratio 0.03 [95% CI 0.00 to 0.64], P=0.02).\n This pilot study suggests that it might be sensible to use Bio-Oss blocks rather than bone harvested from the iliac crest as the interpositional graft in the treatment of resorbed posterior mandible, as patient discomfort is reduced.", "Whether low intensity pulsed ultrasound therapy stimulates osteogenesis in mandibular distraction was investigated in a double-blind trial. Nine patients underwent a vertical mandibular distraction over a distance of 5.1+/-1.2mm. Ultrasound or placebo therapy was started daily from the first day of distraction. After 46+/-8.1 days consolidation, two endosseous implants were inserted and a transmandibular biopsy was taken. Ultrasonographs were taken regularly to follow osteogenesis inside the gap. There were no complications during the 44+/-7.1 months of follow-up. Microradiographic measurements of the biopsies revealed no differences in the area of mineralized tissue in the distraction gap. The cranially distracted bone segment appeared significantly more radiolucent than the caudal bone. Histological examination showed large lacunae inside the cranially distracted bone segment, filled with clusters of osteoclasts and surrounded by clear tetracycline double labels. Within the distraction gap, woven bone was present, with no apparent differences between the treatment groups. Ultrasonographic follow-up revealed that osteogenesis inside the distraction gap progresses from 4 to 20 weeks post distraction, with no differences between the ultrasound and the placebo groups. In summary, ultrasound treatment does not appear to stimulate bone formation in the severely resorbed vertical distracted mandible.", "To compare the efficacy and complications of 2 different techniques for vertical bone augmentation at implant placement: particulated autogenous bone grafts covered either by resorbable collagen barriers supported by osteosynthesis plates (test) or by nonresorbable titanium-reinforced e-polytetrafluoroethylene (e-PTFE) barrier (control).\n Twenty-two partially edentulous patients requiring vertical bone augmentation were randomly allocated to 2 treatment groups of 11 patients each. Early implant failures, the amount of vertically regenerated bone measured intrasurgically, and biologic complications were recorded by an independent assessor blinded to the group allocation. The implant site requiring the most vertical bone regeneration was selected in each patient for the bone gain assessment. Patients were followed from implant insertion with simultaneous augmentation procedure to insertion of the provisional restoration. Paired and independent t tests and Fisher exact tests were conducted to compare means and proportions at the .05 level of significance.\n No patient dropped out or was excluded. Both procedures obtained significant bone gain and achieved the desired results, 2.2 mm (SD 1.5; P < .001) on average for resorbable barriers and 2.5 mm (SD 1.1) for nonresorbable barriers (P < .001). There was no statistically significant difference in bone gain between the 2 procedures (P = .58). Complications occurred in 40% of the patients. There was no difference in occurrence of complications between the procedures (P > .99). Three major complications occurred, 2 in the resorbable group and 1 in the nonresorbable group, which determined the complete failure of the augmentation procedure.\n Both techniques were effective in augmenting bone; however, both were associated with complications. Clinicians and patients must carefully weigh risks and benefits when considering the use of vertical guided bone regeneration.", "The objective of the present report was to study the effect of implant treatment on subjective parameters in edentulous patients with an extremely resorbed mandible. Three different treatment modalities to support an overdenture were compared: transmandibular implant according to Bosker, augmentation of the mandible followed by four endosseous implants, and the insertion of four short endosseous implants. Sixty patients [50 women and 10 men, mean (+/- SD) age 59 (+/- 11) years] met the inclusion criteria and were assigned in one of the three treatment groups. Before treatment and 12 months after placement of the new overdentures, denture satisfaction, psychosocial aspects and experiences during the surgical phase were assessed with a battery of questionnaires. After 1 year, 58 patients were available for evaluation: one patient had died, and one patient had moved out of the region. There was a significant improvement of patient satisfaction and psychosocial functioning in all three treatment groups. At the 1-year evaluation, differences amongst the three groups were not significant. However, in terms of discomfort and pain during the surgical phase as well as the length of this phase (at least 6 months), the augmentation using an autologous bone graft from the iliac crest followed by inserting four endosseous implants 3 months later appeared the least favorite option of the three modalities studied.", "The aim of this study was to evaluate the effect of platelet-rich plasma (PRP) on remodeling of autologous bone grafts used for augmentation of the floor of the maxillary sinus. In five edentulous patients suffering from insufficient retention of their upper denture related to a severely resorbed maxilla, the floor of both maxillary sinus was augmented with an autologous bone graft from the iliac crest. Randomly, PRP was added to the bone graft used to augment the floor of the left or right sinus (split-mouth design). Three months after the reconstruction, bone biopsies were taken with a trephine from the planned implant sites (N=30). Subsequently, three implants were placed in the left and right posterior maxilla. Microradiograms were made of all biopsies (N=30), whereafter the biopsies were processed for light microscopic examination. In addition, clinical parameters were scored. Wound healing was uneventful, clinically no difference was observed between the side treated with PRP or not. Also microradiographical and histomorphological examination of the biopsies revealed no statistical difference between the PRP- and non-PRP side. One implant placed in the PRP side of the graft was lost during the healing phase. Implant-retained overdentures were fabricated 6 months after implantation. All patients functioned well (follow-up 20.2+/-4.3 months). In this study, no beneficial effect of PRP on wound healing and bone remodeling was observed. It is posed that PRP has no additional value in promoting healing of grafted non-critical size defects.", "The purpose of this prospective study was to compare vertical guided bone regeneration (GBR) and vertical distraction osteogenesis (DO) for their ability in correcting vertically deficient alveolar ridges and their ability in maintaining over time the vertical bone gain obtained before and after implant placement. Eleven patients (group 1) were treated by means of vertical GBR with autogenous bone and e-PTFE membranes, while 10 patients (group 2) were treated by means of DO. In group 1, six patients received implants at the time of GBR (subgroup 1A), while five patients had implants placed at the time of membrane removal (subgroup 1B). In group 2, implants were placed at the time of distraction device removal. A total of 25 implants were placed in group 1 and 34 implants were placed in group 2 patients. Three to 5 months after implant placement, patients were rehabilitated with implant-borne dental prostheses. The following parameters were evaluated: (a) bone resorption of the regenerated ridges before and after implant placement; (b) peri-implant clinical parameters 1, 2, and 3 years after prosthetic loading of implants; (c) survival and success rates of implants. Bone resorption values before and after implant placement were significantly higher in group 1. The results suggested that both techniques may improve the deficit of vertically resorbed edentulous ridges, although distraction osteogenesis seems to be more predictable as far as the long-term prognosis of vertical bone gain is concerned. Implant survival rates as well as peri-implant clinical parameters do not differ significantly between the two groups, whereas the success rate of implants placed in group 2 patients was higher than that obtained in group 1 patients.", "To evaluate whether 7-mm-long implants could be a suitable alternative to longer implants placed in vertically augmented bone for the treatment of atrophic posterior mandibles.\n Sixty partially edentulous patients having 7 to 8 mm of residual crestal height and at least 5.5 mm thickness measured on a computed tomography scan above the mandibular canal were randomised to receive either two to three submerged 7-mm-long NanoTite External Hex implants (Biomet 3i) or 10-mm or longer implants (30 patients per group) placed in vertically augmented bone. Bone was augmented with anorganic bovine bone blocks (Bio-Oss) using a sandwich technique and resorbable barriers. The grafts were left healing for 5 months before placing the implants, which were submerged. Four months after implant placement, provisional acrylic prostheses were delivered. Definitive screw-retained metal-ceramic prostheses were delivered 4 months later. Outcome measures were: prosthesis and implant failures, any complications, and time needed to fully recover mental nerve sensitivity. All patients were followed up to the delivery of the final restorations (4 months after loading).\n No patient dropped out. In two patients of the augmented group, there was not enough space to place 10-mm or longer implants as planned and 7-mm-long implants were used instead. The most likely reason for this is that the Bio-Oss blocks fractured in many pieces at placement. One prosthesis could not be placed when planned in the 7-mm group versus three prostheses in the augmented group, because of failure of one implant in each patient. The difference was not statistically significant. All implants were successfully replaced and final prostheses delivered. Four complications (wound dehiscence) occurred during graft healing in the augmented group (one possibly associated with the failure of one implant) versus none in the 7-mm-long implant group. The difference was not statistically significant. No patient suffered from permanent paraesthesia of the alveolar inferior nerve; however, sensitivity was recovered significantly faster in the short implant group.\n The early results of this study suggest that, when the residual bone height over the mandibular canal is between 7 and 8 mm, 7-mm short implants might be a preferable choice since the treatment is faster, cheaper and associated with less morbidity than vertical bone augmentation. These preliminary results must be confirmed by follow-ups of 5 years or more in order to monitor the performance of short implants over time.", "To compare the efficacy of inlay and onlay bone grafting techniques in terms of vertical bone formation and implant outcomes for correcting atrophic posterior mandibles.\n Twenty surgical sites were assigned to two treatment groups, inlay and onlay, with iliac crest as donor site. After 3 to 4 months, 43 implants were placed and loaded 4 months later. The median follow up after loading was 18 months.\n For the inlay versus onlay group, median bone gain was 4.9 versus 6.5 mm (p = .019), median bone resorption was 0.5 versus 2.75 mm (p < .001), and median final vertical augmentation was 4.1 versus 4 mm (p = .190). The implant survival rate was 100% in both groups, while the implant success rate was 90% versus 86.9% (p = .190, not significant). A minor and major complication rate of 20% and 10%, respectively, for both groups was encountered.\n Inlay results in less bone resorption and more predictable outcomes, but requires an experienced surgeon. In contrast, onlay results in greater bone resorption and requires a bone block graft oversized in height, but involves a shorter learning curve. Once implant placement has been carried out, the outcomes are similar for both procedures.", "The purposes of this study were to compare: (a) autogenous bone grafts (ABG) and distraction osteogenesis (DO) for their ability in correcting vertically deficient mandibular ridges and their capability in maintaining over time the vertical bone gain obtained before and after implant placement; and (b) the survival and success rates of implants placed in the reconstructed or distracted areas.\n In a 2-year period (2001-2002), 17 patients presenting with vertically atrophied partially edentulous mandibles requiring implant-supported prosthetic rehabilitation, were included in this study. Patients were randomly assigned to two groups. Eight patients (group 1) were treated with ABG harvested from the mandibular ramus, while nine patients (group 2) were treated by means of DO. In group 1, patients received implants 4-5 months after the reconstructive procedure, while in group 2 implants were placed at the time of distraction device removal (approximately 3 months after the completion of distraction). A total of 19 endosseous implants were placed in group 1, and 21 implants were placed in group 2 patients. For both groups, after an additional 3-5-month period, prosthetic rehabilitation was started.\n Bone resorption before implant placement was significantly higher in group 1 (P=0.01), while no statistically significant differences were found between the two groups as far as survival and success rates of implants and peri-implant bone resorption after the start of prosthetic loading were concerned.\n The results suggested that: (a) both techniques may effectively improve the deficit of vertically resorbed edentulous ridges; (b) survival and success rates of implants placed in the reconstructed/distracted areas are consistent with those of implants placed in native bone." ]

[ "20683766", "16920077" ]

[ "A pilot randomized controlled trial of omega-3 fatty acids for autism spectrum disorder.", "Omega-3 fatty acids supplementation in children with autism: a double-blind randomized, placebo-controlled pilot study." ]

[ "We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (± 4.8) points in the omega-3 group compared to 0.3 (± 7.2) points in the placebo group (p = 0.40; effect size = 0.38). Correlations were found between decreases in five fatty acid levels and decreases in hyperactivity, and the treatment was well tolerated. Although this pilot study did not find a statistically significant benefit from omega-3 fatty acids, the small sample size does not rule out small to moderate beneficial effects.", "There is increasing evidence that fatty acid deficiencies or imbalances may contribute to childhood neurodevelopmental disorders.\n We conducted a randomized, double-blind, placebo-controlled 6-week pilot trial investigating the effects of 1.5 g/d of omega-3 fatty acids (.84 g/d eicosapentaenoic acid, .7 g/d docosahexaenoic acid) supplementation in 13 children (aged 5 to 17 years) with autistic disorders accompanied by severe tantrums, aggression, or self-injurious behavior. The outcome measure was the Aberrant Behavior Checklist (ABC) at 6 weeks.\n We observed an advantage of omega-3 fatty acids compared with placebo for hyperactivity and stereotypy, each with a large effect size. Repeated-measures ANOVA indicated a trend toward superiority of omega-3 fatty acids over placebo for hyperactivity. No clinically relevant adverse effects were elicited in either group.\n The results of this study provide preliminary evidence that omega-3 fatty acids may be an effective treatment for children with autism." ]

[ "16983741", "16971718", "21899712", "17008704", "6423263" ]

[ "Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer.", "Chemotherapy with preoperative radiotherapy in rectal cancer.", "Initial results of a randomized controlled trial comparing clinical and pathological downstaging of rectal cancer after preoperative short-course radiotherapy or long-term chemoradiotherapy, both with delayed surgery.", "Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203.", "Final results of a randomized trial on the treatment of rectal cancer with preoperative radiotherapy alone or in combination with 5-fluorouracil, followed by radical surgery. Trial of the European Organization on Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group." ]

[ "Neoadjuvant chemoradiotherapy does not alter anal sphincter preservation or postoperative complications compared with short-course radiotherapy alone in patients with clinical stage T3 or T4 resectable rectal cancer. The aim of this study was to compare survival, local control and late toxicity in the two treatment groups.\n The study randomized 312 patients to receive either preoperative irradiation (25 Gy in five fractions of 5 Gy) and surgery within 7 days or chemoradiation (50.4 Gy in 28 fractions of 1.8 Gy, bolus 5-fluorouracil and leucovorin) and surgery 4-6 weeks later. The median follow-up of living patients was 48 (range 31-69) months.\n Early radiation toxicity was higher in the chemoradiation group (18.2 versus 3.2 per cent; P < 0.001). The actuarial 4-year overall survival was 67.2 per cent in the short-course group and 66.2 per cent in the chemoradiation group (P = 0.960). Disease-free survival was 58.4 versus 55.6 per cent (P = 0.820), crude incidence of local recurrence was 9.0 versus 14.2 per cent (P = 0.170) and severe late toxicity was 10.1 versus 7.1 per cent (P = 0.360) respectively.\n Neoadjuvant chemoradiation did not increase survival, local control or late toxicity compared with short-course radiotherapy alone.", "Preoperative radiotherapy is recommended for selected patients with rectal cancer. We evaluated the addition of chemotherapy to preoperative radiotherapy and the use of postoperative chemotherapy in the treatment of rectal cancer.\n We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy, preoperative chemoradiotherapy, preoperative radiotherapy and postoperative chemotherapy, or preoperative chemoradiotherapy and postoperative chemotherapy. Radiotherapy consisted of 45 Gy delivered over a period of 5 weeks. One course of chemotherapy consisted of 350 mg of fluorouracil per square meter of body-surface area per day and 20 mg of leucovorin per square meter per day, both given for 5 days. Two courses were combined with preoperative radiotherapy in the group receiving preoperative chemoradiotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy; four courses were planned postoperatively in the group receiving preoperative radiotherapy and postoperative chemotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy. The primary end point was overall survival.\n We enrolled 1011 patients in the trial. There was no significant difference in overall survival between the groups that received chemotherapy preoperatively (P=0.84) and those that received it postoperatively (P=0.12). The combined 5-year overall survival rate for all four groups was 65.2%. The 5-year cumulative incidence rates for local recurrences were 8.7%, 9.6%, and 7.6% in the groups that received chemotherapy preoperatively, postoperatively, or both, respectively, and 17.1% in the group that did not receive chemotherapy (P=0.002). The rate of adherence to preoperative chemotherapy was 82.0%, and to postoperative chemotherapy was 42.9%.\n In patients with rectal cancer who receive preoperative radiotherapy, adding fluorouracil-based chemotherapy preoperatively or postoperatively has no significant effect on survival. Chemotherapy, regardless of whether it is administered before or after surgery, confers a significant benefit with respect to local control. (ClinicalTrials.gov number, NCT00002523 [ClinicalTrials.gov].).\n Copyright 2006 Massachusetts Medical Society.", "The aim of this study was to compare the downstaging achieved after long-course chemoradiotherapy (chRT) and short-term radiotherapy (sRT) followed by delayed surgery.\n A randomized controlled trial was carried out. Eighty-three patients with resectable stage II and III rectal adenocarcinoma were randomized to receive long-course chemoradiotherapy (46) and short-term radiotherapy (5×5 Gy) (37). Surgery was performed 6 weeks after preoperative treatment in both groups.\n The R0 resection rate was 91.3% in the chRT and 86.5% in the sRT group (P=0.734). Sphincter preservation rates were 69.6%vs 70.3% (P=0.342) and postoperative complication rates were 26.1%vs 40.5% (P=0.221). There were more patients with early pT stage [pT0 (complete pathological response) pT1] in the chRT group [21.8%vs 2.7% (P=0.03)] and more patients with pT3 disease in the sRT group [75.7%vs 52.2% (P=0.036)]. There were no differences in pN stage and lymphatic or vascular invasion in either group. Pathological downstaging (stage 0 and I) was observed in eight (21.6%) patients in the sRT group and in 18 (39.1%) in the chRT group (P=0.07). Tumours were smaller after preoperative ChRT (2.5 cm vs 3.3 cm; P=0.04).\n Long-course preoperative chemoradiation resulted in greater statistically significant tumour downsizing and downstaging compared with short-term radiation, but there was no difference in the R0 resection rates. Similar postoperative morbidity was observed in each group.\n © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.", "In 1992, preoperative radiotherapy was considered in France as the standard treatment for T3-4 rectal cancers. The present randomized trial compares preoperative radiotherapy with chemoradiotherapy.\n Patients were eligible if they presented a resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination. Preoperative radiotherapy with 45 Gy in 25 fractions during 5 weeks was delivered. Concurrent chemotherapy with fluorouracil 350 mg/m2/d during 5 days, together with leucovorin, was administered during the first and fifth week in the experimental arm. Surgery was planned 3 to 10 weeks after the end of radiotherapy. All patients should receive adjuvant chemotherapy with the same fluorouracil/leucovorin regimen. The primary end point of the trial was overall survival.\n A total of 733 patients were eligible. Grade 3 or 4 acute toxicity was more frequent with chemoradiotherapy (14.6% v 2.7%; P < .05). There was no difference in sphincter preservation. Complete sterilization of the operative specimen was more frequent with chemoradiotherapy (11.4% v 3.6%; P < .05). The 5-year incidence of local recurrence was lower with chemoradiotherapy (8.1% v 16.5%; P < .05). Overall 5-year survival in the two groups did not differ.\n Preoperative chemoradiotherapy despite a moderate increase in acute toxicity and no impact on overall survival significantly improves local control and is recommended for T3-4, N0-2, M0 adenocarcinoma of the middle and distal rectum.", "To improve surgical results of potentially operable rectal cancer, the European Organization on Research and Treatment of Cancer conducted a two-arm randomized clinical trial to compare the efficiency of preoperative administration of radiotherapy, with or without 5-fluorouracil before radical surgery. Two hundred forty-seven eligible patients were admitted from November 1972 through April 1976. The overall survival observed in the group treated with preoperative radiotherapy appears to be better than in the group of patients where preoperative combined modality was administered. Five-year survival is 59% versus 46% with a marginal statistical significance of P = 0.06. Although the combined modality arm had a higher incidence of side effects and postoperative deaths, it had a greater effect than the radiotherapy-alone arm in controlling the disease process, mainly distant metastases to the liver with a result bordering on statistical significance (P = 0.07). The incidence of nonmalignant and intercurrent deaths were higher in the combined modality group, whereas deaths due to malignancy were higher in the radiotherapy-alone group. Observing more stringent selection in disease and patients' criteria, side effects and intercurrent deaths can be effectively reduced with further improvement in adjuvant therapy results." ]

[ "3445374", "3555083", "17230289", "9469276", "8801151", "9501783", "12014765", "2665493", "7540566", "1709781" ]

[ "[Intra-umbilical administration of oxytocin in the treatment of retained placenta].", "The effect of oxytocin injection into the umbilical vein for the management of the retained placenta.", "Avoiding manual removal of placenta: evaluation of intra-umbilical injection of uterotonics using the Pipingas technique for management of adherent placenta.", "Intraumbilical oxytocin for the management of retained placenta: a randomized controlled trial.", "Intraumbilical vein injection of prostaglandin F2 alpha in retained placenta.", "Intra-umbilical vein injection and retained placenta: evidence from a collaborative large randomised controlled trial. Grupo Argentino de Estudio de Placenta Retenida.", "Is there a place for intra-umbilical oxytocin for the management of retained placenta?", "Removing a retained placenta by oxytocin--a controlled study.", "Intraumbilical oxytocin for management of retained placenta.", "Umbilical vein administration of oxytocin for the management of retained placenta: is it effective?" ]

[ "nan", "In a single-blind study 51 patients with retention of the placenta were randomized into one of three groups: Group 1 was given 10 IU of oxytocin in 10 ml of sodium chloride into the umbilical vein; group 2 was given 10 ml of sodium chloride; group 3 was treated with manual removal of the placenta. No significant differences were recorded in groups 1 and 2, and no advantages were found in comparison with the procedure normally used.", "Manual removal of placenta is performed in 1-3% of cases, and whilst a well established and relatively safe procedure, it is not without complications, which include infection, hemorrhage, uterine rupture, and occasional maternal death.\n A three-arm randomized controlled trial of 50 IU Syntocinon (in 30 ml N saline) versus 800 mcg misoprostol (in 30 ml N saline) versus 30 ml N saline alone (control), injected into the placental bed via the umbilical vein using the Pipingas method. A group sequential research model (triangular test: PEST4) was adopted to minimize the sample size, as retained placenta is a relatively uncommon condition.\n No significant difference in the rate of manual removal was observed between the control and Syntocinon groups. On triggering the automatic stopping rule for this arm of the trial all subsequent cases recruited were allocated to receive either Syntocinon or misoprostol. After a total of 54 cases a significant reduction in manual removal of placenta was observed in the misoprostol group, triggering the automatic stopping rule and terminating the trial.\n Misoprostol (800 mcg) dissolved in 30 ml N saline and administered by intraumbilical injection using the Pipingas technique significantly reduces the need for manual removal for retained adherent placenta, whereas Syntocinon has similar effectiveness to injection of N saline alone.", "To evaluate the ability of intraumbilical oxytocin injection as a treatment for retained placenta after vaginal delivery to reduce the incidence of manual removal and postpartum hemorrhage.\n A randomized controlled trial was set up in a university and a district general hospital. We recruited 81 women with singleton pregnancies who underwent vaginal delivery and who failed to deliver the placenta after 20 minutes of active management of the third stage of labor. Study subjects were randomized to receive either 1) an intraumbilical injection of oxytocin (20 IU in 20 mL of saline); 2) an intraumbilical injection of saline (20 mL); or 3) no treatment. Outcome measures were expulsion of the placenta within 45 minutes of delivery, need for manual removal of the placenta under anesthesia, and postpartum hemorrhage (defined as a blood loss greater than 500 mL).\n Women given an intraumbilical injection of oxytocin had a significant increase in spontaneous expulsion of the placenta within 45 minutes of delivery and fewer manual removals of the placenta, compared with women without treatment (odds ratio [OR] 11.6, 99% confidence interval [CI] 1.4, 272.8; and OR 7.4, 99% CI 1.1, 86.5; respectively). When women given intraumbilical oxytocin were compared with women given only intraumbilical saline, the difference was not statistically significant (OR 6.6, 99% CI 0.9, 77.2 for spontaneous expulsion of the placenta; and OR 4.7, 99% CI 0.8, 39.5 for manual removal). There was no significant difference in the incidence of spontaneous expulsion and manual removal of the placenta between women given intraumbilical saline injection and women without treatment (OR 1.8, 99% CI 0.1, 53.9; and OR 1.6, 99% CI 0.1, 22.4; respectively).\n The results of our study suggest a clinically important beneficial effect of intraumbilical oxytocin injection in the management of retained placenta.", "A randomized protocol was used to study the effect of intraumbilical prostaglandin F2 alpha (Hembate, Upjohn) and oxytocin injection in women with retained placenta. Prostaglandin F2 alpha, 20 mg, diluted to 20 ml in normal saline solution (10 women, group 1), 30 IU of oxytocin, diluted to 20 ml in normal saline solution (11 women, group 2), or 20 ml of normal saline solution alone (7 women, group 3), were injected into the umbilical vein 1 h after delivery. Nine women (group 4, controls) underwent manual removal of the retained placenta. In group 1, placental expulsion occurred in all patients and the duration of the placental expulsion after prostaglandin F2 alpha injection was 6.8 +/- 1.36 (mean +/- SE) min: in group 2, six placental expulsions occurred after 13.3 +/- 1.97 min (mean +/- SE); and in group 3, no effect was recorded after intraumbilical saline injection. We suggest that intraumbilical vein injection of prostaglandin F2 alpha might be a beneficial, non-surgical method for treating retained placenta. Oxytocin might reduce the incidence of manual lysis of the placenta and achieve partial success.", "To determine whether intra-umbilical vein injection with saline solution, with or without oxytocin, reduces the need for manual removal of placenta compared with expectant management.\n Multicenter, randomised controlled trial.\n Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta.\n Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery.\n Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management.\n Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay.\n Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73-1.15), or saline alone (63%; RR 1.00; 95% CI 0.80-1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome.\n Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.", "Intra-umbilical injection of oxytocin has been used to hasten placental separation in retained placenta. A randomised controlled trial was done on 35 consequent women who fulfilled the criteria for retained placenta at the Department of Obstetrics & Gynaecology Ipoh Hospital. Nineteen patients who were recruited into the study group received intraumbilical injection of 301U oxytocin in 27mls saline. Another 16 patients who were in the control group received 30mls of 0.9% sodium chloride (placebo). The primary outcome measured was the need for manual removal of placenta (MRP). Nine out of the 19 patients in the oxytocin group required MRP while 10/16 in the control group required MRP. There was a 24% reduction (95% C.I. 0.41 to 1.39) in the need for MRP in the study group compared to the saline group. our results indicate that intra-umbilical vein injection of oxytocin is not clinically useful for the removal of a retained placenta.", "No increase in maternal plasma oxytocin concentration was detected after administration of 100 IU oxytocin into the umbilical veins of seven women immediately after delivery. The delivery of the placenta was accelerated after umbilical vein injection of 100 IU oxytocin in a placebo-controlled study of 40 women: 12 minutes (4 to 40) in the oxytocin group versus 40 minutes (29 to 40) in the placebo group (median and interquartile ranges), p less than 0.05.", "The purpose of the study was to investigate the removal of a retained placenta.\n Oxytocin was injected into the vein of the umbilical cord. A total of 109 patients with retention of the placenta were randomized into two groups. Active management of the third stage of labor was carried out by giving oxytocin 5 IU intravenously and ergometrine maleate 0.2 mg intramuscularly after delivery of the fetus. Group 1, which comprised 68 patients, was allocated to receive 50 IU oxytocin diluted in 10 ml 0.9% sodium chloride solution, and the 41 patients in group 2 were given 20 ml plasma expander (dextran 70) into the umbilical vein.\n Forty-nine cases (72%) in the oxytocin group and 22 cases (54%) in the dextran 70 group required manual removal of the retained placenta. No significant differences were found between group 1 (oxytocin) and group 2 (dextran 70).\n Our results indicate that intraumbilical vein injection of oxytocin is not effective for removal of a retained placenta.", "In a multicenter randomized controlled trial involving 220 women with retained placenta no beneficial effects could be established of intraumbilical vein administration of 10 IU of oxytocin in 20 ml of saline solution. A reduction was not gained in the rate of manual removal of the placenta and there was no decrease in the amount of blood loss. Oxytocin only induced a minor shortening of the median time interval from administration to the spontaneous expulsion of the placenta as compared with a placebo injection. Maternal serum alpha-fetoprotein levels before and after intraumbilical vein injection did not show evidence of fetomaternal transfusion." ]

[ "20850852", "17062260" ]

[ "Wrapping of the omental pedicle flap around esophagogastric anastomosis after esophagectomy for esophageal cancer.", "Use of pedicled omentum in esophagogastric anastomosis for prevention of anastomotic leak." ]

[ "Esophagogastrectomy for esophageal cancer is the standard surgical treatment as a curative measure or for palliation. Esophagogastric anastomotic leakage and stricture are common life-threatening postoperative complications (more so if the leakage occurs in the chest), and the success of the anastomosis created in the reconstruction of the resected esophagus can highly influence morbidity and mortality.\n A prospective, randomized study was undertaken on 291 patients treated for carcinoma of the esophagus between January 2004 and December 2008. The study excluded 36 patients (12%) who were inoperable. Patients were assigned to 2 treatment groups that consisted of 128 patients in group A and 127 patients in group B according to a restricted, permuted block randomization plan. Patients in group A underwent an esophagogastrectomy with wrapping of the pedicle omental flap around the esophagogastric anastomosis. Group B patients underwent an esophagogastrectomy with only a stapled technique.\n Of all 255 patients who received an esophagogastric anastomosis, 226 (89%) were discharged from the hospital within 15 days of operation. There was no significant difference between these 2 groups in regard to the incidence of pulmonary complications, abdominal or thoracic infections, and days of hospital stay. Anastomotic leaks occurred in a single patient from group A (1%) and in 7 patients from group B (6%). In group A, 33 patients underwent transhiatal esophagogastrectomy and 95 had thoracic esophagogastrectomy, which resulted in an anastomotic leakage in 1 (3%) and 0 (0%) patients, respectively. In group B, 42 patients had transhiatal esophagogastrectomy and 85 had thoracic esophagogastrectomy, which resulted in anastomotic leakage in 5 (12%) and 2 (2%) patients, respectively. The leakage ratio of group B was significant greater than that of group A (P < .05). Two patients were excluded during the evaluation of the benign stricture due to hospital mortality. Anastomotic strictures were noted in 8 patients from group A (6%) and 20 patients from group B (16%), and the difference in the incidence of anastomotic strictures between these 2 groups was statistically significant (P < .05).\n Wrapping of the pedicle omental flap around the esophagogastric stapled anastomosis site decreases the incidence of anastomotic leakage and stricture rate after esophagectomy for esophageal cancer, thereby decreasing the morbidity and mortality of the procedure.\n Copyright © 2011 Mosby, Inc. All rights reserved.", "Esophagogastrectomy for carcinoma of the esophagus is the standard surgical treatment for cure or palliation. Esophagogastric anastomotic leakage is a life-threatening postoperative complication, more so if the leakage occurs in the chest.\n A prospective, randomized study was conducted on 238 patients treated for carcinoma of the esophagus between January 2000 and January 2006. The study excluded 44 patients (18.49%) who were inoperable. The patients were assigned to two treatment groups of 97 each (A and B) according to a restricted permuted block randomization plan. Group A patients underwent esophagogastrectomy with wrapping of the pedicled omentum around the esophagogastric anastomosis. Group B patients underwent esophagogastrectomy without using the omental graft. An Ivor-Lewis type esophagogastrectomy (TTE) was done in 122 patients (62.89%) and a transhiatal esophagogastrectomy (THE) was done in 72 (37.11%).\n Anastomotic leaks occurred in 3 group A patients (3.09%) and in 14 (14.43%) group B patients. In group A, 54 patients underwent THE and 43 had TTE, with anastomotic leakage in 2 (3.70%) and 1 (2.33%) patients, respectively. In group B, 48 patients had THE and 49 had TTE, with anastomotic leakage in 8 (16.26%) and 6 (12.24%), respectively. The difference in the incidence of leakage was statistically significant (p = 0.005). There was no complication related to the omental graft technique nor was there a significant difference in the mortality between the two groups.\n The pedicled omental transposition for reinforcing the anastomotic suture line significantly reduces the incidence of leakage after esophagogastrectomy for carcinoma of the esophagus, thus decreasing the morbidity and mortality of the procedure." ]

[ "2256009", "8888321", "3522114" ]

[ "Effect of nicotine, silver acetate, and ordinary chewing gum in combination with group counselling on smoking cessation.", "Effects of a 2.5-mg silver acetate lozenge on initial and long-term smoking cessation.", "Silver acetate gum as a deterrent to smoking." ]

[ "Four hundred and ninety six smokers participated in a randomised comparison of the effect of silver acetate, nicotine, and ordinary chewing gum on smoking cessation. All were motivated to stop smoking abruptly and all had smoked at least 10 cigarettes a day for at least five years. Side effects and taste acceptability were related to outcome after six months. The participants attended nine meetings over a year, at which lectures, support, and advice about stopping smoking were given. Tobacco abstinence was confirmed by measurement of carbon monoxide in expired air. The chewing gums were used for 12 weeks. After 12 weeks there was a trend towards more abstainers in the nicotine group (59%) than in the silver acetate (50%) and ordinary (45%) chewing gum groups that was not quite significant (p = 0.07). At 26 and 52 weeks the number of cigarette abstainers was similar in the three treatment groups. Subjects in the nicotine chewing gum group had a longer mean time before relapse than those in the silver acetate and ordinary chewing gum groups. Mean success rates for all subjects combined at 12, 26, and 52 weeks were 52.8%, 39.7%, and 23.3%. The side effects of nicotine and silver acetate chewing gum were generally mild and transient, and unimportant except for mouth irritation from silver acetate, which had a negative effect on outcome, and the low taste acceptability of nicotine, which had a strong negative influence on the success rate. The results suggest a short term effect on nicotine chewing gum on smoking cessation, but the abstinence rates after one year were generally disappointing.", "Silver acetate over-the-counter products, such as gum, lozenge, and spray, produce an aversive metallic taste when combined with cigarette smoke. Hence, they hold promise of serving as an effective smoking deterrent, one that may be used on a self-help basis.\n Five hundred adult smokers, male and female, were assigned randomly to one of two experimental conditions, 2.5-mg silver acetate lozenge and placebo lozenge. A double-blind study of the effects of a 2.5-mg silver acetate lozenge on initial (3 weeks) and long-term (12 months) smoking cessation was carried out.\n About 90% of the subjects (n = 500) reported using the lozenge (silver acetate or placebo) for smoking cessation, and they used about five lozenges per day. Over 70% of the quitters (n = 70) reported using the lozenge on an as-needed basis for relapse prevention. The overall objectively verified quit rates for subjects assigned to the silver acetate and placebo conditions at Visit 3 (3 weeks) were 17% (n = 42) and 11% (n = 28), respectively, a difference which approached statistical significance (P = 0.071). When the analysis was restricted to subjects who used the product, a statistically significant difference (P < 0.05) in initial smoking cessation emerged (26%, n = 37 vs 16%, n = 23) for subjects assigned to the silver acetate and placebo conditions. At 12 months follow-up, 26% (n = 11) of initial quitters in the silver acetate condition and 32% (n = 9) of the quitters in the placebo condition were abstinent. This difference was not statistically significant.\n The study demonstrated modest efficacy for the effect of the 2.5-mg silver acetate lozenge on initial smoking cessation for the subset of subjects who used the product as recommended. We failed to demonstrate efficacy of the lozenge for long-term relapse prevention. Additional research on the efficacy of the 2.5-mg silver acetate lozenge and long-term abstinence in general appears warranted.", "Silver acetate chewing gum, a nonprescription medication, produces an unpleasant metallic taste in the mouth of individuals who consume tobacco products in conjunction with this smoking deterrent. Use of the product leads to self-induced aversive conditioning. In the present double-blind controlled study, subjects using silver acetate for three weeks of treatment had a smoking cessation rate of 15 out of 136 (11 percent, p = 0.02). Placebo subjects had a smoking cessation rate of 6 out of 146 (4 percent, p = .102). Without further treatment, the group using silver acetate demonstrated a 7 percent nonsmoking rate at four months compared with a 3 percent nonsmoking rate for the placebo group. Silver acetate demonstrated a modest benefit over placebo as a smoking deterrent in a minimal intervention and highly cost-effective treatment setting." ]

[ "9248875", "6376480", "3512535", "15231461", "12922", "15363480", "12678168", "9892313", "4979702", "9217519", "1673123", "4605009", "17954515", "17894080", "338270", "11982448", "15096079", "11206599", "335787", "2686478", "4556089" ]

[ "Efficacy of lorazepam and haloperidol for rapid tranquilization in a psychiatric emergency room setting.", "Droperidol vs. haloperidol in the initial management of acutely agitated patients.", "A comparison of parenteral loxapine and haloperidol in hostile and aggressive acutely schizophrenic patients.", "A prospective, double-blind, randomized trial of midazolam versus haloperidol versus lorazepam in the chemical restraint of violent and severely agitated patients.", "A double-blind comparison between loxapine and haloperidol by parenteral route in acute schizophrenia.", "Combined therapy with low-potency neuroleptic levomepromazine as an adjunct to haloperidol for agitated patients with acute exacerbation of schizophrenia.", "Comparative study of the effectiveness of zuclopenthixol acetate and haloperidol in acutely disturbed psychotic patients.", "Intramuscular flunitrazepam versus intramuscular haloperidol in the emergency treatment of aggressive psychotic behavior.", "A double-blind comparison of haloperidol with perphenazine in acute psychiatric episodes.", "Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study.", "Parenteral lorazepam versus parenteral haloperidol for the control of psychotic disruptive behavior.", "Rapid tranquilization of acutely psychotic patients with intramuscular haloperidol and chlorpromazine.", "Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine.", "Parenteral haloperidol for rapid control of severe, disruptive symptoms of acute schizophrenia.", "Relative efficacy of parenteral haloperidol and thiothixene for the emergency treatment of acutely excited and agitated patients.", "A double-blind, placebo-controlled dose-response comparison of intramuscular olanzapine and haloperidol in the treatment of acute agitation in schizophrenia.", "Acute treatment of psychotic agitation: a randomized comparison of oral treatment with risperidone and lorazepam versus intramuscular treatment with haloperidol and lorazepam.", "Intramuscular ziprasidone compared with intramuscular haloperidol in the treatment of acute psychosis. Ziprasidone I.M. Study Group.", "Loxapine versus haloperidol parenterally in acute psychosis with agitation. A double-blind study.", "Efficacy of combinations of intramuscular antipsychotics and sedative-hypnotics for control of psychotic agitation.", "Comparison of injectable haloperidol and chlorpromazine." ]

[ "The efficacy of a benzodiazepine was compared with that of a neuroleptic for the rapid tranquilization of patients presenting at a psychiatric emergency room service. Thirty-seven highly agitated patients exhibiting psychotic symptoms were randomly assigned to receive either 2 mg lorazepam or 5 mg haloperidol as needed every 30 min for 4 h. Administration route was either intramuscular injection or oral concentrate. Symptom ratings were conducted each hour using double-blind procedures. Both medications reduced symptom ratings on the Brief Psychiatric Rating Scale and Global Clinical Impression of Overall Symptom Severity Scale. Global Clinical Impression scores for the two medication groups did not differ significantly either at baseline or at 4 h after entry into the study. However, Global Clinical Impression scores of patients in the lorazepam group were less severe at intermittent ratings. The groups did not differ on the Brief Psychiatric Rating Scale at any rating time. No differences were found either in the number of doses administered or in the administration route selected. Given the potential for severe extrapyramidal symptoms developing hours or days after a single dose of haloperidol, lorazepam may provide an excellent alternative for the rapid tranquilization of the acutely agitated psychotic patient in the emergency room setting.", "In a double-blind clinical study, 27 acutely agitated patients were treated with an intramuscular injection of 5 mg of droperidol or 5 mg of haloperidol from identical appearing vials. At 30 minutes following treatment, 81% of the patients treated with haloperidol but only 36% treated with droperidol required a second injection (p less than .05). Thus, droperidol, a safe butyrophenone neuroleptic, appears to be a drug of choice for rapid and reliable control of acute agitation.", "In a parallel groups, double-blind study, 54 acutely psychotic schizophrenics were given loxapine or haloperidol parenterally for 24 to 72 hours, then orally for a total study period of up to 10 days. Dosage ratios of loxapine to haloperidol ranged from a minimum of 2.7:1 to a maximum of 4.4:1. Both groups showed significant and rapid improvement from baseline. Forty-eight percent of the loxapine patients and 33% of the haloperidol patients achieved and maintained a global severity of illness rating of mild or better. By the end of the study, 84% of the loxapine patients and 63% of the haloperidol patients had achieved an improvement rating of moderate or marked. This difference approached significance (p less than .10). The most frequently reported adverse experiences were dystonic reactions and akathisia. The number and severity of adverse experiences did not differ significantly between drug groups. Intramuscular loxapine was at least as effective as haloperidol in the initial management of hostile and aggressive schizophrenic patients. The maintenance of therapeutic response after conversion to oral concentrate was comparable with the two drugs.", "To determine if midazolam is superior to lorazepam or haloperidol in the management of violent and severely agitated patients in the emergency department. Superiority would be determined if midazolam resulted in a significantly shorter time to sedation and shorter time to arousal.\n This was a randomized, prospective, double-blind study of a convenience sample of patients from an urban, county teaching emergency department. Participants included 111 violent and severely agitated patients. Patients were randomized to receive intramuscular midazolam (5 mg), lorazepam (2 mg), or haloperidol (5 mg).\n The mean (+/-SD) age was 40.7 (+/-13) years. The mean (+/-SD) time to sedation was 18.3 (+/-14) minutes for patients receiving midazolam, 28.3 (+/-25) minutes for haloperidol, and 32.2 (+/-20) minutes for lorazepam. Midazolam had a significantly shorter time to sedation than lorazepam and haloperidol (p < 0.05). The mean difference between midazolam and lorazepam was 13.0 minutes (95% confidence interval [95% CI] = 5.1 to 22.8 minutes) and that between midazolam and haloperidol was 9.9 minutes (95% CI = 0.5 to 19.3 minutes). Time to arousal was 81.9 minutes for patients receiving midazolam, 126.5 minutes for haloperidol, and 217.2 minutes for lorazepam. Time to arousal for midazolam was significantly shorter than for both haloperidol and lorazepam (p < 0.05). The mean difference in time to awakening between midazolam and lorazepam was 135.3 minutes (95% CI = 89 to 182 minutes) and that between midazolam and haloperidol was 44.6 minutes (95% CI = 9 to 80 minutes). There was no significant difference over time by repeated-measures analysis of variance between groups in regard to changes in systolic and diastolic blood pressure (p = 0.8965, p = 0.9581), heart rate (p = 0.5517), respiratory rate (p = 0.8191), and oxygen saturation (p = 0.8991).\n Midazolam has a significantly shorter time to onset of sedation and a more rapid time to arousal than lorazepam or haloperidol. The efficacies of all three drugs appear to be similar.", "nan", "nan", "To study the effectiveness, frequency of administration and side effects of zuclopenthixol acetate (ZPTA) and haloperidol (HAL) in the treatment of acute psychotic disturbance with aggression.\n Purposive sampling method was employed in a group of psychotic patients with aggression admitted to Songkla Neuropsychiatric Hospital, they were randomly divided into 2 groups: ZPTA group and HAL group. All of the patients were evaluated daily for 7 consecutive days using the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression Scale (CGI). Statistical analysis was performed by using the Student t-test and Linear regression.\n There were 70 patients with diagnosis of schizophrenia, mania and acute psychosis. Thirty-eight patients were randomly assigned to the ZPTA group and were given 50-100 mg of the drug, while 32 patients received HAL 5-10 mg. The result showed a significant reduction in BPRS or CGI scores in both groups. Patients treated with ZPTA required less frequent administration than did those on HAL (p < 0.05). There was no statistically significant difference in the reduction in scores between the two groups. Nor was there a statistical difference in reduction of aggression based on BPRS rating. Each group of patients showed a few side effects of mild degree.\n Both ZPTA and HAL were effective in the treatment of acute psychosis with aggression, but frequency of administration was lower in the ZPTA group", "The authors examined the efficacy of intramuscular flunitrazepam compared with intramuscular haloperidol for the immediate control of agitated or aggressive behavior in acutely psychotic patients.\n Twenty-eight actively psychotic inpatients, aged 20-60 years, who were under treatment with neuroleptic agents were selected for the study. Each was randomly assigned on a double-blind basis to receive either 5 mg i.m. of haloperidol (N=13) or 1 mg i.m. of flunitrazepam (N=15) during an aggressive event. Verbal and physical aggression was measured over time with the Overt Aggression Scale. Patients were also rated with the Brief Psychiatric Rating Scale and the Clinical Global Impression scale.\n Both flunitrazepam and haloperidol exhibited acute antiaggressive activity. This beneficial effect, as assessed by the Overt Aggression Scale, was obtained within 30 minutes.\n Intramuscular flunitrazepam may serve as a convenient, rapid, safe, and effective adjunct to neuroleptics in reducing aggressive behavior in emergency psychiatric settings.", "nan", "Rapid tranquilization is a routinely practiced method of calming agitated psychotic patients by use of neuroleptics, benzodiazepines, or both in combination. Although several studies have examined the efficacy of the three approaches, none have compared these treatments in a prospective, randomized, double-blind, multicenter trial. Ninety-eight psychotic, agitated, and aggressive patients (73 men and 25 women) were prospectively enrolled during an 18-month period in emergency departments in five university or general hospitals. Patients were randomly assigned to receive intramuscular injections of lorazepam (2 mg), haloperidol (5 mg), or both in combination. Patients in each treatment group received 1 to 6 injections of the same study drug within 12 hours, based on clinical need. They were evaluated hourly after the first injection until at least 12 hours after the last. Efficacy was assessed on the Agitated Behavior Scale (ABS), a modified Brief Psychiatric Rating Scale (MBPRS), Clinical Global impressions (CGI) scale, and an Alertness Scale. Effective symptom reduction was achieved in each treatment group with significant (P < .01) mean decreases from baseline at every hourly ABS evaluation. Significant (P < .05) mean differences on the ABS (hour 1) and MBPRS (hours 2 and 3) suggest that tranquilization was most rapid in patients receiving the combination treatment. Study event incidence (side effects) did not differ significantly between treatment groups, although patients receiving haloperidol alone tended to have more extrapyramidal system symptoms. The superior results produced by the combination treatment support the use of lorazepam plus haloperidol as the treatment of choice for acute psychotic agitation.", "In a double-blind, prospective study, 2 mg of intramuscular lorazepam and 5 mg of intramuscular haloperidol were equally effective in controlling aggression, agitation, and assaultive behavior. Although lorazepam and haloperidol produced an equivalent mean decrease in aggression, significantly more subjects who received lorazepam had a greater decrease in aggression ratings than haloperidol recipients; this effect was independent of sedation. Lorazepam produced significantly fewer extrapyramidal symptoms. These data support the current clinical practice of using lorazepam (alone, or in combination with a neuroleptic) for control of acute aggressive and assaultive behavior.", "nan", "To determine whether haloperidol alone results in swifter and safer tranquillisation and sedation than haloperidol plus promethazine.\n Pragmatic randomised open trial (January-July 2004).\n Psychiatric emergency room, Rio de Janeiro, Brazil.\n 316 patients who needed urgent intramuscular sedation because of agitation, dangerous behaviour, or both.\n Open treatment with intramuscular haloperidol 5-10 mg or intramuscular haloperidol 5-10 mg plus intramuscular promethazine up to 50 mg; doses were at the discretion of the prescribing clinician.\n The primary outcome was proportion tranquil or asleep by 20 minutes. Secondary outcomes were asleep by 20 minutes; tranquil or asleep by 40, 60, and 120 minutes; physically restrained or given additional drugs within 2 hours; severe adverse events; another episode of agitation or aggression; additional visit from the doctor during the subsequent 24 hours; overall antipsychotic load in the first 24 hours; and still in hospital after 2 weeks.\n Primary outcome data were available for 311 (98.4%) people, 77% of whom were thought to have a psychotic illness. Patients allocated haloperidol plus promethazine were more likely to be tranquil or asleep by 20 minutes than those who received intramuscular haloperidol alone (relative risk 1.30, 95% confidence interval 1.10 to 1.55; number needed to treat 6, 95% confidence interval 4 to 16; P=0.002). No differences were found after 20 minutes. However, 10 cases of acute dystonia occurred, all in the haloperidol alone group.\n Haloperidol plus promethazine is a better option than haloperidol alone in terms of speed of onset of action and safety. Enough data are now available to change guidelines that continue to recommend treatments that leave people exposed to longer periods of aggression than necessary and patients vulnerable to distressing and unsafe adverse effects.\n Current Controlled Trials ISRCTN83261243 [controlled-trials.com].", "Intramuscular haloperidol, at three dose levels, (5 mg, 2 mg, and 1 mg) chlorpromazine (25 mg), and placebo were compared for efficacy, rapidity of therapeutic onset, and safety in 50 acute psychotic patients requiring rapid control. The drugs were administered parenterally under double-blind conditions at half-hour intervals until successful control of moderate to very severe symptomatology was achieved or a maximum of four injections had been given. Global evaluation, BPRS, and target symptom ratings were performed. The overall results indicated that the 5 mg and 2 mg haloperidol doses were significantly superior to the 1 mg haloperidol and 25 mg chlorpromazine doses and to placebo. Transfer of patients to oral haloperidol was satisfactorily accomplished. Side effects for all medications were minimal and included slight to moderate EPS and drowsiness. The use of antiparkinson drugs completely controlled the extrapyramidal symptoms.", "In this double-blind study, haloperidol (n = 15) and thiothixene (n = 15), administered parenterally in emergency rooms and outpatient facilities to 30 acutely excited, agitated psychotic patients in hourly doses of 4 mg. or 8 mg., as needed over a four-hour period (total dosage ranging from 4 to 32 mg.), achieved rapid tranquilization in 30 patients. Significant improvement was shown over a six-hour period on BPRS Total Score, the four factors--Thinking Disorder, Anergic state, Excitement and Disorientation, and Depression and also on hourly ratings of 17 symptoms of a Psychiatric Target Symptom Profile. No significant differences were found between the haloperidol-treated and thiothixene-treated groups. Few adverse reactions were noted, all of them mild, the most frequent being drowsiness in six patients.", "An intramuscular (IM) formulation of olanzapine has been developed because there are no rapid-acting IM atypical antipsychotic drugs currently available in the United States for treating acute agitation in patients with schizophrenia.\n Recently hospitalized acutely agitated patients with schizophrenia (N = 270) were randomized to receive 1 to 3 IM injections of olanzapine (2.5, 5.0, 7.5, or 10.0 mg), haloperidol (7.5 mg), or placebo within 24 hours. A dose-response relationship for IM olanzapine in the reduction of agitation was assessed by measuring the reduction in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) scores 2 hours after the first injection. Safety was assessed by recording adverse events and with extrapyramidal symptom scales and electrocardiograms at 24 hours after the first injection.\n Olanzapine exhibited a dose-response relationship for reduction in agitation (F(1,179)= 14.4; P<.001). Mean PANSS-EC reductions 2 hours after the first injection of olanzapine (2.5 mg = -5.5; 5.0 mg = -8.1; 7.5 mg = -8.7; 10.0 mg = -9.4) were superior to those with placebo (-2.9; P =.01 vs olanzapine at 2.5 mg; P<.001 for each other olanzapine dose) but not with haloperidol (-7.5). A dose of 5.0, 7.5, or 10.0 mg of olanzapine caused a greater reduction in agitation than placebo 30 minutes after the first injection. There were no differences between treatment groups for hypotension, the most frequently reported adverse event, or for clinically relevant changes in the QTc interval. There was a greater incidence of treatment-emergent parkinsonism during treatment with IM haloperidol (16.7%) than with 2.5 (P =.03), 5.0 (P =.03), or 7.5 mg (P =.01) of IM olanzapine (0%) or with placebo (0%) (P =.01).\n Intramuscular olanzapine at a dose of 2.5 to 10.0 mg per injection exhibits a dose-response relationship in the rapid treatment of acute agitation in patients with schizophrenia and demonstrates a favorable safety profile.", "Standard treatment for acute psychotic agitation often involves intramuscular administration of the benzodiazepine lorazepam and the antipsychotic haloperidol. This study compared the efficacy and safety of oral treatment with the atypical antipsychotic risperidone plus lorazepam with those of standard intramuscular treatment. We hypothesized that the efficacy and speed of action of both treatments would be similar.\n In a prospective, parallel-group, randomized, rater-blinded noninferiority study conducted at 24 sites in the United States, 162 patients exhibiting agitation associated with active psychosis were randomly assigned to receive either oral treatment with 2 mg of risperidone plus 2 mg of lorazepam (N = 83) or intramuscular treatment with 5 mg of haloperidol plus 2 mg of lorazepam (N = 79). The change scores on a 5-item acute-agitation cluster from the Positive and Negative Syndrome Scale (hallucinatory behavior, excitement, hostility, uncooperativeness, and poor impulse control) were the main outcome measure. The study was conducted from January 8 to August 8, 2001.\n Mean acute-agitation cluster scores were similar in the 2 groups at baseline. Mean score improvements at 30, 60, and 120 minutes after dosing were significant at each timepoint in both groups (p <.0001) and were similar in both groups (p >.05). Both treatments were well tolerated.\n A single oral dose of risperidone plus lorazepam was as effective as parenterally administered haloperidol plus lorazepam for the rapid control of agitation and psychosis. These findings suggest that this oral regimen is an acceptable alternative to the current intramuscular treatment for acute psychotic agitation.", "This 7-day, randomized, open-label, multicenter, international study compared the efficacy and tolerability of intramuscular (i.m.) ziprasidone with haloperidol i.m. and the transition from i.m. to oral treatment in hospitalized patients with acute psychotic agitation (related to DSM-III-R diagnoses).\n Patients received up to 3 days of flexible-dose ziprasidone i.m. (N = 90) or haloperidol i.m. (N = 42) followed by oral treatment to day 7. After an initial ziprasidone i.m. dose of 10 mg, subsequent i.m. doses of 5 to 20 mg could be given every 4 to 6 hours (maximum daily dose = 80 mg) if needed, followed by oral ziprasidone, 80-200 mg/day. Haloperidol i.m. doses of 2.5 to 10 mg were given on entry, followed by 2.5 to 10 mg i.m. every 4 to 6 hours (maximum daily dose = 40 mg) if needed, then by oral haloperidol, 10-80 mg/day.\n The mean reductions in Brief Psychiatric Rating Scale (BPRS) total, BPRS agitation items, and Clinical Global Impressions-Severity scale scores were statistically significantly greater (p < .05, p < .01, and p < .01, respectively) after ziprasidone i.m. treatment compared with haloperidol i.m. treatment. Further reductions in these scores also occurred in both groups following transition to oral treatment. Ziprasidone was associated with a lower incidence of movement disorders and a reduced requirement for anticholinergic medication during both i.m. and oral treatment compared with haloperidol. Movement disorder scale scores improved with ziprasidone i.m. and oral treatment, but deteriorated with haloperidol. Other adverse events were rare with both treatments.\n Ziprasidone i.m. was significantly more effective in reducing the symptoms of acute psychosis and was better tolerated than haloperidol i.m., particularly in movement disorders. The transition from ziprasidone i.m. to oral ziprasidone was effective and well tolerated.", "nan", "The combination of haloperidol, 5 mg, and lorazepam, 4 mg, was both effective and safe for managing agitated behavior in an open trial with acutely psychotic patients. The combination also appeared to be superior to its individual components when studied in a randomized, nonblind trial. The principle of the combined use of antipsychotics and sedative-hypnotics was further tested by comparing two new combinations: thiothixene, 5 mg, and lorazepam, 4 mg, versus haloperidol, 5 mg, and phenobarbital sodium, 130 mg. These combinations had comparable efficacy and safety, and the level of transquilization approached that produced by the haloperidol-lorazepam combination in the preceding studies.", "nan" ]

[ "17764540", "18534438", "16203879", "12379064", "15634273", "14675083", "12433510", "14585938", "9358126", "11858482", "17869635", "12574809", "11575978", "14521593" ]

[ "Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.", "Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.", "Oral direct thrombin inhibitor ximelagatran compared with warfarin for the prevention of venous thromboembolism after total knee arthroplasty.", "Ximelagatran versus warfarin for the prevention of venous thromboembolism after total knee arthroplasty. A randomized, double-blind trial.", "A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial.", "The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study.", "Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: the METHRO II randomised trial.", "Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement.", "A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement.", "A dose-ranging study of the oral direct thrombin inhibitor, ximelagatran, and its subcutaneous form, melagatran, compared with dalteparin in the prophylaxis of thromboembolism after hip or knee replacement: METHRO I. MElagatran for THRombin inhibition in Orthopaedic surgery.", "Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.", "Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement.", "Comparison of the oral direct thrombin inhibitor ximelagatran with enoxaparin as prophylaxis against venous thromboembolism after total knee replacement: a phase 2 dose-finding study.", "Comparison of ximelagatran, an oral direct thrombin inhibitor, with enoxaparin for the prevention of venous thromboembolism following total hip replacement. A randomized, double-blind study." ]

[ "Oral anticoagulants, such as dabigatran etexilate, an oral, direct thrombin inhibitor, that do not require monitoring or dose adjustment offer potential for prophylaxis against venous thromboembolism (VTE) after total knee replacement surgery.\n In this randomized, double-blind study, 2076 patients undergoing total knee replacement received dabigatran etexilate, 150 mg or 220 mg once-daily, starting with a half-dose 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery, for 6-10 days. Patients were followed-up for 3 months. The primary efficacy outcome was a composite of total VTE (venographic or symptomatic) and mortality during treatment, and the primary safety outcome was the incidence of bleeding events.\n The primary efficacy outcome occurred in 37.7% (193 of 512) of the enoxaparin group versus 36.4% (183 of 503) of the dabigatran etexilate 220 mg group (absolute difference, -1.3%; 95% CI, -7.3 to 4.6) and 40.5% (213 of 526) of the 150 mg group (2.8%; 95% CI, -3.1 to 8.7). Both doses were noninferior to enoxaparin based on the pre-specified noninferiority criterion. The incidence of major bleeding did not differ significantly between the three groups (1.3% versus 1.5% and 1.3% respectively). No significant differences in the incidences of liver enzyme elevation and acute coronary events were observed during treatment or follow-up.\n Dabigatran etexilate (220 mg or 150 mg) was at least as effective and with a similar safety profile as enoxaparin for prevention of VTE after total knee-replacement surgery.", "Dabigatran, an oral once-daily unmonitored thrombin inhibitor, has been tested elsewhere using enoxaparin 40 mg once daily. We used the North American enoxaparin 30 mg BID regimen as the comparator. This was a double-blind, centrally randomized trial. Unilateral total knee arthroplasty patients were randomized to receive oral dabigatran etexilate 220 or 150 mg once daily, or enoxaparin 30 mg SC BID after surgery, blinded. Dosing stopped at contrast venography, 12 to 15 days after surgery. Among 1896 patients, dabigatran 220 and 110 mg showed inferior efficacy to enoxaparin (venous thromboembolism rates of 31% [P = .02 vs enoxaparin], 34% [P < .001 vs enoxaparin], and 25%, respectively). Bleeding rates were similar, and no drug-related hepatic illness was recognized. Dabigatran, effective compared to once-daily enoxaparin, showed inferior efficacy to the twice-daily North American enoxaparin regimen, probably because of the latter's more intense and prolonged dosing.", "Warfarin, which requires coagulation monitoring, is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis. This study compared an oral direct thrombin inhibitor, ximelagatran, with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty.\n Following surgery, patients were randomly assigned to fixed-dose oral ximelagatran (36 mg twice daily) or warfarin (target international normalized ratio, 2.5), both administered for seven to twelve days in a double-blind, double-dummy design. Warfarin was initiated on the evening of the day of surgery, and ximelagatran, on the morning after surgery. The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography, objectively confirmed symptomatic deep-vein thrombosis or pulmonary embolism, and death from all causes during treatment.\n Adequate venograms or confirmed symptomatic events (efficacy population) were obtained for 1949 patients. Venous thromboembolism and death from all causes occurred in 22.5% (221) of 982 ximelagatran-treated patients and in 31.9% (308) of 967 warfarin-treated patients (p < 0.001). Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1% (thirty) and 0.2%, respectively, of the patients in the ximelagatran group and in 3.4% (thirty-three) and 0.4%, respectively, of the patients in the warfarin group. The six deaths from all causes included 0.3% (four) of the ximelagatran-treated patients and 0.2% (two) of the warfarin-treated patients. Major bleeding was noted in 1% (twelve) of the ximelagatran-treated patients and in 0.4% (five) of the warfarin-treated patients (p = 0.09).\n Oral ximelagatran (36 mg twice daily), administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty, demonstrates superior efficacy compared with warfarin prophylaxis, with no wound complications and no significant difference with respect to bleeding events, although the rate of major bleeding events was greater with ximelagatran than with warfarin.\n Therapeutic Level I.", "Warfarin is used for prophylaxis of venous thromboembolism in patients undergoing total knee arthroplasty. However, it is associated with rates of deep venous thrombosis (DVT) of approximately 38% to 55% and requires routine coagulation monitoring and frequent dose adjustment. Ximelagatran, an oral direct thrombin inhibitor, has shown promising efficacy and tolerability in patients undergoing total hip or knee arthroplasty.\n To compare the efficacy and safety of ximelagatran and warfarin for prophylaxis of venous thromboembolism after total knee arthroplasty.\n Randomized, double-blind, parallel-group trial.\n 74 North American hospitals.\n 680 patients who had undergone total knee arthroplasty.\n 7 to 12 days of treatment with oral ximelagatran, 24 mg twice daily, starting on the morning after surgery, or warfarin (target international normalized ratio, 2.5 [range, 1.8 to 3.0]), starting on the evening of the day of surgery.\n Principal end points were asymptomatic DVT on mandatory venography; symptomatic DVT confirmed by ultrasonography or venography; symptomatic, objectively proven pulmonary embolism; and bleeding. All were assessed by blinded adjudication locally and at a central study laboratory.\n On central adjudication, incidence of venous thromboembolism was 19.2% (53 of 276 patients) in the ximelagatran group and 25.7% (67 of 261 patients) in the warfarin group (difference, -6.5 percentage points [95% CI, -13.5 to 0.6 percentage points]; P = 0.070). On local assessment, incidence was 25.4% in the ximelagatran group and 33.5% in the warfarin group (P = 0.043). In the ximelagatran and warfarin groups, respectively, major bleeding occurred in 1.7% and 0.9% of patients and minor bleeding occurred in 7.8% and 6.4% of patients. No variables related to bleeding differed significantly between the two groups.\n For prophylaxis of venous thromboembolism, fixed-dose ximelagatran started the morning after total knee arthroplasty is well tolerated and at least as effective as warfarin, but it does not require coagulation monitoring or dose adjustment.", "Dabigatran etexilate is an oral direct thrombin inhibitor undergoing evaluation for the prevention of venous thromboembolism (VTE) following orthopedic surgery.\n In a multicenter, parallel-group, double-blind study, 1973 patients undergoing total hip or knee replacement were randomized to 6-10 days of oral dabigatran etexilate (50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily), starting 1-4 h after surgery, or subcutaneous enoxaparin (40 mg once daily) starting 12 h prior to surgery. The primary efficacy outcome was the incidence of VTE (detected by bilateral venography or symptomatic events) during treatment.\n Of the 1949 treated patients, 1464 (75%) patients were evaluable for the efficacy analysis. VTE occurred in 28.5%, 17.4%, 16.6%, 13.1% and 24% of patients assigned to dabigatran etexilate 50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily and enoxaparin, respectively. A significant dose-dependent decrease in VTE occurred with increasing doses of dabigatran etexilate (P < 0.0001). Compared with enoxaparin, VTE was significantly lower in patients receiving 150 mg twice daily [odds ratio (OR) 0.65, P = 0.04], 300 mg once daily (OR 0.61, P = 0.02) and 225 mg twice daily (OR 0.47, P = 0.0007). Compared with enoxaparin, major bleeding was significantly lower with 50 mg twice daily (0.3% vs. 2.0%, P = 0.047) but elevated with higher doses, nearly reaching statistical significance with the 300 mg once-daily dose (4.7%, P = 0.051).\n Oral administration of dabigatran etexilate, commenced early in the postoperative period, was effective and safe across a range of doses. Further optimization of the efficacy/safety balance will be addressed in future studies.", "Ximelagatran and its subcutaneous (s.c.) form melagatran are novel direct thrombin inhibitors for the prevention and treatment of thromboembolic disease.\n In a double-blind study, 2835 consecutive patients undergoing total hip or knee replacement were randomized to either melagatran/ximelagatran or enoxaparin. Melagatran 2 mg was started immediately before surgery; 3 mg was then administered postoperatively, followed by 24 mg of oral ximelagatran b.i.d. beginning the next day. Enoxaparin 40 mg, administered subcutaneously o.d., was started 12 h before surgery. Both treatments were continued for 8-11 days. The main efficacy outcome measures were major venous thromboembolism (VTE); [proximal deep vein thrombosis (DVT), non-fatal and/or fatal pulmonary embolism (PE), death where PE could not be ruled out], and total VTE (proximal and distal DVT; PE; death from all causes). DVT was detected by mandatory bilateral ascending venography at the end of the treatment period or earlier if clinically suspected. The main safety outcome was bleeding.\n The rates of major and total VTE were significantly lower in the melagatran/ximelagatran group compared with the enoxaparin group (2.3% vs. 6.3%, P = 0.0000018; and 20.3% vs. 26.6%, P < 0.0004, respectively). Fatal bleeding, critical site bleeding and bleeding requiring reoperation did not differ between the two groups. 'Excessive bleeding as judged by the investigator' was more frequent with melagatran/ximelagatran than with enoxaparin.\n In patients undergoing total hip or knee replacement, preoperatively initiated s.c. melagatran followed by oral ximelagatran was significantly more effective in preventing VTE than preoperatively initiated s.c. enoxaparin.", "Heparins substantially reduce the risk of thromboembolic complications after total hip or knee replacement. However, they can be given only by injection and have several other drawbacks. We did a multicentre, randomised, double-blind study to examine the dose-response relation of subcutaneous melagatran, a direct thrombin inhibitor, followed by oral ximelagatran as thromboprophylaxis after total hip or knee replacement. We aimed to compare the efficacy and safety with that of dalteparin.\n Of 1900 patients, 1495 were assigned to four dose categories of subcutaneous melagatran from just before surgery (1.00 mg, 1.50 mg, 2.25 mg, or 3.00 mg twice daily) followed from the day after surgery by oral ximelagatran (8 mg, 12 mg, 18 mg, or 24 mg twice daily). 381 patients were assigned subcutaneous dalteparin 5000 IU once daily, from the evening before surgery. Bilateral venography was done at 7-10 days, and clinically suspected venous thromboembolism (VTE) was confirmed radiologically. The primary endpoint was the rate of deep-vein thrombosis and pulmonary embolism (PE). Analyses were by intention to treat.\n 1876 patients underwent total replacement of hip (n=1270) or knee (n=606); evaluable venograms were obtained in 1473 (79%). Four patients without evaluable venograms had PE. Overall, a significant dose-dependent decrease in VTE was seen with melagatran/ximelagatran (lowest to highest group: 111 [37.8%], 70 [24.1%], 71 [23.7%], and 43 [15.1%]; p=0.0001); there were also significant relations for both total hip and total knee replacement individually. The frequency of VTE was significantly lower with the highest dose of melagatran/ximelagatran than with dalteparin (15.1% vs 28.2%, p<0.0001). There were no reoperations due to bleeding and no critical organ bleeding. Excessive surgical bleeding was uncommon but more frequent in the highest dose group.\n This sequential therapy was effective and safe in patients undergoing major joint replacement surgery. The findings should be confirmed in a large phase III trial.", "In a previous study of the prevention of venous thromboembolism after total knee replacement, the efficacy of ximelagatran, an oral direct thrombin inhibitor that does not require monitoring of coagulation or dose adjustment, was found to be similar to that of warfarin at a dose of 24 mg of ximelagatran twice daily. The purpose of the present study was to determine whether a higher dose of ximelagatran is superior to warfarin.\n This randomized, double-blind trial compared a regimen of 7 to 12 days of oral ximelagatran, at a dose of 24 or 36 mg twice daily, starting the morning after surgery, with warfarin therapy started the evening of the day of surgery. The composite end point of venous thromboembolism and death from all causes and the incidence of bleeding were the primary outcome measures.\n Among the 1851 patients in the efficacy analysis, oral ximelagatran at a dose of 36 mg twice daily was superior to warfarin with respect to the primary composite end point of venous thromboembolism and death from all causes (20.3 percent vs. 27.6 percent; P=0.003). There were no significant differences between these two groups with respect to major bleeding (incidence, 0.8 percent and 0.7 percent, respectively), perioperative indicators of bleeding, wound characteristics, or the composite secondary end point of proximal deep-vein thrombosis, pulmonary embolism, and death (2.7 percent vs. 4.1 percent; P=0.17).\n The efficacy of oral ximelagatran, administered starting the morning after total knee replacement, was superior to that of warfarin for prevention of venous thromboembolism. Rates of hemorrhagic complications with the two drugs were similar.\n Copyright 2003 Massachusetts Medical Society", "Patients who undergo total hip replacement have a high risk of thromboembolic complications. Recombinant hirudin (desirudin), a specific inhibitor of thrombin, represents a new development in antithrombotic therapy. We compared the efficacy and safety of desirudin with those of a low-molecular-weight heparin (enoxaparin) for the prevention of thromboembolic complications in patients undergoing primary total hip replacement.\n Both treatments, which were assigned in a randomized, double-blind manner, were started preoperatively: enoxaparin on the evening before surgery, and desirudin within 30 minutes before the start of surgery. The dose of desirudin was 15 mg subcutaneously twice daily, and the dose of enoxaparin was 40 mg subcutaneously once daily. The duration of treatment was 8 to 12 days. Deep-vein thrombosis was verified by bilateral venography performed at the end of the treatment period or earlier, if there were clinical signs of deep-vein thrombosis.\n At 31 centers in 10 European countries, 2079 eligible patients were randomly assigned to receive desirudin or enoxaparin. A total of 1587 patients were included in the primary analysis of efficacy. In the desirudin group, as compared with the enoxaparin group, there was a significantly lower rate of proximal deep-vein thrombosis (4.5 vs. 7.5 percent, P=0.01; relative reduction in risk, 40.3 percent) and a lower overall rate of deep-vein thrombosis (18.4 vs. 25.5 percent, P=0.001; relative reduction in risk, 28.0 percent). The safety profiles were similar in the two treatment groups.\n When administered 30 minutes before total hip replacement surgery, desirudin is more effective than enoxaparin in preventing deep-vein thrombosis.", "The novel, oral direct thrombin inhibitor, ximelagatran (formerly H 376/95), represents an advance in antithrombotic therapy through its oral availability. After oral administration, ximelagatran is converted to its active form, melagatran. Melagatran can also be administered subcutaneously (s.c.). The results from the first clinical study with ximelagatran are reported. In this randomized, parallel-group, controlled study, 103 patients scheduled for elective total hip or total knee replacement received s.c. melagatran (1, 2 or 4 mg bid) for 2 days commencing immediately before surgery, followed by oral ximelagatran (6, 12 or 24 mg bid) for 6-9 days. Another 33 patients received dalteparin 5000 IU s.c. once daily, started the evening before surgery, for 8-11 days. At bilateral venography, deep vein thrombosis was found in 20.5% (16/78) of patients who had received s.c. melagatran and oral ximelagatran and in 18.5% (5/27) of patients in the dalteparin group. The study did not evaluate a dose-response for efficacy, and no differences between the three dose levels of melagatran and ximelagatran were shown. No pulmonary embolism was diagnosed during treatment. Total bleeding in the s.c. melagatran plus oral ximelagatran groups showed no dose-response and was similar to that seen in the dalteparin group. The pharmacokinetic properties of melagatran in the surgery patients were consistent with those observed for healthy subjects, and the APTT ratio, which increased non-linearly with plasma melagatran concentration, showed a consistent concentration-effect relationship during the treatment period. Ximelagatran and melagatran were well tolerated. In conclusion, ximelagatran and its active form melagatran appear to be promising agents for the prevention of venous thromboembolism following orthopaedic surgery.", "After hip replacement surgery, prophylaxis following discharge from hospital is recommended to reduce the risk of venous thromboembolism. Our aim was to assess the oral, direct thrombin inhibitor dabigatran etexilate for such prophylaxis.\n In this double-blind study, we randomised 3494 patients undergoing total hip replacement to treatment for 28-35 days with dabigatran etexilate 220 mg (n=1157) or 150 mg (1174) once daily, starting with a half-dose 1-4 h after surgery, or subcutaneous enoxaparin 40 mg once daily (1162), starting the evening before surgery. The primary efficacy outcome was the composite of total venous thromboembolism (venographic or symptomatic) and death from all causes during treatment. On the basis of the absolute difference in rates of venous thromboembolism with enoxaparin versus placebo, the non-inferiority margin for the difference in rates of thromboembolism was defined as 7.7%. Efficacy analyses were done by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00168818.\n Median treatment duration was 33 days. 880 patients in the dabigatran etexilate 220 mg group, 874 in the dabigatran etexilate 150 mg group, and 897 in the enoxaparin group were available for the primary efficacy outcome analysis; the main reasons for exclusion in all three groups were the lack of adequate venographic data. The primary efficacy outcome occurred in 60 (6.7%) of 897 individuals in the enoxaparin group versus 53 (6.0%) of 880 patients in the dabigatran etexilate 220 mg group (absolute difference -0.7%, 95% CI -2.9 to 1.6%) and 75 (8.6%) of 874 people in the 150 mg group (1.9%, -0.6 to 4.4%). Both doses were thus non-inferior to enoxaparin. There was no significant difference in major bleeding rates with either dose of dabigatran etexilate compared with enoxaparin (p=0.44 for 220 mg, p=0.60 for 150 mg). The frequency of increases in liver enzyme concentrations and of acute coronary events during the study did not differ significantly between the groups.\n Oral dabigatran etexilate was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar safety profile.", "We evaluated whether a postoperative regimen with melagatran followed by oral ximelagatran, two new direct thrombin inhibitors, was an optimal regimen for thromboprophylaxis in major orthopaedic surgery. In a double-blind study, 2788 patients undergoing total hip or knee replacement were randomly assigned to receive for 8 to 11 days either 3 mg of subcutaneous melagatran started 4-12 h postoperatively, followed by 24 mg of oral ximelagatran twice-daily or 40 mg of subcutaneous enoxaparin once-daily, started 12 h preoperatively. Ximelagatran was to be initiated within the first two postoperative days. The primary efficacy endpoint was venous thromboembolism (deep-vein thrombosis detected by mandatory venography, pulmonary embolism or unexplained death). The main safety endpoint was bleeding. Venous thromboembolism occurred in 355/1146 (31.0%) and 306/1122 (27.3%) patients in the ximelagatran and enoxaparin group, respectively, a difference in risk of 3.7% in favour of enoxaparin (p = 0.053). Bleeding was comparable between the two groups.", "Up to one third of patients who undergo total knee replacement develop deep vein thrombosis after surgery despite receiving low-molecular-weight heparin prophylaxis. Ximelagatran is a novel direct inhibitor of free and clot-bound thrombin.\n We performed a randomized, parallel, dose-finding study of 600 adults undergoing elective total knee replacement at 68 North American hospitals to determine the optimum dose of ximelagatran to use as prophylaxis against venous thromboembolism after total knee replacement. Patients received either ximelagatran twice daily by mouth in blinded fixed doses of 8, 12, 18, or 24 mg or open-label enoxaparin sodium, 30 mg, subcutaneously twice daily, starting 12 to 24 hours after surgery and continuing for 6 to 12 days. We measured the 6- to 12-day cumulative incidence of symptomatic or venographic deep vein thrombosis, symptomatic pulmonary embolism, and bleeding.\n A total of 594 patients received at least 1 dose of the study drug; 443 patients were evaluable for efficacy. Rates of overall venous thromboembolism (and proximal deep vein thrombosis or pulmonary embolism) for the 8-, 12-, 18-, and 24-mg doses of ximelagatran were 27% (6.6%), 19.8% (2.0%), 28.7% (5.8%), and 15.8% (3.2%), respectively. Rates of overall venous thromboembolism (22.7%) and proximal deep vein thrombosis or pulmonary embolism (3.1%) for enoxaparin did not differ significantly compared with 24-mg ximelagatran (overall difference, -6.9%; 95% confidence interval, -18.0% to 4.2%; P=.3). There was no major bleeding with administration of 24 mg of ximelagatran twice daily.\n Fixed-dose, unmonitored ximelagatran, 24 mg twice daily, given after surgery appears to be safe and effective oral prophylaxis against venous thromboembolism after total knee replacement.", "Prophylaxis is recommended following total joint replacement because of the high risk of venous thromboembolism (VTE). Postoperative low-molecular-weight heparin (LMWH) reduces the incidence of venographically detected deep vein thrombosis (DVT) to about 10-15% in total hip replacement (THR) patients. Ximelagatran is a novel, oral direct thrombin inhibitor that selectively and competitively inhibits both free and clot-bound thrombin. We compared the efficacy and safety of ximelagatran with those of enoxaparin for the prevention of VTE in patients undergoing THR.\n This was a prospective, randomized, multicenter, double-blind study conducted principally in the USA and Canada. Patients received fixed-dose oral ximelagatran 24 mg bid or subcutaneous enoxaparin 30 mg bid and matched placebo for 7-12 days; both regimens were initiated the morning after surgery. The incidence of VTE (by postoperative day 12) included thrombosis determined by mandatory venography of the leg on which surgery was performed and symptomatic, objectively proven DVT or pulmonary embolism (PE). VTE and bleeding events were interpreted by an independent central adjudication committee for primary analysis.\n Of the 1838 patients randomized, 1557 had either adequate venography or symptomatic, proven VTE (efficacy population). Overall rate of venography acceptable for evaluation was 85.4%. Overall rates of total VTE were 7.9% (62 of 782 patients) in the ximelagatran group and 4.6% (36 of 775 patients) in the enoxaparin group, with an absolute difference of 3.3% and a 95% confidence interval for the difference of 0.9% to 5.7%. Proximal DVT and/or PE occurred in 3.6% (28 of 782 patients) in the ximelagatran group and 1.2% (nine of 774 patients) in the enoxaparin group. Major bleeding events were observed in 0.8% (seven of 906) of the ximelagatran-treated patients and in 0.9% (eight of 910) of the enoxaparin-treated patients (P > 0.95). Non-inferiority of ximelagatran 24 mg bid based on a prespecified margin of 5% was not met, resulting in superiority of the enoxaparin regimen.\n Both ximelagatran and enoxaparin decreased the overall rate of VTE compared with that reported historically. However, in this study, enoxaparin 30 mg bid was more effective than ximelagatran 24 mg bid for prevention of VTE in THR. Oral ximelagatran was used without coagulation monitoring, was well tolerated, and had bleeding rates comparable to those of enoxaparin. Further refinement by testing a higher dose of ximelagatran in the patients undergoing THR is warranted." ]

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[ "Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial.", "Effectiveness of a counseling intervention after a traumatic childbirth: a randomized controlled trial.", "A two-centred pragmatic randomised controlled trial of two interventions of postnatal support.", "PRISM (Program of Resources, Information and Support for Mothers): a community-randomised trial to reduce depression and improve women's physical health six months after birth [ISRCTN03464021].", "A randomised controlled trial of educational counselling on the management of women who have suffered suboptimal outcomes in pregnancy.", "A preventive intervention for pregnant women on public assistance at risk for postpartum depression.", "Does an early postnatal check-up improve maternal health: results from a randomised trial in Australian general practice.", "Randomised controlled trial of midwife led debriefing to reduce maternal depression after operative childbirth.", "Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial.", "Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors.", "Effects of redesigned community postnatal care on womens' health 4 months after birth: a cluster randomised controlled trial.", "Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations.", "Effects of group prenatal care on psychosocial risk in pregnancy: results from a randomised controlled trial.", "A randomized, controlled trial of nurse home visiting to vulnerable families with newborns.", "Randomized controlled trial of a preventive intervention for perinatal depression in high-risk Latinas.", "Costs and effectiveness of community postnatal support workers: randomised controlled trial.", "Stress debriefing after childbirth: a randomised controlled trial.", "A RCT of peer-mentoring for first-time mothers in socially disadvantaged areas (the MOMENTS Study).", "Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.", "A randomized controlled trial testing the impact of a support/work-planning intervention on first-time parents' health, partner relationship, and work responsibilities.", "Evaluation of antenatal and postnatal support to overcome postnatal depression: a randomized, controlled trial.", "Can midwives reduce postpartum psychological morbidity? A randomized trial.", "Does team midwife care increase satisfaction with antenatal, intrapartum, and postpartum care? A randomized controlled trial.", "Postpartum depression in women receiving public assistance: pilot study of an interpersonal-therapy-oriented group intervention.", "Evaluation of an interpersonal-psychotherapy-oriented childbirth education programme for Chinese first-time childbearing women: a randomised controlled trial.", "A psychosomatic intervention in pregnant in-patient women with prenatal somatic risks." ]

[ "The majority of randomised controlled trials examining the effectiveness of antenatal group interventions at preventing postnatal depression in \"at risk\" women have used a \"psychoeducational\" intervention. The aim of the present study is to evaluate the effectiveness of an antenatal cognitive behavioural group intervention in a primary care setting for pregnant women identified with mild to moderate symptoms in pregnancy and/or at risk of developing depression or anxiety in the perinatal period.\n Subjects were randomised to a CBT group intervention or control condition (information booklet) and administered the EPDS and STAI at pre (Time 1) and post intervention (Time 2), and at 2 months (Time 3) and 4 months postpartum (Time 4). MINIs were administered at Times 1, 3 and 4.\n Of the 774 women approached, 277 accepted and were suitable; thus 191 were randomised to the CBT intervention and 86 to the control condition. The subsequent 52% drop-out left 89 women \"completing\" the CBT groups and 43 in the control group; these two groups were well matched on demographic variables. Intention to treat analyses revealed relatively low mean baseline EPDS scores (means 6.88 -8.16) with no reduction in EPDS scores in either group from Time 1 to Time 4. MINI depression criteria were fulfilled by 19% of all participants at Time 1 but there was no reduction in depression in either group; in contrast those with MINI anxiety diagnoses reduced from 28% in late pregnancy to 16% at four months postpartum in the CBT group with similar reductions in the control group. Analyses on the 132 \"completers\" showed significant symptomatic improvement over time for both the CBT group and control condition. Depression scores in the most symptomatic women (EPDS>12; N=19) decreased steadily by over 50% over the total time course but there were no differences in improvement between the CBT and control groups.\n A number of methodological factors may have obscured our results including a tendency to natural remission in mildly symptomatic subjects and the possibility that our control condition was therapeutic in itself.\n While a modest reduction in depression scores was noted in study \"completers\", both the CBT group intervention control condition were equally beneficial. The reasons for this finding include the low symptom level at baseline; the potential effectiveness of the control condition; and the brevity of the intervention.", "Adverse childbirth experiences can evoke fear and overwhelming anxiety for some women and precipitate posttraumatic stress disorder. The objective of this study was to assess a midwife-led brief counseling intervention for postpartum women at risk of developing psychological trauma symptoms.\n Of 348 women screened for trauma symptoms, 103 met inclusion criteria and were randomized into an intervention (n = 50) or a control (n = 53) group. The intervention group received face-to-face counseling within 72 hours of birth and again via telephone at 4 to 6 weeks postpartum. Main outcome measures were posttraumatic stress symptoms, depression, self-blame, and confidence about a future pregnancy.\n At 3-month follow-up, intervention group women reported decreased trauma symptoms, low relative risk of depression, low relative risk of stress, and low feelings of self-blame. Confidence about a future pregnancy was higher for these women than for control group women. Three intervention group women compared with 9 control group women met the diagnostic criteria for posttraumatic stress disorder at 3 months postpartum, but this result was not statistically significant.\n A high prevalence of postpartum depression and trauma symptoms occurred after childbirth. Although most women improved over time, the intervention markedly affected participants' trajectory toward recovery compared with women who did not receive counseling.\n A brief, midwife-led counseling intervention for women who report a distressing birth experience was effective in reducing symptoms of trauma, depression, stress, and feelings of self-blame. The intervention is within the scope of midwifery practice, caused no harm to participants, was perceived as helpful, and enhanced women's confidence about a future pregnancy.", "To establish whether providing additional postnatal support during the early postnatal months influences women's physical and psychological health and to identify health service benefits.\n Pragmatic randomised controlled trial with a 2 x 2 factorial design with two interventions.\n Community centres, Ayrshire and Grampian, Scotland.\n One thousand and four primiparous women, 83% completed the baseline questionnaire, 71% at six months.\n (1) An invitation to a local postnatal support group run weekly with a facilitator, starting two weeks postpartum. (2) A postnatal support manual, posted two weeks postpartum.\n Data regarding primary outcome postnatal depression (Edinburgh Postnatal Depression Scale, EPDS), secondary outcomes, general health measures (SF-36), social support (SSQ6), use of health services and women's views of interventions were collected at two weeks postpartum and at three and six months.\n There were no significant differences in EPDS scores between the control and trial arms at three and six months, nor were there differences in the SF-36 and the SSQ6 scores. The 95% CI for the difference in EPDS effectively excluded a change in mean score of more than 10% with either intervention. There were no differences in health service attendances in primary or secondary care between the control and trial arms. Of those women who attended the groups, 40% attended six or more. Women reported favourably on the 'pack' with the majority reading it a few times and feeling that it was aimed at them.\n Wide-scale provision by the National Health Service of either support groups or self-help manuals is not appropriate if the aim is to improve measurable health outcomes.", "In the year after birth one in six women has a depressive illness, 94% experience at least one major health problem (e.g. back pain, perineal pain, mastitis, urinary or faecal incontinence), 26% experience sexual problems and almost 20% have relationship problems with partners. Women with depression report less practical and emotional support from partners, less social support, more negative life events, and poorer physical health and see factors contributing to depression as lack of support, isolation, exhaustion and physical health problems. Fewer than one in three seek help in primary care despite frequent health care contacts.\n Primary care and community-based strategies embedded in existing services were implemented in a cluster-randomised trial involving 16 rural and metropolitan communities, pair-matched, within the State of Victoria, Australia. Intervention areas were also provided with a community development officer for two years. The primary aim was to reduce the relative risk of depression by 20% in mothers six months after birth and to improve their physical health. Primary outcomes were obtained by postal questionnaires. The analysis was by intention-to-treat, unmatched, adjusting for the correlated nature of the data.\n 6,248 of 10,144 women (61.6%) in the intervention arm and 5057/ 8,411 (60.1%) in the comparison arm responded at six months, and there was no imbalance in major covariates between the two arms. Women's mental health scores were not significantly different in the intervention arm and the comparison arm (MCS mean score 45.98 and 46.30, mean EPDS score 6.91 and 6.82, EPDS > or = 13 ('probable depression') 15.7% vs. 14.9%, Odds ratio(adj) 1.06 (95% CI 0.91-1.24). Women's physical health scores were not significantly different in intervention and comparison arms (PCS mean scores 52.86 and 52.88).\n The combined community and primary care interventions were not effective in reducing depression, or in improving the physical health of mothers six months after birth.", "To study whether proactive educational counselling, in addition to routine clinical care, reduces psychological morbidity and improves quality of life and client satisfaction among women who suffer suboptimal outcomes during childbirth.\n A randomised controlled trial.\n Obstetric unit of a tertiary teaching hospital.\n Women who had unexpected antenatal, intrapartum or postpartum events leading to suboptimal outcomes during pregnancy and childbirth.\n Educational counselling provided by a trained research nurse in the postnatal ward after delivery. Women in the control group received routine clinical care.\n The Hospital Anxiety and Depression Scale, the General Health Questionnaire and the Clinical Global Impression (before and after counselling, at six weeks and six months post-delivery) and the World Health Organisation Quality of Life scale (WHO-QOL) (at six weeks and six months post-delivery).\n There was no significant difference in psychological morbidity, quality of life or client satisfaction between the counselling group and the control group. Participants who underwent elective caesarean section and who had the educational counselling had significantly lower depression scores [mean 2.6 (SD 2.6)] compared with those receiving routine care [mean 3.9 (SD 3.2)]. On the other hand, educational counselling may have deleterious effect to women's quality of life in those who had instrumental delivery. Participants allocated to the counselling group had a lower mean score 68 (SD 13) in the physical domain of WHO-QOL than those in the intervention group 74 (SD 13).\n Educational counselling, given on top of routine clinical care, does not give additional beneficial effects on the psychological wellbeing and quality of life of women who encountered suboptimal outcomes during pregnancy.", "Promising results were obtained in an earlier pilot study of a preventive intervention based on the principles of interpersonal psychotherapy to reduce the risk of postpartum major depressive disorder. In this study, the authors examined whether the intervention would reduce the risk of postpartum major depressive disorder in a larger sample of pregnant women.\n Ninety-nine pregnant women on public assistance who were assessed to be at risk for postpartum depression were randomly assigned to receive standard antenatal care plus the intervention or standard antenatal care only. Diagnostic interviews were administered 3 months after delivery to assess for major depressive disorder.\n Within 3 months after delivery, eight (20%) of the women in the standard antenatal care condition had developed postpartum major depressive disorder, compared with two (4%) in the intervention condition.\n This study provides further evidence for the efficacy of a brief intervention to reduce the occurrence of major depressive disorder among financially disadvantaged women during a postpartum period of 3 months.", "To investigate whether a visit to a general practitioner one week after discharge results in less depression, increased breastfeeding rates, improved patient wellbeing, fewer physical problems and greater satisfaction with general practice care than the traditional six week postnatal check-up.\n A randomised controlled trial.\n Rural and metropolitan Victoria, Australia. Population Women giving birth at one rural and one metropolitan hospital between February and December 1995 inclusive.\n All women received a letter and appointment date to see a general practitioner for a check-up: the intervention group for one week after hospital discharge, the control group for six weeks after birth. A mail-out survey was conducted at three and six months after birth, including Edinburgh Postnatal Depression Scale and Short Form 36.\n 1017/1407 (72.3%) women giving birth at participating hospitals were eligible for the trial: 683 (67.2%) gave informed consent. The average response rate to postal follow up at three and six months was 67.5%. No significant differences were found between the groups in: Edinburgh Postnatal Depression and Short Form 36 scores; number of problems; breastfeeding rates; or satisfaction with general practitioner care. Women in the intervention group were less likely to attend for their check-up (76.4% vs 88.4%; P = 0.001), more likely to discuss labour and birth at their check-up (OR= 1.77, 95% CI 1.17-2.68), less likely to have a vaginal examination (OR = 0.51; 95%, CI 0.34-0.77) or pap smear (OR = 0.34; 95% CI = 0.22-0.52) at their check; more likely to report difficulties with low milk supply (OR= 1.72; 95% CI = 1.12-2.66) and adjusting to the demands of a new baby (OR = 1.76; 95% CI 1.13 2.74), more likely to talk to a general practitioner about their baby (68.2% vs 58.0%; P=0.02) and less likely to consult a hospital doctor about their baby (7.3% vs 14.0%, P = 0.02).\n To make clinically important improvements in maternal health more is required than early postnatal review.", "To assess the effectiveness of a midwife led debriefing session during the postpartum hospital stay in reducing the prevalence of maternal depression at six months postpartum among women giving birth by caesarean section, forceps, or vacuum extraction.\n Randomised controlled trial.\n Large maternity teaching hospital in Melbourne, Australia.\n 1041 women who had given birth by caesarean section (n= 624) or with the use of forceps (n= 353) or vacuum extraction (n= 64).\n Maternal depression (score >/=13 on the Edinburgh postnatal depression scale) and overall health status (comparison of mean scores on SF-36 subscales) measured by postal questionnaire at six months postpartum.\n 917 (88%) of the women recruited responded to the outcome questionnaire. More women allocated to debriefing scored as depressed six months after birth than women allocated to usual postpartum care (81 (17%) v 65 (14%)), although this difference was not significant (odds ratio=1.24, 95% confidence interval 0.87 to 1.77). They were also more likely to report that depression had been a problem for them since the birth, but the difference was not significant (123 (28%) v 94 (22%); odds ratio=1. 37, 1.00 to 1.86). Women allocated to debriefing had poorer health status on seven of the eight SF-36 subscales, although the difference was significant only for role functioning (emotional): mean scores 73.32 v 78.98, t= -2.31, 95% confidence interval -10.48 to -0.84).\n Midwife led debriefing after operative birth is ineffective in reducing maternal morbidity at six months postpartum. The possibility that debriefing contributed to emotional health problems for some women cannot be excluded.", "Community mobilisation through participatory women's groups might improve birth outcomes in poor rural communities. We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India.\n From 36 clusters in Jharkhand and Orissa, with an estimated population of 228 186, we assigned 18 clusters to intervention or control using stratified randomisation. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study. In intervention clusters, a facilitator convened 13 groups every month to support participatory action and learning for women, and facilitated the development and implementation of strategies to address maternal and newborn health problems. The primary outcomes were reductions in neonatal mortality rate (NMR) and maternal depression scores. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21817853.\n After baseline surveillance of 4692 births, we monitored outcomes for 19 030 births during 3 years (2005-08). NMRs per 1000 were 55.6, 37.1, and 36.3 during the first, second, and third years, respectively, in intervention clusters, and 53.4, 59.6, and 64.3, respectively, in control clusters. NMR was 32% lower in intervention clusters adjusted for clustering, stratification, and baseline differences (odds ratio 0.68, 95% CI 0.59-0.78) during the 3 years, and 45% lower in years 2 and 3 (0.55, 0.46-0.66). Although we did not note a significant effect on maternal depression overall, reduction in moderate depression was 57% in year 3 (0.43, 0.23-0.80).\n This intervention could be used with or as a potential alternative to health-worker-led interventions, and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor populations.\n Health Foundation, UK Department for International Development, Wellcome Trust, and the Big Lottery Fund (UK).\n Copyright 2010 Elsevier Ltd. All rights reserved.", "Social support theory and observational risk factor studies suggest that increased antenatal psychosocial support could prevent post-natal depression. We used empirical knowledge of risk and protective factors for post-natal depression not employed previously in order to develop and evaluate an antenatal preventive intervention.\n We conducted a pragmatic randomized controlled trial in antenatal clinics. We screened 1300 primiparous women and 400 screened positive, 69 screen-positive women were untraceable or not eligible. Of 292 women who completed baseline assessment, 209 consented to randomization, of these 190 provided outcome data 3 months post-natally. 'Preparing for Parenthood', a structured antenatal risk factor reducing intervention designed to increase social support and problem-solving skills, was compared with routine antenatal care only. We compared the percentage depressed at 3 months after childbirth using the self-completion General Health Questionnaire Depression scale and Edinburgh Post-natal Depression Scale (EPDS), and the Schedules for Clinical Assessment in Neuropsychiatry a systematic clinical interview.\n Assignment to the intervention group did not significantly impact on post-natal depression (odds ratio for GHQ-Depression 1.22 (95% CI 0.63-2.39), P = 0.55) or on risk factors for depression. Forty-five per cent of the intervention group women attended sufficient sessions to be likely to benefit from intervention if effective. Attenders benefited no more than non-attenders.\n Prevention services targeting post-natal depression should not implement antenatal support programmes on these lines until further research has demonstrated the feasibility and effectiveness of such methods. The development of novel, low cost interventions effective in reducing risk factors should be completed before further trial evaluation.", "Much postpartum physical and psychological morbidity is not addressed by present care, which tends to focus on routine examinations. We undertook a cluster randomised controlled trial to assess community postnatal care that has been redesigned to identify and manage individual needs.\n We randomly allocated 36 general practice clusters from the West Midlands health region of the UK to intervention (n=17) or control (19) care. Midwives from the practices recruited women and provided care. 1087 (53%) of 2064 women were in practices randomly assigned to the intervention group, with 977 (47%) women in practices assigned to the control group. Care was led by midwives, with no routine contact with general practitioners, and was extended to 3 months. Midwives used symptom checklists and the Edinburgh postnatal depression scale (EPDS) to identify health needs and guidelines for the management of these needs. Primary outcomes at 4 months were obtained by postal questionnaire and included the women's short form 36 physical (PCS) and mental (MCS) component summary scores and the EPDS. Secondary outcomes were women's views about care. Multilevel analysis accounted for possible cluster effects.\n 801 (77%) of 1087 women in the intervention group and 702 (76%) of 977 controls responded at 4 months. Women's mental health measures were significantly better in the intervention group (MCS, 3.03 [95% CI 1.53-4.52]; EPDS -1.92 [-2.55 to -1.29]; EPDS 13+ odds ratio 0.57 [0.43-0.76]) than in controls, but the physical health score did not differ.\n Redesign of care so that it is midwife-led, flexible, and tailored to needs, could help to improve women's mental health and reduce probable depression at 4 months' postpartum.", "This study investigated the ability of a theoretically driven, psychosocial prevention program implemented through childbirth education programs to enhance the coparental relationship, parental mental health, the parent-child relationship, and infant emotional and physiological regulation. A sample of 169 heterosexual, adult couples who were expecting their 1st child was randomized to intervention and control conditions. The intervention families participated in Family Foundations, a series of 8 classes, delivered before and after birth, that was designed as a universal prevention program (i.e., it was applicable to all couples, not just those at high risk). Intent-to-treat analyses indicated significant program effects on coparental support, maternal depression and anxiety, distress in the parent-child relationship, and several indicators of infant regulation. Intervention effects were not moderated by income, but greater positive impact of the program was found for lower educated parents and for families with a father who reported higher levels of insecure attachment in close relationships. These findings support the view that coparenting is a potentially malleable intervention target that may influence family relationships as well as parent and child well-being.\n (c) 2008 APA, all rights reserved.", "Few interventions have succeeded in reducing psychosocial risk among pregnant women. The objective of this study was to determine whether an integrated group prenatal care intervention already shown to improve perinatal and sexual risk outcomes can also improve psychosocial outcomes compared to standard individual care. This randomised controlled trial included pregnant women ages 14-25 from two public hospitals (N = 1047) who were randomly assigned to standard individual care, group prenatal care or integrated group prenatal care intervention (CenteringPregnancy Plus, CP+). Timing and content of visits followed obstetrical guidelines, from 18-week gestation through birth. Each 2-h group prenatal care session included physical assessment, education/skills building and support via facilitated discussion. Using intention-to-treat models, there were no significant differences in psychosocial function; yet, women in the top tertile of psychosocial stress at study entry did benefit from integrated group care. High-stress women randomly assigned to CP+ reported significantly increased self-esteem, decreased stress and social conflict in the third trimester of pregnancy; social conflict and depression were significantly lower 1-year postpartum (all p-values < 0.02). CP+ improved psychosocial outcomes for high-stress women. This 'bundled' intervention has promise for improving psychosocial outcomes, especially for young pregnant women who are traditionally more vulnerable and underserved.", "This project aimed to evaluate the impact of a home visiting programme that targeted families where the child, for environmental reasons, was at great risk of poor health and developmental outcomes.\n Women in the immediate postpartum period were recruited to a randomized double-blind controlled trial on the basis of self-reported vulnerability factors and were randomly assigned to receive either a structured programme of nurse home visiting, supported by a social worker and paediatrician (n = 90), or assigned to a comparison group receiving standard community child health services (n = 91). Parenting stress and maternal depression were measured at enrollment and at 6 weeks. Preventive health behaviour, service satisfaction and home environment outcomes were tested at 6 weeks, as were child health outcomes.\n At six weeks, women receiving the home-based programme had significant reductions in postnatal depression screening scores as well as improvements in their experience of the parental role and improvement in the ability to maintain their own identity. Maternal-infant interactions were more likely to be positive, with significantly higher (better) scores in aspects of the home environment related to optimal development in children, particularly maternal-infant secure attachment. Intervention group mothers were significantly more satisfied with the community child health service.\n This form of intervention for families is effective in promoting secure maternal-infant attachment, preventing maternal mood disorder and is welcomed by the families receiving it. These findings may predict long-term benefits for the healthy development of children otherwise at risk of a range of poor health and development outcomes.", "A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas.\n A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual care (UC; n = 105) or an 8-week CBT group intervention during pregnancy and 3 individual booster sessions during postpartum (n = 112). Participants completed measures assessing depressive symptoms (Center for Epidemiological Studies Depression Scale at baseline; Beck Depression Inventory, Second Edition [BDI-II]) and major depressive episodes (Mood Screener) at 5 time points throughout the perinatal period.\n Intent-to-treat analyses indicated that intervention participants had significantly lower depressive symptoms and fewer cases of moderate depression (BDI-II ≥ 20) at Time 2 than UC participants. These effects were stronger for women who fully participated in the intervention (≥ 4 classes). The cumulative incidence of major depressive episodes was not significantly different between the intervention (7.8%) and UC (9.6%) groups.\n A CBT intervention for low-income, high-risk Latinas reduced depressive symptoms during pregnancy but not during the postpartum period. Low levels of depressive symptoms and lower than expected rates of clinical depression in both groups may partially be due to methodological issues. As perinatal depression is a significant public health problem, more work is needed to prevent perinatal depression in low-income, ethnically diverse women.\n (c) 2011 APA, all rights reserved.", "To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives.\n Randomised controlled trial with six month follow up.\n Recruitment in a university teaching hospital and care provided in women's homes.\n 623 postnatal women allocated at random to intervention (311) or control (312) group. Intervention: Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker. Main outcome measure: General health status as measured by the SF-36 and risk of postnatal depression. Breast feeding rates, satisfaction with care, use of services, and personal costs.\n At six weeks there was no significant improvement in health status among the women in the intervention group. At six weeks the mean total NHS costs were pound 635 for the intervention group and pound 456 for the control group (P=0.001). At six months figures were pound 815 and pound 639 (P=0.001). There were no differences between the groups in use of social services or personal costs. The women in the intervention group were very satisfied with the support worker visits.\n There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36. There were no savings to the NHS over six months after the introduction of the community postnatal support worker service.", "To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders.\n Randomised single-blind controlled trial stratified for parity and delivery mode.\n Two large maternity hospitals in Perth.\n 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group).\n An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery.\n Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition.\n Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98).\n There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.", "Interventions to reduce health inequalities for young children and their mothers are important: involving peers is recommended, but evidence of value for this approach is limited. The authors aimed to examine the effect of an innovative tailored peer-mentoring programme, based on perceived needs, for first-time mothers in socio-economically deprived communities.\n Randomised controlled trial; parallel qualitative study with purposive samples using semistructured interviews.\n Socio-economically disadvantaged areas, Belfast.\n Primigravidae, aged 16-30 years, without significant co-morbidity.\n Peer-mentoring by a lay-worker fortnightly during pregnancy and monthly for the following year, tailored to participants' wishes (home visits/telephone contacts), additional to usual care.\n Infant psychomotor and mental development (Bayley Scales of Infant Development (BSID-II)) at 1 year, assessed by an observer blinded to group allocation. Mothers' health at 1 year postnatal (SF-36).\n Of 534 women invited, 343(64%) participated; 85%, with their children, completed outcome assessments (140 of 172 intervention; 152 of 171 controls). Intervention and control groups did not differ in BSID-II psychomotor (mean difference 1.64, 95% CI -0.94 to 4.21) or mental (-0.81, -2.78 to 1.16) scores, nor SF-36 physical functioning (-5.4, -11.6 to 0.7) or mental health (-1.8, -6.1 to 2.6). Women valued advice given in context of personal experience of child-rearing. Mentors gained health-related knowledge, personal skills and new employment opportunities.\n Despite possible longer-term social advantage, this peer-mentoring programme showed no benefit for infant development or maternal health at 1 year. Further rigorous evaluation of important outcomes of complex interventions promoting health for children in socially disadvantaged communities is warranted. TRIAL REGISTRATION NO: ISRCTN 55055030.", "To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression.\n Multisite randomised controlled trial.\n Seven health regions across Ontario, Canada.\n 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service.\n Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session.\n Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services.\n After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend.\n Telephone based peer support can be effective in preventing postnatal depression among women at high risk.\n ISRCTN 68337727.", "The authors randomly assigned 151 couples expecting their first child to a support/work-planning intervention group or a standard prenatal curriculum group. To evaluate the impact of the intervention, they conducted surveys at baseline and 6-months postpartum to assess mental and physical health, partner satisfaction and caring, work time, housework sharing, and satisfaction with housework sharing. They found no significant group differences on postpartum health or work outcomes, although fathers in the experimental group, in contrast to controls, showed a trend toward less postpartum decline in housework sharing. The study identified a tool to help parents plan their postpartum work responsibilities. The tool, as tested in this trial, did not have a significant impact on parents' work behaviors or health outcomes. Further studies are needed to investigate mechanisms to support young parents during their demanding early childbearing years.", "This randomized, controlled trial tested the hypothesis that women identified as more vulnerable to developing postnatal depression who attended two specific antenatal groups and one postnatal group have a reduced frequency of postnatal depression from 37 to 15 percent at 6 weeks, 12 weeks, and 6 months postpartum. A modified antenatal screening questionnaire was completed, and women identified as more vulnerable to postnatal depression were stratified by parity and randomly allocated to receive extra support groups or to a control group. The Edinburgh Postnatal Depression Scale (EPDS) was used to detect postnatal depression. Attendance at the support groups was low, 31 percent overall. At six weeks, in the intervention group, 8 (13%) of 64 women scored high (> 12) on the EPDS, compared with 11 (17%) controls. Similarly, at 12 weeks 7 (11%) of 63 versus 10 (15%) of 65 women scored higher than 12, and at 6 months, 9 (15%) of 60 versus 6 (10%) of 64 women scored higher than 12, indicating that the intervention did not reduce postnatal depression. It is possible that the method of applying the intervention, using groups separate from the standard antenatal classes, may have affected attendance. More research is required into ways of reaching and supporting women who may become depressed.", "Women who are traumatized after childbirth find that listening, support, counseling, understanding, and explanation are the most useful treatments. However, little evidence is available from randomized trials of the relative efficacy of these treatments as a positive postnatal intervention. This study purpose was to examine if postnatal \"debriefing\" by midwives can reduce psychological morbidity after childbirth.\n A randomized trial was conducted in a regional teaching hospital in northwest England. One hundred and twenty postnatal primigravidas were allocated by sealed envelopes to receive the debriefing intervention (n = 56) or not (n = 58). The main outcome measure was the Hospital Anxiety and Depression (HAD) scale administered by postal questionnaire 3 weeks after delivery. The proportion of women in each group with anxiety and depression scores of more than 10 points were compared, using odds ratios and 95% confidence intervals.\n Women who received the intervention were less likely to have high anxiety and depression scores after delivery when compared with the control group.\n The support, counseling, understanding, and explanation given to women by midwives in the postnatal period provides benefits to psychological well-being. Maternity units have a responsibility to develop a service that offers all women the option of attending a session to discuss their labor.", "Although policymakers have suggested that improving continuity of midwifery can increase women's satisfaction with care in childbirth, evidence based on randomized controlled trials is lacking. New models of care, such as birth centers and team midwife care, try to increase the continuity of care and caregiver. The objective of this study was to evaluate the effect of a new team midwife care program in the standard clinic and hospital environment on satisfaction with antenatal, intrapartum, and postpartum care in low-risk women in early pregnancy.\n Women at Royal Women's Hospital in Melbourne, Australia, were randomly allocated to team midwife care (n = 495) or standard care (n = 505) at booking in early pregnancy. Doctors attended most women in standard care, and continuity of the caregiver was lacking. Satisfaction was measured by means of a postal questionnaire 2 months after the birth.\n Team midwife care was associated with increased satisfaction, and the differences between the groups were most noticeable for antenatal care, less noticeable for intrapartum care, and least noticeable for postpartum care. The study found no differences between team midwife care and standard care in medical interventions or in women's emotional well-being 2 months after the birth.\n Conclusions about which components of team midwife care were most important to increased satisfaction with antenatal care were difficult to draw, but data suggest that satisfaction with intrapartum care was related to continuity of the caregiver.", "This study investigated whether a preventive intervention based on the principles of interpersonal psychotherapy administered to pregnant women would reduce the risk of postpartum major depression.\n Thirty-seven pregnant women receiving public assistance who had at least one risk factor for postpartum depression were randomly assigned to a four-session group intervention or to a treatment-as-usual condition. Thirty-five of the women completed the study. Structured diagnostic interviews were administered to assess for postpartum major depression.\n Within 3 months after they gave birth, six (33%) of the 18 women in the treatment-as-usual condition had developed postpartum major depression, compared with none of the 17 women in the intervention condition.\n A four-session interpersonal-therapy-oriented group intervention was successful in preventing the occurrence of major depression during a postpartum period of 3 months in a group of financially disadvantaged women.", "This study investigated the effects of an interpersonal-psychotherapy-oriented childbirth psychoeducation programme on postnatal depression, psychological well-being and satisfaction with interpersonal relationships in Chinese first-time childbearing women.\n A randomised, controlled trial was conducted in the maternity clinic of a regional hospital in China. The intervention was based on the principles of interpersonal psychotherapy, and consisted of two 90-min antenatal classes and a telephone follow-up within 2 weeks after delivery. One hundred and ninety-four first-time pregnant women were randomly assigned to the intervention group (n=96) or a control group (n=98). Outcomes of the study included symptoms of postnatal depression, psychological well-being and satisfaction with interpersonal relationships, which were measured by the Edinburgh Postnatal Depression Scale (EPDS), General Health Questionnaire (GHQ) and Satisfaction with Interpersonal Relationships Scale (SWIRS), respectively.\n Women receiving the childbirth psychoeducation programme had significantly better psychological well-being (t=-3.33, p=0.001), fewer depressive symptoms (t=-3.76, p=0.000) and better interpersonal relationships (t=3.25, p=0.001) at 6 weeks postpartum as compared with those who received only routine childbirth education.\n An interpersonal-psychotherapy-oriented childbirth psychoeducation programme could be implemented as routine childbirth education with ongoing evaluation. Replication of this study with more diverse study groups, such as mothers with high risks to depression, those with multiple, complicated or multiparas pregnancies, would provide further information about the effects of the programme.\n Copyright (c) 2010 Elsevier Ltd. All rights reserved.", "This study examined whether a short-term psychosomatic intervention during pregnancy had effects on characteristics of labour and delivery as well as on the long-term course of anxiety, depression and physical complaints in pregnant in-patient women.\n All gynaecological and obstetric inpatients of a university hospital, who had either exhibited complications during their pregnancy or were considered high-risk pregnancies, were examined. Symptoms of anxiety and depression (HADS) and physical symptoms (GBB) were assessed by standardised questionnaires. Women with elevated scores on either the HADS or the GBB were randomly assigned to either a treatment group, which had received a psychosomatic intervention or an untreated control group. Of the n = 238 women who were assessed during their stay in our hospital, n = 135 were included in the follow-up 1-year later.\n More than one-third of the participants (38.7%) had elevated scores of anxiety, depression and/or physical symptoms. The psychosomatic intervention had a significant effect on anxiety scores (p = 0.006), but not on depression scores, physical complaints and characteristics of labour and delivery.\n Findings suggest that a short-term psychosomatic intervention can have a positive long-term effect on anxiety symptoms. Future studies are needed to show whether the reduction of anxiety symptoms in turn can lead to a reduction of postnatal complications and lower rates of disturbed mother-child interactions." ]

[ "9579151", "1415060", "8523192" ]

[ "Randomised controlled trial of tyrosine supplementation on neuropsychological performance in phenylketonuria.", "Cognition and tyrosine supplementation among school-aged children with phenylketonuria.", "Effect of high-dose tyrosine supplementation on brain function in adults with phenylketonuria." ]

[ "To test the efficacy of tyrosine supplementation, as an adjunct to dietary treatment, on neuropsychological test performance in individuals with phenylketonuria.\n A randomised controlled trial of tyrosine supplementation using a double blind crossover procedure with three four week phases.\n The Hospital for Sick Children, Toronto.\n 21 individuals with phenylketonuria (ages 6 to 28 years, mean 11.3).\n Participants were given 100 mg/kg body weight/d of L-tyrosine or L-alanine (placebo).\n At baseline, performance on several of the neuropsychological test measures was correlated with tyrosine levels. Dietary supplements of tyrosine increased plasma tyrosine concentrations; however, no change in test performance was found across the tyrosine and placebo phases of the study.\n Tyrosine supplementation of this type does not appear to alter neuropsychological performance in individuals with phenylketonuria.", "nan", "To characterize abnormalities of brain function in patients with phenylketonuria (PKU) who had relaxed or stopped the dietary regimen and to test whether oral high-dose tyrosine (Tyr) supplementation has a beneficial effect.\n Comparison with a control group; double-blind, placebo-controlled study comprising six test times; crossover treatment groups; oral high-dose Tyr therapy (100 mg/kg body weight per day) or placebo administration for 4 weeks.\n Twenty-four early-treated patients with PKU aged 20.8 (16 to 25) years; 24 control subjects.\n Plasma concentrations of phenylalanine and Tyr were monitored. Neuropsychologic tasks, visual evoked potentials, and spectral analysis of electroencephalographic activity were used to evaluate brain function.\n When patients with PKU were compared with control subjects, deficits in certain aspects of brain function were confirmed (i.e., a decreased ability to sustain attention, prolonged latencies of visual evoked potential peaks N1 and P2, and a reduced amount of fast-wave activity on the electroencephalogram). Baseline plasma phenylalanine and Tyr concentrations were in the typical range of adult patients with PKU. The plasma Tyr concentration increased approximately 200% during Tyr supplementation, but no beneficial effects were observed.\n High-dose Tyr supplementation cannot be recommended as an \"alternative\" treatment for patients with PKU after relaxation or termination of strict dietary adherence." ]

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[ "Prospective, randomized, double-blind comparison of metronidazole and tobramycin with clindamycin and tobramycin in the treatment of intra-abdominal sepsis.", "Comparison of imipenem/cilastatin with the combination of aztreonam and clindamycin in the treatment of intra-abdominal infections.", "Management of intra-abdominal infections. The case for intraoperative cultures and comprehensive broad-spectrum antibiotic coverage. The Canadian Intra-abdominal Infection Study Group.", "Comparison of intravenous/oral ciprofloxacin plus metronidazole versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections.", "Treatment of acute bacterial peritonitis: a trial of imipenem/cilastatin against ampicillin-metronidazole-gentamicin.", "Imipenem (N-F-thienamycin) versus netilmicin plus clindamycin. A controlled and randomized comparison in intra-abdominal infections.", "The role of Pseudomonas species in patients treated with ampicillin and Sulbactam for gangrenous and perforated appendicitis.", "Treatment of intra-abdominal infections is appropriate with single-agent or combination antibiotic therapy.", "Results of a clinical trial of clinafloxacin versus imipenem/cilastatin for intraabdominal infections.", "A clinical comparison of cefepime and metronidazole versus gentamicin and clindamycin in the antibiotic management of surgically treated advanced appendicitis.", "Meropenem versus tobramycin with clindamycin in the antibiotic management of patients with advanced appendicitis.", "Comparison of cefotetan versus combination therapy in peritonitis and serious intra-abdominal sepsis.", "Comparison of cefoperazone plus sulbactam with clindamycin plus gentamicin as treatment for intra-abdominal infections.", "A comparison of imipenem/cilastatin with the combination of cefuroxime and metronidazole in the treatment of intra-abdominal infections.", "Prospective randomized comparison of imipenem-cilastatin and piperacillin-tazobactam in nosocomial pneumonia or peritonitis.", "Piperacillin compared with cefuroxime plus metronidazole in diffuse peritonitis.", "Efficacy of two comparative antibiotic regimens in the treatment of serious intra-abdominal infections: results of a multicenter study.", "Piperacillin-tazobactam versus imipenem-cilastatin for treatment of intra-abdominal infections.", "Adjunctive antimicrobial therapy for complicated appendicitis: bacterial overkill by combination therapy.", "Imipenem versus tobramycin--antianaerobe antibiotic therapy in intra-abdominal infections.", "Meropenem (1.5 g/day) is as effective as imipenem/cilastatin (2 g/day) for the treatment of moderately severe intra-abdominal infections.", "Meropenem versus imipenem/cilastatin in the treatment of intra-abdominal infections.", "Biapenem versus imipenem/cilastatin in the treatment of complicated intra-abdominal infections: report from a Swedish Study Group.", "Meropenem versus imipenem/cilastatin in the treatment of intraabdominal infections requiring surgery.", "Meropenem monotherapy versus cefotaxime plus metronidazole combination treatment for serious intra-abdominal infections.", "Monotherapy with a broad-spectrum beta-lactam is as effective as its combination with an aminoglycoside in treatment of severe generalized peritonitis: a multicenter randomized controlled trial. The Severe Generalized Peritonitis Study Group.", "Antibiotic treatment during surgery for diffuse peritonitis: a prospective randomized study comparing the effects of cefuroxime and of a cefuroxime and metronidazole combination.", "The efficacy and safety of isepamicin compared with amikacin in the treatment of intra-abdominal infections.", "Cefminox versus metronidazole plus gentamicin intra-abdominal infections: a prospective randomized controlled clinical trial.", "Piperacillin/tazobactam in comparison with clindamycin plus gentamicin in the treatment of intra-abdominal infections.", "Efficacy of a beta-lactamase inhibitor combination for serious intraabdominal infections.", "A randomized multicentre trial of pefloxacin plus metronidazole and gentamicin plus metronidazole in the treatment of severe intra-abdominal infections. Report from a Swedish Study Group.", "Surgically treated gangrenous or perforated appendicitis. A comparison of aztreonam and clindamycin versus gentamicin and clindamycin.", "A randomized clinical study of cefoperazone and sulbactam versus gentamicin and clindamycin in the treatment of intra-abdominal infections." ]

[ "In a prospective, double-blind study, clindamycin was compared with metronidazole, each combined with tobramycin and all by the intravenous route in the treatment of intra-abdominal sepsis. Twenty-three patients received clindamycin and 34 patients received 35 courses of metronidazole. Analysis of the clinical responses of patients indicates that the two antibiotic regiments are of equal efficacy in that there was no difference between them in terms of defervescence or duration of infection. Few adverse effects were noted, and all appeared to be of a minor nature.", "The clinical safety and efficacy of imipenem/cilastatin in the treatment of intra-abdominal infections was compared with the combination of aztreonam and clindamycin in a randomized prospective trial. The severity of illness was determined by means of the Apache II score and a fixed outcome reporting scheme was used. One hundred and four patients were entered into the study, of whom 80 were evaluable. Forty-two patients were treated with imipenem/cilastatin (500 + 500 mg qds) and 38 with aztreonam (600 tds) and clindamycin (1000 mg tds). The study groups were comparable for age and sex. The imipenem/cilastatin group differed from the aztreonam and clindamycin group in having significantly more patients with the diagnosis of acute appendicitis (P < 0.01) and a significantly lower mean Apache score (P < 0.05). The predominate microorganisms isolated in both groups were Escherichia coli and Bacteroides fragilis. Treatment with imipenem/cilastatin proved successful in 71% and failed in 24%, and initial success only was seen in 5%. The numbers in the group treated with aztreonam and clindamycin were 64%, 29% and 7% respectively. Severity of illness, as measured by Apache II score, had no influence on the study outcome. Imipenem/cilastatin as well as the combination of aztreonam and clindamycin were effective in the treatment of abdominal infections and no major adverse reactions were seen.", "To test the hypothesis that comprehensive broad-spectrum empirical antimicrobial therapy is superior to limited-spectrum empirical antimicrobial therapy in intra-abdominal infections.\n Prospective, randomized, double-blinded study.\n University-affiliated hospitals in Canada.\n Two hundred thirteen patients with intra-abdominal infections and planned operative or percutaneous drainage.\n Limited-spectrum empirical antimicrobial therapy consisted of cefoxitin sodium, 2 g, intravenously, every 6 hours (n = 109). Comprehensive broad-spectrum empirical antimicrobial therapy consisted of a combination of imipenem and cilastatin sodium, 500 mg, intravenously, every 6 hours (n = 104).\n Failure to cure the intra-abdominal infection (persistence of infection or death).\n Of initial isolates, 98% were sensitive to imipenem plus cilastin sodium compared with 72% for cefoxitin. No difference was found in the failure rate between treatment groups. Among various reasons for failure (including technical), 12 of 80 patients in the limited-spectrum empirical antimicrobial therapy group had resistant organisms at a second intervention compared with 1 of 74 in the comprehensive broad-spectrum empirical antimicrobial therapy group (P < .003, chi 2). One death in the limited-spectrum empirical antimicrobial therapy group was due to autopsy-proved disseminated Pseudomonas aeruginosa (blood, peritoneum, lung, and pleural fluid) that was resistant to cefoxitin, and the other was associated with peritonitis due to cefoxitin-resistant Enterobacter cloacae. One death in the comprehensive broad-spectrum empirical antimicrobial therapy group was associated with peritonitis from Clostridium perfringens that was sensitive to imipenem plus cilastin sodium, and the other was associated with peritonitis from Pseudomonas aeruginosa that was resistant to imipenem plus cilastin sodium.\n Treatment failure of intra-abdominal infection may be due, in part, to the presence of resistant pathogens at the site of infection. Therefore, routine culture of these sites seems worthwhile and empirical therapy should be as comprehensive as possible and should cover all potential pathogens.", "To compare the safety and efficacy of intravenous (IV) ciprofloxacin plus IV metronidazole (CIP+MET) with that of IV piperacillin/tazobactam (PIP/TAZO) in adults with complicated intraabdominal infections, and to compare the efficacy of sequential IV-to-oral CIP+MET therapy with that of the IV CIP-only regimen.\n Treatment of intraabdominal infections remains a challenge, mainly because of their polymicrobial etiology and attendant death and complications. Antimicrobial regimens using sequential IV-to-oral therapy may reduce the length of hospital stay.\n In this multicenter, randomized, double-blind trial involving 459 patients, clinically improved IV-treated patients were switched to oral therapy after 48 hours. Overall clinical response was the primary efficacy measurement.\n A total of 282 patients (151 CIP+MET, 131 PIP/TAZO) were valid for efficacy. Of these patients, 64% CIP+MET and 57% PIP/TAZO patients were considered candidates for oral therapy. Patients had a mean APACHE II score of 9.6. The most common diagnoses were appendicitis (33%), other intraabdominal infection (29%), and abscess (25%). Overall clinical resolution rates were statistically superior for CIP+MET (74%) compared with PIP/TAZO (63%). Corresponding rates in the subgroup suitable for oral therapy were 85% for CIP+MET and 70% for PIP/TAZO. Postsurgical wound infection rates were significantly lower in CIP+MET (11%) versus PIP/TAZO patients (19%). Mean length of stay was 14 days for CIP+MET and 17 days for PIP/TAZO patients.\n CIP+MET, initially administered IV and followed by CIP+MET oral therapy, was clinically more effective than IV PIP/TAZO for the treatment of patients with complicated intraabdominal infections.", "Imipenem/cilastatin at a dose of 0.5 g six hourly was compared to conventional combination therapy with ampicillin 0.5 g six hourly, metronidazole 0.5 g eight hourly and gentamicin 80 mg eight hourly (with dose adjustment by trough and peak serum levels) in the treatment of severe intra-abdominal infections. All antibiotics were given intravenously. Forty-five patients entered the trial. Of the 19 evaluable patients in the imipenem/cilastatin group, 16 were clinically cured with five microbiological successes and two failures. Of 24 evaluable patients in the combination group, 22 were clinically cured with one microbiological success and one failure. One patient in each group suffered an adverse effect. Patients in the I/C group tended to be older with more women and more severe infections. The origin of peritonitis was similar. I/C did not differ from combination therapy in efficacy or safety and was comparable in cost. However, I/C was easier to administer than combination therapy and there was no need for serum concentration monitoring.", "In a randomized study the clinical and bacteriologic effectiveness of imipenem was compared with the classical combination of netilmicin with clindamycin in patients who had surgery for an intraperitoneal infection, localized or generalized, with positive bacteriologic findings of the specimen taken at surgery. Excluded were all patients who received other antibiotics before surgery, or who died within 3 days after antibiotic therapy was started. Imipenem was given at a dose of 500 mg t.i.d., clindamycin 600 mg t.i.d., and netilmicin according to serum levels. The diagnoses ranged from postoperative peritonitis, gallbladder empyema, perforated gastroduodenal ulcer, small bowel perforation with and without obstruction, and perforated appendicitis to perforation of the colon. The bacteriologic work-up included examination of the primary specimen (aerobic and anaerobic), the urine, feces, and serologic testing for Candida albicans once or twice a week and after the course of antibiotic therapy. In addition, pH measurements of abscesses and drainage fluids were performed. Ninety-three patients entered the study. Forty-seven patients were treated with imipenem (test group), and 46 patients were treated with the combination therapy (control group). The two groups did not show significant differences in age, sex, diagnostic groups, risk factors, primary bacteriology, and duration of therapy (mean: 6.7 days). Thirty-eight patients (80.9%) treated with imipenem were cured, six patients (12.8%) were improved, and there were three (6.4%) failures. The respective numbers for the control group were 31 (67.4%), 10 (21.7%), and 5 (10.9%). The mean duration of hospitalization was 19 days for the test group and 24.5 days for the control group. There were four wound infections in the test group and 11 wound infections in the control group. Imipenem is at least as effective in the adjuvant therapy of intra-abdominal infections as the combination of netilmicin with clindamycin.", "A prospective, randomized, double-blinded comparison of Sulbactam and ampicillin and clindamycin and gentamicin is described. The combination of ampicillin and Sulbactam was not as effective in the management of perforated appendicitis and gangrenous appendicitis as was clindamycin and gentamicin. While both combinations of antibiotics had good anaerobic activity and failures were not associated with the recovery of Bacteroides fragilis group organisms, infectious complications were seen in patients from whom Pseudomonas were isolated. These pseudomonads were not nosocomially acquired and were found especially in patients with perforated appendicitis. We concluded that the combination of clindamycin and gentamicin, although less convenient to administer to the patient, remains the adjunctive antibiotic management of choice for perforated or gangrenous appendicitis. The epidemiologic factors of Pseudomonas species as a primary pathogen in peritonitis deserves further attention.", "In a prospective, randomized, single-blind trial, we studied 112 adults with intra-abdominal infections and compared antibiotic therapy with cefoxitin plus placebo to therapy with tobramycin plus clindamycin. Seventy-five percent of patients receiving tobramycin-clindamycin and 71% of those receiving cefoxitin-placebo had either shock, bacteremia, malnutrition, alcoholism, rapidly or ultimately fatal underlying disease, infection originating from the distal small bowel or colon, or had had failed therapy before treatment (\"high-risk\" group). One third of the patients in both groups grew bacteria in the initial culture resistant to the antibiotic regimen used. Ten patients receiving cefoxitin-placebo (17%) and 11 receiving tobramycin-clindamycin (21%) had recurrence of infection or died of infection (clinical failures). Nineteen failures occurred in high-risk patients (p less than 0.05) and 17 were in patients that had antibiotic-resistant bacteria in the initial culture (p less than 0.01). Adverse effects were rare and remitted after antibiotics were stopped. Our results suggest that both cefoxitin and tobramycin-clindamycin are appropriate antibiotic regimens to treat intra-abdominal infections. Clinical failure is more common in high-risk patients and when antibiotic-resistant organisms are isolated from initial cultures.", "Clinafloxacin is a novel quinolone with wide activity against the plethora of microorganisms encountered in intraabdominal infections. This trial was performed to examine its clinical efficacy.\n Clinafloxacin is representative of a new class of quinolones with considerable antimicrobial activity resulting from their mechanisms of action and pharmacodynamics. There is, however, concern about specific potential toxicities, including photosensitivity.\n This prospective, randomized, double-blind trial was conducted to compare clinafloxacin with imipenem/cilastatin as adjuncts in the management of complicated intraabdominal infections.\n Five hundred twenty-nine patients were included in the intent-to-treat population, with 312 meeting all criteria for the valid population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was the most common (approximately 50%). One hundred twenty-three of the 150 valid patients treated with clinafloxacin (82%) had successful outcomes, as did 130 of the 162 (80%) treated with imipenem. For the intent-to-treat groups, 219 of 259 patients treated with clinafloxacin (85%) had successful outcomes, as did 219 of 270 patients treated with imipenem/cilastatin (81%). Treatment failure occurred in 39 patients who underwent drainage. There were substantially more gram-negative organisms recovered from the patients with treatment failure who were initially treated with imipenem/cilastatin.\n The results of this study clearly demonstrate the safety and efficacy of clinafloxacin in the treatment of a range of intraabdominal infections, and in patients with a broad range of physiologic disturbances.", "Many antibiotics and antibiotic combinations are used for the treatment of peritonitis because of advanced (gangrenous or perforated) appendicitis. An aminoglycoside combined with an antianaerobe antibiotic is one standard treatment, but there is concern about the potential nephrotoxicity of the aminoglycoside and the necessity for monitoring aminoglycoside blood levels. Cefepime, a new broad-spectrum cephalosporin with a prolonged serum half-life, has excellent activity against gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa. Its spectrum of activity is similar to the aminoglycosides, but it has less potential for inducing renal injury. A double-blind, randomized study compared cefepime, 2 grams every 12 hours IVPB plus metronidazole 0.5 grams every eight hours IVPB (C/M) with gentamicin 1.5 milligrams per kilograms of IVPB plus clindamycin 0.9 grams q eight hours IVPB (G/C), administered up to 14 days, in 96 surgically treated patients with gangrenous or perforated appendicitis. Fifty patients had advanced appendicitis (nine gangrenous and 41 perforated) in the C/M group and 46 patients (six gangrenous and 40 perforated) in the G/C group. The mean number of days of postoperative fever (C/M, 4.4 +/- 2.7 versus G/C, 5.0 +/- 2.2), postoperative hospitalization (C/M, 2.0 +/- 1.9 versus G/C, 2.0 +/- 2.1) and antibiotic therapy (C/M, 6.3 +/- 1.9 versus G/C, 6.9 +/- 1.9) was similar in the two treatment groups. There were 11 treatment failures (C/M, three; G/C, eight; p = 0.13), six of which were probably a result of enterococci. No deaths occurred. Our study results show that the efficacy of cefepime plus metronidazole is equivalent to that of clindamycin plus gentamicin.", "Meropenem (MP), a new carbapenem antibiotic, has excellent antimicrobial activity against the enteric flora commonly encountered in acute appendicitis. Although similar to imipenem, it may have clinical advantages.\n We compared patients with advanced appendicitis (gangrenous or perforated) treated with 1,000 mg MP every eight hours with those given the combination of tobramycin 5 mg/kg/day at eight hour intervals and clindamycin 900 mg every eight hours. Both treatments were given intravenously. Patients were randomized to either group of the double-blind study.\n Of 129 evaluable cases, 63 received MP and 66 received both tobramycin and clindamycin (T/C). The two groups were similar in age, sex, and severity of disease. The mean number of days of postoperative fever (MP = 3.1 +/- 1.7 SD compared to T/C = 4.4 +/- 2.2 SD, p < or = 0.01), days of antibiotic therapy (MP = 6.1 +/- 1.6 SD compared to T/C = 7.3 +/- 2.2 SD, p = 0.01), and therefore hospital stay (MP = 8.0 +/- 3.5 SD compared to T/C = 9.4 +/- 2.6 SD, p < 0.01) were significantly better for patients treated with MP. No difference was found between the numbers of failures in each group (MP = 5 compared to T/C = 6).\n This study demonstrates a small but significant reduction (approximately one day) in post-operative fever, duration of antibiotic treatment, and hospital stay for patients treated with MP compared to those treated with T/C.", "nan", "This study compared the safety and efficacy of cefoperazone plus sulbactam with that of clindamycin plus gentamicin in the treatment of intra-abdominal infection. Seventy-six patients were included in the analysis of an open, randomized, comparative, single-site trial. Forty-seven patients received cefoperazone-sulbactam, and 29 patients received clindamycin plus gentamicin. Thirty-three patients (70%) who received cefoperazone-sulbactam and 15 patients (52%) who received clindamycin plus gentamicin were cured of infection, did not suffer a relapse within one month after the end of treatment, and did not receive any other antibiotics during the follow-up period (P = 0.17). In patients treated with cefoperazone-sulbactam there were four cases of superinfection, one patient had a prolonged prothrombin time, six patients had a poor response, two patients received antibiotics during follow-up, and one patient died during follow-up because of cancer. Treatment with clindamycin plus gentamicin was associated with five cases of superinfection, four patients had a poor response, four patients had a drug reaction, and one patient required antibiotics in the follow-up period. Serum levels of cefoperazone-sulbactam measured at one and three hours after dosing were consistent with earlier findings in normal volunteers. Two hundred and one pathogens were isolated, and 17 of 122 aerobic isolates (14%) were resistant to cefoperazone-sulbactam, and 17 of 122 (14%) were resistant to both clindamycin and gentamicin. Eleven of 79 (14%) anaerobic isolates were resistant to cefoperazone, none was resistant to cefoperazone-sulbactam, and 10 of 79 (13%) were resistant to clindamycin. The results of this study show that cefoperazone-sulbactam is an effective and safe alternative to clindamycin plus gentamicin in the treatment of intra-abdominal infections.", "515 patients with intra-abdominal infection participated in an open randomized comparative multicenter trial in order to compare the efficacy, safety, and tolerance of imipenem/cilastatin with cefuroxime/metronidazole. 258 patients (mean age 56 years) received imipenem/cilastatin 1.5-2.0 g/day, and 257 patients (mean age 54 years) received cefuroxime 3.0-4.5 g/day plus metronidazole 1.0-1.5 g/day for at least 3 days. 130/161 evaluable patients (80.8%) receiving imipenem/cilastatin and 124/145 evaluable patients (85.5%) receiving cefuroxime/metronidazole were clinically cured. The microbiological response was favorable in 86.9% in the imipenem/cilastatin group and in 90.8% in the cefuroxime/metronidazole group. The two treatment groups were similar with respect to median time to defervescence which was 4 days. The median duration of treatment was 6 days and the median time to discharge from hospital was 9 days in both groups. Drug-related adverse reactions were observed in 14 patients receiving iminpenem/cilastatin and in 8 patients receiving cefuroxime/metronidazole. 19 patients in the imipenen/cilastatin group and 12 patients in the cefuroxime/metronidazole group died. No correlation was found between the deaths and the study drugs. The present study shows that intra-abdominal infections can be treated successfully with imipenem/cilastatin as well as with cefuroxime/metronidazole.", "Nosocomial pneumonia and acute peritonitis may be caused by a wide array of pathogens, and combination therapy is often recommended. We have previously shown that imipenem-cilastatin monotherapy was as efficacious as the combination of imipenem-cilastatin plus netilmicin in these two settings. The efficacy of imipenem-cilastatin is now compared to that of piperacillin-tazobactam as monotherapy in patients with nosocomial pneumonia or acute peritonitis. Three hundred seventy one patients with nosocomial pneumonia or peritonitis were randomly assigned to receive either imipenem-cilastatin (0.5 g four times a day) or piperacillin-tazobactam (4.5 g three times a day). Three hundred thirteen were assessable (154 with nosocomial pneumonia and 159 with peritonitis). For nosocomial pneumonia, clinical-failure rates in the piperacillin-tazobactam group (13 of 75 [17%]) and in the imipenem-cilastatin group (23 of 79 [29%]) were similar (P = 0.09), as were the numbers of deaths due to infection (6 in the imipenem-cilastatin group [8%], 7 in the piperacillin-tazobactam group [9%]) (P = 0.78). For acute peritonitis, clinical success rates were comparable (piperacillin-tazobactam, 72 of 76 [95%]; imipenem-cilastatin, 77 of 83 [93%]). For infections due to Pseudomonas aeruginosa, 45 patients had nosocomial pneumonia (21 in the piperacillin-tazobactam group and 24 in the imipenem-cilastatin group) and 10 had peritonitis (5 in each group). In the patients with nosocomial pneumonia, clinical failure was less frequent in the piperacillin-tazobactam group (2 of 21 [10%]) than in the imipenem-cilastatin [corrected] group (12 of 24 [50%]) (P = 0.004). Bacterial resistance to allocated regimen was the main cause of clinical failure (1 in the piperacillin-tazobactam group and 12 in the imipenem-cilastatin group). For the patients with peritonitis, no difference in clinical outcome was observed (five of five cured in each group). The overall frequencies of adverse events related to treatment in the two groups were similar (24 in the piperacillin-tazobactam group, 22 in the imipenem-cilastatin group). Diarrhea was significantly more frequent in the piperacillin-tazobactam group (10 of 24) than in the imipenem-cilastatin group (2 of 22). This study suggests that piperacillin-tazobactam monotherapy is at least as effective and safe as imipenem-cilastatin monotherapy in the treatment of nosocomial pneumonia or peritonitis. In P. aeruginosa pneumonia, piperacillin-tazobactam achieved a better clinical efficacy than imipenem-cilastatin, due to reduced development of microbiological resistance. Tolerance was comparable, with the exception of diarrhea, which was more frequent with piperacillin-tazobactam.", "Eighty-five patients were randomly allocated to receive either piperacillin (n = 38) or cefuroxime plus metronidazole (n = 45) after surgical treatment of diffuse peritonitis; 78 were evaluable. A mean of 1.5 (piperacillin group) and 1.7 (cefuroxime/metronidazole group) pathogens/patient were identified. Twenty-seven patients (71%) were successfully treated in the piperacillin group compared with 29 (64%) in the cefuroxime/metronidazole group. These data suggest that piperacillin was neither better nor worse than cefuroxime/metronidazole in diffuse, secondary peritonitis.", "A multicenter, open-label randomized trial was conducted to evaluate the efficacy and tolerability of monotherapy with imipenem-cilastatin (I-C) compared with combination therapy with clindamycin and an aminoglycoside (C+A) for treatment of 117 patients with serious intra-abdominal infections. Fifty-three patients (45%) received I-C and 64 patients (55%) received C+A. The overall clinical success rate was 96.2% for the I-C patients and 92.2% for the C+A patients. Clinical failure rates were 3.8% and 7.8%, respectively (P = NS). Eradication or suppression of pathogens was observed in 81.8% and 82.2% of patients, respectively. Uniform bacteriologic response was observed among all infection subgroups. Fourteen of 145 patients experienced adverse symptoms, including six of 66 (9.1%) monotherapy patients and eight of 79 (10.1%) combination-therapy patients (P = NS). The results of this study demonstrate that I-C monotherapy was as effective as C+A combination therapy for the treatment of serious intra-abdominal infections, regardless of the site or severity of infection or the clinical status of the patient. Both regimens also were found to be comparable in tolerability.", "In order to compare the clinical and microbiological efficacies and safety of piperacillin plus tazobactam with those of imipenem plus cilastatin, 134 patients with intra-abdominal infections (73 patients with appendicitis) participated in an open randomized comparative multicenter trial. A total of 40 men and 29 women (mean age, 53 years; age range, 18 to 92 years) were enrolled in the piperacillin-tazobactam group and 40 men and 25 women (mean age, 54 years; age range, 16 to 91 years) were enrolled in the imipenem-cilastatin group. The patients received either piperacillin (4 g) and tazobactam (500 mg) every 8 h or imipenem and cilastatin (500 mg each) every 8 h. Both regimens were given by intravenous infusion. A total of 113 patients were clinically evaluable. Of 55 patients who received piperacillin-tazobactam, 50 were clinically cured, while 40 of 58 patients in the imipenem-cilastatin group were clinically cured. The differences were significant (Wilcoxon test; P = 0.005). There were 4 failures or relapses in the piperacillin-tazobactam group and 18 failures or relapses in the imipenem-cilastatin group. The microorganisms isolated were eradicated in similar proportions in the two patient groups. Adverse reactions, mainly gastrointestinal disturbances and nausea, were noted in 13 patients who received piperacillin-tazobactam and in 14 patients who received imipenem-cilastatin. Results of the present study show that piperacillin-tazobactam is effective and safe for the treatment of intra-abdominal infections.", "Although single antimicrobials with broad-spectrum aerobic and anaerobic coverage are effective in patients with appendicitis, many general surgeons continue to use multiple agents. A prospective, double-blind, randomized trial was designed to detect any clinical correlate of in vitro susceptibility advantage of multiple antimicrobials as adjunctive therapy for 114 patients undergoing operation for complicated appendicitis. There was clinical resolution of intraabdominal infections with no occurrence of postoperative infectious complications in 90% (36 of 40) of the cefotetan group and 86% (31 of 36) of the clindamycin/amikacin group (p = 0.11). The number of patients who had changes in antibiotic therapy due to postoperative complications was higher in the clindamycin/amikacin group: five (12.5%), compared to one (2.8%) in the cefotetan group (p = 0.07). Although Bacteroides fragilis group organisms resistant to cefotetan were identified, none was responsible for the postoperative infections. Adverse drug events in 28% of the cefotetan group and 26% of the clindamycin/amikacin group consisted primarily of transient elevations of liver function tests. Monotherapy with a second-generation, broad-spectrum cephalosporin, such as cefotetan, given twice a day is an economical and effective adjunctive regimen in patients with complicated appendicitis for which operation is the definitive treatment. Aminoglycosides and other, more potent antimicrobials should be reserved for resistant organisms or nosocomial infections.", "The authors compared broad-spectrum monotherapy with imipenem to an aminoglycoside-based antibiotic regimen for the management of intra-abdominal infections. One hundred and four patients who had intra-abdominal infection were randomly allocated to receive imipenem (52) or tobramycin plus clindamycin or metronidazole (52). Patients treated with imipenem had fewer febrile episodes and occurrences of breakthrough bacteremia, less antibiotic resistance and need for drug change; their hospital stay was shorter. The death rate from sepsis was 4% in patients who received imipenem and 13% in those who received the combined regimen (p = 0.08). Treatment was successful in 79% of patients on imipenem versus 67% of those receiving an aminoglycoside. Patient stratification by the APACHE II system and probability of death calculation using delayed-type hypersensitivity scores predicted a similar death rate for the two treatment groups. Imipenem appears to be a safe and efficacious alternative broad-spectrum antibiotic for treating patients who are seriously ill with intra-abdominal infection.", "This multicentre, open-label, randomised trial compared meropenem (0.5 g/8 h) and imipenem/cilastatin (at the commonly used dosage of 0.5 g/6 h) in monotherapy in patients with moderately severe intra-abdominal infections (IAIs). In total, 161 patients were randomised (82 meropenem, 79 imipenem/cilastatin). The mean APACHE II scores in the two groups were 5.8 and 6.4, respectively. At the end of therapy, 65/71 (91.6%) evaluable meropenem recipients were clinically cured or improved, compared to 60/64 (93.8%) imipenem/cilastatin recipients. This difference and that in an intention-to-treat analysis (82.1 vs 86.1%, respectively), were not statistically significant. Both drugs were generally well tolerated. Thus, meropenem 0.5 g/8 h is as clinically effective and well tolerated as imipenem/cilastatin 0.5 g/6 h in moderately severe IAIs.", "In order to compare the clinical and microbiological efficacy and safety of meropenem with imipenem/cilastatin, 249 patients with intra-abdominal infections participated in an open randomised comparative multicentre trial. Seventy-five men and 57 women (mean age 51 years) were enrolled in the meropenem group and 67 men and 50 women (mean age 52 years) in the imipenem/cilastatin group. The patients received either meropenem, 500 mg q 8 h, or imipenem/cilastatin, 500 mg/500 mg q 8 h by intravenous infusion for up to 17 days (mean 5 days). Ninety-seven of 99 patients (98%) receiving meropenem were clinically cured while 86 of 90 patients (96%) in the imipenem/cilastatin group were clinically cured. The microbiological response was satisfactory in 89 of 94 evaluable patients (95%) receiving meropenem and in 78 of 81 evaluable patients (96%) receiving imipenem/cilastatin. There was no significant difference in clinical and microbiological efficacy between the two treatment groups. Adverse reactions were noted in 26 patients receiving meropenem and in 36 patients receiving imipenem/cilastatin. The present study shows that meropenem is effective and well tolerated in the treatment of intra-abdominal infections.", "118 patients with complicated intra-abdominal infections participated in an open randomized comparative multicenter trial in order to compare the clinical and microbiological efficacy and safety of biapenem with imipenem/cilastatin (Tienam). 31 men and 27 women (mean age 52.3 years) were enrolled in the biapenem group, and 43 men and 17 women (mean age 52.3 years) in the imipenem/cilastatin group. The patients received either biapenem 500 mg every 8 h or imipenem/cilastatin 500 mg/500 mg every 6 h by intravenous infusion for up to 13 days (mean 6.5 days). 28/43 evaluable patients (65.1%) receiving biapenem and 27/40 evaluable patients (67.5%) in the imipenem/cilastatin group were clinically cured. The microbiological response was satisfactory in 28/43 evaluable patients (65.1%) receiving biapenem and in 27/40 evaluable patients (67.5%) receiving imipenem/cilastatin. No significant differences in clinical or microbiological efficacy between the two treatment groups were found. The present study shows that biapenem may be useful in the treatment of intra-abdominal infections.", "In a prospective randomized study meropenem was compared with imipenem/cilastatin in the treatment of 62 patients with intraabdominal infections requiring surgery. The patients were suffering from diffuse or local peritonitis of moderate severity complicating in most cases gangrenous appendicitis, stomach perforation or gallbladder disease. There were 30 patients in the meropenem group and 32 patients in the imipenem/cilastatin group. Both antibiotic regimens were given intravenously at a dosage of 1 g every 8 h for a mean duration of 7.7 days in the meropenem group versus 8.6 days in the imipenem/cilastatin group. Fifty-nine aerobic strains and 15 anaerobic strains were isolated from cultures of pus taken intraoperatively, the meropenem MICs ranging from < or = 0.25 to 2 micrograms/ml. At follow-up at least one month after treatment the outcome was considered successful in all of 27 evaluable patients given meropenem and in all of 29 evaluable patients given imipenem/cilastatin. Both antibiotic regimens were well tolerated.", "In an open, randomised, multicentre trial, the efficacy and tolerability of empirical meropenem monotherapy (1 g intravenously every 8 hours) and cefotaxime (2 g every 8 hours) plus metronidazole (0.5 g intravenously every 8 hours) for 5 to 10 days was compared in 94 patients with serious intra-abdominal infection who required surgery. Eighty-three patients had an evaluable clinical response. Significantly more patients in the meropenem group had a satisfactory clinical response at the end of treatment (41/43 [95.3%] vs 30/40 [75.0%]; p = 0.008). The bacteriological response was also higher in the meropenem group (31/33 vs 26/32). In the bacteriologically evaluable population, a satisfactory clinical response was observed in 31/33 of those who received meropenem compared to 24/32 of the cefotaxime/metronidazole recipients (p = 0.03). Empirical meropenem monotherapy should prove a useful alternative to the currently standard combination treatment for serious intraabdominal infections.", "In a randomized trial conducted in 35 centers, we compared the clinical efficacy and safety of piperacillin plus tazobactam (TAZ) alone (monotherapy [MT]) versus those of TAZ combined with amikacin (AMK) (combined therapy [CT]) for the treatment of severe generalized peritonitis (SGP). Primary analysis consisted of blind assessment by an independent committee of the failure rate 30 days after the end of treatment in the modified intent-to-treat (ITT) analysis (mITT) population. Of the 241 patients with suspected SGP randomized into the study, 227 were eligible for ITT analysis, including 204 (99 in the MT group and 105 in the CT group) with confirmed SGP (mITT population). A total of 159 patients were eligible for per-protocol (PP) analysis. The clinical failure rates were equivalent in the mITT and PP populations (MT versus CT): 56 versus 52%, (odds ratio [OR] 0.87, 90% confidence interval [CI] = 0. 6 to 1.27) for mITT and 49 versus 49% (OR = 1.03, 90% CI = 0.67 to 1. 59) for PP analysis. Mortality rates (ITT population, 19%; PP population, 21%) and overall adverse event rates (ITT population, 55%; PP population, 54%) were also similar. Six patients (three in MT group and three in the CT group) developed acute renal failure. In conclusion, the addition of AMK to TAZ does not seem to be necessary for the treatment of SGP, even after adjustment for the simplified acute physiology score (SAPS II) and type of SGP.", "In a prospective randomized open study of patients operated upon for diffuse peritonitis, the effects of two different antibiotic regimens were evaluated. Cefuroxime given as a single drug (Group I; n = 59) was compared with a combination of cefuroxime and metronidazole (Group II; n = 63). Bacteriological cultures, both aerobic and anaerobic, were obtained peroperatively and in the event of any complication. The antibiotic sensitivities of isolated bacteria, and the serum and tissue concentrations of cefuroxime were determined. Postoperative infectious complications occurred in 22 per cent of Group I patients (cefuroxime), and in 17.5 per cent of Group II (cefuroxime plus metronidazole). The mortality rates were 5 per cent for Group I and 8 per cent for Group II. Tissue concentrations of cefuroxime were well above the MIC (minimal inhibiting concentration) values for most of the bacteria isolated. From a few patients in Group I, however, cultures were obtained with isolates sensitive to metronidazole but resistant to cefuroxime. Our findings suggest that, in the antibiotic treatment of patients operated for diffuse peritonitis, an agent which is primarily effective against aerobic bacteria (but not entirely without effect on anaerobes) is as effective as combination therapy covering both aerobic and anaerobic bacteria.", "This multicentre, randomised, open-label, parallel group study compared the efficacy and safety of isepamicin (15 mg/kg once daily) and amikacin (7.5 mg/kg twice daily) when given intravenously in combination with metronidazole to 267 hospitalised adults with intra-abdominal infections. Clinical cure or improvement was achieved in 96.3% (130/135) evaluable patients (efficacy population) in the isepamicin group and 94.3% (66/70) patients in the amikacin group. Bacteriological elimination occurred in 93.3% (126/135) evaluable isepamicin patients and 95.7% (67/170) amikacin patients. there was not statistically significant differences between the groups. Adverse events were reported by 9% of patients in the isepamicin group (16/178) and 10% of patients in the amikacin group (9/89). Events considered to be related to treatment occurred in 6% of patients in both groups. The most frequent adverse events were diarrhoea, nausea and vomiting. Renal problems caused three patients (2 isepamicin, 1 amikacin) to withdraw from the study. Ototoxicity (detected by audiometric testing) occurred in one patient (treated with isepamicin). In conclusion, isepamicin at a dose of 15 mg/kg once daily was shown to be as effective as amikacin (7.5 mg/kg twice daily) in the treatment of intra-abdominal infections in hospitalised adults also treated with metronidazole. Both treatments were well tolerated.", "The aim of this prospective study was to compare the safety and efficacy of a new cephamycin, cefminox 2 g/12 h, to those of the usual regimen combining metronidazole 500 mg/8 h and gentamicin 80 mg/8 h (M+G).\n 160 patients with clinically proven intra-abdominal infection were prospectively included in an open parallel randomized comparative multicenter trial. Antibiotics were started preoperatively and discontinued after clinical and laboratory evidence of resolution of the infection. Serum and peritoneal fluid levels and serum bactericidal activities were also studied.\n 150 patients were clinically evaluable. There was one failure in the cefminox group and three in the M+G group (not significant, RR: 1.07, 95% CI: 1-1.15). No differences were found in the number of wound infections, length of stay or duration of antibiotic therapy. Adverse effects were reported in 11 cases, all of them mild to moderate. Escherichia coli and Bacteroides fragilis were the most frequently found microorganisms.\n Cefminox is as effective and as safe as M+G in the treatment of intra-abdominal infections.", "Concerned about the inactivation of piperacillin by beta-lactamase and the risk of aminoglycoside-induced nephrotoxicity and clindamycin-induced enterocolitis, we conducted the following phase III clinical trial.\n Between November 1991 and March 1993, 77 surgical patients with intraabdominal infections were enrolled and randomly assigned in a 3:2 ratio to receive either piperacillin/tazobactam or clindamycin plus gentamicin to compare safety, tolerance and efficacy between both two treatment groups.\n There were 76 clinically and 50 bacteriologically evaluable patients with 80 isolated pathogens. The demographic data were comparable in both groups. There was no statistically significant difference of clinical response at any time-point of treatment, with 97.8% favorable clinical response rate in piperacillin tazobactam group and 96.6% in clindamycin plus gentamicin group at endpoint. The bacteriological eradication rates were similar, with 97.7% in piperacillin/tazobactam group and 94.4% in clindamycin plus gentamicin group at pathogen level, and 96.7% in piperacillin/tazobactam group and 95.0% in clindamycin plus gentamicin group at patient level. By susceptibility tests, only 3 (4%) isolated pathogens were resistant to piperacillin/tazobactam, which was much superior to the use of piperacillin, clindamycin or gentamicin alone in antimicrobial activity. The piperacillin tazobactam-related adverse experiences included 1 (2.1%) urticaria and 2 (4.3%) diarrhea. However, there were no significant differences in the adverse experiences between these two groups.\n This study has demonstrated that piperacillin/tazobactam is comparable with clindamycin plus gentamicin in efficacy, safety and tolerance in the treatment of surgical patients with intra-abdominal infections. The combination of piperacillin/tazobactam could potentially be the treatment of choice in adjunt to surgical management in intra-abdominal infection.", "A double-blind trial was conducted in 385 patients with suspected bacterial intra-abdominal infections to compare the efficacy and safety of ampicillin-sulbactam with cefoxitin. Patients were randomized to receive either 3 g ampicillin-sulbactam (2 g ampicillin-1 g sulbactam), or 2 g cefoxitin, every 6 hours. To be evaluable, patients had to demonstrate positive culture evidence of peritoneal infection at the time of operation. A total of 197 patients were evaluable for clinical efficacy. The two treatment groups were comparable in demographic features and in the presence of risk factors for infection. Clinical success (absence of infection and of adverse drug reaction) was observed in 86% of patients in the ampicillin-sulbactam group and 78% in the cefoxitin group. Eradication of infection occurred in 88% of the ampicillin-sulbactam group and 79% of the cefoxitin group. There were no differences in the nature or frequency of side effects observed in the two groups. Ampicillin-sulbactam demonstrated no difference in safety or efficacy when compared with cefoxitin in the treatment of serious intra-abdominal infections of bacterial origin.", "In order to compare the efficacy and safety of pefloxacin plus metronidazole with those of gentamicin plus metronidazole, 271 patients with severe intraabdominal infection were enrolled in an open, randomized comparative trial. Seventy males and 66 females (mean age 54 years; range 18-90) were enrolled in the pefloxacin/metronidazole group and 74 males and 61 females (mean age 52 years; range 18-90) in the gentamicin/metronidazole group. After verification of the intra-abdominal infection by laparotomy, drainage or puncture and microbiological cultures, patients received iv either pefloxacin 400 mg, bd, after an 800-mg loading dose, or gentamicin 1.4 mg/kg body weight every 8-24 h depending on the renal function. Metronidazole was given to both groups as a 500 mg intravenous infusion tid. Eighty-seven patients were excluded from the efficacy analysis, principally because of unproven infection, previous antimicrobial therapy or treatment duration less than three days. Ninety-four of 104 patients receiving pefloxacin/metronidazole (90.4%) were cured or improved and there were two failures and eight relapses. In the gentamicin/metronidazole group, 64 of 80 patients (80.0%) were cured or improved while there were three failures, nine relapses, and two deaths. The bacteria originally isolated were eradicated in similar proportions of the patients in the two groups. Eleven of 136 patients receiving pefloxacin/metronidazole (8.1%) and seven of 135 patients given gentamicin/metronidazole (5.2%) had adverse reactions. This study shows that pefloxacin can be considered as effective and safe as gentamicin for the treatment of severe intraabdominal infections.", "A randomized, double-blinded, controlled clinical study of 84 patients with surgically treated gangrenous or perforated appendicitis was done to compare the efficacy of the combination of aztreonam, the first monobactam antibiotic, with gentamicin when either was combined with clindamycin. Fifty-six patients who were treated with aztreonam and clindamycin (A/C) and 28 patients who were treated with gentamicin and clindamycin (G/C) fulfilled criteria for evaluation. A matched historic control group of 56 G/C patients was also included for comparison. All measures of outcome, including days of fever, hospitalization, antibiotic therapy, and the incidence of antibiotic failures, were similar. It was concluded that aztreonam was as effective as gentamicin in this study and may offer some advantages with regard to toxicity and serum drug level monitoring.", "This report summarizes the experience of investigators in four medical centres who compared the combination of cefoperazone/sulbactam against gentamicin/clindamycin in the treatment of intra-abdominal infections. One hundred and fifty-two patients were enrolled in the study and all were evaluable for safety and tolerance, 110 were evaluable for efficacy. Of the 76 patients (49 male, 27 female) treated with cefoperazone/sulbactam 66 (86.8%) were cured, five (6.6%) improved and five (6.6%) failed to respond to treatment. Of 34 patients treated with gentamicin/clindamycin, 21 (61.8%) were cured, four (11.8%) improved and nine (26.4%) failed. Cure rates for patients receiving cefoperazone/sulbactam were significantly higher than those of patients receiving gentamicin/clindamycin (P less than 0.006). Failures in both groups were attributable in part to pseudomonal and enterococcal infection and abscess formation. The addition of sulbactam to cefoperazone rendered cefoperazone-resistant organisms susceptible to cefoperazone in 11 of the 76 cases (14.4%) and thus permitted treatment with this agent. The present study confirms the safety and clinical efficacy of cefoperazone/sulbactam and suggests that this combination is a viable alternative to an aminoglycoside plus clindamycin for intra-abdominal infections." ]