# Datasets: allenai /cochrane_sparse_max

Languages: English
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review_id (string)pmid (sequence)title (sequence)abstract (sequence)target (string)
"CD007697"
[ "16394043" ]
[ "Aggressive surgical effort and improved survival in advanced-stage ovarian cancer." ]
[ "Residual disease after initial surgery for ovarian cancer is the strongest prognostic factor for survival. However, the extent of surgical resection required to achieve optimal cytoreduction is controversial. Our goal was to estimate the effect of aggressive surgical resection on ovarian cancer patient survival.\n A retrospective cohort study of consecutive patients with International Federation of Gynecology and Obstetrics stage IIIC ovarian cancer undergoing primary surgery was conducted between January 1, 1994, and December 31, 1998. The main outcome measures were residual disease after cytoreduction, frequency of radical surgical resection, and 5-year disease-specific survival.\n The study comprised 194 patients, including 144 with carcinomatosis. The mean patient age and follow-up time were 64.4 and 3.5 years, respectively. After surgery, 131 (67.5%) of the 194 patients had less than 1 cm of residual disease (definition of optimal cytoreduction). Considering all patients, residual disease was the only independent predictor of survival; the need to perform radical procedures to achieve optimal cytoreduction was not associated with a decrease in survival. For the subgroup of patients with carcinomatosis, residual disease and the performance of radical surgical procedures were the only independent predictors. Disease-specific survival was markedly improved for patients with carcinomatosis operated on by surgeons who most frequently used radical procedures compared with those least likely to use radical procedures (44% versus 17%, P < .001).\n Overall, residual disease was the only independent predictor of survival. Minimizing residual disease through aggressive surgical resection was beneficial, especially in patients with carcinomatosis.\n II-2." ]
"We found only low quality evidence comparing ultra-radical and standard surgery in women with advanced ovarian cancer and carcinomatosis. The evidence suggested that ultra-radical surgery may result in better survival.  It was unclear whether there were any differences in progression-free survival, QoL and morbidity between the two groups. The cost-effectiveness of this intervention has not been investigated. We are, therefore, unable to reach definite conclusions about the relative benefits and adverse effects of the two types of surgery. In order to determine the role of ultra-radical surgery in the management of advanced stage ovarian cancer, a sufficiently powered randomised controlled trial comparing ultra-radical and standard surgery or well-designed non-randomised studies would be required."
"CD000174"
[ "8627434", "2677294", "3373404", "3321891", "8201485", "11430325", "3373405", "3174314", "9078828", "3312552", "3906073", "1305392", "3998921", "10730525" ]
[ "Prophylactic indomethacin therapy in the first twenty-four hours of life for the prevention of patent ductus arteriosus in preterm infants treated prophylactically with surfactant in the delivery room.", "Indomethacin reduces the risks of severe intraventricular hemorrhage.", "Administration of indomethacin for the prevention of periventricular-intraventricular hemorrhage in high-risk neonates.", "Early intravenous indomethacin prolongs respiratory support in very low birth weight infants.", "Low-dose indomethacin therapy and extension of intraventricular hemorrhage: a multicenter randomized trial.", "Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants.", "Randomized low-dose indomethacin trial for prevention of intraventricular hemorrhage in very low birth weight neonates.", "Prophylactic indomethacin for prevention of intraventricular hemorrhage in premature infants.", "Effects of early indomethacin administration on oxygenation and surfactant requirement in low birth weight infants.", "Prevention of symptomatic patent ductus arteriosus with a single dose of indomethacin.", "Randomized indomethacin trial for prevention of intraventricular hemorrhage in very low birth weight infants.", "[Indomethacin in the prevention of subependymal-intraventricular hemorrhage in preterm newborns with conventional mechanical ventilation].", "Indomethacin therapy on the first day of life in infants with very low birth weight.", "Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams." ]
"Prophylactic indomethacin has short-term benefits for preterm infants including a reduction in the incidence of symptomatic PDA, PDA surgical ligation, and severe intraventricular haemorrhage. However, there is no evidence of effect on mortality or neurodevelopment."
"CD008805"
[ "6024144", "4915981" ]
[ "White phosphorus burns and massive hemolysis.", "The treatment of chemical burns: specialized diagnostic, therapeutic, and prognostic considerations." ]
[ "nan", "nan" ]
"First aid for phosphorus burns involves the common sense measures of acting promptly to remove the patient's clothes, irrigating the wound(s) with water or saline continuously, and removing phosphorus particles. There is no evidence that using copper sulphate to assist visualisation of phosphorus particles for removal is associated with better outcome, and some evidence that systemic absorption of copper sulphate may be harmful. We have so far been unable to identify any other comparisons relevant to informing other aspects of the care of patients with phosphorus burns. Future versions of this review will take account of information in articles published in languages other than English, which may contain additional evidence based on treatment comparisons."
"CD000248"
[ "1159434", "14168625", "13969171", "14250709" ]
[ "Trial of long-term anticoagulant therapy in the treatment of small stroke associated with a normal carotid arteriogram.", "CEREBRAL VASCULAR DISEASE IN RELATION TO LONG-TERM ANTICOAGULANT THERAPY.", "Anticoagulant therapy in cerebral infarction. Report on cooperative study.", "CEREBRAL APOPLEXY. A CLINICAL, RADIOLOGICAL, ELECTROENCEPHALOGRAPHIC AND PATHOLOGICAL STUDY WITH SPECIAL REFERENCE TO THE PROGNOSIS OF CEREBRAL INFARCTION AND THE RESULT OF LONG-TERM ANTICOAGULATION THERAPY." ]
[ "The clinical features of 49 patients who had sustained small strokes in the internal carotid artery territory, who were normotensive, free from cardiac or other relevant disease, and who each had a normal appropriate single vessel angiogram are presented. These were randomized into two groups: group A, 25 patients, who received only supportive treatment; group B, 24 patients who were treated with anticoagulants for an average period of 18 months. There was a reduced incidence of neurological episodes during the administration of anticoagulant therapy but, after treatment was discontinued, there was no significant difference between the two groups. In view of the relatively benign prognosis for this syndrome, unless special facilities exist for the personal control of anticoagulant treatment, the dangers may outweigh the benefits.", "nan", "nan", "nan" ]
"Compared with control, there was no evidence of benefit from long-term anticoagulant therapy in people with presumed non-cardioembolic ischaemic stroke or transient ischaemic attack, but there was a significant bleeding risk."
"CD004431"
[ "15240203", "11212135", "6487909", "3693660", "12690582", "11784832", "12883103", "4074113", "10780138", "11777121", "11527284", "8116338", "12583502" ]
[ "Computer-aided retraining of memory and attention in people with multiple sclerosis: a randomized, double-blind controlled trial.", "Neuropsychological counseling improves social behavior in cognitively-impaired multiple sclerosis patients.", "An evaluation of cognitive-behaviour therapy for depression in patients with multiple sclerosis.", "Efficacy of stress-inoculation training in coping with multiple sclerosis.", "A randomized clinical trial of a wellness intervention for women with multiple sclerosis.", "Evaluation of cognitive assessment and cognitive intervention for people with multiple sclerosis.", "Effects of treatment for depression on fatigue in multiple sclerosis.", "Group psychotherapy: benefits in multiple sclerosis.", "Telephone-administered cognitive-behavioral therapy for the treatment of depressive symptoms in multiple sclerosis.", "Comparative outcomes for individual cognitive-behavior therapy, supportive-expressive group psychotherapy, and sertraline for the treatment of depression in multiple sclerosis.", "Unit management of depression of patients with multiple sclerosis using cognitive remediation strategies: a preliminary study.", "Effects of neuropsychological treatment in patients with multiple sclerosis.", "Symptom management and adjustment of patients with multiple sclerosis: a 4-year longitudinal intervention study." ]
"The diversity of psychological interventions identified indicates the many ways in which they can potentially help people with MS. No definite conclusions can be made from this review. However there is reasonable evidence that cognitive behavioural approaches are beneficial in the treatment of depression, and in helping people adjust to, and cope with, having MS."
"CD008039"
[ "11554954", "15482357", "16492236", "17563841", "15579612", "16618262", "8427430", "9825271" ]
[ "Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial.", "Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.", "Rofecoxib in the acute treatment of migraine: a randomized controlled clinical trial.", "Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial.", "Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial.", "Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study.", "The efficacy of metoclopramide in the treatment of migraine headache.", "Effectiveness of ibuprofen-arginine in the treatment of acute migraine attacks." ]
"We found no new studies since the last version of this review. Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo."
"CD003287"
[ "10526722", "11544612", "12757987", "10480767", "10321421", "12017407", "10834413", "11711322", "12873294", "11194244", "9686700", "10880892", "10480503", "10332684", "9183237", "9083709", "9000704", "11453959", "9167105", "12027927", "9444449", "15713351", "10332682", "12213353", "9250454", "15377436", "11476360", "11874927", "10784225", "12768948", "9032100", "9802741", "11553203", "12201618", "12873289", "9545126", "11694699", "12448933", "11131100", "11767232", "15523183", "11590992", "14557006", "14617222", "15111514", "9405901" ]
[ "Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. U.K. Lispro Study Group.", "Severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia: a comparative study of insulin lispro and regular human insulin.", "Insulin lispro is as effective as regular insulin in optimising metabolic control and preserving beta-cell function at onset of type 1 diabetes mellitus.", "Improved postprandial glycemic control during treatment with Humalog Mix25, a novel protamine-based insulin lispro formulation. Humalog Mix25 Study Group.", "Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Mix50 Study Group.", "Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents.", "Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes.", "A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump.", "Insulin lispro: a potential role in preventing nocturnal hypoglycaemia in young children with diabetes mellitus.", "Efficacy, safety, and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes.", "Use of the short-acting insulin analogue lispro in intensive treatment of type 1 diabetes mellitus: importance of appropriate replacement of basal insulin and time-interval injection-meal.", "Improved blood glucose variability, HbA1c insuman Infusat and less insulin requirement in IDDM patients using insulin lispro in CSII. The Swedish Multicenter Lispro Insulin Study.", "Metabolic and immunologic effects of insulin lispro in gestational diabetes.", "Contribution of postprandial versus interprandial blood glucose to HbA1c in type 1 diabetes on physiologic intensive therapy with lispro insulin at mealtime.", "Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group.", "Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group.", "Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Multicenter Insulin Lispro Study Group.", "Treatment with insulin lispro changes the insulin profile but does not affect the plasma concentrations of IGF-I and IGFBP-1 in type 1 diabetes.", "Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy.", "Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients.", "Efficacy of insulin lispro in combination with NPH human insulin twice per day in patients with insulin-dependent or non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group.", "The effect of improved post-prandial blood glucose control on post-prandial metabolism and markers of vascular risk in people with Type 2 diabetes.", "Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog-CSII Study Group.", "Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus.", "Metabolic efficacy of preprandial administration of Lys(B28), Pro(B29) human insulin analog in IDDM patients. A comparison with human regular insulin during a three-meal test period.", "Effect of insulin lispro on glycaemic control in Chinese diabetic patients receiving twice-daily regimens of insulin.", "Lispro insulin in type 1 diabetic patients on a Mediterranean or normal diet: a randomized, cross-over comparative study with regular insulin.", "Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes.", "A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. The UK Trial Group.", "Humalog Mix25 improves 24-hour plasma glucose profiles compared with the human insulin mixture 30/70 in patients with type 2 diabetes mellitus.", "Insulin lispro in CSII: results of a double-blind crossover study.", "Improved glycemic control with insulin aspart: a multicenter randomized double-blind crossover trial in type 1 diabetic patients. UK Insulin Aspart Study Group.", "Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus.", "Effects of a fixed mixture of 25% insulin lispro and 75% NPL on plasma glucose during and after moderate physical exercise in patients with type 2 diabetes.", "Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes.", "Human insulin analogue [LYS(B28), PRO(B29)]: the ideal pump insulin?", "Insulin lispro lowers postprandial glucose in prepubertal children with diabetes.", "Insulin lispro improves postprandial glucose control in patients with diabetes mellitus.", "Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial.", "A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents.", "Special management of insulin lispro in continuous subcutaneous insulin infusion in young diabetic children: a randomized cross-over study.", "Preprandial combination of lispro and NPH insulin improves overall blood glucose control in type 1 diabetic patients: a multicenter randomized crossover trial.", "Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women.", "Comparison of additional metformin or NPH insulin to mealtime insulin lispro therapy with mealtime human insulin therapy in secondary OAD failure.", "A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes.", "Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. The Benelux-UK Insulin Lispro Study Group." ]
"Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child."
"CD008194"
[ "16322168", "15671460" ]
[ "A randomized, controlled trial of the effectiveness of community-based case management in insuring uninsured Latino children.", "The State Children's Health Insurance Program: a multicenter trial of outreach through the emergency department." ]
[ "Lack of health insurance adversely affects children's health. Eight million US children are uninsured, with Latinos being the racial/ethnic group at greatest risk for being uninsured. A randomized, controlled trial comparing the effectiveness of various public insurance strategies for insuring uninsured children has never been conducted.\n To evaluate whether case managers are more effective than traditional methods in insuring uninsured Latino children.\n Randomized, controlled trial conducted from May 2002 to August 2004.\n A total of 275 uninsured Latino children and their parents were recruited from urban community sites in Boston.\n Uninsured children were assigned randomly to an intervention group with trained case managers or a control group that received traditional Medicaid and State Children's Health Insurance Program (SCHIP) outreach and enrollment. Case managers provided information on program eligibility, helped families complete insurance applications, acted as a family liaison with Medicaid/SCHIP, and assisted in maintaining coverage.\n Obtaining health insurance, coverage continuity, the time to obtain coverage, and parental satisfaction with the process of obtaining insurance for children were assessed. Subjects were contacted monthly for 1 year to monitor outcomes by a researcher blinded with respect to group assignment.\n One hundred thirty-nine subjects were assigned randomly to the intervention group and 136 to the control group. Intervention group children were significantly more likely to obtain health insurance (96% vs 57%) and had approximately 8 times the adjusted odds (odds ratio: 7.78; 95% confidence interval: 5.20-11.64) of obtaining insurance. Seventy-eight percent of intervention group children were insured continuously, compared with 30% of control group children. Intervention group children obtained insurance significantly faster (mean: 87.5 vs 134.8 days), and their parents were significantly more satisfied with the process of obtaining insurance.\n Community-based case managers are more effective than traditional Medicaid/SCHIP outreach and enrollment in insuring uninsured Latino children. Case management may be a useful mechanism to reduce the number of uninsured children, especially among high-risk populations.", "We evaluated emergency department (ED)-based outreach for the State Children's Health Insurance Program (SCHIP).\n We conducted a multicenter trial among uninsured children (< or = 18 years) who presented to 5 EDs in 2001 and 2002. On-site staff enrolled consecutive subjects for a control period followed by an intervention period during which staff handed out SCHIP applications to the uninsured. The primary outcome was state-level confirmation of insured status at 90 days.\n We followed 223 subjects (108 control, 115 intervention) by both phone interview and state records. Compared to control subjects, those receiving a SCHIP application were more likely to have state health insurance at 90 days (42% vs 28%; P<.05; odds ratio [OR]=3.8; 95% confidence interval [CI]=1.7, 8.6). Although the intervention effect was prominent among 118 African Americans (50% insured after intervention vs 31% of controls, P<.05), lack of family enrollment in other public assistance programs was the primary predictor of intervention success (OR=3.7; 95% CI=1.6, 8.4).\n Handing out insurance applications in the ED can be an effective SCHIP enrollment strategy, particularly among minority children without connections to the social welfare system. Adopted nationwide, this simple strategy could initiate insurance coverage for more than a quarter million additional children each year." ]
"The two studies included in this review provide evidence that in the US providing health insurance information and application assistance, and handing out application materials in hospital emergency departments can probably both improve insurance coverage of children. Further studies evaluating the effectiveness of different outreach strategies for expanding health insurance coverage of children in different countries are needed, with careful attention given to study design."
"CD000505"
[ "671204", "683224", "8477163", "463541", "7666265" ]
[ "Umbilical artery catheters: high, low, or no.", "Low positioning of umbilical-artery catheters increases associated complications in newborn infants.", "Randomized trial of umbilical arterial catheter position: clinical outcome.", "Umbilical artery catheterization in newborns. I. Thrombosis in relation to catheter type and position.", "The association of heparin exposure with intraventricular hemorrhage among very low birth weight infants." ]
[ "nan", "We performed a randomized prospective study of the effect of placement position of umbilical-artery catheters on complication rates in high-risk newborn infants. A higher complication rate (31 of 40 vs. 13 of 33) (P less than 0.005) occurred in the group with the catheter tip at the third to fourth lumbar segment, as compared to those with the tip at the seventh to eighth thoracic segment, owing to more episodes of blanching and cyanosis of the extremities. There was no difference between groups in the rate of complications requiring catheter removal. Aortography revealed thrombosis in 21 of 23 patients studied, but there was no clinical evidence of impaired circulation. In retrospect, we found that, independently of catheter position, administration of antibiotics through the catheter was associated with an increased rate of complications (63 vs. 20 per cent). Umbilical-artery catheterization entails potential risks regardless of the position of the catheter; placement of the catheter with its tip at the seventh to eighth thoracic segment may be associated with fewer complications than at lower positions.", "In order to determine if umbilical arterial catheter position affects the incidence of necrotizing enterocolitis, clinical outcome was analysed in 308 infants whose umbilical arterial catheter had been randomly allocated to a high (n = 162) or a low (n = 146) position. Necrotizing enterocolitis was classified as suspected or confirmed; all renal, lower limb and local catheter complications were also recorded. High umbilical arterial catheters were in place for longer than low catheters, provided more samples and were removed as an emergency less often. Lower limb blanching and cyanosis were more common with low catheters. Eleven cases of confirmed necrotizing enterocolitis occurred in the \"high\" group and nine in the \"low\" group. One case of fatal aortic thrombosis was encountered in the high group. Positioning umbilical arterial catheters in a high position allowed longer functional use and did not increase the incidence of necrotizing enterocolitis.", "Seventy-one sick newborn infants, who had an umbilical artery catheterized, were randomized in one of four catheter groups: long end-hole-, short end-hole-, long side-hole- or short side-hole catheter. A long catheter means a high position of the catheter tip (Th6--11) and a short catheter a low position of the tip (L3--5). An angiography through the indwelling catheter in order to diagnose thrombosis was performed before the catheter was withdrawn. Dissection of the aorta and its brances was performed on infants who died. The total frequency of thromboses was 26%. There were no thromboses among infants with long end-hole catheters while infants with short end-hole catheters had thrombosis in 26%, long side-hole catheters in 33% and short side-hole catheters in 64%. Long end-hole catheters functioned better than the others. Only 6 of 16 infants with thrombosis had physical signs from the legs, while 12 infants without thrombosis had similar signs.", "To determine whether there is a relationship between exposure to heparin and an increased risk of intraventricular hemorrhage (IVH), we analyzed data from a cohort of infants who had been subjects in a randomized clinical trial of umbilical artery catheter placement. Data from 862 infants who survived the first 6 days of life were used for analysis. The incidence of IVH (grades 1 through 4) was 28.6%. The mean (SD) birth weight for infants with IVH was 954 gm (247 gm) compared with 1053 gm (253 gm) among infants without IVH (p < 0.01). The mean (SD) heparin intake among infants with an IVH was 83.5 units/kg/day (48.7) compared with 59.4 units/kg/day (48.7) among infants without an IVH (p < 0.01). With the use of logistic regression modeling to adjust for a number of potentially confounding variables, including fluid intake and birth weight, we observed an odds ratio for an IVH of 1.96 (95% confidence interval = 1.32, 2.91) for infants with second through fourth quartile intakes of heparin compared with that for infants with first quartile heparin intakes. Although we cannot rule out the possibility that the observations from this model may be confounded by factors associated with the severity of illness of the infant, these data support the findings of previous reports of an association between heparin exposure and the risk for an IVH." ]
"There appears to be no evidence to support the use of low placed umbilical artery catheters. High catheters should be used exclusively."
"CD004493"
[ "11291373", "2213870", "15376818", "8812826", "2057468", "17663611", "8757573", "3437450", "9786373", "12018753", "8435601", "16201856", "12509592", "10181020", "11550729", "12079251", "12612363", "11850136", "14636795", "7673531" ]
[ "The influence of a family program on adolescent tobacco and alcohol use.", "The efficacy of social-influence prevention programs versus \"standard care\": are new initiatives needed?", "Reducing the risks of alcohol use among urban youth: three-year effects of a computer-based intervention with and without parent involvement.", "Tobacco use measurement, prediction, and intervention in elementary schools in four states: the CATCH Study.", "The Tromsø Survey: the Family Intervention study--the effect of intervention on some coronary risk factors and dietary habits, a 6-year follow-up.", "An adaptive approach to family intervention: linking engagement in family-centered intervention to reductions in adolescent problem behavior.", "Long-term follow-up of the Busselton six-year controlled trial of prevention of children's behavior disorders.", "How generalizable are the effects of smoking prevention programs? Refusal skills training and parent messages in a teacher-administered program.", "Long-term effects of nurse home visitation on children's criminal and antisocial behavior: 15-year follow-up of a randomized controlled trial.", "Tobacco and alcohol use outcomes of a school-based intervention in New Delhi.", "Evaluation of two school smoking education programmes under normal classroom conditions.", "Effects of a controlled family-based health education/counseling intervention.", "Sustaining and broadening intervention impact: a longitudinal randomized trial of 3 adolescent risk reduction approaches.", "Effects of a school-based smoking prevention program among subgroups of adolescents.", "Randomized trial of brief family interventions for general populations: adolescent substance use outcomes 4 years following baseline.", "Longitudinal substance initiation outcomes for a universal preventive intervention combining family and school programs.", "Can parents who smoke socialise their children against smoking? Results from the Smoke-free Kids intervention trial.", "A randomized controlled trial of two primary school intervention strategies to prevent early onset tobacco smoking.", "A randomized trial of a family-based smoking prevention intervention in managed care.", "Preventing escalation in problem behaviors with high-risk young adolescents: immediate and 1-year outcomes." ]
"Some well-executed RCTs show family interventions may prevent adolescent smoking, but RCTs which were less well executed had mostly neutral or negative results. There is thus a need for well-designed and executed RCTs in this area."
"CD003734"
[ "5109955" ]
[ "Reduction of young driver crashes in a controlled pilot study: two-year follow-up in one Michigan high school." ]
[ "nan" ]
"This systematic review provides no evidence that post-licence driver education is effective in preventing road traffic injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic offences, this may be due to selection biases or bias in the included trials. Because of the large number of participants included in the meta-analysis (close to 300,000 for some outcomes) we can exclude, with reasonable precision, the possibility of even modest benefits."
"CD000296"
[ "8889459", "12135030", "12548062", "16733496", "9301500", "8078529", "9663720", "8078530", "15095852", "9753485", "10961590", "11922560", "7605858" ]
[ "Oral pH-modified release budesonide versus 6-methylprednisolone in active Crohn's disease. German/Austrian Budesonide Study Group.", "Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States.", "A comparison of budesonide and prednisone for the treatment of active pediatric Crohn disease.", "Beclomethasone dipropionate for the treatment of mild-to-moderate Crohn's disease: an open-label, budesonide-controlled, randomized study.", "Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group.", "Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group.", "Bone turnover during short-term therapy with methylprednisolone or budesonide in Crohn's disease.", "A comparison of budesonide with prednisolone for active Crohn's disease.", "Budesonide versus prednisolone for the treatment of active Crohn's disease in children: a randomized, double-blind, controlled, multicentre trial.", "Budesonide versus prednisone in the treatment of active Crohn's disease. The Israeli Budesonide Study Group.", "Quality of life rapidly improves with budesonide therapy for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group.", "Budesonide and mesalazine in active Crohn's disease: a comparison of the effects on quality of life.", "Budesonide and prednisolone suppress peripheral blood natural killer cells in Crohn's disease." ]
"Budesonide is more effective than placebo or mesalamine for induction of remission in Crohn's disease. Although short-term efficacy with budesonide is less than with conventional steroids, particularly in those with severe disease or more extensive colonic involvement, the likelihood of adverse events and adrenal suppression is lower."
"CD006181"
[ "2498657" ]
[ "A randomized, controlled trial of very early prophylactic ligation of the ductus arteriosus in babies who weighed 1000 g or less at birth." ]
[ "We speculated that prophylactic ligation of the ductus arteriosus would reduce mortality and morbidity in very-low-birth-weight infants. To test this hypothesis, we randomly assigned 84 babies who weighed 1000 g or less at birth and required supplemental oxygen either to receive standard treatment (n = 44) or to undergo prophylactic surgical ligation of the ductus arteriosus on the day of birth (n = 40). The ductus was ligated in babies in the control group only if the shunt was hemodynamically important. All the babies were followed for one year. The incidence of necrotizing enterocolitis was reduced in the group that underwent prophylactic ligation (3 of 40 [8 percent]) as compared with the control group (13 of 44 [30 percent]; P = 0.002). The frequency of death, bronchopulmonary dysplasia, retinopathy of prematurity, and intraventricular hemorrhage was similar in both groups. Because early enteral feeding may have increased the incidence of necrotizing enterocolitis, we analyzed separately the babies who were fed early. Among the infants who were fed within 14 days of birth, those who underwent prophylactic ligation had a lower incidence of necrotizing enterocolitis (1 of 11 [9 percent]) than those who did not (13 of 24 [54 percent]; P = 0.001). Within the control group, the infants who were fed within 14 days of birth and whose ductus was ligated for medical reasons within 5 days of birth had a lower incidence of necrotizing enterocolitis (2 of 10 [20 percent]) than those whose ductus was ligated later or not at all (11 of 14 [79 percent]; P = 0.004). We conclude that early surgical closure of the ductus arteriosus reduces the risk of necrotizing enterocolitis in infants of very low birth weight who require supplemental oxygen." ]
"Prophylactic surgical ligation of the PDA did not decrease mortality or BPD in ELBW infants. A significant reduction of stage II or III NEC was noted. Based on the current evidence, the high rate of spontaneous closure, availability of effective safe medical therapies, and the potential short and long-term complications of surgical ligation, the use such prophylactic surgical therapy is not indicated in the management of the preterm infants."
"CD002818"
[ "14759641", "2730380", "7501140", "2972270", "2889518" ]
[ "Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial.", "Amantadine treatment of fatigue associated with multiple sclerosis.", "Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo.", "Amantadine, fatigue, and multiple sclerosis.", "A randomized controlled trial of amantadine in fatigue associated with multiple sclerosis. The Canadian MS Research Group." ]
"The efficacy of amantadine in reducing fatigue in people with MS is poorly documented, as well as its tolerability. It is advisable to: (1) improve knowledge on the underlying mechanisms of MS-related fatigue; (2) achieve an agreement on accurate, reliable and responsive outcome measures of fatigue; (3) perform good quality RCTs."
"CD007182"
[ "7654268", "3484773", "3501750", "10190377", "12604518", "2802557", "10225575", "2188590", "10212779", "3158277", "7928829", "8449579", "215795", "15728165", "12195873", "3492486", "893246", "3157008" ]
[ "Randomized comparative trial and cost analysis of 3-day antimicrobial regimens for treatment of acute cystitis in women.", "Randomized study of single-dose, three-day, and seven-day treatment of cystitis in women.", "Ofloxacin versus trimethoprim-sulphamethoxazole in acute cystitis.", "A randomized trial of short-course ciprofloxacin, ofloxacin, or trimethoprim/sulfamethoxazole for the treatment of acute urinary tract infection in women. Ciprofloxacin Urinary Tract Infection Group.", "Cefpodoxime-proxetil versus trimethoprim-sulfamethoxazole for short-term therapy of uncomplicated acute cystitis in women.", "Ofloxacin versus trimethoprim-sulfamethoxazole for treatment of acute cystitis.", "A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection.", "Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.", "Comparative study of single-dose and three-day therapy for acute uncomplicated cystitis.", "Norfloxacin versus trimethoprim-sulfamethoxazole in the therapy of uncomplicated, community-acquired urinary tract infections.", "Nitrofurantoin modified release versus trimethoprim or co-trimoxazole in the treatment of uncomplicated urinary tract infection in general practice.", "Cefuroxime axetil versus ofloxacin for short-term therapy of acute uncomplicated lower urinary tract infections in women.", "Comparative controlled clinical trial of pivmecillinam and nalidixic acid in patients with acute simple urinary tract infections.", "Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: a randomized trial.", "Three days of pivmecillinam or norfloxacin for treatment of acute uncomplicated urinary infection in women.", "Comparison of ciprofloxacin and co-trimoxazole in the treatment of uncomplicated urinary tract infection in women.", "A comparison of pivmecillinam and cotrimoxazole in the treatment of simple cystitis in general practice.", "Efficacy of norfloxacin in urinary tract infection biological effects on vaginal and fecal flora." ]
[ "To determine the efficacy, safety, and costs associated with four different 3-day regimens for the treatment of acute uncomplicated cystitis in women.\n A prospective randomized trial with a cost analysis.\n Women with acute cystitis attending a student health center.\n Treatment with 3-day oral regimens of trimethoprim-sulfamethoxazole, 160 mg/800 mg twice daily, macrocrystalline nitrofurantoin, 100 mg four times daily, cefadroxil, 500 mg twice daily, or amoxicillin, 500 mg three times daily.\n Six weeks after treatment, 32 (82%) of 39 women treated with trimethoprim-sulfamethoxazole were cured compared with 22 (61%) of 36 treated with nitrofurantoin (P = .04 vs trimethoprim-sulfamethoxazole), 21 (66%) of 32 treated with cefadroxil (P = .11 vs trimethoprim-sulfamethoxazole), and 28 (67%) of 42 treated with amoxicillin (P = .11 vs trimethoprim-sulfamethoxazole). Persistence of significant bacteriuria was less common with trimethoprim-sulfamethoxazole (3%) and cefadroxil (0%) compared with nitrofurantoin (16%; P = .05 vs trimethoprim-sulfamethoxazole) and amoxicillin (14%; P = .11 vs trimethoprim-sulfamethoxazole). Persistence of bacteriuria was associated with amoxicillin-resistant strains in the amoxicillin group but nitrofurantoin-susceptible strains in the nitrofurantoin group. Trimethoprim-sulfamethoxazole was more successful in eradicating Escherichia coli from rectal cultures soon after therapy and from urethral and vaginal cultures at all follow-up visits compared with the other treatment regimens. Adverse effects were reported by 16 (35%) of 46 patients receiving trimethoprim-sulfamethoxazole, 18 (43%) of 42 receiving nitrofurantoin, 12 (30%) of 40 receiving cefadroxil, and 13 (25%) of 52 receiving amoxicillin. The mean costs per patient were less with trimethoprim-sulfamethoxazole ($114) and amoxicillin ($131) compared with nitrofurantoin ($155) and cefadroxil ($155).\n A 3-day regimen of trimethoprim-sulfamethoxazole is more effective and less expensive than 3-day regimens of nitrofurantoin, cefadroxil, or amoxicillin for treatment of uncomplicated cystitis in women. The increased efficacy of trimethoprim-sulfamethoxazole is likely related to its antimicrobial effects against E coli in the rectum, urethra, and vagina.", "We evaluated the following five treatment regimens for acute cystitis in nonpregnant women: cefadroxil, 1,000 mg single-dose; cefadroxil, 500 mg twice a day for three days; cefadroxil, 500 mg twice a day for seven days; trimethoprim-sulfamethoxazole (TMP-SMZ), 320-1,600 mg single-dose, and TMP-SMZ, 160-800 mg twice a day for three days. At four weeks after the end of treatment, 25%, 58%, 70%, 65%, and 88% of patients, respectively, remained cured of infection. The results indicated that three-day treatment (1) might improve cure rates (over single-dose), (2) would reduce incidence of relapse (vs. single-dose), and (3) may be as curative as seven-day treatment. The results of the antibody-coated bacteria test did not predict treatment failure or relapse.", "The clinical and bacteriological efficacy and adverse reactions of ofloxacin vs trimethoprim-sulphamethoxazole were investigated in a double-blind, randomised study in 250 female patients (125 in each group) with acute, uncomplicated lower urinary tract infections. The dosages of ofloxacin and trimethoprim-sulphamethoxazole were 100mg and 160mg + 800mg twice daily, respectively. The duration of therapy was 3 days. 81% of the patients had significant bacteriuria. Escherichia coli was isolated in 76% and Staphylococcus saprophyticus in 11% of the infections. The bacteriological elimination, clinical cure and improvement rates of the evaluable patients on ofloxacin treatment were 92 and 95%, respectively. The corresponding figures on trimethoprim-sulphamethoxazole therapy were 88 and 90%. Adverse reactions were clinically unimportant, and none of the patients had to stop treatment. Mild and transient side effects, mainly from the gastrointestinal tract, central nervous system and skin, were reported by 19 and 22% of the patients in the ofloxacin and trimethoprim-sulphamethoxazole groups, respectively. None of the differences in clinical and bacteriological efficacy and side effects of ofloxacin vs trimethoprim-sulphamethoxazole were statistically significant. Ofloxacin appears to be an appropriate antibiotic for short term therapy of acute, uncomplicated, lower urinary tract infections, comparing favourably with trimethoprim-sulphamethoxazole treatment in this study.", "Bladder infections are very common in otherwise healthy women, and short-course antimicrobial treatment appears effective for many episodes of cystitis. This study reports the results of short-course ciprofloxacin, ofloxacin, and trimethoprim/sulfamethoxazole therapy.\n We performed a randomized, double-blind study of the efficacy and safety of a 3-day course of oral ciprofloxacin 100 mg twice daily, ofloxacin 200 mg twice daily, or trimethoprim/sulfamethoxazole 160/800 mg twice daily in women with acute, uncomplicated, symptomatic lower urinary tract infection.\n A total of 866 patients were enrolled, of whom 688 (79%) were evaluated for the efficacy of treatment (229 treated with ciprofloxacin, 228 treated with trimethoprim/sulfamethoxazole, and 231 treated with ofloxacin). The most frequent reason for exclusion was the failure to identify a pretreatment pathogen. The most commonly isolated pathogen was Escherichia coli (81%). Eradication of the pretreatment pathogen at the end of therapy occurred in 94% of ciprofloxacin, 93% of trimethoprim/sulfamethoxazole, and 97% of ofloxacin-treated patients. At follow-up evaluation at 4 to 6 weeks, recurrence rates (relapse or reinfection) were 11% in the ciprofloxacin, 16% in the trimethoprim/sulfamethoxazole, and 13% in the ofloxacin treatment group. Clinical success at the end of therapy was 93% in the ciprofloxacin, 95% in the trimethoprim/sulfamethoxazole, and 96% in the ofloxacin treatment groups. The frequency of all adverse events was 31% for ciprofloxacin, 41% for trimethoprim/sulfamethoxazole, and 39% for ofloxacin-treated patients (P = 0.03). Premature discontinuation of study drug due to an adverse event was more common in trimethoprim/sulfamethoxazole-treated patients (n = 9) compared with those given ciprofloxacin (n = 2) or ofloxacin (n = 1; P = 0.02).\n Ciprofloxacin, ofloxacin, and trimethoprim/sulfamethoxazole had similar efficacy when given for 3 days to treat acute, symptomatic, uncomplicated lower urinary tract infection in women.", "One hundred sixty-three women with uncomplicated acute lower urinary tract infections were included in a multicenter randomized study comparing cefpodoxime-proxetil (one 100-mg tablet twice daily) with trimethoprim-sulfamethoxazole (one double-strength tablet [160/800 mg] twice daily) for 3 days. A total of 30 women in both arms were excluded from the study for various reasons. At 4 to 7 days after the discontinuation of therapy, 62 of 63 (98.4%) cefpodoxime-proxetil recipients and 70 of 70 (100%) trimethoprim-sulfamethoxazole patients were clinically cured and demonstrated bacteriological eradication, respectively. At 28 days after treatment, 48 of 55 (87.3%) and 43 of 50 (86%) cefpodoxime-proxetil recipients as well as 51 of 60 (85%) and 42 of 50 (84%) trimethoprim-sulfamethoxazole recipients were clinically cured and demonstrated bacteriological eradication, respectively. Independently of the prescribed regimen, a significant difference (P < 0.001) in failure rates was observed only for patients with a previous history of three or more episodes of acute cystitis per year. With the exception of one patient in the trimethoprim-sulfamethoxazole arm who discontinued therapy because of gastrointestinal pain, both antimicrobials were well tolerated. In conclusion, cefpodoxime-proxetil treatment for 3 days was as safe and effective as trimethoprim-sulfamethoxazole for 3 days for the treatment of uncomplicated acute cystitis in women.", "We compared the safety and efficacies of ofloxacin and trimethoprim-sulfamethoxazole for the treatment of acute uncomplicated cystitis in women enrolled in a multicenter study. Data from three centers were combined for this report because the study design and study populations were identical, and patients were enrolled within an 18-month period. Cure rates for evaluable patients 4 weeks after treatment were high for all regimens: ofloxacin (200 mg) twice daily for 3 days, 22 of 25 (88%) cured; ofloxacin (200 mg) twice daily for 7 days, 42 of 49 (86%) cured; ofloxacin (300 mg) twice daily for 7 days, 25 of 25 (100%) cured; and trimethoprim-sulfamethoxazole (160/800 mg) twice daily for 7 days, 46 of 52 (88%) cured. Ofloxacin was more effective than trimethoprim-sulfamethoxazole in eradicating Escherichia coli from rectal cultures during and 1 week after treatment. Both ofloxacin and trimethoprim-sulfamethoxazole markedly reduced vaginal colonization with E. coli during and 4 weeks after therapy. Emergence of resistant coliforms in rectal flora was found in 5 (19%) of 27 patients treated with trimethoprim-sulfamethoxazole but none of 50 ofloxacin-treated patients who were studied (P = 0.004). Adverse effects were equally common among the four treatment groups. We conclude that 3 to 7 days of ofloxacin is as safe and effective as trimethoprim-sulfamethoxazole for treatment of uncomplicated cystitis in women and that ofloxacin effectively reduces the fecal and vaginal reservoirs of coliforms in such patients.", "The study was undertaken to compare the safety and efficacy of twice-daily ciprofloxacin for 3 days with standard 7 day therapy with either co-trimoxazole or nitrofurantoin in the treatment of women with acute, uncomplicated urinary tract infections (UTI). This multicentre, prospective, randomized, double-blind trial compared oral ciprofloxacin (100 mg bd) for 3 days with co-trimoxazole (160/800 mg bd) or nitrofurantoin (100 mg bd) for 7 days. Bacteriological and clinical evaluations were performed at study entry, during therapy and 4-10 days and 4-6 weeks after the completion of therapy. The primary efficacy parameter was eradication of the causative organism 4-10 days following treatment. Of 713 women enrolled and evaluable for safety, 521 were evaluable for efficacy (168 ciprofloxacin, 174 co-trimoxazole, 179 nitrofurantoin). Escherichia coli (83%) was the most frequently isolated pathogen in all treatment groups. Bacteriological eradication was reported in 88% of ciprofloxacin patients, 93% of co-trimoxazole patients and 86% of nitrofurantoin patients. At the 4-6 week follow-up, ciprofloxacin had statistically significantly higher eradication rates (91%) than co-trimoxazole (79%; 95% confidence limit (CL) = -20.6%, -3.9%) and nitrofurantoin (82%; 95% CL = -17.1%, -0.9%). Clinical resolution 4-10 days after therapy and at the 4-6 week follow-up was similar among the three treatment groups. The overall incidence of treatment-emergent adverse events was not significantly different (P = 0.093) among the three drug regimens, although co-trimoxazole was associated with a greater number of adverse events than ciprofloxacin (P < or = 0.05). Ciprofloxacin also caused fewer episodes of nausea than either of the other agents (P < or = 0.01).", "We conducted a randomized controlled trial of orally administered amifloxacin versus trimethoprimsulfamethoxazole (TMP-SMX) as treatments of acute uncomplicated urinary tract infection in women. Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX.", "To assess the efficacy and safety of a single-dose therapy for acute uncomplicated cystitis (AUC), we compared 4 treatment regimens in 120 women. Patients eligible for the study were randomly assigned to one of four treatment groups: Ciprofloxacin (CPFX) 200 mg in a single oral dose (group A); 200 mg once daily for 3 days (group B); 200 mg twice daily for 3 day (group C); and cefpodoxime-proxcetil (CPDX-PR) 200 mg once daily for 3 days (group D). The efficacy was evaluated 3 days after the single-dose therapy or at the end of a three-day therapy according to the criteria proposed by the Japanese UTI Committee. The overall clinical efficacy in a total of 107 patients was evaluated to be excellent, moderate, and poor in 72 (67.3%), 35 (31.8%), and 1 (0.9%), respectively. The causative organisms were eradicated in 88.0, 85.2, 85.2, and 82.1% of the patients in groups A, B, C, and D, respectively. Recurrence was identified in 3 (2 in group A and one in group D) of 16 patients who were followed at 2 to 3 weeks after the treatment. No adverse reactions related to the antibiotics were recognized in the study. There were no significant differences in the clinical efficacy or recurrence rate among these four treatment regimens. These results indicate that the single-dose therapy of CPFX is the treatment of choice in women with AUC.", "In a prospective, randomized trial, norfloxacin (400 mg perorally, twice a day) was compared with trimethoprim-sulfamethoxazole (160-800 mg perorally, twice a day) in 45 patients with uncomplicated urinary tract infections. Escherichia coli was the most common isolate. Infections due to Enterobacter spp., Proteus mirabilis, Pseudomonas spp., and Staphylococcus spp. were also treated. Norfloxacin was equivalent in effectiveness and safety to trimethoprim-sulfamethoxazole, with a cure rate of 91% at the 5- to 9-day posttherapy visit and 88% at the 4- to 6-week posttherapy visit. It was well tolerated and had a low incidence of side effects.", "A total of 538 patients from 45 different general practice centres across the UK was admitted to an open study and randomized to one of the following treatment groups: nitrofurantoin modified release (MR) 100 mg bd, trimethoprim 200 mg bd or co-trimoxazole 960 mg bd. Each patient received seven days of medication. Clinical cure, defined as relief from symptoms at visit 2, occurred in 87.2% of the patients treated with nitrofurantoin MR, 84.5% of the co-trimoxazole group and 86.5% of the trimethoprim group. The bacteriological cure rate for nitrofurantoin MR was comparable to co-trimoxazole at 82.3% and 83.2%, respectively, with trimethoprim the lowest at 76.8%. Whilst the cure rate for Escherichia coli infection was similar, 81.5% cured with nitrofurantoin MR, 82.5% with co-trimoxazole and 78.4% by trimethoprim, for non-E. coli pathogens nitrofurantoin MR was equivalent to co-trimoxazole with 86.7% cure but higher than trimethoprim at 72.0%. In-vitro sensitivity to all pathogens isolated at baseline was very high for nitrofurantoin at 96.1%, significantly higher than either co-trimoxazole or trimethoprim at 87.5% (P < 0.01). The test drugs were equally well tolerated with 28 patients (15.7%) reporting adverse events with nitrofurantoin MR, 28 (15.5%) with co-trimoxazole and 28 (15.6%) with trimethoprim. However, nitrofurantoin MR showed fewer patients with drug-related adverse events (5.6%) as judged by the investigator, compared to co-trimoxazole (8.8%) or trimethoprim (7.3%). (ABSTRACT TRUNCATED AT 250 WORDS)", "In a multicentre study 163 women with acute lower urinary tract infection were treated orally with either 125 mg cefuroxime axetil or 100 mg ofloxacin twice daily for three days. Both antimicrobial agents were generally well tolerated. Four patients in the group treated with cefuroxime axetil and two in the group treated with ofloxacin experienced adverse events. Clinical cure and improvement were registered in 56 of 66 (84.8%) and 59 of 62 (95.2%) of the evaluable patients treated with cefuroxime axetil and ofloxacin, respectively. Seven to nine days after therapy, bacteriuria (CFU < 10(3)/ml) had been eliminated in 53 of 66 (80.3%) and 57 of 64 (89.1%) of the evaluable patients receiving cefuroxime axetil and ofloxacin, respectively. The results were not statistically significantly different (p > 0.1). Pathogens present at baseline were eliminated by up to an MIC of 16 mg/l of cefuroxime axetil, independent of susceptibility to this agent. There was no difference with regard to efficacy and tolerance between patients treated with cefuroxime axetil and those treated with ofloxacin. On the basis of the MICs of six antimicrobial agents (cefuroxime, ofloxacin, cefadroxil, ampicillin, trimethoprim with and without sulfamethoxazole) determined for the pathogens isolated prior to therapy, resistance rates were lowest for cefuroxime (2.2%) and ofloxacin (3.4%).", "We performed a controlled double-blind clinical study with PMPC to investigate its therapeutic usefulness in acute simple cystitis in comparison with NA, with the results as follows: 1. In both treatment groups, PMPC proved to be remarkably more active (MIC) than NA against the bacterial isolates tested in vitro. 2. PMPC, administered in dosis (200 mg per day) one-tenth those of NA (2,000 mg per day), produced a greater improvement (therapeutic effects) than NA. 3. Side-effects were apparently less frequent with PMPC, as compared to NA. The results indicate a remarkable usefulness of PMPC in the treatment of acute simple cystitis.", "The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied.\n To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure.\n Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 10(2) colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization.\n Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months.\n The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E coli colonization at the 2-week follow-up visit.\n Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P = .004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001).\n A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.", "Pivmecillinam is a unique beta-lactam antimicrobial that has been used for the treatment of acute uncomplicated urinary infection for > 20 y. Since this agent was introduced, the quinolone antimicrobials have become widely used for the same indication. This study compared the efficacy of a 3-d regimen of pivmecillinam 400 mg b.i.d. with norfloxacin 400 mg b.i.d. Women aged between 18 and 65 y presenting with symptoms of acute cystitis of < 7 d duration were eligible for enrollment; 483 were randomized to receive pivmecillinam and 471 to receive norfloxacin. In each group, 30% of women had negative urine cultures prior to therapy. Bacteriologic cure at early post-therapy follow-up was achieved in 222/298 (75%) pivmecillinam patients and 276/302 (91%) norfloxacin patients [p < 0.001; 95% confidence interval (CI) 12.0-21.8]. Clinical cure/improvement at Day 4 following initiation of therapy was observed in 434/457 (95%) women who received pivmecillinam and 425/442 (96%) who received norfloxacin (p = 0.39; 95% CI 1.5-3.9). Early post-therapy (11 +/- 2 d) clinical cure was achieved in 360/437 women (82%) who received pivmecillinam and 381/433 (88%) who received norfloxacin (p = 0.019; 95% CI 0.9-10.3). In women aged < or = 50 y, early clinical cure rates were 294/351 (84%) for pivmecillinam and 299/340 (88%) for norfloxacin (p = 0.11; 95% CI 1.0-9.4). Adverse effects were similar for both regimens, and there was no evidence of the emergence of organisms of increasing resistance with therapy. Short-course therapy with norfloxacin was superior to that with pivmecillinam in terms of bacteriologic outcome, although differences in clinical outcome were less marked. In conclusion, short-course therapy with pivmecillinam is an effective empirical treatment for pre-menopausal women.", "Sixty-five women with uncomplicated urinary tract infection were evaluated in a prospective, randomized, double blind study comparing ciprofloxacin (250 mg twice daily for ten days) with co-trimoxazole (160 mg trimethoprim and 800 mg sulphamethoxazole twice daily for ten days). Results were analysed with respect to eradication of the urinary tract pathogen, resolution of clinical symptoms, incidence of relapse, and incidence of adverse effects. Among the 31 women who received ciprofloxacin, there was eradication of the micro-organism and complete resolution of clinical symptoms in 100% five to nine days after completion of therapy. Among the 34 patients who received co-trimoxazole, there was eradication in 94% and clinical resolution in 91%. Of the ciprofloxacin-treated women 6.5% (2/31) relapsed compared with 18% (6/34) of co-trimoxazole-treated women. Overall cure rates for 65 patients were 93.5% and 82.3% for ciprofloxacin and co-trimoxazole (difference not statistically significant), respectively. A statistically significant (P less than 0.05) increase in adverse side effects was noted in patients treated with co-trimoxazole. Based upon preliminary data it appears that ciprofloxacin is as effective and less toxic than co-trimoxazole for treatment of uncomplicated urinary tract infection in women.", "Pivmecillinam was compared with cotrimoxazole in the treatment of uncomplicated bacterial cystitis in general practice. Similar bacteriological cure rates were obtained with the two treatments. Although micrococci were judged resistant to pivmecillinam by the disc sensitivity method used, cystitis attributed to these organisms and to resistant strains of Proteus mirabilis responded as readily as those due to apparently sensitive Gram-negative bacteria. Pivmecillinam was well tolerated.", "Forty women with uncomplicated urinary tract infections were assigned randomly to receive 400 mg. norfloxacin or 160 mg. trimethoprim and 800 mg. sulfamethoxazole twice daily for 10 days. Of the 20 patients receiving norfloxacin none had bacteriuria during or 7 days after therapy and 5 patients were reinfected within 6 weeks of therapy discontinuation. Of the 20 patients receiving trimethoprim-sulfamethoxazole therapy 1 presented with a strain resistant to trimethoprim-sulfamethoxazole and was excluded from the study. The remaining 19 patients were uninfected during and 7 days after therapy, and 6 patients were reinfected 6 weeks after therapy. All documented recurrences were caused by bacteria sensitive to the initial therapeutic agent. Anal and vaginal Enterobacteriaceae maintained their sensitivity to norfloxacin. One patient on trimethoprim-sulfamethoxazole presented with and 2 patients acquired resistant anal and vaginal Enterobacteriaceae. No adverse reactions occurred in either treatment group. Norfloxacin was as effective and safe as trimethoprim-sulfamethoxazole without emergence of resistant bacteria associated with trimethoprim-sulfamethoxazole." ]
"No differences were observed between the classes of antimicrobials included in this review for the symptomatic cure of acute uncomplicated UTI. Fluoroquinolones proved more effective than beta-lactams for the short-term bacteriological outcome, probably with little clinical significance. Individualised treatment should take into consideration the predictable susceptibility of urinary pathogens in local areas, possible adverse events and resistance development, and patient preference."
"CD009148"
[ "10561655", "12748513", "3524234", "8169910", "2358916", "6379529", "8399011", "2372330" ]
[ "Comparison of visual and computerized interpretation of nonstress test results in a randomized controlled trial.", "Screening for fetal well-being in a high-risk pregnant population comparing the nonstress test with umbilical artery Doppler velocimetry: a randomized controlled clinical trial.", "Fetal acoustic stimulation testing. II. A randomized clinical comparison with the nonstress test.", "Comparison of the acoustic stimulation test with nonstress test. A randomized, controlled clinical trial.", "Vibroacoustic stimulation and fetal heart rate in nonstress tests.", "Fetal biophysical profile score and the nonstress test: a comparative trial.", "The effect of introduction of umbilical Doppler recordings to obstetric practice.", "Effect of vibratory acoustic stimulation on the duration of fetal heart rate monitoring tests." ]
"There are insufficient data from randomised trials to guide practice regarding the management of DFM. Based on the results of other systematic reviews of management strategies for women whose babies are thought to be at risk of compromise for various reasons, the following strategies show promise and may be prioritised for further research: Doppler ultrasound studies, computerised cardiotocography, and fetal arousal to facilitate cardiotocography. For settings where electronic fetal assessment methods are not available, clinical fetal arousal tests should be investigated."
"CD004667"
[ "8924098", "11251497", "2927328", "11251496", "7565233", "11212998", "12787235", "8494832", "11080465" ]
[ "A randomized, controlled trial of nurse-midwifery care.", "Team midwifery care in a tertiary level obstetric service: a randomized controlled trial.", "The 'Know Your Midwife' scheme--a randomised trial of continuity of care by a team of midwives.", "Does team midwife care increase satisfaction with antenatal, intrapartum, and postpartum care? A randomized controlled trial.", "Continuity of care by a midwife team versus routine care during pregnancy and birth: a randomised trial.", "Collaboration in maternity care: a randomised controlled trial comparing community-based continuity of care with standard hospital care.", "Changing Childbirth: a pilot project.", "Simulated home delivery in hospital: a randomised controlled trial.", "A randomised study of midwifery caseload care and traditional 'shared-care'." ]
"Most women should be offered midwife-led models of care and women should be encouraged to ask for this option although caution should be exercised in applying this advice to women with substantial medical or obstetric complications."
"CD006164"
[ "15230999", "10701059", "7835254" ]
[ "School-milk intervention trial enhances growth and bone mineral accretion in Chinese girls aged 10-12 years in Beijing.", "[Prevention of vitamin D deficiency in adolescents and pre-adolescents. An interventional multicenter study on the biological effect of repeated doses of 100,000 IU of vitamin D3].", "Factors affecting the morbidity of vitamin D deficiency rickets and primary protection." ]
"There a only few studies on the prevention of nutritional rickets in term born children. Until new data become available, it appears sound to offer preventive measures (vitamin D or calcium) to groups of high risk, like infants and toddlers; children living in Africa, Asia or the Middle East or migrated children from these regions into areas where rickets is not frequent. Due to a marked clinical heterogeneity and the scarcity of data, the main and adverse effects of preventive measures against nutritional rickets should be investigated in different countries, different age groups and in children of different ethnic origin."
"CD003996"
[ "9432077", "7282909", "3172958", "4997484", "3402097", "3530224", "9738752", "3124628", "11773839", "7810316" ]
[ "Use of antibiotic prophylaxis in ear surgery.", "Effectiveness of prophylactic antibiotic treatment in mastoid surgery.", "Antimicrobial prophylaxis in ear surgery.", "Prophylactic antibiotics in otolaryngologic surgery: a double-blind study.", "Tympanoplasty surgery and prophylactic antibiotics: surgical results.", "Efficacy of perioperative ceftazidime in the surgical treatment of chronic otitis media due to Pseudomonas aeruginosa. Preliminary report of a prospective, controlled study.", "Prophylactic antibiotics in surgery for chronic ear disease.", "The role of prophylactic antibiotics in middle ear surgery. A study on phenoxymethylpenicillin prophylaxis.", "Preoperative topical ofloxacin solution for tympanoplasty: a randomized, controlled study.", "[Antibiotic prophylaxis in otological and otoneurological surgery]." ]
[ "A prospective, double-blind, randomized, placebo-controlled study was performed to evaluate the effect of antibiotic prophylaxis in ear surgery. The present study reports on the results of 750 patients, half of whom received cefuroxime for 1 day, the other half, placebo. All postoperative infections occurring within 2 weeks after the intervention were recorded, together with several preoperative and perioperative parameters. It is concluded that exploratory tympanoplasties (including stapedotomy) and \"dry perforation\" tympanoplasties should be considered \"clean\" operations according to the American National Research Council and do not benefit from antibiotic prophylaxis. On the other hand, tympanoplasties performed on draining ears and on ears with cholesteatoma should be considered \"dirty\" operations for which antibiotic prophylaxis may decrease the postoperative infection rate by factor 3. All postoperative infections healed without sequels under proper treatment, except for three that resulted in graft necrosis--one in the placebo group and two in the cefuroxime group. In consequence, prophylaxis may not be mandatory in the dirty group, although the authors advocate its use for the sake of patient and surgeon comfort.", "This article describes a prospective study of the effectiveness of prophylactic antibiotic treatment in preventing infection following mastoid surgery. Seventy-two patients who underwent surgery for chronic middle ear disease served as the basis for this study. Bacteriologic findings from middle ear discharge, showing aerobic and anaerobic bacteria, are reported. The patients were randomly classified into two groups, one undergoing surgery with preventive antibiotic treatment with clindamycin and gentamycin and the other undergoing surgery without antibiotic therapy. The early postoperative inflammatory complications are presented. No significant differences were found in the incidence of these complications between the two groups. In view of the results, the effectiveness of preventive antibiotic treatment in mastoid surgery is questioned.", "The purpose of this research was to assess the efficacy of prophylactic antibiotic administration in ear surgery over a wide range of cases. Additional objectives include the assessment of the relative effect of patient age, duration of operation, preoperative condition, and the success of tympanoplasty. Prospectively, in a controlled study, 4,000 patients were studied employing cephalosporin and oxacillin as prophylactic antimicrobials. No statistically significant difference in postoperative otologic infection rates was observed. This conclusion was unaltered by the operative duration, patient age, or preoperative condition. Grafting success was not improved.", "nan", "This paper reports a multicentre, controlled, blind, prospective, randomized study into the use of prophylactic systemic antibiotics in myringoplasty surgery. A total of 130 individuals were randomly allocated to either an antibiotic or a non-antibiotic group. Each individual was clinically and audiometrically assessed preoperatively, and 8 weeks postoperatively. It was found that systemic prophylactic antibiotics did not influence either the success rate of myringoplasty surgery or the audiometric result.", "A prospective open and controlled study of perioperative antibiotics was conducted in patients with chronic otitis media (COM). Drug efficacy was found in a subgroup of 26 patients, who were characterized by preoperative aural drainage culturing Pseudomonas aeruginosa. Fourteen of these patients were randomized to receive ceftazidime (cephalosporin) for 5 days at the operation, while 12 had no antibiotic treatment. The occurrence of subsequent aural drainage was compared with the actual clinical and microbiological conditions of the ears 2 months after the operation; statistically significant differences were found in favor of the group treated with ceftazidime. Further studies must define the role of ceftazidime and other antibiotics in the management of patients with COM.", "The role of prophylactic antibiotics in otologic surgery continues to be debated and perhaps misused. Prior studies have provided conflicting evidence with regard to the benefit obtained from the use of prophylactic antibiotics in surgery for chronic otitis media. The current study was designed to evaluate the role of prophylactic antibiotics in the outcomes of surgery for chronic ear disease. It was the authors' impression that there was no indication for prophylactic antibiotics in such surgery.\n Randomized prospective study performed in a tertiary care facility.\n Patients who met inclusion criteria (n = 146) were randomly assigned to an antibiotic treatment group or a control group receiving no prophylactic antibiotics. Patients in the antibiotic treatment group were given preoperative intravenous antibiotics followed by oral antibiotics for 5 days after surgery. Patients were followed postoperatively and observed for clinical evidence of infection and graft failure.\n There was no statistically significant difference between the two groups with regard to the incidence of postoperative infection or graft survival.\n The use of prophylactic antibiotics in surgery for chronic ear disease cannot be recommended based on the findings of this study.", "A randomized prospective double-blind study was performed testing the value of phenoxymethylpenicillin in conjunction with middle ear surgery. The patients were evaluated for clinical signs of infection and with bacteriologic cultures both pre- and postoperatively. No difference in clinical signs of infection was noted between the pre- and postoperative evaluations. A significantly larger number of patients, however, presented with postoperative positive bacteriologic cultures as compared with the preoperative cultures. This increase was particularly evident in the placebo group. The two microorganisms that were found in increased numbers postoperatively were Staphylococcus epidermidis and Pseudomonas strains. The value of prophylactic antibiotic treatment and phenoxymethylpenicillin treatment in particular is discussed.", "To establish the efficacy of immediate preoperative ototopical ofloxacin eardrops in eradicating middle ear pathogens and improving operative outcome.\n Single-blind, randomized control study.\n Tertiary referral center, ambulatory clinic, and hospital setting.\n Consecutive patients with chronic suppurative otitis media for Type I tympanoplasty (myringoplasty).\n The patients were randomly assigned to 3 groups: Group A underwent 10-minute daily treatments with eardrops for 2 weeks before surgery, Group B underwent 3-minute daily treatments for 2 weeks before surgery, and Group C underwent no treatment.\n Preoperative and perioperative bacteriology and success of the surgery as defined by an intact tympanic membrane in the eighth week postsurgery.\n There were 101 patients entered in the study. The preoperative, perioperative, and postoperative observation of discharge and quantity of the discharge were compared, and no differences were found among the groups (Kruskal-Wallis test). The perioperative culture results were analyzed and 18/21 (86%) became culture negative in Group A, 23/27 (85%) became culture negative in Group B, and 3/21 (14%) became culture negative in the control group (Group C versus Group A or Group B, chi(2) tests p < 0.001). The success rates of surgery as defined by an intact tympanic membrane showed no difference: 28/33 (85%), 27/33 (82%), and 31/35 (89%) in Groups A, B, and C, respectively. The preoperative positive bacteriology rate in the surgical failures was 10/15 (67%), compared with 16/76 (21%) for the successful procedures (p < 0.001).\n Our study has shown that ofloxacin successfully eradicates most bacterial flora preoperatively. We cannot, however, confirm the benefits of its preoperative usage in improving the graft success rate.", "nan" ]
"There is no strong evidence that the large-scale use of prophylactic antibiotics in clean and clean-contaminated ear surgery is helpful in reducing postoperative complications such as wound infection, discharge from the outer ear canal, labyrinthitis and graft failure."
"CD005146"
[ "17954515", "14512476", "17954514" ]
[ "Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine.", "Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine.", "Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine." ]
"All treatments evaluated within the included studies are effective. Benzodiazepines, however, have the potential to cause respiratory depression, probably midazolam more so than lorazepam, and use of this group of drugs outside of services fully confident of observing for and managing the consequences of respiratory distress is difficult to justify. Haloperidol used on its own is at such risk of generating preventable adverse effects that unless it is the only choice, this evidence directs that this sole treatment should be avoided. Olanzapine IM is valuable when compared with haloperidol plus promethazine but its duration of action is short and re-injection is frequently needed. Haloperidol plus promethazine used in two diverse situations in Brazil and India has much evidence to support its swift and safe clinically valuable effects."
"CD001744"
[ "1586049", "9337824", "15316206", "10596681" ]
[ "A double-blind trial of nocturnal supplemental oxygen for sleep desaturation in patients with chronic obstructive pulmonary disease and a daytime PaO2 above 60 mm Hg.", "Effect of long-term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia.", "Long-term oxygen therapy stops the natural decline of endurance in COPD patients with reversible hypercapnia.", "A randomized trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease patients." ]
[ "The efficacy of nasal oxygen during sleep was evaluated in patients with COPD, episodic rapid eye movement sleep desaturation, and a daytime PaO2 greater than 60 mm Hg. The double-blind, randomized 3-yr trial used nasal oxygen versus room air in two groups of nocturnal sleep desaturating subjects. The setting was the outpatient chest clinic of a Veterans Affairs Medical Center. There were 51 patients with moderate to severe COPD, daytime PaO2 greater than or equal to 60 mm Hg: 38 with proven REM sleep desaturation and 13 without desaturation. Nocturnal oxygen at 3 L/min was delivered by concentrator to 19 desaturating subjects, and room air at 3 L/min was delivered by defective concentrator to the remaining 19 desaturating subjects. There was no gas therapy for the 13 nondesaturating subjects. The nocturnal desaturator group who received supplemental oxygen during sleep over 36 months showed a significant downward trend in pulmonary artery pressure (-3.7 mm Hg) compared with desaturating patients treated with room air (+3.9 mm Hg). Nonvascular parameters of hypoxia, such as hemoglobin and red blood cell mass, did not differ between the sham- and oxygen-treated groups. Mortality was decidedly higher in the desaturating patients compared with non-desaturating subjects, but there was no significant difference between oxygen- and sham-treated desaturating subjects. We conclude that nasal supplemental oxygen used during sleep to reverse episodic desaturation in COPD patients whose daytime PaO2 is above 60 mm Hg has a beneficial effect in reducing pulmonary artery pressure.(ABSTRACT TRUNCATED AT 250 WORDS)", "To date only two controlled studies have been published on the effects of domiciliary oxygen treatment on survival in patients with chronic obstructive pulmonary disease (COPD) with advanced respiratory failure. The survival in such patients despite oxygen treatment remains poor. The prescription of long term oxygen therapy (LTOT) in less severe disease remains controversial. The aim of this study was to evaluate the rationale for prescribing oxygen to patients with COPD with moderate hypoxaemia.\n One hundred and thirty five patients with COPD, with PaO2 7.4-8.7 kPa (56-65 mmHg) and advanced airflow limitation (mean (SD) forced expiratory volume in one second (FEV1) 0.83 (0.28) 1), were randomly allocated to a control (n = 67) and LTOT (n = 68) group. The patients were followed every three months for at least three years or until death.\n The cumulative survival rate was 88% at one year, 77% at two years, and 66% at three years. No significant differences were found in survival rates between patients treated with LTOT and controls, nor did longer oxygen use (over 15 hours per day) improve survival. Younger age, better spirometric values, and higher body mass index predicted better survival.\n Domiciliary oxygen treatment does not prolong survival in patients with COPD with moderate hypoxaemia. Airway limitation seems to determine survival in this group of patients.", "Respiratory muscle weakness is one of the most important causes of hypercapnia in patients with COPD. There is evidence that stable hypercapnic patients will benefit from long-term oxygen therapy (LTOT).\n The prognostic role of reversible hypercapnia in COPD is still unclear. Early implementation of LTOT in these patients may influence endurance time and mortality.\n In this pilot study, we investigated 28 patients (26 males, 49-74 years) with COPD, advanced airflow limitation [forced expiratory volume in 1 s (percentage of predicted value) 40.8 +/- 10.2] and mild hypoxaemia (pO(2) 66.5 +/- 6.3 mm Hg). All patients had developed a moderate reversible hypercapnia during an acute exacerbation or during exercise testing (peak pCO(2) 48.0 +/- 2.5 mm Hg). Patients were allocated randomly to a control group (n = 14) or an LTOT group (n = 14). The two groups were well matched in terms of physiological data. Lung function, endurance time (cycle ergometer), dyspnoea score, blood gases and LTOT compliance were measured at baseline and every 6 months over a period of 3 years.\n Endurance time increased from 6.4 +/- 2.7 min at baseline to 7.1 +/- 2.7 min after 1 year in the LTOT group and decreased from 6.1 +/- 3.0 to 4.9 +/- 3.8 min in the controls (p < 0.05). After 1 year, the end-exercise dyspnoea score was significantly lower in the LTOT group (4.5 +/- 1.5) than in the controls (5.7 +/- 1.9).\n COPD patients with reversible hypercapnia and mild hypoxaemia benefit from LTOT in terms of endurance time and a reduction of exertional dyspnoea after 1 year.\n Copyright 2004 S. Karger AG, Basel", "The beneficial effects of nocturnal oxygen therapy (NOT) in chronic obstructive pulmonary disease (COPD) patients with mild-to-moderate daytime hypoxaemia (arterial oxygen tension (Pa,O2) in the range 7.4-9.2 kPa (56-69 mmHg)) and exhibiting sleep-related oxygen desaturation remains controversial. The effectiveness of NOT in that category of COPD patients was studied. The end points included pulmonary haemodynamic effects after 2 yrs of follow-up, survival and requirement for long-term oxygen therapy (LTOT). Seventy-six patients could be randomized, 41 were allocated to NOT and 35 to no NOT (control). The goal of NOT was to achieve an arterial oxygen saturation of >90% throughout the night. All these patients underwent polysomnography to exclude an associated obstructive sleep apnoea syndrome. The two groups exhibited an identical meansD daytime Pa,O2 of 8.4+/-0.4 kPa (63+/-3 mmHg) at baseline. Twenty-two patients (12 in the NOT group and 10 in the control group, p=0.98) required LTOT during the whole follow-up (35+/-14 months). Sixteen patients died, nine in the NOT group and seven in the control group (p=0.84). Forty-six patients were able to undergo pulmonary haemodynamic re-evaluation after 2 yrs, 24 in the NOT and 22 in the control group. In the control group, mean resting pulmonary artery pressure increased from 19.8+/-5.6 to 20.5+6.5 mmHg, which was not different from the change in mean pulmonary artery pressure in the NOT group, from 18.3+/-4.7 to 19.5+/-5.3 mmHg (p= 0.79). Nocturnal oxygen therapy did not modify the evolution of pulmonary haemodynamics and did not allow delay in the prescription of long-term oxygen therapy. No effect of NOT on survival was observed, but the small number of deaths precluded any firm conclusion. These results suggest that the prescription of nocturnal oxygen therapy in isolation is probably not justified in chronic obstructive pulmonary disease patients." ]
"Long-term home oxygen therapy improved survival in a selected group of COPD patients with severe hypoxaemia (arterial PaO2 less than 55 mm Hg (8.0 kPa)). Home oxygen therapy did not appear to improve survival in patients with mild to moderate hypoxaemia or in those with only arterial desaturation at night."
"CD004931"
[ "2792672", "15672051", "3294079", "2194894", "2767500", "3294080" ]
[ "A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity.", "Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up.", "Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity.", "Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon.", "Effect of the gastric balloon versus sham procedure on weight loss in obese subjects.", "Effect of gastric bubble as a weight reduction device: a controlled, crossover study." ]
"Evidence from this review is limited for decision making, since there was large heterogeneity in IGB trials, regarding both methodological and clinical aspects. However, a co-adjuvant factor described by some authors in the loss and maintenance of weight has been the motivation and the encouragement to changing eating habits following a well-organized diet and a program of behavioural modification. The IGB alone and the technique of positioning appear to be safe. Despite the evidence for little additional benefit of the intragastric balloon in the loss of weight, its cost should be considered against a program of eating and behavioural modification."
"CD006245"
[ "16468111", "10856009", "2406126", "2044499" ]
[ "[Education of children with epilepsy and their parents by the modular education program epilepsy for families (FAMOSES)--results of an evaluation study].", "A randomized field trial of ACINDES: a child-centered training model for children with chronic illnesses (asthma and epilepsy).", "Randomized trial of a program to enhance the competencies of children with epilepsy.", "Impact of the Children's Epilepsy Program on parents." ]
[ "The aim of the study was to evaluate the efficacy of the modular educational program for children with epilepsy and their parents (FAMOSES). This program was developed by an interdisciplinary project group to improve knowledge, coping, treatment outcome, emotional and practical adaptation to the condition.\n A prospective, controlled, multi-center, pre-post study design was used to examine the efficacy of the program in the treatment group compared to the waiting group (control group). Questionnaires included epilepsy specific scales regarding knowledge, attitudes, restrictions in daily living, epilepsy related fears, coping with the chronic disease and generic instruments (quality of life, KINDL). 55 parents of the treatment group completed the questionnaires three months before the course and three months later; the corresponding waiting group included 48 parents. Respectively, 31 children, who participated in the program, completed the questionnaires immediately before the course and three months later; the corresponding waiting group included 19 children.\n Children, who attended the program, showed improvements in the domains perceived restrictions (significant, medium effect size), absence from school and seizure frequency. Not significantly greater compared to the control group were the improvements of knowledge, attitudes and fears regarding to the epilepsy. Parents of the treatment group showed significant enhancements in epilepsy specific knowledge (large effect size), attitudes toward the epilepsy, management of epileptic seizures and significant reductions of fears and restrictions of their child with epilepsy (small to medium effect sizes).", "A randomized field trial of a child-centered model of training for self-management of chronic illnesses was conducted of 355 Spanish-speaking school-aged children, between 6 and 15 years old, with moderate to severe asthma and epilepsy, in Buenos Aires, Argentina. The model, based on play techniques, consists of five weekly meetings of 8-10 families, with children's and parents' groups held simultaneously, coordinated by specially trained teachers and outside the hospital environment. Children are trained to assume a leading role in the management of their health; parents learn to be facilitators; and physicians provide guidance, acting as counselors. Group activities include games, drawings, stories, videos, and role-playing. Children and parents were interviewed at home before the program and 6 and 12 months after the program, and medical and school records were monitored for emergency and routine visits, hospitalizations, and school absenteeism. In asthma and epilepsy, children in the experiment showed significant improvements in knowledge, beliefs, attitudes, and behaviors compared to controls (probability of experimental gain over controls = .69 for epilepsy and .56 for asthma, with sigma2 = .007 and .016, respectively). Parent participants in the experiment had improved knowledge of asthma (39% before vs. 58% after) and epilepsy (22% before vs. 56% after), with a probability of gain = .62 (sigma2 = .0026) with respect to the control group. Similar positive outcomes were found in fears of child death (experimental 39% before vs. 4% after for asthma, 69% before vs. 30% after for epilepsy), as well as in disruption of family life and patient-physician relationship, while controls showed no change. Regarding clinical variables, for both asthma and epilepsy, children in the experimental group had significantly fewer crises than the controls after the groups (P = .036 and P = .026). Visits to physicians showed a significant decrease for those with asthma (P = .048), and emergency visits decreased for those with epilepsy (P = .046). An 18-item Children Health Locus of Control Scale (CHLCS) showed a significant increase in internality in experimental group children with asthma and epilepsy (P < .01), while controls did not change or performed worse 12 months after the program. School absenteeism was reduced significantly for those with asthma and epilepsy (for the group with asthma, fall/winter P = .006, and spring P = .029; for the group with epilepsy, P = .011).\n The program was successful in improving the health, activity, and quality of life of children with asthma and epilepsy. The data suggested that an autonomous (Piagetian) model of training is a key to this success, reinforcing children's autonomous decision making.", "A randomized, controlled trial was conducted in Santiago, Chile to test the impact of a child-centered, family-focused educational program for children aged 7-14 years with epilepsy and for their parents. The objectives of the program developed and pilot-tested in Los Angeles, California were to increase the children's knowledge, perceptions of competency, and skills related to dealing with seizures. Children in the experimental group (n = 123) and their parents separately attended four 1 1/2-h sessions and then met together at the end of each session to share learning experiences. Control children (n = 113) and their parents attended three 2-h sessions with a traditional lecture followed by question-and-answer format. All participants were pretested and then retested 5 months after completion of the educational intervention. Although there was some knowledge increase among children in the control group, the knowledge of children in the experimental group was significantly enhanced in a variety of areas related to management of their seizures and unnecessary restriction of their social and play activities. There was a significant increase in the self-perceptions of social competency of children in the experimental group. Children in the experimental group without serious behavioral problems also reported significantly better behavior after the intervention than did control children. There was no impact on children's disclosure of their diagnosis to friends and others.", "A randomized controlled trial was conducted in Santiago, Chile to test the efficacy of the Children's Epilepsy Program, a child-centered, family-focused intervention developed and pilot tested in Los Angeles, CA, U.S.A., using a counseling model for parents of children with seizure disorders to help them (a) deal with their anger, resentment, and grief related to the loss of a normal child; (b) increase their knowledge about caring for their child; (c) reduce anxieties related to having a child with a seizure disorder; and (d) improve their decision-making skills. All parents were pretested and then retested 5 months after the educational interventions. Parents in the experimental group (n = 185) and their children separately attended four 1 1/2-h sessions and then met together at the end of each session to share learning experiences. Comparison group parents (n = 180) and their children jointly attended three 2-h lecture sessions followed by question-and-answer periods. Although parents' overall knowledge of epilepsy was relatively high initially, it improved considerably in both comparison and experimental groups. With regard to anxiety, at the 5-month evaluation, experimental group parents and mothers in particular were more likely than control parents to state that they were less anxious (p less than 0.001), and their anxiety, as measured by the Taylor Manifest Anxiety scale, was significantly reduced (p less than 0.01)." ]
"While each of the programmes in this review showed some benefit to children with epilepsy their impacts were extremely variable. No programme showed benefits across the full range of outcomes. No study appears to have demonstrated any detrimental effects but the evidence in favour of any single programme is insufficient to make it possible to recommend one programme rather than another. More trials, carried out by independent research teams, are needed."
"CD008234"
[ "15072419", "18607963" ]
[ "Selective vestibular ablation by intratympanic gentamicin in patients with unilateral active Ménière's disease: a prospective, double-blind, placebo-controlled, randomized clinical trial.", "Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial." ]
[ "To establish the efficacy of intratympanic gentamicin treatment in patients with unilateral Ménière's disease.\n This was a prospective, double-blind, randomized clinical trial of intratympanic gentamicin versus intratympanic buffer solution (placebo) in patients with established active Ménière's disease in the affected ear. Outcome measures included the number of vertiginous spells, degree of sensorineural hearing loss, labyrinthine function and labyrinthine asymmetry.\n Topical gentamicin provided a significant reduction in the number of vertiginous spells, although a \"placebo effect\" was also observed. Sensorineural hearing loss did not occur in the gentamicin group, although some deterioration occurred in the placebo group.\n Intratympanic gentamicin is a safe and efficient treatment for the vertiginous spells associated with Ménière's disease. When applied early in the course of the disease, it may prevent some of the sensorineural hearing deterioration associated with it.", "Intratympanic application of gentamicin is a relatively safe and efficient treatment for the reduction of complaints of vertigo attacks associated with Menière's disease. The treatment also reduces the severity of the perceived aural fullness.\n To investigate the effectiveness of intratympanic gentamicin treatment in patients with unilateral Menière's disease.\n In a prospective, double-blind, randomized, placebo-controlled clinical trial subjects scored vertigo complaints, aural fullness and tinnitus, before, during and up to 1 year after treatment. Hearing loss was monitored with pure tone audiometry.\n Gentamicin treatment resulted in a significant reduction of the score for vertigo complaints and the score for perceived aural fullness. A small increase in hearing loss (average 8 dB) was measured in the gentamicin group." ]
"Based on the results of the two included studies, intratympanic gentamicin seems to be an effective treatment for vertigo complaints in Ménière's disease, but carries a risk of hearing loss."
"CD008341"
[ "18383539", "19644849", "19560810", "19066176" ]
[ "Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study.", "Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis.", "Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial.", "Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study." ]
"With an overall high grade of evidence, at the FDA-approved dose, golimumab is significantly more efficacious than placebo in treatment of patients with active RA , when used in combination with methotrexate. The short-term safety profile, based on short-term RCTs, is reasonable with no differences in total adverse events, serious infections, cancer, tuberculosis or deaths. Long-term surveillance studies are needed for safety assessment."
"CD003728"
[ "3679106" ]
[ "Group art therapy as an adjunct to treatment for chronic outpatients." ]
[ "Art therapy has lagged behind other therapeutic modalities in being subjected to rigorous evaluation of its effectiveness. This study examines psychosocial outcome for a group of chronic psychiatric outpatients. Half the patients were randomly assigned to a ten-week supportive art therapy group as an adjunct to treatment; the other patients served as a control group. Patients who remained in the art therapy group for the full ten weeks reported a significant improvement in their attitudes toward themselves as measured by the Progress Evaluation Scales, and their therapists rated them as significantly better able to get along with others. The authors believe the study demonstrates the potential of supportive art therapy to enhance functioning of chronic psychiatric patients in the short run. Empirical attention to long-term gains and to the efficacy of specific forms of art therapy is needed in the future." ]
"Randomised studies are possible in this field. Further evaluation of the use of art therapy for serious mental illnesses is needed as its benefits or harms remain unclear."
"CD003466"
[ "15772025", "6210163", "19106207", "7118759", "19635943", "19758364", "9474293", "15513722", "6181049" ]
[ "The effect of intervention on the free-play experience for mothers and their infants with developmental delay and cerebral palsy.", "Social interaction between parents and babies: validation of an intervention procedure.", "The effect of aided language stimulation on vocabulary acquisition in children with little or no functional speech.", "Programming \"loose training\" as a strategy to facilitate language generalization.", "Effects of it takes two to talk--the hanen program for parents of preschool children with cerebral palsy: findings from an exploratory study.", "Intensive speech and language therapy for older children with cerebral palsy: a systems approach.", "In-service training for schools on augmentative and alternative communication.", "Evaluating parent use of functional communication training to replace and enhance prelinguistic behaviours in six children with developmental and physical disabilities.", "Nonvocal language acquisition in adolescents with severe physical disabilities: Bliss symbol versus iconic stimulus formats." ]
"Firm evidence of the positive effects of SLT for children with cerebral palsy has not been demonstrated by this review. However, positive trends in communication change were shown. No change in practice is recommended from this updated review. Further research is needed to describe this client group, and its possible clinical subgroups, and the methods of treatment currently used in SLT. Research is also needed to investigate the effectiveness of new and established interventions and their acceptability to families. Rigour in research practice needs to be extended to enable firm associations between therapy and the communication change to be made. There are now sufficient data to develop randomised controlled studies of dysarthria interventions and group parent training programmes. Such research is urgently needed to ensure clinically effective provision for this group of children, who are at severe risk of social and educational exclusion."
"CD002173"
[ "4398782", "1615179", "415495", "6810423", "4209680", "5004629", "3929698", "6230059", "4631823", "6791596", "806293", "413493", "3092689", "4101988", "10213547", "6775752", "5536092", "7979527", "5001717" ]
[ "Effect of cromolyn sodium on childhood asthma.", "Inhaled sodium cromoglycate for pre-term children with respiratory symptoms at follow-up.", "The use of nebulised sodium cromoglycate in children.", "Nebulised sodium cromoglycate in the treatment of wheezy bronchitis in infants and young children.", "A \"double-blind\" trial of disodium cromoglycate in Thai asthmatic children.", "Treatment of children in an asthma centre with disodium cromoqlycate. Double-blind crossover trial.", "Nebulised sodium cromoglycate in recurrently wheezy preschool children.", "Nebulised ipratropium bromide and sodium cromoglycate in the first two years of life.", "Effect of cromolyn sodium (disodium cromoglycate) on the peripheral eosinophilia of asthmatic children.", "Nebulised cromoglycate, theophylline, and placebo in preschool asthmatic children.", "Betamethasone 17 valerate aerosol and disodium chromoglycate in severe childhood asthma.", "Nebulized sodium cromoglycate in young asthmatic children. Double-blind trial.", "Nebulised sodium cromoglycate in the treatment of wheezy bronchitis. A multicentre double-blind placebo controlled study.", "Disodium cromoglycate in pollen asthma.", "Randomised placebo-controlled trial of inhaled sodium cromoglycate in 1-4-year-old children with moderate asthma.", "Controlled trial of cromoglycate and slow-release aminophylline in perennial childhood asthma.", "Disodium cromoglycate (intal) in the treatment of bronchial asthma in children.", "Efficacy of cromoglycate in persistently wheezing infants.", "Treatment of bronchial asthma with disodium cromoglycate (Intal) in children." ]
"There is insufficient evidence to be sure about the efficacy of sodium cromoglycate over placebo. Publication bias is likely to have overestimated the beneficial effects of sodium cromoglycate as maintenance therapy in childhood asthma."
"CD002886"
[ "2882288", "2267922", "10503682", "8135557", "3302924", "7359263" ]
[ "Effect of a single oral dose of prednisolone in acute childhood asthma.", "Placebo controlled trial of systemic corticosteroids in acute childhood asthma.", "Nebulized budesonide versus oral steroid in severe exacerbations of childhood asthma.", "Prednisolone and salbutamol in the hospital treatment of acute asthma.", "Intravenous methylprednisolone efficacy in status asthmaticus of childhood.", "Corticosteroids in status asthmaticus." ]
"Systemic corticosteroids produce some improvements for children admitted to hospital with acute asthma. The benefits may include earlier discharge and fewer relapses. Inhaled or nebulised corticosteroids cannot be recommended as equivalent to systemic steroids at this time. Further studies examining differing doses and routes of administration for corticosteroids will clarify the optimal therapy."
"CD006769"
[ "11078836" ]
[ "Amniotic membrane transplantation for repair of leaking glaucoma filtering blebs." ]
[ "To compare the safety and efficacy of human preserved amniotic membrane transplant with conjunctival advancement for repair of late-onset glaucoma filtering bleb leaks.\n A prospective, randomized clinical trial compared amniotic membrane transplant with conjunctival advancement in patients with leaking glaucoma filtering blebs. Intraocular pressure, number of glaucoma medications, and reoperation for glaucoma or persistent or recurrent bleb-leak were compared in the two groups. Patients were followed for a minimum of 1 year.\n Mean intraocular pressure was the same at 6 (amniotic membrane transplant, 15.4 +/- 4.4, conjunctival advancement 14.1 +/- 6.4, P = 0.6), 12 (amniotic membrane transplant, 15.0 +/- 6.3, conjunctival advancement, 13.2 +/- 6.6, P = 0.5), and 24 (amniotic membrane transplant, 17.2 +/- 7.1, conjunctival advancement, 15.0 +/- 6.3, P = 0.6) months. The mean number of glaucoma medications in use was the same in the two groups at all time intervals. After an average follow-up of 19 months, there were seven failures in the amniotic membrane transplant group (two with persistent leaks that were unresponsive to further suturing, two with late-onset leaks, and three who required repeat glaucoma surgery) and none in the conjunctival advancement group. The cumulative survival rate for amniotic membrane transplant was 81% at 6 months, 74% at 1 year, and 46% at 2 years. The cumulative survival rate was 100% for conjunctival advancement throughout follow-up.\n Amniotic membrane transplantation does not offer an effective alternative to conjunctival advancement for repair of leaking glaucoma filtering blebs." ]
"Although a variety of treatments have been proposed for bleb leaks, there is no evidence of their comparative effectiveness. The evidence in this review was provided by a single trial that compared two surgical procedures (conjunctival advancement and amniotic membrane transplant). The trial did show a superiority of conjunctival advancement, which was regarded as standard treatment, to amniotic membrane transplantation. There is a need for more randomised trials to validate the findings of this single trial and provide more information on the different types of interventions, especially non-surgical treatments compared to surgical procedures. We recommend that any intervention should be compared to a standard procedure, which is to date conjunctival advancement."
"CD005573"
[ "10466665", "15507864", "15647189", "15569116" ]
[ "Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial.", "Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.", "Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial.", "Randomized placebo-controlled trial assessing the effect of bifidobacteria-fermented milk on active ulcerative colitis." ]
[ "Ulcerative colitis has been suggested to be caused by infection and there is circumstantial evidence linking Escherichia coli with the condition. Our aim was to find out whether the administration of a non-pathogenic strain of E. coli (Nissle 1917) was as effective as mesalazine in preventing relapse of ulcerative colitis. We also examined whether the addition of E. coli to standard medical therapy increased the chance of remission of active ulcerative colitis.\n This was a single-centre, randomised, double-dummy study in which 120 patients with active ulcerative colitis were invited to take part. 116 patients accepted; 59 were randomised to mesalazine and 57 to E. coli. All patients also received standard medical therapy together with a 1-week course of oral gentamicin. After remission, patients were maintained on either mesalazine or E. coli and followed up for a maximum of 12 months. A two-stage, conditional, intention-to-treat analysis was done.\n 44 (75%) patients in the mesalazine group attained remission compared with 39 (68%) in the E. coli group. Mean time to remission was 44 days (median 42) in the mesalazine group and 42 days (median 37) for those treated with E. coli. In the mesalazine group, 32 (73%) patients relapsed compared with 26 (67%) in the E. coli group. Mean duration of remission was 206 days in the mesalazine group (median 175) and 221 days (median 185) in the E. coli group.\n Our results suggest that treatment with a non-pathogenic E. coli has an equivalent effect to mesalazine in maintaining remission of ulcerative colitis. The beneficial effect of live E. coli may provide clues to the cause of ulcerative colitis.", "Balsalazide is well tolerated and effective in treating acute ulcerative colitis. VSL#3 is a probiotic cocktail proven to be effective in preventing flare-ups of chronic pouchitis. We compared the efficacy and safety of low-dose balsalazide (2.25 g/day) plus 3 g/day VLS#3 (group A) with medium-dose balsalazide alone (group B) and with mesalazine (group C) in the treatment of mild-to-moderate active ulcerative colitis.\n Ninety patients (30 per group) were randomly enrolled, with a treatment duration of 8 weeks. Efficacy was assessed by symptoms assessment, endoscopic appearance, and histological evaluation.\n Balsalazide/VSL#3 was significantly superior to balsalazide alone and to mesalazine in obtaining remission: 24 patients of group A were in remission [per-protocol: 85.71% (C.I.95%: 62-96), on intention-to-treat: 80% (C.I.95%: 59-91)], while 21 group B [per-protocol: 80.77% (C.I. 95%: 51-82), on intention-to-treat: 77% (C.I.95%: 43-81)] and 16 group C patients [per-protocol: 72.73% (C.I. 95%: 30-75), on intention-to-treat: 53.33% (C.I.95%: 42-62)] were in remission (p<0.02). Balsalazide with or without VSL#3 was better tolerated than mesalazine: two group C patients were withdrawn from the study because of severe side-effects; 1 group A (3.33%), 3 group B (10%) and 4 group C (13.33%) patients experienced slight side-effects. The balsalazide/VSL#3 combination was faster in obtaining remission than balsalazide alone or mesalazine (4, 7.5, and 13 days in groups A, B and C, respectively) and also better in improving all parameters evaluated.\n Balsalazide/VSL#3 may be a very good choice in the treatment of active mild-to-moderate active ulcerative colitis instead of balsalazide alone or mesalazine.", "Ulcerative colitis (UC) is an acute and chronic inflammatory disease of the large bowel with unknown aetiology. The immune response against normal commensal microorganisms is believed to drive inflammatory processes associated with UC. Therefore, modulation of bacterial communities on the gut mucosa, through the use of probiotics and prebiotics, may be used to modify the disease state.\n A synbiotic was developed for use in UC patients combining a probiotic, Bifidobacterium longum, isolated from healthy rectal epithelium, and a prebiotic (Synergy 1), a preferential inulin-oligofructose growth substrate for the probiotic strain. Treatment was employed in a double blinded randomised controlled trial using 18 patients with active UC for a period of one month. Clinical status was scored and rectal biopsies were collected before and after treatment, and transcription levels of epithelium related immune markers were measured.\n Sigmoidoscopy scores (scale 0-6) were reduced in the test group (start 4.5 (1.4), end 3.1 (2.5)) compared with placebo (start 2.6 (2.1), end 3.2 (2.2)) (p=0.06). mRNA levels for human beta defensins 2, 3, and 4, which are strongly upregulated in active UC, were significantly reduced in the test group after treatment (p=0.016, 0.038, and 0.008, respectively). Tumour necrosis factor alpha and interleukin 1alpha, which are inflammatory cytokines that drive inflammation and induce defensin expression, were also significantly reduced after treatment (p=0.018 and 0.023, respectively). Biopsies in the test group had reduced inflammation and regeneration of epithelial tissue.\n Short term synbiotic treatment of active UC resulted in improvement of the full clinical appearance of chronic inflammation in patients receiving this therapy.", "Probiotics are efficacious for treating and maintaining remission of ulcerative colitis.\n To conduct a randomized placebo-controlled trial of bifidobacteria-fermented milk supplementation as a dietary adjunct in treating active ulcerative colitis.\n Twenty patients with mild to moderate, active, ulcerative colitis randomly received 100 mL/day of bifidobacteria-fermented milk or placebo for 12 weeks with conventional treatment.\n Clinical and endoscopic activity indices and histological scores were similar in the two groups before treatment. Although improvements were significant in both groups, the clinical activity index was significantly lower in the bifidobacteria-fermented milk than in the placebo group after treatment. The post-treatment endoscopic activity index and histological score were significantly reduced in the bifidobacteria-fermented milk, but not the placebo group. Increases in faecal butyrate, propionate and short-chain fatty acid concentrations were significant in the bifidobacteria-fermented milk, but not the placebo group. No adverse effects were observed in either group.\n Supplementation with this bifidobacteria-fermented milk product is safe and more effective than conventional treatment alone, suggesting possible beneficial effects in managing active ulcerative colitis. This is a pilot study and further larger studies are required to confirm the result these preliminary results." ]
"Conventional therapy combined with a probiotic does not improve overall remission rates in patients with mild to moderate ulcerative colitis. However, there is limited evidence that probiotics added to standard therapy may provide modest benefits in terms of reduction of disease activity in patients with mild to moderately severe ulcerative colitis. Whether probiotics are as effective in patients with severe and more extensive disease and whether they can be used as an alternative to existing therapies is unknown. Further well designed, larger randomised controlled trials are needed to determine whether probiotics can be used as an alternative to current treatment modalities."
"CD005976"
[ "12243918", "15070633" ]
[ "Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial.", "Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial." ]
[ "For most infections, especially acute respiratory infections (ARIs), the recommended duration of therapy is not based on strong scientific or clinical criteria. Shorter courses of antibiotics for non-severe pneumonia would result in lower costs, enhance patient compliance, and might help to contain antimicrobial resistance. We aimed to compare the clinical efficacy of 3-day and 5-day courses of amoxicillin in children with non-severe pneumonia.\n We recruited 2000 children, aged 2-59 months, with non-severe pneumonia (WHO criteria) diagnosed in the outpatient departments of seven hospitals. Patients were randomly assigned to 3 days or 5 days of treatment with oral amoxicillin. The primary outcome was treatment failure. Analyses were by intention to treat.\n We allocated 1000 children to 3 days of treatment and 1000 to 5 days. Treatment failed in 209 (21%) patients in the 3-day group, and in 202 (20%) in the 5-day group (difference 0.7%; 95% CI -1.8 to 3.2). In 12 (1%) children in the 3-day group and in 13 (1%) in the 5-day group the disease relapsed (difference 0.1%; -0.6 to 0.8). Treatment was more likely to fail in children who did not adhere to treatment (p<0.0001), in those younger than 12 months (p<0.0001), in those whose illness lasted for 3 days or longer (p=0.004), in those whose respiratory rate was more than 10 breaths/min above the age-specific cut-off (p=0.004), and in those with vomiting (p=0.009). Non-adherence was also associated with failure of treatment in the 5-day group (p<0.0001).\n Treatment with oral amoxicillin for 3-days was equally as effective as treatment for 5 days in children with non-severe pneumonia. The most important risk factor for treatment failure was non-compliance, which was also associated with longer duration of therapy.", "To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children.\n Randomised, double blind, placebo controlled multicentre trial.\n Outpatient departments of seven referral hospitals in India.\n 2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days.\n Oral amoxicillin 31-54 mg/kg/day in three divided doses.\n Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3.\n The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)).\n Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia." ]
"The evidence of this review suggests that a short course (three days) of antibiotic therapy is as effective as a longer treatment (five days) for non-severe CAP in children under five years of age. However, there is a need for more well-designed RCTs to support our review findings."
"CD001289"
[ "8756815", "9596315", "1745841" ]
[ "Short-term recombinant human DNase in bronchiectasis. Effect on clinical state and in vitro sputum transportability.", "Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase I. rhDNase Study Group.", "Role of bromhexine in exacerbations of bronchiectasis. Double-blind randomized multicenter study versus placebo." ]
[ "We report a double blind placebo-controlled phase II study of the efficacy and safety of nebulized recombinant human DNase (rhDNase) administered for 14 d to adults with bronchiectasis not caused by cystic fibrosis. All were in a stable clinical state at the commencement of the study, and they received (1) rhDNase 2.5 mg twice daily, (2) rhDNase once daily, or (3) placebo (excipient only) inhalation. The outcome measures were spirometry, subjective quality of life/dyspnea, and safety. We also measured the ciliary transportability of the sputum expectorated before and after the treatment period, using the mucus-depleted bovine trachea. The drug was well tolerated, but it produced no significant change in any of the outcome variables or in sputum transportability. When the drug was incubated with bronchiectatic sputum in vitro, a fall in transportability was observed. We discuss possible explanations for the lack of a measurable benefit from rhDNase in this study population, which appears to contrast with the improvements shown in cystic fibrosis using studies of similar design.", "To study the safety and efficacy of aerosolized recombinant human DNase I in the treatment of idiopathic bronchiectasis.\n Double-blind, randomized, placebo-controlled, multicenter study.\n Three hundred forty-nine adult outpatients in stable condition with idiopathic bronchiectasis from 23 centers in North America, Great Britain, and Ireland.\n Study patients received aerosolized rhDNase or placebo twice daily for 24 weeks. Primary end points were incidence of pulmonary exacerbations and mean percent change in FEV1 from baseline over the treatment period.\n Pulmonary exacerbations were more frequent and FEV1 decline was greater in patients who received rhDNase compared with placebo during this 24-week trial.\n rhDNase was ineffective and potentially harmful in this group of adult outpatients in stable condition with idiopathic bronchiectasis. This contrasts with previously published results that demonstrated efficacy of rhDNase in patients with cystic fibrosis bronchiectasis.", "The effectiveness of bromhexine in the treatment of patients with bronchiectasis, in a stage of clinical exacerbation, was assessed in a double-blind, placebo-controlled trial involving 88 in-patients. Bronchiectasis was diagnosed by bronchography and/or CT scan. Bromhexine or matched placebo was administered as 30-mg capsules three times daily per os. Ceftazidine, 1 g i.m., was given to all patients once a day for the first week only. Bromhexine seemed to improve the clinical picture, with significantly positive trends for expectoration, quantity of sputum and auscultatory findings. It also increased the FEV1 and was well-tolerated. Both patients and investigators judged it efficacious." ]
"There is not enough evidence to evaluate the routine use of mucolytics for bronchiectasis. High doses of bromhexine coupled with antibiotics may help with sputum production and clearance."
"CD006189"
[ "15727375", "3730737", "13160496", "7236953", "15479896" ]
[ "Frozen shoulder syndrome: comparison of oral route corticosteroid and intra-articular corticosteroid injection.", "A controlled study of oral prednisolone in frozen shoulder.", "Oral cortisone therapy in periarthritis of the shoulder; a controlled trial.", "The upper limb: the frozen shoulder.", "Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial." ]
[ "Twenty-six patients with frozen shoulder syndrome (Stage 2 and 3) were included in this study conducted at Dr. Kariadi General Hospital, Semarang, Indonesia and randomly allocated into 2 groups: 40 mg triamcinolone intra-articular injection and triamcinolone oral tablets. The result showed that triamcinolone intra-articular injection group \"cured\" rate was 5.8 times higher at week one compared to the triamcinolone tablet group. Sixty-two percent of the cases with triamcinolone intra-articular injection achieved their \"cured\" condition after one week of therapy, compared with only 14% of the triamcinolone tablets group. We conclude that, intra-articular corticosteroid injection provide faster improvement compared to oral route.", "Forty patients with frozen shoulder were randomly allocated to a treated group who received oral prednisolone or a nontreatment group who received no specific therapy. All the patients were encouraged to perform home pendular exercise. The improvement in pain at night showed a significantly different pattern in the two groups (p less than 0.05), with the treated group improving more rapidly. Pain on movement and at rest and the recovery in the range of movement was not significantly different in the two groups. There was no difference between the patient groups at the end of the study (8 months follow-up) and patients still had a marked restriction in range (p less than 0.0001) when compared to normal controls of similar age and sex.", "nan", "nan", "To determine whether a short course of prednisolone is superior to placebo for improving pain, function, and range of motion in adhesive capsulitis.\n Double blind, randomised, placebo controlled trial.\n Community based rheumatology practice in Australia.\n 50 participants (24 active, 26 placebo); 46 completed the 12 week protocol. Entry criteria were age > or =18 years, pain and stiffness in predominantly one shoulder for > or =3 weeks, and restriction of passive motion by >30 degrees in two or more planes.Interventions: 30 mg oral prednisolone/day for three weeks or placebo.\n Overall, night, and activity related pain, SPADI, Croft shoulder disability questionnaire, DASH, HAQ, SF-36, participant rated improvement, and range of active motion measured at baseline and at 3, 6, and 12 weeks.\n At 3 weeks, there was greater improvement in overall pain in the prednisolone group than in the placebo group (mean (SD) change from baseline, 4.1 (2.3) v 1.4 (2.3); adjusted difference in mean change between the two groups, 2.4 (95% CI, 1.1 to 3.8)). There was also greater improvement in disability, range of active motion, and participant rated improvement (marked or moderate overall improvement in 22/23 v 11/23; RR = 2 (1.3 to 3.1), p = 0.001). At 6 weeks the analysis favoured the prednisolone group for most outcomes but none of the differences was significant. At 12 weeks, the analysis tended to favour the placebo group.\n A three week course of 30 mg prednisolone daily is of significant short term benefit in adhesive capsulitis but benefits are not maintained beyond six weeks." ]
"Available data from two placebo-controlled trials and one no-treatment controlled trial provides "Silver" level evidence (www.cochranemsk.org) that oral steroids provides significant short-term benefits in pain, range of movement of the shoulder and function in adhesive capsulitis but the effect may not be maintained beyond six weeks."
"CD009043"
[ "19797985", "19948625" ]
[ "A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder.", "Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder." ]
"Evidence from two randomized controlled trials suggests that aripiprazole can be effective in treating some behavioral aspects of ASD in children. After treatment with aripiprazole, children showed less irritability, hyperactivity, and stereotypies (repetitive, purposeless actions). Notable side effects must be considered, however, such as weight gain, sedation, drooling, and tremor. Longer studies of aripiprazole in individuals with ASD would be useful to gain information on long-term safety and efficacy."
"CD003582"
[ "10629368" ]
[ "Clinical trial of induction of labor versus expectant management in twin pregnancy." ]
[ "The appropriate date of delivery in twin pregnancies is supposed to be earlier than that in singleton pregnancy. The aim of this study was to compare two strategies for managing twin pregnancies (i.e., immediate induction and expectant management).\n Seventeen patients underwent immediately induced labor by administration of oral prostaglandin E(2) at 37 weeks, while 19 patients underwent expectant management.\n The average gestational age at delivery in the induction group was 37.5 +/- 0.4 weeks, significantly earlier than that in the expectant management group (39.0 +/- 1.1 weeks). However, there were no significant differences in the average birth weight between the two groups (2, 700 +/- 330 g in the induction group vs. 2,672 +/- 392 g in the expectant management group). The cesarean delivery rate in the induction group was 18%, not significantly different from that in the expectant management group (32%). The most common indication for cesarean section in the expectant management group was maternal infection, while there was no maternal infection in the induction group (p = 0.08).\n It may be acceptable do intervene in twin pregnancies earlier than in singleton pregnancies during term.\n Copyright 2000 S. Karger AG, Basel" ]
"The small trial identified was underpowered to detect the outcome measures of interest. Consequently, there are insufficient data available to support a practice of elective delivery from 37 weeks' gestation for women with an otherwise uncomplicated twin pregnancy at term."
"CD004765"
[ "2460414" ]
[ "Dye laser photocoagulation of macular subretinal neovascularization in pathological myopia. A randomized study of three different wavelengths." ]
[ "The authors present a randomized study of 27 eyes affected by pathological myopia with macular subretinal neovascularization which were treated with a tunable dye laser. The effectiveness of three different wavelengths (577, 590 and 620 nm) in the direct treatment of subretinal neovascularizations was evaluated in 3 groups of 9 patients each. Statistical analysis of both visual and anatomical results did not show significant differences among the three wavelengths used." ]
"Despite its use over several years the effectiveness of laser photocoagulation for myopic CNV has not been established. Although there was a suggestion of short-term effectiveness in one small study on non-subfoveal CNV the results were potentially biased. Observational studies suggest that the enlargement of the atrophic laser scar after laser treatment of non-subfoveal CNV could be a potentially vision-threatening long-term complication, even in eyes free of CNV recurrence."
"CD003685"
[ "10566565", "11087881" ]
[ "The safety profile, tolerability, and effective dose range of rofecoxib in the treatment of rheumatoid arthritis. Phase II Rofecoxib Rheumatoid Arthritis Study Group.", "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group." ]
[ "Nonsteroidal anti-inflammatory drugs. (NSAIDs) inhibit both cyclooxygenase (COX)-1 and COX-2 isoenzymes and are effective in the treatment of inflammatory disorders. This 8-week, double-masked, placebo-controlled trial was undertaken to assess the safety profile, tolerability, and effective dose range of once-daily rofecoxib, a COX-2-specific inhibitor, in the treatment of rheumatoid arthritis (RA). After a 3- to 15-day washout of prior NSAID therapy, 658 patients were randomly allocated to receive placebo or rofecoxib 5 mg, 25 mg, or 50 mg once daily. Safety profile, tolerability, and efficacy were evaluated after 2, 4, and 8 weeks of therapy. Six hundred fifty-eight patients (168, 158, 171, and 161 in the placebo and 5-mg, 25-mg, and 50-mg rofecoxib groups, respectively) were enrolled at 79 clinical centers in the United States. Mean age was 55 years, mean duration of RA was 10 years, and 506 (77%) of the 658 patients were female. All groups had similar baseline demographic characteristics. Patients taking rofecoxib 25 and 50 mg showed significant clinical improvement compared with those taking placebo; 43.9% in the rofecoxib 25-mg group and 49.7% in the rofecoxib 50-mg group completed the treatment period and achieved an American College of Rheumatology 20 response (P = 0.025 and 0.001 vs. placebo, respectively). The 5-mg dose of rofecoxib did not differ significantly from placebo. Patients in the rofecoxib 25- and 50-mg groups showed significant improvement in key individual efficacy measurements, including patient global assessment of pain, patient and investigator global assessment of disease activity, and Stanford Health Assessment Questionnaire Disability Index (P<0.05 vs placebo). Compared with placebo, significantly fewer patients in the 25-mg and 50-mg rofecoxib groups discontinued therapy because of lack of efficacy (P = 0.02 and P = 0.032, respectively). Our results show that rofecoxib 25 and 50 mg once daily was effective and generally well-tolerated in patients with RA.", "Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis.\n We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).\n Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P<0.001). The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.005). The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.\n In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor." ]
"In patients with RA, rofecoxib demonstrates a greater degree of efficacy than placebo, while having a comparable safety profile. Rofecoxib demonstrates a similar degree of efficacy as naproxen, but with a significantly lower rate of ulceration and gastrointestinal bleeding. Rofecoxib was associated with a greater risk for MI, but the exact significance and pathophysiology of this possible relationship is unclear. Rofecoxib was voluntarily withdrawn from global markets in October 2004. It cannot therefore be prescribed and therefore there are no implications for practice concerning its use. None the less when considering which NSAID to use, it must be borne in mind that the toxicity of NSAIDs is variable amongst patients and drugs and it tends to be dose related and associated with variation in the mode of action, absorption, distribution and metabolism.There remains a number of questions over both the benefits and risks associated with Cox II selective agents and further work is ongoing. It is likely that this issue will not be resolved until research has enabled a fuller understanding of the complex mechanism by which the Cox system operates."
"CD003438"
[ "3769894", "18074710", "18853562", "5262986", "5810168", "15530927", "8799442", "16435703" ]
[ "Can the conspicuity of objects be predicted from laboratory experiments?", "Effects of age and illumination on night driving: a road test.", "Highlighting human form and motion information enhances the conspicuity of pedestrians at night.", "Actual pedestrian visibility and the pedestrian's estimate of his own visibility.", "Safety clothing for human traffic obstacles.", "High visibility safety apparel and nighttime conspicuity of pedestrians in work zones.", "Effects of retroreflector positioning on nighttime recognition of pedestrians.", "Limitations in drivers' ability to recognize pedestrians at night." ]
"Visibility aids have the potential to increase visibility and enable drivers to detect pedestrians and cyclists earlier. Biomotion markings, which highlight the movement and form of the pedestrian, showed evidence of improving pedestrians' conspicuity at night. Public acceptability of various effective strategies which improve visibility would merit further development. However, the effect of visibility aids on pedestrian and cyclist safety remains unknown. A cluster randomised controlled trial involving large communities may provide an answer to this question. It would, however, be a challenging trial to conduct. Studies that collect data of road traffic injuries relating to the use of visibility aids also warrant consideration."
"CD007825"
[ "22054336", "21487425", "18519821", "11994884", "17116916", "16918861", "16267182", "18606949", "15823886", "21680632", "16253541" ]
[ "Enhancing ventilation in homes of children with asthma: pragmatic randomised controlled trial.", "Effectiveness of a multi-disciplinary family-based programme for treating childhood obesity (the Family Project).", "Prevention of negative symptom psychopathologies in first-episode schizophrenia: two-year effects of reducing the duration of untreated psychosis.", "Care management, dementia care and specialist mental health services: an evaluation.", "The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial.", "Using school staff to establish a preventive network of care to improve elementary school students' control of asthma.", "A whole system study of intermediate care services for older people.", "Five-year follow-up of a randomized multicenter trial of intensive early intervention vs standard treatment for patients with a first episode of psychotic illness: the OPUS trial.", "Interdisciplinary collaboration between primary care, social insurance and social services in the rehabilitation of people with musculoskeletal disorder: effects on self-rated health and physical performance.", "Effectiveness of anonymised information sharing and use in health service, police, and local government partnership for preventing violence related injury: experimental study and time series analysis.", "Impact evaluation of a Dutch community intervention to improve health-related behaviour in deprived neighbourhoods." ]
"Collaboration between local health and local government is commonly considered best practice. However, the review did not identify any reliable evidence that interagency collaboration, compared to standard services, necessarily leads to health improvement. A few studies identified component benefits but these were not reflected in overall outcome scores and could have resulted from the use of significant additional resources. Although agencies appear enthusiastic about collaboration, difficulties in the primary studies and incomplete implementation of initiatives have prevented the development of a strong evidence base. If these weaknesses are addressed in future studies (for example by providing greater detail on the implementation of programmes; using more robust designs, integrated process evaluations to show how well the partners of the collaboration worked together, and measurement of health outcomes) it could provide a better understanding of what might work and why. It is possible that local collaborative partnerships delivering environmental Interventions may result in health gain but the evidence base for this is very limited. Evaluations of interagency collaborative arrangements face many challenges. The results demonstrate that collaborative community partnerships can be established to deliver interventions but it is important to agree goals, methods of working, monitoring and evaluation before implementation to protect programme fidelity and increase the potential for effectiveness."
"CD005940"
[ "3425252" ]
[ "Prediction of preterm birth." ]
[ "The aim of this study was to assess the value of screening of cervical status in normal as well as in pregnancies with risk factors. 1327 pregnancies were studied prospectively; 16% had a medical history of earlier obstetrical or gynecological complications (group I) and 6% had complications during the first 24 weeks of the current pregnancy (group II). The remainder were considered low-risk pregnancies and randomly divided into groups III and IV. In groups I, II and III cervical scoring in accordance with Westin was performed in weeks 24, 28 and 32. The incidence of births before 37 weeks of gestation was 5.6% in group I, 8.8% in group II, 1.5% in group III and 0.7% in group IV. In presence of the risk factors, 61% of the spontaneous preterm deliveries were predicted early in pregnancy. The predictive value of a normal cervical score was high (about 95%) in all groups. In uncomplicated pregnancies the predictive value of a pathological score was only 4% and for cervical dilatation, 6%. In the risk groups the predictive value of a pathological cervix was 3-5-fold higher. Cervical examination in low-risk pregnancies does not improve prediction of preterms but is a complement in a system for indication for preterm delivery in women with defined risk factors." ]
"We found no evidence to support the use of RDCA in pregnancy to reduce the prevalence of preterm birth. We have found insufficient evidence to assess adverse effects of the intervention."
"CD006273"
[ "12411847", "7893564", "15800328", "15684225" ]
[ "Hypodermoclysis for control of dehydration in terminal-stage cancer.", "The effect of intravenous fluid infusion on blood and urine parameters of hydration and on state of consciousness in terminal cancer patients.", "Effects of parenteral hydration in terminally ill cancer patients: a preliminary study.", "Association between hydration volume and symptoms in terminally ill cancer patients with abdominal malignancies." ]
[ "Many of those involved in palliative care have justifiable objections to the introduction of intravenous hydration in patients with dehydration-associated symptoms and advanced cancer. Researchers from the University of Buenos Aires carried out a randomized, comparative and prospective trail to determine the usefulness of hypodermoclysis in the control of thirst, chronic nausea and delirium. Forty-two patients were randomized into two groups. Both groups received drugs subcutaneously (haloperidol 2.5 mg every 4 hours to control delirium and/or metoclopramide 10 mg every 4 hours to control chronic nausea). The study group also received 1000 ml 5% dextrose in water infusion plus 140 milliequivalent per litre (mEq/L) sodium chloride, at a rate of 42 ml/hour per day. Both groups showed significant and equal improvements in relief of thirst and chronic nausea at 24 hours. After 48 hours, this improvement was maintained in the group that received hydration, but only for the relief of chronic nausea. Delirium did not improve significantly in either group during the 48-hour trial period. Current data suggest that decisions on rehydration of patients with terminal-phase cancer should be based more on the patient's comfort than on providing optimal hydration.", "This prospective study was undertaken to assess the state of hydration in terminal cancer patients with and without intravenous fluids during the last 48 hours of their lives and to correlate various measures of hydration with their state of consciousness. We examined indicators of hydration in the plasma and urine of 68 consecutive patients for whom data were available at 48 hours or less before death. Thirteen of the patients were being treated with intravenous (IV) fluids. Nearly all of the patients studied were found to be dehydrated, as determined by laboratory measurements. State of consciousness correlated inversely with serum sodium (p < 0.001) and urine osmolality (p < 0.02). Patients receiving intravenous fluids were not better hydrated than those without IV therapy, nor was their state of consciousness improved. In light of these findings, which suggest there is no clinical benefit from intravenous infusions, decisions regarding intravenous fluid therapy during the last hours of life should be guided by the preferences of the dying patient and his family.", "Most patients with cancer develop decreased oral intake and dehydration before death. This study aimed to determine the effect of parenteral hydration on overall symptom control in terminally ill cancer patients with dehydration.\n Patients with clinical evidence of mild to moderate dehydration and a liquid oral intake less than 1,000 mL/day were randomly assigned to receive either parenteral hydration with 1,000 mL (treatment group) or placebo with 100 mL normal saline administered over 4 hours for 2 days. Patients were evaluated for target symptoms (hallucinations, myoclonus, fatigue, and sedation), global well-being, and overall benefit.\n Twenty-seven patients randomly assigned to the treatment group had improvement in 53 (73%) of their 73 target symptoms versus 33 (49%) of 67 target symptoms in the placebo group (n=22; P = .005). Fifteen (83%) of 18 and 15 (83%) of 18 patients had improved myoclonus and sedation after hydration versus eight (47%) of 17 and five (33%) of 15 patients after placebo (P = .035 and P = .005, respectively). There were no significant differences of improvement in hallucinations or fatigue between groups. When blinded to treatment, patients (17 [63%] of 77) and investigators (20 [74%] of 27) perceived hydration as effective compared with placebo in nine (41%) of 22 patients (P = .78) and 12 (54%) of 22 investigators (P = .15), respectively. The intensity of pain and swelling at the injection site were not significantly different between groups.\n Parenteral hydration decreased symptoms of dehydration in terminally ill cancer patients who had decreased fluid intake. Hydration was well tolerated, and a placebo effect was observed. Studies with larger samples and a longer follow-up period are justified.", "To explore the association between hydration volume and symptoms during the last 3 weeks of life in terminally ill cancer patients.\n This was a multicenter, prospective, observational study of 226 consecutive terminally ill patients with abdominal malignancies. Primary responsible physicians and nurses evaluated the severity of membranous dehydration (dehydration score calculated from three physical findings), peripheral edema (edema score calculated from seven physical findings), ascites and pleural effusion (rated as physically undetectable to symptomatic), bronchial secretion, hyperactive delirium (Memorial Delirium Assessment Scale), communication capacity (Communication Capacity Scale), agitation (Agitation Distress Scale), myoclonus and bedsores.\n Patients were classified into two groups: the hydration group (n=59) who received 1 l or more of artificial hydration per day, 1 and 3 weeks before death, and the non-hydration group (n=167). The percentage of patients with deterioration in dehydration score in the final 3 weeks was significantly higher in the non-hydration group than the hydration group (35% versus 14%; P=0.002), while the percentages of patients whose symptom scores for edema, ascites and pleural effusion increased were significantly higher in the hydration group than the non-hydration group (44% versus 29%, P=0.039; 29% versus 8.4%, P <0.001; 15% versus 5.4%, P=0.016; respectively). After controlling for multiple covariates and treatment settings, the association between hydration group and dehydration/ascites score was statistically significant. Subgroup analysis of patients with peritoneal metastases identified statistically significant interaction between hydration group and dehydration/pleural effusion score. There were no significant differences in the degree of bronchial secretion, hyperactive delirium, communication capacity, agitation, myoclonus or bedsores.\n Artificial hydration therapy could alleviate membranous dehydration signs, but could worsen peripheral edema, ascites and pleural effusions. It is suggested that the potential benefits of artificial hydration therapy should be balanced with the risk of worsening fluid retention symptoms. Further clinical studies are strongly needed to identify the effects of artificial hydration therapy on overall patient well-being, and an individualized treatment and close monitoring of dehydration and fluid retention symptoms is strongly recommended." ]
"Since the last version of this review no new studies were found. However there is one ongoing, high quality study that has not reached full recruitment. There are insufficient good quality studies to make any recommendations for practice with regard to the use of medically assisted hydration in palliative care patients."
"CD006815"
[ "4605357", "12444816", "9809861" ]
[ "The use of hydroxyzine (Vistaril) in the treatment of anxiety neurosis.", "Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study.", "A multicentre double-blind comparison of hydroxyzine, buspirone and placebo in patients with generalized anxiety disorder." ]
[ "nan", "The prevalence of generalized anxiety disorder (GAD) represents an important public health issue. Hydroxyzine, an antagonist of histamine receptors, showed both efficacy and safety in previous short-term double-blind studies over placebo in this pathology. The aim of the current study was to confirm those positive results over a 3-month period in adult outpatients.\n This multicenter, parallel (hydroxyzine [50 mg/day]; bromazepam [6 mg/day]), randomized, double-blind, placebo-controlled trial included 2 weeks of single-blind run-in placebo, 12 weeks of double-blind randomized treatment, and 4 weeks of single-blind run-out placebo. Three hundred thirty-four of 369 selected outpatients with a diagnosis of GAD according to DSM-IV criteria and a Hamilton Rating Scale for Anxiety (HAM-A) total score >/= 20 were randomized before entering the double-blind period. The primary outcome criterion was the change in the HAM-A score from baseline to 12 weeks of double-blind treatment with hydroxyzine compared with placebo.\n In the intent-to-treat analysis, the mean +/- SD change in HAM-A scores from baseline to endpoint was -12.16 +/- 7.74 for hydroxyzine and -9.64 +/- 7.74 for placebo (p =.019). Results at endpoint for percentage of responders (p =.003) and remission rates (p =.028), Clinical Global Impressions-Severity scale score (p =.001), maintenance of efficacy (p =.022), and Hospital Anxiety and Depression scale score on day 84 (p =.008) also confirmed the efficacy of hydroxyzine over placebo. The study showed no statistically significant difference between hydroxyzine and bromazepam. Except for drowsiness, which was more frequent with bromazepam, safety results were comparable in the 3 groups.\n Hydroxyzine showed both efficacy and safety in the treatment of GAD and appears to be an effective alternative treatment to benzodiazepine prescription.", "The efficacy of hydroxyzine and buspirone, controlled by placebo, was investigated in a double-blind, parallel group, multicentre study conducted in France and the UK. A total of 244 patients with generalised anxiety disorder in primary care was allocated randomly to treatments with hydroxyzine (12.5 mg morning and mid-day, 25 mg evening), buspirone (5 mg morning and mid-day, 10 mg evening) or placebo (three capsules/day) for 4 weeks, preceded by a 1-week single-blind placebo run-in and followed by 1-week single-blind placebo administration. Rating scales were applied on days -7,0,7,14, 12,28 and 35. Seventy percent of the patients were female, the average age was 41 +/- 11 years, and the mean Hamilton Anxiety Score at day 0 was 26.5 +/- 4.2. Only 31 of the 244 patients dropped out, but equally in the three groups. Intention-to-treat LOCF analyses on the primary variable showed a significant difference only between hydroxyzine and placebo with respect to improvement on the Hamilton Anxiety Scale (10.75 versus 7.23 points, respectively). Secondary variables such as CGI and self-ratings (HAD scale) showed both hydroxyzine and buspirone to be more efficacious than placebo. Thus, hydroxyzine is a useful treatment for GAD." ]
"The included studies did not report on all the outcomes that were pre-specified in the protocol for this review. Even though more effective than placebo, due to the high risk of bias of the included studies, the small number of studies and the overall small sample size, it is not possible to recommend hydroxyzine as a reliable first-line treatment in GAD."
"CD002997"
[ "15176685", "8473676", "11520711", "12065339", "10875487", "8430965", "10383596" ]
[ "Clarithromycin reduces the severity of bronchial hyperresponsiveness in patients with asthma.", "Efficacy and safety of low-dose troleandomycin therapy in children with severe, steroid-requiring asthma.", "Trial of roxithromycin in subjects with asthma and serological evidence of infection with Chlamydia pneumoniae.", "Mycoplasma pneumoniae and Chlamydia pneumoniae in asthma: effect of clarithromycin.", "Clarithromycin suppresses bronchial hyperresponsiveness associated with eosinophilic inflammation in patients with asthma.", "A double-blind study of troleandomycin and methylprednisolone in asthmatic subjects who require daily corticosteroids.", "Anti-inflammatory effect of roxithromycin in patients with aspirin-intolerant asthma." ]
"Considering the small number of patients studied, there is insufficient evidence to support or to refute the use of macrolides in patients with chronic asthma. Further studies are needed in particular to clarify the potential role of macrolides in some subgroups of asthmatics such as those with evidence of chronic bacterial infection."
"CD006358"
[ "12795394", "11758877", "9091670" ]
[ "The effects of a time-limited welfare program on children: the moderating role of parents' risk of welfare dependency.", "Preschool and school age children under welfare reform.", "The effect of monetary incentives and peer support groups on repeat adolescent pregnancies. A randomized trial of the Dollar-a-Day Program." ]
"The review set out to examine the potential of financial support to poor families to improve circumstances for children. However, on the basis of current evidence we cannot state unequivocally whether financial benefits delivered as an intervention are effective at improving child health or well-being in the short term. Our conclusions are limited by the fact that most of the studies had small effects on total household income and that, while no conditions were attached to how money was spent, all studies included strict conditions for receipt of payments. We note particular concerns by some authors that sanctions and conditions (such as working hours) placed on families may increase family stress."
"CD003309"
[ "12559133" ]
[ "The effects of the shallow and the deep endotracheal suctioning on oxygen saturation and heart rate in high-risk infants." ]
[ "An experimental study involving repeated-measures within subjects was conducted to examine the effects of shallow and deep endotracheal suctioning (ETS) on the SpO(2) and HR in 27 ventilated high-risks infants. The order in which subjects received the ETS protocol was randomly assigned. The results showed no significant changes in both the SpO(2) and HR responses before, during and after ETS between the two ETS protocols. It is concluded that when there is no beneficial effect of performing deep ETS, it should not be carried out due to the potential hazard of direct irritation with more negative pressure on the airways in high-risk infants." ]
"There is no evidence from randomised controlled trials concerning the benefits or risks of deep versus shallow suctioning of endotracheal tubes in ventilated neonates and infants. Further high quality research is required."
"CD002309"
[ "17573446", "19716960", "17463412", "19716961", "11498212", "16099292" ]
[ "Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD.", "Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials.", "Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease.", "Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.", "Cilomilast, a selective phosphodiesterase-4 inhibitor for treatment of patients with chronic obstructive pulmonary disease: a randomised, dose-ranging study.", "Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial." ]
"In people with COPD, PDE4 inhibitors offered benefit over placebo in improving lung function and reducing likelihood of exacerbations, however, they had little impact on quality of life or symptoms. Gastrointestinal adverse effects and weight loss were common. The optimum place of PDE4 inhibitors in COPD management remains to be defined. Longer-term trials are needed to determine whether or not PDE4 inhibitors modify FEV1 decline, healthcare utilisation or mortality in COPD."
"CD001991"
[ "6734291", "21714641", "5345935", "1991274", "3711252", "2776873" ]
[ "Screening for early lung cancer. Results of the Memorial Sloan-Kettering study in New York.", "Reduced lung-cancer mortality with low-dose computed tomographic screening.", "Earlier diagnosis and survival in lung cancer.", "Screening for lung cancer. A critique of the Mayo Lung Project.", "Multiphasic Health Checkup Evaluation: a 16-year follow-up.", "A 10 year follow-up of semi-annual screening for early detection of lung cancer in the Erfurt County, GDR." ]
"The current evidence does not support screening for lung cancer with chest radiography or sputum cytology. Annual low-dose CT screening is associated with a reduction in lung cancer mortality in high-risk smokers but further data are required on the cost effectiveness of screening and the relative harms and benefits of screening across a range of different risk groups and settings."
"CD003144"
[ "7006425", "3896372", "6375991", "2064291" ]
[ "Randomized prospective evaluation of the EEA stapler for colorectal anastomoses.", "Staples or sutures for low colorectal anastomoses: a prospective randomized trial.", "[Technic of rectum anastomoses in rectum resection. A controlled study: instrumental suture versus hand suture].", "[The best anastomoses after colonic resection]." ]
[ "A randomized, prospective study should be done to evaluate any new procedure or instrument. Our experience with the end-to-end anastomosis (EEA) stapler suggests that an anastomosis can be created in a shorter time than is required for the traditional hand-sewn technique. This difference is even greater when the anastomosis is technically difficult and located deep within the pelvis. There appears to be little difference in the security of a hand-sewn anastomosis compared with that of stapled anastomosis. Postoperative complications appear similar. With the stapler, however, there is an increased risk of intraoperative complications that are not apparent with the traditional hand-sewn technique. These include rectal tears and anastomotic defects. It appears that the EEA stapler can save as many as 12 percent of rectums that otherwise might have to be removed because of technical inability to perform an anastomosis.", "One hundred and eighteen patients undergoing low colorectal anastomoses were randomly allocated to reconstitution by either single layer interrupted extramucosal sutures or circular staple gun. In the 60 patients undergoing sutured anastomosis there were 2 (3 per cent) clinical leaks and 4 (7 per cent) radiological leaks, and no failures. Of the 58 patients who underwent stapled anastomosis there were 4 failures, 7 (12 per cent) clinical leaks, 14 (24 per cent) radiological leaks and 1 death. Stapled anastomoses were more than ten times as expensive as sutured anastomoses and there were no savings in time or numbers of associated colostomies. An interrupted extramucosal suture technique remains the ultimate standard for low colorectal anastomosis.", "Stapler and manual sutures in rectal end-to-end anastomoses were compared in a controlled trial. The following results were obtained: For the analysis the cases naturally separated into three groups, A (manual suture), B (planned stapler suture) and WD (\"withdrawn\" cases, from both groups, in which continence could be maintained only with a stapler suture). The distribution of the WD cases in dependence on localization and sex varied significantly from groups A and B, while A and B remained comparable, in spite of the WD cases. The analysis of the date showed no, or only slight, clinical differences. In a comparison of the two stapler groups B and WD, significantly more suture dehiscences, colocutaneous fistulae and post-operative disturbances in bladder function were found in group WD. As a general conclusion we can state that: In comparable anastomosis localizations it is possible to achieve almost the same clinical results with both suture techniques. With a circular stapler it is, however, technically possible to perform rectum resections in cases in which this was not previously possible, particularly in men with a narrow pelvis and a stale pelvic floor. To what extent this still is an advantage after the local recurrences are taken into consideration remains to be seen.", "Among the numerous anastomotic techniques after colonic resection, the mechanical sutures using staplers have been credited with a lower incidence of anastomotic leakage than hand-sewn anastomoses. This hypothesis has been tested in two multicentre, prospective, randomized trials after right hemicolectomy for carcinoma and after left colectomy with colorectal anastomosis. After right hemicolectomy, the stapled anastomosis using the GIA and TA staplers appeared to be superior to all hand-sewn anastomoses. This superiority was not apparent after left colectomy followed by colorectal anastomosis. Although the leakage rate of stapled anastomoses was similar to hand-sewn anastomoses, they carry a high rate of intra-operative mishaps. Furthermore, the stapler does not permit a lower anastomosis in this study. Finally, the overall cost of a stapled anastomosis is superior to the cost of an hand-sewn anastomosis." ]
"The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis surgery, regardless of the level of anastomosis. There were no randomised clinical trials comparing these two types of anastomosis in elective conditions in the last decade. The relevance of this research question has possibly lost its strength where elective surgery is concerned. However, in risk situations, such as emergency surgery, trauma and inflammatory bowel disease, new clinical trials are needed."
"CD004654"
[ "9802740", "11092289", "12797714", "11483229", "10868832", "15161773", "15660732", "12757988", "10333912", "12351462", "12832314", "10631622", "12213867" ]
[ "A randomized placebo-controlled trial of repaglinide in the treatment of type 2 diabetes.", "Nateglinide alone and in combination with metformin improves glycemic control by reducing mealtime glucose levels in type 2 diabetes.", "The effect of prandial glucose regulation with repaglinide on treatment satisfaction, wellbeing and health status in patients with pharmacotherapy naïve Type 2 diabetes: a placebo-controlled, multicentre study.", "Repaglinide improves blood glucose control in sulphonylurea-naive type 2 diabetes.", "Rapid and short-acting mealtime insulin secretion with nateglinide controls both prandial and mean glycemia.", "Repaglinide versus nateglinide monotherapy: a randomized, multicenter study.", "Effects of nateglinide on myocardial microvascular reactivity in Type 2 diabetes mellitus--a randomized study using positron emission tomography.", "Comparison of glycaemic control and cardiovascular risk profile in patients with type 2 diabetes during treatment with either repaglinide or metformin.", "Effect of repaglinide addition to metformin monotherapy on glycemic control in patients with type 2 diabetes.", "Repaglinide versus metformin in combination with bedtime NPH insulin in patients with type 2 diabetes established on insulin/metformin combination therapy.", "Efficacy and safety of combination therapy: repaglinide plus metformin versus nateglinide plus metformin.", "Repaglinide in type 2 diabetes: a 24-week, fixed-dose efficacy and safety study.", "Efficacy and safety of nateglinide in type 2 diabetic patients with modest fasting hyperglycemia." ]
"Meglitinides may offer an alternative oral hypoglycaemic agent of similar potency to metformin, and may be indicated where side effects of metformin are intolerable or where metformin is contraindicated. However, there is no evidence available to indicate what effect meglitinides will have on important long-term outcomes, particularly mortality."
"CD009138"
[ "6386793", "1924659", "1546154", "6211994", "2649156", "7003429", "2858187", "7044154", "8297924", "7592505", "3927356", "2201481", "4923928", "9413414", "7868849", "108739", "7873952", "7156248", "6371879", "2236455", "7231652", "3133710", "6225150", "8471679", "2258378", "7306613", "2941771", "6406443", "6431461", "2963054", "3283804", "538213", "3157576", "1666199" ]
[ "A double-blind study of the efficacy and safety of dothiepin hydrochloride in the treatment of major depressive disorder.", "A controlled study of mianserin in moderately to severely depressed outpatients.", "A comparison of moclobemide, amitriptyline and placebo in depression: a Canadian multicentre study.", "Controlled trial of zimelidine, a 5-HT reuptake inhibitor, for treatment of depression.", "Verapamil in affective disorders: a controlled, double-blind study.", "Comparative effects of phenelzine and amitriptyline: a placebo controlled trial.", "Alprazolam, amitriptyline, doxepin, and placebo in the treatment of depression.", "Trazodone in depressed outpatients.", "Thyroid functioning during treatment for depression.", "A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression.", "Cianopramine and amitriptyline in the treatment of depressed patients--a placebo-controlled study.", "Clovoxamine in the treatment of depressed outpatients: a double-blind, parallel-group comparison against amitriptyline and placebo.", "Controlled trial of amitriptyline in general practice.", "A double-blind, placebo-controlled study comparing the effects of sertraline versus amitriptyline in the treatment of major depression.", "A double-blind, placebo-controlled study comparing mianserin and amitriptyline in moderately depressed outpatients.", "A placebo-controlled multicenter trial of Limbitrol versus its components (amitriptyline and chlordiazepoxide) in the symptomatic treatment of depressive illness.", "Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care.", "The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo.", "A double-blind non-crossover placebo-controlled study between group comparison of trazodone and amitriptyline on cardiovascular function in major depressive disorder.", "Mirtazapine vs. amitriptyline vs. placebo in the treatment of major depressive disorder.", "Relationship between response to phenelzine and MAO inhibition in a clinical trial of phenelzine, amitriptyline and placebo.", "Experimental comparison between the effect of standardized trazodone-amitriptyline and placebo treatment in vitalized depressive patients.", "A double-blind evaluation of zimelidine in comparison to placebo and amitriptyline in patients with major depressive disorder.", "A clinical test of noradrenergic involvement in the therapeutic mode of action of an experimental antidepressant.", "Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression.", "Neuropsychological assessment and EEG sleep in affective disorders.", "A double-blind comparative trial of zimelidine, amitriptyline, and placebo in patients with mixed anxiety and depression.", "Antidepressant response and plasma concentrations of bupropion.", "Amoxapine and amitriptyline. I. Relative speed of antidepressant action.", "Predictors of therapeutic benefit from amitriptyline in mild depression: a general practice placebo-controlled trial.", "Comparison of adinazolam, amitriptyline, and placebo in the treatment of melancholic depression.", "Changes in weight during treatment for depression.", "High incidence of multisystemic reactions to zimeldine.", "Platelet alpha-2 adrenoreceptor activity pre-treatment and post-treatment in major depressive disorder with melancholia." ]
"Amitriptyline is an efficacious antidepressant drug. It is, however, also associated with a number of side effects. Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences."
"CD007045"
[ "11843249", "15499601" ]
[ "Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer.", "Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer." ]
"There is a need for well designed, adequately powered phase III trials assessing the effect of SIRT when used with modern combination chemotherapy regimens. Further studies are also needed for patients with refractory disease with a particular focus on the impact on quality of life."
"CD007368"
[ "15158629", "20882421", "20375190" ]
[ "Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial.", "Zinc supplementation in severe acute lower respiratory tract infection in children: a triple-blind randomized placebo controlled trial.", "A randomized controlled trial of the effect of zinc as adjuvant therapy in children 2-35 mo of age with severe or nonsevere pneumonia in Bhaktapur, Nepal." ]
"Evidence provided in this review is insufficient to recommend the use of zinc as an adjunct to standard antibiotic therapy for pneumonia in children aged two to 35 months."
"CD002973"
[ "10988090" ]
[ "Continuous tracheal gas insufflation in preterm infants with hyaline membrane disease. A prospective randomized trial." ]
[ "In mechanically ventilated neonates, the instrumental dead space is a major determinant of total minute ventilation. By flushing this dead space, continuous tracheal gas insufflation (CTGI) may allow reduction of the risk of overinflation. We conducted a randomized trial to evaluate the efficacy of CTGI in reducing airway pressure over the entire period of mechanical ventilation while maintaining oxygenation. A total of 34 preterm newborns, ventilated in conventional pressure-limited mode, were enrolled in two study arms, to receive or not receive CTGI. Transcutaneous Pa(CO(2)) (tcPa(CO(2))) was maintained at 40 to 46 mm Hg in both groups to ensure comparable alveolar ventilation. Respiratory data were collected several times during the first day and daily until Day 28. Both groups were similar at the time of inclusion. During the first 4 d of the study, the difference between peak pressure and positive end-expiratory pressure was significantly lower in the CTGI group by 18% to 35%, with the same tcPa(CO(2)) level and with no difference in the ratio of tcPa(O(2)) to fraction of inspired oxygen (245 +/- 29 versus 261 +/- 46 mm Hg [mean +/- SD] over the first 4 d). Extubation occurred sooner in the CTGI group (p < 0.05), and the duration of mechanical ventilation was shorter (median: 3.6 d; 25th to 75th quartiles: 1.5 to 12.0 d; versus median: 15.6 d; 25th to 75th quartiles: 7.9 to 22.2; p < 0.05) than in the non-CTGI group. CTGI allows the use of low-volume ventilation over a prolonged period and reduces the duration of mechanical ventilation." ]
"There is evidence from a single RCT that TGI may reduce the duration of mechanical ventilation in preterm infants - although the data from this small study do not give sufficient evidence to support the introduction of TGI into clinical practice. The technical requirements for performing TGI (as performed in the single included study) are great. There is no statistically significant reduction in the total duration of respiratory support or hospital stay. TGI cannot be recommended for general use at this time."
"CD004107"
[ "7570436", "11405516", "8541826", "8793447", "11371411", "9616530", "10955751", "9476870", "2148702", "11844120", "9154850", "8605463", "9404750", "8148679" ]
[ "Peak flow based asthma self-management: a randomised controlled study in general practice. British Thoracic Society Research Committee.", "Benefit from the inclusion of self-treatment guidelines to a self-management programme for adults with asthma.", "The effects of a cognitive behavioural intervention in asthmatic patients.", "A controlled assessment of an asthma self-management plan involving a budesonide dose regimen. OPTIONS Research Group.", "Evaluation of two different educational interventions for adult patients consulting with an acute asthma exacerbation.", "One-year economic evaluation of intensive vs conventional patient education and supervision for self-management of new asthmatic patients.", "Influence of peak expiratory flow monitoring on an asthma self-management education programme.", "A randomized trial comparing peak expiratory flow and symptom self-management plans for patients with asthma attending a primary care clinic.", "Evaluation of peak flow and symptoms only self management plans for control of asthma in general practice.", "A randomized trial of peak-flow and symptom-based action plans in adults with moderate-to-severe asthma.", "Influence on asthma morbidity of asthma education programs based on self-management plans following treatment optimization.", "Randomised comparison of guided self management and traditional treatment of asthma over one year.", "The effect of a peak flow-based action plan in the prevention of exacerbations of asthma.", "Effectiveness of routine self monitoring of peak flow in patients with asthma. Grampian Asthma Study of Integrated Care (GRASSIC)." ]
"Optimal self-management allowing for optimisation of asthma control by adjustment of medications may be conducted by either self-adjustment with the aid of a written action plan or by regular medical review. Individualised written action plans based on PEF are equivalent to action plans based on symptoms. Reducing the intensity of self-management education or level of clinical review may reduce its effectiveness."
"CD002879"
[ "1361594", "9655732", "3541946", "2844548", "359091", "7000127", "9228354", "3282826", "3296296", "6998599", "2236929", "8323338", "2856542" ]
[ "Comparison of oral-steroid sparing by high-dose and low-dose inhaled steroid in maintenance treatment of severe asthma.", "Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. The Dutch Asthma Study Group.", "Twice daily administration of beclomethasone dipropionate dry-powder in the management of chronic asthma.", "Effects of inhaled beclomethasone dipropionate on beta 2-receptor function in the airways and adrenal responsiveness in bronchial asthma.", "Beclomethasone dipropionate dry-powder inhalation compared with conventional aerosol in chronic asthma.", "Beclomethasone dipropionate in asthma: a comparison of two methods of administration.", "A comparison of double-strength beclomethasone dipropionate (84 microg) MDI with beclomethasone dipropionate (42 microg) MDI in the treatment of asthma.", "Six-month double-blind, controlled trial of high dose, concentrated beclomethasone dipropionate in the treatment of severe chronic asthma.", "Twice daily beclomethasone dipropionate administered with a concentrated aerosol inhaler: efficacy and patient compliance.", "Beclomethasone dipropionate aerosol compared with dry powder in the treatment of asthma.", "Dose-related effect of beclomethasone dipropionate on airway responsiveness in asthma.", "Short-term growth during treatment with inhaled fluticasone propionate and beclomethasone dipropionate.", "Dose-dependent inhibitory effect of inhaled beclomethasone on late asthmatic reactions and increased responsiveness to methacholine induced by toluene diisocyanate in sensitised subjects." ]
"BDP appears to demonstrate a shallow dose response effect in long-term asthma for a small number of efficacy outcomes over range of daily doses from 400 mcg/d to 1600 mcg/d, although the clinical significance of the improvements afforded by higher doses is questionable."
"CD002086"
[ "6216858", "131678", "3157706", "138560", "1981436", "12695127", "9649660", "16312705", "150346", "14988688", "17436825", "2938993", "11867968", "11701404", "16702498", "21269305", "2965628", "15588555", "17436826", "2530191", "11586012" ]
[ "Efficacy of minocycline compared with tetracycline in treatment of acne vulgaris.", "Minocycline in acne vulgaris: a double-blind study.", "An accurate photographic method for grading acne: initial use in a double-blind clinical comparison of minocycline and tetracycline.", "Minocycline therapy in acne vulgaris.", "A double-blind comparison of topical clindamycin and oral minocycline in the treatment of acne vulgaris.", "Lymecycline in the treatment of acne: an efficacious, safe and cost-effective alternative to minocycline.", "A comparison of the efficacy and safety of lymecycline and minocycline in patients with moderately severe acne vulgaris.", "Josamycin versus minocycline in the treatment of papulopustular acne.", "Minocycline versus doxycycline in the treatment of acne vulgaris. A double-blind study.", "A systemic type I 5 alpha-reductase inhibitor is ineffective in the treatment of acne vulgaris.", "Dose-ranging efficacy of new once-daily extended-release minocycline for acne vulgaris.", "Isotretinoin versus minocycline in cystic acne: a study of lipid metabolism.", "Lymecycline and minocycline in inflammatory acne: a randomized, double-blind intent-to-treat study on clinical and in vivo antibacterial efficacy.", "Comparison of combined azelaic acid cream plus oral minocycline with oral isotretinoin in severe acne.", "Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, double-blind, randomized, parallel-group study.", "Efficacy of oral antibiotics on acne vulgaris and their effects on quality of life: a multicenter randomized controlled trial using minocycline, roxithromycin and faropenem.", "Efficacy of low-dose cyproterone acetate compared with minocycline in the treatment of acne vulgaris.", "Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne.", "Safety and efficacy of a new extended-release formulation of minocycline.", "[Treatment of acne vulgaris. A comparison of doxycycline versus minocycline].", "Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris." ]
"Minocycline is an effective treatment for moderate to moderately-severe inflammatory acne vulgaris, but there is still no evidence that it is superior to other commonly-used therapies. This review found no reliable evidence to justify the reinstatement of its first-line use, even though the price-differential is less than it was 10 years ago. Concerns remain about its safety compared to other tetracyclines."
"CD007598"
[ "11984383", "19731848", "10434220", "14770380", "17304779", "12776641", "9378876" ]
[ "Isopropyl alcohol inhalation: alternative treatment of postoperative nausea and vomiting.", "Comparison of inhalation of isopropyl alcohol vs promethazine in the treatment of postoperative nausea and vomiting (PONV) in patients identified as at high risk for developing PONV.", "An alternative method to alleviate postoperative nausea and vomiting in children.", "Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea.", "A comparative analysis of isopropyl alcohol and ondansetron in the treatment of postoperative nausea and vomiting from the hospital setting to the home.", "Comparison of inhaled isopropyl alcohol and intravenous ondansetron for treatment of postoperative nausea.", "Peppermint oil: a treatment for postoperative nausea." ]
"Isopropyl alcohol was more effective than saline placebo for reducing postoperative nausea and vomiting but less effective than standard anti-emetic drugs. There is currently no reliable evidence for the use of peppermint oil."
"CD001865"
[ "8998184", "12590989", "12173678", "17196358", "21149743", "16338740", "12394349", "8327418", "7707420", "11988381", "10564627", "8302104", "7563045", "16720537", "19105686", "12215248", "20978060", "18308500", "10391568", "18573775", "10564629", "16832795", "16916540", "19418107", "15749130", "20157016", "10160231", "16580059", "17627015", "12781927", "16377602", "9552998", "9388791", "16427245", "10358689", "21636633", "1949916", "8279610", "18190370", "21090893" ]
[ "Controlled trial of pretest education approaches to enhance informed decision-making for BRCA1 gene testing.", "Comparison of tailored interventions to increase mammography screening in nonadherent older women.", "Comparisons of tailored mammography interventions at two months postintervention.", "The effect of telephone versus print tailoring for mammography adherence.", "Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial.", "Effects of breast cancer risk counseling for sexual minority women.", "Effects of risk counseling on interest in breast cancer genetic testing for lower risk women.", "A randomized trial of the impact of risk assessment and feedback on participation in mammography screening.", "Effects of individualized breast cancer risk counseling: a randomized trial.", "Effects of a mammography decision-making intervention at 12 and 24 months.", "Tailored risk notification for women with a family history of breast cancer.", "Strategies to increase mammography utilization.", "Effect of interventions on stage of mammography adoption.", "Effects of communicating social comparison information on risk perceptions for colorectal cancer.", "Mammography screening after risk-tailored messages: the women improving screening through education and risk assessment (WISER) randomized, controlled trial.", "Pre-counseling education materials for BRCA testing: does tailoring make a difference?", "A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial.", "A randomized trial of two print interventions to increase colon cancer screening among first-degree relatives.", "Adherence by African American men to prostate cancer education and early detection.", "Randomized trial of a self-administered decision aid for colorectal cancer screening.", "Cost-effectiveness comparison of five interventions to increase mammography screening.", "A randomized trial to improve early detection and prevention practices among siblings of melanoma patients.", "Effects of a telephone counseling intervention on sisters of young women with breast cancer.", "A randomized trial of generic versus tailored interventions to increase colorectal cancer screening among intermediate risk siblings.", "Increasing colorectal cancer screening among individuals in the carpentry trade: test of risk communication interventions.", "Effects of a mail and telephone intervention on breast health behaviors.", "Do tailored behavior change messages enhance the effectiveness of health risk appraisal? Results from a randomized trial.", "Impact of a multimedia intervention \"Skinsafe\" on patients' knowledge and protective behaviors.", "Effects of colon cancer risk counseling for first-degree relatives.", "Tailored messages for breast and cervical cancer screening of low-income and minority women using medical records data.", "The efficacy of tailored print materials in promoting colorectal cancer screening: results from a randomized trial involving callers to the National Cancer Institute's Cancer Information Service.", "Screening for hypercholesterolaemia in primary care: randomised controlled trial of postal questionnaire appraising risk of coronary heart disease.", "Encouraging underscreened women to have cervical cancer screening: the effectiveness of a computer strategy.", "Results of a randomized study of telephone versus in-person breast cancer risk counseling.", "A randomized trial of breast cancer risk counseling: the impact on self-reported mammography use.", "Effect of evidence based risk information on \"informed choice\" in colorectal cancer screening: randomised controlled trial.", "A randomized controlled trial to motivate worksite fecal occult blood testing.", "Physicians' recommendations for mammography: do tailored messages make a difference?", "Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458].", "Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients." ]
[ "In response to the isolation of the BRCA1 gene, a breast-ovarian cancer-susceptibility gene, biotechnology companies are already marketing genetic tests to health care providers and to the public. Initial studies indicate interest in BRCA1 testing in the general public and in populations at high risk. However, the optimal strategies for educating and counseling individuals have yet to be determined.\n Our goal was to evaluate the impact of alternate strategies for pretest education and counseling on decision-making regarding BRCA1 testing among women at low to moderate risk who have a family history of breast and/or ovarian cancer.\n A randomized trial design was used to evaluate the effects of education only (educational approach) and education plus counseling (counseling approach), as compared with a waiting-list (control) condition (n = 400 for all groups combined). The educational approach reviewed information about personal risk factors, inheritance of cancer susceptibility, the benefits, limitations, and risks of BRCA1 testing, and cancer screening and prevention options. The counseling approach included this information, as well as a personalized discussion of experiences with cancer in the family and the potential psychological and social impact of testing. Data on knowledge of inherited cancer and BRCA1 test characteristics, perceived risk, perceived benefits, limitations and risks of BRCA1 testing, and testing intentions were collected by use of structured telephone interviews at baseline and at 1-month follow-up. Provision of a blood sample for future testing served as a proxy measure of intention to be tested (in the education and counseling arms of the study). The effects of intervention group on study outcomes were evaluated by use of hierarchical linear regression modeling and logistic regression modeling (for the blood sample outcome). All P values are for two-sided tests.\n The educational and counseling approaches both led to significant increases in knowledge, relative to the control condition (P < .001 for both). The counseling approach, but not the educational approach, was superior to the control condition in producing significant increases in perceived limitations and risks of BRCA1 testing (P < .01) and decreases in perceived benefits (P < .05). However, neither approach produced changes in intentions to have BRCA1 testing. Prior to and following both education only and education plus counseling, approximately one half of the participants stated that they intended to be tested; after the session, 52% provided a blood sample.\n Standard educational approaches may be equally effective as expanded counseling approaches in enhancing knowledge. Since knowledge is a key aspect of medical decision-making, standard education may be adequate in situations where genetic testing must be streamlined. On the other hand, it has been argued that optimal decision-making requires not only knowledge, but also a reasoned evaluation of the positive and negative consequences of alternate decisions. Although the counseling approach is more likely to achieve this goal, it may not diminish interest in testing, even among women at low to moderate risk. Future research should focus on the merits of these alternate approaches for subgroups of individuals with different backgrounds who are being counseled in the variety of settings where BRCA1 testing is likely to be offered.", "Recent increases in mammography use have led to a decrease in mortality from breast cancer.\n Building on the Health Belief Model, the Transtheoretical Model, and past effectiveness of tailored interventions, we conducted a prospective randomized trial (n = 773) to test the efficacy on mammography adherence of tailored interventions delivered by five different methods, i.e., telephone counseling, in-person counseling, physician letter, and combinations of telephone with letter and in-person with letter.\n All five interventions increased mammography adherence significantly relative to usual care (odds ratios, 1.93 to 3.55) at 6 months post intervention. The combination of in-person with physician letter was significantly more effective than telephone alone or letter alone. Women thinking about getting a mammogram at baseline were more likely to be adherent by 6 months; even those in usual care achieved 48% adherence compared with 50-70% in the intervention groups. In contrast, women not thinking about getting a mammogram needed the interventions to increase their adherence from 13% to over 30%.\n All five interventions were effective at increasing mammography adherence. Women not thinking about getting a mammogram were most likely to benefit from these tailored interventions while other women might need less intensive interventions.", "The recent decrease in breast cancer mortality has been linked in part to increased breast cancer screening. Although the percentage of women screened once is rising, rate of continued adherence is poor. The purpose of this article is to assess the effects of tailored mammography interventions implemented prospectively in a factorial design contrasting groups receiving either (a) usual care (no intervention), (b) tailored telephone counseling for mammography, (c) tailored mailed materials promoting mammography, or (d) a combination of tailored mail and telephone counseling. This prospective, randomized study with a 2 x 2 factorial design included women 51 years and older (N = 1,367) who were not adherent with mammography at baseline. The intervention is based on integration of the Transtheoretical and Health Belief Models. Participants were enrolled in one of two health maintenance organizations or seen in a university-related primary care clinic. Baseline data were collected on mammography history and beliefs and knowledge related to mammography. Data were collected via telephone interviews using previously developed scales. The follow-up interviewers were conducted with 976 women. The sample was 41% White, 56% African American, and 3% other. Mean age at baseline was 66.5. Logistic regression indicates that postintervention mammography status in all three intervention groups was significantly better than usual care, with odds ratios ranging from 1.66 (telephone only) to 2.16 (telephone plus mail).", "The purpose of this intervention was to increase mammography adherence in women who had not had a mammogram in the last 15 months.\n A prospective randomized intervention trial used four groups: (1) usual care, (2) tailored telephone counseling, (3) tailored print, (4) tailored telephone counseling and print. Participants included a total of 1244 women from two sites-a general medicine clinic setting serving predominately low-income clientele and a Health Maintenance Organization (HMO). Computer-tailored interventions addressed each woman's perceived risk of breast cancer, benefits and/or barriers and self-efficacy related to mammography screening comparing delivery by telephone and mail.\n Compared to usual care all intervention groups increased mammography adherence significantly (odds ratio 1.60-1.91) when the entire sample was included.\n All interventions groups demonstrated efficacy in increasing mammography adherence as compared to a usual care group. When the intervention analysis considered baseline stage, pre contemplators (women who did not intend to get a mammogram) did not significantly increase in mammography adherence as compared to usual care.\n Women who are in pre contemplation stage may need a more intensive intervention.", "Colorectal cancer is a leading cause of cancer mortality, yet effective screening tests are often underused. Electronic patient messages and personalized risk assessments delivered via an electronic personal health record could increase screening rates.\n We conducted a randomized controlled trial in 14 ambulatory health centers involving 1103 patients ranging in age from 50 to 75 years with an active electronic personal health record who were overdue for colorectal cancer screening. Patients were randomly assigned to receive a single electronic message highlighting overdue screening status with a link to a Web-based tool to assess their personal risk of colorectal cancer. The outcomes included colorectal cancer screening rates at 1 and 4 months.\n Screening rates were higher at 1 month for patients who received electronic messages than for those who did not (8.3% vs 0.2%, P < .001), but this difference was no longer significant at 4 months (15.8% vs 13.1%, P = .18). Of 552 patients randomized to receive the intervention, 296 (54%) viewed the message, and 47 (9%) used the Web-based risk assessment tool. Among 296 intervention patients who viewed the electronic message, risk tool users were more likely than nonusers to request screening examinations (17% vs 4%, P = .04) and to be screened (30% vs 15%, P = .06). One-fifth of patients (19%) using the risk assessment tool were estimated to have an above-average risk for colorectal cancer.\n Electronic messages to patients produce an initial increase in colorectal cancer screening rates, but this effect is not sustained over time.\n clinicaltrials.gov Identifier: NCT01032746.", "Sexual minority women (lesbian and bisexual) represent a vulnerable group regarding their breast health. The participants in this study were 150 women aged 18-74 recruited via public announcements in mainstream and sexual minority communities in the greater Seattle metropolitan area. Potential participants were recruited to participate in a randomized trial of a breast cancer risk counseling intervention for sexual minority women. The counseling intervention produced significant reductions in perceived risk of breast cancer, anxieties and fears about breast cancer at 6 and 24 months, and increases in breast screening rates at 24 months in the intervention arm, compared with the control arm participants. These data add to the growing body of knowledge on sexual minority women's health and point to areas of community action and future research.", "A randomized trial was conducted to test the effects of two counseling methods (genetic counseling and group counseling) against a control no-intervention condition on interest in genetic testing in lower risk women.\n After completing baseline surveys, women (N = 357) were randomized to one of three conditions: to receive individual genetic risk counseling, to receive a group psychosocial group counseling, or to serve as a control group. Participants completed follow-up questionnaires 6 months after randomization.\n All participants had some familial history of breast cancer, but none had a family history indicative of autosomal dominant genetic mutation. At baseline over three fourths of the sample judged themselves to be appropriate candidates for testing. By the end of the survey, two thirds (70%) of the women in the counseling group still judged themselves to be appropriate candidates for testing. Findings were similar for interest in genetic testing. Changes in beliefs about genetic testing (e.g., beliefs about potential stigma associated with testing) altered the effects of counseling.\n These results indicate that counseling can change interest in genetic testing only slightly and that changing women's beliefs about the properties of testing might be one mechanism of doing so.", "Although rates of mammography screening among women in the general population have been increasing they still fall short of national goals. This study evaluated the effects on rates of participation in mammography screening of obtaining risk factor information and providing general or personalized risk information through direct mailed correspondence.\n Women enrollees in a health maintenance organization (N = 2,076), age 50 and above, were randomized to one of the following four groups: (a) no risk factor questionnaire + generic invitation, (b) no risk factor questionnaire + general risk invitation, (c) risk factor questionnaire + general risk invitation, and (d) risk factor questionnaire + personal risk invitation. Computerized visit records were monitored for 12 months following a mailed invitation to assess whether a mammogram had been obtained.\n Overall participation was 37.5% and the rate of participation did not differ significantly across groups (P = 0.26). Participation was related to age (P < 0.02), with rates highest for women ages 60-69 years (42.7%) compared with those for women ages 50-59 (35.5%) and those age 70+ (33.7%). Among women with a family history of breast cancer, the personalized risk invitation was associated with significantly higher participation compared with general risk invitation (66.7 versus 42.9%, respectively; P < 0.003).\n Women with a family history of breast cancer are more likely to obtain a mammogram if that fact is reinforced as a risk factor. Research on environmental barriers to mammography screening may suggest alternative strategies for increasing participation.", "Studies have shown that a majority of women with a family history of breast cancer have exaggerated perceptions of their own risk of this disease and experience excessive anxiety. In response to the need to communicate more accurate risk information to these women, specialized programs for breast cancer risk counseling have been initiated in medical centers across the United States.\n Our purpose was 1) to evaluate the impact of a standardized protocol for individualized breast cancer risk counseling on comprehension of personal risk among first-degree relatives of index breast cancer patients and 2) to identify women most and least likely to benefit from such counseling.\n This study is a prospective randomized trial comparing individualized breast cancer risk counseling to general health counseling (control). We studied 200 women aged 35 years and older who had a family history of breast cancer in a first-degree relative. Women with a personal history of cancer were excluded. Risk comprehension was assessed as the concordance between perceived \"subjective\" lifetime breast cancer risk and estimated \"objective\" lifetime risk.\n The results of logistic regression analysis showed that women who received risk counseling were significantly more likely to improve their risk comprehension, compared with women in the control condition (odds ratio [OR] = 3.5; 95% confidence interval [CI] = 1.3-9.5; P = .01). However, in both groups, about two thirds of women continued to overestimate their lifetime risks substantially following counseling. Examination of subjects by treatment interaction effects indicated that risk counseling did not produce improved comprehension among the large proportion of women who had high levels of anxious preoccupation with breast cancer at base line (P = .02). In addition, white women were less likely to benefit than African-American women (OR = 0.34; 95% CI = 0.11-0.99; P = .05).\n Efforts to counsel women about their breast cancer risks are not likely to be effective unless their breast cancer anxieties are also addressed.\n Attention to the psychological aspects of breast cancer risk will be critical in the development of risk-counseling programs that incorporate testing for the recently cloned breast cancer susceptibility gene, BRCA1 (and BRCA2 when that gene has also been cloned).", "Most women are not getting regular mammograms, and there is confusion about several mammography-related issues, including the age at which women should begin screening. Numerous groups have called for informed decision making about mammography, but few programs have resulted. Our research is intended to fill this gap.\n We conducted a randomized controlled trial, which ran from 1997 to 2000. Women aged 40 to 44 and 50 to 54, who were enrolled in Blue Cross Blue Shield of North Carolina, were randomly assigned to one of three groups: usual care (UC), tailored print (TP) materials, or TP plus tailored telephone counseling (TP+TC). We assessed the impact of tailored interventions on knowledge about breast cancer and mammography, accuracy of breast cancer risk perceptions, and use of mammography at two time points after intervention-12 and 24 months.\n At 12 and 24 months, women who received TP+TC had significantly greater knowledge and more accurate breast cancer risk perceptions. Compared to UC, they were 40% more likely to have had mammograms (odds ratio=0.9-2.1). The effect was primarily for women in their 50s. TP had significant effects for knowledge and accuracy, but women who received TP were less likely to have had mammography.\n Decision-making interventions, comprised of two tailored print interventions (booklet and newsletter), delivered a year apart, with or without two tailored telephone calls, significantly increased knowledge and accuracy of perceived breast cancer risk at 12 and 24 months post-intervention. The effect on mammography use was significant in bivariate relationships but had a much more modest impact in multivariate analyses.", "Evidence indicates that although first-degree relatives of breast cancer cases are at increased risk of developing the disease themselves, they may be underutilizing screening mammography. Therefore, interventions to increase the use of mammography in this group are urgently needed.\n A randomized two-group design was used to evaluate an intervention to increase mammography use among women (N = 901) with at least one first-degree relative with breast cancer. A statewide cancer registry was used to obtain a random sample of breast cancer cases who identified eligible relatives. The mailed intervention consisted of personalized risk notification and other theoretically driven materials tailored for high-risk women.\n An overall significant intervention effect was observed (8% intervention group advantage) in mammography at post-test. There was an interaction of the intervention with age such that there was no effect among women <50 years of age and a fairly large (20% advantage) effect among women 50+ and 65+. Health insurance, education, and having had a mammogram in the year before baseline assessment were positive predictors of mammography at post-test. Perceived risk, calculated risk, and relationship to index cancer case were not associated with mammography receipt.\n The intervention was successful in increasing mammography rates among high-risk women 50+ years of age. Further work is needed to determine why it was ineffective among younger women.\n Copyright 1999 American Health Foundation and Academic Press.", "This study compared the effects of theoretically driven interventions on compliance with mammography utilization. A 2 x 2 factorial design yielded four groups: a control group, a belief intervention group, an informational intervention group, and a belief/informational intervention group. A probability sample of 301 women, age 35 and older, without a history of breast cancer were randomly assigned to groups. Subjects in the intervention groups received individually tailored messages to alter beliefs or provider information related to mammography screening. Belief messages were developed from Health Belief Model constructs. Belief interventions significantly influenced all belief variables except perceived susceptibility in the desired direction. Women in the belief/informational intervention group were almost four times more likely than those in the control group to comply with mammography recommendations in the year following intervention (odds ratio = 3.75). In addition, belief variables and intervention significantly predicted mammography compliance 1 year postintervention.", "Mammography has been found significantly to impact mortality in women; however, compliance is still problematic. A theoretical model which combined Health Belief Model (HBM) constructs with stage of mammography adoption was used to investigate the effect of an individualized belief and/or informational intervention on mammography compliance. A control group and three intervention groups (belief, information, and belief and information) were used. A probability sample of 405 women ages 40-88 years without a prior history of breast cancer was randomly assigned to groups. Subjects in the intervention group received individually tailored messages to alter beliefs or provider information related to mammography screening. Women in the combined belief/information group were over two times more likely to have been compliant with mammography 1 year postintervention than those in the control. In addition, groups who received the belief intervention had significantly more women that went from a lower to a higher stage of mammography adoption.", "People typically believe their health risks are lower than those of others (i.e., optimistic bias). We sought to increase perceptions of colorectal cancer (CRC) risk among adults aged 50-75 who were nonadherent to fecal occult screening (FOBT). 160 participants were randomized to receive information about the following: (1) general CRC risk factors (control), (2) general and tailored CRC risk factor feedback (absolute risk group), or (3) absolute CRC risk factor feedback plus CRC feedback as to how their total number of risk factors compared with that of others (absolute plus comparative risk group). Primary outcomes were perceived absolute and comparative risks, attitudinal ambivalence toward FOBT, and screening intentions; the secondary outcome was return of a completed FOBT. Participants who were told that they had more than the average number of risk factors believed their comparative CRC risk was higher than that of controls and of participants informed that they did not have more than the average number of risk factors. Perceived absolute risk did not vary by group. Participants who received social comparison risk factor feedback expressed greater intentions to screen via a FOBT than participants who received absolute risk feedback and controls; they also expressed less ambivalence about FOBT screening than controls. Although not statistically significant, participants informed they were at lower comparative risk had the highest proportion of completing an FOBT than any other group. These results suggest that providing social comparison CRC risk factor feedback can effectively reduce optimistic comparative risk perceptions. Contrary to findings of models of health behavior change, being informed that one does not have more than the average number of CRC risk factors, while resulting in lower evaluations of perceived comparative risk, did not result in higher ambivalence toward and lower intentions to screen using FOBT or the lowest rate of screening.", "A randomized trial investigated the impact of risk-tailored messages on mammography in diverse women in the Virginia Commonwealth University Health System's gynecology clinics.\n From 2003 to 2005, 899 patients > or =40 years of age were randomized to receive risk-tailored information or general information about breast health. Multiple logistic regression analyses summarize their breast health practices at 18 months.\n At baseline, 576 (64%) women reported having a mammogram in the past year. At 18-month follow-up, mammography rates were 72.6% in the intervention group and 74.2% in the control group (N.S.). Women (n = 123) who reported worrying about breast cancer \"often\" or \"all the time\" had significantly higher mammography rates with the intervention (85.0%) vs. the controls (63.5%). No significant differences existed in clinical breast examination, self-examination, or mammography intentions between the two study arms. However, intervention women with lower education reported significantly fewer clinical breast examinations at follow-up.\n The brief intervention with a risk-tailored message did not have a significant effect overall on screening at 18 months. However, among those who worried, mammography rates in the intervention group were higher. Individual characteristics, such as worry about breast cancer and education status, may impact interventions to improve breast cancer prevention practices.", "Although tailored print materials (TPMs) have been assessed for a variety of behavioral targets, their effectiveness as decision aids for genetic testing had not been evaluated at the time this study began. We compared TPMs and non-tailored print material (NPMs) that included similar content about genetic testing for breast and ovarian cancer susceptibility. TPMs were prepared especially for an individual based on information from and about her. We mailed baseline surveys to 461 women referred by physicians or identified through a tumor registry. All had personal and family histories of breast and/or ovarian cancer and, on the basis of these histories, an estimated > or =10% probability of carrying a mutation in the breast/ovarian cancer genes BRCA1 or BRCA2. The 325 (70%) who responded were randomly assigned to receive TPM or NPM. Followup surveys, mailed 2 weeks following receipt of print materials, were returned by 262 women (81% of baseline responders). Participants were predominately white (94%) and well-educated (50% college graduates). The mean age was 49 years. At follow-up, TPM recipients exhibited significantly greater improvement in percent of correct responses for the 13-item true/false measure of knowledge (24% increase for TPM vs. 16% for NPM; p < 0.0001) and significantly less over-estimation of risk of being a mutation carrier (40% TPM group overestimated vs. 70% NPM; p < 0.0001). Anxiety did not differ significantly between groups. Reactions to materials differed on two items: \"seemed to be prepared just for me\" (76% TPM vs. 52% NPM; p < 0.001) and \"told me what I wanted to know about BRCA1 and 2 testing\" (98% TPM vs. 91% NPM; p < 0.05). TPMs showed an advantage in increasing knowledge and enhancing accuracy of perceived risk. Both are critical components of informed decision making.", "To determine whether a decision aid designed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer.\n Randomised controlled trial.\n Areas in New South Wales, Australia identified as socioeconomically disadvantaged (low education attainment, high unemployment, and unskilled occupations).\n 572 adults aged between 55 and 64 with low educational attainment, eligible for bowel cancer screening.\n Patient decision aid comprising a paper based interactive booklet (with and without a question prompt list) and a DVD, presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing. The control group received standard information developed for the Australian national bowel screening programme. All materials and a faecal occult blood test kit were posted directly to people's homes.\n Informed choice (adequate knowledge and consistency between attitudes and screening behaviour) and preferences for involvement in screening decisions.\n Participants who received the decision aid showed higher levels of knowledge than the controls; the mean score (maximum score 12) for the decision aid group was 6.50 (95% confidence interval 6.15 to 6.84) and for the control group was 4.10 (3.85 to 4.36; P<0.001). Attitudes towards screening were less positive in the decision aid group, with 51% of the participants expressing favourable attitudes compared with 65% of participants in the control group (14% difference, 95% confidence interval 5% to 23%; P=0.002). The participation rate for screening was reduced in the decision aid group: completion of faecal occult blood testing was 59% v 75% in the control group (16% difference, 8% to 24%; P=0.001). The decision aid increased the proportion of participants who made an informed choice, from 12% in the control group to 34% in the decision aid group (22% difference, 15% to 29%; P<0.001). More participants in the decision aid group had no decisional conflict about the screening decision compared with the controls (51% v 38%; P=0.02). The groups did not differ for general anxiety or worry about bowel cancer.\n Tailored decision support information can be effective in supporting informed choices and greater involvement in decisions about faecal occult blood testing among adults with low levels of education, without increasing anxiety or worry about developing bowel cancer. Using a decision aid to make an informed choice may, however, lead to lower uptake of screening. Trial registration ClinicalTrials.gov NCT00765869 and Australian New Zealand Clinical Trials Registry 12608000011381.", "First-degree relatives (FDRs) of people diagnosed with colorectal cancer (CRC) have a two- to threefold increased risk of developing the same disease. Tailored print interventions based on behavior change theories have demonstrated considerable promise in facilitating health-promoting behaviors. This study compared the impact of two mailed print interventions on CRC screening outcomes among FDRs.\n This randomized trial compared effects of two mailed print interventions--one tailored and one nontailored--on participation in CRC screening among FDRs of CRC survivors. Data collected via phone interviews from 140 FDRs at baseline, 1 week post-intervention, and 3 months post-intervention.\n At 3 months, both the tailored and nontailored interventions yielded modest but statistically insignificant increases in adherence to any CRC screening test (14% vs. 21%, respectively; p=0.30). While there were no main effects for tailored versus nontailored interventions, there were significant interactions that showed that the tailored print intervention had significantly greater effects on forward stage movement for CRC screening depending on stage of adoption at baseline, race, and objective CRC risk. Receipt of the tailored intervention was 2.5 times more likely to move baseline precontemplators and contemplators forward in stage of adoption for colonoscopy (95% CI: 1.10-5.68) and was three times more likely to move Caucasians forward in stage of adoption for FOBT (95% CI: 1.00-9.07). In addition, the tailored intervention was 7.7 times more likely to move people at average risk forward in stage of adoption for colonoscopy (95% CI: 1.25-47.75).\n The tailored print intervention was more effective at moving Caucasians, those in precontemplation and contemplation at baseline, and those at average risk forward in their stage of adoption for CRC screening.\n Both tailored and nontailored print interventions showed moderate effects for increasing CRC screening participation. Tailored print interventions may be more effective for certain subgroups.", "This study was designed to identify factors that predict adherence by African American men to prostate cancer education and early detection.\n In the spring of 1995, the authors identified 548 African American men who were patients at the University Health Services of the University of Chicago, were ages 40-70 years, and did not have a personal history of prostate cancer. Baseline telephone survey data were collected from 413 men (75%). Participants were randomly assigned to either a minimal or an enhanced intervention group. Men in the former group were mailed a letter and a reminder that invited them to a urology clinic for prostate cancer education and early detection. Men in the enhanced intervention group were sent the same correspondence and were also given print material and telephone contacts, which were tailored to each recipient.\n Adherence was significantly higher (OR = 2.6, CI: 1.7-3.9) in the enhanced intervention group than in the minimal intervention group (51% and 29%, respectively). Men who were age 50 years or older (OR = 1.7, CI: 1.1-2.8), were married (OR = 1.8, CI: 1.2-2.9), believed that prostate cancer early detection examination should be performed in the absence of symptoms (OR = 2.3, CI: 1.3-4.0), and self-reported an intention to have an early detection examination (OR = 1.9, CI: 1.2-2.9) were also more likely to adhere.\n A tailored behavioral intervention can influence adherence to prostate cancer early detection among African American men. Individual background and cognitive and psychosocial characteristics may also affect behavior. Future studies should assess the impact of this type of intervention on cognitive and psychologic correlates of decision-making and behavior along the continuum of prostate cancer care. [See editorial on pages 1-2, this issue.]", "Previous studies have not assessed whether evidence-based information about the outcomes of colorectal cancer screening increases informed choice among people from a range of socioeconomic backgrounds nor have they assessed whether this can be administered away from a health-care provider.\n Randomized controlled trial in six primary care locations. Three hundred and fourteen people aged 50-74 years received a self-administered decision aid (DA) booklet about outcomes of biennial faecal occult blood testing (FOBT) screening or government consumer guidelines (G).\n Significantly more DA recipients (20.9%) were 'informed' compared with G recipients (5.8%) (P = 0.0001, OR 4.32; 95% CI 2.49 to 7.52); the DA did not affect values clarity (61.9% clear after DA versus 59.1% after G) nor screening decisions overall (87.3% would screen after DA versus 90.5% after G). Test uptake at one month was uniformly low (5.2% DA versus 6.6% G); mostly due to being 'too busy'. DA recipients were more likely to make decisions 'integrating' knowledge with values (10.4% DA versus 1.5% G). Decisions not to screen were equally uncommon in both groups but more likely to be uninformed in G (P = 0.03). More DA recipients from all education levels were 'informed' (P = 0.02), particularly in lower education (50.0% DA versus 17.8% G) and university-educated groups (79.4% DA versus 32.1% G).\n Detailed absolute risk and benefit information about FOBT screening can be effectively used at home by people to increase informed choice. The DA was effective in people with lower education levels.\n Unique Protocol ID 211705 ClinicalTrials.gov ID NCT 00148226.", "Mammography is the primary method used for breast cancer screening. However, compliance with recommended screening practices is still below acceptable levels. This study examined the cost-effectiveness of five combinations of physician recommendation and telephone or in-person individualized counseling strategies for increasing compliance with mammography.\n There were 808 participants who were randomly assigned to one of six groups. A logistic regression model with compliance as the dependent variable and group as the independent variable was used to test for significant differences and a ratio of cost to improvement in mammogram compliance evaluated the cost-effectiveness.\n Three of the interventions (in-person, telephone plus letter, and in-person plus letter) had significantly better compliance rates compared with the control, physician letter, or telephone alone. However, when considering costs, only one emerged as the superior strategy. The cost-effectiveness ratios for the five interventions show that telephone-plus-letter is the most cost-effective strategy, achieving a 35.6% mammography compliance at a marginal cost of 0.78 per 1% increase in women screened.\n A tailored phone prompt and physician reminder is an effective and economical intervention to increase mammography. Future research should confirm this finding and address its applicability to practice.\n Copyright 1999 American Health Foundation and Academic Press.", "Identifying high-risk individuals for melanoma education and risk reduction may be a viable strategy to curb the incidence of melanoma, which has risen precipitously in the past 50 years. The first-degree relatives of melanoma patients represent a risk group who may experience a 'teachable moment' for enhanced education and risk reduction.\n We report a randomized trial testing an intervention that provided personalized telephone counseling and individually tailored materials to siblings of recently-diagnosed melanoma patients. The purpose of this study was to test whether an intervention could lead to improvements in siblings' skin cancer risk reduction practices. Intervention condition participants received the following: (1) an initial motivational and goal-setting telephone intervention session delivered by the health educator; (2) three sets of computer-generated materials specifically tailored to individual responses from the baseline survey; (3) three telephone counseling sessions with the health educator, timed to follow receipt of the mailed materials; and (4) linkages to free screening programs. Families in the usual care arm received the suggestion from the physician that patients diagnosed with melanoma notify the family members about their diagnosis and encourage the family members to be screened.\n 494 siblings were recruited to the study and 403 siblings remained in the study through at least 6 months. At 12 months, intervention siblings were more likely to examine all moles, including those on the back (OR, 1.76; 95% CI, 1.06-2.91). Compared with baseline, the number of participants in both groups that had received a skin cancer examination more than doubled, with no differences between groups. At 12 months, two-thirds of siblings in both groups reported routine use of sunscreen, but there were no differences in change over baseline between the two groups.\n This study is the one of the first, to our knowledge, to address skin cancer risk-reduction strategies in a sample of individuals who have a recent family diagnosis of melanoma. Diagnosis of melanoma in a family member provides an important opportunity to intervene with others in that family. The components of the intervention may provide a useful foundation for future efforts to target the more than half million siblings at risk for melanoma, a lethal but preventable disease.", "Women that have a first-degree relative diagnosed with breast cancer at an early age are at increased risk of the disease, yet they often lack information about their personal risk of breast cancer and early detection measures. An intervention to provide objective risk information, reduce worries, and promote screening and healthy behaviors was developed.\n In 1999-2002, a randomized pre-post design was used to test a tailored telephone counseling intervention with a sample of 163 women whose sisters were diagnosed with breast cancer at age 50 or younger in the San Francisco Bay Area. Participants were interviewed by telephone regarding their breast cancer risk factors, perceived risk, worries, lifestyle factors, and screening behavior. A modified Gail model was used to compute an objective measure of individualized lifetime risk.\n Risk overestimates averaged 25 percentage points. The intervention was effective in reducing overestimates in women age 50 and over but not in those under 50. The intervention was effective in increasing physical activity and reinforcing the conviction to maintain good breast health, but not in decreasing worries or increasing screening.\n Telephone counseling appears to be a viable tool for reducing risk overestimates and promoting healthy behaviors among sisters of women with breast cancer.", "Individuals with a sibling who has had colorectal cancer diagnosed before age 61 are at increased risk for colorectal cancer and may derive particular benefit from screening. Tailored interventions may increase participation in appropriate colorectal cancer screening.\n This study evaluated the efficacy of two tailored interventions and a generic print intervention.\n Participant siblings (N = 412) who were not up-to-date with colorectal cancer screening were randomly assigned to receive either a generic print pamphlet, a tailored print pamphlet, or a tailored print pamphlet and tailored counseling call. Colorectal cancer screening 6 months after the baseline interview was the outcome measure.\n Results indicated that colorectal cancer screening adherence increased among intermediate risk siblings enrolled in all three intervention groups. Participants in both tailored intervention groups reported having colorectal cancer screening at significantly higher rates than participants in the generic print group. The increase in colorectal cancer screening in the tailored print and counseling call group was not significantly higher than that achieved by the tailored print alone. Decisional balance partially mediated treatment effects. Tailored behavioral interventions are effective methods for increasing screening adherence but telephone counseling did not add significantly to treatment effects.", "Individuals in the carpentry trade, due to lifestyle habits and occupational exposures, may be at above-average risk for colorectal cancer (CRC). Based on the literature which suggests that increasing perceived risk motivates behavior change, we report on the effectiveness of four risk-communication interventions targeted to increase initial, yearly and repeat fecal occult screening (FOBT) among carpenters (N = 860) over a 3-year period.\n Our 2 x 2 factorial design intervention study varied two dimensions of providing CRC risk factor information: (1) type of risk factor-one set of interventions emphasized three basic risk factors (age, family history and polyps); the other set emphasized a comprehensive set of risk factors including basic, lifestyle, and occupational factors, and (2) tailoring/not tailoring risk factor information. Participants were provided FOBTs. Outcomes were the proportion of returned FOBTs.\n Varying the amount and intensity of delivering CRC risk factors information affected neither risk perceptions nor initial, yearly, or repeat screening. However, yearly and repeat screening rates were greater among participants who received interventions addressing comprehensive set of risk factors, especially with increasing age.\n Tailoring on several CRC risk factors appears insufficient to increase and sustain elevated perceptions of CRC risks to promote screening.", "This study evaluated a mail and telephone intervention to improve breast health behaviors while maintaining quality of life. Women recruited from the general public were randomized to a stepped-intensity intervention consisting of mailings, telephone calls, and counseling (if requested or appropriate given a woman's genetic risk for breast cancer) or to a delayed treatment control group. Outcomes (mammography screening and quality of life) were measured at baseline in a telephone survey and again at a 12-month follow-up period. Women in the intervention group significantly increased screening mammography uptake by 12% and quality of life by 5.3 scale points compared to control participants. Changes in knowledge of breast cancer, genetic testing, and cancer worry all significantly predicted intervention changes. This successful intervention can help women make better breast health choices without causing increased worry.", "Health risk appraisal (HRA) remains one of the most widely used health promotion tools despite only equivocal evidence for its effectiveness. Theories of behavior change predict conventional HRA's ineffectiveness because risk information alone is seldom sufficient to change complex behaviors. In this study, a randomized trial compared the effects of feedback from an enhanced HRA with a typical HRA and a control group among adult patients from eight family medicine practices. The enhanced HRA assessed behavior-specific psychosocial factors and provided patients with computer-generated, individually-tailored behavior change information in addition to typical HRA risk feedback. Changes in seven behaviors were assessed at a 6 month follow-up. Overall, patients receiving enhanced HRA feedback were 18% more likely to change at least one risk behavior than were patients receiving typical HRA feedback or no feedback (OR = 1.18, 95% CI = 1.00, 1.39). The enhanced HRA feedback appeared to promote changes in cholesterol screening, dietary fat consumption and physical activity, but not in smoking, seat belt use, mammography and Pap smears. We conclude that the addition of theory-based, individually-tailored behavior change information may improve the effectiveness of HRA.", "Rates of malignant melanoma are rising, with those people with sun-sensitive skin most at risk. Health education interventions are needed to help people protect themselves by detecting early signs of melanoma and by protecting their skin from sunburn. This study aimed to evaluate the impact of an interactive multimedia intervention \"Skinsafe\" on patients' knowledge about melanoma and on their skin protective behaviors.\n In this cluster-randomized, controlled trial conducted in Nottinghamshire, UK, doctors and nurses in 5 family practices prescribed Skinsafe to patients with higher risk skin characteristics. Measures of melanoma knowledge, perceived risk of melanoma and reported skin protective behaviors were obtained at baseline and at 6-month follow-up from 259 patients receiving the intervention and 330 patients with higher risk skin characteristics in 5 matched control practices.\n Participants had low levels of melanoma knowledge at baseline. At follow-up, the intervention group had higher knowledge scores than control (3.71 vs. 3.03, P < or = 0.001), reported more protective skin behaviors (5.36 vs. 5.06, P = 0.007) and were more likely to report mole checking (odds ratio 1.67, 95% CI 1.04 to 2.70, P = 0.035). The Skinsafe intervention was evaluated positively by patients and could be used to support melanoma health education within clinical settings.", "Individuals with a first-degree relative who has had colorectal cancer are at increased risk for colorectal cancer and thus can benefit from early detection. Tailored risk counseling may increase adherence to screening guidelines in these persons. The present study evaluated a culturally sensitive Colon Cancer Risk Counseling (CCRC) intervention for relatives of colorectal cancer patients.\n A randomized trial evaluated personalized CCRC sessions with print materials and follow-up phone calls compared with a comparable General Health Counseling (GHC) intervention. One hundred and seventy-six siblings and children of colorectal cancer patients, living in Hawaii, were assessed at baseline and 4 and 12 months after intervention. Physician verification of colorectal cancer screening reports supplemented survey data.\n The CCRC intervention had a significant treatment effect at 4 months (13% greater increase than for GHC) that plateaued to a trend at 12 months. For those who were nonadherent at baseline, the CCRC led to a 17% net increase in screening adherence. Participants rated the CCRC intervention better than GHC for the amount and usefulness of new information.\n Using a study design that compared risk counseling to an attention-matched and tailored control condition provided a rigorous test of CCRC that emphasized the relevance of family experience with colorectal cancer. The combination face-to-face, phone, and small media risk counseling intervention for people with a family history of colorectal cancer should be considered for adoption in health care and public health settings.", "Barriers to screening and early detection often result in cancers in low-income and minority women diagnosed at stages too advanced for optimal treatment. This randomized controlled trial examined whether a personalized form (PF) letter containing generic cancer information and a personalized tailored (PT) letter containing minimally tailored individualized risk factor information based on medical records data affected breast and cervical cancer screening among 1574 urban low-income and minority women. The personalized form-letter group was significantly more likely to schedule a screening appointment and to have undergone a Pap test and mammography within 1 year after the intervention than were the tailored letter and control groups (P<0.001 for all comparisons). Personalized tailored letters that contain individualized cancer risk factor information may decrease the likelihood of receiving cancer screening among medically underserved low-income and minority women, but personalized form letters that contain generic cancer information may improve these rates in this disadvantaged population.", "In this large randomized trial among callers to the Cancer Information Service (CIS), tailored print materials were tested for efficacy in promoting colorectal cancer (CRC) screening (fecal occult blood test [FOBT], flexible sigmoidoscopy, or colonoscopy). All participants completed baseline interviews at the end of their usual service calls to the CIS, as well as short-term (6-month) and longer-term (14-month) telephone follow-up interviews. The study sample (n = 4,014) was restricted to English-speaking CIS callers 50 + years of age, who would be eligible for CRC screening at 14 months follow-up and did not call the CIS about CRC or CRC screening. Four experimental conditions were compared: a single untailored (SU) mailout of print material (the control condition); a single tailored (ST) mailout of print material; four (multiple) tailored (MT) mailouts of print materials spanning 12 months, all of which were tailored to information obtained at baseline; and four (multiple) retailored (MRT) mailouts also spanning 12 months, with retailoring of the print materials (mailouts 2, 3, and 4) based on updated information obtained from the 6-month follow-up interviews. Consistent with the main hypothesis of this trial, a significant linear trend across the SU, ST, MT, and MRT groups was found at 14 months (42%, 44%, 51%, and 48%, respectively, p = 0.05). Only for MT was there a significant difference compared with SU (p = 0.03) for the sample as a whole, while no differences were found for MT vs. MRT at 14 months. Significant moderator effects in the predicted direction were found among females, younger participants, and among those with a history of CRC screening, all of which involved the SU vs. MT MRT comparisons. Only among younger participants (ages 50-59) was there a difference between SU vs. ST at 14 months. Given these results, we conclude from this trial the following: (1) the MRT intervention failed to show added benefit beyond the MT intervention, (2) the significant intervention effects involving the MT and MRT conditions can be explained by tailoring and/or the longitudinal nature of both interventions, and (3) the most compelling evidence in support of tailoring was found for the ST condition among younger participants, where a significant need for interventions exists at the national level. Directions for future research are discussed in light of the results summarized above.", "To validate a self administered postal questionnaire appraising risk of coronary heart disease. To determine whether use of this questionnaire increased the percentage of people at high risk of coronary heart disease and decreased the percentage of people at low risk who had their cholesterol concentration measured.\n Validation was by review of medical records and clinical assessment. The questionnaire appraising risk of coronary heart disease encouraged those meeting criteria for cholesterol measurement to have a cholesterol test and was tested in a randomised controlled trial. The intervention group was sent the risk appraisal questionnaire with a health questionnaire that determined risk of coronary heart disease without identifying the risk factors as related to coronary heart disease; the control group was sent the health questionnaire alone.\n One capitation funded primary care practice in Canada with an enrolled patient population of about 12 000.\n Random sample of 100 participants in the intervention and control groups were included in the validation exercise. 5686 contactable patients aged 20 to 69 years who on the basis of practice records had not had a cholesterol test performed during the preceding 5 years were included in the randomised controlled trial. 2837 were in the intervention group and 2849 were in the control group.\n Sensitivity and specificity of assessment of risk of coronary heart disease with risk appraisal questionnaire. Rate of cholesterol testing during three months of follow up.\n Sensitivity of questionnaire appraising coronary risk was 87.5% (95% confidence interval 73.2% to 95.8%) and specificity 91.7% (81.6% to 97.2%). Of the patients without pre-existing coronary heart disease who met predefined screening criteria based on risk, 45 out of 421 in the intervention group (10.7%) and 9 out of 504 in the control group (1.8%) had a cholesterol test performed during follow up (P<0.0001). Of the patients without a history of coronary heart disease who did not meet criteria for cholesterol testing, 30 out of 1128 in the intervention group (2.7%) and 18 out of 1099 in the control group (1.6%) had a cholesterol test (P=0.175). Of the patients with pre-existing coronary heart disease, 1 out of 15 in the intervention group (6.7%) and 1 out of 23 in the control group (4.3%) were tested during follow up (P=0.851, one tailed Fisher's exact test).\n Although the questionnaire appraising coronary risk increased the percentage of people at high risk who obtained cholesterol testing, the effect was small. Most patients at risk who received the questionnaire did not respond by having a test.", "Computers that collect data from patients and provide both patients and practitioners with printed feedback on a range of health risks are a tool for assisting general practitioners with preventive care. This study assessed the impact of computer-generated printed feedback on cervical screening among women who were underscreened for cervical cancer.\n Female attenders at two Australian general practices were randomly allocated to Experimental or Control groups. Women in both groups completed a health risk survey on a touch screen computer prior to their consultation. Those in the Experimental group received printed pages summarizing their results, including their eligibility for cervical screening and last Pap test, for themselves and their doctor. The number and proportion of underscreened women who had a Pap test in the 6 months after completing the computer survey, as determined by pathology records, were examined.\n Of the 679 participants, 139 were classified as underscreened on the basis of self-report (74 Experimental, 65 Control) and 272 on the basis of their pathology records (148 Experimental, 124 Control). Overall about one-third of women had a test in the 6-month period, and the differences between the groups were not significant for women overall (18-70 years) or for women 18-49 years. Among women 50-70 who were underscreened based on self-report, those receiving the printout were more likely to have a Pap test in the next 6 months (P < 0.05). This pattern was also evident, but did not reach statistical significance, for older women who were underscreened based on pathology records.\n We are unable to draw conclusions regarding the effectiveness of the computer system due to the modest proportions of women screened, the small numbers, and the fact that the computer survey may have created an intervention effect in the Control group. As the study suggests the computer system is acceptable to women and may be effective for encouraging screening among older women, further exploration of the system is desirable.", "Women of all risk levels have reported high interest in obtaining genetic testing for breast cancer risk. Breast cancer risk counseling may help women to learn about their risk and appropriate options of testing. This study measured the effects of an intervention in-person and by telephone, compared to a control group.\n Participants were 340 women, recruited through a network of primary care physicians. They received a baseline questionnaire in the mail, were randomized to one of the three study arms, and completed a follow-up survey 3 months later.\n Both types of counseling were very well received. The counseling decreased women's cancer worry, risk perceptions, and intentions to pursue genetic testing. There were similar effects for both in-person and telephone counseling.\n Genetic counseling can be used to inform women at all risk levels about their breast cancer risk.\n Breast cancer risk counseling can be done in-person and by telephone--thereby reaching women in remote areas.", "We evaluated the impact of individualized breast cancer risk counseling on mammography use among women at risk for breast cancer.\n Participants (n = 508) were randomized to the breast cancer risk counseling intervention or a general health education control intervention, and 85% completed follow-up.\n In multivariate modeling, a significant group-by-education interaction demonstrated that among less-educated participants, breast cancer risk counseling led to reduced mammography use. There was no intervention effect among the more-educated participants.\n These results suggest that standard breast cancer risk counseling could have an adverse impact on the health behaviors of less-educated women.", "To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer.\n Randomised controlled trial with 6 months' follow-up.\n German statutory health insurance scheme.\n 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no history of colorectal cancer).\n Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests; official information leaflet of the German colorectal cancer screening programme (control).\n The primary end point was \"informed choice,\" comprising \"knowledge,\" \"attitude,\" and \"combination of actual and planned uptake.\" Secondary outcomes were \"knowledge\" and \"combination of actual and planned uptake.\" Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months.\n The response rate for return of both questionnaires was 92.4% (n = 1457). 345/785 (44.0%) participants in the intervention group made an informed choice, compared with 101/792 (12.8%) in the control group (difference 31.2%, 99% confidence interval 25.7% to 36.7%; P < 0.001). More intervention group participants had \"good knowledge\" (59.6% (n = 468) v 16.2% (128); difference 43.5%, 37.8% to 49.1%; P < 0.001). A \"positive attitude\" towards colorectal screening prevailed in both groups but was significantly lower in the intervention group (93.4% (733) v 96.5% (764); difference -3.1%, -5.9% to -0.3%; P<0.01). The intervention had no effect on the combination of actual and planned uptake (72.4% (568) v 72.9% (577); P = 0.87).\n Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge, with little change in attitudes. The intervention did not affect the combination of actual and planned uptake of screening. Trial registration Current Controlled Trials ISRCTN47105521.", "Colorectal cancer is second only to lung cancer as a cause of cancer death in the United States. Studies have shown that fecal occult blood (FOB) tests are effective in detecting colorectal cancer in its early stages. To increase the participation in the FOB test among the working population, a randomized controlled trial was conducted. A total 278 federal employees 40 years or older in Washington State were randomly divided into a intervention group which received a Colorectal Cancer Risk Appraisal and a control group which received a simple information letter. After three months a follow-up questionnaire was sent to all participants to measure the effectiveness of the intervention. As a result of the study, the intervention group had a 4.3% higher compliance rate with the FOB test during the three month follow-up period (p = .10). The largest effect of the intervention was on the employees' intention to get a FOB test within the next year (62.6% in the intervention group vs. 36.2% in the control group, OR = 3.18, p less than .001).", "Message tailoring, based on individual needs and circumstances, is commonly used to enhance face-to-face patient counseling. Only recently has individual tailoring become feasible for printed messages. This study sought to determine whether printed tailored recommendations addressing women's specific screening and risk status and perceptions about breast cancer and mammography are more effective than standardized printed recommendations.\n Computer-assisted telephone interviews were conducted with 435 women, aged 40 to 65 years, who had visited family practice groups within the previous 2 years. Subjects were randomly allocated to receive individually tailored or standardized mammography recommendation letters mailed from physicians to patients' homes. Follow-up interviews were conducted 8 months later.\n Tailored letter recipients were more likely to remember and to have read more of their letters than standardized version recipients. After controlling for baseline status, tailored letter receipt was associated with more favorable follow-up mammography status for women with incomes below26,000 and for Black women.\n Tailored messages are a more effective medium for physicians' mammography recommendations; tailoring may be especially important for women of low socioeconomic status.", "To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making.\n A cluster randomised controlled trial.\n Primary health care.\n Women in early pregnancy consulting a GP.\n GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting.\n Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post.\n Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes.\n A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.", "Improving strategies for risk reduction among family members of patients with melanoma may reduce their risk for melanoma.\n To evaluate the effects of two behavioral interventions designed to improve the frequency of total cutaneous skin examination by a health provider (TCE), skin self-examination (SSE), and sun protection among first degree relatives of patients with melanoma; and to evaluate whether increased intentions, increased benefits, decreased barriers, and improved sunscreen self-efficacy mediated the effects of the tailored intervention, as compared with the generic intervention on TCE, SSE, or sun protection.\n Four hundred forty-three family members (56 parents, 248 siblings, 239 children) who were nonadherent with these practices were randomly assigned to either a generic (N = 218) or a tailored intervention (N = 225) which included 3 print mailings and 1 telephone session. Participants completed measures of TCE, SSE, and sun protections at baseline, 6 months, and 1 year, and measures of intentions, benefits, barriers, and self-efficacy at baseline and 6 months.\n Those enrolled in the tailored intervention had almost a twofold increased probability of having a TCE ( p < .0001). Treatment effects in favor of the tailored intervention were also noted for sun protection habits ( p < .02). Increases in TCE intentions mediated the tailored intervention's effects on TCE. Increases in sun protection intentions mediated effects of the tailored intervention's effect on sun protection.\n Tailored interventions may improve risk reduction practices among family members of patients with melanoma.\n © 2010 APA, all rights reserved." ]
"There is strong evidence from three trials that personalised risk estimates incorporated within communication interventions for screening programmes enhance informed choices. However the evidence for increasing the uptake of such screening tests with similar interventions is weak, and it is not clear if this increase is associated with informed choices. Studies included a diverse range of screening programmes. Therefore, data from this review do not allow us to draw conclusions about the best interventions to deliver personalised risk communication for enhancing informed decisions. The results are dominated by findings from the topic area of mammography and colorectal cancer. Caution is therefore required in generalising from these results, and particularly for clinical topics other than mammography and colorectal cancer screening."
"CD007070"
[ "15998750", "16770975", "1477566", "18758677", "19501658", "18311814", "16131290" ]
[ "A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia.", "Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial.", "Electroacupuncture in fibromyalgia: results of a controlled trial.", "A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia.", "Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs).", "Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia.", "Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency." ]
"There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted."
"CD001087"
[ "9545998", "475542", "6578788", "16103032", "7953031" ]
[ "Randomized trial of general hospital and residential alternative care for patients with severe and persistent mental illness.", "A comparative trial of home and hospital psychiatric care. One-year follow-up.", "Psychiatric hospital versus community treatment: the results of a randomised trial.", "Randomised controlled trial of acute mental health care by a crisis resolution team: the north Islington crisis study.", "Home-based versus hospital-based care for people with serious mental illness." ]
"Care based on crisis intervention principles, with or without an ongoing home care package, appears to be a viable and acceptable way of treating people with serious mental illnesses. If this approach is to be widely implemented it would seem that more evaluative studies are still needed."
"CD000163"
[ "1988896", "2030849", "11423890", "8688397", "9492730", "15515998", "9740522", "8623871", "12212131" ]
[ "Peritoneal closure or non-closure at cesarean.", "A randomized study of closure of the peritoneum at cesarean delivery.", "A randomized controlled study of peritoneal closure at cesarean section.", "Nonclosure of the visceral and parietal peritoneum at caesarean section: a randomised controlled trial.", "Randomized study of non-closure of peritoneum in lower segment cesarean section.", "Closure vs non-closure of the visceral and parietal peritoneum at cesarean delivery: 16 year study.", "Closure versus non-closure of peritoneum at cesarean section--evaluation of pain. A randomized study.", "Closure or nonclosure of the visceral peritoneum at cesarean delivery.", "[Clinical analysis of 318 cases of new-mode cesarean section]." ]
"There was improved short-term postoperative outcome if the peritoneum was not closed. This in itself can support those who opt not to close the peritoneum. Long-term studies following caesarean section are limited; there is therefore no overall evidence for non-closure until long-term data become available. [Note: The 18 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]"
"CD009581"
[ "16454975" ]
[ "XS0601 reduces the incidence of restenosis: a prospective study of 335 patients undergoing percutaneous coronary intervention in China." ]
[ "XS0601, consisting of active ingredients (Chuangxiongol and paeoniflorin), has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies. The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention (PCI).\n A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 patients were randomized into treatment with the oral administration of XS0601, or a placebo for 6 months after successful PCI. Angiographic follow-up was scheduled at 6 months, and clinical follow-ups performed at 1, 3 and 6 months after PCI. The primary end point was angiographic restenosis. The secondary end points were the combined incidence of death, target lesion nonfatal myocardial infarction, repeat angioplasty, and coronary artery bypass graft surgery.\n A total of 308 patients (91.9%) completed the study and 145 cases (47.1%) received angiographic follow-up. The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group (26.0% vs. 47.2%, P < 0.05), and the minimum lumen diameter (MLD) was greater [(2.08 +/- 0.89) mm for XS0601 vs. (1.73 +/- 0.94) mm for placebo, P < 0.05]. XS0601 also significantly reduced the combined incidence of major adverse cardiac event (10.4% in the XS0601 group vs. 22.7% in the placebo group, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group (7.1% and 11.0%) as compared with those in placebo group (19.5% and 42.9%) (P < 0.05). No significant side effects occurred within the 6-month follow-up period in the XS0601 group.\n Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients." ]
"The summary estimates indicate a protective effect of Xiongshao on restenosis and suggest that Xiongshao capsule may be used to prevent restenosis after a PCI procedure in CHD patients. However, this evidence is derived from small randomised trials, all conducted in China, and two of the included trials showed important methodological limitations that undermine the validity of the findings. Additional high-quality research trials with sufficient sample size are required."
"CD009270"
[ "3941934", "7413719", "351429" ]
[ "Anticonvulsant effect of cannabidiol.", "Chronic administration of cannabidiol to healthy volunteers and epileptic patients.", "Toward drugs derived from cannabis." ]
[ "nan", "In phase 1 of the study, 3 mg/kg daily of cannabidiol (CBD) was given for 30 days to 8 health human volunteers. Another 8 volunteers received the same number of identical capsules containing glucose as placebo in a double-blind setting. Neurological and physical examinations, blood and urine analysis, ECG and EEG were performed at weekly intervals. In phase 2 of the study, 15 patients suffering from secondary generalized epilepsy with temporal focus were randomly divided into two groups. Each patient received, in a double-blind procedure, 200-300 mg daily of CBD or placebo. The drugs were administered for along as 4 1/2 months. Clinical and laboratory examinations, EEG and ECG were performed at 15- or 30-day intervals. Throughout the experiment the patients continued to take the antiepileptic drugs prescribed before the experiment, although these drugs no longer controlled the signs of the disease. All patients and volunteers tolerated CBD very well and no signs of toxicity or serious side effects were detected on examination. 4 of the 8 CBD subjects remained almost free of convulsive crises throughout the experiment and 3 other patients demonstrated partial improvement in their clinical condition. CBD was ineffective in 1 patient. The clinical condition of 7 placebo patients remained unchanged whereas the condition of 1 patient clearly improved. The potential use of CBD as an antiepileptic drug and its possible potentiating effect on other antiepileptic drugs are discussed.", "Recent work aimed at the introduction of natural and synthetic cannabinoids as drugs is reviewed. Delta1-Tetrahydrocannabinol (delta1-THC) is mainly investigated as a potential drug against glaucoma and asthma, and as an antiemetic agent in cancer chemotherapy. Cannabidiol is being tried in the clinic against epilepsy and as a hypnotic. Numerous synthetic cannabinoids are currently being investigated as analgetics and as sedative-relaxants." ]
"No reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy. The dose of 200 to 300 mg daily of cannabidiol was safely administered to small numbers of patients, for generally short periods of time, and so the safety of long term cannabidiol treatment cannot be reliably assessed."
"CD001213"
[ "8219661" ]
[ "A double-blind, randomized, placebo-controlled trial of n-3 fatty acid based lipid infusion in acute, extended guttate psoriasis. Rapid improvement of clinical manifestations and changes in neutrophil leukotriene profile." ]
[ "Twenty patients hospitalized for acute psoriasis guttata with a minimum 10% of body surface area involvement (range 10-90%) completed a 10-day trial in which they were randomly allocated to receive daily infusions with either an n-3 fatty acid based lipid emulsion [100 ml/day with 2.1 g eicosapentaenoic (EPA) and 21 g docosahexaenoic acid (DHA)] or a conventional n-6 lipid emulsion (EPA + DHA < 0.1 g/100 ml). The severity of disease was evaluated by scoring daily erythema, infiltration, and desquamation and by a subjective scoring of clinical manifestations offered by the patients. Leukotriene (LT) and platelet-activating factor (PAF) generation were investigated in ionophore-stimulated neutrophils obtained on days 0, 1, 3, 5, 10, and 40. Moderate improvement in clinical manifestations was noted in the n-6 group (changes in score systems between 16-25% from baseline within 10 days). In contrast, the severity of disease markedly decreased in all patients of the n-3 group, with improvements in all score systems ranging between 45% and 76% within 10 days (P < 0.05 for each variable). The difference in response to the two regimens was evident within 4-7 days after onset of lipid infusion. A more than ten fold increase in neutrophil EPA-derived 5-lipoxygenase product formation (LTB5, its omega-oxidation products, non-enzymatic degradation products of LTA5 and 5-hydroxyeicosapentaenoic acid) was noted in the n-3 group but not in the n-6 group. Neutrophil PAF generation increased in the n-6 group but decreased in the n-3 group. In conclusion, modulation of eicosanoid metabolism by intravenous n-3 fatty acid supplementation appears to exert a rapid beneficial effect on inflammatory skin lesions in acute guttate psoriasis." ]
"There is currently no firm evidence on which to base treatment of acute guttate psoriasis. Studies comparing standard treatment modalities, including phototherapy and topical regimens, are required to enable informed decisions on treatment choices to be made."
"CD006842"
[ "10024754", "15635998", "7675553", "11093342", "11093341", "7478782", "12004158", "9792567", "16305267", "12556258", "9674466", "9701429", "19703826", "8905888", "11391327", "2390665", "11596162", "7809441", "10497374", "7921452", "14679493" ]
[ "Effects of the flutter device on pulmonary function studies among pediatric cystic fibrosis patients.", "Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression.", "Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study.", "[Evaluation of autodrainage methods in a selected group of cystic fibrosis patients with home environment factors taken into consideration].", "[Evaluation of the efficiency of selected thoracic physiotherapy methods used in the treatment of patients with cystic fibrosis].", "Comparison of effects of an intrapulmonary percussive ventilator to standard aerosol and chest physiotherapy in treatment of cystic fibrosis.", "[Long-term evaluation of effectiveness for selected chest physiotherapy methods used in the treatment of cystic fibrosis].", "Comparison of the flutter device to standard chest physiotherapy in hospitalized patients with cystic fibrosis: a pilot study.", "Physiologic evidence for high-frequency chest wall oscillation and positive expiratory pressure breathing in hospitalized subjects with cystic fibrosis.", "A comparison of the therapeutic effectiveness of and preference for postural drainage and percussion, intrapulmonary percussive ventilation, and high-frequency chest wall compression in hospitalized cystic fibrosis patients.", "Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs autogenic drainage.", "Effects of flutter and PEP mask physiotherapy on symptoms and lung function in children with cystic fibrosis.", "Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis.", "A comparison of bronchial drainage treatments in cystic fibrosis.", "Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (flutter) physiotherapy in the treatment of cystic fibrosis.", "High-frequency chest compression system to aid in clearance of mucus from the lung.", "Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study.", "The Flutter VRP1 as an adjunct to chest physiotherapy in cystic fibrosis.", "Comparison of Flutter device and chest physical therapy in the treatment of cystic fibrosis pulmonary exacerbation.", "Comparison of high frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis.", "Comparison of active cycle of breathing and high-frequency oscillation jacket in children with cystic fibrosis." ]
"There was no clear evidence that oscillation was a more or less effective intervention overall than other forms of physiotherapy. More adequately-powered long-term randomised controlled trials are necessary."
"CD003651"
[ "12181464", "11273219" ]
[ "15 Month follow up of African children following vaginal cleansing with benzalkonium chloride of their HIV infected mothers during late pregnancy and delivery.", "Vaginal lavage with chlorhexidine during labour to reduce mother-to-child HIV transmission: clinical trial in Mombasa, Kenya." ]
[ "To study mother to child HIV-1 transmission (MTCT) and infant mortality following benzalkonium chloride (BC) disinfection.\n A randomised, double blind phase II placebo controlled trial. Women testing positive for HIV-1 infection in prenatal care units in Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso, from November 1996 to April 1997 were eligible, with their informed consent. Women self administered daily a vaginal suppository of 1% BC (53) or matched placebo (54) from 36 weeks of pregnancy, plus a single dose during labour. The neonate was bathed with 1% BC solution or placebo within 30 minutes after birth. MTCT rate was assessed based on repeated polymerase chain reaction (PCR) and serology results. For the present analysis, children were followed up to 15 months.\n A total of 107 women were enrolled. Of 103 eligible liveborn children, 23 were HIV infected, 75 uninfected, and five of indeterminate status. MTCT transmission rate was 24.2% overall (95% confidence interval (CI): 14.3% to 30.4%). On an intent to treat basis, the transmission rate did not differ between the two groups (23.5%, CI 13.8 to 38.5, in the BC group and 24.8%, CI 15.0 to 39.6, in the placebo group at 15 months). Similarly, there was no difference in mortality at 15 months (22.9%, CI 13.7 to 36.9, in the BC group and 16.5%, CI 9.0 to 29.4, in the placebo group).\n This analysis failed to suggest any benefit of BC disinfection on mother to child HIV transmission or perinatal and infant mortality.", "To evaluate the effect of vaginal lavage with diluted chlorhexidine on mother-to child transmission of HIV (MTCT) in a breastfeeding population.\n This prospective clinical trial was conducted in a governmental hospital in Mombasa, Kenya. On alternating weeks, women were allocated to non-intervention or to intervention consisting of vaginal lavage with 120 ml 0.2% chlorhexidine, later increased to 0.4%, repeated every 3 h from admission to delivery. Infants were tested for HIV by DNA polymerase chain reaction within 48 h and at 6 and 14 weeks of life.\n Enrolment and follow-up data were available for 297 and 309 HIV-positive women, respectively, in the non-lavage and the lavage groups. There was no evidence of a difference in intrapartum MTCT (17.2 versus 15.9%, OR 0.9, 95% CI 0.6-1.4) between the groups. Lavage solely before rupture of the membranes tended towards lower MTCT with chlorhexidine 0.2% (OR 0.6, 95% CI 0.3-1.1), and even more with chlorhexidine 0.4% (OR 0.1, 95% CI 0.0-0.9).\n The need remains for interventions reducing MTCT without HIV testing, often unavailable in countries with a high prevalence of HIV. Vaginal lavage with diluted chlorhexidine during delivery did not show a global effect on MTCT in our study. However, the data suggest that lavage before the membranes are ruptured might be associated with a reduction of MTCT, especially with higher concentrations of chlorhexidine." ]
"Currently, there is no evidence of an effect of vaginal disinfection on the risk of MTCT of HIV. Given its simplicity and low cost, there is need for a large well-designed and well-conducted randomised controlled trial to assess the additive effect of vaginal disinfection on the risk of MTCT of HIV in antiretroviral treated women."
"CD006745"
[ "9425919", "12889565", "15973099", "16009687" ]
[ "Prospective randomized controlled trial comparing percutaneous acetic acid injection and percutaneous ethanol injection for small hepatocellular carcinoma.", "Comparison of percutaneous acetic acid injection and percutaneous ethanol injection for hepatocellular carcinoma in cirrhotic patients: a prospective study.", "Percutaneous ethanol injection versus surgical resection for the treatment of small hepatocellular carcinoma: a prospective study.", "Randomised controlled trial comparing percutaneous radiofrequency thermal ablation, percutaneous ethanol injection, and percutaneous acetic acid injection to treat hepatocellular carcinoma of 3 cm or less." ]
[ "To assess whether ultrasound-guided percutaneous acetic acid injection is superior to percutaneous ethanol injection in the treatment of small hepatocellular carcinoma (HCC), 60 patients with one to four HCCs smaller than 3 cm were entered onto a randomized controlled trial. Thirty-one and 29 patients, respectively, were treated by percutaneous acetic acid injection using 50% acetic acid or by percutaneous ethanol injection using absolute ethanol. There were no significant differences in age, sex ratio, Child-Pugh class, size of tumors, or number of tumors between the two groups. When there was no evidence of viable HCC from biopsy, plain and helical dynamic computed tomography, or angiography, the treatment was considered successful and was discontinued. All original tumors were treated successfully by either therapy. However, 8% of 38 tumors treated with percutaneous acetic acid injection and 37% of 35 tumors treated with percutaneous ethanol injection developed a local recurrence (P < .001) during the follow-up periods of 29 +/- 8 months and 23 +/- 10 months, respectively. The 1- and 2-year survival rates were 100% and 92% in percutaneous acetic acid injection and 83% and 63% in percutaneous ethanol injection (P = .0017). A multivariate analysis of prognostic factors revealed that treatment was an independent predictor of survival. The risk ratio of percutaneous acetic acid injection versus percutaneous ethanol injection was 0.120 (range, 0.027-0.528; P = .0050). In conclusion, percutaneous acetic acid injection is superior to percutaneous ethanol injection in the treatment of small HCC.", "Ultrasound-guided percutaneous ethanol injection (PEI) and percutaneous acetic acid injection (PAI) are effective in the treatment of hepatocellular carcinoma (HCC). We conducted a prospective study to compare the therapeutic efficacy of both these methods.\n Sixty-three patients were treated by PAI using 50% acetic acid and 62 by PEI using pure ethanol. There were no significant baseline differences in age, sex, Child-Pugh class, tumour size and number, or other clinico-biochemical parameters between the two groups.\n During a follow-up period of 24 +/- 9 (range 6-38) months, 19 (30%) of the PAI group and 21 (34%) of the PEI group died (P = 0.704). The 1- and 3-year survival rates were 84% and 51% for the PAI group and 81% and 46% for the PEI group (P = 0.651). The corresponding tumour recurrence rates were 51% and 74% for the PAI group, and 54% and 64% for the PEI group (P = 0.787). The treatment sessions were 3.9 +/- 1.6 and 6.2 +/- 2.3 for the PAI and PEI groups, respectively, in each treatment cycle (P = 0.008). A multivariate analysis using the Cox regression model revealed that ascites (relative risk (RR) 3.1, 95% confidence interval (CI) 1.5-6.3, P = 0.002), large (>3 cm) or multinodular HCCs (RR 2.4, 95% CI 1.1-5.4, P = 0.04), and development of tumour recurrence (RR 7.0, 95% CI 3.1-16.0, P < 0.001) were independent, poor prognostic factors in both groups.\n PAI and PEI are equally effective in the treatment of HCC. PAI has the advantage of fewer treatment sessions in each treatment course. Careful pretreatment patient selection may improve survival.", "To compare disease recurrence and survival among patients with small hepatocellular carcinoma after surgical resection or percutaneous ethanol injection therapy, 2 treatments that have not been evaluated with a prospective study.\n A total of 76 patients were randomly assigned to 2 groups based on treatment; all had one or 2 tumors with diameter </=3 cm, with hepatitis without cirrhosis or Child class A or B cirrhosis without evident ascites or bleeding tendency.\n Follow-up ranged from 12 to 59 months. Among percutaneous injection patients, 18 had recurrence 1 to 37 months after treatment (true recurrence, 11; original safety margin inadequate, 3; limitation of imaging technology to detect tiny tumors, 4). Three injection therapy patients died of cancer 25, 37, and 57 months after treatment. For the surgical resection group, 15 had recurrence 2 to 54 months after treatment (true recurrence, 12; limitation of imaging, 2; neck metastasis, 1). Five resection patients died of cancer at 11, 20, 23, 26, and 52 months, respectively. By Cox regression model and Kaplan-Meier survival analysis, there is no statistical significance for recurrence and survival between treatment groups. However, tumor size larger than 2 cm and alpha-fetoprotein over 200 ng/mL correlated with higher recurrence rate, and Child class B liver cirrhosis correlated with shorter survival.\n Percutaneous ethanol injection therapy appears to be as safe and effective as resection, and both treatments can be considered first-line options for small hepatocellular carcinoma.", "The aim of this study was to compare the outcomes of radiofrequency thermal ablation (RFTA), percutaneous ethanol injection (PEI), and percutaneous acetic acid injection (PAI) in the treatment of hepatocellular carcinoma (HCC).\n A total of 187 patients with HCCs of 3 cm or less were randomly assigned to RFTA (n = 62), PEI (n = 62), or PAI (n = 63). Tumour recurrence and survival rates were assessed.\n One, two, and three year local recurrence rates were 10%, 14%, and 14% in the RFTA group, 16%, 34%, and 34% in the PEI group, and 14%, 31%, and 31% in the PAI group (RFTA v PEI, p = 0.012; RFTA v PAI, p = 0.017). One, two, and three year survival rates were 93%, 81%, and 74% in the RFTA group, 88%, 66%, and 51% in the PEI group, and 90%, 67%, and 53% in the PAI group (RFTA v PEI, p = 0.031; RFTA v PAI, p = 0.038). One, two, and three year cancer free survival rates were 74%, 60%, and 43% in the RFTA group, 70%, 41%, and 21% in the PEI group, and 71%, 43%, and 23% in the PAI group (RFTA v PEI, p = 0.038; RFTA v PAI, p = 0.041). Tumour size, tumour differentiation, and treatment methods (RFTA v PEI and PAI) were significant factors for local recurrence, overall survival, and cancer free survival. Major complications occurred in 4.8% of patients (two with haemothorax, one gastric perforation) in the RFTA group and in none in two other groups (RFTA v PEI and PAI, p = 0.035).\n RFTA was superior to PEI and PAI with respect to local recurrence, overall survival, and cancer free survival rates, but RFTA also caused more major complications." ]
"PEI and PAI do not differ significantly regarding benefits and harms in patients with early HCC, but only a limited number of patients have been examined and the risk of bias was high in all trials. There is also insufficient evidence to determine whether PEI or segmental liver resection is more effective. While some data from the single trial suggested that PEI was safer, the high risk of bias and the lack of any confirmatory evidence make an assessment impossible."
"CD000299"
[ "8150348", "7047267", "2007362", "8147352", "6363219" ]
[ "Controlled trial of anti-tuberculous chemotherapy for two years in Crohn's disease.", "Sulphadoxine-pyrimethamine therapy in Crohn's disease.", "Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo.", "Antimycobacterial therapy in Crohn's disease: results of a controlled, double-blind trial with a multiple antibiotic regimen.", "Controlled trial of rifampicin and ethambutol in Crohn's disease." ]
[ "One hundred and thirty patients with active symptoms of Crohn's disease were treated in a double blind randomised controlled trial with rifampicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analyses were based on 126 patients, 63 in each treatment group. Thirty seven in the active and 30 in the placebo group had previous surgical procedures. There was no difference in concomitant treatment between the two groups. Thirty in the active and 46 in the placebo groups were taking corticosteroids at entry to the trial. Forty eight of 63 patients in the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adverse reaction, and failure to comply. There was no significant difference in the mean number of months completed between the two groups. Nineteen adverse reactions were recorded for 17 patients in the active group compared with three reactions in patients on placebo. All of the nine patients withdrawn early because of adverse reactions were in the active group. Fifteen patients on active treatment and 14 on placebo had surgery during the trial with no difference in the type of surgery required between the groups. Radiological assessments based on 98 patients at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strictures on placebo compared with active treatment but without a statistically significant difference. No differences were found between groups for the total prednisolone dose or the number of days on which prednisolone dose was 10 mg or above. Serial measurements of body weight and Crohn's disease activity index (CDAI) together with blood values for albumin, haemoglobin, white cell count, and platelets showed no consistent different differences between groups. There were occasional significant differences for some of these values between groups, which were not sustained. The trail provides little evidence of tangible benefit from the trail treatment.", "nan", "In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N = 25) or to steroids and matching placebo (N = 24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12; P = NS) with a fall in disease activity score from 10.5 +/- 4.4 to 3.3 +/- 3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6; P = NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.", "Several recent reports have suggested an association of atypical mycobacteria with Crohn's disease.\n The goal of this double-blind, placebo-controlled trial was to determine the efficacy of treatment with antimycobacterial drugs in maintaining clinical remission and in reducing active inflammatory lesions.\n Forty patients (15 male) with refractory, steroid-dependent Crohn's disease were randomized to receive 2 months of tapering steroids plus either a 9-month regimen of ethambutol, clofazimine, dapsone and 1-day dose only of rifampicin (n = 22), or identical placebo.\n Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months. Three of the remaining 19 patients on active drug relapsed during the study period, compared with 11 of 17 on placebo (log likelihood ratio = 4.6; p = 0.03). Another patient was withdrawn in remission at 5 months for anemia related to dapsone. Nine patients whose disease relapsed or persisted on placebo were crossed over to active drug; five achieved sustained remission, two failed, and two were withdrawn for side effects. Substantial endoscopic or radiologic healing did not occur.\n This study suggests that the treatment regimen with rifampicin, ethambutol, clofazimine, and dapsone is effective in relief of symptoms and maintenance of remission in some Crohn's disease patients.", "We pursued the possibility that Mycobacterium kansasii might be an aetiological agent in Crohn's disease by carrying out a trial of treatment with antimycobacterial drugs. Twenty seven patients with Crohn's disease took part in a two year randomised double blind, crossover, controlled trial of rifampicin plus ethambutol against placebo. Fourteen patients completed the trial; four required an operation; five were withdrawn as poor compliers, and four because of adverse effects. There was no significant difference in response to the active drugs compared with placebo when expressed in terms of a Crohn's disease activity index or any clinical indicator of disease activity. There was no suggestion that any subgroup of patients - for example, different regions of bowel affected or previous operation - were favourably affected by the drugs. There was no consistent pattern of change in prednisolone requirements although eight patients on long term sulphasalazine had a significant reduction in their plasma sulphapyridine concentrations during the active treatment period. A significant reduction in total white blood count and an increase in plasma ALT were seen during active therapy. The results of the study do not suggest that rifampicin and ethambutol have a role to play in the treatment of Crohn's disease." ]
"Anti-tuberculous therapy may be effective in maintaining remission in patients with Crohn's disease when remission has been induced with corticosteroids combined with anti-tuberculous therapy. However, the results which support this conclusion come from a subgroup of only two trials with small numbers of patients and should be interpreted with caution. Use of this therapy cannot be recommended on the basis of this evidence."
"CD007893"
[ "8948303", "8564089", "1677063", "7594425", "7589392", "3169499", "9832182", "1970370", "2193613", "3281603", "9468460", "2676910", "1986287", "10964582", "8215491", "8007592" ]
[ "Adding low-dose cyclosporin A to parenteral gold therapy in rheumatoid arthritis: a double-blind placebo-controlled study.", "Double-blind, placebo-controlled study of cyclosporin A as a corticosteroid-sparing agent in corticosteroid-dependent asthma.", "Double-blind, controlled, crossover study of cyclosporin in adults with severe refractory atopic dermatitis.", "Serial changes in blood pressure, renal function, endothelin and lipoprotein (a) during the first 9 days of cyclosporin therapy in males.", "Treatment of steroid-dependent bronchial asthma with cyclosporin.", "Pilot study of cyclosporin A in patients with symptomatic primary biliary cirrhosis.", "Lack of effect of a single oral dose of cyclosporine on systemic blood pressure and on forearm blood flow and vascular resistance in humans.", "Low-dose cyclosporin versus placebo in patients with rheumatoid arthritis.", "Efficacy and toxicity of cyclosporine in chronic progressive multiple sclerosis: a randomized, double-blinded, placebo-controlled clinical trial. The Multiple Sclerosis Study Group.", "Cyclosporin in rheumatoid arthritis: a double blind, placebo controlled study in 52 patients.", "Cyclosporine-induced hypertension and decline in renal function in healthy volunteers.", "[Results of cyclosporin treatment of severe, chronic psoriasis vulgaris].", "Cyclosporine for plaque-type psoriasis. Results of a multidose, double-blind trial.", "Each administration of cyclosporin A enhances skin microvascular reactivity in renal transplant recipients.", "Cyclosporine in the treatment of palmoplantar pustulosis. A randomized, double-blind, placebo-controlled study.", "Sequential effects of cyclosporine therapy on blood pressure, renal function and neurohormones." ]
"Cyclosporine statistically significantly increases blood pressure compared to placebo in a dose-related fashion. The magnitude of increase in blood pressure is clinically significant and increases the risk of stroke, myocardial infarction, heart failure and other adverse cardiovascular events associated with elevated BP. Consequently prescribers should try to find the lowest effective dose in all patients receiving cyclosporine chronically."
"CD000066"
[ "19793585", "3305229", "21742284", "18715434", "1609525" ]
[ "Prevention of striae gravidarum with cocoa butter cream.", "[Effectiveness of Alphastria cream in the prevention of pregnancy stretch marks (striae distensae). Results of a double-blind study].", "Effects of olive oil on striae gravidarum in the second trimester of pregnancy.", "Cocoa butter lotion for prevention of striae gravidarum: a double-blind, randomised and placebo-controlled trial.", "[Attempt of preventive treatment of striae gravidarum using preventive massage ointment administration]." ]
"We found no high-quality evidence to support the use of any of the topical preparations in the prevention of stretch marks during pregnancy. There is a clear need for robust, methodologically rigorous randomised trials involving larger sample sizes to evaluate the effects of topical preparations on the development of stretch marks in pregnancy. In addition, it is important that preparations commonly used by women to prevent and treat stretch marks are evaluated within the context of robust, methodologically rigorous and adequately powered randomised trials."
"CD009009"
[ "3711252", "4569090", "19664653", "3797397", "12100779", "1256483", "4723642", "3903732", "4669179", "9602398", "7112052", "594708", "3720755", "608798" ]
[ "Multiphasic Health Checkup Evaluation: a 16-year follow-up.", "Social research problems in studies involving multiphasic health testing.", "Five years of lifestyle intervention improved self-reported mental and physical health in a general population: the Inter99 study.", "Systematic risk factor screening and education: a community-wide approach to prevention of coronary heart disease.", "General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up.", "A controlled trial of multiphasic screening.", "A study to evaluate the effectiveness of multiphasic screening in Yugoslavia.", "WHO European Collaborative Trial of multifactorial prevention of coronary heart disease.", "Impact of a screening programme in general practice: a randomized controlled trial.", "Effects of an assessment of needs for medical and social services on long-term mortality: a randomized controlled study.", "The influence of repeated health examinations on mortality in a prospective cohort study, with a comment on the autopsy frequency. The study of men born in 1913.", "Effects of a health screening on mortality and causes of death in middle-aged men. A prospective study from 1970 to 1974 of mean in Malmö, born 1914.", "The multifactor primary prevention trial in Göteborg, Sweden.", "A controlled trial of multiphasic screening in middle-age: results of the South-East London Screening Study. The South-East London Screening Study Group." ]
"General health checks did not reduce morbidity or mortality, neither overall nor for cardiovascular or cancer causes, although the number of new diagnoses was increased. Important harmful outcomes, such as the number of follow-up diagnostic procedures or short term psychological effects, were often not studied or reported and many trials had methodological problems. With the large number of participants and deaths included, the long follow-up periods used, and considering that cardiovascular and cancer mortality were not reduced, general health checks are unlikely to be beneficial."
"CD008613"
[ "14686958" ]
[ "Effect of hormone replacement therapy on cardiovascular risk factors in postmenopausal women with diabetes." ]
[ "Hormone replacement therapy (HRT) in postmenopausal women improves menopausal symptoms, decreases the incidence of osteoporotic fracture, but the effects on cardiovascular risk factors remain controversial.\n To test the hypothesis that HRT may have beneficial effects on the cardiovascular risk profile in postmenopausal women with diabetes.\n One hundred and fifty postmenopausal patients with type 1 (T1DM) and type 2 diabetes (T2DM) were randomized to receive HRT (Kliofem) or placebo for 12 months. We monitored the effects on cardiovascular risk factors, including lipid profile, glycaemic control, blood pressure and body weight.\n Mean low-density lipoprotein (LDL) cholesterol was associated with a nonsignificant decrease [-0.14 mmol/l (CI=-0.44, 0.17) (p=0.37)] in the Kliofem-treated group. Total cholesterol fell by 0.42 mmol/l (CI=-0.78, -0.05) (p=0.027). High-density lipoprotein (HDL) cholesterol was reduced by a mean of 0.07 mmol/l compared to a mean rise of 0.12 mmol/l on placebo. There were apparent differences in the treatment effects between T1DM and T2DM. There was no change in triglycerides or apoprotein B and no effect on glycaemic control, blood pressure or menopausal symptom scores. In the Kliofem group, BMI fell by 0.66 kg/m2 compared to an increase of 0.14 kg/m2 for placebo patients (p=0.046).\n Although the long-term effects of HRT in women with or without diabetes appear to suggest that some types of HRT either confer no cardiovascular protection or may increase risk, the impact of Kliofem diabetic women on cardiovascular risk factors is probably neutral." ]
"There is a lack of evidence around the use of HRT in women with type 1 diabetes. The one study that has been undertaken in this area is underpowered. More RCTs are required in the area to examine the impact of HRT on glycaemic control and cardiovascular outcomes."
"CD006286"
[ "17533178", "18179756", "20430451", "23119911", "7862473", "12612277" ]
[ "The role of mometasone furoate aqueous nasal spray in the treatment of adenoidal hypertrophy in the pediatric age group: preliminary results of a prospective, randomized study.", "Intranasal flunisolide treatment in children with adenoidal hypertrophy.", "Medical treatment of adenoid hypertrophy with \"fluticasone propionate nasal drops\".", "Chronic adenoid hypertrophy in children - is steroid nasal spray beneficial?", "Pediatric adenoidal hypertrophy and nasal airway obstruction: reduction with aqueous nasal beclomethasone.", "Frequency of surgery among children who have adenotonsillar hypertrophy and improve after treatment with nasal beclomethasone." ]