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CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

[Management of postoperative transurethral catheterization with two technics for bladder drainage in surgery for pelvic floor relaxation].

Fifty patients with diagnoses of pelvic floor relaxation or stress urinary incontinence were randomly allocated to either transurethral closed, or transurethral open bladder drainage after vaginal surgery for pelvic floor relaxation or stress urinary incontinence. Postoperative normal bladder function resumed more rapidly when transurethral closed drainage was used (P < 0.05). Postoperative use transurethral closed bladder drainage significantly reduced urinary tract infection (P < 0.05), so most of the patients didn't need bladder catheterization at time of discharge, as opposed to more than half those with transurethral open drainage, who left the hospital with a catheter in place (P < 0.05). We that is both beneficial and efficient to use transurethral closed bladder drainage than transurethral open bladder drainage after a pelvic floor relaxation or stress urinary incontinence surgery.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Early removal advances discharge home. Comparison of midnight and early morning catheter removal following prostatectomy.

Resumption of normal voiding is necessary before prostatectomy patients can be discharged from hospital. This study assesses the effect upon this of the timing of catheter removal.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Timing of antibiotic prophylaxis with cefotaxime for prostatic resection: better in the operative period or at urethral catheter removal?

There are two critical moments for the development of severe infectious complications following transurethral prostatectomy (TURP): the operative and immediate postoperative periods, and the day that the postoperative drainage catheter is removed. To optimize the timing of antibiotic prophylaxis with cefotaxime, two prospective randomized studies were conducted in patients with preoperatively sterile urine. In Study 1, all patients (n = 50) received cefotaxime 1 g intramuscular (i.m.) 1 hour preoperatively and were then randomized to receive either a second identical dose of cefotaxime 1 hour before catheter removal 24 hours later, or no further antibiotic treatment. In Study 2, patients (n = 89) were randomized to receive either cefotaxime 1 g i.m. 1 hour preoperatively or no preoperative antibiotic, after which all received cefotaxime 1 g i.m. 1 hour before catheter removal. Results were compared using identical evaluation criteria for infection in both studies: incidence of fever (temperature > 38 degrees C), bacteriuria (10(5) organisms/mL) and positive blood cultures, and duration of hospital stay (days). In Study 1, infection was significantly reduced with respect to all parameters in the group receiving two doses of cefotaxime, and total drug treatment costs were halved. In Study 2, the groups did not differ with respect to any parameter. We conclude that a single dose of cefotaxime 1 g i.m. 1 hour preoperatively provides inadequate cover for urethral catheter removal 24 hours later, and that prophylaxis with a single dose of cefotaxime 1 g i.m. 1 hour before catheter removal is just as effective as two doses given 1 hour preoperatively and 1 hour before catheter removal. Prophylactic coverage is essential during the action of removing the catheter and the time immediately following the operation. Long-term antibiotic coverage (24 hours or more) is not necessary. Thus, following TURP in patients with preoperatively sterile urine undergoing continuous bladder irrigation for 24 hours postoperatively, the optimal dose schedule for antibiotic prophylaxis with cefotaxime is a single 1-g dose given i.m. 1 hour before catheter removal.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

A comparison of midnight versus early morning removal of urinary catheters after transurethral resection of the prostate.

This article describes a study that compares the outcomes of midnight versus early morning urethral catheter removal after transurethral resection of the prostate. SUBJECTS AND SETTING/METHODS: The research setting was a large, metropolitan hospital in Sydney, Australia. Forty-eight patients who had undergone transurethral resection of the prostate were randomly assigned to either group A, catheter removal at 2400 hours (n = 20), or group B, catheter removal at 0600 hours (n = 28). Data collected included time to first void, volume of first void, time between catheter removal and discharge from hospital, weight of prostatic resection, and tissue pathology. There was no significant difference between the 2 groups with respect to pathology, weight of prostatic resection, mean volume of first void, or time to first void after catheter removal. There was a significant difference in the time between catheter removal and discharge from hospital. Eighty-five percent of those having catheters removed at 2400 hours were discharged on the same day as catheter removal, as compared with 65% of those who underwent catheter removal at 0600 hours (chi 2 = 12.684; P < 0.005). After transurethral resection of the prostate, removal of the urethral catheter at 2400 hours reduced the length of hospital stay, but did not significantly affect the time to first void or the volume of the first void.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

[Handling of Foley catheter regarding urinary retention syndrome following vaginal surgery].

The post surgical urinary retention syndrome is a frequent problem after vaginal surgery. In many medical centers it is used a transurethral vesical drainage for three to five days with or without vesical reeducation to prevent it. In order to determine the importance of the time of drainage and vesical reeducation in the presence of this syndrome 106 patients submitted to vaginal surgery were studied at random and prospectively, in our service. Patients were distributed in three groups: the first one, with 37 women in which the drainage was withdrawn at 24 hours; in the second group it was retired at 72 hours and in the third group the drainage was removed at 72 hours with previous vesical reeducation. The results show that those patients who were less time under vesical drainage presented a minor frequency of urinary retention after surgery (24.3% vs 30.7% and 43.7%).

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Are in-dwelling catheters necessary for 24 hours after hysterectomy?

In-dwelling catheters for 24 hours after operation are used routinely in gynecologic surgery. This study assesses whether the immediate removal of an in-dwelling catheter after the operation affects the rate of recatheterization, febrile morbidity, symptomatic urinary tract infections, or subjective pain assessments. This study was a prospective randomized controlled trial comprised of 250 women who underwent hysterectomy and who did not require bladder suspension or strict fluid treatment. The in-dwelling catheter was removed either immediately after the operation or on the first day after the operation. The association between clinical variables and the length of catheterization were assessed by chi-squared analysis. Patients were assigned randomly into 2 groups, with no significant differences in the outcomes, only in the perception of pain. Clinical events included fever (>/=38.5 degrees C) that occurred in 6 patients in the in-dwelling catheter group compared with 5 patients in the early removal group (P=.01), symptomatic urinary tract infections in 3 patients in both groups (P=.99), and recatheterization in 3 patients in the in-dwelling catheter group compared with 5 patients in the early removal group (P=.17). Subjectively, patients in the early removal group reported significantly less pain than did the in-dwelling group (P<.001). The early removal of in-dwelling catheters after operation was not associated with an increased rate of febrile events, urinary tract infections, or need for recatheterization. In addition, subjective pain assessment was significantly less in the early removal group. Early removal of an in-dwelling catheter immediately after operation is not associated with adverse events.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate.

To examine the effect of bladder infusion before catheter removal on patients' readiness for discharge and the day of discharge after transurethral resection of the prostate (TURP). The study comprised 75 consecutive patients undergoing TURP who were randomized to either have their catheter removed in the standard manner (38 patients), or to undergo bladder infusion before a trial of voiding (ToV) on the second day after TURP (37 patients). In those undergoing bladder infusion, seven (19%) patients were discharged on the same day as their ToV, compared with five (13%) in the standard group. Of the 75 patients, 15 (68%) were discharged by the third day after TURP whether or not the bladder had been filled. In the infusion group, 23 (62%) were ready for discharge on the same day as their TOV, compared with only 14 (37%) in the standard group (P < 0.05). Bladder infusion before a ToV after TURP significantly increases the rate of readiness for discharge, allowing an early decision to discharge on the second day in a large proportion of patients.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery.

This prospective study was done to see if reducing transurethral Foley catheterization from 3 days to 1 would lead to fewer urinary tract infections without an increase in voiding problems. Ninety-one women undergoing retropubic surgery for stress urinary incontinence (Burch or Marshall-Marchetti-Krantz) were randomized to either 1 or 3 days' catheterization. Antibiotics were not used. Infection was diagnosed in 9 (20.0%) patients in the 1-day group and in 16 (34.8%) in the 3-day group. Delayed voiding occurred in 13 (28.9%) and 10 (21.7%) patients, respectively, and 5 (11.1%) and 3 (6.5%), respectively, received a new catheter. The differences do not reach statistical significance. Therefore, catheter time may safely be reduced to 1 day. This may lead to fewer infections but also somewhat more voiding problems. If a transurethral catheter is to be used, on balance the two regimens are equivalent.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Postoperative urinary bladder irrigation in the female; a controlled trial.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Could the incidence of postoperative urinary tract infection be reduced by reversing the sequence of vaginal cleansing and urethral catheterization?

Postoperative urinary tract infection (UTI) is a common hospital infection after gynaecological operations. A prospective randomized study was performed to examine whether the incidence of UTI could be reduced by reversing the sequence of vaginal cleansing and urethral catheterization. Subjects were randomly allocated to: (1) urethral catheterization before vaginal cleansing; and (2) urethral catheterization after vaginal cleansing. Urine cultures were performed immediately after the procedures as the baseline, on the day of catheter removal, and two days after catheter removal. Patients were examined daily after the operation for any urinary symptoms and fever. The incidences of preoperative asymptomatic bacteriuria were similar in both groups, seven of 84 in group 1 vs. eight of 83 in group 2. Among those with negative urine culture before the operation, 77 in group 1 and 75 in group 2, there was no significant difference in postoperative bacteriuria at catheter removal (23 vs. 22) and two days later (35 vs. 42). No significant difference was noted in the incidence of UTI (5 vs. 10, P = 0.25), with a trend towards less UTI in group 1. Voiding discomfort was more common, and fever less common in group 1. There were significant associations between urine culture results at three different occasions. Bacteriuria at catheter removal is associated with a 7.2 times risk of bacteriuria two days later, 2.4 times risk of urinary symptoms and 3.2 times risk of UTI. Routine surveillance at catheter removal is not cost-effective. We conclude that postoperative bacteriuria and UTI are common. Reversing the sequence of the procedures cannot reduce the incidence. There is no evidence to change the status quo.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Suprapubic versus transurethral bladder drainage after colposuspension/vaginal repair.

Ninety-two patients with preoperative sterile urine undergoing colposuspension or vaginal repair operation for stress urinary incontinence and/or genital descensus were randomized to either suprapubic or transurethral postoperative catheter drainage. The prevalence of significant bacteriuria on the fifth postoperative day was statistically significantly lower when using suprapubic catheter (20.8%) than with transurethral catheter drainage (45.5%). This applied especially to colposuspension. The rate of postoperatively impaired bladder emptying also tended to be reduced when using suprapubic catheter. At follow-up after one year, postoperative bacteriuria was closely correlated to increased rates of both clinical cystitis and asymptomatic significant bacteriuria. Thus it is recommended to use suprapubic bladder drainage not only after colposuspension but also after vaginal repair in an effort to avoid an increased risk of urinary infections.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Urinary drainage following radical hysterectomy for cervical carcinoma - a pilot comparison of urethral and suprapubic routes.

Twenty-four patients who underwent radical hysterectomy and pelvic node dissection for cervical carcinoma were randomized in a pilot study to compare continuous postoperative drainage by urethral and suprapubic catheters. There were no statistically significant differences in either the duration of continuous catheter drainage before the return of spontaneous voiding or the incidence of urinary tract infection in the two groups. Power calculations reveal that 628 patients require to be entered into each arm of a future study in order to be able to detect the former difference should it exist (alpha = 0.05, beta = 0.2, difference = 16% of one s.d.) and 41 in the latter (alpha = 0.05, beta = 0.2, 92.9% urethral group had UTI, 70% suprapubic group had UTI). We conclude that differences in these objective measures of catheter efficacy and morbidity between the groups, if they exist, are clinically irrelevant. On this basis we suggest that individual gynaecological oncologists should continue to use whichever method of catheter drainage best suits their clinical practice.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Early catheter removal following radical perineal prostatectomy: a randomized clinical trial.

Radical perineal prostatectomy allows for a watertight closure of the urethrovesical anastomosis. This trial determined that early catheter removal may be feasible and desirable in patients undergoing radical perineal prostatectomy. Early catheter removal can lead to improved patient comfort and well-being.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Removal of urinary catheters: midnight vs 0600 hours.

In the fields of both nursing and medicine there is a dearth of published literature on the optimum time to remove indwelling urinary catheters (IDCs) following urological surgery. Tradition seems to be in favour of removing IDCs at 0600 hours despite a lack of evidence to support this practice. This study was undertaken to determine whether midnight removal of IDCs resulted in patients' resuming normal voiding patterns. A prospective clinical trial was conducted to determine the impact midnight removal of urinary catheters would have on the patients' voiding pattern, and subsequent discharge from hospital. One hundred and sixty patients were entered into the study. The patients were allocated at random to have their urinary catheter removed either at midnight or at 0600 hours. Patients who had their catheters removed at midnight passed a greater volume of urine with both their first (268 ml compared with 177 ml; P<0.0001) and second voids (322 ml compared with 195 ml; P<0.0001) than their counterparts in the 0600 group. This permitted earlier discharge from hospital. The results reported in this study support the findings of earlier research that midnight removal of IDC leads to an earlier resumption of normal voiding patterns, permits earlier discharge from hospital and appears to reduce patients' anxiety. The recommendation from this study is that there should be a change in hospital policy so that the majority of IDCs are removed at midnight.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Early catheter removal following transurethral prostatectomy--impact on length of hospital stay.

To investigate whether early catheter removal following transurethral prostatectomy (TURP) is safe and whether it has any effect on the length of hospital stay. Following transurethral prostatectomy 59 patients were randomized into one of two groups: those whose catheter was removed on day 1 after surgery and those whose catheter was removed on day 2. The incidence of complications and the duration of post-operative hospital stay were assessed. Catheter removal on day 1 led to a significantly shorter post-operative hospital stay (2.3 days versus 3.3 days) and did not incur a higher incidence of complications. Removal of the catheter on the first day following TURP is safe in selected patients and leads to a shorter post-operative hospital stay.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Postoperative care following internal urethrotomy.

A randomized prospective study was set up to assess the role of postoperative catheter drainage and the value of hydraulic self-dilatation of the urethra after internal urethrotomy. Sixty-two patients were admitted into the study and followed-up for two years. The results support the use of a no-catheter posturethrotomy management and advocate the encouragement of postoperative hydraulic self-urethral dilatation.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

[Bladder drainage in patients undergoing the Pereyra surgical procedure].

Postoperative acute urinary retention was evaluated in the patients who underwent Pereyra procedure. Comparison of suprapubic and urethral catheterization. Between January 1994 and July 1995, fifty two patients with urinary stress incontinence underwent Pereyra procedure, 31 female patient with suprapubic drainage (cistofix Ch 15) and 17 urethral catherization with a latex foley catheter. Sponatneous micturition and urinary retention was evaluated until the catheter was removed. Mean age was 43.8 years (32 a 66), the duration of suprapubic vesical drainage with suprapubic catheter were 3 days in 58.6% of the patients, and more than 3 days in 41.29%. Recatheterizacion in the patients with urethral drainage was more frequent. Urinary retention after 7 days was present in 23.99% with suprapubic vesical drainage and 28.5% with urethral catheter. Recatheterization is more frequent in patients with urethral catheter.

CD004374

Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery.

To determine whether prolonged urinary bladder catheterisation after vaginal prolapse surgery is advantageous. Randomised controlled trial. A large training hospital in the Netherlands. Patients undergoing anterior colporrhaphy. One hundred patients were included. Patients were randomised into two groups. In one group (n= 50), a transurethral catheter was in place for four days post-operatively and removed on the fifth post-operative day. In the other group (n= 50), catheterisation was not prolonged and the catheter was removed the morning after surgery. Residual volumes after removal of the catheter were measured by ultrasound scanning. Where residual volumes of >200 mL were found the patient was recatheterised for three more days. Urinary cultures were taken before removal of the catheter. Six patients were excluded: four in the standard prolonged catheterisation group and two in the not prolonged catheterisation group. Need for recatheterisation, urinary tract infection, mean duration of catheterisation and hospital stay. Residual volumes exceeding 200 mL and need for recatheterisation occurred in 9% in the standard prolonged catheterisation group versus 40% of patients in the not prolonged catheterisation group (OR 0.15, 95% CI 0.045-0.47). Positive urine cultures were found in 40% of cases in the standard prolonged catheterisation group compared with 4% in the not prolonged catheterisation group (OR 15, 95% CI 3.2-68.6). Mean duration of catheterisation was 5.3 days in the standard prolonged catheterisation group and 2.3 days in the not prolonged catheterisation group (P < 0.001). Mean duration of hospitalisation was 7 days in the standard prolonged catheterisation group and 5.7 days in the not prolonged group (P < 0.001). The disadvantages of prolonged catheterisation outweigh the advantages, therefore, removal of the catheter on the morning after surgery may be preferable and longer term catheterisation should only be undertaken where there are specific indications.

CD004954

We did not find good evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the six RCTs is insufficient to provide clear guidelines for practice, the possibility of clinical benefit has not been excluded. Further research is required to better define the role of HBOT in this condition.

A pilot study of hyperbaric oxygen in the treatment of human stroke.

We administered hyperbaric oxygen or air in a double-blind prospective protocol to 39 patients with ischemic cerebral infarction. We interrupted the study when we noticed what appeared to be a trend favoring the air-treated patients, whose neurological deficits were less severe (mean +/- SEM score on graded neurological examination: air, 25.6 +/- 4.9; oxygen, 34.5 +/- 7.5) and whose infarcts were smaller (air, 29.0 +/- 12.2 cm3; oxygen, 49.2 +/- 11.7 cm3) at 4 months. The trend, we decided, was probably an artifact of the randomization process. Nevertheless, we chose not to resume the trial because the treatment was difficult to administer by schedule (for various reasons the treatment protocol was broken in 15 of the 39 patients), was poorly tolerated (eight of the 39 patients refused to continue treatments), and did not produce dramatic improvement.

CD004954

We did not find good evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the six RCTs is insufficient to provide clear guidelines for practice, the possibility of clinical benefit has not been excluded. Further research is required to better define the role of HBOT in this condition.

Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study.

Hyperbaric oxygen therapy (HBO) has promise as a treatment for acute stroke. This study was conducted to evaluate the efficacy, safety, and feasibility of using HBO in acute ischemic stroke. We conducted a randomized, prospective, double-blind, sham-controlled pilot study of 33 patients presenting with acute ischemic stroke who did not receive thrombolytics over a 24-month period. Patients were randomized to treatment for 60 minutes in a monoplace hyperbaric chamber pressurized with 100% O2 to 2.5-atm absolute (ATA) in the HBO group or 1.14 ATA in the sham group. Primary outcomes measured included percentage of patients with improvement at 24 hours (National Institutes of Health Stroke Scale [NIHSS]) and 90 days (NIHSS, Barthel Index, modified Rankin Scale, Glasgow Outcome Scale). Secondary measurements included complications of treatment and mortality at 90 days. Baseline demographics were similar in both groups. There were no differences between the groups at 24 hours (P=0.44). At 3 months, however, a larger percentage of the sham patients had a good outcome defined by their stroke scores compared with the HBO group (NIHSS, 80% versus 31.3%; P=0.04; Barthel Index, 81.8% versus 50%; P=0.12; modified Rankin Scale, 81.8% versus 31.3%; P=0.02; Glasgow Outcome Scale, 90.9% versus 37.5%; P=0.01) with loss of statistical significance in a intent-to-treat analysis. Although our HBO protocol appears feasible and safe, it does not appear to be beneficial and may be harmful in patients with acute ischemic stroke.

CD004954

We did not find good evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the six RCTs is insufficient to provide clear guidelines for practice, the possibility of clinical benefit has not been excluded. Further research is required to better define the role of HBOT in this condition.

Hyperbaric oxygen in the treatment of acute ischemic stroke. A double-blind pilot study.

The effects of hyperbaric oxygen (HBO) therapy on humans are uncertain. Our study aims first to outline the practical aspects and the safety of HBO treatment and then to evaluate the effect of HBO on long-term disability. Patients who experienced middle cerebral artery occlusion and were seen within 24 hours of onset were randomized to receive either active (HBO) or sham (air) treatment. The HBO patients were exposed daily to 40 minutes at 1.5 atmospheres absolute for a total of 10 dives. We used the Orgogozo scale to establish a pretreatment functional level. Changes in the Orgogozo scale score at 6 months and 1 year after therapy were used to assess the therapeutic efficacy of HBO. In addition, we used the Rankin scale and our own 10-point scale to assess long term-disability at 6 months and 1 year. Two sample t tests and 95% confidence intervals were used to compare the mean differences between the two treatment groups. Student's two-tailed test was used to compare the differences between pretherapeutic and posttherapeutic scores at 6 months and 1 year in the two treatment groups. Over the 3 years of study enrollment, 34 patients were randomized, 17 to hyperbaric treatment with air and 17 to hyperbaric treatment with 100% oxygen. There was no significant difference at inclusion between groups regarding age, time from stroke onset to randomization, and Orgogozo scale scores. Neurological deterioration occurred during the first week in 4 patients in the sham group, 3 of whom died; this worsening was clearly related to the ischemic damage. Treatment was also discontinued for 3 patients in the HBO group who experienced myocardial infarction, a worsening related to the ischemic process, and claustrophobia. Therefore, 27 patients (13 in the sham group and 14 in the HBO group) completed a full course of therapy. The mean score of the HBO group was significantly better on the Orgogozo scale at 1 year (P < .02). However, the difference at 1 year between pretherapeutic and posttherapeutic scores was not significantly different in the two groups (P < .16). Moreover, no statistically significant improvement was observed in the HBO group at 6 months and 1 year according to Rankin score (P < .78) and our own 10-point scale (P < .50). Although the small number of patients in each group precludes any conclusion regarding the potential deleterious effect of HBO, we did not observe the major side effects usually related to HBO. Accordingly, it can be assumed that hyperbaric oxygen might be safe. We hypothesize that HBO might improve outcome after stroke, as we detected an outcome trend favoring HBO therapy. A large randomized trial might be required to address the efficacy of this therapy.

CD005550

The use of prophylactic steroids in pediatric patients to reduce postoperative complications commonly experienced following cardiopulmonary bypass surgery is not supported by the existing evidence. Further well designed and adequately powered randomized controlled trials are needed to more accurately estimate the benefit and harm of this intervention.

Dexamethasone reduces the inflammatory response to cardiopulmonary bypass in children.

A randomized, prospective, double-blind study of 29 children was performed to evaluate the hypothesis that dexamethasone administration prior to cardiopulmonary bypass would decrease the inflammatory mediator release and improve the postoperative clinical course. Fifteen children received dexamethasone (1 mg/kg intravenously) and 14 (controls) received saline solution 1 hour prior to CPB. Serial blood analyses for interleukin-6, tumor necrosis factor-alpha, complement component C3a, and absolute neutrophil count were performed. Postoperative variables evaluated included temperature, supplemental fluids, alveolar-arterial oxygen gradient, and days of mechanical ventilation. Dexamethasone caused an eightfold decrease in interleukin-6 levels and a greater than threefold decrease in tumor necrosis factor-alpha levels after CPB (p < 0.05). Complement component C3a and absolute neutrophil count were not affected by dexamethasone. The mean rectal temperature for the first 24 hours postoperatively was significantly lower in the group given dexamethasone than in the controls (37.2 degrees +/- 0.4 degrees C versus 37.7 degrees +/- 4 degrees C; p = 0.007). Dexamethasone-treated patients required less supplemental fluid during the first 48 hours (22 +/- 28 mL/kg versus 47 +/- 34 mL/kg; p = 0.04). Compared with controls, dexamethasone-treated children had significantly lower alveolar-arterial oxygen gradients during the first 24 hours (144 +/- 108 mm Hg versus 214 +/- 118 mm Hg; p = 0.02) and required less mechanical ventilation (median duration, 3 days versus 5 days; p = 0.02). Dexamethasone administration prior to CPB in children leads to a reduction in the postbypass inflammatory response as assessed by cytokine levels and clinical course.

CD005550

The use of prophylactic steroids in pediatric patients to reduce postoperative complications commonly experienced following cardiopulmonary bypass surgery is not supported by the existing evidence. Further well designed and adequately powered randomized controlled trials are needed to more accurately estimate the benefit and harm of this intervention.

Systemic inflammatory response related to cardiopulmonary bypass and its modification by methyl prednisolone: high dose versus low dose.

The objective of our study was to investigate the safety and efficacy of high-dose methyl prednisolone (MP) in modifying the systemic inflammatory response (SIR) to cardiopulmonary bypass (CPB) and to compare its efficacy with low-dose MP in children undergoing cardiac surgery for congenital heart disease. Thirty children with congenital heart disease undergoing CPB were randomly assigned to two groups: group 1 (n = 15) received 30 mg/kg MP by an intravenous infusion for 30 minutes and group 2 (n = 15) received 2 mg/kg intravenously, before the onset of CPB. Postoperative clinical parameters were recorded, and serum interleukin (IL)-6 and 8 levels, acute phase reactants, and blood biochemistry were determined serially for both groups. In both groups plasma IL-6 and 8 levels were elevated above the preoperative levels at 2 and 24 hours after declamping. The peak levels were obtained at 2-hour samples. The difference between the two groups in terms of postoperative IL-6 and 8 levels was not statistically significant. C-reactive protein (CRP) levels and polymorphonuclear leukocyte counts, postoperative core temperature, duration of mechanical ventilation, period of stay in intensive care unit, oxygenation indices, and biochemical parameters of patients did not significantly differ in the two groups. Only 1 patient in group 1 had elevated liver enzymes, blood urea nitrogen, and creatinine in the postoperative period. No significant complications were observed due to treatment with high-dose MP. Although postoperative IL and CRP levels indicated a SIR in our patients, the clinical picture was apparently affected in only 1 patient and she was in the high-dose MP group. CPB initiates a SIR that is associated with an increase in neutrophil count, CRP, and IL-6 and 8 levels. High-dose (30 mg/kg) MP was not superior to low-dose (2 mg/kg) in blunting the SIR to CPB in pediatric patients undergoing open-heart surgery.

CD005550

The use of prophylactic steroids in pediatric patients to reduce postoperative complications commonly experienced following cardiopulmonary bypass surgery is not supported by the existing evidence. Further well designed and adequately powered randomized controlled trials are needed to more accurately estimate the benefit and harm of this intervention.

Effects of dexamethasone on clinical course, C-reactive protein, S100B protein and von Willebrand factor antigen after paediatric cardiac surgery.

Anti-inflammatory treatment with glucocorticoids during cardiopulmonary bypass can reduce inflammatory mediator release, but the effects of glucocorticoid on outcome are controversial. We studied the effects of dexamethasone on clinical course, C-reactive protein, von Willebrand factor antigen (vWf:Ag) and S100B in a randomized masked study of children after open cardiac surgery. Twenty children weighing >10 kg received dexamethasone (1 mg kg(-1)) and 20 controls received saline after induction of anaesthesia. We measured vWf:Ag as a marker of endothelial activation, S100B as a marker of cerebral protein release and C-reactive protein as a marker of inflammatory activity. Oxygenation, body temperature, fluid balance, leucocyte and platelet counts, days in the intensive care unit (ICU) and days on mechanical ventilation were noted. Dexamethasone decreased C-reactive protein concentration on the first postoperative day (P<0.05), but did not affect the release of vWf:Ag or S100B. There was no significant difference in oxygenation, body temperature, fluid balance, leucocyte and platelet counts, days in the ICU or days on mechanical ventilation between the placebo and dexamethasone-treated groups. Administration of dexamethasone before cardiopulmonary bypass for paediatric cardiac surgery decreased the inflammatory response, but did not affect the immediate features after surgery or changes in vWf:Ag or S100B.

CD005550

The use of prophylactic steroids in pediatric patients to reduce postoperative complications commonly experienced following cardiopulmonary bypass surgery is not supported by the existing evidence. Further well designed and adequately powered randomized controlled trials are needed to more accurately estimate the benefit and harm of this intervention.

Combined steroid treatment for congenital heart surgery improves oxygen delivery and reduces postbypass inflammatory mediator expression.

Steroid administration during cardiopulmonary bypass is thought to improve cardiopulmonary function by modulating bypass-related inflammation. This study was designed to compare preoperative and intraoperative methylprednisolone (MP) to intraoperative MP alone with respect to postbypass inflammation and clinical outcome. Twenty-nine pediatric patients undergoing bypass procedures were randomly assigned to receive preoperative and intraoperative MP (30 mg/kg 4 hours before bypass and in bypass prime, n=14) or intraoperative MP only (30 mg/kg, n=15). Myocardial inflammatory mediator mRNA expression was determined in paired atrial biopsies (before and after bypass) by ribonuclease protection. Before and after bypass, serum IL-6 and IL-10 were measured by ELISA. Postoperative outcome was assessed by intubation time, CICU length of stay, fluid balance, arterio-venous O2 difference (DeltaA-VO2), and inotrope requirements. Compared with intraoperative MP alone, combined preoperative and intraoperative MP was associated with reduced myocardial mRNA expression for IL-6, MCP-1, and ICAM-1 both before and after bypass (P<0.05). Patients who received combined steroids had lower serum IL-6 and increased IL-10 at end-bypass (P<0.05), although differences were negligible by 24 hours. Combined MP treatment was associated with reduced fluid requirements, lower body temperature, and lower DeltaA-VO2 for the first 24 hours after surgery (P<0.05), along with trends toward improvement in other clinical outcomes. Compared with intraoperative steroid treatment, combined preoperative and intraoperative steroid administration attenuates inflammatory mediator expression more effectively and is associated with improved indexes of O2 delivery in the first 24 hours after congenital heart surgery. These findings need to be confirmed in a larger multicenter trial.

CD006001

We could not find convincing evidence to support or refute endoscopic biliary stenting on the mortality in patients with pancreatico-biliary malignancy. Large randomised trials are needed to settle the question of pre-surgical biliary stenting.

Evaluation of preoperative biliary drainage in the surgical management of pancreatic head carcinoma.

In a consecutive series of 38 patients, resectional surgery was performed for carcinoma of the caput pancreatis (ampullary, distal common bile duct and pancreatic duct). In group A (n = 19), preoperative biliary drainage was accomplished via an endoprosthesis introduced during endoscopic retrograde cholangiopancreatography. Group B (n = 19) had no preoperative biliary drainage. The interval from admission to operation averaged 15 days in group A and 4 days in group B. Two group B patients died of causes unrelated to absence of preoperative biliary drainage. In group B, however, the intrabiliary pressure was higher than in group A and was associated with heightened incidence of biliary infection, bacteremia and intraoperative bleeding. The intergroup difference in incidence of early complications was statistically significant. The findings support the value of preoperative biliary drainage in patients who are candidates for surgical treatment of carcinoma of the pancreatic head.

CD006001

We could not find convincing evidence to support or refute endoscopic biliary stenting on the mortality in patients with pancreatico-biliary malignancy. Large randomised trials are needed to settle the question of pre-surgical biliary stenting.

Preoperative endoscopic drainage for malignant obstructive jaundice.

The role of preoperative endoscopic drainage for patients with malignant obstructive jaundice was evaluated in a randomized controlled trial. A total of 87 patients were assigned to either early elective surgery (44 patients) or endoscopic biliary drainage followed by exploration (43). Thirty-seven patients underwent successful stent insertion and 25 had effective biliary drainage. Complications related to endoscopy occurred in 12 patients. After endoscopic drainage significant reductions of hyperbilirubinaemia, indocyanine green retention and serum albumin concentration were observed. Patients with hilar lesions had a significantly higher incidence of cholangitis and failed endoscopic drainage after stent placement. The overall morbidity rate (18 patients versus 16) and mortality rate (six patients in each group) were similar in the two treatment arms irrespective of the level of biliary obstruction. Despite the improvement of liver function, routine application of endoscopic drainage had no demonstrable benefit. Endoscopic drainage is indicated only when early surgery is not feasible, especially for patients with distal obstruction.

CD005640

T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Evaluation of primary duct closure vs T-tube drainage following choledochotomy.

CD005640

T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Primary closure versus T-tube drainage after open choledochotomy.

Choledochotomy followed by T-tube has long been a standard surgical treatment for choledocholithiasis. It is still a preferred choice in many hospitals where minimal invasive procedures are not feasible. The use of T-tube is not without complications. To avoid the complications associated with T-tube, we have performed primary closure of the common bile duct (CBD) after exploration. This pilot study assesses the safety of primary closure of CBD, which would help form a basis for implementation on a wider scale. To compare the clinical results of primary closure with T-tube drainage after open choledochotomy and assess the safety of primary closure for future application on a greater mass. This comparative study was conducted at surgical unit IV Liaquat University of Medical and Health Sciences, Jamshoro, from January 2007 to December 2007. Thirty-five patients were included in the study of which 16 patients underwent primary closure. Thirty-five patients were included in the study. The mean age of patients who had primary closure done (n = 16) was 46.0 +/-16.8 and there were two (12.5%) males and 14 (87.5%) females. After primary closure of the CBD, bile leakage was noted in one patient (6.3%), which subsided without any biliary peritonitis as compared to the T-tube group in which two patients (10.5%) had bile leakage. Postoperative jaundice was seen in one patient (5.3%) who had a T-tube because of a blockage of CBD. Not a single patient had a retained stone in both groups as well as no recurrence of CBD stones. The postoperative hospital stay after primary closure was 5.56 +/-1.1 days as compared to after T-tube drainage which was 13.6 +/-2.3 days. The total cost of treatment in patients who underwent primary closure was USD194.5 +/-41.5 but after T-tube drainage it was USD548.6 +/-88.5. The median follow up duration for both groups was 6 months. Primary CBD closure is a safe and cost effective alternative to routine T-tube drainage after open choledochotomy.

CD005640

T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Choledochotomy for biliary lithiasis: T-tube drainage or primary closure. Effects on postoperative bacteremia and T-tube bile infection.

To compare the incidence of postoperative bacteremia in patients with biliary lithiasis after choledochotomy supplemented by either T-tube drainage or primary common bile duct closure, 117 patients who underwent surgery are presented in this clinical trial. It has been shown that primary common bile duct closure is associated with a lower incidence of postoperative bacteremia (3.3 percent), a lower mortality rate (0 percent), and a lower early morbidity rate (13.3 percent) than T-tube drainage (31.5, 3.5, and 36.1 percent, respectively). The above evidence supports the view that T-tube drainage might well provoke the exogenous acquisition of environmental microorganisms and thus promote further infection.

CD005640

T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Primary duct closure versus T-tube drainage following exploration of the common bile duct.

T-tube drainage of the common bile duct (CBD) following duct exploration has become standard surgical practice. This randomized prospective study has compared primary closure versus T-tube drainage of the CBD following exploration for calculous disease. Thirty-seven patients underwent primary closure and 26 underwent closure over T-tube. Both groups were comparable in terms of age, indications for surgery, associated illnesses, pre-operative bilirubin, amylase and white cell count. Forty-three per cent of operations were performed by a consultant in the primary closure group and 65% in the T-tube group. There was no significant difference in the duration of operation, incidence of wound infection, surgical or other complications following operation between the two groups. However, the postoperative stay was significantly prolonged in the T-tube group, to a median of 11 days, compared to 8 days in the primary closure group (P = 0.0001). This prolongation in stay was unrelated to whether admission was as an emergency or elective. T-tube drainage of the bile continued for a median of 7 days postoperative, whereas the bile drained via a wound drain in only 13 (35%) of the primary closure group, for a median of 5 days in these 13 patients. Long-term follow up was achieved in 48 patients, by a questionnaire sent at a median of 2.8 years following operation. Abdominal pains following recovery from the operation were experienced by 18% of the primary closure group and 20% of the T-tube group. No patient developed jaundice or pancreatitis, nor needed further biliary surgery following operation.(ABSTRACT TRUNCATED AT 250 WORDS)

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Shoulder arthroplasty in the young patient.

We reviewed the performance of 22 shoulder implant arthroplasties in 19 patients age 50 or younger at surgery. Patients were evaluated by telephone interview, written questionnaire, and radiographic examination. The average age at surgery was 38.6 years, and the average follow-up was 5.6 years. Patients were grouped by disease process (rheumatoid arthritis [RA], avascular necrosis [AVN], trauma, and hemophilic arthropathy [HA]) and type of prosthesis (total vs. hemiarthroplasty). The highest scores (best shoulder function) were seen in patients with hemiarthroplasty for HA. Patients with hemiarthroplasty for trauma and AVN scored similarly, whereas those with a hemiarthroplasty for RA scored lowest. Patients with RA who had a total shoulder arthroplasty scored higher than patients with hemiarthroplasty. When patients in our population with longer follow-up were compared with those with a shorter follow-up, no downward trends in shoulder function were seen. Accelerated deterioration of function of shoulder arthroplasties was not observed in our young patient population.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Evaluation of surgeries for rheumatoid shoulder based on the destruction pattern.

To identify the optimal treatment of rheumatoid shoulder, we analyzed the clinical results of shoulder surgeries according to each type of shoulder destruction pattern. Forty-seven shoulder surgeries for rheumatoid arthritis (18 arthroscopic synovectomies, 10 total shoulder replacements, 19 humeral head replacements) were assessed clinically and compared in regard to 5 different destruction patterns of rheumatoid shoulder (nonprogressive, arthrosis-like, erosive, collapse, and mutilating patterns). For nonprogressive-type shoulders, we were able to obtain both pain relief and range of motion (ROM) improvement with arthroscopic synovectomy. For erosive-type shoulders, we could obtain pain relief but no ROM improvement with synovectomy; and we obtained both pain relief and ROM improvement with prosthetic replacement. For the collapse-type shoulders, we could not obtain pain relief or ROM improvement with arthroscopic synovectomy, but did obtain pain relief with prosthetic replacement. For mutilating-type shoulders, we could obtain only pain relief with prosthetic replacement. The results of the various surgeries for rheumatoid shoulder were distinctly different depending on the shoulder destruction patterns. These findings could be of value for the selection of treatment, including a surgical procedure, for rheumatoid shoulders. For the nonprogressive-type and for erosive-type shoulders before bone destruction progresses, arthroscopic synovectomy should be selected. For erosive-type shoulders after bone destruction, for the collapse-type, and for mutilating-type shoulders, prosthetic replacement should be selected. In regard to the prosthetic replacement, the humeral component should be cemented because the incidence of migration in noncemented humeral component procedures was high.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Outcome of Copeland surface replacement shoulder arthroplasty.

We report the outcome of humeral head surface replacement hemiarthroplasty performed at our institution using the Copeland prosthesis. We followed 56 shoulders (52 patients) for a mean of 34.2 months (range, 24-63 months). Two were lost to follow-up, and there were six deaths unrelated to the shoulder surgery. Preoperative diagnoses in the remainder were osteoarthritis (20), rheumatoid arthritis (26), rotator cuff tear arthropathy (1), and post-traumatic arthrosis (1). The mean age was 68 years. Constant scores for the whole group improved from a mean preoperative score of 16.4 (range, 8-36) to 54.0 (range, 20-83) at last follow-up (P < .05). Three cases underwent subsequent arthroscopic subacromial decompression for impingement symptoms. One case required revision for aseptic loosening to a stemmed implant. Contained, nonprogressive osteolysis was seen in 2 cases. One periprosthetic humeral neck fracture was managed successfully nonoperatively. These results are comparable to those obtained with a modern stemmed hemiarthroplasty and are similar to Copeland's own series.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life.

This study examines long-term outcomes of total shoulder arthroplasty (TSA) via survivorship analysis, patient questionnaires, and minimum 10-year physical examinations. The study group consisted of 320 consecutive TSAs performed in 267 patients between 1974 and 1988. Diagnoses included rheumatoid arthritis (69%), osteoarthritis (22%), and juvenile rheumatoid arthritis (4.7%). Minimum 10-year physical examination follow-up was obtained on a subset of 72 TSAs at a mean (+/- SD) of 14.0 +/- 2.7 years. A Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was obtained from 80 patients with 103 TSAs at a mean of 15.4 +/- 3.4 years after the index procedure (range, 10.4-23.2 years). Kaplan-Meier survivorship rates with revision as the endpoint at 5, 10, 15, and 20 years were 98%, 93%, 88%, and 85%, respectively. Of the shoulders, 22 (6.9%) required a revision, most commonly for loosening of one or both components (15 shoulders). Dislocation occurred earlier than other causes of revision or complication (P < .05, analysis of variance). Minimum 10-year physical examination follow-up revealed lasting, significant improvements in range of motion and strength. The patients' subjective assessments of TSA were favorable in that 92% felt that their shoulder was "much better" or "better" after TSA. The mean DASH score was 49 +/- 25; no significant differences were found among diagnoses. Long-term analysis of the Neer-type TSA revealed survivorship rates comparable to other joint replacements. The significant improvements in relief of pain, shoulder range of motion, and strength are associated with a high degree of patient satisfaction.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Outcome after cup hemiarthroplasty in the rheumatoid shoulder: a retrospective evaluation of 39 patients followed for 2-6 years.

33 rheumatoid patients, treated with hemispherical cup resurfacing hemiarthroplasty of the shoulder without medullary fixation (6 bilaterally), were reviewed after mean 4.4 (2-6) years. The median Constant score was 30 (15-79), mean proximal migration of the humerus 55 (SD 5.2) mm and mean glenoid erosion 2.6 (SD 1.7) mm. Proximal migration and glenoid erosion did not correlate with shoulder function or pain. Radiographic signs of loosening (changes in cup inclination combined with changes in cup distance above the greater tuberosity) occurred in one quarter of the shoulders. At follow-up, 26 patients were satisfied with the procedure, despite poor shoulder function and radiographic deterioration.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Total shoulder replacement in rheumatoid disease: 7- to 13-year follow-up of 37 joints.

We made a prospective study of 58 consecutive Neer II total shoulder replacements in 49 rheumatoid patients. Cemented glenoid and press-fit humeral components had been used. After a mean follow-up of 9.5 years (7 to 13), 11 patients (15 shoulders) had died, one shoulder had been arthrodesed and five patients (five shoulders) had been lost to follow-up. Of the remaining 37 shoulders 29 were painfree or had only slight discomfort, four had pain on unusual activity, and four had moderate or severe pain. There were satisfactory improvements in the mean range of active elevation (53 degrees to 75 degrees) and external rotation (5 degrees to 38 degrees); satisfactory performance of the activities of daily living had been maintained throughout follow-up. Radiographs showed loosening in ten shoulders of nine glenoid and nine humeral components but of these only three had significant symptoms. Three loose glenoid components and two loose humeral components required revision. We consider that the Neer total shoulder replacement provides a reasonable medium to long-term outcome in rheumatoid arthritis, but recommend that the humeral component should be routinely cemented.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Humeral head replacement for glenohumeral arthritis.

From July 1977 through March of 1983, humeral head replacement was performed on 35 shoulders with osteoarthritis and 32 shoulders with rheumatoid arthritis and followed-up for an average of 9.3 years. Satisfactory pain relief was achieved in 44 (66%) and 52 of the shoulders (78%) were described by patients as being much better or better. Active elevation was improved from an average of 84 degrees to an average of 110 degrees with external rotation improving from 20 degrees to 44 degrees. Strength improvement also occurred. Only three complications developed, and these did not affect the final outcome. Because of moderate or severe pain, 12 shoulders (18%) required revision to total shoulder arthroplasty, and all patients were relieved of their pain. The result ratings were excellent in 10 shoulders, satisfactory in 23, and unsatisfactory in 34 (51%). With longer follow-up, a satisfactory level of pain relief may not continue for those patients with osteoarthritis and rheumatoid arthritis who have had humeral head replacement alone. Whereas this form of treatment should certainly be considered in those patients who have inadequate glenoid bone to support a glenoid implant and probably be considered in younger patients or patients who wish to remain more active, these latter patients must be fully appraised that the probability of continuing pain relief is less than has often been appreciated.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Augmented subscapularis muscle transposition for rotator cuff repair during shoulder arthroplasty in patients with rheumatoid arthritis.

The effectiveness of rotator cuff repair by augmented subscapularis transposition via the Leeds-Keio artificial ligament was evaluated in patients with rheumatoid arthritis undergoing total shoulder arthroplasty. The minimum follow-up period was 2 years. Final clinical scores (Hospital for Special Surgery scoring system) and the incidence of radiolucency and upward migration of shoulder components in 20 shoulders with rotator cuff repair by augmented subscapularis transposition were superior to those of 19 shoulders with cuff repair by subscapularis transposition alone and similar to those of 22 shoulders with intact rotator cuffs. In shoulders with augmented subscapularis transposition and intact cuffs, clinical scores continued to improve even after the first postoperative year. Our augmented subscapularis transposition did not increase postoperative complications. We conclude that cuff repair by augmented subscapularis transposition is an acceptable alternative for repairing a supraspinatus or supraspinatus and infraspinatus rotator cuff defect in rheumatoid arthritis patients undergoing total shoulder arthroplasty.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Cement and press-fit humeral stem fixation provides similar results in rheumatoid patients.

It is unclear whether humeral stems should be fixed with or without cement. We question whether press-fit fixation would provide similar results to cemented stem fixation. We prospectively randomized 26 shoulders in 24 patients with rheumatoid arthritis (20 women, 4 men) to have either a cemented or press-fit stem. In the press-fit group, stems were matched to the medullary canal, while lavage, pressurizing and distal plugging were used in the cemented group. We followed patients with conventional radiographs and radiostereometric analysis (RSA) at 5 to 7 days, 4 months, 1 year, and 2 years after surgery. One patient died from unrelated causes before the 1-year followup, while the remaining patients were followed according to the protocol. All but two patients were very satisfied or satisfied at 2 years. No stem was radiographically loose. There was no difference in micromotion between groups. The average rotation for all axes was less than 0.25 degrees for both groups and the average translation was less than 0.32 mm for all three axes including subsidence, which was less than 0.1 mm for the uncemented stems. We concluded at 2 years these stems provided similar fixation in rheumatoid shoulders. Level of Evidence: Therapeutic Level I. See the Guidelines for Authors for a complete description of levels of evidence.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Total shoulder replacement in rheumatoid arthritis: proximal migration and loosening.

A prospective study of 62 Neer mark II total shoulder arthroplasties performed during the period from 1981 to 1990 on 51 patients with rheumatoid arthritis was undertaken to evaluate factors associated with component loosening and proximal humeral migration. Thirty-two (51%) showed proximal migration of the humerus before surgery was performed. The mean follow-up time was 92 months (range 52 to 139 months). The results revealed proximal migration in 55% of the patients (34 shoulders), and 40% (25 shoulders) showed progressive radiographic loosening of the glenoid component. Five of 12 press-fit humeral components demonstrated progressive radiographic loosening, whereas no signs of loosening were found in 50 cemented humeral components. In spite of progressive component loosening and progressive migration, this study demonstrated good pain relief in 89% of the patients (55 shoulders) and also a significant improvement in range of movement and function. The presence of proximal humeral migration did not significantly influence the average results-neither pain relief, range of movement, abduction force, nor function. Also, component loosening did not significantly influence the average pain relief, range of movement, abduction force, or function. The risk of clinical asymptomatic loosening is a relatively late complication that is eventually followed by pronounced bone destruction related to the loose component. Long-term radiographic control of total shoulders with rheumatoid arthritis is recommended. Hemiarthroplasty with a cemented humeral prosthesis may be a better treatment in the end stage of rheumatoid arthritis of the shoulder.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Total shoulder arthroplasty versus hemiarthroplasty for rheumatoid arthritis of the shoulder: results of 303 consecutive cases.

Between January 1, 1976 and December 31, 1991, 195 total shoulder arthroplasties and 108 hemiarthroplasties were performed in 247 patients in patients with rheumatoid arthritis. One hundred and eighty-seven total shoulder arthroplasties and 95 hemiarthroplasties with complete preoperative evaluation, operative records, and minimum 2-year follow-up (mean, 11.6 years) or follow-up until revision were included in the clinical analysis. Twenty patients had died and 1 was lost to follow-up. All 303 shoulders were included in the survival analysis. There was significant long term pain relief (P < .0001), improvement in active abduction (P < .0001), and external rotation (P < .0001) with both hemiarthroplasty and total shoulder arthroplasty (TSA). There was not a significant difference in improvement in pain and motion comparing hemiarthroplasty and TSA for patients with a thin or torn rotator cuff. However, among patients with an intact rotator cuff, improvement in pain and abduction were significantly greater with TSA. Additionally, among patients with an intact rotator cuff, the risk for revision was significantly lower for TSA (P = .04). Radiographs were available for 152 total shoulder arthroplasties and 63 hemiarthroplasties with a minimum 2-year follow-up. Glenoid erosion was present in 62 of 63 hemiarthroplasties (98%). Glenoid periprosthetic lucency was present in 110 of 152 total shoulder arthroplasties (72%). The data from this study indicate that there is marked long-term pain relief and improvement in motion with shoulder arthroplasty. Among patients with an intact rotator cuff, TSA appears to be the preferred procedure for pain relief, improvement in abduction, and lower risk of revision surgery.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Total shoulder arthroplasty with the Neer prosthesis: long-term results.

We determined the outcome of 113 total shoulder replacement arthroplasties performed with a Neer prosthesis between 1975 and 1981. The operations were performed for the treatment of osteoarthritis, rheumatoid arthritis, and old fractures or dislocations with traumatic arthritis. The probability of implant survival was 93% after 10 years and 87% after 15 years. Complications requiring reoperation developed in 14 shoulders. Seventy-nine patients with 89 replacements were available for follow-up a minimum of 5 years after the operation (mean 12.2 years, range 5 to 17 years). Relief from moderate or severe pain was achieved in 83% of shoulders. Active abduction improved by an average of 40 degrees to an average of 117 degrees. The amount of elevation that was regained was related to the amount of rotator cuff disease. Seventy-five glenoid components developed bone-cement radiolucencies, and 39 (44%) glenoid components had radiographic evidence of definite loosening. Glenoid loosening was associated with pain. A shift in position of the humeral component occurred in 49% of the press-fit stems and in none of the cemented stems. Humeral component loosening was not associated with pain.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Rotator cuff repair during shoulder arthroplasty in rheumatoid arthritis.

A prospective study of 40 shoulder arthroplasties in patients with rheumatoid arthritis was performed to evaluate the results of rotator cuff repair at the time of arthroplasty. A large cuff tear was present in 21 shoulders, and good repair of the cuff was performed in 9. In the other shoulders the repair was considered insufficient. All patients were clinically evaluated using the Hospital for Special Surgery 100-point scoring system. The minimum follow-up period for inclusion in this study was 2 years. The quality of the repair of the ruptured cuff at the time of surgery had a significant influence on the postoperative clinical score (linear regression model, P = .002). The clinical score of the shoulders with good repair of the rotator cuff improved considerably and continued to improve even after the first-year follow-up examination. Meticulous repair of the ruptured cuff at the time of arthroplasty is recommended.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Grammont reverse total shoulder arthroplasty in patients with rheumatoid arthritis and nonreconstructible rotator cuff lesions.

This study was undertaken to determine whether patients with severe rheumatoid arthritis and irreparable rotator cuff rupture can be treated successfully with the Grammont shoulder arthroplasty. Seven patients with rheumatoid arthritis (8 shoulders) with nonreconstructible rotator cuff lesions and Larsen stage-V radiographic changes of the glenoid and the humeral head underwent a Grammont reverse shoulder arthroplasty. The Constant score improved from a mean of 17 points (range 4 to 25) preoperatively to a mean of 63 points (range 41 to 79) at a mean of 54 months (range 48 to 73) after shoulder arthroplasty. The mean strength at 90 degrees of abduction measured 3.6 kg (range 1 to 6). Shoulder instability was not observed. Complications included septic implant loosening (1 shoulder), aseptic glenoid loosening (2), and failed acromion osteosynthesis following the transacromial approach (3). These data of Grammont arthroplasty are encouraging with respect to restoration of stability and satisfactory function in rheumatoid, cuff-deficient shoulders. However, glenoid loosening remained a serious problem, and transacromial approaches were complicated by failure of acromial fixation.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Copeland surface replacement arthroplasty of the shoulder in rheumatoid arthritis.

Shoulder arthroplasty with a stemmed prosthesis is a recognized treatment for rheumatoid arthritis of the shoulder. The humeral component of the Copeland cementless surface replacement arthroplasty consists of a cup for surface replacement with a short central peg for primary fixation to the bone. We hypothesized that surface replacement may offer some advantages over stemmed prostheses. Between 1986 and 1998, seventy-five shoulders underwent surface replacement arthroplasty (thirty-three hemiarthroplasties and forty-two total shoulder arthroplasties) for the treatment of rheumatoid arthritis. The results of these procedures were reviewed after an average duration of follow-up of 6.5 years. Patients were assessed with use of the Constant score, a patient satisfaction score, and radiographs. The average Constant score was 47.9 points (age and sex-adjusted score, 71%) in the hemiarthroplasty group and 53.4 points (age and sex-adjusted score, 76%) in the total shoulder replacement group. The mean range of active flexion improved from 50 degrees in the hemiarthroplasty group and 47 degrees in the total shoulder replacement group to 101 degrees and 104 degrees, respectively. Seventy-two of the seventy-five shoulders were considered by the patients to be much better or better at the time of the review. Of the sixty-eight humeral implants that were evaluated radiographically, fifty-six (82%) showed no lucencies, eleven (16%) showed localized lucencies of <1 mm in width, and one was definitely loose. Of the thirty-nine glenoid implants that were evaluated radiographically, nineteen (49%) showed no lucencies, nineteen showed localized lucencies of <1 mm, and one was definitely loose. No lucencies were observed adjacent to the hydroxyapatite-coated implants. Thirty-nine (57%) of the sixty-eight shoulders showed some degree of superior subluxation. Three patients required a major reoperation: two required a revision because of loosening of both components, and one patient with pain at the site of a hemiarthroplasty had a revision to a total shoulder arthroplasty to provide relief. The indications for this surface replacement are the same as those for the conventional stemmed prostheses, but the surface replacement has the advantage of bone preservation as well as avoidance of the potential complications associated with a long humeral stem in rheumatoid bone. This procedure is not suitable for severely damaged joints in which the humeral head is insufficient or too soft. Level of Evidence: Therapeutic study, Level IV (case series [no, or historical, control group]). See Instructions to Authors for a complete description of levels of evidence.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

The DUROM cup humeral surface replacement in patients with rheumatoid arthritis.

Rheumatoid arthritis often leads to severe destruction of the glenohumeral joint, including synovitis and inflammation-induced alterations of the rotator cuff. Cup arthroplasty, or surface replacement of the shoulder, was introduced in the 1980s. The aim of this study was to evaluate the midterm results of the DUROM cup surface replacement for patients with rheumatoid arthritis affecting the glenohumeral joint. From 1997 to 2000, forty-two DUROM cup hemiprostheses were implanted in a cohort of thirty-five patients (forty-two shoulders), who were evaluated preoperatively and again at three, twelve, and more than sixty months postoperatively. Six patients (seven shoulders) were lost to follow-up. Thirty-five shoulders in twenty-nine patients (twenty-one women and eight men with an average age of 61.4 years) could be evaluated prospectively after an average follow-up period of 73.1 months. Patients were evaluated clinically with the use of the Constant score, and a detailed radiographic analysis was performed to determine the presence of endoprosthetic loosening, glenohumeral subluxation, and glenoid bone loss. The mean Constant score for the thirty-five shoulders increased from 20.8 points preoperatively to 64.3 points at a mean of 73.1 months postoperatively. There were three revisions: one to replace an implant that was too large, another to treat glenoid erosion, and a third due to loosening of the implant. No additional cases of loosening of the prosthesis or changes in cup position were observed radiographically. Over the five-year follow-up period, proximal migration of the cup increased in 63% of the shoulders, and the glenoid depth increased in 31%. With the numbers studied, no differences in clinical outcome were identified between patients with a massive rotator cuff tear and those with a smaller or no tear. The midterm results of the cemented DUROM cup surface replacement for patients with advanced rheumatoid arthritis of the shoulder are very encouraging, even for patients with a massive tear of the rotator cuff. The advantage of this cup arthroplasty is the less complex bone-sparing surgery. In the event of failure of the implant, other reliable salvage options remain.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

The results of shoulder arthroplasty in patients with rheumatoid arthritis.

We have performed a clinical and radiological analysis of 105 shoulder arthroplasties in patients with rheumatoid arthritis. The clinical results showed improvements in the Constant-Murley and Association of Shoulder and Elbow Surgeons score of 21 and 35, respectively. Both were statistically significant (p < 0.001). This improvement was maintained over a period of 8.8 years. There was no statistically significant difference in the scores after hemiarthroplasty and those after total arthroplasty. The presence of an intact rotator cuff was associated with improved function in both groups. In spite of the use of an uncemented humeral stem, no implant was radiologically loose or at risk. There was lucency in a single zone in 14 implants. One glenoid component was at risk and 16 had lucency in a single zone. There was, however, a significant difference in the amount of lucency which was associated with pegged and keeled glenoid components (p = 0.005). In the group with hemiarthroplasty, two or more years after surgery there was superior migration of the humeral component by more than 5 mm in 18 shoulders (28%) and medial migration by more than 2 mm in eight (16%). Both superior and medial migration had an effect on the outcome. Revision was undertaken in four patients for persistent pain relating to medial migration. With revision taken as the endpoint for survival after eight years, 92% were found to be still in situ.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Arthroplasty of the shoulder in rheumatoid arthritis with rotator cuff dysfunction.

We carried out a retrospective analysis of 17 total shoulder replacements using the reversed Delta III prosthesis in patients with rheumatoid arthritis of the glenohumeral joint complicated by rotator cuff dysfunction. Outcome was assessed using the Constant-Murley scoring system. In addition, general health status was assessed with the Short Form Health Survey and radiographical analysis of the prostheses undertaken. Mean age at the time of surgery was 64 years. Thirteen shoulders were followed up for more than 5 years (mean 87 months). Median Constant-Murley score was 59.0; median scores for general health were 33.40 and 49.36 for the physical and mental components respectively. Radiographical analysis revealed evidence of lucencies about the humeral component in all cases and about the glenoid component in five cases. Despite the good clinical results, the high incidence of radiographical lucencies is of concern.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

[Bipolar shoulder prosthesis for rheumatoid arthritis with irreparable rotator cuff tear: results after 5 years' follow-up].

The goal of this study was to assess the clinical and radiological outcome of bipolar shoulder prosthesis in twelve shoulders with rheumatoid arthritis (RA) and irreparable rotator cuff tears. The follow-up was more than five years (range 2-9 years). In addition, in order to investigate the effect of rheumatoid arthritis on outcome, results were compared with ten bipolar shoulder prostheses implanted for osteoarthritis with massive rotator cuff tears. The mean preoperative Constant score was 16.9 points with 2.6 points for pain, 4.2 points for activity, 9.5 points for motion and 0.6 points for force. The preoperative active motion was 63.8 degrees for forward flexion, 45 degrees for abduction and 12 degrees for active external rotation. At last follow-up, the average Constant score was 39.4 points with 10.7 points for pain, 10.8 points for activity, 13.8 points for motion and 4.1 points for force. Regarding the active motion, mean forward flexion was 83.7 degrees, 70.4 degrees for abduction and 29.1 degrees for external rotation. The complication rate was low, mainly superior migration due to infraspinatus tear and glenoid wear. Satisfactory deltoid arm level was achieved in all patients and no loosening was observed. Preoperative and postoperative scores of the rheumatoid group were not significantly different from the arthritis group (p<0.001). Our findings suggest that bipolar shoulder prosthesis provides a viable replacement alternative in RA combined with massive rotator cuff tear with a low rate of complication. Bipolar shoulder prosthesis demonstrates no clear superiority over conventional hemiarthroplasty regarding improved motion and glenoid wear. In addition, no significant difference with arthritis was observed (p<0.05), assuming that outcome depends principally on the preoperative condition of the rotator cuff. Some massive tears involving the subscapularis tendon can lead to anterior recurrence after bipolar shoulder prosthesis. They might be a limit to the procedure and require a reversed shoulder prosthesis or a glenohumeral arthrodesis.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Improvements in survival of the uncemented Nottingham Total Shoulder prosthesis: a prospective comparative study.

The uncemented Nottingham Total Shoulder Replacement prosthesis system (Nottingham TSR) was developed from the previous BioModular shoulder prosthesis taking into consideration the causes of the initial implant's failure. We investigated the impact of changes in the design of Nottingham TSR prosthesis on its survivorship rate. Survivorship analyses of three types of uncemented total shoulder arthroplasty prostheses (BioModular, initial Nottingham TSR and current Nottingham TSR systems with 11, 8 and 4 year survivorship data respectively) were compared. All these prostheses were implanted for the treatment of disabling pain in the shoulder due to primary and secondary osteoarthritis or rheumatoid arthritis. Each type of the prosthesis studied was implanted in consecutive group of patients--90 patients with BioModular system, 103 with the initial Nottingham TSR and 34 patients with the current Nottingham TSR system. The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired t test. The 8-year and 11-year survivorship rates for the initially used modified BioModular uncemented prosthesis were relatively low (75.6% and 71.7% respectively) comparing to the reported survivorship of the conventional cemented implants. The 8-year survivorship for the uncemented Nottingham TSR prosthesis was significantly higher (81.8%), but still not in the desired range of above 90%, that is found in other cemented designs. Glenoid component loosening was the main factor of prosthesis failure in both prostheses and mainly occurred in the first 4 postoperative years. The 4-year survivorship of the currently re-designed Nottingham TSR prosthesis, with hydroxylapatite coating of the glenoid baseplate, was significantly higher, 93.1% as compared to 85.1% of the previous Nottingham TSR. The initial Nottingham shoulder prosthesis showed significantly higher survivorship than the BioModular uncemented prosthesis, but lower than expected. Subsequently re-designed Nottingham TSR system presented a high short term survivorship rate that encourages its ongoing use.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Arthroscopic rotator cuff debridement in patients with rheumatoid arthritis.

There is little information available concerning the results of rotator cuff debridement in patients with rheumatoid arthritis (RA). We performed a review of 16 shoulders with underlying RA that underwent arthroscopic rotator cuff tear debridement; there were 10 full-thickness tears and 6 partial-thickness tears. Of the 10 patients with full-thickness rotator cuff tears, 8 had unsatisfactory results, whereas none of the patients with partial-thickness tears had unsatisfactory results. Pain was improved in 5 of 6 shoulders with partial-thickness cuff tears, whereas only 5 of 10 with full-thickness tears had an improvement with regard to pain. Motion did not improve in either group. Patients with RA who require operative intervention for pain relief because of rotator cuff tearing can be treated successfully with debridement alone. However, pain relief was less predictable with large or massive tears when compared with partial-thickness tears, and functional gains were not achieved in either group.

CD006188

The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials.

Rotator cuff repair in patients with rheumatoid arthritis.

Currently, there is very little information available regarding the results of rotator cuff repair in patients with rheumatoid arthritis. Therefore, we reviewed our experience to determine the results, the risk factors for an unsatisfactory outcome, and the rates of failure of this procedure. We retrospectively reviewed the records of all patients with rheumatoid arthritis who had undergone repair of a rotator cuff tear at our institution from 1988 to 2002. Twenty-three shoulders in twenty-one patients were identified. The median duration of follow-up for the twenty shoulders that did not require revision surgery was 9.7 years. Nine shoulders had a partial-thickness tear, and fourteen had a full-thickness tear. The shoulders were assessed with regard to pain, functional outcome, and overall patient satisfaction. Patients with both partial and full-thickness rotator cuff tears had significant improvements in terms of overall pain (p < 0.05) and satisfaction (p < 0.05). Patients who had undergone repair of a partial-thickness tear had improved active elevation (from 155 degrees to 180 degrees; p = 0.03), whereas patients who had undergone repair of a full-thickness tear did not have improved elevation. Six of the fourteen shoulders with a full-thickness tear had an unsatisfactory result, whereas only two of the nine shoulders with a partial-thickness tear had an unsatisfactory result. Rotator cuff repair in patients with rheumatoid arthritis can be challenging. However, durable pain relief and patient satisfaction can be achieved. Functional gains should not be expected in patients with full-thickness rotator cuff tears. Repair of the rotator cuff in patients with rheumatoid arthritis can be undertaken when nonoperative measures for pain relief have failed.

CD007987

There is some risk of bias in the included studies, with limited information available to assess possible bias and to fully assess the findings of one included study. Whilst the evidence presented here does seem promising with regard to the ability of such interventions to improve parenting knowledge and skill in this population, there is a need for larger RCTs of interventions before conclusions can be drawn about the effectiveness of parent training for this group of parents.

Promoting health and home safety for children of parents with intellectual disability: a randomized controlled trial.

The objective of this study was to evaluate the efficacy of a home-based intervention targeted to parents with intellectual disability to promote child health and home safety in the preschool years. A total of 63 parents were recruited for the study with 45 parents (40 mothers and 5 fathers) from 40 families completing the project. The research design permitted comparison between the intervention and three alternative conditions with all parents receiving the intervention in an alternating sequence over the life of the project. The intervention consisted of 10 weekly lessons carried out in the parent's home focusing on child health and home safety. The program was adapted to suit the Australian context from the UCLA Parent--Child Health and Wellness Project (Tymchuk, Groen, & Dolyniuk, 2000). Outcome measures assessed parental health and safety behaviours. Standard measures included parental health, intelligence and literacy. The intervention improved parents' ability to recognize home dangers, to identify precautions to deal with these dangers and resulted in a significant increase in the number of safety precautions parents implemented in their homes with all gains being maintained at 3 months post-intervention. Parents' health behaviours including improved understanding of health and symptoms of illness, knowledge of and skills needed to manage life-threatening emergencies, knowledge about visiting the doctor, knowing when to call, what information to provide and what questions to ask, and how to use medicines safely significantly increased. Again, all gains were maintained 3 months post-intervention. The intervention was effective regardless of parental health, literacy skills, and IQ. This form of home-based intervention promotes a healthy and safe environment which is a prerequisite to continuing parental custody.

CD000328

The overall analysis shows a benefit in pulmonary outcomes in the group electively ventilated with HFJV. Of concern is the significant increase in acute brain injury in one trial which used lower mean airway pressures when ventilating with HFJV. There are as yet no long term pulmonary or neurodevelopmental outcomes from any of the trials.

Early randomized intervention with high-frequency jet ventilation in respiratory distress syndrome.

To determine whether early use of high-frequency jet ventilation reduces neonatal mortality or pulmonary morbidity rates, we randomly selected 42 infants with clinical and radiographic evidence of severe respiratory distress syndrome to receive either high-frequency jet ventilation or conventional ventilation. Separate sequential analyses (two-sided, alpha = 0.05, power = 0.95 to detect 85:15 advantage) were performed for mortality rates, air leaks, bronchopulmonary dysplasia, intraventricular hemorrhage, and assignment crossover, and a combined analysis was performed, with death overriding other outcome variables. Enrollment was completed when the combined analysis reached the sequential design boundary indicating no treatment difference. Mortality rates (19% among infants receiving high-frequency jet ventilation vs 24% among infants receiving conventional ventilation), the incidence of air leaks (48% vs 52%), bronchopulmonary dysplasia (39% vs 41%), and intraventricular hemorrhage (33% vs 43%), and assignment crossovers (14% vs 24%) did not differs significantly between the treatment groups. We conclude that early use of high-frequency jet ventilation does not prevent or substantially reduce mortality or morbidity rates associated with assisted ventilation.

CD000328

The overall analysis shows a benefit in pulmonary outcomes in the group electively ventilated with HFJV. Of concern is the significant increase in acute brain injury in one trial which used lower mean airway pressures when ventilating with HFJV. There are as yet no long term pulmonary or neurodevelopmental outcomes from any of the trials.

Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome.

To test the hypothesis that high-frequency jet ventilation (HFJV) will reduce the incidence and/or severity of bronchopulmonary dysplasia (BPD) and acute airleak in premature infants who, despite surfactant administration, require mechanical ventilation for respiratory distress syndrome. Multicenter, randomized, controlled clinical trial of HFJV and conventional ventilation (CV). Patients were to remain on assigned therapy for 14 days or until extubation, whichever came first. Crossover from CV to HFJV was allowed if bilateral pulmonary interstitial emphysema or bronchopleural fistula developed. Patients could cross over to the other ventilatory mode if failure criteria were met. The optimal lung volume strategy was mandated for HFJV by protocol to provide alveolar recruitment and optimize lung volume and ventilation/perfusion matching, while minimizing pressure amplitude and O2 requirements. CV management was not controlled by protocol. Eight tertiary neonatal intensive care units. Preterm infants with birth weights between 700 and 1500 g and gestational age <36 weeks who required mechanical ventilation with FIO2 >0.30 at 2 to 12 hours after surfactant administration, received surfactant by 8 hours of age, were <20 hours old, and had been ventilated for <12 hours. Outcome Measures. Primary outcome variables were BPD at 28 days and 36 weeks of postconceptional age. Secondary outcome variables were survival, gas exchange, airway pressures, airleak, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and other nonpulmonary complications. A total of 130 patients were included in the final analysis; 65 were randomized to HFJV and 65 to CV. The groups were of comparable birth weight, gestational age, severity of illness, postnatal age, and other demographics. The incidence of BPD at 36 weeks of postconceptional age was significantly lower in babies randomized to HFJV compared with CV (20.0% vs 40.4%). The need for home oxygen was also significantly lower in infants receiving HFJV compared with CV (5.5% vs 23.1%). Survival, incidence of BPD at 28 days, retinopathy of prematurity, airleak, pulmonary hemorrhage, grade I-II IVH, and other complications were similar. In retrospect, it was noted that the traditional HFJV strategy emphasizing low airway pressures (HF-LO) rather than the prescribed optimal volume strategy (HF-OPT) was used in 29/65 HFJV infants. This presented a unique opportunity to examine the effects of different HFJV strategies on gas exchange, airway pressures, and outcomes. HF-OPT was defined as increase in positive end-expiratory pressure (PEEP) by >/=1 cm H2O from pre-HFJV baseline and/or use of PEEP of >/=7 cm H2O. Severe neuroimaging abnormalities (PVL and/or grade III-IV IVH) were not different between the CV and HFJV infants. However, there was a significantly lower incidence of severe IVH/PVL in HFJV infants treated with HF-OPT compared with CV and HF-LO. Oxygenation was similar between CV and HFJV groups as a whole, but HF-OPT infants had better oxygenation compared with the other two groups. There were no differences in PaCO2 between CV and HFJV, but the PaCO2 was lower for HF-LO compared with the other two groups. The peak inspiratory pressure and DeltaP (peak inspiratory pressure-PEEP) were lower for HFJV infants compared with CV infants. HFJV reduces the incidence of BPD at 36 weeks and the need for home oxygen in premature infants with uncomplicated RDS, but does not reduce the risk of acute airleak. There is no increase in adverse outcomes compared with CV. HF-OPT improves oxygenation, decreases exposure to hypocarbia, and reduces the risk of grade III-IV IVH and/or PVL.

CD000328

The overall analysis shows a benefit in pulmonary outcomes in the group electively ventilated with HFJV. Of concern is the significant increase in acute brain injury in one trial which used lower mean airway pressures when ventilating with HFJV. There are as yet no long term pulmonary or neurodevelopmental outcomes from any of the trials.

High-frequency jet ventilation in the early management of respiratory distress syndrome is associated with a greater risk for adverse outcomes.

The objective of this investigation was to determine if high-frequency jet ventilation (HFJV) used early in the treatment of premature infants with respiratory distress syndrome was effective in reducing pulmonary morbidity without increasing the occurrence of adverse neurologic outcomes. A total of 73 premature infants who met the inclusion criteria (gestational age of less than 33 weeks, birth weight of more than 500 g, age of less than 24 hours, need for assisted ventilation with peak inspiratory pressure of more than 16 and FIO2 more than 0.30, and roentgenographic evidence of respiratory distress syndrome) were randomized to either conventional (n = 36) or to high-frequency jet (n = 37) ventilation. Our goals were to maintain the infants on the assigned ventilator for at least 7 days unless they could either be extubated or meet crossover criteria. Univariate analyses were initially used to compare the two groups. Stepwise logistic regression was subsequently used to assess whether various factors independently influenced adverse outcomes. The two groups of infants were similar in all obstetrical, perinatal, and neonatal demographic characteristics. The mean birth weight and gestational age in the conventional group were 930 g and 26.6 weeks and in the HFJV group, 961 g and 26.9 weeks. The infants were randomized at similar ages (7.1 and 7.3 hours of life, respectively). Their prerandomization ventilator settings and arterial blood gases were nearly identical. There were no differences in pulmonary outcomes (occurrence of air leaks, need for oxygen or ventilation at 36 weeks postconception), and there were no differences in the mean number of days oxygen was required, number of days ventilated, or length of hospital stay. Infants ventilated with HFJV were significantly more likely to develop cystic periventricular leukomalacia (10 vs 2, P = .022) or to have a poor outcome (grade IV hemorrhage, cystic periventricular leukomalacia, or death) (17 vs 7, P = .016). Logistic regression analysis revealed HFJV to be a significant independent predictor of both cystic periventricular leukomalacia and a poor outcome. The presence of hypocarbia was not an independently significant predictor of adverse outcomes. With the HFJV treatment strategy that we used, use of the high-frequency jet ventilator in the early management of premature infants with respiratory distress syndrome resulted in significantly more adverse outcomes than in those treated with conventional mechanical ventilation.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Change in trend of contraceptive uptake--effect of educational leaflets and counseling.

The study was conducted to determine the impact of counseling and educational leaflets on contraceptive practices of couples. Randomization of 600 women was done in two groups matched for age, parity and socioeconomic status at the Department of Obstetrics and Gynaecology, Shifa Foundation Community Health Centre, Shifa International Hospital, Islamabad, Pakistan. In Group A, the intervention group was exposed to contraceptive counseling and educational leaflets in the postnatal ward after delivery, whereas in Group B, the nonintervention group was not given any formal contraceptive advice. Later on, both groups were assessed regarding their contraceptive practices. At their follow-up visit (8-12 weeks) postpartum, 19 (6.3%) women in the nonintervention group had started contraceptive use, whereas 153 (50.8%) had decided to start contraception in the next 6 months, and 129 (42.8%) women were still undecided. The main contraceptive user was the male partner (n=117, 38.8%), and the most common method used was coitus interruptus (n=62, 36.3%). In the intervention group, 170 women (56.9%) had started using contraceptives, whereas 129 (43.1%) had decided to start contraceptive use in the next 6 months. The predominant contraceptive user was the females (n=212-70.9%), and the most popular method chosen was oral contraceptive pills (n=111, 37.1%). There is a definite increase in contraceptive uptake in women provided with educational leaflets and counseling session with a shift toward use of more reliable contraceptive methods.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Increasing contraceptive use in rural Pakistan: an evaluation of the Lady Health Worker Programme.

Past efforts to promote family planning in Pakistan have been disappointing, but between 1990-91 and 2000-01 contraceptive use has more than doubled. This rise has coincided with a concerted effort on the part of the Pakistani government to increase access to contraceptive services, particularly in rural areas. The Lady Health Worker Programme (LHWP), initiated under the Ministry of Health in the early 1990s, aimed at integrating family planning into the doorstep provision of primary health care. This paper presents findings from the first national evaluation of this Programme. Data are analyzed from a random sample survey of 4277 women living in households served by the LHWP and those living in control areas. Logistic regression analysis was performed to determine the effect of the Programme on the uptake of modern reversible contraceptive methods, controlling for other independent variables. The data provide strong evidence that the LHWP has succeeded in increasing modern contraceptive use among rural women. Women served by Lady Health Workers are significantly more likely to use a modern reversible method than women in communities not served by the Programme (OR=1.50, 95% CI=1.04-2.16, p=0.031), even after controlling for various household and individual characteristics. The model of providing doorstep services through community-based female workers should remain central to achieving universal access to safe family planning methods by the end of the decade--the long-term objective of Pakistan's most recent population policy adopted in 2002.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Use of traditional medical practitioners to delivery family planning services in Uttar Pradesh.

This pilot study conducted in Muzaffarnagar district in the state of Uttar Pradesh, India, demonstrates the potential for using traditional medical practitioners in the delivery of family planning services after a brief training period. Practitioners participated continuously in the program for an intervention period of two years during which their services were accepted by the community. The impact of their involvement was reflected in increased knowledge of permanent as well as reversible contraceptive methods and in higher contraceptive use rates, especially of reversible methods adopted by women younger than 25 years (from 8 percent to 37 percent), in the intervention villages, as compared with increased knowledge and use (from 13 percent to 25 percent) of permanent methods alone in the control villages.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Is postpartum contraceptive advice given antenatally of value?

In response to the concept that a good postpartum program should begin prenatally, this study was designed to determine whether the provision of expert contraceptive counseling during the antenatal period would have an impact on contraceptive uptake, patterns of contraceptive usage, and pregnancy rates during the first year after childbirth. Over 500 women attending antenatal clinics in each of three centers (Edinburgh, Scotland; Shanghai, People's Republic of China; Cape Town, South Africa) were randomized to receive expert contraceptive advice (participants, n = 771) or the standard advice routinely given in that setting (controls, n = 866). Follow-up was by postal or interviewer-administered questionnaires at 16 and 52 weeks after childbirth. There were no significant differences in the prevalence of contraceptive use at one year (over 79% in all centers) between participants and controls. In Edinburgh, participants were more likely to undergo sterilization (p < 0.01) than controls, otherwise there were no differences among Edinburgh, Shanghai, or Cape Town in either the methods of contraception chosen or in the methods used over time. Contraceptive counseling delivered antenatally appeared to have no impact on the pregnancy rate during the first year after childbirth. In Shanghai, over 11% of women in both groups underwent termination of pregnancy in the year of follow-up. In conclusion, although women in all centers said they found the opportunity to discuss contraception antenatally was useful, it had very little effect on contraceptive use or on subsequent pregnancy rates.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

The effectiveness of contraceptive counseling for women in the postabortion period: an intervention study.

Brazilian women who have undergone abortion use contraceptive methods; however, their use of contraceptive methods is inconsistent and/or inappropriate. This randomized trial evaluated the effectiveness of a personalized counseling on contraceptive acceptability and its use for postabortion women in the northeast of Brazil. It was conducted in July 2008 to September 2009, enrolling 246 women randomly distributed in intervention (n=123) and control (n=123) groups. An intention-to-treat analysis was performed. In the follow-up, 98.4% women in the intervention group were using contraceptive methods compared with 70.6% women in the control group (p<.001). The probability of adherence and of the use of any kind of contraceptive method 6 months after the abortion was 41% greater in the intervention group. The strategy on individualized contraceptive counseling increased the acceptance and the use of contraceptive methods and increased the adequate use of the methods. Copyright © 2011 Elsevier Inc. All rights reserved.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Community-based distribution and contraception usage in Iran.

Despite the availability of free contraception from family planning clinics, the rate of unwanted pregnancy in Iran is still high. The effectiveness of other methods for contraceptive supply should, therefore, be evaluated. The aim of this study was to determine the effects of community-based distribution (CBD) on contraceptive usage in Iran. This controlled field trial study involved 297 individuals (100 subjects in the CBD group and 197 subjects in the control group) from four major remote areas of Hamedan, Iran. Stratified random sampling was used. Data analysis suggested that using CBD has four major effects: (1) it increases the level of contraceptive knowledge (p<0.0001), (2) it enhances correct contraceptive choice by couples (p<0.0001), (3) it improves contraceptive usage (p<0.0001) and (4) it improves contraceptive continuation rates (p<0.0001). CBD facilitates better knowledge, proper choice, and correct and continuous usage of contraception. This method should, therefore, be adopted for family planning services in remote areas of Iran.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Effect of postnatal home visits on maternal/infant outcomes in Syria: a randomized controlled trial.

Early postpartum home visiting is universal in many Western countries. Studies from developing countries on the effects of home visits are rare. In Syria, where the postpartum period is rather ignored, this study aimed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities; infant morbidity; uptake of postpartum care; use of contraceptive methods; and on selected neonatal health practices. A randomized controlled trial was carried out in Damascus. Three groups of new mothers were randomly allocated to receive either 4 postnatal home visits (A), one visit (B), or no visit (C). A total of 876 women were allocated and followed up. Registered midwives with special training made a one or a series of home visits providing information, educating, and supporting women. A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants (28.5% and 30%, respectively) as compared with Group C (20%), who received no visits. There were no reported differences between groups in other outcomes. While postpartum home visits significantly increased exclusive breastfeeding, other outcomes did not change. Further studies framed in a nonbiomedical context are needed. Other innovative approaches to improve postnatal care in Syria are needed.

CD008896

Community-based interventions and antenatal contraceptive counselling improved uptake of copper IUD contraception. Since the copper IUD is one of the most effective reversible contraceptive methods, primary care and family planning and practitioners could consider adopting these interventions. Although our review suggests these interventions are clinically effective, a cost-benefit analysis may be required to evaluate applicability.

Impact of antenatal counselling on couples' knowledge and practice of contraception in Mansoura, Egypt.

The impact of antenatal counselling on couples' knowledge and practice of contraception was investigated. An interview questionnaire was used before and after conducting counselling sessions with 200 pregnant women and 100 spouses. The participants were followed up immediately after delivery and 3 months later. Both the control and study groups displayed a lack of knowledge of contraception. Counselling sessions improved the couples' knowledge and practice in the study group. Involving husbands in family planning counselling sessions led to joint decisions being made and encouraged women's use of contraception. The majority of couples retained most of the information given. Integrating family planning counselling into antenatal care in all facilities and involving the husband are recommended.

CD003046

Radiofrequency thermal ablation seems a potentially promising technique for the treatment of small hepatocellular carcinoma. However, more randomised clinical trials are needed.

Small hepatocellular carcinoma: comparison of radio-frequency ablation and percutaneous microwave coagulation therapy.

To evaluate the effectiveness of radio-frequency (RF) ablation and percutaneous microwave coagulation (PMC) for treatment of hepatocellular carcinoma (HCC). Seventy-two patients with 94 HCC nodules were randomly assigned to RF ablation and PMC groups. Thirty-six patients with 48 nodules were treated with RF ablation, and 36 patients with 46 nodules were treated with PMC. Therapeutic effect, residual foci of untreated disease, and complications of RF ablation and PMC were prospectively evaluated with statistical analyses. The number of treatment sessions per nodule was significantly lower in the RF ablation group than in the PMC group (1.1 vs 2.4; P <.001). Complete therapeutic effect was achieved in 46 (96%) of 48 nodules treated with RF ablation and in 41 (89%) of 46 nodules treated with PMC (P =.26). Major complications occurred in one patient treated with RF ablation and in four patients treated with PMC (P =.36). During follow-up (range, 6-27 months), residual foci of untreated disease were seen in four of 48 nodules treated with RF ablation and in eight of 46 nodules treated with PMC. No significant difference in rates of residual foci of untreated disease was noted (P =.20, log-rank test). RF ablation and PMC thus far have had equivalent therapeutic effects, complication rates, and rates of residual foci of untreated disease. However, RF tumor ablation can be achieved with fewer sessions. Copyright RSNA, 2002

CD003046

Radiofrequency thermal ablation seems a potentially promising technique for the treatment of small hepatocellular carcinoma. However, more randomised clinical trials are needed.

Small hepatocellular carcinoma in cirrhosis: randomized comparison of radio-frequency thermal ablation versus percutaneous ethanol injection.

To compare the effectiveness of radio-frequency (RF) thermal ablation with that of percutaneous ethanol injection (PEI) for the treatment of small hepatocellular carcinoma (HCC) in patients with cirrhosis. A series of 102 patients with hepatic cirrhosis and either single HCC 5 cm in diameter or smaller or as many as three HCCs each 3 cm or smaller (overall number of lesions, 142) randomly received either RF ablation (n = 52) or PEI (n = 50) as the sole first-line anticancer treatment. Mean follow-up was 22.9 months +/- 9.4 (SD) in the RF group and 22.4 months +/- 8.6 in the PEI group. Prognostic value of treatment techniques was assessed with univariate and multivariate Cox proportional hazards regression models. One- and 2-year survival rates were 100% and 98% in the RF group and 96% and 88% in the PEI group, respectively (univariate relative risk [RR] = 0.20; 95% CI: 0.02, 1.69; P =.138). One- and 2-year local recurrence-free survival rates were 98% and 96% in the RF group and 83% and 62% in the PEI group, respectively (univariate RR = 0.17; 95% CI: 0.06, 0.51; P =.002). One- and 2-year event-free survival rates were 86% and 64% for the RF group and 77% and 43% for the PEI group, respectively (univariate RR = 0.48; 95% CI: 0.27, 0.85; P =.012). RF treatment was confirmed as an independent prognostic factor for local recurrence-free survival rates with multivariate analysis (adjusted RR = 0.20; 95% CI: 0.05, 0.73; P =.015). RF ablation is superior to PEI with respect to local recurrence-free survival rates.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Twin- versus single-bag disconnect systems: infection rates and cost of continuous ambulatory peritoneal dialysis.

Although twin-bag disconnect fluid-transfer systems for continuous ambulatory peritoneal dialysis (CAPD) have a lower rate of catheter-related infection than single-bag systems, their greater monetary purchase cost has prevented universal adoption. Therefore, a single-center randomized study was performed in 63 adult patients to compare the efficiency and total cost of Freeline Solo (FS, twin-bag) and Basic Y (BY, single-bag) systems. Patients were new to CAPD (N = 39), or had a new CAPD catheter, or had had no episodes of peritonitis or exit-site infection in the previous 12 months (N = 24). Total follow-up was 631 patient months (pt.mon), and 53 patients were still on the trial at its termination. Patients rated FS as easier to use than BY (P < 0.001). Peritonitis occurred on 23 occasions in 12 out of 30 patients using BY, and on seven occasions in five of 33 patients using FS. Time to first infection was less with BY than FS (hazard ratio, 2.4; 95% confidence interval (CI), 1.0 to 5.3; P < 0.04). Cumulative incidence of peritonitis was 1 per 14.0 pt.mon with BY and 1 per 46.5 pt.mon with FS (odds ratio, 3.6; 95% CI 1.5 to 8.5; P = 0.004). Length of hospitalization for peritonitis or exit-site infection was 98 days in six patients with BY, versus 17 days in two patients with FS. With BY, four catheters were removed because of infection, but none with FS (P < 0.05). With BY, the total cost of infection was $AUD127,079 ($5033 per pt.yr) versus $19,250 ($704 per pt.yr) with FS, which offset the higher purchase cost of FS. The total cost of CAPD was $AUD956 per pt.yr less with FS than BY. In conclusion, the higher purchase cost of the FS twin-bag system is more than offset by savings from its lower incidence of peritonitis.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Prevention of peritonitis with disconnect systems in CAPD: a randomized controlled trial. The Mexican Nephrology Collaborative Study Group.

Recently, disconnect systems for CAPD that are associated with a reduced frequency of peritonitis have been introduced. Our objective was to compare the incidence of peritonitis using three current CAPD systems in a high-risk population with low educational and socioeconomic levels, and high prevalence of malnutrition. In a prospective controlled trial, 147 patients commencing CAPD were randomly assigned to one of three groups: 29 to the conventional, 57 to the Y-set, and 61 to the twin bag systems. The number of peritonitis episodes was registered, and patients were followed up for an average of 11.3 months. The average peritonitis-free interval for the conventional group was 6.1 months, for the Y system was 12.0 months, and for the twin bag was 24.8 months (P < 0.001). By multivariate analysis, the only factor associated with peritonitis was the CAPD system. Peritonitis-related hospitalization was 5.3 +/- 2.0, 2.7 +/- 1.0, and 1.5 +/- 0.9 days/patient/year in the conventional, Y system, and twin bag groups, respectively. The cost per bag was similar for the conventional and Y system, but higher for the twin bag. However, the total costs of treatment (pesos/patient/year) were lower for twin bag (62,159 for the conventional, 70,275 for the Y system, and 54,387 for the twin bag), due to the lower peritonitis incidence and associated hospitalizations. Y system and twin bag use was associated with a reduction of 50 and 75% peritonitis incidence, respectively, in patients on CAPD. The cost of the twin bag was actually lower, because of savings from a decreased usage of antibiotics and fewer hospitalizations.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

A randomized prospective study of the cost-effectiveness of the conventional spike, O-set, and UVXD techniques in continuous ambulatory peritoneal dialysis.

To compare the clinical outcome and cost-effectiveness of three techniques for continuous ambulatory peritoneal dialysis (CAPD): the conventional spike technique (C), the O-set (O), and UVXD (U, ultraviolet irradiation connection box). A randomized and prospective comparison of three CAPD techniques. A tertiary referral and a satellite dialysis center. One hundred patients with end-stage renal failure between 10 and 70 years of age, with good hand-eye coordination and not anticipated to receive a living related transplant within 6 months. Patients were randomized by referral to a table of random numbers to perform one of the three CAPD techniques. Training time, details of peritonitis and exit-site infection (ESI) including the costs of antibiotic treatment, outpatient visits, hospital stays, technique, and patient survival were analyzed after a minimum follow-up period of one year. There were 38, 31, and 31 patients in groups C, O, and U, respectively, and the total observation periods were 838, 802, and 745 patient-months, respectively. The peritonitis rates for C, O, and U were 21.5, 30.8, and 29.8 patient-months/episode, respectively. The corresponding ESI rates were 16.4, 14.9, and 24 patient-months/episode, respectively. When the time from the commencement of CAPD to the first infection was expressed using the Kaplan-Meier life table analysis, 39.5%, 67.7%, and 61.3% of patients in Groups C, O, and U were free from peritonitis at one year (p = 0.088). The corresponding figures for ESI were 52.6%, 48.4%, and 61.3% (p = 0.35). There was no significant difference in technique survival in the three treatment groups. An analysis of the costs related to the use of antibiotics, outpatient visits, and hospital stays necessary for the treatment of peritonitis and ESI and those related to training time, additional equipment, and consumables required for the three CAPD techniques showed that, overall, the cost in O was the lowest, followed by U and C (U.S. $158, $170, and $179 per patient-month, respectively). It was concluded that the O-set is a more cost-effective CAPD technique than UVXD, while both are more cost-effective than the conventional spike technique.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Comparison of continuous ambulatory peritoneal dialysis-related infections with different "Y-tubing" exchange systems.

Despite several modifications of the continuous ambulatory peritoneal dialysis (CAPD) technique over the last decade, peritonitis remains a major source of morbidity and is the leading cause of dropout for patients maintained on CAPD therapy. Recently, Baxter Healthcare introduced the Ultra Twin bag system, which uses drainage and infusion bags both secured to Y connecting tubing. Previous nonrandomized studies comparing the Ultra Twin bag system with other systems have indicated an improvement in the peritonitis rate with the Ultra Twin bag system. In this study, 82 patients were randomized to use the Ultra Twin bag system or the Ultra Y-set system, which uses only the drainage bag already attached to the Y connecting tubing. Peritonitis rates were significantly lower with the Ultra Twin bag system, one episode per 33.9 patient months, compared with the Ultra Y-set system, one episode per 11.7 patient months (P < 0.05). Furthermore, the 1-yr infection-free survival rates with the Ultra Twin bag system and the Ultra Y-set system were 71 and 40%, respectively. Exit-site infections were lower with the Ultra Twin bag system, one episode per 12.5 patient months, compared with the Ultra Y-set system, one episode per 28.3 patient months, although this difference was not statistically significant (P = 0.084). The effect of the reduction in the infection rate on patient dropout with the Ultra Twin bag system remains to be addressed.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Prospective controlled trial of a Y-connector and disinfectant to prevent peritonitis in continuous ambulatory peritoneal dialysis.

A controlled study in two centres compared the efficacy of the standard continuous ambulatory peritoneal dialysis (CAPD) system with that of a new method consisting of a Y-shaped set filled with sodium hypochlorite during the dwelling time. 62 new CAPD patients were randomly allocated to the standard method (group A: 30 patients; age 55.5 +/- 17.5 years) or to the Y-system (group B: 32 patients; age 55.1 +/- 14.3 years). In group A, there were 31 peritonitis episodes in 17 patients (57%) during a cumulative period of 351 months--1 episode every 11.3 patient-months. In group B, there were 11 peritonitis episodes in 10 patients (31%) during 363 months--1 episode every 33 patient-months. Life-table analysis showed a significant difference between the incidence of peritonitis in the two groups. The Y-system method is simple and economical and the frequency and the severity of side-effects appears to be acceptable.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Randomized study of peritonitis with conventional versus O-set techniques in continuous ambulatory peritoneal dialysis.

We performed a prospective randomized trial, comparing the incidence of peritonitis between a flush-disconnect (O-System, Baxter, Deerfield, IL) (OS) and a conventional (System II, Baxter) (CS) continuous ambulatory peritoneal dialysis (CAPD) method. Sixty consenting patients with no significant physical disabilities who commenced CAPD after May 1987 were entered and followed for a minimum of 12 months. Thirty were placed on the OS system and 30 were placed on CS. Age, gender, and time for training did not differ significantly. The period of observation for OS was 375 months; CS was observed for 430 months. OS patients experienced 28 episodes of peritonitis (13.4 months/patient/episode) compared with 88 (4.9 months/patient/episode) in CS (p less than 0.005). By 6 months, 32% of OS patients had had at least one episode of peritonitis, compared with 62% of CS patients; at 12 months, these figures rose to 48% for OS and 91% for CS (p less than 0.01) patients (Life Table Analysis). The median survival time to first peritonitis episode was 5.1 months in CS and 9.7 months in OS (p less than 0.01). Exit-site infections occurred in 14/30 (46%) of patients on OS and in 13/30 (43%) of CS patients. We conclude that the OS was associated with a significant reduction in the incidence of peritonitis.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Controlled trial of a Y-set dialysis delivery system to prevent peritonitis in patients receiving continuous ambulatory peritoneal dialysis.

Peritonitis rates were compared in patients receiving continuous ambulatory peritoneal dialysis (CAPD) via either a Y-set dialysate delivery system or a standard system. Forty patients in each arm of the trial were matched for age (range 20-67 years, mean 49 years), and remained in the study for similar periods (range 3-36 months, mean 14.1 months). The observation time was 564 patient-months for each arm of the trial. There were 22 episodes of peritonitis in nine out of 40 patients using the Y-set and 57 episodes in 21 out of 40 patients using the standard system (P = 0.005 Wilcoxon signed rank test for episodes, P = 0.02 McNemar's chi 2 test for patients). Peritonitis rates were one episode per 25 patient-months in the Y-set group, and one episode per 9.7 patient-months in the standard group. In the Y-set group there were significantly fewer episodes caused by coagulase-negative staphylococci and Acinetobacter spp. There was no difference in the rate of episodes caused by Staphylococcus aureus, streptococci, enterococci, corynebacteria, enterobacteria or pseudomonads. There was no difference in the incidence of catheter exit wound infections. The Y-set dialysis delivery system is effective in reducing peritonitis rates in CAPD patients caused by organisms derived from the commensal skin flora, principally coagulase-negative staphylococci, but does not reduce peritonitis caused by other organisms.

CD003078

Disconnect systems should be the preferred exchange systems in CAPD.

Comparison of double-bag and Y-set disconnect systems in continuous ambulatory peritoneal dialysis: a randomized prospective multicenter study.

We performed a multicenter, single-blinded, prospective randomized study on the use of a double-bag disconnect system (B) versus a Y-set disconnect system (Y). The peritonitis rate, exit site infection, clinical outcome, and patients' acceptance to the procedure were assessed. A total of 120 new end-stage renal failure patients of three regional hospitals were randomized: 60 each to the B and the Y systems. The results of 60 patients on the B system and 51 on the Y system were analyzable. They were followed up for a median of 16 months. Peritonitis rates for the B and the Y systems were 33.5 and 29.4 patient-months per episode, respectively. Exit site infection rates for the B and Y systems were 17.4 and 16.0 patient-months per episode, respectively. Four catheters were removed in each group. Patients on the B system were hospitalized for 2.1 days per patient per year related to peritonitis and exit site infection, and those on the Y system were hospitalized for 1.2 days. There was no significant difference between the B and Y systems in the incidences of peritonitis (all causes and those due to coagulase-negative staphylococci), exit site infection, and in hospitalization days. However, there was a higher percentage of gram-positive infections in the Y system (52%) than in the B system (32%) and a lower percentage of gram-negative infections in the Y system (16%) than in the B system (32%). Patients on the B system had a better acceptance of the procedure than patients on the Y system, as assessed by a six-item, 10-point questionnaire (total score, 43.1 +/- 10.2 v 37.6 +/- 9.4; P < 0.005 at 1 month; 44.6 +/- 9.1 v 39.8 +/- 8.6; P < 0.01 at 6 months). From this study, it is concluded that the B and Y systems are similar in the incidences of peritonitis and exit site infection, although the B system is better accepted by patients. This is probably the first multicenter randomized study comparing the double-bag and Y-set disconnect system using only new patients who had never used other systems of continuous ambulatory peritoneal dialysis.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Sertraline in children and adolescents with obsessive-compulsive disorder: a multicenter randomized controlled trial.

The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder; however, empirical support for this assertion has been weaker for children and adolescents than for adults. To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder. Randomized, double-blind, placebo-controlled trial. One hundred eighty-seven patients: 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years randomized to receive either sertraline (53 children, 39 adolescents) or placebo (54 children, 41 adolescents). Twelve US academic and community clinics with experience conducting randomized controlled trials. Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy, after which patients continued to receive this dosage of medication for 8 more weeks. Control patients received placebo. The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH GOCS), and the NIMH Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) rating scales. In intent-to-treat analyses, patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS (adjusted mean, -6.8vs -3.4, respectively; P=.005), the NIMH GOCS (-2.2 vs -1.3, respectively; P=.02), and the CGI-I (2.7 vs 3.3, respectively; P=.002) scales. Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study. Based on CGI-I ratings at end point, 42% of patients receiving sertraline and 26% of patients receiving placebo were very much or much improved. Neither age nor sex predicted response to treatment. The incidence of insomnia, nausea, agitation, and tremor were significantly greater in patients receiving sertraline; 12 (13%) of 92 sertraline-treated patients and 3 (3.2%) of 95 placebo-treated patients discontinued prematurely because of adverse medical events (P=.02). No clinically meaningful abnormalities were apparent on vital sign determinations, laboratory findings, or electrocardiographic measurements. Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Clomipramine treatment of childhood obsessive-compulsive disorder. A double-blind controlled study.

Nineteen children (mean [+/- SD] age, 14.5 +/- 2.3 years) with severe, primary obsessive-compulsive disorder completed a ten-week, double-blind, controlled trial of clomipramine hydrochloride (mean dosage, 141 mg/day) or placebo, each of which was administered for five weeks. Half of the subjects had not responded to previous treatment with other tricyclic antidepressants. There was a significant improvement in observed and self-reported obsessions and compulsions that was independent of the presence of depressive symptoms at baseline. Improvement in obsessive-compulsive symptoms did not correlate significantly with plasma concentrations of the drug or its metabolites. Clomipramine appears to be effective in the treatment of children with obsessive-compulsive disorder and the treatment seems to be independent of an antidepressant effect.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group.

Drugs that selectively inhibit serotonin reuptake are effective treatments for adults with mood and anxiety disorders, but limited data are available on the safety and efficacy of serotonin-reuptake inhibitors in children with anxiety disorders. We studied 128 children who were 6 to 17 years of age; who met the criteria for social phobia, separation anxiety disorder, or generalized anxiety disorder; and who had received psychological treatment for three weeks without improvement. The children were randomly assigned to receive fluvoxamine (at a maximum of 300 mg per day) or placebo for eight weeks and were evaluated with rating scales designed to assess the degree of anxiety and impairment. Children in the fluvoxamine group had a mean (+/-SD) decrease of 9.7+/-6.9 points in symptoms of anxiety on the Pediatric Anxiety Rating Scale (range of possible scores, 0 to 25, with higher scores indicating greater anxiety), as compared with a decrease of 3.1+/-4.8 points among children in the placebo group (P<0.001). On the Clinical Global Impressions-Improvement scale, 48 of 63 children in the fluvoxamine group (76 percent) responded to the treatment, as indicated by a score of less than 4, as compared with 19 of 65 children in the placebo group (29 percent, P<0.001). Five children in the fluvoxamine group (8 percent) discontinued treatment because of adverse events, as compared with one child in the placebo group (2 percent). Fluvoxamine is an effective treatment for children and adolescents with social phobia, separation anxiety disorder, or generalized anxiety disorder.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Fluoxetine for the treatment of childhood anxiety disorders.

To assess the efficacy and tolerability of fluoxetine for the acute treatment of children and adolescents with generalized anxiety disorder, separation anxiety disorder, and/or social phobia. Anxious youths (7-17 years old) who had significant functional impairment were randomized to fluoxetine (20 mg/day) (n = 37) or placebo (n = 37) for 12 weeks. Fluoxetine was effective in reducing the anxiety symptoms and improving functioning in all measures. Using intent-to-treat analysis, 61% of patients taking fluoxetine and 35% taking placebo showed much to very much improvement. Despite this improvement, a substantial group of patients remained symptomatic. Fluoxetine was well tolerated except for mild and transient headaches and gastrointestinal side effects. Youths with social phobia and generalized anxiety disorder responded better to fluoxetine than placebo, but only social phobia moderated the clinical and functional response. Severity of the anxiety at intake and positive family history for anxiety predicted poorer functioning at the end of the study. Fluoxetine is useful and well tolerated for the acute treatment of anxious youths. Investigations regarding the optimization of treatment to obtain full anxiety remission and the length of treatment necessary to prevent recurrences are warranted.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder.

Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p = .01) but not by the CY-BOCS (p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.

To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study. Subjects, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994. After a 7- to 14-day single-blind, placebo washout/screening period, subjects were randomly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks. Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term, open-label trial of fluvoxamine. Analyses used an intent-to-treat sample with a last-observation-carried-forward method. Mean Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores with fluvoxamine were significantly (p < .05) different from those with placebo at weeks 1, 2, 3, 4, 6, and 10. Significant (p < .05) differences between fluvoxamine and placebo were observed for all secondary outcome measures at all visits. Based on a 25% reduction of CY-BOCS scores, 42% of subjects taking fluvoxamine were responders compared with 26% taking placebo. Forty-six (19 fluvoxamine, 27 placebo) of 120 randomized subjects discontinued early. Adverse events with a placebo-adjusted rate greater than 10% were insomnia and asthenia. Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety.

Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy. In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at weeks 4, 8, and 12. The percentages of children who were rated as very much or much improved on the Clinician Global Impression-Improvement scale were 80.7% for combination therapy (P<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo (23.7%). Combination therapy was superior to both monotherapies (P<0.001). Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with cognitive behavioral therapy than with sertraline. Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.) 2008 Massachusetts Medical Society

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

A Randomized controlled trial of venlafaxine ER versus placebo in pediatric social anxiety disorder.

Social anxiety disorder, which occurs in 2% to 5% of children and adolescents, is associated with significant distress and functional impairment. The objective of the randomized, masked controlled trial conducted in 48 academic and community centers in the United States was to evaluate the efficacy of venlafaxine ER in children and adolescents with generalized social anxiety disorder. A volunteer sample of 293 outpatients, age 8 to 17, who met diagnostic criteria for social anxiety disorder and were enrolled between February 2000 and March 2003 participated. Venlafaxine ER or placebo was titrated from a starting dose of 37.5 mg to a maximum dose of 225 mg over 16 weeks. The primary dependent measures were the Social Anxiety Scale, child or adolescent version (SAS-CA) and for responder analysis, a (dichotomized) Clinical Global Impressions-Improvement (CGI-I) score. Compared with placebo, intent-to-treat random regression analyses indicated a statistically significant advantage for venlafaxine ER (p = .001) on the SAS-CA. On the CGI-I responder analysis, 56% (95% confidence interval [CI], 47%-64%) of venlafaxine ER treated subjects responded, which was statistically superior to placebo (37% [95% CI, 29%-45%]). Three venlafaxine ER and no placebo patients developed treatment-emergent suicidality; there were no completed suicides. Venlafaxine ER is an effective and reasonably well-tolerated treatment for generalized social anxiety disorder in children and adolescents. As with other antidepressants, careful clinical monitoring for adverse events, including treatment-emergent suicidality, is essential.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Clinical, cognitive, and neurophysiological effects of alprazolam in children and adolescents with overanxious and avoidant disorders.

In a double-blind, placebo-controlled study, the efficacy and safety of alprazolam was investigated in childhood and adolescent anxiety disorders. Thirty patients (mean, 12.6 years) diagnosed with overanxious or avoidant disorders participated in the study. Evaluations included clinical, laboratory, cognitive, and qualitative EEG measurements. On a clinical global rating, there was no statistical difference between alprazolam and placebo. Relative to baseline EEG, acute alprazolam administration increased beta power in the right occipital lead, and chronic administration increased beta power in both leads. Alprazolam was well tolerated, and adverse effects were few, mild, and transient.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Efficacy and safety of extended-release venlafaxine in the treatment of generalized anxiety disorder in children and adolescents: two placebo-controlled trials.

The authors evaluated the efficacy, safety, and tolerability of extended-release venlafaxine in the treatment of pediatric generalized anxiety disorder. Two randomized, double-blind, placebo-controlled trials were conducted at 59 sites in 2000 and 2001. Participants 6 to 17 years of age who met DSM-IV criteria for generalized anxiety disorder received a flexible dosage of extended-release venlafaxine (N=157) or placebo (N=163) for 8 weeks. The primary outcome measure was the composite score for nine delineated items from the generalized anxiety disorder section of a modified version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children, and the primary efficacy variable was the baseline-to-endpoint change in this composite score. Secondary outcome measures were overall score on the nine delineated items, Pediatric Anxiety Rating Scale, Hamilton Anxiety Rating Scale, Screen for Child Anxiety Related Emotional Disorders, and the severity of illness and improvement scores from the Clinical Global Impression scale (CGI). The extended-release venlafaxine group showed statistically significant improvements in the primary and secondary outcome measures in study 1 and significant improvements in some secondary outcome measures but not the primary outcome measure in study 2. In a pooled analysis, the extended-release venlafaxine group showed a significantly greater mean decrease in the primary outcome measure compared with the placebo group (-17.4 versus -12.7). The response rate as indicated by a CGI improvement score <3 was significantly greater with extended-release venlafaxine than placebo (69% versus 48%). Common adverse events were asthenia, anorexia, pain, and somnolence. Statistically significant changes in height, weight, blood pressure, pulse, and cholesterol levels were observed in the extended-release venlafaxine group. Extended-release venlafaxine may be an effective, well-tolerated short-term treatment for pediatric generalized anxiety disorder.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

SET-C versus fluoxetine in the treatment of childhood social phobia.

To determine the efficacy of fluoxetine, pill placebo, and Social Effectiveness Therapy for Children (SET-C) for children and adolescents with social phobia. Youths ages 7 to 17 were randomly assigned to one of the treatment conditions. Outcome was evaluated using self-reports, parent ratings, independent evaluator ratings, and behavioral assessment. Both fluoxetine and SET-C were more efficacious than placebo in reducing social distress and behavioral avoidance and increasing general functioning. SET-C was superior to fluoxetine on each of these measures and was the only treatment superior to placebo in terms of improving social skills, decreasing anxiety in specific social interactions, and enhancing ratings of social competence. Furthermore, whereas fluoxetine appears to exert maximum effect by 8 weeks, SET-C provides continued improvement through week 12. Both fluoxetine and SET-C are efficacious for social phobia, although SET-C appears to provide added benefit by enhancing social skills.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Treatment of elective mutism with fluoxetine: a double-blind, placebo-controlled study.

To evaluate the efficacy of treatment with fluoxetine in reducing symptoms associated with elective mutism. Sixteen subjects with elective mutism were treated with placebo (single-blind) for 2 weeks. Fifteen placebo nonresponders were then randomly assigned to double-blind treatment with fluoxetine at a dose of 0.6 mg/kg/day (N = 6) or continued placebo (N = 9) for an additional 12 weeks. Outcome ratings were completed by the treating psychiatrist, parents, and teachers. Significant improvements over time on ratings of elective mutism, anxiety, and social anxiety, rated by clinician, parents, and teachers, were demonstrated in both fluoxetine- and placebo-treated subjects. Subjects treated with fluoxetine were significantly more improved than placebo-treated subjects on parent's ratings of mutism change and global change. Clinician and teacher ratings did not reveal significant differences between treatment groups. Although improved, most subjects in both treatment groups remained very symptomatic at the end of the study period. Side effects were minimal. Fluoxetine may be beneficial and safe in the treatment of children with elective mutism. Longer periods of treatment may yield more substantial therapeutic benefits. Further study is indicated.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Placebo-controlled trial of sertraline in the treatment of children with generalized anxiety disorder.

The study compared the safety and efficacy of sertraline, a selective serotonin reuptake inhibitor, and placebo in the treatment of generalized anxiety disorder in children and adolescents. The study subjects were 22 children and adolescents age 5-17 years who met the DSM-IV criteria for generalized anxiety disorder according to the Anxiety Disorders Interview Schedule for Children-Revised and who had a Hamilton Anxiety Rating Scale score > or = 16. The patients underwent a 2-3-week prestudy evaluation period, followed by a 9-week double-blind treatment phase in which they were randomly assigned in blocks of four to receive either sertraline or pill placebo. The maximum dose of sertraline was 50 mg/day. Primary outcome measures were the Hamilton anxiety scale and the Clinical Global Impression scale. The Hamilton anxiety scale total score, psychic factor, and somatic factor and the Clinical Global Impression severity and improvement scales showed significant differences with treatment in favor of sertraline over placebo beginning at week 4. Self-report measures reflected these results at the end of treatment. The results of this double-blind, placebo-controlled trial suggest that sertraline at the daily dose of 50 mg is safe and efficacious for the treatment of generalized anxiety disorder in children and adolescents.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial.

To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring. A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE=0.82) and -5.34 points (SE=0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval=-5.60 to -1.29, p=.002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events. Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder.

Social anxiety disorder is a debilitating, highly prevalent disorder in children and adolescents. If left untreated, it can interfere with emotional, social, and school functioning. To evaluate the efficacy and tolerability of paroxetine in children and adolescents with social anxiety disorder. Multicenter, 16-week, randomized, double-blind, placebo-controlled, flexible-dose, parallel-group, outpatient study. Patients A total of 322 children (8-11 years of age) and adolescents (12-17 years of age) with social anxiety disorder as their predominant psychiatric illness. Intervention Eligible patients were randomized (1:1) to receive paroxetine (10-50 mg/d) or placebo. Four hundred twenty-five patients were screened, and 322 were randomized to treatment. Of these, 319 were included in the intention-to-treat population (paroxetine, n = 163; placebo, n = 156). At the week 16 last observation carried forward end point, the odds of responding (Clinical Global Impression-Improvement score of 1 or 2) were statistically significantly greater for paroxetine (77.6% response [125/161]) than for placebo (38.3% response [59/154]) (adjusted odds ratio, 7.02; 95% confidence interval, 4.07 to 12.11; P<.001). The proportion of patients who were "very much" improved (Clinical Global Impression-Improvement score of 1) was 47.8% (77/161) for paroxetine compared with 14.9% (23/154) for placebo. Adverse events occurring at an incidence of 5% or greater for paroxetine and twice that for placebo were insomnia (14.1% vs 5.8%), decreased appetite (8.0% vs 3.2%), and vomiting (6.7% vs 1.9%). Withdrawals due to adverse events were infrequent (5.5% [9/163] for paroxetine and 1.3% [2/156] for placebo). Paroxetine is an effective, generally well-tolerated treatment for pediatric social anxiety disorder.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Clonazepam in childhood anxiety disorders.

There is evidence for the efficacy and safety of clonazepam (CZP) in adult anxiety disorders, but no formal studies to substantiate clinical reports of similar benefit in children with anxiety disorders. In this double-blind pilot study, 15 children, aged 7 to 13 years, entered a randomly assigned, double-blind crossover trial of 4 weeks of CZP (up to 2 mg/day) and 4 weeks of placebo. Twelve children completed the trial. All but 1 had a diagnosis of separation anxiety disorder, and all but 2 had comorbid diagnoses. Nine children appeared to have moderate to significant clinical improvement, but statistical comparisons on several ratings failed to confirm a trend in favor of CZP. Side effects of drowsiness, irritability, and/or oppositional behavior were notable in 10 children in the CZP phase compared with 5 in the placebo phase. Clonazepam was believed to have clinical benefit for some children, but this was not confirmed statistically in this small sample. Problematic side effects of drowsiness and disinhibition were common and possibly were due to rapid titration.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Clinical controlled trial of chlorimipramine in adolescents with obsessive-compulsive disorder.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Fluoxetine in children and adolescents with OCD: a placebo-controlled trial.

To examine the safety and efficacy of fluoxetine in child and adolescent obsessive-compulsive disorder (OCD). Between 1991 and 1998, 43 patients were randomly assigned to fluoxetine or placebo for 8 weeks. Dosing was fixed for the first 6 weeks (up to 60 mg/day) and then could be increased to 80 mg/day. Responders entered an 8-week maintenance phase. The primary outcome measures were the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinical Global Impression-Improvement (CGI-I) scale. Analyses were done on the intent-to-treat sample. Fluoxetine patients (n = 21) had significantly lower CY-BOCS scores than placebo patients (n = 22) after 16 (but not 8) weeks. Fluoxetine responders (n = 11) had significantly lower CY-BOCS scores than placebo responders (n = 7) after an additional 8 weeks of treatment. After 16 weeks, 57% of fluoxetine (versus 27% of placebo) patients were much or very much improved on the CGI-I scale (p <.05). No patient terminated the study because of adverse medication effects. Fluoxetine was well tolerated and effective for the treatment of child and adolescent OCD, but fluoxetine's full effect took more than 8 weeks to develop.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial.

The empirical literature on treatment of obsessive-compulsive disorder (OCD) in children and adolescents supports the efficacy of short-term OCD-specific cognitive-behavior therapy (CBT) or medical management with selective serotonin reuptake inhibitors. However, little is known about their relative and combined efficacy. To evaluate the efficacy of CBT alone and medical management with the selective serotonin reuptake inhibitor sertraline alone, or CBT and sertraline combined, as initial treatment for children and adolescents with OCD. The Pediatric OCD Treatment Study, a balanced, masked randomized controlled trial conducted in 3 academic centers in the United States and enrolling a volunteer outpatient sample of 112 patients aged 7 through 17 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of OCD and a Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score of 16 or higher. Patients were recruited between September 1997 and December 2002. Participants were randomly assigned to receive CBT alone, sertraline alone, combined CBT and sertraline, or pill placebo for 12 weeks. Change in CY-BOCS score over 12 weeks as rated by an independent evaluator masked to treatment status; rate of clinical remission defined as a CY-BOCS score less than or equal to 10. Ninety-seven of 112 patients (87%) completed the full 12 weeks of treatment. Intent-to-treat random regression analyses indicated a statistically significant advantage for CBT alone (P = .003), sertraline alone (P = .007), and combined treatment (P = .001) compared with placebo. Combined treatment also proved superior to CBT alone (P = .008) and to sertraline alone (P = .006), which did not differ from each other. Site differences emerged for CBT and sertraline but not for combined treatment, suggesting that combined treatment is less susceptible to setting-specific variations. The rate of clinical remission for combined treatment was 53.6% (95% confidence interval [CI], 36%-70%); for CBT alone, 39.3% (95% CI, 24%-58%); for sertraline alone, 21.4% (95% CI, 10%-40%); and for placebo, 3.6% (95% CI, 0%-19%). The remission rate for combined treatment did not differ from that for CBT alone (P = .42) but did differ from sertraline alone (P = .03) and from placebo (P<.001). CBT alone did not differ from sertraline alone (P = .24) but did differ from placebo (P = .002), whereas sertraline alone did not (P = .10). The 3 active treatments proved acceptable and well tolerated, with no evidence of treatment-emergent harm to self or to others. Children and adolescents with OCD should begin treatment with the combination of CBT plus a selective serotonin reuptake inhibitor or CBT alone.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Clomipramine hydrochloride in childhood and adolescent obsessive-compulsive disorder--a multicenter trial.

Children and adolescents with obsessive compulsive disorder were studied in an 8-week, multicenter, double-blind, parallel groups trial of clomipramine hydrochloride (CMI) versus placebo. Efficacy assessments included the child version of the Yale-Brown Obsessive Compulsive Scale and the National Institute of Mental Health Global rating scale. At the end of 8 weeks, CMI-treated patients showed a mean reduction in Yale-Brown Obsessive Compulsive Scale score of 37% compared to 8% in the placebo group. Side effects were typical of tricyclic antidepressants. In a 1-year open label treatment, CMI continued to be effective and well tolerated.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Impact of comorbidity on treatment response to paroxetine in pediatric obsessive-compulsive disorder: is the use of exclusion criteria empirically supported in randomized clinical trials?

To examine the influence of psychiatric comorbidity on response and relapse rates in children and adolescents treated with paroxetine for obsessive-compulsive disorder (OCD). Patients responding following 16 weeks of treatment (phase I) were randomized to continued paroxetine or to placebo for 16 additional weeks (phase II). OCD response (phase I) and relapse (phase II) criteria were based on the Clinical Global Impression-Improvement Scale and the Children's Yale-Brown Obsessive Compulsive Scale. The presence of OCD and other psychiatric disorders was ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version interview. At entry, 193 of 335 (57.6%) patients had at least one psychiatric disorder in addition to OCD, and 102 of 335 (30.4%) had multiple other disorders. Although the response rate to paroxetine in the overall population was high (71%), the response rates in patients with comorbid attention deficit hyperactivity disorder, tic disorder, or oppositional defiant disorder (56%, 53%, and 39%, respectively) were significantly less than in patients with OCD only (75%) (intent-to-treat population, last observation carried forward analysis, p < 0.05). Psychiatric comorbidity was associated with a greater rate of relapse in the total patient population (46% for one or more comorbid disorders [p = 0.04] and 56% for two or more comorbid disorders [p < 0.05] vs. 32% for no comorbidity). The results of these post hoc analyses show that comorbid illness adversely impacted response to pharmacotherapy with paroxetine in pediatric OCD and significantly increased risk of relapse following withdrawal from treatment. Continued paroxetine treatment reduced the relapse rates in all groups compared with placebo, including those with comorbid illness. Because pediatric OCD is frequently comorbid with other psychiatric disorders, results of randomized, controlled pediatric OCD trials that use multiple exclusion criteria may not generalize to more naturalistic OCD samples.

CD005170

Medication treatments can be effective in paediatric anxiety disorders, acting to reduce core symptoms, and should be considered as part of the treatment of these disorders. The greatest number of trials showing efficacy to date have assessed the SSRIs in treating paediatric OCD. There is no clear evidence to show that any particular class of medication is more effective or better tolerated than any other. As quantitative data was only available for the SSRIs and venlafaxine the routine use of benzodiazepines cannot be recommended, especially given concerns of dependency and treatment -related emergent adverse events associated with this class of drugs. Future RCTs could help identify potential clinical moderators of treatment efficacy. Studies of the long-term efficacy of medication treatment, optimal dosage, as well as direct comparisons of pharmacotherapy and psychotherapy are also warranted.

Fluoxetine treatment for obsessive-compulsive disorder in children and adolescents: a placebo-controlled clinical trial.

This study assesses the efficacy and tolerability of fluoxetine in the acute treatment of child and adolescent obsessive-compulsive disorder (OCD) during a 13-week, double-blind, placebo-controlled study. Eligible patients aged 7 to 17 (N = 103) were randomized at a ratio of 2:1 to receive either fluoxetine or placebo. Dosing was initiated at 10 mg daily for 2 weeks, then increased to 20 mg daily. After 4 weeks of treatment, and again after 7 weeks of treatment, non-responders could have their dosage increased by 20 mg daily, for a maximum possible dosage of 60 mg daily. Primary measure of efficacy was improvement in OCD symptoms as measured by the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). All analyses were intent-to-treat. Fluoxetine was associated with significantly greater improvement in OCD as assessed by the CY-BOCS (p = .026) and other measures than was placebo. Fluoxetine was well tolerated and had a rate of discontinuation for adverse events similar to that of placebo (p = 1.00). Fluoxetine 20 to 60 mg daily was effective and well tolerated for treatment of OCD in this pediatric population.

CD001281

Long-acting beta-2 agonists, particularly salmeterol, are more effective than theophylline in improving morning and evening PEF, but are not significantly different in their effect on FEV1. There is evidence of decreased daytime and nighttime short-acting beta-2 agonist requirement with salmeterol. Fewer adverse events occurred in participants using long-acting beta-2 agonists (salmeterol and formoterol) as compared to theophylline.

Salmeterol versus theophylline in the treatment of asthma.

Although theophylline is recommended by current guidelines for the management of asthma in patients with persistent symptoms, theophylline has a narrow therapeutic index, requiring individual dose titration and regular monitoring of serum theophylline concentrations to avoid adverse effects. To compare the inhaled long-acting bronchodilator, salmeterol, with the oral bronchodilator, theophylline, in the maintenance treatment of asthma. In two multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group studies, patients received salmeterol aerosol 42 micrograms, extended-release theophylline capsules, or placebo twice daily for 12 weeks. Of 638 adult and adolescent patients with moderate asthma who entered the prebaseline theophylline titration period, 154 were withdrawn prior to randomization (71 due to theophylline-related adverse effects); 484 patients comprised the intent-to-treat population. The mean serum theophylline concentration measured approximately seven hours postdose during the titration period in the theophylline group was 12.7 mg/L (70 mumol/L). The same dose during the treatment period resulted in a mean serum theophylline concentration between 7.6 to 7.9 mg/L (42-44 mumol/L) when measured approximately 12 hours postdose. Salmeterol was significantly more effective than theophylline or placebo in improving mean morning PEF over the entire 12 weeks (P < or = .02). Mean predose FEV1 improved significantly with salmeterol compared with placebo (P < .001); there was no difference between theophylline and placebo. Salmeterol was also significantly more effective than theophylline or placebo (P < .02) in improving asthma symptoms, reducing nighttime awakenings, and reducing the daily use of albuterol. After 12 weeks of treatment, patients in the salmeterol group expressed significantly greater overall satisfaction with their asthma medication than did patients who received theophylline (P < .01). Patients in the theophylline group experienced more gastrointestinal adverse events than did patients in the salmeterol group (P < .05). Salmeterol, 42 mg twice daily, was better tolerated and significantly more effective than extended-release theophylline twice daily in the maintenance treatment of asthma.

CD001281

Long-acting beta-2 agonists, particularly salmeterol, are more effective than theophylline in improving morning and evening PEF, but are not significantly different in their effect on FEV1. There is evidence of decreased daytime and nighttime short-acting beta-2 agonist requirement with salmeterol. Fewer adverse events occurred in participants using long-acting beta-2 agonists (salmeterol and formoterol) as compared to theophylline.

Nocturnal asthma therapy. Inhaled bitolterol versus sustained-release theophylline.

Many asthmatics complain of increased symptoms, awakenings, and need for additional medications during the sleeping hours. Sustained-release theophylline (THEO) may be superior to conventional inhaled bronchodilators in preventing nocturnal asthma symptoms and the early morning decrement in lung function common to this population. However, recent studies have demonstrated that THEO may delay sleep onset and perturb sleep stage distribution. No previous study has evaluated electroencephalographic, cardiac, and gas exchange indices during sleep in asthmatics treated with THEO compared with a long-acting inhaled beta 2-agonist. The study goals were to determine if theophylline perturbed sleep when compared with beta 2-agonists and to determine which agent achieved best control of daytime and nocturnal pulmonary symptoms and lung dysfunction. We evaluated 26 subjects with mild to moderate asthma and a history of frequent nocturnal symptoms who previously demonstrated decrements in AM lung function. THEO was compared with 3 puffs every 8 h (6 A.M., 2 P.M., and 10 P.M.) of bitolterol (BITOL), a long-acting beta 2-agonist, in a randomized, double-blind, placebo-controlled cross-over study. Each drug was administered for a 2-wk period ending with two consecutive nights of sleep evaluation followed by cross-over to the alternate drug regimen. During THEO administration, plasma concentrations on awakening were 11.4 +/- 0.69 micrograms/ml as compared with 0.00 micrograms/ml during BITOL. THEO was not found to disrupt sleep as sleep latency, total sleep time, percentage of total sleep time spent in Stages 1, 2, and 3/4 and in REM sleep were similar during each regimen.(ABSTRACT TRUNCATED AT 250 WORDS)

CD001281

Long-acting beta-2 agonists, particularly salmeterol, are more effective than theophylline in improving morning and evening PEF, but are not significantly different in their effect on FEV1. There is evidence of decreased daytime and nighttime short-acting beta-2 agonist requirement with salmeterol. Fewer adverse events occurred in participants using long-acting beta-2 agonists (salmeterol and formoterol) as compared to theophylline.

Comparison of inhaled salmeterol and individually dose-titrated slow-release theophylline in patients with reversible airway obstruction. European Study Group.

The aim of this study was to compare the clinical efficacy of salmeterol versus theophylline in the treatment of moderate-to-severe asthma. One hundred and eighty nine asthmatic patients (forced expiratory volume in one second (FEV1) or peak expiratory flow (PEF) >50% of predicted) were randomized to receive either salmeterol dry powder, 50 microg b.i.d. via a Diskhaler (n=92) or dose-titrated slow-release theophylline capsules ("Theo-Dur") b.i.d. (n=97), in a double-blind, double-dummy, parallel group study for 4 weeks. Patients had previously been titrated with theophylline to a serum theophylline level of 10-20 microg x mL-1. The median percentage of nights with no asthma symptoms rose from 14% in both groups at baseline to 71% with salmeterol and to 46% with theophylline (p=0.044). There was also a significant increase for salmeterol in the median percentage of nights with no rescue salbutamol use (from 36 to 86%) compared with theophylline (from 71 to 78%; p=0.002). The mean morning PEF increased from 337 L x min-1 in the salmeterol group and 332 L x min-1 in the theophylline group to 372 and 357 L x min-1, respectively. No significant difference between the two treatments was observed for PEF, symptoms or additional salbutamol medication during the day. The incidence of gastrointestinal symptoms (gastric irritation, nausea and vomiting) was greater among patients receiving theophylline (11%) than with salmeterol (3%). These findings suggest that inhaled salmeterol is more effective in relieving symptoms of asthma, and better tolerated than theophylline in patients with moderate-to-severe asthma.