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PubMed2001

Adjunctive intravaginal metronidazole for the prevention of postcesarean endometritis: a randomized controlled trial.

OBJECTIVE: To estimate the efficacy of preoperative administration of intravaginal metronidazole for the prevention of postcesarean endometritis. METHODS: This double-masked, placebo-controlled randomized trial included patients of at least 24 weeks' gestation undergoing cesarean deliveries for various indications. Patients were randomized to receive either 5 g of metronidazole gel intravaginally or matching placebo before the initiation of the cesarean. All patients underwent surgical cleansing of the abdomen, and most received prophylactic antibiotics after cord clamping. Patients with chorioamnionitis and/or suspected allergy to metronidazole were excluded. For a two-sided alpha of 0.05 and beta of 0.20 (80% power), 120 subjects were required in each group. The main outcome variable was the incidence of postcesarean endometritis. Secondary outcome variables included presence of febrile morbidity, wound infection, days on antibiotics, and length of postpartum hospitalization. Neonatal outcomes included birth weight, Apgar scores less than 7 at 5 minutes, umbilical arterial pH less than 7.16, admission and length of stay in the neonatal intensive care unit, and length of hospital stay. RESULTS: Of 112 patients receiving metronidazole, eight (7%) developed postcesarean endometritis, compared with 19 of 112 (17%) of those receiving placebo gel (relative risk 0.42, 95% confidence interval 0.19, 0.92). No significant differences were noted between treatment groups with respect to the other outcome variables. CONCLUSION: The preoperative administration of 5 g of intravaginal metronidazole gel appears to reduce the incidence of postcesarean endometritis.

Administration, Intravaginal↗
PubMed1994

Slow-release sodium fluoride in the management of postmenopausal osteoporosis. A randomized controlled trial.

OBJECTIVE: To test whether intermittent treatment with slow-release sodium fluoride and continuous calcium citrate supplementation inhibits vertebral fractures without causing fluoride complications. DESIGN: A placebo-controlled, randomized trial. SETTING: Outpatient setting of specialty clinics in Dallas and Temple, Texas. INTERVENTIONS: Slow-release sodium fluoride (25 mg twice daily) in repeated 14-month cycles (12 months on treatment followed by 2 months off treatment) compared with placebo. Both groups took calcium citrate (400 mg calcium twice daily) continuously. PATIENTS: 110 patients with postmenopausal osteoporosis were randomly assigned to two groups. In the slow-release sodium fluoride group, 48 of 54 patients completed more than 1 cycle of treatment (mean, 2.44 cycles/patient), whereas 51 of 56 patients in the placebo group completed at least 1 cycle (mean, 2.14 cycles/patient) in this interim analysis. MEASUREMENTS: Vertebral fracture rate and lumbar bone mineral content. Vertebral fractures were quantified from yearly radiographs. Bone mass was determined annually by densitometry. RESULTS: In the sodium fluoride group, the mean L2 to L4 bone mineral content increased by 4% to 6% in each cycle and the mean femoral neck bone density increased by 4.1% and 2.1% during the first two cycles, but the radial bone density did not change. The placebo group showed no statistical change in bone mass at any site. Compared with the placebo group, the sodium fluoride group had a lower individual new vertebral fracture rate (0.057/patient cycle compared with 0.204/patient cycle, P = 0.017), a higher fracture-free rate (83.3% compared with 64.7%, P = 0.042), and a lower group fracture rate (0.085/patient cycle compared with 0.239/patient cycle, P = 0.006). The side-effect profile was similar for the two groups; no patient developed microfractures, hip fractures, or blood loss anemia. CONCLUSIONS: Intermittent slow-release sodium fluoride plus continuous calcium citrate, administered for about 2.5 years, inhibits new vertebral fractures, increases the mean spinal bone mass without decreasing the radial shaft bone density, and is safe to use.

Aged↗
PubMed2003

Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial.

OBJECTIVE: To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In a double-blind placebo-controlled randomized trial between January 1999 and March 2000, 100 men with symptoms of BPH, aged < 80 years, with a maximum urinary flow rate of 5-15 mL/s for a voiding volume of 150 mL, were randomly and equally allocated to 320 mg S. repens extract or placebo (paraffin oil). The main outcome measures were the International Prostate Symptom Score (IPSS), peak urinary flow rate, and the Rosen International Index of Erectile Function (IIEF) questionnaire. RESULTS: There was no significant difference between the treatments over the 12 weeks of the study in the IPSS, peak urinary flow rate or for the IIEF questionnaire. CONCLUSIONS: During the trial all participants had some improvement in their symptoms of BPH but there was no significant beneficial effect of this S. repens extract over placebo in this 12-week trial.

Androgen Antagonists↗
PubMed1991

Insulin and glucagon infusion in acute alcoholic hepatitis: a prospective randomized controlled trial.

In a randomized, controlled trial to investigate the possible benefit of insulin and glucagon therapy in severe acute alcoholic hepatitis, 86 patients were randomized to receive 30 U insulin and 3 mg glucagon in 250 ml 5% dextrose over 12 hr each day for 3 wk or a similar regime of identical placebo. No significant differences were seen in patients' clinical characteristics and disease severity in the treated and placebo groups. Of the 43 patients receiving insulin and glucagon, 15 (35%) died within 4 wk of randomization, compared with 14 deaths (33%) in the control patients (p = not significant). When the patients surviving the first 4 wk were examined there were five more deaths in the treatment group, compared with one death in the control group at 6-mo follow-up (p = not significant). No significant differences in the frequency of short-term or long-term complications of alcoholic liver disease or relapse to alcohol were seen when the two groups were compared, although hypoglycemia was seen in six patients during infusion of insulin and glucagon. Similarly, no significant differences were seen in the improvement in clinical or biochemical features at 4 wk and at 6 mo in survivors when the insulin and glucagon-treated patients were compared with patients in the placebo group. This study does not confirm previous reports that insulin and glucagon infusion improves the outcome of severe acute alcoholic hepatitis.

Acute Disease↗
PubMed2001

Effect of continuous positive airway pressure on sleep architecture in the sleep apnea-hypopnea syndrome: a randomized controlled trial.

There is randomized controlled evidence that patients with sleep apnea-hypopnea syndrome (SAHS) treated with continuous positive airway pressure (CPAP) have improved daytime function and quality of life. "Before-and-after" data indicate that CPAP improves sleep quality, but there is no randomized controlled evidence of this. We tested the hypothesis that CPAP improved sleep quality in patients with SAHS. We also sought correlations between polysomnographic (PSG) indices and benefit from use of CPAP. Twenty-two patients with SAHS (median, [interquartile range] apnea-hypopnea index, 40 [25-65] events/h) spent 1 mo receiving CPAP and 1 mo receiving placebo capsules, in random order, and home sleep studies were performed at the end of each month. CPAP resulted in a lower arousal index, less Stage 1, and more Stage 3+4 sleep, but there was no increase in Stage REM (rapid eye movement) sleep. Improvement in Epworth score after 6-12 mo of treatment correlated significantly with PSG indices on CPAP: sleep efficiency index (r = 0.78, p < 0.001), Stage REM (r = 0.55, p = 0.001), Stage 3+4 (r = 0.5, p = 0.02), and arousal index (r = -0.43, p = 0.05). This study provides randomized controlled trial evidence that patients with SAHS sleep better when receiving CPAP. Patients with good sleep quality on CPAP at 1 mo are likely to gain later benefit in subjective daytime sleepiness.

Female↗
PubMed2003

Soy isoflavones have a favorable effect on bone loss in Chinese postmenopausal women with lower bone mass: a double-blind, randomized, controlled trial.

Animal studies have shown that soy isoflavones have an effect in preventing estrogen-related bone loss, but few data are available in humans, especially in the Asian populations. This double-blind, placebo-controlled, randomized trial examines the effects of soy isoflavones on bone loss in postmenopausal Chinese women, aged 48-62 yr. Two hundred and three eligible subjects were randomly assigned to three treatment groups with daily doses of placebo (1 g starch; n = 67), mid-dose (0.5 g starch, 0.5 g soy extracts, and approximately 40 mg isoflavones; n = 68), and high dose (1.0 g soy extracts and approximately 80 mg isoflavones; n = 68). All were given 12.5 mmol (500 mg) calcium and 125 IU vitamin D(3). Bone mineral density (BMD) and bone mineral content (BMC) of the whole body, spine, and hip were measured using dual energy x-ray absorptiometry at baseline and 1 yr post treatment. Both univariate and multivariate analyses showed that women in the high dose group had mild, but statistically significantly, higher favorable change rate in BMC at the total hip and trochanter (P < 0.05) compared with the placebo and mid-dose groups, even after further adjustments for the potential confounding factors. Further stratified analyses revealed that the positive effects of soy isoflavone supplementation were observed only among women with lower initial baseline BMC (median or less). In conclusion, soy isoflavones have a mild, but significant, independent effect on the maintenance of hip BMC in postmenopausal women with low initial bone mass.

Asian People↗
PubMed2003

A mental health intervention for schoolchildren exposed to violence: a randomized controlled trial.

CONTEXT: No randomized controlled studies have been conducted to date on the effectiveness of psychological interventions for children with symptoms of posttraumatic stress disorder (PTSD) that has resulted from personally witnessing or being personally exposed to violence. OBJECTIVE: To evaluate the effectiveness of a collaboratively designed school-based intervention for reducing children's symptoms of PTSD and depression that has resulted from exposure to violence. DESIGN: A randomized controlled trial conducted during the 2001-2002 academic year. SETTING AND PARTICIPANTS: Sixth-grade students at 2 large middle schools in Los Angeles who reported exposure to violence and had clinical levels of symptoms of PTSD. INTERVENTION: Students were randomly assigned to a 10-session standardized cognitive-behavioral therapy (the Cognitive-Behavioral Intervention for Trauma in Schools) early intervention group (n = 61) or to a wait-list delayed intervention comparison group (n = 65) conducted by trained school mental health clinicians. MAIN OUTCOME MEASURES: Students were assessed before the intervention and 3 months after the intervention on measures assessing child-reported symptoms of PTSD (Child PTSD Symptom Scale; range, 0-51 points) and depression (Child Depression Inventory; range, 0-52 points), parent-reported psychosocial dysfunction (Pediatric Symptom Checklist; range, 0-70 points), and teacher-reported classroom problems using the Teacher-Child Rating Scale (acting out, shyness/anxiousness, and learning problems; range of subscales, 6-30 points). RESULTS: Compared with the wait-list delayed intervention group (no intervention), after 3 months of intervention students who were randomly assigned to the early intervention group had significantly lower scores on symptoms of PTSD (8.9 vs 15.5, adjusted mean difference, - 7.0; 95% confidence interval [CI], - 10.8 to - 3.2), depression (9.4 vs 12.7, adjusted mean difference, - 3.4; 95% CI, - 6.5 to - 0.4), and psychosocial dysfunction (12.5 vs 16.5, adjusted mean difference, - 6.4; 95% CI, -10.4 to -2.3). Adjusted mean differences between the 2 groups at 3 months did not show significant differences for teacher-reported classroom problems in acting out (-1.0; 95% CI, -2.5 to 0.5), shyness/anxiousness (0.1; 95% CI, -1.5 to 1.7), and learning (-1.1, 95% CI, -2.9 to 0.8). At 6 months, after both groups had received the intervention, the differences between the 2 groups were not significantly different for symptoms of PTSD and depression; showed similar ratings for psychosocial function; and teachers did not report significant differences in classroom behaviors. CONCLUSION: A standardized 10-session cognitive-behavioral group intervention can significantly decrease symptoms of PTSD and depression in students who are exposed to violence and can be effectively delivered on school campuses by trained school-based mental health clinicians.

Child↗
PubMed2004

Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689].

BACKGROUND: Randomized controlled trials comparing different vasectomy occlusion techniques are lacking. Thus, this multicenter randomized trial was conducted to compare the probability of the success of ligation and excision vasectomy with, versus without, fascial interposition (i.e. placing a layer of the vas sheath between two cut ends of the vas). METHODS: The trial was conducted between December 1999 and June 2002 with a single planned interim analysis. Men requesting vasectomies at eight outpatient clinics in seven countries in North America, Latin America, and Asia were included in the study. The men were randomized to receive vasectomy with versus without fascial interposition. All surgeons performed the vasectomies using the no-scalpel approach to the vas. Participants had a semen analysis two weeks after vasectomy and then every four weeks up to 34 weeks. The primary outcome measure was time to azoospermia. Additional outcome measures were time to severe oligozoospermia (<100 000 sperm/mL) and vasectomy failure based on semen analyses. RESULTS: We halted recruitment after the planned interim analysis, when 841 men had been enrolled. Fascial interposition decreased time to azoospermia (hazard ratio [HR], 1.35; P < 0.0001) and time to severe oligozoospermia (HR, 1.32; P < 0.0001) and reduced failures based on semen analysis by about half, from 12.7% (95% confidence interval [CI], 9.7 to 16.3) to 5.9% (95% CI, 3.8 to 8.6) (P < 0.0001). Older men benefited less from fascial interposition than younger men in terms of the speed of achieving azoospermia. However, the number of vasectomy failures was reduced to a similar degree in all age groups. Slightly more adverse events occurred in the fascial interposition group, but the difference was not significant. These failure rates may appear high to practitioners in countries such as the USA, but they are similar to results from other careful studies of ligation and excision techniques. CONCLUSION: Fascial interposition significantly improves vasectomy success when ligation and excision is the method of vas occlusion. A limitation of this study is that the correlation between postvasectomy sperm concentrations and risk of pregnancy is not well quantified.

Adult↗
PubMed1975

Proximal gastric vagotomy: interim results of a randomized controlled trial.

In a randomized controlled trial 50 patients with duodenal ulcer treated by proximal gastric vagotomy (P.G.V.) without drainage were compared with 50 who underwent selective vagotomy and gastrojejunostomy. The clinical results were assessed in 99 patients one to four years after operation. Patients who had undergone P.G.V. had significantly less dumping, nausea, and bile vomiting and fared better in their overall clinical grading. The postoperative Visick grading of the 50 patients with P.G.V. was similar to that of 56 controls with no known gastrointestinal disease who had not undergone operation. The results obtained in the patients who had had P.G.V. without drainage were compared with those of a further group of 24 patients subjected of P.G.V. with gastrojejunostomy, and the better results obtained in the former group were thought to be due to elimination of the drainage procedure. The average follow-up period of the trial was just over two years, but there were no indications that the recurrent ulceration rate after P.G.V. would be any higher than after other types of vagotomy and drainage.

Adult↗
PubMed1986

Alcohol and high-density-lipoprotein cholesterol: a randomized controlled trial.

1. A randomized controlled trial of cross-over design was set up to examine the effect of alcohol on blood lipids and certain haematological variates relevant to ischaemic heart disease. 2. One hundred subjects drank some alcohol for 4 weeks (mean intake 18.4 g/d) and abstained totally for 4 weeks, the order of these periods being randomized. 3. Alcohol appeared to produce a rise of 7% in serum high-density-lipoprotein (HDL) cholesterol, probably due to a rise in the HDL2 subfraction. 4. No significant change was detected in plasma fibrinogen or the other haematological indices. 5. These results are consistent with the hypothesis that a moderate intake of alcohol confers some protection against heart disease.

Adult↗
PubMed1993

Does feedback improve the quality of cervical smears? A randomized controlled trial.

In a randomized controlled trial three methods of feedback of increasing intensity, directed at 183 doctors taking cervical smears, were compared with respect to their effects on the sampling quality of smears. Overall, feedback was found to have no influence on quality criteria in the crude data analysis. However, a significantly larger decrease in the percentage of smears lacking endocervical cells was found in the groups receiving monthly overviews of their results with peer comparison, when compared with the groups not receiving this type of feedback (odds ratio 0.75). Moreover, feedback appeared to have a clear effect on the presence of endocervical cells among doctors submitting a substantial number of smears in the intervention period, as opposed to those who submitted fewer smears. A positive correlation was also observed between the increase in the group mean of the proportions of smears containing pathological cells and the intensity of the feedback. However, this increase did not reach statistical significance. This study suggests that monthly feedback with peer comparison may have a positive relationship with some aspects of quality improvement in cervical screening.

Adult↗
PubMed2001

Hydrosalpinx and IVF outcome: cumulative results after salpingectomy in a randomized controlled trial.

BACKGROUND: A randomized controlled trial of salpingectomy prior to IVF in patients with hydrosalpinges has been conducted in Scandinavia. The results from the first transfer cycle have been published and clearly demonstrated an improved pregnancy outcome after salpingectomy had been performed in patients with hydrosalpinges large enough to be visible on ultrasound. The present article is aimed at analysing the effect of salpingectomy on cumulative birth rate, including all individual transfer cycles. METHODS AND RESULTS: A total of 186 women underwent 452 cycles. Among the 77 women randomized to no surgical intervention, 24 underwent salpingectomy after one or two failed cycles. Cumulative results were analysed by Cox regression, taking into account the number of cycles per patient and the presence of a salpingectomy after a previous transfer. Salpingectomy implied a significant increase in birth rate (hazard ratio 2.1, 95% CI 1.6-3.6, P = 0.014). Within the subgroup of patients with ultrasound-visible hydrosalpinges, the birth rate was even higher (hazard ratio 3.8, 95% CI 1.5-9.2, P = 0.004). Implantation rate was significantly higher in patients who had undergone salpingectomy (27.2% versus 20.2, P = 0.03) and, in the subgroup of patients with ultrasound-visible hydrosalpinges, the difference was even larger (30.3% versus 17.1%, P = 0.003). CONCLUSIONS: The results of the cumulative cycles strengthen the recommendation for a laparoscopic salpingectomy prior to IVF in patients with ultrasound-visible hydrosalpinges.

Adult↗
PubMed1991

Elevation of serum progesterone with oral micronized progesterone after in vitro fertilization. A randomized, controlled trial.

In a randomized, controlled trial, oral micronized progesterone (P4) supplementation effectively elevated luteal phase serum P4 levels after in vitro fertilization (IVF). Of 34 nonconception IVF cycles, 12 were supplemented with oral micronized P4, 200 mg four times daily, beginning the day of oocyte retrieval, while 22 control cycles did not receive supplementation. With oral micronized P4 supplementation the P4 levels were higher (P less than .001) and the luteal phase longer (P less than .05). Oral micronized P4 supplementation appears to be a convenient method of supporting serum P4 levels during the luteal phase after IVF.

Administration, Oral↗
PubMed1995

Long-term effect of feedback and peer comparison on the sampling quality of cervical smears--a randomized controlled trial.

In a randomized controlled trial the effect of feedback and peer review directed at the sample-taking doctor (n = 179) on the sampling quality of cervical smears (n = 21,240) was studied. This paper reports the impact 6 and 12 months after the end of the intervention. Monthly feedback with peer comparison was related to a net improvement in the proportion of cervical smears without endocervical cells during the intervention period, as well as during a follow-up period lasting until 15 months after the end of the intervention. This improvement seemed to be related to a minimum of 50 or even 100 smears performed each year and was therefore not confirmed on clustered data analysis. There is a strong suggestion that the intervention also related to an increase of the number of smears showing cytological pathology, although this study lacked sufficient power to test this hypothesis.

Cluster Analysis↗
PubMed2005

The effects of vitamin C supplementation on serum concentrations of uric acid: results of a randomized controlled trial.

OBJECTIVE: Reductions in serum uric acid levels are clinically relevant. Previous studies have suggested a uricosuric effect of vitamin C. Whether vitamin C reduces serum uric acid is unknown. We undertook this study to determine the effects of vitamin C supplementation on serum uric acid concentrations. METHODS: The study was a double-blinded placebo-controlled randomized trial conducted in research units affiliated with an academic institution. Study participants were 184 nonsmokers, randomized to take either placebo or vitamin C supplements (500 mg/day) for 2 months. RESULTS: At the end of the study period, serum uric acid levels were significantly reduced in the vitamin C group (mean change -0.5 mg/dl [95% confidence interval -0.6, -0.3]), but not in the placebo group (mean change 0.09 mg/dl [95% confidence interval -0.05, 0.2]) (P < 0.0001). The same pattern of results was evident in subgroups defined by age, sex, race, body mass index, chronic illness, diuretic use, and quartiles of baseline serum ascorbic acid levels. In the subgroups, from the lowest to the highest quartile of baseline serum uric acid, net mean changes (95% confidence intervals) in serum uric acid with vitamin C supplementation were -0.4 (-0.8, 0.01), -0.5 (-0.9, -0.2), -0.5 (-0.8, -0.2), and -1.0 (-1.6, -0.4) mg/dl (P = 0.06, 0.005, 0.003, and 0.002, respectively). Compared with placebo, vitamin C increased the estimated glomerular filtration rate. CONCLUSION: Supplementation with 500 mg/day of vitamin C for 2 months reduces serum uric acid, suggesting that vitamin C might be beneficial in the prevention and management of gout and other urate-related diseases.

Adult↗
PubMed1986

Early physical therapy effects on the high-risk infant: a randomized controlled trial.

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

Analysis of Variance↗
PubMed2026

Short-term aerobic exercise as an adjunct treatment for depression in acute geriatric psychiatry: Results of a randomized controlled trial.

BACKGROUND: This randomized controlled trial examined whether short-term aerobic exercise provided additional clinical benefit over an active control in older inpatients with depression in geriatric psychiatry. METHODS: 100 patients (mean age 76&#xa0;years) were randomized to 2-week supervised aerobic ergometer training (intervention group, IG) or a flexibility program (control group, CG), both delivered in addition to treatment as usual (TAU). Adherence, training exposure and adverse events were recorded to assess feasibility. The primary outcome was clinical improvement measured with the Clinical Global Impression of Change (CGI). Secondary outcomes included depressive symptom severity assessed by the Beck Depression Inventory-II (BDI-II) and clinician-rated Hamilton Rating Scale for Depression (HAMD), physical activity, 6-min walk test (6MWT) performance, and fluoxetine-equivalent antidepressant dose (FLX). RESULTS: Thirty-nine participants attended at least 80% of sessions, with lower adherence in the IG. Weekly training duration differed between groups (74.0&#xa0;&#xb1;&#xa0;31.9 vs. 95.0&#xa0;&#xb1;&#xa0;25.3&#xa0;min/week, p&#xa0;=&#xa0;.003). CGI did not differ between groups (IG: MD -0.31, 95% CI -0.67 to 0.05; p&#xa0;=&#xa0;.069). Depressive symptom severity decreased over time in both groups (p&#xa0;<&#xa0;.001), without significant between-group differences for HAMD (MD -0.22, 95% CI -2.55 to 2.12) or BDI-II (MD -0.62, 95% CI -3.68 to 2.45). 6MWT and FLX increased over time (both p&#xa0;<&#xa0;.001), without group differences (6MWT: MD -1.08&#xa0;m, 95% CI -20.04 to 17.89; FLX: MD 5.69&#xa0;mg/day, 95% CI -2.40 to 13.77). CONCLUSION: Short-term aerobic exercise was deliverable, but showed no additional clinical benefit over low-intensity flexibility during TAU. Further research should determine dose, duration and adherence for clinically relevant effects.

Humans↗