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PubMed2004

Selective serotonin reuptake inhibitor and venlafaxine use in children and adolescents with major depressive disorder: a systematic review of published randomized controlled trials.

OBJECTIVE: This review critiques published randomized placebo-controlled trials pertaining to the efficacy and safety of selective serotonin reuptake inhibitors (SSRIs) and venlafaxine in the treatment of major depressive disorder in children and adolescents. METHOD: Medline was searched for articles meeting defined inclusion criteria. The following key terms were used: depressive disorders, antidepressive agents, fluoxetine, paroxetine, sertraline, citalopram, fluvoxamine, venlafaxine, child, and adolescent. RESULTS: Six articles met inclusion criteria. Only 2 studies claim efficacy by significant results in primary outcomes; both have since been contested in further analysis. Not one study adequately examines safety, particularly with respect to whether a link exists between antidepressant use and induction of suicidal ideation or attempts. CONCLUSION: Published studies on SSRI or venlafaxine use in children and adolescents are inconclusive with respect to safety and efficacy, owing to inappropriate claims of efficacy, lack of improvement in global functioning scores, nonstandardized data collection regarding adverse effects, exclusion of suicidal subjects in the recruitment process, grouping of children and adolescents together, small sample sizes, conflict of interest posed by pharmaceutical company sponsorship, and publishing bias. Future investigators should consider these factors when developing study designs.

Adolescent↗
PubMed1978

Antacid titration in the prevention of acute gastrointestinal bleeding: a controlled, randomized trial in 100 critically ill patients.

We randomized 100 critically ill patients at risk of developing acute gastrointestinal ulceration and bleeding into two groups. One (51 patients) received antacid prophylaxis, and the other (49 patients) received no specific form of prophylaxis. Hourly antacid titration kept the pH of the gastric contents above 3.5. Two of the 51 patients who received antacid prophylaxis and gastrointestinal bleeding. Twelve of the 49 control patients bled (P less than 0.005). Of the 12 patients in the control group who bled, seven were placed on antacid medication, and all seven apparently stopped bleeding. Analysis of all the patients showed that an increasing prevalence of respiratory, failure, sepsis, peritonitis, jaundice, renal failure and hypotension was correlated with a greater frequency of bleeding. No patients required operative treatment to control bleeding. These data indicate that the occurrence of acute gastrointestinal bleeding in critically ill patients can be reduced by antacid titration.

Acute Disease↗
PubMed2001

Antidepressants as analgesics: a review of randomized controlled trials.

This review provides an overview of 59 randomized placebo-controlled trials that examined the analgesic effect of antidepressants. To summarize, there is significant evidence that the tricyclic group of antidepressants is analgesic and that trazodone is not; the data regarding selective serotonin reuptake inhibitors are conflicting. To date, there are no randomized controlled trials examining the potential analgesic action of nefazodone or venlafaxine, but on the basis of initial clinical reports and its structural similarity to other analgesics, venlafaxine shows promise as an analgesic.

Analgesics↗
PubMed2006

Natural health products in the prevention and treatment of osteoporosis: systematic review of randomized controlled trials.

BACKGROUND: Consumers are increasingly looking to natural health products to manage specific diseases such as osteoporosis. As a result, healthcare providers need evidence-based information on which to base recommendations regarding use and efficacy. OBJECTIVE: To identify natural health products (NHPs, ie, dietary supplements) advocated for the prevention and treatment of osteoporosis and systematically review the evidence from randomized controlled trials for the effect of NHPs on bone mineral density (BMD)/fracture rate in women. METHODS: MEDLINE, Natural Medicines Comprehensive Database, and the Internet were initially searched to identify NHPs advocated for prevention and treatment of osteoporosis. For NHPs having evidence to support their claim, the aforementioned sources, along with International Pharmaceutical Abstracts, the Cochrane Library, the International Bibliographic Information on Dietary Supplements, the Cumulative Index to Nursing & Allied Health, and HerbMed, were searched to locate randomized controlled trials published in English between 1966 and October 2004. Bibliographies of identified articles were also searched. Randomized controlled trials were selected if they evaluated the use of a single NHP in women, using BMD/fracture rate as the outcome measure. NHPs were excluded from further evaluation if a review had already been published. Data were extracted using predetermined criteria and studies appraised using the Jadad scale. Forty-five NHPs were identified that the authors claimed to be beneficial in prevention and treatment of osteoporosis, with 15 having evidence to support their claim. Calcium; copper; evening primrose oil; fish oils; fluoride; magnesium; manganese; strontium; vitamin D; and black, green, and oolong tea did not meet study criteria. RESULTS: Results from randomized controlled trials evaluating dehydroepiandrosterone (DHEA), phytoestrogens, and vitamin K2 (menaquinone or menatetrenone) were promising; however, study limitations suggest the need for confirmatory evidence. CONCLUSIONS: Although no definitive conclusions can be drawn, the relative safety of phytoestrogens, DHEA, and vitamin K2 at the studied doses, as well as preliminary positive results from randomized controlled trials, provides some initial support for the use of these NHPs in the prevention and treatment of osteoporosis in women.

Biological Products↗
PubMed1993

Randomized controlled trial of patch angioplasty for carotid endarterectomy. The Joint Vascular Research Group.

A randomized controlled trial was performed to evaluate patch angioplasty for patients undergoing carotid endarterectomy. There were 213 patient episodes affecting 148 men and 65 women, with 109 allocated to patch angioplasty. Following surgery six patients suffered transient ischaemic attacks but these did not delay discharge from hospital. Six individuals (four patched operations, two not patched) required re-exploration for postoperative haemorrhage and eight (two patched procedures, six not) had potentially serious neurological problems after operation. Of these eight patients, four (none receiving patch angioplasty) underwent re-exploration and in each case a clot was removed and a patch inserted; three of the four made a good long-term recovery. The other four patients suffered completed strokes from which one died. Two further patients (one patched procedure, one not) died after operation from myocardial events, giving an overall 30-day stroke or mortality rate of 2.8 per cent. Objective follow-up assessment with duplex scanning at 1 year was completed by 94.8 per cent of patients; significantly more vessel restenoses and occlusions were observed in those not receiving patches (P < 0.01). Patch angioplasty reduces the number of immediate postoperative complications, and significantly lowers vessel restenosis and occlusion rates at 1 year after operation.

Aged↗
PubMed1990

Quantitative changes in dietary fat intake and serum cholesterol in women: results from a randomized, controlled trial.

We compared observed and predicted changes in serum cholesterol in women with mammographic dysplasia who participated for 12 mo in a randomized, controlled trial of a low-fat, high-carbohydrate diet, in which total fat intake was reduced from an average of 37% of calories to 21% and carbohydrate intake increased from 44% to 52% of calories. Changes observed in serum cholesterol were greater than those predicted (by the formulas of Hegsted and Keys) for subjects with initial serum cholesterol values in the upper tertile of the population, were not significantly different from those predicted for subjects with baseline values in the middle tertile, and were significantly less than those predicted for subjects with initial values in the lower tertile. These results show that the usefulness of serum cholesterol as a marker of change in dietary fat intake in women depends on the distribution of serum cholesterol values in the population studied.

Adult↗
PubMed1997

Methadone vs. L-alpha-acetylmethadol (LAAM) in the treatment of opiate addiction. A meta-analysis of the randomized, controlled trials.

The authors conducted a meta-analysis of the reported randomized, controlled trials comparing methadone to L-alpha-acetylmethadol (LAAM) to assess the efficacy of LAAM relative to methadone in the treatment of opiate addiction. All studies were conducted in standard outpatient opiate addiction treatment clinics. Most patients were men from lower socioeconomic strata. A statistically significant risk difference favoring methadone was detected for retention-in-treatment and discontinuation of treatment because of side effects. The risk difference for illicit drug use favored LAAM, but was not significant. A small treatment difference in favor of methadone was noted. LAAM does appear to be a relatively effective alternative in the treatment of opiate addiction, more so in certain select situations.

Adult↗
PubMed2006

Update in ARDS management: recent randomized controlled trials that changed our practice.

In the last 7 years, 14 randomized controlled trials in patients with acute respiratory distress syndrome (ARDS) have shown that: Mechanical ventilation with a tidal volume of 6 mL/kg of predicted body weight is better than mechanical ventilation with a tidal volume of 12 mL/kg of predicted body weight. Prone positioning improves oxygenation but poses safety concerns. A high level of positive end-expiratory pressure does not improve survival. High-frequency oscillatory ventilation is in theory the ideal "lung-protective" method, but its benefits have not been proven. No drug therapy has been shown to improve survival in patients with ARDS. Exogenous surfactant may improve oxygenation but has no significant effect on the death rate or length of use of mechanical ventilation. Low-dose inhaled nitric oxide has no substantial impact on the duration of ventilatory support or on the death rate. Partial liquid ventilation may be beneficial in young patients with acute lung injury or ARDS, although further study is needed to confirm this.

Glycine↗
PubMed1991

Endoscopic injection to arrest peptic ulcer hemorrhage: a prospective, randomized controlled trial; preliminary results.

Over a period of 10 months, we conducted a prospective randomized controlled trial of endoscopic injection for the arrest of peptic ulcer hemorrhage in 84 patients. We injected pure alcohol (PA, 99.8%), 50% glucose in water (G/W), 3% NaCl solution, and normal saline solution (N/S, controls) to stop bleeding. The ultimate success rates in the four groups were: 81% (17/21) in the PA group, 80% (16/20) in the 50% G/W group, 65.2% (15/23) in the 3% NaCl group, and 80% (16/20) in the N/S group (p greater than 0.05). The volume of blood transfusion (mean +/- s. e. m.) for each patient was 1,200 ml +/- 433 ml in the PA group, 1,130 +/- 356 ml in the 50% G/W group, 1,704 +/- 330 ml in the 3% NaCl group, 1,400 +/- 548 ml in the N/S group (p greater than 0.05). The duration of hospitalization (mean +/- s. e. m.) was 5.7 +/- 1.5 days in the PA group, 3 +/- 1.3 days in the 50% G/W group, 6.1 +/- 1.1 days in the 3% NaCl group, and 5 +/- 1.1 days in the N/S group (p greater than 0.05). No complication of perforation or aspiration pneumonia was observed during hospitalization. We suggest that endoscopic injection with the above solutions be used as the first line of therapeutic endoscopy for arrest of peptic ulcer hemorrhage.

Aged↗
PubMed2000

Raloxifene and estrogen effects on quality of life in healthy postmenopausal women: a placebo-controlled randomized trial.

OBJECTIVE: To assess the effects of raloxifene, estrogen, and placebo on quality of life in healthy, asymptomatic, postmenopausal women. METHODS: In a multicenter, double-blind, 12-month study, 398 women were assigned randomly to one of four groups: raloxifene HCl, 60 (n = 97) or 150 mg/day (n = 100); conjugated equine estrogens, 0. 625 mg/day (n = 96); or placebo (n = 105). The Women's Health Questionnaire, a validated quality-of-life instrument for perimenopausal and postmenopausal women, was administered at baseline and 3-month intervals. RESULTS: Overall, quality of life from baseline to end point was preserved equally in all treatment groups. Six domains (depressed mood, somatic symptoms, memory/concentration, sexual behavior, sleep problems, and perceived attractiveness) were unchanged in all groups. Three domains (menstrual symptoms, vasomotor symptoms, and anxiety/fears) were statistically significantly different among groups. Mean scores for menstrual symptoms significantly worsened and vasomotor symptoms significantly improved from baseline to end point in the estrogen group. Mean scores for vasomotor symptoms did not worsen at any point in the raloxifene 60 mg/day group. Mean anxiety/fears scores improved significantly during raloxifene 60 mg/day administration throughout treatment (P <.05), irrespective of previous hormone replacement therapy, baseline estradiol (E2) levels, or years postmenopause. CONCLUSION: Most quality-of-life domains were not affected by treatment with estrogen or raloxifene. Estrogen provided relief from vasomotor symptoms but caused menstrual symptoms. Raloxifene 60 mg/day improved anxiety levels in postmenopausal women.

Climacteric↗
PubMed1996

A placebo- and active-controlled randomized trial of prophylactic treatment of seasonal allergic rhinitis with mometasone furoate aqueous nasal spray.

BACKGROUND: Topical nasal corticosteroids have become a mainstay of treatment for the symptoms of seasonal allergic rhinitis (SAR). It is likely that topical corticosteroids, by blocking an initial influx of inflammatory cells in the nasal mucosa induced by aeroallergens, may have a preventive effect on nasal allergy symptoms when administered before the pollen season. OBJECTIVE: This study was designed to assess the efficacy and safety of an 8-week course of mometasone furoate nasal spray (MFNS), 200 micrograms once daily, in the treatment of SAR compared with beclomethasone dipropionate aqueous nasal spray (BDP), 168 micrograms twice daily, and placebo vehicle, when treatment is initiated before the anticipated onset of the ragweed season. METHODS: Three hundred forty-nine patients with SAR to ragweed pollen from nine centers in the Northeast and Midwest of the United States were randomized to one of the three intranasal study medications (MFNS, 200 micrograms once daily, BDP, 168 micrograms twice daily, or placebo vehicle), starting 4 weeks before the estimated start of the ragweed season. RESULTS: The proportion of "minimal symptom" days (total nasal symptom score < or = 2) was statistically significantly higher in both the MFNS and BDP groups when compared with the placebo vehicle group (p < 0.01). The two active treatment groups were not statistically significantly different from each other. MFNS and BDP displayed a similar safety profile that did not differ from placebo. CONCLUSIONS: This suggests that MFNS, 200 micrograms (once daily), is a useful therapy in the prophylactic treatment of SAR.

Administration, Intranasal↗
PubMed1994

Quinidine as a resistance modulator of epirubicin in advanced breast cancer: mature results of a placebo-controlled randomized trial.

PURPOSE: To evaluate the effect of quinidine, a putative modulator of P-glycoprotein-mediated drug resistance, on the response rate and toxicity profile of epirubicin in patients with advanced breast cancer. PATIENTS AND METHODS: Between 1989 and 1992, 223 eligible patients were randomized in double-blind fashion to receive epirubicin 100 mg/m2 by intravenous (i.v.) bolus and prednisolone 25 mg orally twice daily, along with either placebo or quinidine (250 mg) capsules, taken for 4 days before and 2 days after chemotherapy. Treatment was continued for a maximum of eight courses. RESULTS: Ten eligible patients did not complete the first cycle of treatment. Of the remaining patients, 106 in the placebo arm received 619 courses of treatment, and 107 in the quinidine arm received 612 courses. The median cumulative dose of epirubicin in both arms was 600 mg/m2. The median quinidine level (measured before epirubicin administration in 288 courses) was 5.5 mumol/L; at this concentration, the drug partially reverses anthracycline resistance in multidrug-resistant (MDR) breast carcinoma cells in vitro. There were no statistically significant differences in hematologic or gastrointestinal toxicity between the two arms. The response rate in the placebo arm was 44% (6% complete remission [CR], 38% partial remission [PR]), and in the quinidine arm was 43% (4% CR, 39% PR). Surviving patients have been monitored for a median time of 74 weeks, and there is no significant difference in the overall or progression-free survival between the two arms. The median survival times were 59 weeks for placebo and 47 weeks for quinidine patients. The estimated relative death rate (quinidine/placebo) was 1.2 (P = .247; 95% confidence interval [CI], 0.88 to 1.63). CONCLUSION: Quinidine at this dose does not significantly alter the toxicity profile, response rate, or survival after epirubicin chemotherapy in patients with advanced breast cancer. This may be due to ineffective modulation of P-glycoprotein by quinidine or the lack of expression of mdr-1 in a sufficient proportion of cells in these tumors, or alternative mechanisms underlying resistance to epirubicin.

Adult↗
PubMed1996

Comparison of granisetron, ondansetron, and tropisetron in the prophylaxis of acute nausea and vomiting induced by cisplatin for the treatment of head and neck cancer: a randomized controlled trial.

BACKGROUND: A single-institution, prospective, randomized, open controlled trial was carried out on head and neck cancer patients to compare granisetron (GRA), ondansetron (OND), and tropisetron (TRO) in the prevention of cisplatin-induced acute nausea and vomiting. All patients were chemotherapy-naive and treated with cisplatin on Day 1 (80 to 100 mg/m2). METHODS: One hundred seventeen patients were treated for a total of 463 cycles of cisplatin-based chemotherapy and randomized to receive 24 mg of OND intravenously (i.v.), 3 mg of GRA i.v., or 5 mg of TRO i.v. for the control of acute nausea and emesis. RESULTS: In the GRA group, complete response (CR) was obtained in 119 of 165 cycles (72.1%), major response (MR) in 32 cycles (19.4%), minor response (MiR) in 5 cycles (3%), and a failure (F) in 9 cycles (5.5%). In the OND group, CR was obtained in 110 of 150 cycles (73.3%), MR in 31 cycles (20.7%), MiR in 2 cycles (1.3%), and F in 7 cycles (4.7%). In the TRO group, CR was obtained in 100 of 148 cycles (67.6%), MR in 26 cycles (17.6%), MiR in 15 cycles (10.1%), and F in 7 cycles (4.7%). Major efficacy (CR + MR) was obtained in 151 of 165 cycles (91.5%) for GRA, in 141 of 150 cycles (94.0%) for OND, and in 126 of 148 cycles (85.2%) for TRO. The difference in major efficacy between OND and TRO was statistically significant. When comparing MiR, both GRA and OND were more effective than TRO. No other significant differences were observed among the three antiemetic agents. CONCLUSIONS: Although our results were achieved in an open trial, they show that GRA and OND are equally effective antiemetic agents in the prevention of cisplatin induced acute nausea and vomiting. TRO provides almost the same protection but is not as effective as OND for major efficacy. All three antiemetics can be administered safely to patients undergoing chemotherapy with cisplatin at doses of 80 mg/m2 or more.

Adult↗
PubMed2006

Immunoadsorption in severe C4d-positive acute kidney allograft rejection: a randomized controlled trial.

Antibody-mediated rejection (AMR) frequently causes refractory graft dysfunction. This randomized controlled trial was designed to evaluate whether immunoadsorption (IA) is effective in the treatment of severe C4d-positive AMR. Ten out of 756 kidney allograft recipients were included. Patients were randomly assigned to IA with protein A (N = 5) or no such treatment (N = 5) with the option of IA rescue after 3 weeks. Enrolled recipients were subjected to tacrolimus conversion and, if indicated, 'anti-cellular' treatment. All IA-treated patients responded to treatment. One death unrelated to IA occurred after successful reversal of rejection. Four control subjects remained dialysis-dependent. With the exception of one patient who developed graft necrosis, non-responders were subjected to rescue IA, however, without success. Because of a high graft loss rate in the control group the study was terminated after a first interim analysis. Even though limited by small patient numbers, this trial suggests efficiency of IA in reversing severe AMR.

Adult↗
PubMed2001

Growth hormone treatment in children with chronic renal failure: a meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the benefits and side effects of recombinant human growth hormone (hGH) treatment in children with chronic renal failure. METHODS: Two reviewers independently assessed relevant randomized controlled trials for methodologic quality, extracted data, and estimated summary treatment effects by use of a random effects model. RESULTS: Ten randomized controlled trials involving 481 children were identified. Treatment with hGH (28 IU/m(2)/wk) resulted in a significant increase in height standard deviation score at 1 year (4 trials, weighted mean difference [WMD] = 0.77, 95% CI = 0.51 to 1.04), and a significant increase in height velocity at 6 months (2 trials, WMD = 5.7 cm/y, 95% CI 4.4 to 7.0) and 1 year (2 trials, WMD = 4.1 cm/y, 95% CI 2.6 to 5.6), but there was no further increase in height indexes during the second year of administration. Compared with the 14 IU/m(2)/wk group, there was an increase of 1.4 cm/y (0.6 to 2.2) in height velocity in the group treated with 28 IU/m(2)/wk. The frequency of reported side effects of hGH were similar to that of the control group. CONCLUSION: On average, 1 year of treatment with 28 IU/m(2)/wk hGH in children with chronic renal failure results in an increase of 4 cm/y in height velocity above that of untreated control subjects, but there was no demonstrable benefit for longer courses or higher doses of treatment.

Adolescent↗
PubMed2003

Randomized controlled trials of epilepsy surgery.

PURPOSE: To review the following aspects of surgical randomized controlled trials (RCTs) in epilepsy: rationale, methodological issues, and state of the art. METHODS: An overview of the literature and author's experience with methodological issues in surgical RCTs, contrasting them with those encountered in medical trials; a general comparison of RCTs and non-RCTs (observational studies); and a literature search for and review of existing surgical RCTs in epilepsy. RESULTS: Nonrandomized (observational) studies provide useful but potentially biased information about the effect of interventions. Because of their ability to deal with bias, RCTs are the optimum vehicle to obtain a true estimate of the effect of interventions, including surgery. Only seven surgical RCTs, encompassing 535 patients, have been performed in epilepsy, with variable adhesion to standard methodology for conducting RCTs. The major issues facing researchers undertaking surgical RCTs in epilepsy include timing of the study in relation to adoption of the intervention as standard practice, acceptance of randomization to an invasive procedure, timing of randomization in relation to the actual intervention, standardization of the surgical procedure, blinding, and patient recruitment. CONCLUSIONS: RCTs are the gold standard for evaluating surgical treatments. Despite the large number and types of surgical interventions used to treat epilepsy, only a handful has been subjected to the scientific rigour of RCTs. The challenges faced by researchers undertaking surgical RCTs in epilepsy are substantial but not insurmountable. Possible avenues to address these methodological hurdles are suggested.

Clinical Protocols↗
PubMed2003

Improving adherence to antidepressants: a systematic review of interventions.

BACKGROUND: Effectiveness of antidepressant medication is reduced by patients' nonadherence. Several interventions to improve adherence in patients diagnosed with unipolar depression have been tested. OBJECTIVE: To systematically review the effectiveness of interventions that aimed to improve adherence to antidepressant medication in patients with unipolar depression. METHOD: Systematic review of English-language articles of randomized controlled trials obtained by a computerized literature search of MEDLINE (1966-January 2002) using the terms patient compliance, patient dropout, treatment refusal, patient education, adherence, clinical trial, randomized controlled trial, controlled trial, depressive disorder, and depression; PSYCINFO (1984-January 2002) using the terms random, clinical, control, trial, adherence, compliance, noncompliance, dropouts, patient education, depression, major depression, affective disorders, and dysthymic disorder; EMBASE (1980-January 2002) using the terms patient compliance, patient dropouts, illness behavior, treatment refusal, patient education, clinical trial, controlled study, randomized controlled trial, and depression; and the Cochrane Controlled Trials Register (no restrictions) using the terms random*, complian*, adheren*, pharmacotherapy, regimen*, educat*, medicat*, depression, and depressive disorder. RESULTS: Educational interventions to enhance adherence failed to demonstrate a clear benefit on adherence and depression outcome. However, collaborative care interventions tested in primary care demonstrated significant improvements in adherence during the acute and continuation phase of treatment and were associated with clinical benefit, especially in patients suffering from major depression who were prescribed adequate dosages of antidepressant medication. CONCLUSION: We found evidence to support the introduction of interventions to enhance adherence with antidepressant medication in primary care, not only because of better adherence but also because of better treatment results. Because collaborative care interventions require additional resources, a better understanding of the mode of action of different programs is needed to reduce avoidable costs. The effectiveness of educational interventions needs more evidence.

Antidepressive Agents↗