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Results for “Randomized controlled trials”

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PubMed1985

A randomized controlled trial of quality assurance in sixteen ambulatory care practices.

A crossover randomized controlled trial of cycles of quality assurance in 16 primary care (8 medical, 8 pediatric) group practices was conducted. Of four medical and four pediatric tasks important to patient outcome, two were randomly assigned to experimental intervention (a quality assurance cycle), and two were also measured and used as blinded controls for each medical or pediatric group practice. Task performance was measured in each group for 12 months prior to, 9 months during, and 9 months after the experimental intervention, using as a performance score the percentage of evaluation criteria failed of those applicable to a case. As a result of quality assurance intervention, quality of performance was significantly improved in two of the tasks (P less than 0.0001, with 6.7, and 9.8 percentage points improvement), and marginally improved in one task (P = 0.06, 5.7 percentage points improvement). Surprisingly, tasks with lower perceived effect on patient health (low physician motivation) had greater improvement in quality. Unimproved tasks were associated with the perceived need for delivery system changes beyond the immediate control of the individual practitioner.

Adolescent↗

PubMed2004

A simple, fast, easy method to identify the evidence base in pain-relief research: validation of a computer search strategy used alone to identify quality randomized controlled trials.

UNLABELLED: Clinicians need a simple, fast, reliable, and inexpensive way of identifying the evidence base relevant to their clinical practice. It is often believed that the only way to identify all relevant evidence is to perform hand-searches of the literature to supplement computer searches; this is complex and labor intensive. However, most of quality randomized controlled trials cited in systematic reviews in pain medicine are listed in computer databases. We performed two studies to investigate the efficiency-in terms of sensitivity, specificity, and precision-of three computer search strategies: Optimally Sensitive Search Strategy, which is used by the Cochrane Collaboration; RCT.pt, a standard MEDLINE strategy; and DBRCT.af, which is a new single-line computer algorithm based on the assumption that double-blinded, randomized controlled trials would be indexed with "double-blind," "random," or variations of these terms in MEDLINE and EMBASE. DBRCT.af was found to be highly sensitive (97%) in identifying quality randomized controlled trials in pain medicine. The precision (ratio of randomized controlled trials to the number of nonrandomized trials identified) was 82%, and the specificity in excluding the nonrandomized controlled trials was 98%. We conclude that clinicians can now use DBRCT.af to update and conduct de novo systematic reviews in pain-relief research. IMPLICATIONS: Quality evidence about what is good clinical practice in pain treatment is buried in the medical literature among large quantities of other information. This article describes how any clinician with access to the Internet can identify those quality studies reliably, quickly, and inexpensively.

Analgesia↗

PubMedDate not supplied

A prospective, randomized controlled trial of chronic esophageal variceal sclerotherapy.

The results of a prospective, randomized controlled trial of chronic esophageal variceal sclerotherapy conducted over a 38-month period are presented. One-hundred twenty patients were randomized following variceal bleeding, 63 to esophageal variceal sclerotherapy and 57 to control. Mean follow-up was similar in both groups (esophageal variceal sclerotherapy, 12.5 +/- 8.8 months; control, 14.9 +/- 6.6 months). Twenty-one percent of the patients in each group were lost to follow-up. Esophageal variceal sclerotherapy decreased rebleeding as evidenced by a decrease in the mean bleeding risk factor, transfusion requirement and by an increase in bleeding free interval; differences between the treated and control groups in these parameters were especially significant after variceal obliteration. A high incidence of asymptomatic ulceration and low frequency of strictures were notable effects of esophageal variceal sclerotherapy. Cumulative life table analysis revealed no differences in survival between esophageal variceal sclerotherapy and control groups. However, when patients who received portal-systemic shunt surgery (esophageal variceal sclerotherapy, 6%; control, 28%) were removed from the analysis at the time the shunt surgery was performed (defining the shunt as an endpoint, a significant difference in survival (p less than 0.05, F ratios) in favor of esophageal variceal sclerotherapy was observed.

Adult↗

PubMedDate not supplied

Role of azathioprine in severe ulcerative colitis: one-year, placebo-controlled, randomized trial.

OBJECTIVE: To investigate the efficacy of azathioprine in treating patients with severe ulcerative colitis. DESIGN: One-year, randomized, placebo-controlled trial. SUBJECTS: 83 patients with severe ulcerative colitis were enrolled. Fifty patients who relapsed within two months on corticosteroid withdrawal were randomized into two groups. The azathioprine group received oral sulfasalazine (6-8 g/day), oral prednisolone (1 mg/Kg/day) and oral azathioprine (2 mg/Kg/day). The placebo group received oral sulfasalazine (6-8 g/day), oral prednisolone (1 mg/Kg/day) and placebo. Corticosteroids were tapered over 12-16 weeks. RESULTS: Five patients (2 in azathioprine group, 3 in placebo group) dropped out of the study. Three patients in the azathioprine group had side effects. The number of patients going into complete remission and partial remission was not significantly different in the two groups. The proportion of relapses in the azathioprine group was lower than in the placebo group (p < 0.05). CONCLUSIONS: In patients with ulcerative colitis, azathioprine had no effect in achieving remission, when given in combination with prednisolone; however, it lowers the proportion of relapses. Side effects like pancreatitis and hepatitis are mild and respond promptly to drug withdrawal.

Azathioprine↗

PubMed2004

Prevention of urinary incontinence by behavioral modification program: a randomized, controlled trial among older women in the community.

PURPOSE: We determined whether a behavioral modification program (BMP) taught to groups of continent older women would decrease the incidence of urinary incontinence, increase pelvic muscle strength and improve voiding control. MATERIALS AND METHODS: We performed a randomized, controlled trial comparing a BMP treatment group to a control, no treatment group in ambulatory, postmenopausal, continent women (0 to 5 days of incontinent episodes in the previous year) 55 years and older who were followed for 12 months. Qualified volunteers from 4 Michigan counties were randomly assigned to a control or a treatment group, consisting of a 2-hour classroom presentation on BMP followed 2 to 4 weeks later with individualized evaluation to test knowledge, adherence and skills in behavioral techniques, and brief reinforcement of the technique as needed. Followup was done by telephone and mail every 3 months except month 12, when all participants underwent final clinical evaluation. Outcome measures were continence status, pelvic floor muscle strength and voiding frequency/intervoid interval. RESULTS: A total of 195 control and 164 treated participants completed the study. Baseline data on the 2 groups were not statistically different. At 12 months the treatment group was statistically significantly better than the control group in continence status (p = 0.01), pelvic muscle strength (pressure score p = 0.0003 and displacement score p <0.0001), improved voiding frequency (p <0.0001) and intervoid interval (p <0.0001). CONCLUSIONS: To our knowledge we report the first randomized, controlled trial of BMP for preventing urinary incontinence in older women. It demonstrated feasibility and efficacy in improving continence status, pelvic muscle strength and voiding control as long as a year after treatment.

Aged↗

PubMed2006

Effect of exercise on extraskeletal risk factors for hip fractures in elderly women with low BMD: a population-based randomized controlled trial.

UNLABELLED: We conducted a 30-month population-based, randomized, controlled trial in 160 elderly women at risk for fractures on the basis of a low baseline BMD. Mainly home-based weight-bearing exercise was effective in improving strength, balance, and gait. INTRODUCTION: Evidence on the effect of exercise on extraskeletal risk factors for hip fractures comes mainly from studies in voluntary low-risk women, and no population-based, long-term interventions have been performed in elderly women with low bone mass. The aim of this study was to determine the effect of long-term weight-bearing exercise on balance, muscle strength, and gait in elderly women at risk for fractures on the basis of a low baseline BMD. MATERIALS AND METHODS: A birth cohort of 1690 women 70-73 years of age were invited to the radius and hip BMD measurements; 96 women were excluded because of medical reasons; 160 women with radius and hip BMD values of >2 SD below the reference value were included in the trial. The participants were randomly assigned to 30 months of impact, balancing, and strengthening exercises or to no intervention. Main outcome measures were body sway length and leg strength at month 30. Secondary endpoints included gait speed, endurance, and grip strength. Outcomes were assessed at 0, 12, 24, and 30 months using blinded operators. Repeated-measures ANOVA was used to determine statistical significance. The analyses were performed on an intention-to-treat basis. RESULTS: Body sway increased more in the control group than in the exercise group over time (time-group interaction, p < 0.001). Leg strength improved in the exercise group and decreased in the control group (interaction, p < 0.001). A significant time-group interaction (p < 0.001) in favor of the exercise group was found on the following secondary endpoints: the timed up and go test score, walking speed, and distance walked in 2 minutes. CONCLUSIONS: Weight-bearing exercise is an effective way of modifying extraskeletal risk factors for fractures in elderly women.

Absorptiometry, Photon↗

PubMed2006

Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To assess effectiveness of microdiscectomy in lumbar disc herniation patients with 6 to 12 weeks of symptoms but no absolute indication for surgery. SUMMARY OF BACKGROUND DATA: There is limited evidence in favor of discectomy for prolonged symptoms of lumbar disc herniation. However, only one randomized trial has directly compared discectomy with conservative treatment. METHODS: Fifty-six patients (age range, 20-50 years) with a lumbar disc herniation, clinical findings of nerve root compression, and radicular pain lasting 6 to 12 weeks were randomized to microdiscectomy or conservative management. Fifty patients (89%) were available at the 2-year follow-up. Leg pain intensity was the primary outcome measure. RESULTS: There were no clinically significant differences between the groups in leg or back pain intensity, subjective disability, or health-related quality of life over the 2-year follow-up, although discectomy seemed to be associated with a more rapid initial recovery. In a subgroup analysis, discectomy was superior to conservative treatment when the herniation was at L4-L5. CONCLUSIONS: Lumbar microdiscectomy offered only modest short-term benefits in patients with sciatica due to disc extrusion or sequester. Spinal level of the herniation may be an important factor modifying effectiveness of surgery, but this hypothesis needs verification.

Adult↗

PubMed1992

A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction.

OBJECTIVE: To examine the temporal relationship between accumulating data from randomized control trials of treatments for myocardial infarction and the recommendations of clinical experts writing review articles and textbook chapters. DATA SOURCES: (1) MEDLINE search from 1966 to present; search terms used were myocardial infarction, clinical trials, multicenter studies, double-blind method, meta-analysis, and the text word "random:"; (2) references from pertinent articles and books; and (3) all editions of English-language general medical texts and manuals and review articles on treatment of myocardial infarction. STUDY SELECTION: Randomized control trials of therapies for reducing the risk of total mortality in myocardial infarction (acute and secondary prevention). Review articles and textbook chapters dealing with the general clinical management of patients with myocardial infarction. DATA EXTRACTION: Two authors read the material and recorded the results; disagreements were resolved by conference. DATA SYNTHESIS: We used the technique of cumulative meta-analysis (performing a new meta-analysis when the results of a new clinical trial are published) and compared the results with the recommendations of the experts for various treatments for myocardial infarction. Discrepancies were detected between the meta-analytic patterns of effectiveness in the randomized trials and the recommendations of reviewers. Review articles often failed to mention important advances or exhibited delays in recommending effective preventive measures. In some cases, treatments that have no effect on mortality or are potentially harmful continued to be recommended by several clinical experts. CONCLUSIONS: Finding and analyzing all therapeutic trials in a given field has become such a difficult and specialized task that the clinical experts called on to summarize the evidence in a timely fashion need access to better databases and new statistical techniques to assist them in this important task.

Humans↗

PubMed2004

Systematic review: incidence of abdominal/pelvic surgery amongst patients using tegaserod in randomized controlled trials.

BACKGROUND: In the USA, tegaserod is contraindicated in patients with a history of bowel obstruction, abdominal adhesions or symptomatic gall-bladder disease due to a non-significant difference in abdominal surgery between tegaserod-using and placebo-using patients in Phase III trials. AIM: To calculate the incidence of abdominal and pelvic surgery in tegaserod-using and placebo-using patients in randomized controlled trials and to assess the possible association between medication and surgery, using pre-specified criteria in a blind adjudication procedure. METHODS: Primary study selection criteria included: (i) randomized controlled trial; (ii) comparison of tegaserod vs. placebo; and (iii) results reporting the incidence of abdominal and pelvic surgery. A panel of experts in epidemiology and functional bowel disorders reviewed the history of each patient who underwent surgery. Experts were blind with regard to whether patients used tegaserod or placebo. Using pre-specified criteria, experts rated the likelihood of an association between medication use and surgery. RESULTS: Thirteen randomized controlled trials (n =9857 patients) met the primary study selection criteria. No significant difference in the incidence of abdominal/pelvic surgery was identified between tegaserod-using and placebo-using patients: pelvic surgery, 0.16% vs. 0.19% (P = 0.80); abdominal surgery (non-cholecystectomy), 0.15% vs. 0.19% (P = 0.61); cholecystectomy, 0.13% vs. 0.03% (P = 0.17); total abdominal/pelvic surgery, 0.44% vs. 0.41% (P = 1.00). Post-adjudication, there was no significant difference in the incidence of abdominal/pelvic surgery between tegaserod-using and placebo-using patients. CONCLUSION: Data from randomized controlled trials demonstrate a similar incidence of abdominal/pelvic surgery in tegaserod-using and placebo-using patients.

Abdomen↗

PubMed1989

Randomized controlled trial of an educational booklet for patients presenting with back pain in general practice.

A randomized controlled trial was used to evaluate an educational booklet on back pain for patients presenting to five group practices during one calendar year. The booklet had no immediate effect on consultations for back pain, but in the period from two weeks to one year after presentation significantly fewer patients in the group receiving the booklet consulted with back pain (35.6%) than in the control group (42.2%) (P less than 0.05). There were no significant differences between the booklet and control groups in certified absence from work owing to back pain. Referral to hospital, referral to physiotherapy, admissions to hospital and laminectomies were all less common in the booklet group. The reduction in the combined referral rate to physiotherapy and hospital, and the reduction in laminectomy rate almost reached statistical significance at the 5% level. In replying to a questionnaire sent one year after entry to the study 94.1% of respondents in the booklet group said that they had read the book, 84.0% said that they found it useful, and 68.0% said that they still had a copy. Scores on a 15-item test of knowledge about back pain were significantly higher in the group of patients who had received the booklet than in the control group. The results suggest that the booklet had some effect in altering both the knowledge and behaviour of patients with back pain. The provision of an educational booklet was a method of giving information which was appreciated by both patients and doctors.

Adult↗

PubMed2003

Influence of weight reduction on blood pressure: a meta-analysis of randomized controlled trials.

Increased body weight is a strong risk factor for hypertension. A meta-analysis of randomized controlled trials was performed to estimate the effect of weight reduction on blood pressure overall and in population subgroups. Twenty-five randomized, controlled trials (comprising 34 strata) published between 1966 and 2002 with a total of 4874 participants were included. A random-effects model was used to account for heterogeneity among trials. A net weight reduction of -5.1 kg (95% confidence interval [CI], -6.03 to -4.25) by means of energy restriction, increased physical activity, or both reduced systolic blood pressure by -4.44 mm Hg (95% CI, -5.93 to -2.95) and diastolic blood pressure by -3.57 mm Hg (95% CI, -4.88 to -2.25). Blood pressure reductions were -1.05 mm Hg (95% CI, -1.43 to -0.66) systolic and -0.92 mm Hg (95% CI, -1.28 to -0.55) diastolic when expressed per kilogram of weight loss. As expected, significantly larger blood pressure reductions were observed in populations with an average weight loss >5 kg than in populations with less weight loss, both for systolic (-6.63 mm Hg [95% CI, -8.43 to -4.82] vs -2.70 mm Hg [95% CI, -4.59 to -0.81]) and diastolic (-5.12 mm Hg [95% CI, -6.48 to -3.75] vs -2.01 mm Hg [95% CI, -3.47 to -0.54]) blood pressure. The effect on diastolic blood pressure was significantly larger in populations taking antihypertensive drugs than in untreated populations (-5.31 mm Hg [95% CI, -6.64 to -3.99] vs -2.91 mm Hg [95% CI, -3.66 to -2.16]). This meta-analysis clearly shows that weight loss is important for the prevention and treatment of hypertension.

Blood Pressure↗

PubMed2004

Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy: a meta-analysis of randomized controlled trials.

CONTEXT: Implantable cardioverter defibrillator (ICD) therapy is effective in primary and secondary prevention of sudden cardiac death among patients with prior myocardial infarction and depressed ejection fraction. However, conclusive evidence of survival benefit in patients with nonischemic cardiomyopathy (NICM) is still lacking. OBJECTIVE: To determine whether ICD therapy reduces all-cause mortality in patients with NICM. DATA SOURCES: MEDLINE (1966-2004), EMBASE (1991-2004), the Cochrane Central Register of Controlled Trials (through first quarter, 2004), reports presented at scientific meetings (2003-2004), and bibliographic review of secondary sources. Search terms included defibrillator, randomized controlled trials, clinical trials, and sudden death. STUDY SELECTION: Eligible studies were prospective randomized controlled trials of ICD or combined cardiac resynchronization therapy and defibrillator (CRT-D) vs medical therapy enrolling at least some individuals with NICM and reporting all-cause mortality as an outcome. Of 675 potentially relevant articles screened initially, 8 reports of randomized trials enrolling a total of 2146 patients with NICM were included. DATA EXTRACTION: Included studies were reviewed to determine the number of patients randomized, mean duration of follow-up, primary end point, mortality of ICD cohort, and mortality of control cohort. DATA SYNTHESIS: Five primary prevention trials enrolling 1854 patients with NICM were identified; pooled analysis suggested a significant reduction in total mortality among patients randomized to ICD or CRT-D vs medical therapy (risk ratio [RR], 0.69; 95% confidence interval [CI], 0.55-0.87; P = .002). Mortality reduction remained significant even after elimination of CRT-D trials. Two of the 3 secondary prevention trials presented subgroup estimates for ICD efficacy in NICM. Pooled analysis of these secondary prevention trials (n = 256 patients with NICM) indicated an equivalent but nonsignificant mortality reduction with ICD therapy (RR, 0.69; 95% CI, 0.39-1.24; P = .22). Analysis of all 7 trials combined demonstrated a statistically significant 31% overall reduction in mortality with ICD therapy (RR, 0.69; 95% CI, 0.56-0.86; P = .002). CONCLUSION: ICD therapy appears to significantly reduce mortality in selected patients with NICM.

Cardiomyopathies↗

PubMed2005

Can computer-generated evidence-based care suggestions enhance evidence-based management of asthma and chronic obstructive pulmonary disease? A randomized, controlled trial.

OBJECTIVE: Translation of evidence-based guidelines into clinical practice has been inconsistent. We performed a randomized, controlled trial of guideline-based care suggestions delivered to physicians when writing orders on computer workstations. STUDY SETTING: Inner-city academic general internal medicine practice. STUDY DESIGN: Randomized, controlled trial of 246 physicians (25 percent faculty general internists, 75 percent internal medicine residents) and 20 outpatient pharmacists. We enrolled 706 of their primary care patients with asthma or chronic obstructive pulmonary disease. Care suggestions concerning drugs and monitoring were delivered to a random half of the physicians and pharmacists when writing orders or filling prescriptions using computer workstations. A 2 x 2 factorial randomization of practice sessions and pharmacists resulted in four groups of patients: physician intervention, pharmacist intervention, both interventions, and controls. DATA EXTRACTION/COLLECTION METHODS: Adherence to the guidelines and clinical activity was assessed using patients' electronic medical records. Health-related quality of life, medication adherence, and satisfaction with care were assessed using telephone questionnaires. PRINCIPAL FINDINGS: During their year in the study, patients made an average of five scheduled primary care visits. There were no differences between groups in adherence to the care suggestions, generic or condition-specific quality of life, satisfaction with physicians or pharmacists, medication compliance, emergency department visits, or hospitalizations. Physicians receiving the intervention had significantly higher total health care costs. Physician attitudes toward guidelines were mixed. CONCLUSIONS: Care suggestions shown to physicians and pharmacists on computer workstations had no effect on the delivery or outcomes of care for patients with reactive airways disease.

Academic Medical Centers↗

PubMed2003

Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial.

A dual-centre, randomized, double-blind, vehicle-controlled study was conducted to evaluate the safety and efficacy of short courses of therapy with imiquimod 5% cream in clearing >/=75% of baseline solar keratoses (SK) within a field of treatment. Subjects with 5-15 baseline SK within one treatment area (scalp, forehead and temples, or both cheeks) were randomized to apply imiquimod or vehicle cream to the entire treatment area three times a week for 3 weeks. Subjects were assessed 4 weeks after completing the first course for clearance of lesions. Subjects with <75% clearance were commenced on a second 3-week course of study cream. Subjects with >/=75% clearance were followed up until study completion without further therapy. All subjects were evaluated at the study endpoint of 14 weeks after initiating therapy for assessment of the primary outcome (>/=75% clearance of baseline solar keratoses). Twenty-one out of 29 (72%) imiquimod-treated subjects cleared >/=75% of baseline lesions compared with 3/10 (30%) subjects using the vehicle cream (Fisher's exact test, P = 0.027). Imiquimod was well tolerated. The present study has a short follow-up endpoint, but suggests that imiquimod is a potential therapeutic alternative in patients with SK.

Administration, Topical↗

PubMed2006

Standards of reporting of randomized controlled trials in general surgery: can we do better?

OBJECTIVE: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. SUMMARY BACKGROUND DATA: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. METHODS: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. RESULTS: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). CONCLUSION: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology.

General Surgery↗

PubMed2002

Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials.

BACKGROUND: Women commonly use soy products, herbs, and other complementary and alternative medicine (CAM) therapies for menopausal symptoms. Randomized, controlled trials have evaluated the efficacy and short-term safety of these therapies. PURPOSE: To review randomized, controlled trials of CAM therapies for menopausal symptoms in order to better inform practice and guide future research. DATA SOURCES: Searches of MEDLINE for articles published from January 1966 through March 2002, of the Alternative and Complementary Database (AMED) of the British Library for articles published from January 1985 through December 2000, and of the authors' own extensive files. Search terms were hot flash/flush, menopause, and climacteric, combined with phytoestrogens, alternative medicine, herbal medicine, traditional medicine, Traditional Chinese Medicine (TCM ), Ayurveda, naturopathy, chiropractic, osteopathy, massage, yoga, relaxation therapy, homeopathy, aromatherapy, and therapeutic touch. STUDY SELECTION: 29 randomized, controlled clinical trials of CAM therapies for hot flashes and other menopausal symptoms were identified; of these, 12 dealt with soy or soy extracts, 10 with herbs, and 7 with other CAM therapies. DATA EXTRACTION: Each author extracted information from half of the studies on the number of patients, study design, outcome measures, and results; the other author then checked these results. DATA SYNTHESIS: Soy seems to have modest benefit for hot flashes, but studies are not conclusive. Isoflavone preparations seem to be less effective than soy foods. Black cohosh may be effective for menopausal symptoms, especially hot flashes, but the lack of adequate long-term safety data (mainly on estrogenic stimulation of the breast or endometrium) precludes recommending long-term use. Single clinical trials have found that dong quai, evening primrose oil, a Chinese herb mixture, vitamin E, and acupuncture do not affect hot flashes; two trials have shown that red clover has no benefit for treating hot flashes. CONCLUSIONS: Black cohosh and foods that contain phytoestrogens show promise for the treatment of menopausal symptoms. Clinical trials do not support the use of other herbs or CAM therapies. Long-term safety data on individual isoflavones or isoflavone concentrates are not available.

Acupuncture Therapy↗

PubMed2000

Randomized controlled trials and consensus as a basis for interventions in internal medicine.

OBJECTIVES: To estimate the proportion of routine clinical interventions in internal medicine that are supported by the results of randomized controlled trials or consensus amongst experienced internists. DESIGN: Retrospective review of case records allowed one or more major diagnosis-intervention combination(s) to be identified for each patient. The scientific literature was searched for metaanalyses and randomized controlled trials in electronic databases that supported the specific intervention used. When support from randomized trials was lacking, possible consensus on management was sought by asking national expert panels of experienced clinicians. SETTING: Department of Medicine at a Swedish teaching hospital. SUBJECTS: At total of 197 consecutively admitted medical inpatients. RESULTS: Fifty per cent of the diagnosis-intervention combinations (186/369) were supported by results from randomized controlled trial evidence and 34% (125/369) were supported by consensus amongst experienced clinicians. The proportion of interventions based on randomised controlled trials was highest in patients with cardiac (64%) and other circulatory diagnoses (73%). There were no important differences between sexes or between age groups. CONCLUSIONS: Half of the interventions used in routine clinical practice amongst medical inpatients are supported by results from randomized controlled trials. These results refute popular claims that only a small proportion of medical interventions are supported by scientific evidence.

Aged↗

PubMed1994

Randomized controlled trial of tamoxifen versus placebo in inoperable hepatocellular carcinoma.

A randomized controlled trial of tamoxifen (60 mg/die) versus placebo was performed in patients with cirrhosis and advanced inoperable hepatocellular carcinoma. Twenty-two patients were matched and coupled for sex, age, Child-Pugh class and tumour mass and then randomized to tamoxifen or placebo. Median survival was 74 weeks in the tamoxifen group (range 27 to 144 weeks) and 52 weeks in the placebo group (range 4 to 112 weeks). The survival of patients treated with tamoxifen improved significantly compared to the controls (Logrank-test, p = 0.04). These findings suggest that the effect of the antiestrogen tamoxifen is both statistically and clinically significant in increasing survival in patients with advanced hepatocellular carcinoma.

Aged↗