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Results for “Randomized trial”

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At least 505 records · Page 28Linked to original sources

PubMed1983

Regional intravenous guanethidine vs. stellate ganglion block in reflex sympathetic dystrophies: a randomized trial.

Regional intravenous guanethidine blocks and stellate ganglion blocks have been compared in a randomized trial. Nineteen patients, randomly allocated to two groups of therapy and exhibiting severe reflex sympathetic dystrophy following peripheral nerve lesions, have been treated. The performance of the intravenous guanethidine block is of longer duration and superior to stellate ganglion block, as regards some early pharmacological effects (skin temperatures and amplitude of plethysmographic waves recorded before blockade and 15 min, 60 min, 24 h, 48 h after institution of the block). In fact the intravenous guanethidine group shows a persistent and significant increase of the skin temperature and of the plethysmographic traces in the blocked side 24 h and 48 h after blockade in comparison with the patients treated with stellate ganglion block. Concerning the therapeutic effects (changes in pain scores and clinical signs--hyperpathia, allodynia, vasomotor disturbances, trophic changes, oedema and limited motion), recorded at the end of treatment and 1 month and 3 months follow-up, an intravenous guanethidine block carried out every 4 days up to a total of 4 blocks is comparable with a stellate ganglion block every day up to a total of 8 blocks. The results of this study show that regional sympathetic block with guanethidine is a good therapeutic tool in the treatment of reflex dystrophies, especially on account of its negligible risks and contraindications.

Adult↗

PubMed2000

Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible?

OBJECTIVE: To evaluate the feasibility of conducting a large randomized trial of HRT in symptomatic women with early-stage breast cancer. DESIGN: Open randomized study. SETTING: Outpatient clinics at The Royal Marsden and St. George's Hospitals, London. PATIENT(S): One hundred postmenopausal women with early-stage breast cancer, experiencing vasomotor symptoms and/or vaginal dryness. INTERVENTION(S): Randomization (1:1) to HRT or no HRT for 6 months. MAIN OUTCOME MEASURE(S): Acceptance, continuance rates, and the reasons eligible women declined study entry. RESULT(S): Acceptance (38.8%) and continuance rates (>80%) were encouraging. The efficacy of HRT did not appear to be antagonized with concomitant tamoxifen. Seventy-five percent of women continued HRT after the study ended. Three women developed metastatic disease. Two used HRT. CONCLUSION(S): Despite informed consent, a national UK randomized trial of HRT should be feasible and has now been planned. Successful implementation necessitates the provision of information about HRT and the estrogen deficiency side effects of breast cancer therapy to health professionals and women with breast cancer.

Adult↗

PubMed2002

Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B.

The quality of randomization of Chinese randomized trials on herbal medicines for hepatitis B was assessed. Search strategy and inclusion criteria were based on the published protocol. One hundred and seventy-six randomized clinical trials (RCTs) involving 20,452 patients with chronic hepatitis B virus (HBV) infection were identified that tested Chinese medicinal herbs. They were published in 49 Chinese journals. Only 10% (18/176) of the studies reported the method by which they randomized patients. Only two reported allocation concealment and were considered as adequate. Twenty percent (30/150) of the studies were imbalanced at the 0.05 level of probability for the two treatments and 13.3% (20/150) imbalanced at the 0.01 level in the randomization. It is suggested that there may exist misunderstanding of the concept and the misuse of randomization based on the review.

Data Interpretation, Statistical↗

PubMed2000

Prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin: a multicenter randomized trial.

We report a prospective randomized multicenter trial that tested the efficacy of combining ursodeoxycholic acid and norfloxacin in the prevention of polyethylene stent clogging in patients with obstructive jaundice due to an unresectable malignancy at the level of the common bile duct. After insertion of a 10-Fr straight polyethylene stent, patients were allocated to receive oral treatment with ursodeoxycholic acid and norfloxacin, or conservative treatment. The primary outcome measure was stent blockage within six months. Thirty-three patients (group I) received ursodeoxycholic acid and norfloxacin, and 29 received conservative treatment (group II). At six months, cumulative stent patency rate did not differ significantly between group I (47+/-11%, mean +/- SE, median 149 days) and group II patients (24+/-10%, mean +/- SE, median 100 days, P = 0.23, log-rank test). Four stents were clogged by ursodeoxycholic acid. Survival did not differ between the two groups. Combined therapy with ursodeoxycholic acid and norfloxacin failed to improve stent patency. Moreover, ursodeoxycholic acid can cause stent obstruction.

Aged↗

PubMed1985

Specificity, sensitivity, and prevalence in the design of randomized trials: a univariate analysis.

The number of cases needed to conduct a randomized trial is related to the sensitivity and specificity of a measurement indicative of a condition, to the prevalence of the condition, to the expected benefit of therapy (or other basis for change), and to the statistical precision desired. Sample size calculations frequently ignore sensitivity and specificity (at least qualitatively) probably because no simple formula is provided in the literature. Such a formula is included here. As an example, the number of patients required for a randomized clinical trial was calculated for a clinical outcome (nonfatal myocardial infarction or coronary artery disease death) used to detect atherosclerotic heart disease and is compared to the sample sizes required for each of three noninvasive diagnostic studies (exercise ECG ST depression, exercise LVEF reduction, and thallium myocardial imaging) performed for the detection of atherosclerotic heart disease. We calculated that the sample size should be much smaller when these diagnostic studies are employed compared to the clinical outcome, thereby offering the potential for reduced cost and complexity of a randomized clinical trial.

Adult↗

PubMed2001

Assessment of decision support for blood test ordering in primary care. a randomized trial.

BACKGROUND: Different methods for changing blood test-ordering behavior in primary care have been proven effective. However, randomized trials comparing these methods are lacking. OBJECTIVE: To compare the effect of two versions of BloodLink, a computer-based clinical decision support system, on blood test ordering among general practitioners. DESIGN: Randomized trial. SETTING: 44 practices of general practitioners in the region of Delft, the Netherlands. PARTICIPANTS: 60 general practitioners in 44 practices who used computer-based patient records in their practices. INTERVENTION: After stratification by solo practices and group practices, practices were randomly assigned to use BloodLink-Restricted, which initially displays a reduced list of tests, or BloodLink-Guideline, which is based on the guidelines of the Dutch College of General Practitioners. MEASUREMENTS: Average number of blood tests ordered per order form per practice. RESULTS: General practitioners who used BloodLink-Guideline requested 20% fewer tests on average than did practitioners who used BloodLink-Restricted (mean [+/-SD], 5.5 +/- 0.9 tests vs. 6.9 +/- 1.6 tests, respectively; P = 0.003, Mann-Whitney test). CONCLUSIONS: Decision support based on guidelines is more effective in changing blood test-ordering behavior than is decision support based on initially displaying a limited number of tests. Guideline-driven decision support systems can be effective in reducing the number of laboratory tests ordered by primary care practitioners.

Decision Support Techniques↗

PubMed1993

Randomized Trials in Loco-Regionally Confined Prostate Cancer: Past, Present, and Future.

Over the last 30 years, a vast literature has been published on the available therapeutic approaches for loco-regionally confined prostate cancer. However, it is remarkable how few well designed and well conducted randomized trials have set out to compare them. As a result there is no consensus on the appropriate management of either early stage or locally advanced disease and treatment is still given on the basis of physician preconception, training, and instinct. Published trials have been weakened by the long natural history of prostate cancer and its unpredictable pace. Ten to 15 years are required to fully assess the clinical impact of therapy. By the time of publication, the original therapies frequently have become outmoded or the staging procedures shown to be inadequate by current standards. Prostate-specific antigen is a tumor marker that has powerful prognostic value and detects recurrence long before it becomes clinically apparent. Its use will allow for improved stratification in future studies and shorten the time of follow-up required to assess disease-free survival. Randomized trials will yield results in 5 years rather than the decades previously judged necessary. A renewed emphasis on the randomized trial in prostate cancer is now possible allowing for the rapid and scientific testing of both standard and novel treatment strategies.

Journal Article↗

PubMed1991

Monitoring a randomized clinical trial for futility: the north-Norwegian lidocaine intervention trial.

Randomized clinical trials of acute disease are usually designed as single-look, fixed sample size trials. This methodological study compares the conventional approach with a multiple-look, group sequential design with stopping rules for both treatment efficacy and for an inconclusive trial outcome, called trial futility. An ongoing trial on pre-hospital prophylaxis of sudden death in acute myocardial infarction forms the basis of the analysis. The effects of introducing multiple looks (or interim analyses) and tests for futility were obtained by binomial simulation. The introduction of four looks (that is, three interim and a final analysis) resulted in a modest increase in the maximal number of patients required. This was, however, fully compensated for by the high probability of early termination in case of treatment efficacy. The addition of futility tests, enabling termination at half the maximum trial size when there is no treatment difference, resulted in only a negligible reduction of overall power. We conclude that multiple-look, group sequential designs testing for both treatment efficacy and trial futility may improve the cost-effectiveness of randomized trials of acute disease.

Binomial Distribution↗

PubMed1984

Prevention of cytomegalovirus infection by prophylaxis with an intravenous, hyperimmune, native, unmodified cytomegalovirus globulin. Randomized trial in bone marrow transplant recipients.

We have completed a randomized trial to evaluate the safety and effectiveness of hyperimmune cytomegalovirus intravenous human globulin in prevention of cytomegalovirus infection and related problems in bone marrow transplant recipients. Prophylactic intravenous administration of this native, intact, hyperimmune, cytomegalovirus IgG, at a dose of 200 mg/kg 25, 50, and 75 days following transplant resulted in complete protection against cytomegalovirus infection during the 120 days covered by the treatment (p = 0.009). There was no interstitial pneumonia or mortality in the group receiving the hyperimmune IgG. This is significant at the p = 0.014 when compared with the supporting treatment control group. In bone marrow transplant recipients, prophylaxis with a total dosage of 0.6 g/kg of an intravenous hyperimmune cytomegalovirus globulin was safe and afforded effective protection against cytomegalovirus infection and interstitial pneumonia in this high-risk population.

Adolescent↗

PubMed1992

A randomized trial of reduced doses of azidothymidine in Japanese patients with human immunodeficiency virus type 1 infection.

Adverse reactions to the standard dose (1,200 mg/day-1,500 mg/day) of azidothymidine (AZT) are serious. An in vitro pharmacokinetic study of intracellular AZT-5'-triphosphate suggested the feasibility of a clinical trial with reduced doses of AZT. A randomized trial with reduced doses of AZT (group A; 400 mg/day, n = 15, group B; 800 mg/day, n = 13), was conducted enrolling 28 patients with human immunodeficiency virus infection. The effective rate of AZT on CD4+ lymphocyte counts was similar for both groups, but the duration of the effect of AZT was significantly longer in group A (p less than 0.05). In group B, adverse reactions were more frequently observed (p less than 0.01), and AZT was withdrawn or the dose was reduced more frequently (p less than 0.05). These results suggest that AZT at a dose of 400 mg/day is less toxic, and is more beneficial for long-term treatment.

Adolescent↗

PubMed2002

Application of the development stages of a cluster randomized trial to a framework for valuating complex health interventions.

INTRODUCTION: Trials of complex health interventions often pose difficult methodologic challenges. The objective of this paper is to assess the extent to which the various development steps of a cluster randomized trial to optimize antibiotic use in nursing homes are represented in a recently published framework for the design and evaluation of complex health interventions. In so doing, the utility of the framework for health services researchers is evaluated. METHODS: Using the five phases of the framework (theoretical, identification of components of the intervention, definition of trial and intervention design, methodological issues for main trial, promoting effective implementation), corresponding stages in the development of the cluster randomized trial using diagnostic and treatment algorithms to optimize the use of antibiotics in nursing homes are identified and described. RESULTS: Synthesis of evidence needed to construct the algorithms, survey and qualitative research used to define components of the algorithms, a pilot study to assess the feasibility of delivering the algorithms, methodological issues in the main trial including choice of design, allocation concealment, outcomes, sample size calculation, and analysis are adequately represented using the stages of the framework. CONCLUSIONS: The framework is a useful resource for researchers planning a randomized clinical trial of a complex intervention.

Aged↗

PubMed1994

Comparison of the prophylactic usefulness of epirubicin and doxorubicin in the treatment of superficial bladder cancer by intravesical instillation: a multicenter randomized trial. Kobe University Urological Oncology Group.

A multicentric randomized trial was conducted for the purpose of investigating the prophylactic efficacy of intravesical epirubicin instillation following transurethral resection of superficial bladder cancer in comparison with the efficacy of doxorubicin. The patients were centrally randomized into 2 groups and received 19 intravesical instillations of epirubicin or doxorubicin at 30 mg/30 ml physiological saline twice a week for 4 weeks and then once monthly for 11 months. A total of 150 patients with Ta and T1 superficial bladder cancer were entered in the trial, and 114 were evaluable. The nonrecurrence rates determined for each group at 1 and 2 years by the Kaplan-Meier method were 92.8% and 88.6%, respectively, for the epirubicin group and 86.4% and 81.7%, respectively, for the doxorubicin group. The differences between the two groups were not statistically significant. The main side effects encountered in this study were symptoms of bladder irritation such as micturitional pain, pollakisuria, and hematuria. The respective frequencies of those symptoms were 10%, 15.0%, and 5.0% in the epirubicin group and 14.8%, 14.8%, and 0 in the doxorubicin group. These results suggest that epirubicin is a useful drug, comparable with doxorubicin, for intravesical instillation chemotherapy in the prophylactic treatment of superficial bladder cancer.

Administration, Intravesical↗

PubMed1998

Rationale and design of the International Verapamil SR/Trandolapril Study (INVEST): an Internet-based randomized trial in coronary artery disease patients with hypertension.

OBJECTIVES: The primary objective of the International Verapamil SR/Trandolapril Study (INVEST) is to compare the risk for adverse outcomes (all-cause mortality, nonfatal myocardial infarction [MI] or nonfatal stroke) in hypertensive patients with coronary artery disease (CAD) treated with either a calcium antagonist-based or a noncalcium antagonist-based strategy. BACKGROUND: Treatment recommendations for hypertension include initial therapy with a diuretic or beta-adrenergic blocking agent, for which reductions in morbidity and mortality are documented from randomized trials but are less than expected from epidemiologic data. For this reason, recent attention has focused on calcium antagonists or angiotensin-converting enzyme inhibitors. While these agents reduce blood pressure, outcome data from large randomized trials are lacking, but some case-control data, dominated by short-acting dihydropyridines, suggest an increased risk of cardiovascular events. These studies had methodologic limitations and did not differentiate among calcium antagonist types and formulations. Several studies differentiating among calcium antagonist types and an overview of published randomized trials show no increased risk with verapamil and suggestion for benefit in CAD patients. METHODS: A total of 27,000 CAD patients with hypertension will be randomized at 1,500 primary care sites to receive either a calcium antagonist-based (verapamil) or beta-blocker/diuretic-based (atenolol/hydrochlorothiazide) antihypertensive care strategy. The study uses a novel, electronic "paper-less" system for direct on-screen data entry, randomization and drug distribution from a mail pharmacy linked to the coordination center via the Internet. RESULTS: Contract negotiations with the United States and international sites are ongoing. Patients being enrolled are predominantly elderly (72% aged 60 years or older) men (54%), with either an abnormal coronary angiogram or prior MI (71%). In addition to hypertension, CAD and elderly age, most patients (89%) have one or more associated conditions (diabetes, dyslipidemia, smoking, cerebral or peripheral vascular disease, etc.) contributing to increased risk for adverse outcome. While 26% have diabetes, most of these are noninsulin dependent. Using the protocol strategies, target blood pressures (according to JNC VI) have been reached in 58% at the fourth visit, and as expected most (89%) are requiring multiple antihypertensive drugs. CONCLUSION: The design and baseline characteristics of the initial patients recruited for a prospective, randomized, international, multicenter study comparing two therapeutic strategies to control hypertension in CAD patients are described.

Aged↗

PubMedDate not supplied

Anterior lesser curve seromyotomy with posterior truncal vagotomy versus proximal gastric vagotomy: results of a prospective randomized trial 3-8 years after surgery.

In a prospective randomized trial, anterior lesser curve seromytomy with posterior truncal vagotomy (ASPTV, n = 50) was compared with proximal gastric vagotomy (PGV, n = 50). Most of our patients were young men with ASA grade I risk, and 80% were expatriates. They were followed up for 3 to 8 years after surgery. The mean reductions of basal acid output (BAO) and insulin-stimulated peak acid output (IPAO) were 85% and 88%, respectively, soon after surgery for both ASPTV and PGV groups. These values remained at 70% and 60% of their preoperative level for 1 year. Good to excellent results (Visick I and II) were recorded in 76% of cases in both groups. The recurrent ulcer rate was 14% for PGV and 12% for ASPTV. This trial suggests that for the treatment of duodenal ulcer ASPTV is as good an operation as PGV.

Adult↗

PubMed2004

Safety reporting in randomized trials of mental health interventions.

OBJECTIVE: The authors aimed to evaluate the adequacy of the reporting of safety information in publications of randomized trials of mental-health-related interventions. METHOD: The authors randomly selected 200 entries from the PsiTri registry of mental-health-related controlled trials. This yielded 142 randomized trials that were analyzed for adequacy and relative emphasis of their content on safety issues. They examined drug trials as well as trials of other types of interventions. RESULTS: Across the 142 eligible trials, 103 involved drugs. Twenty-five of the 142 trials had at least 100 randomly chosen subjects and at least 50 subjects in a study arm. Among drug trials, only 21.4% had adequate reporting of clinical adverse events, and only 16.5% had adequate reporting of laboratory-determined toxicity, while 32.0% reported both the numbers and the reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted 1/10 of a page in their results sections to safety, and 58.3% devoted more space to the names and affiliations of authors than to safety. None of the trials of nondrug interventions had adequate or even partially adequate reporting of either clinical adverse events or laboratory-determined toxicity. In multivariate modeling, long-term trials and trials conducted in the United States devoted even less space to safety, while schizophrenia trials devoted more space to safety than did trials in other areas. CONCLUSIONS: Safety reporting is largely neglected across trials of mental-health-related interventions, thus hindering the assessment of risk-benefit ratios for rational decision making in mental health care.

Decision Making↗

PubMed2005

Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial.

OBJECTIVE: This prospective, randomized, open-label, multicenter, community-based study was conducted to compare cyclobenzaprine 5 mg three times daily (TID) orally (CYC5) given for 7 days as monotherapy or in combination with ibuprofen 400 mg TID (CYC5/IBU400) or 800 mg TID (CYC5/IBU800) in adults with acute neck or back pain with muscle spasm. STUDY DESIGN: Eligible patients were 18-65 years old, had cervical or thoracolumbar pain and spasm for < or = 14 days, and, aside from the prescribed study medications, discontinued treatment with all analgesics, anti-inflammatory agents, and skeletal muscle relaxants during the study period. Randomization was 1:1:1 to the three treatment groups. Treatment outcome was assessed after 3 and 7 days of therapy using five patient-rated scales: spasm, pain, patient global impression of change (PGIC), medication helpfulness, and Oswestry Disability Index (ODI). RESULTS: A total of 867 patients provided postbaseline data and were included in the intent-to-treat population (CYC5, n = 288; CYC5/IBU400, n = 286; CYC5/IBU800, n = 293). All three treatment groups demonstrated significant improvements from baseline in PGIC, spasm, pain, ODI, and medication helpfulness (p < 0.001 for all comparisons) after 3 and 7 days of therapy. There were no significant differences in mean PGIC among groups after 3 days of therapy (p = 0.65 for treatment effect) or after 7 days of therapy (primary endpoint; p = 0.41). A PGIC responder analysis of changes from baseline showed that 88% and 93% of patients reported at least mild improvement after 3 and 7 days of therapy, respectively. All three treatments were well tolerated, with no significant differences between treatments regarding the number of adverse events (AEs) reported or number of patients reporting AEs. The most common AEs in all groups were fatigue, somnolence, dizziness, sedation, and nausea. Limitations of this study include an unblinded design and possible introduction of bias into efficacy and safety results by use of a voluntary telephone reporting system. CONCLUSIONS: This randomized, community-based clinical trial demonstrated that combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone in adult patients with acute neck and back pain with muscle spasm. All treatments were well tolerated.

Adolescent↗

PubMed1996

Therapeutics and inflammatory bowel disease: a guide to the interpretation of randomized controlled trials.

Randomized controlled trials are the optimal means of assessing the efficacy of new treatments. This report reviews the methodology of clinical trials in inflammatory bowel disease using examples from recent randomized trials of therapy for Crohn's disease and other gastrointestinal diseases to show key principles. Guidelines for the practicing clinician to evaluate these studies are provided.

Guidelines as Topic↗

PubMed1995

Recruitment for phase II of the Trials of Hypertension Prevention. Effective strategies and predictors of randomization. Trials of Hypertension Prevention (TOHP) Collaborative Research Group.

Phase II of the Trials of Hypertension Prevention is a multicenter, randomized, controlled trial designed to determine the efficacy of weight loss and reduction of sodium intake for lowering blood pressure and incidence of hypertension among persons with high-normal levels of blood pressure. The 2 x 2 factorial study design includes weight loss alone, restricted sodium intake alone, the combination of weight loss and sodium restriction, and a control group. Nine clinical centers used a variety of recruitment strategies to enroll 2382 participants over 17 months, which exceeded the sample size goal of 2250. Among randomized participants, 21% were minorities and 34% were women. Overall, direct mail generated the most randomized participants (73%), followed by community screening (12%) and media advertisement (11%). Referrals from community health care providers yielded few participants. Prescreening improved overall efficiency and reduced costs. Participants who were more likely to drop out voluntarily during the three-visit screening regimen tended to be younger, single, male, smokers, and less educated.

Adult↗