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Results for “Randomized trial”

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At least 595 records · Page 33Linked to original sources

PubMed1984

Effect of emepronium bromide (Cetiprin) on symptoms and urinary bladder function after transurethral resection of the prostate. A double-blind randomized trial.

75 patients were randomized to be treated with either emepronium bromide (Cetiprin) 200 mg 4 times a day or placebo after transurethral resection of the prostate. The patients were evaluated urodynamically pre- and postoperatively, and further evaluated by micturition symptom charts. No significant differences in symptoms or objective findings were found between the patients treated with emepronium bromide and those treated with placebo.

Aged↗

PubMed2005

Luteal phase support in in vitro fertilization: meta-analysis of randomized trials.

OBJECTIVE: To determine if luteal phase support improves the pregnancy rate in in vitro fertilization (IVF) cycles. DESIGN: A meta-analysis of randomized trials of luteal phase support was carried out with the main outcome measure being the pregnancy rate per cycle. RESULTS: Fifty-nine trials were evaluated. Eighteen trials met the inclusion criteria. Five main themes were identified: human chorionic gonadotropin (hCG) versus progesterone; progesterone versus progesterone and hCG; progesterone versus placebo; hCG versus placebo, and hCG versus progesterone versus no support. CONCLUSION: Luteal phase support is definitely indicated in IVF treatment cycles. This meta-analysis favored hCG above progesterone as luteal phase support with respect to pregnancy rates. Further prospective randomized trials are needed to determine a definite consensus with respect to the duration of luteal phase support in IVF cycles.

Chorionic Gonadotropin↗

PubMed2000

Screening for lung cancer: do we need randomized trials?

In a scientifically ideal randomized controlled trial (RCT) on the efficacy of screening for lung cancer, screening-detected cases would be allocated to immediate intervention or to no action until symptoms lead to diagnostics. The study would provide for learning about the extent to which earlier interventions (defined by disease stage and stage-conditional tumor size) enhance curability, and also about the distributions of disease stage and stage-conditional tumor size at the time of diagnosis under the particular regimen of screening and its associated diagnostics. Because ethics call for randomization to screening or no screening, this contrast no longer provides for studying the curability function of shared concern for all regimens of screening; it addresses only the overall curability advantage specific to the regimen deployed. The same information that is provided by the scientifically ideal RCT is obtainable from a noncomparative study in which each member of the study cohort is subject to both screening and early intervention, so long as the problem of "overdiagnosis" is avoided by documenting growth before biopsy for cytologic or histologic criteria of malignancy and so long as the outcome of intervention is documented by follow-up. The ethically feasible RCT, in addition to compromising the objects of study, involves validity problems of its own and is less efficient by an order of magnitude.

Humans↗

PubMed1997

Total versus subtotal gastrectomy: surgical morbidity and mortality rates in a multicenter Italian randomized trial. The Italian Gastrointestinal Tumor Study Group.

OBJECTIVE: The purpose of this study was to analyze postoperative morbidity and mortality of patients included in a randomized trial comparing total versus subtotal gastrectomy for gastric cancer. SUMMARY BACKGROUND DATA: There is controversy as to whether the optimal surgery for gastric cancer in the distal half of the stomach is subtotal or total gastrectomy. Although only a randomized trial can resolve this oncologic dilemma, the first step is to demonstrate whether the two procedures are penalized by different postoperative morbidity and mortality rates. METHODS: A total of 624 patients with cancer in the distal half of the stomach were randomized to subtotal gastrectomy (320) or total gastrectomy (304), both associated with a second-level lymphadenectomy, in a multicenter trial aimed at assessing the oncologic outcome after the two procedures. The end points considered were the occurrence of a postoperative event, complication, or death and length of postoperative stay. RESULTS: Nonfatal complications and death occurred in 9% and 1% of subtotal gastrectomy patients and in 13% and 2% of total gastrectomy patients, respectively. Multivariate analysis of postoperative events showed that splenectomy or resection of adjacent organs was associated with a twofold risk of postoperative complications. Random surgery and extension of surgery influenced the length of stay. The mean length of stay, adjusted for extension of surgery, was 13.8 days for subtotal gastrectomy and 15.4 days for total gastrectomy. CONCLUSIONS: Our data show that subtotal and total gastrectomies, with second-level lymphadenectomy, performed as an elective procedure have a similar postoperative complication rate and surgical outcome. A conclusive long-term evaluation of the two operations and an accurate estimate of the oncologic impact of surgery on long-term survival, not penalized by excess surgical risk of one of the two operations, are consequently feasible.

Aged↗

PubMed2006

Homocysteine-lowering trials for prevention of cardiovascular events: a review of the design and power of the large randomized trials.

BACKGROUND: Dietary supplementation with folic acid and vitamin B12 lowers blood homocysteine concentrations by about 25% to 30% in populations without routine folic acid fortification of food and by about 10% to 15% in populations with such fortification. In observational studies, 25% lower homocysteine has been associated with about 10% less coronary heart disease (CHD) and about 20% less stroke. METHODS: We reviewed the design and statistical power of 12 randomized trials assessing the effects of lowering homocysteine with B-vitamin supplements on risk of cardiovascular disease. RESULTS: Seven of these trials are being conducted in populations without fortification (5 involving participants with prior CHD and 2 with prior stroke) and 5 in populations with fortification (2 with prior CHD, 2 with renal disease, and 1 with prior stroke). These trials may not involve sufficient number of vascular events or last long enough to have a good chance on their own to detect reliably plausible effects of homocysteine lowering on cardiovascular risk. But, taken together, these 12 trials involve about 52,000 participants: 32,000 with prior vascular disease in unfortified populations and 14,000 with vascular disease and 6000 with renal disease in fortified populations. Hence, a combined analysis of these trials should have adequate power to determine whether lowering homocysteine reduces the risk of cardiovascular events within just a few years. CONCLUSION: The strength of association of homocysteine with risk of cardiovascular disease may be weaker than had previously been believed. Extending the duration of treatment in these trials would allow any effects associated with prolonged differences in homocysteine concentrations to emerge. Establishing a prospective meta-analysis of the ongoing trials of homocysteine lowering should ensure that reliable information emerges about the effects of such interventions on cardiovascular disease outcomes.

Cardiovascular Diseases↗

PubMed1999

Acupuncture for migraine and headache in primary care: a protocol for a pragmatic, randomized trial.

UNLABELLED: This paper presents the protocol for a randomized trial of acupuncture for migraine and headache. SUBJECTS: Four hundred patients with migraine or headache will be recruited from GP practices. INCLUSION CRITERIA: Eighteen to 65 years old, contractable by telephone, onset at least 1 year prior at age less than 50, two headaches per month in the previous 6 months, adequate data completion and headache severity during pre-randomization baseline. EXCLUSION CRITERIA: Pregnancy or malignancy, cluster headache, serious pathological aetiology, cranial neuralgia, acupuncture treatment in the past year. DESIGN: Following a 4-week baseline, patients will be allocated to acupuncture or control by minimized randomization. Up to 12 acupuncture treatments will be provided by advanced members of the Acupuncture Association of Chartered Physiotherapists. The type of acupuncture given will be recorded. STUDY MEASURES: Outcome will be assessed by headache diary, medication diary and SF36 at 3 months and 1 year. Resource use and days off sick will be assessed by quarterly questionnaire. Adverse events will be monitored by self-report. The primary outcome measure will be the change in mean daily headache score between baseline and the 1 year follow-up. An economic evaluation will also be undertaken.

Acupuncture Therapy↗

PubMed1999

What randomized trials and systematic reviews can offer decision makers.

It is important to recognize the studies that yield the most reliable evidence upon which to base treatment decisions. Randomized trials have a particular place in providing high-quality unbiased comparisons of different treatments, when carried out to a high methodological standard. Empirical evidence shows that such trials are not always done well, and also that poor methodology is associated with biased findings. Consumers of the published literature need to be able to recognize which trials can be trusted. Systematic reviews and meta-analyses offer an organized approach to assessing all the relevant literature on a topic, particularly when several randomized trials address the same treatment comparison. Like trials, systematic reviews and meta-analyses need to be carried out to a high standard. They offer particular potential for providing the most useful information for clinical decision making. Critical aspects of these types of study are considered in this paper.

Bias↗

PubMed2000

Analysis of cluster randomized trials in primary care: a practical approach.

BACKGROUND: Cluster randomized trials increasingly are being used in health services research and in primary care, yet the majority of these trials do not account appropriately for the clustering in their analysis. OBJECTIVES: We review the main implications of adopting a cluster randomized design in primary care and highlight the practical application of appropriate analytical techniques. METHODS: The application of different analytical techniques is demonstrated through the use of empirical data from a primary care-based case study. CONCLUSION: Inappropriate analysis of cluster trials can lead to the presentation of inaccurate results and hence potentially misleading conclusions. We have demonstrated that adjustment for clustering can be applied to real-life data and we encourage more routine adoption of appropriate analytical techniques.

Cluster Analysis↗

PubMed1991

Role of gastric colonization in the development of pneumonia in critically ill trauma patients: results of a prospective randomized trial.

Critically ill trauma patients were entered in a prospective, randomized trial to determine the role of gastric colonization in the development of pneumonia. Trauma patients admitted to the SICU were randomized to receive antacids (n = 27), continuous IV cimetidine (n = 32), or sucralfate (n = 30). Quantitative nasogastric tube (NGT) cultures were obtained biweekly and correlated with gastric pH, the incidence of pneumonia, and the incidence of pneumonia caused by an organism previously isolated from the stomach (percentage of gastric source of pneumonia--% GSP). Patients receiving antacids had a significantly greater pH than those receiving cimetidine (5.6 +/- 1.03 vs. 4.7 +/- 1.03; p = 0.006). However, there was no significant difference between the overall incidence of pneumonia, the percentage of NGT isolates greater than 10(6)/ml, or the % GSP. The gastric bacteriology of the three subgroups was nearly identical, with Candida albicans, Enterococci, and beta-hemolytic Streptococci being the most frequently isolated organisms. Gastric growth of organisms preceding their appearance in the blood occurred in 5 of 89 (5.6%) patients. These results suggest that 1) in trauma patients, the incidence of pneumonia is not increased by the use of stress ulcer prophylactic agents that elevate gastric pH; 2) increases in gastric pH progressively increased the number of intragastric bacteria but this did not correlate with an increased incidence of % GSP; and 3) while organisms in the upper intestinal tract may be pathogens for pneumonia, they are uncommonly a source of bacteremia in seriously injured patients.

Adolescent↗

PubMed2006

Comparison of petal of Crocus sativus L. and fluoxetine in the treatment of depressed outpatients: a pilot double-blind randomized trial.

Depression is one of the most common neuropsychiatric conditions, with a lifetime prevalence approaching 17%. Although a variety of pharmaceutical agents is available for the treatment of depression, psychiatrists find that many patients cannot tolerate the side effects, do not respond adequately, or finally lose their response. On the other hand, many herbs with psychotropic effects have far fewer side effects. They can provide an alternative treatment or be used to enhance the effect of conventional antidepressants. A number of recent preclinical and clinical studies indicate that stigma and petal of Crocus sativus have antidepressant effect. Our objective was to compare the efficacy of petal of C. sativus with fluoxetine in the treatment of depressed outpatients in an 8-week pilot double-blind randomized trial. Forty adult outpatients who met the DSM- IV criteria for major depression based on the structured clinical interview for DSM- IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind and randomized trial, patients were randomly assigned to receive capsule of petal of C. sativus 15 mg bid (morning and evening) (Group 1) and fluoxetine 10 mg bid (morning and evening) (Group 2) for a 8-week study. At the end of trial, petal of C. sativus was found to be effective similar to fluoxetine in the treatment of mild to moderate depression (F=0.03, d.f.=1, P=0.84). In addition, in the both treatments, the remission rate was 25%. There were no significant differences in the two groups in terms of observed side effects. The present study is supportive of other studies which show antidepressant effect of C. sativus.

Adult↗

PubMed1991

Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty--results of a randomized trial.

Increasing the primary success rate in recanalization of peripheral vascular occlusions is one aim of using laser techniques in the treatment of peripheral vascular disease. Although reports of lasers enabling recanalization after failure of guide wires have been numerous, direct comparisons of the success of the two techniques in a randomized trial have been few. The results of a randomized trial showed no statistical difference in recanalization of femoropopliteal occlusions between the conventional guide wire and hybrid laser probe. The number of patients with iliac occlusions was small and comparisons are difficult to make, but the findings suggest that the hybrid laser probe has little to offer. Immediate crossover to the alternative method allowed investigation of the relationship between the two methods in practice. Combining the two methods improved the primary success rate from 82% to 91% for femoropopliteal occlusions randomized to laser thermal recanalization and from 74% to 91% for those randomized to conventional recanalization.

Angioplasty, Balloon↗

PubMedDate not supplied

A randomized trial of topical corticosteroids in epithelial healing after keratoplasty.

A prospective randomized trial evaluating the effect of topical 1% prednisolone acetate on epithelial defects after keratoplasty in 39 patients (18 in the untreated group and 21 in the treated group) failed to reveal any significant differences in healing between the two groups (p less than 0.16 to p less than 0.54 on post-operative days 1-5). The mean time needed for complete healing was 1.94 days in the untreated group and 2.81 days in the steroid treated group (p less than 0.09). Patients given subconjunctival methylprednisolone sodium succinate had larger initial defects (mean 33.5 mm2) than those not given subconjunctival steroids (mean 16.1 mm2), but the time for complete epithelial healing did not differ significantly (2.75 days vs. 1.91 days; p less than 0.14). As clinically used post-keratoplasty topical steroids do not appear to significantly delay epithelial healing in most patients.

Administration, Topical↗

PubMed1999

A randomized trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis. North America Nephrotic Syndrome Study Group.

UNLABELLED: A randomized trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis. BACKGROUND: A clinical trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis (FSGS) was conducted. Despite the fact that it is the most common primary glomerulonephritis to progress to renal failure, treatment trials have been very limited. METHODS: We conducted a randomized controlled trial in 49 cases of steroid-resistant FSGS comparing 26 weeks of cyclosporine treatment plus low-dose prednisone to placebo plus prednisone. All patients were followed for an average of 200 weeks, and the short- and long-term effects on renal function were assessed. RESULTS: Seventy percent of the treatment group versus 4% of the placebo group (P < 0. 001) had a partial or complete remission of their proteinuria by 26 weeks. Relapse occurred in 40% of the remitters by 52 weeks and 60% by week 78, but the remainder stayed in remission to the end of the observation period. Renal function was better preserved in the cyclosporine group. There was a decrease of 50% in baseline creatinine clearance in 25% of the treated group compared with 52% of controls (P < 0.05). This was a reduction in risk of 70% (95% CI, 9 to 93) independent of other baseline demographic and laboratory variables. CONCLUSIONS: These results suggest that cyclosporine is an effective therapeutic agent in the treatment of steroid-resistant cases of FSGS. Although a high relapse rate does occur, a long-term decrease in proteinuria and preservation of filtration function were observed in a significant proportion of treated patients.

Adult↗

PubMed2004

Effect sizes in cumulative meta-analyses of mental health randomized trials evolved over time.

BACKGROUND AND OBJECTIVE: Meta-analyses of randomized trials may incorporate new evidence, and estimated treatment effects changeover time. We evaluated whether the certainty and estimates of efficacy and tolerability of mental health interventions change over time, as more trials appear on the same topics. METHODS: One hundred meta-analyses (1,024 trial entries; 99,303 participants) with an outcome of death, relapse, failure or dropout and with five or more trials published in three or more different years were examined with cumulative meta-analysis and recursive cumulative meta-analysis. RESULTS: Eight meta-analyses reached formal statistical significance (P < .05) at some point, but lost this significance eventually when more trials were published; typically large effect sizes in early trials were dissipated with further evidence. With 500 randomized subjects,95% of the time, subsequent changes in odds ratio might be up to 1.5-fold. For death, relapse, and failure outcomes, a decrease in effect size was somewhat more common than an increase, when more data became available (157 vs. 125, P = .06). This was most clear for comparisons of pharmacotherapies versus placebo (79 vs. 51, P = .009). CONCLUSIONS: Evidence based on a small number of randomized subjects should be interpreted cautiously. Early treatment efficacy of pharmacotherapies is occasionally overestimated.

Data Interpretation, Statistical↗

PubMed2006

Target of rapamycin inhibitors (sirolimus and everolimus) for primary immunosuppression of kidney transplant recipients: a systematic review and meta-analysis of randomized trials.

BACKGROUND: Target of rapamycin inhibitors (TOR-I) have a novel mode of action but uncertain clinical role. We performed a systematic review of randomized trials where immunosuppressive regimens containing TOR-I were compared with other regimens as initial therapy for kidney transplant recipients. METHODS: Databases (inception, June 2005) and conference proceedings (1996-2005) were searched. Two independent reviewers assessed trials for eligibility and quality. Results at 1 year, are expressed as relative risk (RR), where values<1 favor TOR-I, or lower dose of TOR-I, and for continuous outcomes are expressed as weighted mean difference (WMD), both expressed with 95% confidence intervals (CI). RESULTS: Thirty-three trials (142 reports) were included (27 trials of sirolimus, 5 of everolimus, and 1 of head-to-head comparison). When TOR-I replaced calcineurin inhibitors (CNI) (8 trials with 750 participants), there was no difference in acute rejection (RR, 1.03; 95% CI, 0.74-1.44), but serum creatinine was lower (WMD, -18.31 micromol/L; 95% CI, -30.96 to -5.67) and bone marrow more suppressed (leukopenia: RR 2.02; 95% CI, 1.12-3.66; thrombocytopenia: RR, 6.97; 95% CI, 2.97-16.36; and anaemia: RR, 1.67; 95% CI, 1.27-2.20). When TOR-I replaced antimetabolites (11 trials with 3966 participants), acute rejection and cytomegalovirus infection (CMV) were reduced (RR, 0.84; 95% CI, 0.71-0.99; RR, 0.49; 95% CI, 0.37-0.65, respectively), but hypercholesterolemia was increased (RR, 1.65; 95% CI, 1.32-2.06). When low- was compared with high-dose TOR-I, with equal CNI dose (10 trials with 3,175 participants), rejection was increased (RR, 1.23; 95% CI, 1.06-1.43) but calculated glomerular filtration rate (GFR) higher (WMD, 4.27 mL/min; 95% CI, 1.12-7.41), and when lower-dose TOR-I and standard-dose CNI were compared with higher-dose TOR-I and reduced CNI, acute rejection was reduced (RR, 0.67; 95% CI, 0.52-0.88), but calculated GFR was also reduced (WMD, -9.46 mL/min; 95% CI, -12.16 to -6.76). There was no significant difference in mortality, graft loss, or malignancy risk for TOR-I in any comparison. CONCLUSIONS: TOR-I have been evaluated in four different primary immunosuppressive algorithms: as replacement for CNI and antimetabolites, in combination with CNI at low and high doses, and with a variable dose of CNI. Generally, surrogate endpoints for graft survival favor TOR-I (lower risk of acute rejection and higher GFR), and surrogate endpoints for patient outcomes are worsened by TOR-I (bone marrow suppression and lipid disturbance). Long-term hard-endpoint data from methodologically robust randomized trials are still required.

Creatinine↗

PubMed1990

A randomized trial of hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma.

A randomized trial of hepatic arterial chemoembolization was conducted in 42 patients with unresectable hepatocellular carcinoma. These patients represented 41% of patients with hepatocellular carcinoma seen during the inclusion period. In the remaining 59%, 9% had resectable tumours and 50% had unresectable tumours with contraindication for chemoembolization. Patients received either repeated chemoembolization with gelfoam powder and doxorubicin (group 1) or symptomatic treatment (group 2). There was no difference in age, prevalence of cirrhosis or staging according to Okuda between the two groups of patients. A complete tumour response (assessed by arteriography, ultrasonography and serum alphafetoprotein) was observed in four patients, and a partial response in three other patients from group 1. Actuarial survival rates were 33 and 24% in group 1 and 52 and 31% in group 2 at 6 and 12 months, respectively (differences were not significant--logrank test). With the treatment used in our study, chemoembolization did not prolong the survival time of patients with unresectable hepatocellular carcinoma. There were, however, some complete or partial responses. The high spontaneous 1-year survival rate of untreated patients was probably due to the exclusion of the most severely ill patients. Our results do not support the use of this method of chemoembolization in the treatment of hepatocellular carcinoma.

Adult↗

PubMed2004

Single blastocyst transfer: a prospective randomized trial.

OBJECTIVE: To determine the efficacy of single blastocyst transfer. DESIGN: Prospective randomized trial. SETTING: Private assisted reproductive technology unit. PATIENT(S): Forty-eight women undergoing IVF-embryo transfer with day 3 FSH 12 mm in diameter on day of hCG administration. INTERVENTION(S): Embryo culture to the blastocyst stage in sequential media G1/G2 followed by transfer of either one or two blastocysts. MAIN OUTCOME MEASURE(S): Implantation rate, ongoing pregnancy rate, and twinning. RESULT(S): The transfer of a single blastocyst resulted in an implantation and ongoing pregnancy rate of 60.9% with no twins. The transfer of two blastocysts resulted in an implantation rate of 56%, an ongoing pregnancy rate of 76% with a 47.4% incidence of twins. CONCLUSION(S): Single blastocyst transfer is an effective method of eliminating multiple births while maintaining high pregnancy rates in this selected group of patients.

Adult↗

PubMed1991

Aztreonam therapy in children with febrile neutropenia: a randomized trial of aztreonam plus flucloxacillin versus piperacillin plus gentamicin.

In a prospective, randomized trial in 100 febrile neutropenic children, aztreonam plus flucloxacillin was compared with piperacillin plus gentamicin. At the 72 h clinical assessment there was no statistically significant difference between the two groups. However, in microbiologically documented infections there was a higher response rate in the piperacillin/gentamicin group (57%) than in the aztreonam/flucoxacillin group (41%). This was contributed to by the poorer Gram-positive cover of the aztreonam/flucloxacillin combination. In clinically documented infections and unexplained fevers the response rate of the two antibiotic regimens was identical. There were two deaths; one early death (in the piperacillin/gentamicin arm) and one late death. At the final assessment a successful outcome was obtained in the remaining patients. In the aztreonam/flucloxacillin group 75% of the episodes required modification compared with 59% in the piperacillin/gentamicin group.

Adolescent↗