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Results for “Randomized trial”

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PubMed2005

High dose sequential chemotherapy with autologous transplantation versus dose-dense chemotherapy MegaCEOP as first line treatment in poor-prognosis diffuse large cell lymphoma: an "Intergruppo Italiano Linfomi" randomized trial.

BACKGROUND AND OBJECTIVES: Poor prognosis diffuse large cell lymphoma (DLCL) responds poorly to standard chemotherapy. Randomized studies comparing high-dose chemotherapy with autologous stem-cell transplantation (ASCT) against standard chemotherapy have produced conflicting results. Dose-dense chemotherapy with granulocyte colony-stimulating factor (G-CSF) support seems to hold promise. The purpose of this multicenter, randomized trial was to compare failure-free and overall survival in patients with poor prognosis DLCL treated with high-dose sequential (HDS) chemotherapy followed by ASCT or an outpatient dose-dense chemotherapy regimen (MegaCEOP). DESIGN AND METHODS: Between 1996 and 2001, 130 DLCL patients, aged < or = 60 years, with intermediate-high or high-risk disease, according to the International Prognostic Index score, and/or bone marrow involvement were enrolled. Sixty were randomized to HDS chemotherapy plus high-dose mitoxantrone and melphalan with ASCT (arm A) and 66 to the MegaCEOP regimen (6-8 courses of an escalated dose of cyclophosphamide and epirubicin plus vincristine and prednisone with G-CSF every 2-weeks) (arm B); 4 patients were considered ineligible. RESULTS: The complete remission rate was 59% in arm A and 70% in arm B (p = 0.18). After a median follow-up of 78 months, the 6-year failure-free survival was 45% in arm A and 48% in arm B (hazard ratio = 1.15, 95% confidence intervals = 0.72-1.84, p = 0.56). The 5-year overall survival was 49% in arm A and 63% in arm B (hazard ratio = 1.67, 95% confidence interval = 0.98-2.85, p = 0.06). Two cases of secondary acute myeloid leukemia were observed after treatment in group A. INTERPRETATION AND CONCLUSIONS: HDS and ASCT as initial therapy for patients with poor-prognosis DLCL does not provide a benefit over that of outpatient dose-dense MegaCEOP chemotherapy.

Adolescent↗

PubMed1987

Prevention of myopic progress by glasses. Study design and the first-year results of a randomized trial among schoolchildren.

We report the design and first-year follow-up results of a randomized trial of three different types of corrective lenses: (1) minus lenses with full correction for continuous use (the reference group); (2) minus lenses with full correction for distant vision only; and (3) bifocal lenses. Two hundred and forty 9- to 11-year-old mildly myopic schoolchildren were randomly allocated to the three treatment groups to be followed up to 3 years. During the first year, 73% of the children were compliant with their treatment. Refraction values after the first year were obtained from all but one child. In the second group (spectacles for distant vision only) myopia had progressed somewhat more than in the reference group. In respect of other values (school achievement, reading habits, and accidents) there were no statistically significant differences between the groups.

Accommodation, Ocular↗

PubMed1990

Randomized trial of combination antibiotic therapy in patients with hematological disorders. Hanshin Study Group of Hematopoietic Disorders and Infection.

A 3 arm prospective randomized trial was designed to compare the effectiveness of aztreonam (AZT) + clindamycin (CLDM), amikacin (AMK) + AZT and CLDM + AMK as antibiotic therapy for fever in patients with hematological disorders. Between July 1987 and June 1988, one hundred and sixty of the 199 febrile episodes entered in this study were evaluated for response. Underlying diseases were hematological malignancies in 88.8% of the subjects, and there was no statistically significant differences in incidences of the diseases among the 3 groups. Efficacy rates were 64.2% in the AZT + CLDM group, 52.8% in the AMK + AZT group and 35.2% in the CLDM + AMK group. Efficacy rates in those with neutrophil counts was less than 500/microliters before starting the antibiotics were 53.3%, 43.8% and 25.0%, respectively, in the 3 groups. The combination of AZT + CLDM was found to be the most effective even in the treatment of infections associated with febrile neutropenic patients.

Adolescent↗

PubMed1993

Randomized trial of intraumbilical vein oxytocin in midtrimester pregnancy losses.

OBJECTIVE: The purpose of this double-blind prospective randomized trial was to determine whether high-dose intraumbilical vein oxytocin injection shortens the third stage of labor in midtrimester pregnancy losses. STUDY DESIGN: Patients (n = 50) with spontaneous or induced midtrimester pregnancy losses (14 to 26 weeks' gestation) were randomized to receive either 100 IU of oxytocin in 20 ml of normal saline solution or 20 ml of normal saline solution alone as a placebo. The umbilical vein was injected as soon as the cord was clamped. Outcome data were collected. RESULTS: Of the 50 patients randomized, 45 completed the study. Five were excluded after randomization because of either cesarean delivery (1 patient) or en caul delivery (4 patients). Twenty-one patients received oxytocin, and 14 received placebo. Ten patients who were not injected because of technical failure were evaluated separately. There were no differences between the three groups with regard to gestational age, fetal weight, length of the third stage, blood loss, or need for operative removal of the placenta. CONCLUSION: Injection of high-dose oxytocin into the umbilical vein in second-trimester pregnancy losses does not shorten the third stage of labor or decrease the need for surgical intervention because of retained placenta.

Abortion, Spontaneous↗

PubMed1990

Randomized trial of sulfamethoxazole + trimethoprim versus procaine penicillin for the outpatient treatment of childhood pneumonia in Zimbabwe.

Reported are the results of a randomized trial of sulfamethoxazole + trimethoprim versus procaine penicillin for the outpatient treatment of pneumonia in 614 children aged 3 months to 12 years at primary health care clinics in Chitungwiza, a large town near Harare, Zimbabwe. Diagnosis and treatment were carried out by nurses, without medical supervision. The presence of lower respiratory tract infection that required antibiotics was diagnosed on the basis of a recent history of a cough and the presence of a respiratory rate of greater than 50 per minute. Patients were followed up by a research nurse with minimal drop-out losses. Referred children were examined and assessed by a doctor at the Chitungwiza General Hospital. Of the study children, 65 (11%) were referred to hospital, but only 8 (1.3%) had pneumonia that required a change in the treatment (5 in the sulfamethoxazole + trimethoprim group and 3 in the procaine penicillin group). There were no significant differences in outcome between the two treatment groups. One child, who had evidence of infection with human immunodeficiency virus (HIV), died. Sulfamethoxazole + trimethoprim and procaine penicillin were highly and equally effective for the outpatient treatment of children who had been clinically diagnosed to have pneumonia by primary health care workers.

Ambulatory Care↗

PubMedDate not supplied

A meta-analysis of randomized trials of fish oil in prevention of restenosis following coronary angioplasty.

The efficacy of fish oil in decreasing restenosis following percutaneous transluminal coronary angioplasty (PTCA) remains controversial despite seven published reports of randomized trials involving 951 patients. We performed a meta-analysis to determine whether these trials, viewed in aggregate, demonstrate a significant benefit. We evaluated rates of restenosis two to 12 months after PTCA and calculated an estimate of the overall effect and 95% confidence interval (CI). The typical odds ratio (treatment versus control) was 0.71 (95% CI 0.54, 0.94), P = 0.016 (two-tailed). The data show a strong and highly significant (P less than .0001) relationship between daily fish oil dose and gastrointestinal side effects. While compatible with a small to moderate benefit of fish oil on rates of restenosis, these results require confirmation in a randomized clinical trial large enough to distinguish reliably between a clinically meaningful benefit and a null result.

Angioplasty, Balloon, Coronary↗

PubMed1991

A randomized trial comparing imipenem/cilastatine alone with latamoxef plus tobramycin in febrile neutropenic patients with lung cancer.

We conducted a randomized trial to compare the efficacy of imipenem/cilastatine (IPM/CS) monotherapy with that of a combination of latamoxef (LMOX) and tobramycin (TOB) in the initial management of fever and neutropenia in patients with lung cancer. Leukocytopenic febrile patients (less than 3,000 leukocytes per microliters; temperature greater than 38 degrees C) with lung cancer given induction therapy were randomly assigned to receive intravenous treatment with either 1 g IPM/CS twice daily or 2 g LMOX plus 90 mg TOB twice daily. A total 101 febrile episodes were studied. Fifty-one episodes were treated with IPM/CS and 50 with LMOX+TOB. Fifty-nine of the febrile episodes were bacteriologically confirmed, while an organism could not be isolated despite the presence of obvious clinical infection in the remaining 42. The response rate was 82% with IPM/CS and 80% with combination therapy. This difference was not statistically significant. The response rate regarding gram-negative infections was 10 out of 14 (71%) in the IPM/CS group and seven out of 12 (58%) in the LMOX+TOB group. This difference was also not significant (P = 0.484). The response rate in severely neutropenic patients (neutrophils less than 100/microliters) was low (P = 0.078). Three patients in the IPM/CS group were withdrawn from the study due to skin rash and vomiting. Therapy with IPM/CS monotherapy was as effective as a combination regimen.

Adult↗

PubMed2002

The addition of a tramadol infusion to morphine patient-controlled analgesia after abdominal surgery: a double-blinded, placebo-controlled randomized trial.

UNLABELLED: In this double-blinded, randomized controlled trial, we tested whether the addition of tramadol to morphine for patient-controlled analgesia (PCA) resulted in improved analgesia efficacy and smaller morphine requirements compared with morphine PCA alone after abdominal surgery in adults. Sixty-nine patients were randomly allocated into two groups, each receiving morphine 1 mg/mL via PCA after surgery. The tramadol group received an intraoperative initial loading dose of tramadol (1 mg/kg) and a postoperative infusion of tramadol at 0.2 mg. kg(-1). h(-1). The control group received an intraoperative equivalent volume of normal saline and a postoperative saline infusion. Postoperatively, tramadol was associated with improved subjective analgesic efficacy (P = 0.031) and there was significantly less PCA morphine use in the tramadol group (P = 0.023). No differences between the groups were found with regard to nausea, antiemetic use, sedation, or quality of recovery (all P > 0.05). We conclude that a tramadol infusion combined with PCA morphine improves analgesia and reduces morphine requirements after abdominal surgery compared with morphine PCA alone. IMPLICATIONS: In this study, we determined whether adding a second pain-killing drug, tramadol, could improve pain relief after major surgery in patients receiving morphine patient-controlled analgesia. We found that patients receiving tramadol had significantly better opinions of their pain relief and used significantly less morphine with no increase in side effects.

Abdomen↗

PubMed1993

A community-based randomized trial of praziquantel to control schistosomiasis morbidity in schoolchildren in Zambia.

A community-based, double-blind, randomized trial of praziquantel was carried out in an area of Zambia endemic for schistosomiasis. The aim of the study was to assess the impact of the treatment on Schistosoma mansoni morbidity. A total of 377 infected children, aged seven to 19 years, was randomized into two groups: one of 190 (group A) and one of 187 (group B). All children were treated with 40 mg praziquantel/kg at the start of the study. Six months later, the children in group A were re-treated with the same dose of praziquantel, while the children in group B were given placebos. All children were followed up three, six and 12 months after the initial treatment, morbidity being clinically evaluated at the six- and 12-month follow-ups. The results show that, in both groups of children, there were significant reductions in splenomegaly, hepatomegaly, and subjective symptoms of morbidity six and 12 months after initial treatment. However, there were no significant differences, between the two groups, in the prevalences of these symptoms of morbidity. It therefore appears that once-yearly treatment of children, in this and similar endemic areas, is sufficient to reduce schistosomiasis morbidity to, and maintain it at, a tolerable level.

Adolescent↗

PubMed2002

Prospective randomized trial of heliox-driven continuous nebulizers in the treatment of asthma in the emergency department.

The purpose of this study was to evaluate the efficacy of heliox-driven continuous nebulizers in the management of moderate to severe asthma exacerbations in the Emergency Department (ED). The trial was a prospective, randomized, double-blind, controlled trial in a university Emergency Department (volume 65,000 patients/year) of patients 18-55 years of age with acute asthma exacerbations. Patients were placed on continuous nebulizers driven by 70:30 heliox or air with 30% O(2). Respiratory rate, peak expiratory flow rate (PEFR), forced expiratory volume at 1 s (FEV1), and Borg dyspnea scale were measured at 0 and 2 h. Disposition and patient satisfaction were also assessed. A total of 36 patients completed the study (18 heliox, 18 air). There was no difference between groups in baseline variables. There was significant interval improvement within both groups at 2 h in PEFR, FEV1, Borg, and respiratory rate. There was no significant difference between heliox 70:30 and air/oxygen in PEFR [mean between-group improvement difference 17 liters/min, 95% confidence interval (CI) -20-51], FEV1 (0.03 liters/sec, 95% CI -0.22-0.30), or respiratory rate (mean between-group improvement difference 0.5, 95% CI -2.7-3.8). There was a significant improvement in the patients' perceived dyspnea as measured by the Borg dyspnea scale at 2 h in the heliox group (1.6, 95% CI 0.3-3.0). In this trial of patients with moderate-severe asthma exacerbation, heliox-driven continuous nebulizers failed to demonstrate an improvement in respiratory rate, oxygen saturation, PEFR, or FEV1 at 2 h. However, there was a significant improvement in the patients' perceived dyspnea on heliox over air/oxygen measured by the Borg dyspnea scale.

Adolescent↗

PubMed2002

Discrepancy between published report and actual conduct of randomized clinical trials.

Randomized clinical trial (RCT) publications with inappropriate random-sequence generation, lack of allocation concealment, or imperfect blinding yield inflated estimates of effect compared to those in which adequate methods are described. RCTs that do not state methods used yield similar effect estimates, suggesting that inadequate methods were used. We compared RCT publications with investigator reports of actual practice for 40 rheumatology RCTs published in 1997/1998. In RCTs in which these methods were not described in the trial reports and would thus have been characterized as "inadequate," investigators reported using methods of random-sequence generation and allocation concealment that would be considered adequate in 77.4 and 78.1% of RCTs, respectively. This suggests that, in contrast to previous reports, inadequate random-sequence generation and allocation concealment, per se, may not be a major problem in RCTs. Characterizing RCTs as "good" or "poor" quality based on the published report is likely to be inappropriate.

Bias↗

PubMed2002

Late results concerning feasibility and compliance from a randomized trial of ultrasonographic screening for abdominal aortic aneurysm.

BACKGROUND: The study was an update at 10 years of a randomized trial of the efficacy of screening for abdominal aortic aneurysm (AAA). The extent of benefit, feasibility and compliance were examined, and reasons why this intervention may fail a proportion of those screened were identified. METHODS: A total of 6058 men aged 65 years and over were randomized to a group invited to attend ultrasonographic screening or to a control group. The mortality rate from AAA in the two arms of the trial was compared using a Poisson model. Analyses were by intention to treat. RESULTS: There was a 21 per cent reduction in mortality rate from AAA over the 10-year follow-up (relative risk 0.79 (95 per cent confidence interval 0.53 to 1.40)). The observed relative mortality reduction peaked at 4 years with a 52 per cent reduction in the study group. Eighteen of 24 AAA deaths in the study group were among those who did not attend the first screen, or failed to comply with the follow-up protocol. CONCLUSION: A greater awareness of the benefits of full participation in a screening programme could provide a larger and sustained mortality reduction.

Aged↗

PubMed2003

Randomized trial of physical activity and calcium supplementation on bone mineral content in 3- to 5-year-old children.

A meta-analysis of adult exercise studies and an infant activity trial show a possible interaction between physical activity and calcium intake on bone. This randomized trial of activity and calcium supplementation was conducted in 239 children aged 3-5 years (178 completed). Children were randomized to participate in either gross motor or fine motor activities for 30 minutes/day, 5 days per week for 12 months. Within each group, children received either calcium (1000 mg/day) or placebo. Total body and regional bone mineral content by DXA and 20% distal tibia measurements by peripheral quantitative computed tomography (pQCT) were obtained at 0 and 12 months. Three-day diet records and 48-h accelerometer readings were obtained at 0, 6, and 12 months. Higher activity levels were observed in gross motor versus fine motor activity groups, and calcium intake was greater in calcium versus placebo (1354 +/- 301 vs. 940 +/- 258 mg/day, p < 0.001). Main effects of activity and calcium group were not significant for total body bone mineral content or leg bone mineral content by DXA. However, the difference in leg bone mineral content gain between gross motor and fine motor was more pronounced in children receiving calcium versus placebo (interaction, p = 0.05). Children in the gross motor group had greater tibia periosteal and endosteal circumferences by pQCT compared with children in the fine motor group at study completion (p < 0.05). There was a significant interaction (both p < or = 0.02) between supplement and activity groups in both cortical thickness and cortical area: among children receiving placebo, thickness and area were smaller with gross motor activity compared with fine motor activity, but among children receiving calcium, thickness and area were larger with gross motor activity. These findings indicate that calcium intake modifies the bone response to activity in young children.

Bone Density↗

PubMed2004

Availability of large-scale evidence on specific harms from systematic reviews of randomized trials.

PURPOSE: To assess how frequently systematic reviews of randomized controlled trials convey large-scale evidence on specific, well-defined adverse events. METHODS: We searched the Cochrane Database of Systematic Reviews for reviews containing quantitative data on specific, well-defined harms for at least 4000 randomized subjects, the minimum sample required for adequate power to detect an adverse event due to an intervention in 1% of subjects. Main outcome measures included the number of reviews with eligible large-scale data on adverse events, the number of ineligible reviews, and the magnitude of recorded harms (absolute risk, relative risk) based on large-scale evidence. RESULTS: Of 1727 reviews, 138 included evidence on > or =4000 subjects. Only 25 (18%) had eligible data on adverse events, while 77 had no harms data, and 36 had data on harms that were nonspecific or pertained to <4000 subjects. Of 66 specific adverse events for which there were adequate data in the 25 eligible reviews, 25 showed statistically significant differences between comparison arms; most pertained to serious or severe adverse events and absolute risk differences <4%. In 29% (9/31) of a sample of large trials in reviews with poor reporting of harms, specific harms were presented adequately in the trial reports but were not included in the systematic reviews. CONCLUSION: Systematic reviews can convey useful large-scale information on adverse events. Acknowledging the importance and difficulties of studying harms, reporting of adverse effects must be improved in both randomized trials and systematic reviews.

Humans↗

PubMed1989

A randomized trial of less intense postoperative warfarin or aspirin therapy in the prevention of venous thromboembolism after surgery for fractured hip.

A randomized trial was carried out with 194 patients to compare the effectiveness of sodium warfarin or aspirin with that of placebo in the prevention of venous thromboembolism after surgery for fractured hip. Prophylaxis was commenced postoperatively and continued for 21 days or until patient discharge, whichever was earlier. All patients underwent surveillance with iodine 125-fibrinogen leg scanning and impedance plethysmography, with subsequent venography. Venous thromboembolism occurred in 13 patients (20.0%) in the warfarin group, 27 patients (40.9%) in the aspirin group, and 29 patients (46.0%) in the placebo group. Proximal vein thrombosis or pulmonary embolism occurred in 6 patients (9.2%) in the warfarin group, 7 patients (10.6%) in the aspirin group, and 19 patients (30.2%) in the placebo group. The results of this study show that sodium warfarin therapy is safe and effective in preventing thromboembolic complications in patients undergoing surgery for fractured hip, and that aspirin therapy is an equally safe and effective method for preventing proximal vein thrombosis or pulmonary embolism.

Adult↗

PubMed2004

Bayesian methods for analysis of binary outcome data in cluster randomized trials on the absolute risk scale.

A Bayesian hierarchical modelling approach to the analysis of cluster randomized trials has advantages in terms of allowing for full parameter uncertainty, flexible modelling of covariates and variance structure, and use of prior information. Previously, such modelling of binary outcome data required use of a log-odds ratio scale for the treatment effect estimate and an approximation linking the intracluster correlation (ICC) to the between-cluster variance on a log-odds scale. In this paper we develop this method to allow estimation on the absolute risk scale, which facilitates clinical interpretation of both the treatment effect and the between-cluster variance. We describe a range of models and apply them to data from a trial of different interventions to promote secondary prevention of coronary heart disease in primary care. We demonstrate how these models can be used to incorporate prior data about typical ICCs, to derive a posterior distribution for the number needed to treat, and to consider both cluster and individual level covariates. Using these methods, we can benefit from the advantages of Bayesian modelling of binary outcome data at the same time as providing results on a clinically interpretable scale.

Bayes Theorem↗

PubMed1999

Multicenter randomized trial and a systematic overview of lidocaine in acute myocardial infarction.

BACKGROUND: More than 20 randomized trials and 4 meta-analyses have been conducted on the use of prophylactic lidocaine in acute myocardial infarction (MI). The results suggest that lidocaine reduces ventricular fibrillation (VF) but increases mortality rates in acute MI. METHODS AND RESULTS: Patients with ST-elevation MI who were examined <6 hours after symptom onset (n = 903) were randomly assigned to either lidocaine or no lidocaine and to either streptokinase and heparin or heparin alone. Lidocaine was given as 4 boluses of 50 mg each every 2 minutes, then an infusion of 3 mg/min for 12 hours, then 2 mg/min for 36 hours. We compared the incidence of in-hospital death and ventricular arrhythmias. We then performed a meta-analysis of prophylactic lidocaine in acute MI that included these and prior trial results. The rates of VF and death with and without lidocaine were calculated for each trial, then odds ratios (OR) with confidence intervals (CI) were calculated for the risk of these events overall with and without lidocaine. Patients given lidocaine in the randomized study had significantly less VF (2.0% vs 5.7% without lidocaine, P =.004) and a trend toward increased mortality rates (9.7% vs 7.0%, P =.145). Meta-analysis revealed nonsignificant trends toward reduced VF (OR 0.71, 95% CI 0.47 to 1. 09) and increased mortality rates (OR 1.12, 95% CI 0.91 to 1.36) with lidocaine. CONCLUSIONS: Lidocaine reduces VF but may adversely affect mortality rates. The routine use of prophylactic lidocaine in acute MI is not recommended.

Anti-Arrhythmia Agents↗

PubMed2002

Paper or screen, mother tongue or English: which is better? A randomized trial.

CONTEXT: To compare family physicians' ability to retain information when reading a review article on paper vs on screen, and in their mother tongue vs in English. METHODS: Randomized trial of 114 Scandinavian family physicians who read a review article in October or November 2000 from the Journal of Trauma for 10 minutes either on paper and in English, on screen and in English, on paper in their mother tongue, or on screen in their mother tongue. To assess comprehension, they immediately completed a questionnaire with 6 open questions about 13 key facts from the review article. Sum score was on a scale from 0 (no correct answers) to 13 points (all questions answered correctly). RESULTS: There was no significant difference between readers of paper vs screen versions, with a median (interquartile range [IQR]) of 4 (2-6) vs 4 (2-5), respectively (P =.97). Physicians who read in their mother tongue scored significantly higher than those who read in English, with a median (IQR) of 4 (3-6) vs 3 (2-4) (P =.01). CONCLUSION: The medium (paper vs screen) did not influence the ability of family physicians to retain medical information. They best retained medical information when reading in their mother tongue.

Adult↗