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Results for “Randomized Controlled Trials as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 145 records · Page 8Linked to original sources
PubMed1990

Multicentre, double-blind comparison of terfenadine and cetirizine in patients with seasonal allergic rhinitis.

This double-blind, multicentre study was designed to compare the efficacy and tolerability of terfenadine 120 mg with cetirizine 10 mg, each taken once daily, in the treatment of seasonal allergic rhinitis. Two hundred and eighty-five patients were recruited to the study by nine general practice centres in the south of England during the 1989 hay-fever season. Symptom severity was assessed daily by the patient and before and after the one-week treatment period by the investigator. At the second clinic visit both patient and investigator assessed the overall response to treatment. The two treatment groups were well matched for all demographic variables and baseline symptom scores. Improvement in all seven symptoms (nasal congestion, sneezing, rhinorrhoea, itching nose, itching eyes, watery eyes and red eyes) and overall response to treatment were similar in both treatment groups. Adverse events were mainly of mild to moderate severity and were reported by 14 patients on terfenadine and 21 patients treated with cetirizine (p = 0.317). This study confirmed terfenadine's role as the treatment of choice in hayfever. A single 120 mg dose in the morning effectively reduced symptoms by 43 to 70 per cent of baseline values, with an acceptably low incidence of side effects. Cetirizine at a single dose of 10 mg displayed equal efficacy in controlling hayfever symptoms but, in common with other studies, had a significantly greater incidence of drowsiness (p = 0.046).

Adult↗
PubMed1990

Gabapentin in partial epilepsy. UK Gabapentin Study Group.

Gabapentin is an analogue of gamma aminobutyric acid (GABA) which has anticonvulsant properties in animals. In a multicentre, double-blind, placebo-controlled, parallel-group study of 1200 mg/day gabapentin as additional therapy in 127 patients with drug-resistant partial epilepsy, 25% of patients who received gabapentin had the number of partial seizures at least halved, compared with 9.8% of patients given placebo. The median reduction in partial seizure frequency during 12 weeks' treatment was 29.2% with gabapentin compared with 12.5% with placebo. The mean adjusted response ratio for gabapentin (-0.192) was significantly better than the ratio of -0.060 for placebo by analysis of variance. 62% of patients who received gabapentin reported mostly mild or moderate adverse effects compared with 41% on placebo; no interactions were observed between gabapentin and other standard anticonvulsants. Gabapentin is an effective additional treatment for patients with partial epilepsy refractory to standard therapy, is fairly well tolerated, and appears to have a favourable efficacy-to-toxicity ratio.

Acetates↗
PubMedDate not supplied

[Treatment using immucytal in children with recurrent respiratory infections: an Italian multicenter experience].

120 children, 71 male and 49 female, aged between 2 years and 15 years (mean 6.15 +/- 3.52 years) with recurrent respiratory infections, were treated with Immucytal, an immunomodulator of bacterial origin, based on membrane proteoglycan fractions plus bacterial ribosomes. The children, selected on the basis of the previous year's clinical score, were treated according to a random design with either Immucytal or placebo, using the same dosage of one puff per nostril plus one puff in the oropharyngeal cavity three times a day, as follows: 1st month: two weeks' treatment, one week wash out, one week's treatment. 2nd, 3rd, 4th months: two weeks' treatment, two week's wash out. Monthly throughout the treatment period the frequency and severity of airway infections episodes were assessed using the same score as for admission. Blood chemistry test, immunological assays (circulating Ig, lymphocyte subpopulations, Merieux Multitest in vivo blastization test) and respiratory tests (spirometry using a pneumotachigraph) were done before and after the treatment. 118/120 children completed treatment; the two dropouts were in the placebo group, one for compliance and the other because of headaches. Respiratory symptoms improved significantly in the actively treated children already from the first month, but not in the placebo group. This improvement consisted of reduction of the respiratory infectious episodes in both the upper and lower airways. No changes were noted in respiratory function parameters. From the immunological viewpoint, there were significant rises in serum IgA and IgM and enhanced skin response tot he Multitest; there was no change in the percentages of different circulating lymphocyte subpopulations.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

Initiation of antiretroviral therapy in HIV infection: a review of interstudy consistencies.

A number of clinical trials have explored the optimal dosage for antiretroviral therapy and, in various ways, the optimal time, in terms of stage of human immunodeficiency virus (HIV) disease, at which treatment should begin. Some studies have shown that treatment with zidovudine results in a delay in progression to more advanced stages of HIV disease, and that the benefits are more durable among persons who started zidovudine with higher CD4+ cell counts. Efficacy is preserved and toxicity is reduced when zidovudine is used at dosages lower than those originally recommended. The Concorde study found that administration of zidovudine to asymptomatic persons was associated with increases in CD4+ cell counts and improvement in delaying disease progression at 55 weeks, but found no correlation between time of initiation of therapy and either longer-term delay in onset of symptomatic disease or ultimate survival. The analysis of these results, however, is complicated because of premature crossover of study participants from deferred treatment to immediate treatment. The consensus of the discussants of these studies is that antiretroviral treatment should be initiated by the time the CD4+ cell count has fallen to 200-500 cells/mm3. Although recognizing that, in general, viral infections call for treatment, the panelists were divided in their opinions about treatment of asymptomatic patients with CD4+ cell counts > 500/mm3.

Cohort Studies↗
PubMed2001

Design and analytic considerations in determining the cost-effectiveness of early intervention in asthma from a multinational clinical trial.

Demand for economic and outcomes data in support of drug formulary listing in private and government-sponsored health programs has led to fundamental changes in drug development. In part as a response to these pressures, the pharmaceutical industry has begun to include economic and quality-of-life endpoints in clinical trials with the hope of providing information to answer health policy questions on the economic value of its products. Here, the design and health economic techniques that will be used to analyze the START (inhaled Steroid Treatment As Regular Therapy in early asthma) study-a multinational (31 countries), randomized, placebo-controlled trial of 7240 patients with mild asthma over 3 years-will be presented. START compares the effect of once-daily administration of an inhaled glucocorticosteroid (Pulmicort Turbuhaler to conventional therapy in the management of newly diagnosed asthma, for which the use of this therapy is currently not the standard. The START study will examine both clinical effectiveness (measured as symptom-free days) and asthma-related costs for both treatment arms, aggregated for all patients across all countries. We believe that presenting the analytical plan prior to disseminating the results is an important way of increasing the credibility of economic evaluations. However, using clinical trials for collecting economic data poses several challenges, and the methods for conducting such evaluations are being developed. This paper will present and discuss several methodological options and the current state of the art for conducting economic evaluations alongside multinational clinical trials.

Administration, Inhalation↗
PubMed2002

[Ankle braces prevent ligament injuries].

The Cochrane collaboration has performed a meta-analysis of all studies found on the prevention of ankle ligament injuries, frequent in sports like soccer, European handball and basketball. Interventions include the use of modified footwear and associated supports, training programmes and health education. Five randomized trials totalling 3,954 participants were included. With the exception of ankle disc training, all prophylactic interventions entailed the application of an external ankle support in the form of a semi-rigid orthosis, air-cast or high top shoes. The studies showed a significant reduction in the number of ankle sprains in individuals allocated to external ankle support. This reduction was greater for those with a previous history of ankle sprains.

Ankle Injuries↗
PubMed2000

Work and productivity loss in the rizatriptan multiple attack study.

The objective of this study was to measure the self-reported effect of acute migraine and its treatment on paid work and productivity loss. Patients self-administered a questionnaire in which the impact of a recent migraine on paid work and productivity activities was assessed. We included the questionnaire in a randomized, double-blind, placebo-controlled, crossover, out-patient study designed to examine the safety and efficacy of rizatriptan (5-HT1B/1D receptor agonist) 10 mg p.o. in patients treating four separate migraine attacks. A total of 407 patients, aged 18-65 years, suffering from moderate to severe migrainous headaches was studied. Patients receiving rizatriptan compared with placebo reported 0.7 fewer hours (P < 0.01) of paid worked missed due to absenteeism, 0.4 fewer hours (P < 0.05) of productive time lost on the job, and 1.1 fewer total hours (P < 0.01) of work loss per migraine attack. Rizatriptan compared with placebo significantly reduced migraine-related work loss associated with absenteeism and decreased effectiveness on the job.

Absenteeism↗
PubMedDate not supplied

Profile of Journal of Dentistry for Children and Pediatric Dentistry journal articles by evidence typology: thirty-year time trends (1969-1998) and implications.

PURPOSE: This study was performed to assess the profile of Journal of Dentistry for Children and Pediatric Dentistry journal articles by evidence typology and measure their changes over a thirty-year period (1969-1998). METHODS: All issues of both journals during the study period (1969-98) were manually reviewed. The publications were ranked by the quality of the evidence. Editorials, letters to the editor, abstracts, and organization-related communications were excluded from consideration. The publications were analyzed by journal and also by decade of publication, i.e., 1969-78, 1979-88 or 1989-98. RESULTS: There were 2848 publications included in the data set with descriptive studies, case reports, etc. comprising the majority (71%). No distinctive trends in the evidence typology were detected over the decades in either journal. CONCLUSION: There is a need to improve the quality of the evidence in the two pediatric dental journals reviewed.

Case-Control Studies↗
PubMed1996

Meta-analysis of clinical trials: a consumer's guide.

Meta-analysis is a popular statistical tool allowing the synthesis of related research studies in a quantitative manner. Components of a good meta-analysis are first discussed, with a view toward critical reading of reports of meta-analyses. Examples include lipid-lowering drugs and coronary artery bypass graft surgery. A role for meta-analysis in the design and monitoring of clinical trials was examined at a workshop held at the National Institutes of Health and aspects of these uses of meta-analyses are considered. Basic analytical and graphical methods of meta-analysis are briefly reviewed. The goal is to encourage more thoughtful evaluation of the many meta-analyses that are published or are presented.

Clinical Trials as Topic↗