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At least 91 records · Page 5Linked to original sources
PubMed1990

Flunarizine (10 and 20 mg) i.v. versus placebo in the treatment of acute migraine attacks: a multi-centre double-blind study.

In a multi-centre, randomized double-blind study, the effect and tolerance of 10 and 20 mg flunarizine i.v. versus placebo was tested on 102 migraineurs with acute migraine attacks with and/or without aura. Thirty-seven patients received 10 mg flunarizine, 32 received 20 mg and 33 received placebo. The groups were comparable. Response to treatment was defined as pain reduction of at least 50% within 60 min on a visual analogue scale after i.v. drug administration. This effect was noted on 59.4% with 20 mg flunarizine, on 24.3% with 10 mg flunarizine and on 30.3% with placebo. The tolerance of flunarizine i.v. was similar to placebo. Blood pressure and pulse rate were not affected by flunarizine. All in all, 20 mg flunarizine i.v. appeared to be a suitable alternative for treatment of acute migraine attacks.

Acute Disease↗
PubMed1989

A 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm) in acne vulgaris: a randomized, double-blind comparative study.

A double-blind, randomized multi-centre study was performed to evaluate the efficacy of a 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm). One-hundred and twenty-two patients suffering from acne vulgaris were treated with either Zineryt lotion or 2% erythromycin lotion. Acne grading and lesion counts for comedones, papules, pustules, nodules and macules were performed at each visit at 0, 1, 2, 4, 8 and 12 weeks. Treatment with Zineryt lotion was found to be more effective than with 2% erythromycin as regards the reduction in number of the acne lesions and the severity grade of the acne.

Acetates↗
PubMed1989

Effect of fish oil on blood pressure and blood lipids in men with mild to moderate hypertension.

Forty men with mild to moderate hypertension were given one of two dietary supplements for 6 weeks: 20 capsules of fish oil (MaxEPA) or placebo (olive and corn oil). The MaxEPA supplement provided about 7 g omega-3-fatty acids pr day, whereas the placebo contained about 7 g omega-6-fatty acids and only 0.2 g omega-3-fatty acids. A clinical insignificant reduction in blood pressure was noted in both groups. In the fish oil group, the serum triglyceride levels fell by 30%. A decrease in the ratio total cholesterol/high density lipoprotein (HDL-) cholesterol was noted in both groups, most pronounced in the placebo group. No significant effect on total serum cholesterol level was observed during this study.

Adult↗
PubMed1999

Handsearching the Journal of the Royal Naval Medical Service for Trials.

As part of the Cochrane Collaboration's international research endeavour, the authors carried out a handsearch of the Journal of the Royal Naval Medical Service from 1948 to 1998, searching for randomised controlled trials (RCTs) and controlled clinical trials (CCTs). Five trials were identified, of which three were RCTs and two were CCTs. The first trial was published in 1960. The identified trials were in the fields of dentistry (two trials), gastroenterology, occupational medicine and orthopaedic surgery. Of the five trials, only two had been located previously through a rigorous interrogation of Medline. The three newly identified trials were reported to the UK Cochrane Centre, and details of these three trials were entered into Medline for use by clinicians and investigators in the future.

Controlled Clinical Trials as Topic↗
PubMed2003

Does acetaminophen affect liver function in alcoholic patients?

Acetaminophen in doses of 4 g/d did not affect liver function of alcoholic patients in this randomized study. These results do not rule out the possibility of acetaminophen-induced liver failure in alcoholic patients, especially patients with pre-existing liver disease or those who continue to drink. Patient-oriented outcomes (ie, studying chronic acetaminophen use in alcoholics to determine the incidence of developing hepatic failure) ultimately would resolve this controversy. However, these data do cast doubt on the medical myth (based on case reports) that acetaminophen use in alcoholics causes hepatotoxicity.

Acetaminophen↗
PubMedDate not supplied

[Prophylactic effect of Misoprostol on gastric lesions induced by aspirin (ASA) in healthy subjects].

Aspirin (ASA) and other nonsteroidal anti-inflammatory drugs (NSAIDs), are extensively used for treating rheumatic diseases, inflammatory problems, and pain of different etiologies. However, their use is limited by the damage they may produce to the gastroduodenal mucosa. The purpose of this double-blind, multicenter, randomized, placebo-controlled study was to assess and corroborate the protective effect of misoprostol on the gastric mucosa against ASA injury. Following endoscopic screening, 60 healthy male and female subjects were assigned, at random, to one of two treatment groups. One group was treated with ASA (3.0 g/day, in three divided doses) and misoprostol (600 mcg/day, co-administered with ASA); the other with ASA and placebo. After six days of treatment, endoscopy was repeated and the gastric mucosa was graded on a 5 point endoscopic score. Protection was defined as mucosa having an endoscopic score of 2 or less (10 or fewer hemorrhages or erosions). Misoprostol produced a significant (p = 0.005) and profound protection of the gastric mucosa against ASA injury and was well tolerated. These results suggest that misoprostol should have significant therapeutic utility in the treatment and prevention of gastropathy due to NSAIDs.

Adolescent↗
PubMed1989

Comparison of the antihypertensive effects of betaxolol and chlorthalidone as monotherapy and in combination.

In this multicenter, double-blind, parallel study, the antihypertensive effects of betaxolol (20 mg once daily) and/or chlorthalidone (25 mg once daily) were analyzed in 186 patients with essential hypertension. Following a 2- to 4-week placebo baseline period, patients were randomized to one of two treatment groups (betaxolol or chlorthalidone) and studied for 6 weeks while receiving single therapy and an additional 6 weeks with a combination of the two agents. Significant decreases from baseline supine diastolic blood pressure (SDBP) were observed in both groups at the end of the single-therapy phase (11 mm Hg in SDBP for betaxolol and 12 mm Hg in SDBP for chlorthalidone); a further significant decrease (7 mm Hg for betaxolol and 8 mm Hg for chlorthalidone in SDBP) was observed from the end of the single-therapy phase to the end of the combination-therapy phase. Changes in supine systolic blood pressure (SSBP) from baseline to the end of the single-therapy phase were 10 mm Hg for the betaxolol and 16 mm Hg for the chlorthalidone group. In all cases, within-group changes were statistically significant. From the end of single therapy to end of combination therapy there was an additional 14-mm Hg and 13-mm Hg reduction in SSBP in the betaxolol and chlorthalidone groups, respectively. Overall, 89% of the randomized patients completed the single-treatment phase (phase I), and 89% of those patients completed the combined therapy phase (phase II). There was no significant difference between treatment groups in the clinical response rate (SDBP at or below 90 mm Hg or a decrease from baseline of at least 10 mm Hg). A substantial percentage of patients completing phase I responded to either single agent (58% for betaxolol and 65% for chlorthalidone). Among patients completing phase II therapy, the combination of the two agents produced a greater response rate (83% for the betaxolol-first group and 85% for the chlorthalidone-first group). In conclusion, both agents were effective and well tolerated. The most frequent adverse events in the single-therapy phase were headache, arthralgia, and dizziness, while bradycardia, rhinitis, arthralgia, and dizziness were most frequent in the combination-therapy phase. The combination of betaxolol (20 mg) and chlorthalidone (25 mg) once daily produced an additive antihypertensive effect regardless of which drug was administered first.

Betaxolol↗
PubMed1990

Design of a multicenter randomized trial for the Stroke Prevention in Atrial Fibrillation Study. The Stroke Prevention in Atrial Fibrillation Investigators.

Individuals with nonvalvular atrial fibrillation are at increased risk of stroke. The Stroke Prevention in Atrial Fibrillation Study is a 15-center randomized clinical trial examining the risks and benefits of low-intensity warfarin (prothrombin time of 1.3-1.8 times control) and aspirin (325 mg/day) in patients with constant or intermittent atrial fibrillation. Candidates for anticoagulation (group I) are randomized to receive warfarin in an open-label fashion, aspirin, or placebo; the last two treatments are given in a double-blind fashion. Warfarin-ineligible patients (group II) are randomized to receive aspirin or placebo in a double-blind fashion. Primary end points are ischemic stroke and systemic embolism. Secondary end points are death, transient ischemic attack, myocardial infarction, and unstable angina pectoris. Analysis is based on the intention-to-treat principle. The anticipated rate of primary end points in patients receiving placebo is 6%/yr. The sample size of 1,644 patients is based on a projected reduction in the rate of primary end points of 50% by warfarin and of 33% by aspirin (beta = 0.2, alpha = 0.05). Patient entry commenced in June 1987 and will continue for 3 years, with an additional year of follow-up. High-risk subsamples identified by clinical and echocardiographic criteria are sought prospectively.

Aspirin↗
PubMed2003

DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE).

The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) was a multi-center, randomized, investigator-initiated trial. Patients enrolled in the trial had non-ischemic cardiomyopathy (LVEF 10 PVCs/hr or non-sustained ventricular tachycardia defined as 3 to 15 beats at a rate of >120 bpm) on Holter monitor or telemetry within the past 6 months. All patients received standard oral medical therapy for heart failure including angiotensin converting enzyme inhibitors and beta-blockers. Patients were randomized to implantable cardioverter defibrillator (ICD) versus no ICD. Patients were followed for 2 to 3 years. The primary endpoint was total mortality. Quality of life and pharmacoeconomics analysis was also performed. A registry tracked patients who met basic inclusion criteria but were not randomized. We estimated an annual total mortality of 15% at 2 years in the treatment arm that did not receive an ICD. The ICD was expected to reduce mortality by 50%. Approximately 229 patients were required in each treatment group. Forty-five centers were included in this trial that was designed to last an estimated 4 years. Enrollment was projected to occur over 2 1/2 years with a post enrollment follow-up of 1 1/2 years.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1989

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

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

Adult↗
PubMed1996

Update: vinorelbine (navelbine) in non-small cell lung cancer.

Vinorelbine (navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), a novel semisynthetic vinca alkaloid, is the first drug approved by the Food and Drug Administration in over 20 years for the first-line treatment of ambulatory patients with unresectable advanced non-small cell lung cancer (NSCLS). In a multicenter, randomized US trial, single-agent vinorelbine produced response rates of 12%, compared with prior single-center studies demonstrating a response rate of 30%. Furthermore, in the US trial, median survival for patients receiving vinorelbine was 30 weeks, with a 1-year survival rate of 25%, compared with 22 weeks for 5-fluorouracil and leucovorin, with a 1-year survival rate of 16%. This impact on survival was confirmed in a European multicenter randomized trial. In this study, vinorelbine as a single agent demonstrated a median survival of 31 weeks, with a 1-year survival rate of 30%. Single-agent vinorelbine was comparable to the combination of vindesine/cisplatin, which had a median survival of 32 weeks and a 1-year survival rate of 27%. By contrast, the combination of vinorelbine/cisplatin produced a medial survival of 40 weeks and a 1-year survival rate of 35%. The major dose-limiting toxic effect of vinorelbine is granulocytopenia. Vinorelbine has demonstrated a survival advantage in patients with advanced NSCLC in two controlled clinical trials and has been associated with a favorable safety profile associated with a low incidence of hospitalization. These findings would suggest that vinorelbine alone or in combination with cisplatin may be a cost-effective treatment for appropriate patients with advanced NSCLC.

Agranulocytosis↗
PubMed1990

A randomized comparison of intensive maintenance treatment for adult acute myelogenous leukemia using either cyclic alternating drugs or repeated courses of the induction-type chemotherapy: AML-6 trial of the EORTC Leukemia Cooperative Group.

Out of 515 evaluable patients (median age, 47 years) who entered the study from 1983 to 1986, 67.4% achieved complete remission (CR) after one cycle (256) or two cycles (91) of daunorubicin (DNR) (45 mg/m2 days 1-3), cytosine arabinoside (Ara-C) (200 mg/m2 i.v. days 1-7), and vincristine (VCR) (1 mg/m2 day 2). A partial remission was achieved by 3.7% of patients, 15% were resistant, 11.3% died during hypoplasia, and 2.7% died during induction. Patients achieving CR received one consolidation course in which administration of DNR was limited to 1 day. Two hundred and forty-eight patients were randomized for six courses of maintenance every 6 weeks: either DNR + VRC day 1 + Ara-C s.c. days 1-5, or AMSA 150 mg/m2 day 1 alternating with high-dose (HD)-Ara-C 3 g/m2 q12 h day 1 + 2 or 5-azacytidine 150 mg/m2 days 1-3. Two hundred and thirty-three patients were randomized when bone marrow transplantation (BMT) had not been planned or performed and 15 patients were randomized before the BMT. Sixty patients received BMT, 17 autografts, and 43 allografts. Median time from CR to BMT was 15 weeks. Forty-two patients were not randomized mainly because of toxicity or treatment refusal. Median DFS for both chemotherapy groups was 12 months and 23% were alive at 4 years. Median survival from CR was 22 months, and 34% were alive at 4 years. There was no difference in disease-free interval (DFI) and disease-free survival (DFS) between the two chemotherapy arms. Of 60 transplanted patients, 42% were alive at 4 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗