Showing papers on "Placebo-controlled study published in 1977"

Maintenance digoxin after an episode of heart failure: placebo-controlled trial in outpatients.

Abstract: The need for maintenance digoxin treatment was assessed in a double-blind, variable-dose, crossover comparison with placebo. Forty-six outpatients who had been prescribed the drug for heart failure were studied; 33 were in sinus rhythm and the remainder in atrial fibrillation. Mean serum digoxin concentrations in those with sinus rhythm averaged 1-33 nmol/l, but a lower concentration, averaging 0-97 nmol/l, was accepted in those with atrial fibrillation as six of them developed bradycardia. Sixteen of the 46 patients deteriorated on placebo, and eight completely recovered when digoxin was reintroduced; in the remainder additional diuretics were required temporarily. Spirometric values deteriorated on changing to placebo whether or not the patient showed clinical evidence of recurrence of heart failure. In a separate study of nine patients who showed no clinical evidence of deterioration on placebo, reintroduction of digoxin caused a shortening of left ventricular ejection time, which persisted for at least a month. This suggests that the inotropic response to digoxin is sustained during maintenance treatment.

Amoxycillin and co-trimoxazole in presumed viral respiratory infections of childhood: placebo controlled trial

Abstract: A double-blind randomized controlled trial of amoxycillin, co-trimoxazole, and placebo was conducted on 197 children presenting with presumed viral respiratory infections. Routine throat swabs were taken to exclude streptococcal diseases. The three disease categories studied--nasopharyngitis, pharyngotonsillitis, and bronchitis (including laryngotracheobronchitis)--showed a generally similar pattern of resolution irrespective of treatment. Nevertheless, seven out of 66 children receiving placebo were withdrawn from the trial with unremitting symptoms or complications thought to require antimicrobial treatment. Only two of 56 children receiving amoxycillin and none of 75 receiving co-trimoxazole were withdrawn. Three other children receiving amoxycillin and three receiving placebo were seen during the trial but further treatment was not thought to be necessary. Thus the return consultation rate in children receiving placebo therapy was 15% compared with 4% for those receiving antimicrobial treatment. Antimicrobial treatment was associated with less nasal discharge on the eighth day of treatment. Placebo treatment allowed an earlier return to normal activity. There was a high incidence of possible side effects on all regimens including placebo. It is concluded that the benefits of antimicrobial treatment in presumed viral respiratory infections are marginal, and they should not be routinely prescribed for these conditions.

Double-blind placebo-controlled study of loperamide (Imodium) in chronic diarrhoea caused by ileocolic disease or resection.

Abstract: Loperamide (R 18 553) was compared with placebo in a double-blind crossover study of 21 patients with chronic diarrhoea caused by ileocolic disease or resection. Eighteen patients completed the trial. At a median daily dose of 6 mg the new antidiarrhoeal preparation was found to be superior to placebo in controlling chronic diarrhoea. The frequency and weight of stools significantly decreased, the stools became more solid, and carmine transit time was prolonged during loperamide therapy. Loperamide was consistently preferred to placebo by the patients. Gastrointestinal side-effects were few and comparable during both treatment periods.

Droperidol in acutely agitated patients. A double-blind placebo-controlled study.

Abstract: Forty-one acutely agitated patients received an i.v. injection of 4 ml of a double blind solution containing either 10 mg of droperidol or placebo. The need for further medication (5 mg of haloperidol after 3 minutes or individually adapted psychotropics after 30 minutes) was used as a parameter for the evaluation of the results. Three minutes after the injection, haloperidol was needed by only six out of 19 patients of the droperidol group, but by 19 patients of the control group. Thirty minutes after the first injection, further medication was needed by only four droperidol patients and 10 placebo patients. No side effects could be attributed to the double blind medication.

Sanomigran for migraine prophylaxis, controlled multicenter trial in general practice.

Abstract: SYNOPSIS Pizotifen, a tricyclic antiserotonin agent and inhibitor of certain other biogenic amines, was effective in reducing the severity and frequency of migraine attacks, producing complete remission in some cases, in a double-blind placebo controlled trial in 36 patients. Serious side effects were not reported during the trial period.

A Multicentre Study Comparing Mazindol and Placebo in Obese Patients

Abstract: Mazindol is chemically unrelated to the phenethylamines and has not shown the side-effects or abuse potential of the amphetamine anorectics. To further define its potential for causing weight loss, a six-week double-blind placebo controlled study was undertaken in four centres. A common protocol was used except in one centre, behavioural modification also was employed, whereas in the other centres, no additional measures were used to cause weight loss. Two hundred and forty-five obese patients were assigned randomly to two mazindol groups and one placebo group in each centre. Ninety-eight and forty patients receiving mazindol and placebo respectively completed the protocol. The conclusions were: (a) no significant clinical or laboratory abnormalities occurred from mazindol therapy, (b) the placebo therapy patients did not lose weight without behavioural modification, (c) the placebo therapy group had a higher drop-out rate compared to the mazindol therapy group attributable to the patients' dissatisfaction with failure to lose weight, (d) mazindol therapy without behavioural modification and behavioural modification alone both resulted in a statistically significant mean weight loss of 1 pound/patient/week and (e) mazindol plus behavioural modification resulted in a greater mean weight loss of 1/2 pound/patient/week than with behavioural modification alone. Hence, mazindol is of value in the initial therapy of obesity.

Betahistine hydrochloride (serc) in cerebrovascular disease: a placebo-controlled study

Abstract: A double-blind, placebo-controlled, clinical study was performed to assess the effects of oral betahistine hydrochloride (Serc) on mental impairment and physical disability in patients with established cerebrovascular disease. Fifty-three patients were admitted to the study during 18 months. Forty-five patients completed the study. They received either betahistine 24 mg daily or placebo for eight weeks. Clinical assessments of general functional activity were done and a battery of nine mental function tests was administered pretreatment and at two-weekly intervals during therapy. The results were analysed statistically using distribution-free tests. Significant differences were demonstrated between betahistine and placebo at week 8 of treatment for associate learning, digit retention, general knowledge, orientation, sentence learning and simple arithmetic. These differences were consistently in favour of betahistine at or close to the 5% level of significance. The results of the remaining mental function tests showed no significant differences between betahistine and placebo, but trends were in favour of the former. General functional activity assessments also demonstrated that betahistine-treated patients were significantly better than those on placebo (P less than or equal to 0.05). No untoward side-effects were noted during the study.