Showing papers on "Placebo-controlled study published in 1982"

Alprazolam in the treatment of generalized anxiety and panic disorders: a double-blind placebo-controlled study

Abstract: In a double-blind controlled study lasting 8 weeks, 50 anxious psychoneurotic outpatients with a primary diagnosis of generalized anxiety or panic disorder were randomly assigned to alprazolam (n=30), a new benzodiazepine, or placebo (n=20), after a washout period of 1 week. Alprazolam at dosages between 0.25 and 3 mg/day was found to be significantly better than placebo in the treatment of either disorder. The finding that alprazolam was effective in the treatment of panic disorder is of interest as this diagnostic category is usually treated with tricyclic antidepressants or MAO inhibitors.

Placebo effect in surgery for Menière's disease. A double-blind placebo-controlled study on endolymphatic sac shunt surgery.

Abstract: • To investigate the placebo effect in surgery for Meniere's disease, a double-blind controlled study was undertaken, comparing effects of a regular endolymphatic shunt with those of regular mastoidectomy. Thirty patients with typical Meniere's disease, selected because of unsuccessful medical treatment, participated. Patients completed daily dizziness questionnaires three months before and 12 months after surgery, with registration of nausea, vomiting, vertigo, tinnitus, hearing impairment, and pressure in the ears. Patients were operated on at two universities, and the patients operated on at one underwent controlled study each month at the other. At termination of the trial, both investigators and patients gave their opinions of the efficacy of the operations. Minor differences were seen between active and placebo groups, but the greatest difference in symptoms was found when preoperative and postoperative scores were compared: both groups improved significantly. ( Arch Otolaryngol 1981;107:271-277)

A placebo controlled study of the cardiovascular effects of fluvoxamine and clovoxamine in human volunteers.

Abstract: 1 Fluvoxamine and clovoxamine, two new potential antidepressants were given to 27 healthy male volunteers in a double-blind, placebo controlled, three-way crossover study. 2 Neither compound affected the electrical intervals of 24 h ambulant electrocardiographic monitoring with the exception of a small increase in R-R interval. 3 There were no changes in blood pressure measurements. 4 The only notable unwanted symptom was nausea for both fluvoxamine and clovoxamine.

Pirenzepine in non-ulcer dyspepsia. A double-blind, placebo controlled trial.

Abstract: Fifty patients (with non-ulcer dyspepsia) were admitted to a double-blind, placebo-controlled trial to study the effects of pirenzepine (100 mg/daily) on non-ulcer dyspepsia. Ten patients did not complete the trial. After 4 weeks of treatment, statistically significant improvement (P less than 0.001) was observed endoscopically in the pirenzepine group. The relief of dyspepsia was significantly greater in the pirenzepine-treated group. The tolerability of pirenzepine was good.

A multicentre placebo-controlled trial comparing the efficacy of mianserin and chlordiazepoxide in general practice patients with primary anxiety.

Abstract: In a double-blind multicentre trial in general practice, 144 patients with primary anxiety received daily treatment with mianserin or chlordiazepoxide, 30-60 mg, or placebo. There were no statistically significant differences in efficacy between the three treatments in the 106 patients who completed the 6-week trial. However, there was a substantial trend in favour of mianserin (P= 0.1), but not chlordiazepoxide, over placebo as assessed by the difference in overall improvement on the Hamilton Anxiety Scale. This trend may be clinically significant since more patients dropped out from the placebo group because of lack of effect or deterioration than did from the active treatment groups, particularly during the latter part of the trial. Side effects occurred to a similarly low extent with all treatments, except that mianserin caused more weight gain and, initially, more drowsiness than placebo, while placebo produced more nausea and vomiting. Taken together with the evidence from previous trials in patients with anxiety, these results support the notion that mianserin has anxiolytic properties.

Use of bromocriptine in unexplained infertility.

Abstract: In order to determine whether infertility of unexplained aetiology would respond to therapy with bromocriptine, 50 regularly ovulating infertile patients were studied in a double-blind placebo controlled trial. Following an observation cycle in which midluteal urinary oestrogen and pregnanediol excretion and late luteal serum PRL and hCG levels were determined, patients were randomly allocated to treatment with either bromocriptine or placebo for three cycles. Patients who did not conceive were then treated for three cycles with the alternative therapy. Eighteen women (36%) conceived, five during the observation cycle, four during treatment with bromocriptine, four whilst receiving placebo and five during the 12 month follow-up period. The pregnancy rate achieved in patients treated with bromocriptine was thus no better than that for the group as a whole.

A placebo-controlled study to determine the efficacy of oral disopyramide phosphate for the prophylaxis of ventricular dysrhythmias after acute myocardial infarction.

Abstract: 1 To evaluate oral disopyramide phosphate in the prophylaxis of dysrhythmias occurring in acute myocardial infarction (MI) patients (presenting within 12 h of symptoms, age 21-70 years), a placebo-controlled, randomized double-blind, in hospital trial was conducted. After prognostic stratification (anterior and non-anterior MI at each of 4 regional hospitals) patients were randomly assigned to receive oral disopyramide phosphate (loading dose 150, 200, or 300 mg followed 6 h later by 100, 150, or 200 mg every 6 h for patients assessed to weigh less than 55, 55-85, or greater than 85 kg, respectively or matching placebo. The primary exclusion criteria were overt heart failure, systolic BP less than 100 mmHg, significant heart block or history of urinary retention. Active drug or placebo was continued for 7 days or until (a) detection of "warning arrhythmias' requiring i.v. lignocaine intervention (greater than 5 for 7 days or until (a) detection of "warning arrhythmias' requiring i.v. lignocaine intervention (greater than 5 premature ventricular contractions (PVCs)/min, R on T PVCs, multifocal PVCs, bigeminal PVCs, ventricular tachycardia or ventricular fibrillation) or (b) onset of exclusion criteria. In addition, plasma drug concentrations were determined and 24 h electrocardiographic tapes were obtained on day 1, and on one of days 4-7 but these results are not presented here. 2 Out of 121 patients entering the trial, 101 had confirmatory ECG and enzyme changes. Of these, 9 of 47 patients receiving disopyramide phosphate required lignocaine compared to 20 of 54 receiving placebo (19% v 37%; P = 0.047). Corresponding numbers for patients discontinuing trial medication for other non-fatal complications of MI were 5 and 3, and for those dying, were 3 (2 infarct extensions and 1 massive infarction), and 0, respectively. Respective numbers discontinuing trial medication for possible drug side effects (viz. urinary retention requiring catheterization) were 6 and 1 (P = 0.031). 3 In circumstances where i.v. therapy is deemed impractical, use of oral disopyramide phosphate given prophylactically in patients with acute MI may reduce the incidence of "warning arrhythmias' by a clinically significant extent.

A placebo-controlled trial shows no effect of vasopressin on recovery from closed head injury.

Abstract: Vasopressin and its analogues have been claimed to benefit patients with posttraumatic amnesia. To test this hypothesis a double-blind, placebo-controlled, prospective trial of vasopressin was carried out in the chronic (rehabilitation) phase of recovery from closed head injury. Seven patients who received vasopressin and 6 who received a placbo were comparable in age, sex, and degree of disability upon entry into the study. Both groups inproved at the same rate in mental status, neurological status, and activities of daily living.

Long-term treatment of duodenal ulcer with pirenzepine. A double-blind, placebo-controlled trial.

Abstract: Sixty out-patients with duodenal ulcers that were healed at the end of a 4-week treatment with pirenzepine, cimetidine or placebo were admitted to a double-blind placebo-controlled trial to study the effectiveness of pirenzepine (100 mg/daily) in preventing recurrence of ulcers. Six patients did not complete the trial. After 12 months of treatment 15 of the 26 patients had recurrences in the pirenzepine-treated group and 27 of the 28 in the placebo group. The difference is highly significant (X2 = 9.570, P less than 0.01). The tolerability of pirenzepine was good.

Comparison of twice-daily ranitidine and placebo in the treatment of duodenal ulcer--a multicentre study in the United Kingdom.

Abstract: Treatment of duodenal ulcer with the H2-receptor antagonist ranitidine, 150 mg twice daily has been assessed in a double-blind, placebo controlled study at seven centres in the United Kingdom. One hundred-and-twenty-nine patients entered the trial with endoscopically confirmed duodenal ulcer. Five patients did not comply with the protocol and were excluded from the analysis. Nine patients (1 ranitidine, 8 placebo) did not complete the initial 4 weeks' treatment due to poor symptomatic response; one hundred-and-fifteen (58 ranitidine, 57 placebo) were endoscopically assessed after 4 weeks. The average 4-week healing rate among patients on ranitidine (83%) was significantly greater than that for the placebo group (32%, p less than 0.01). Forty-four patients whose ulcers had not healed received further treatment with ranitidine 150 mg b.d. on an open basis. After a total of up to 8 weeks' active treatment only three patients had not healed. Ulcer symptoms resolved or improved in a greater proportion of patients on ranitidine, and this was associated with a significantly lower antacid consumption. There was no serious unwanted effect associated with ranitidine treatment, and the twice daily dose of 150 mg is apparently a safe and effective short-term treatment for duodenal ulceration.