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European Heart Journal 1986 7(12):1030-1036;
Copyright © 1986 by the European Society of Cardiology.
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© 1986 The European Society of Cardiology

Time course of long-term placebo therapy effects in angina pectoris

J. P. BOISSEL, A. M. PHILIPPON, E. GAUTHIER, J. SCHBATH and J. M. DESTORS

B.I.S. RESEARCH GROUP Unité de Pharmacologie Clinique, Hôpital Neuro-Cardiologique 162, avenue Lacassagne, 69424 Lyon Cedex 03

revised 3 June 1986; accepted 8 January 1986.

Address for correspondence: Prof. J. P. Boissel, 162, avenue Lacassagne, 69424 Lyon Cedex 03, France.

Abstract

A cohort of thirty-five patients with angina pectoris were followed-up for six months with placebo as the only anti-anginal treatment apart from short-acting nitroglycerin. Only patients with at least five attacks per week were entered into the study. Prior to the study, their average number of attacks per week was 10.3 (± 0.9) and their average nitroglycerin tablet consumption per week was 10.6 (± 1.2). After admission into the study, the individual dosage of placebo could be blindly titrated during the first eight weeks. Once an adequate dosage was found, it was continued for 6 months. The primary end-point was predefined success or failure of the placebo treatment. Failure was assessed on the lack of improvement, occurrence of ‘side-effects’, or need for other anti-anginal treatment. In 27 patients, the placebo treatment was said to be a success (95% confidence limits of the percentage of success: 60–90%). No severe cardiac event occurred (confidence limits: 0–10%). Six patients developed ‘side-effects’. The number of attacks per week decreased by 48% (P<0.0001) during the titration period (8 weeks) and by 77%> during the whole 6 months. Exercise test improved, however, less markedly.

Key Words: Angina pectoris • placebo • long-term treatment


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