ABSTRACT
In a single blind clinical trial the effects of Tobanum (chloranolol), a beta-adrenergic receptor blocker, on 450 patients were examined. The side effects were detected by placebo control. Complaints were recorded on a questionnaire in the placebo period as well as in the active treatment period. Every fourth patient reported complaints in the placebo period and every third had a new complaint in the active period. Qualitative and quantitative analysis of the complaints indicated that Tobanum has mainly cardiorespiratory side effects judging from the beta-blocker characteristics. The study draws attention to the need for awareness of complaints in the placebo period for correct evaluation of side effects.
Subject(s)
Adrenergic beta-Antagonists/adverse effects , Angina Pectoris/drug therapy , Arrhythmias, Cardiac/drug therapy , Hypertension/drug therapy , Propanolamines/adverse effects , Adrenergic beta-Antagonists/therapeutic use , Adult , Aged , Central Nervous System Diseases/chemically induced , Clinical Trials as Topic , Drug Eruptions/etiology , Female , Gastrointestinal Diseases/chemically induced , Humans , Male , Middle Aged , Propanolamines/therapeutic useABSTRACT
The incidence of side-effects on administration of chloranolol (Tobanum), a beta-adrenergic receptor blocking drug, to 2066 patients with hypertension, angina pectoris or arrhythmias was measured by three different methods. In 600 patients in an efficacy trial (Group 1) both spontaneously reported complaints and objective signs were tabulated. A side effect - directed method, utilising a questionnaire containing a list of possible side-effects was also used, with the questionnaire being completed by the physician. 35 questions referred to anticipated and other side-effects. The trial was performed in two groups: in 537 patients a placebo was also given (Group 2), and in another set of 929 patients (Group 3) the questionnaire inquiry was performed uncontrolled, without placebo. All three groups were comparable in their distribution of sexes, ages and diagnoses, the mean daily dose of chloranolol its use alone or in combination, and in a similar duration of treatment. 55% of all patients received chloranolol therapy for a period of more than 3 months. The ratio of in- and outpatients was 1:5. The side-effect incidence was independent of the age and sex of the patients and of the dose of chloranolol. The incidence was also unaffected whether chloranolol was used alone or in combination. The number of side-effects differed markedly between the three groups, their ratio was 1:10:24 in Groups 1, 2 and 3. Two-thirds of the side-effects subsided spontaneously within 1 month of their onset.(ABSTRACT TRUNCATED AT 250 WORDS)
