[Multicenter double-blind study of the action of Broncho-Vaxom in chronic bronchitis].

The efficacy of Broncho-Vaxom has been evaluated by a multicentric working group of physicians in 75 patients with chronic bronchitis using a randomized double-blind trial. Initial data of the selected patients showed no significant differences in history, previous medication, individual state and spirometric lung function values between the control group (n = 39) and the cases treated with the test medication (n = 36). After 30-day initial treatment both physician and patient favoured the active substance (p less than 0.01) although there was statistically no evidence of a curative effect measured by objective criteria. Longterm follow-up over a period of six months again revealed a more effective course in the Broncho-Vaxom group according to individual observations (p less than 0.05). In fact there was an impressive trend towards reduction of clinical symptoms with Broncho-Vaxom medication. However, statistical analysis of individual symptoms' scores and lung function tests did not show significant alterations within the two groups. Taking in account the complexity of bronchitic disease, statistical demonstration of a beneficial effect of Broncho-Vaxom with respect to clinical symptoms and lung function tests probably needs a longer observation period, a larger population and a choice of more sensitive methods.

RCT Entities:   Population Interventions Outcomes