Clinical efficacy of Broncho-Vaxom in adult patients with chronic purulent sinusitis--a multi-centric, placebo-controlled, double-blind study.

This study was designed to test the clinical effectiveness of Broncho-Vaxom (an orally applicable bacterial lysate) in a large number of adult patients suffering from chronic purulent sinusitis. Broncho-Vaxom or placebo was administered to 284 patients presenting with chronic purulent sinusitis within the bounds of a multicentric, randomized double-blind study. Patients were clinically examined before admittance to the study and at 1, 2, 3 and 6 months after treatment initiation (one capsule daily for a period of 10 days per month during 3 consecutive months). The sinuses were x-rayed before and at 3 and 6 months after therapy began. Patients assessed the severity of their symptoms on a scale of 0 to 4: 0 = no symptoms, 1 = light symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms. The average severity score for coughing during the course of Broncho-Vaxom therapy decreased in the third month of treatment from 2.34 before treatment to 0.85, compared to placebo before treatment (2.41) and after treatment (1.24). The score decreased further to 0.61 in the sixth month after the initiation of Broncho-Vaxom therapy, with no further decrease as a result of placebo therapy (1.25). Comparable average score courses for expectorations and headache also occurred. In the first month of Broncho-Vaxom therapy, a decrease was already apparent in the severity of the main sinusitis symptom: purulent nasal discharge. The score was 1.55 in the first month of Broncho-Vaxom treatment compared to 1.80 in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)