Clinical efficacy of Broncho-VaxomB 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. A continuous decrease to 0.58 after Broncho-Vaxom@ therapy in the 6th month occurred, compared to 1.29 after placebo therapy. Six months after therapy began, the average number of reinfections in the placebo group was almost double that occurring in the Broncho-Vaxom@-treated group. The number of patients with obstructed sinuses decreased from 54 to 9 in the Broncho-Vaxom@ group and from 46 to 25 in the placebo group. Side effects were minimal. Broncho-Vaxom@ proved to be an effective therapy in alleviating symptoms and recurrence of sinusitis.