Abstract
This study evaluated the safety and efficacy of the immunostimulatory agent OM-85 BV in 112 male car-factory workers who were highly susceptible to acute respiratory tract infections (ARTIs), each having experienced ≥ 4 ARTIs during 1999. From January to March 2000, each worker received one capsule of OM-85 BV (7 mg) per day for 10 consecutive days each month. The patients were followed for a further 9 months. Mean number of ARTIs decreased from 8.2 ± 2.1 per worker in 1999 to 5.3 ± 2.9 in 2000; i.e. a difference of −2.9 (95% confidence intervals, −3.5 to −2.4). Similar effects were observed in men who had different job roles, and no adverse events were reported during drug administration. We concluded that OM-85 BV appears to be safe and effective in reducing the incidence of ARTIs in susceptible workers, although further double-blind, placebo-controlled clinical trials are required.