Preventive effect of an immunomodulator, OM-85 BV, on acute exacerbations of chronic bronchitis in elderly patients. Preliminary results at six months in 291 patients
Abstract
Three hundred fifty six patients aged 65 years or more (mean age 81.8 years) who were suffering from chronic bronchitis were included in a double-blind trial against placebo to assess the preventative effect of OM-85 BV against acute exacerbations of chronic bronchitis. OM-85 BV is an immunostimulant composed of lyophilised factions of 8 bacteria which are most frequently encountered during the course of respiratory tract infections. 291 patients completed the study. In the group treated by OM-85 BV, a significant increase in the number of patients with no episode of acute bronchitis was noted (96 versus 71, p = 0.006). There was a 38.8% reduction in the absolute numbers of episodes of acute bronchitis and a 33% reduction in the number of prescriptions for antibiotics, however there was no difference in the number of pneumonias and bronchopneumonias. These results show the protective effect of OM-85 BV against bronchial superinfections in a large population of elderly patients suffering from chronic bronchitis.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 291 participants or records.
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