ArticleJournal of thoracic disease2025
Efficacy of OM-85 (Broncho-Vaxom) for prevention of acute exacerbations in patients with chronic airway diseases or chronic bronchitis: a systematic review and meta-analysis.
Article in Journal of thoracic disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The oral immunostimulant OM-85 (Broncho-Vaxom) has been suggested to reduce exacerbation frequency in patients with chronic obstructive pulmonary disease (COPD) or chronic bronchitis; however, its efficacy remains unclear. This study aimed to evaluate the effectiveness of OM-85 in preventing acute exacerbations in this patient population. Methods: We conducted a systematic review and meta-analysis using PubMed, Embase, and the Cochrane Central Register through April 2025. Eligibility was limited to peer-reviewed, full-length randomized controlled trials (RCTs) in English. Odds ratios (ORs) and mean difference (MD) with 95% confidence intervals (CIs) were calculated for between-group (OM-85 and placebo) comparisons. The methodological quality of the included studies was assessed the Cochrane risk of bias guidelines. The primary outcome was acute exacerbation rates on predefined outcomes. The secondary outcome was the rate of adverse events. Results: A total of five RCTs involving 1,724 patients were included. The methodological quality of the included studies was generally acceptable, with selection bias related to inadequate sequence generation and allocation concealment identified as the most frequent source of potential bias. The proportion of patients free from acute exacerbations was 39.2% with OM-85 and 30.3% with placebo (OR, 1.73; 95% CI: 1.04 to 2.87; P=0.03). As substantial heterogeneity was detected among the included studies (I2=80%), a random-effects model was applied. And the pooled estimates showed no statistically significant difference in the cumulative number of exacerbation episodes per patient between the OM-85 and placebo groups (0.63 Conclusions: Our findings suggest that OM-85 therapy provides some benefits in improving exacerbation outcomes compared with placebo in patients with COPD or chronic bronchitis. Additional research is required to verify these findings due to the small number of trials and between-study heterogeneity.
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