Preventive treatment of chronic bronchitis: a meta-analysis of clinical trials with a bacterial extract (OM-85 BV) and a cost-effectiveness analysis

Monaldi Arch Chest Dis. 1994 Sep;49(4):302-7.


Chronic bronchitis is a lifelong disease with significant effects on the patient and on the costs to health insurance institutions. Acute exacerbations in chronic bronchitic patients may have a negative impact on patients' quality of life and on the progression of the disease, particularly in more severe patients. The clinical efficacy of the immunoactive bacterial extract OM-85 BV has been shown in several clinical trials, a cost-effectiveness evaluation (CEA) of its use in chronic bronchitic patients has not been fulfilled so far. In this study a meta-analysis on the preventive treatment of acute exacerbations with OM-85 BV and a CEA, focusing on direct costs only, was performed. The meta-analysis showed a mean value of 0.6 prevented acute exacerbations per 6 months per patient, and a reduction of 9 days in antibiotic treatment per 6 months per patient. CEA evaluated the different cost elements. The mean direct cost (consultations, antibiotics, etc.) for the treatment of 1 acute exacerbation in chronic bronchitic patients was calculated as 143, 459 Lira. Thus for 0.6 prevented acute exacerbations per 6 months per patient a reduction in cost of 86,075 Lira (0.6-143,459) could be expected. The additional costs for the preventive treatment with OM-85 BV, based on prices for Italy, are 34,980 Lira per patient per 6 months. In conclusion, the effective cost savings per patient per 6 months are 51, 095 Lira. The sensitivity analysis revealed only one critical parameter, i.e. the clinical effectiveness of OM-85 BV. Even assuming 0.3 prevented exacerbations per 6 months per patient, the preventive treatment still proved to be cost effective.

Publication types

  • Meta-Analysis

MeSH terms

  • Adjuvants, Immunologic / economics
  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / economics
  • Anti-Bacterial Agents / therapeutic use
  • Bacteria*
  • Bronchitis / economics
  • Bronchitis / therapy*
  • Cell Extracts*
  • Chronic Disease
  • Clinical Trials as Topic*
  • Cost Control
  • Cost Savings
  • Cost-Benefit Analysis
  • Costs and Cost Analysis
  • Fees, Medical
  • Humans
  • Insurance, Health
  • Italy
  • Middle Aged
  • Quality of Life


  • Adjuvants, Immunologic
  • Anti-Bacterial Agents
  • Broncho-Vaxom
  • Cell Extracts