title: Preventive treatment of chronic bronchitis: a meta-analysis of clinical trials with a bacterial extract (OM-85 BV) and a cost-effectiveness analysis.
abstract: 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.
authors.affiliation: Institute for Medical Informatics and Biostatistics (IMIB), Riehen, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Bergemann
authors.forename: A
authors.initials: A
authors.lastname: Brandt
authors.forename: U
authors.initials: U
authors.lastname: Zoellner
authors.forename: C F
authors.initials: CF
authors.lastname: Donner
mesh_terms: D000276:Adjuvants, Immunologic / Q000191:economics / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000191:economics / Q000627:therapeutic use; D001419:Bacteria; D001991:Bronchitis / Q000191:economics / Q000628:therapy*; D002457:Cell Extracts; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003363:Cost Control; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D005251:Fees, Medical; D006801:Humans; D007348:Insurance, Health; D007558:Italy; D008875:Middle Aged; D011788:Quality of Life; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D000900:Anti-Bacterial Agents; D002457:Cell Extracts; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates