TY - JOUR
T1 - Clinical efficacy of OM-85 BV in COPD and chronic bronchitis
T2 - A systematic review
AU - Sprenkle, Mark D.
AU - Niewoehner, Dennis E.
AU - MacDonald, Roderick
AU - Rutks, Indulis
AU - Wilt, Timothy J.
PY - 2005
Y1 - 2005
N2 - OM-85 BV is an immunomodulatory agent used for prevention of exacerbations in persons with chronic lung disease. We conducted a systematic review of OM-85 BV to evaluate its efficacy and safety. A systematic search for relevant articles was performed. Studies were included if they involved persons with chronic obstructive pulmonary disease or chronic bronchitis and were randomized to OM-85 BV or placebo. Investigators extracted data on study design, participant characteristics, and clinical outcomes. Thirteen trials involving 2066 individuals met inclusion criteria. Three trials enrolled an older, more homogenous population with chronic obstructive pulmonary disease. Utilizing quantitative pooled analysis in these studies, with one or more acute exacerbations as the endpoint, we found a non-statistically significant trend in favor of OM-85 BV [relative risk 0.83, 95% confidence interval 0.65-1.05]. Ten trials enrolled a heterogeneous population with chronic bronchitis. In these trials, exacerbation rates were less with OM-85 BV in 4 of 9 trials reporting this outcome. Varied results in the outcomes of hospitalization, symptom scores, and antibiotic or steroid use were found across studies. Withdrawals and adverse events were similar between OM-85 BV and placebo. While OM-85 BV is used to prevent exacerbations in persons with chronic lung disease, consistent evidence across multiple important outcomes does not exist to clearly demonstrate clinical benefit. Further randomized controlled trials enrolling large numbers of persons with well-defined COPD are necessary to confirm the effectiveness of this agent.
AB - OM-85 BV is an immunomodulatory agent used for prevention of exacerbations in persons with chronic lung disease. We conducted a systematic review of OM-85 BV to evaluate its efficacy and safety. A systematic search for relevant articles was performed. Studies were included if they involved persons with chronic obstructive pulmonary disease or chronic bronchitis and were randomized to OM-85 BV or placebo. Investigators extracted data on study design, participant characteristics, and clinical outcomes. Thirteen trials involving 2066 individuals met inclusion criteria. Three trials enrolled an older, more homogenous population with chronic obstructive pulmonary disease. Utilizing quantitative pooled analysis in these studies, with one or more acute exacerbations as the endpoint, we found a non-statistically significant trend in favor of OM-85 BV [relative risk 0.83, 95% confidence interval 0.65-1.05]. Ten trials enrolled a heterogeneous population with chronic bronchitis. In these trials, exacerbation rates were less with OM-85 BV in 4 of 9 trials reporting this outcome. Varied results in the outcomes of hospitalization, symptom scores, and antibiotic or steroid use were found across studies. Withdrawals and adverse events were similar between OM-85 BV and placebo. While OM-85 BV is used to prevent exacerbations in persons with chronic lung disease, consistent evidence across multiple important outcomes does not exist to clearly demonstrate clinical benefit. Further randomized controlled trials enrolling large numbers of persons with well-defined COPD are necessary to confirm the effectiveness of this agent.
KW - Broncho vaxom
KW - Chronic bronchitis
KW - Chronic obstructive pulmonary disease
KW - Meta-analysis
KW - OM-85 BV
UR - http://www.scopus.com/inward/record.url?scp=20144376856&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=20144376856&partnerID=8YFLogxK
U2 - 10.1081/COPD-200050674
DO - 10.1081/COPD-200050674
M3 - Article
C2 - 17136978
AN - SCOPUS:20144376856
SN - 1541-2555
VL - 2
SP - 167
EP - 175
JO - COPD: Journal of Chronic Obstructive Pulmonary Disease
JF - COPD: Journal of Chronic Obstructive Pulmonary Disease
IS - 1
ER -