Abstract
Background
Recurrent acute respiratory tract infections (ARTI) are a common problem in childhood. Some evidence suggests a benefit regarding the prevention of ARTI in children treated with the immunomodulator OM-85 BV (Bronchovaxom).
Methods
We summarised the evidence on the effectiveness of the immunomodulator OM-85 BV in the prevention of ARTI in children. We searched randomised comparisons of oral purified bacterial extracts against inactive controls in children with respiratory tract diseases in nine electronic databases and reference lists of included studies. We extracted salient features of each study, calculated relative risks (RR) or weighted mean differences (WMD) and performed meta-analyses using random-effects models.
Results
Thirteen studies (2,721 patients) of low to moderate quality tested OM-85 BV. Patients and outcomes differed substantially, which impeded pooling results of more than two trials. Two studies (240 patients) reporting on the number of patients with less than three infections over 6 month of follow-up in children not in day care showed a trend for benefit RR 0.82 (95% CI, 0.65–1.02). One out of two studies examining the number of children not in day care without infections over 4–6 month reported a significant RR of 0.42 (95% CI, 0.21–0.82) whereas the smaller, second study did not [RR 0.92 (95% CI, 0.58–1.46)]. Two studies reporting the number of antibiotic courses indicated a benefit for the intervention arm [WMD 2.0 (95% CI, 1.7–2.3)]. Two out of the three studies showed a reduction of length of episodes of 4–6 days whereas a third study showed no difference between the two groups.
Conclusion
Evidence in favour of OM-85 BV in the prevention of ARTI in children is weak. There is a trend for fewer and shorter infections and a reduction of antibiotic use.
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References
Undertaking Systematic Reviews of Research on Effectiveness CRD’s Guidance for those Carrying Out or Commissioning Reviews. CRD Report Number 4 (2nd Edition) (2001) Ref type internet communication
Anonymous (1998) Acute respiratory infections: the forgotten pandemic. Bull World Health Organ 76:101–107
Collet JP, Ducruet T, Kramer MS, Haggerty MSC, Floret D, Chomel JJ, Durr F, Epichrèche Research Group (1993) Stimulation of nonspecific immunity to reduce the risk of recurrent infecions in children attending day-care centers. Pediatr Infect Dis J 12:648–652
DeBaets F, Kint J, Pauwels R, Leroy J (1992) IgG subclass deficiency in children with recurrent bronchitis. Eur J Pediatr 151:274–278
Deeks JJ, Altman DG, Bradburn MJ (2001) Statistical methods for examining heterogeneity and combining results from several studies in meta-analyses. Systematic Reviews in Health Care - Meta-analysis in context, Second Edition Chapter 15, page 285
Del-Rio-Navarro B, Luis Senre-Monge JJ, Berber A, Torres-Alcantara S, Avita-Castanon L, Gomez Barreto D (2003) Use of OM-85 Bv in children suffering from recurrent respiratory tract infections and subnormal IgG subclass levels. Allergologia et Immonopahtologia 31:7–13
Egger M, Smith GD, Altman DG (2001) Systematic Reviews in Health Care. BMJ Publishing Group, London, pp 3–487
Gomez Barreto D, De la Torre C, Alvarez A, Faure A, Berber A (1998) Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children. Allergol Immunopathol (Madr) 26:17–22
Gutierrez-Tarango MD, Berber A (2001) Safety and efficacy of two courses of OM-85 BV in the prevention of respiratory tract infections in children during 12 months. Chest 119:1742–1748
Heikkinen T, Thint M, Chonmaitree T (1999) Prevalence of various respiratory viruses in the middle ear during acute otitis media. N Engl J Med 340:260–264
Jara-Perez JV, Berber A (2000) Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial. Clin Ther 22:748–759
Kjaergard LL, Als-Nielsen B (2002) Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 325:249
Maestroni GJ, Losa GA (1984) Clinical and immunobiological effects of an orally administered bacterial extract. Int J Immunopharmacol 6:111–117
Martin du Pan RE, Martin du Pan RC (1982) Etude clinique de prévention des infections des voies respiratoires supérieures de l’enfant de l’âge préscolaire. Schweizerische Rundschau für Medizin Praxis 71:1385–1389
Paupe J (1991) Immunotherapy with an oral bacterial extract (OM-85 BV) for upper respiratory infections. Respiration 58:150–154
Riedl-Seifert RJ, van Aubel A, Kämmereit A, Elsasser U (1993) Infektrezidive im Kindesalter- noch immer eine Crux medicorum? Ergebinsse einer plazebokontrollierten Doppelblindstudie mit einem oralen Baktrienlysat bei infektanfälligen Kindern. J Pharmacol u Ther 3:108–117
Schaad UB, Farine JC, Fux T (1986) Prospective placebo-controlled double-blind study using a bacterial lysate in infections of the respiratory tract and ENT region in children. Helv Paediatr Acta 41:7–17
Schaad UB, Mütterlein R, Goffin H (2002) Immunostimulation with OM-85 BV in children with recurrent infections of the upper respiratory tract. A double-blind, placebo-controlled multicenter study. Chest 122:2042–2049
Schulz KF, Grimes DA (2002) Allocation concealment in randomised trials: defending against deciphering. Lancet 359:614–618
Schulz KF, Grimes DA (2002) Generation of allocation sequences in randomised trials: chance, not choice. Lancet 359:515–519
Sramek J, Josifko M, Helcl J, Holoubkova E, Janout V, Kozesnik B, Macatova I (1986) Bacterial lysate (I.R.S. 19) applied intranasally in the prevention of acute respiratory diseases in children: a randomized double-blind study. J Hyg Epidemiol Microbiol Immunol 30:377–385
Steurer-Stey C, Bachmann LM, Steurer J, Tramer MR (2004) Oral purified bacterial extracts in chronic bronchitis and COPD: systematic review. Chest 126:1645–1655
Zagar S, Lofler-Badzek D (1988) Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. ORL J Otorhinolaryngol Relat Spec 50:397–404
Acknowledgements
We thank Dr. P. Estermann, information specialist from the Library Service of the Zurich University Hospital, for his help in searching electronic databases.
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CS initiated the project and is the study guarantor. CS and LL searched and extracted the data. DS cross-checked extracted data. LMB and JS cross-checked and analysed extracted data. All authors participated in discussing the results and writing the paper.
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Steurer-Stey, C., Lagler, L., Straub, D.A. et al. Oral purified bacterial extracts in acute respiratory tract infections in childhood: a systematic quantitative review. Eur J Pediatr 166, 365–376 (2007). https://doi.org/10.1007/s00431-006-0248-3
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DOI: https://doi.org/10.1007/s00431-006-0248-3