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Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Discussion

RTIs are important causes of morbidity, mortality, and disability in children, and therefore are one of the main costs for the health-care system.” In order to reduce the incidence and complications of RTIs, it is necessary to explore new alternatives for the prevention of this kind of infection.
We have presented a trial to investigate the safety and efficacy of the bacterial extracts OM-85 BV covering a period of 12 months with two courses of administration. We tried to exclude the patients with the clinical suspicion of allergy from the trial (familial history of allergy, seasonal or food-related wheezing or nasal itchiness, or nasal folds); yet, presence of allergy cannot be completely ruled out. As the definitions for upper and lower ARTIs overlap with allergy symptoms, it is possible that some allergy clinical pictures were diagnosed as ARTIs. However, the randomization would distribute the effect in both groups.
The mean number of infections showed a reduction in the OM-85 BV group with respect to the placebo group. In contrast, Mexican 6-month trials have showed a reduction in infections of 2.25 ± 0.58 vs 4.68 ± 0.94, ie, 52% (ages, 1 to 11 years), and another reduction of 1.43 ± 0.94 vs 2.99 ± 0.81 (52%) in patients aged 6 to 13 years.
When ARTI data were grouped by calendar months, the OM-85 BV effect was significant from May to August and had a trend from September to December: larger sample sizes would be required to detect these monthly differences. In a previous trial, when all the patients began treatment with the trial medications in September, the preventive effect of OM-85 BV could be demonstrated from October to February.
It is important to note that the number of ARTIs as well as the number of antibiotic courses decreased in both groups regarding the period before the trial. It is possible that as the children grew older, they had a lower incidence of ARTI or that there had been a previous overreport. The reduction in the use of antibiotic may be ascribed to the decrease in the number of ARTIs and to close follow-up of the patients. It was not possible to detect a consistent effect of the medication in the severity of ARTIs, because of the small number of patients suffering from ARTIs in the OM-85 BV group.
The duration of the illness, courses of antibiotics or other drugs, and the duration of therapy are dependent on the number of ARTIs and their decrease; in fact, it could be considered that only the number of ARTIs is significantly different. Considering a low cost of treatment-day of $5 (US dollars) (for instance, the public price of a day of penicillin treatment in Mexico is $5) and duration of treatment of 7 days per episode, a reduction of three ARTIs per patient would save at least $105 in medications per year. Seventy percent of the children receiving OM-85 BV had less than six ARTIs compared to 20% in the placebo group.
There was a trend to have lower absenteeism in the OM-85 BV group, but it was not significant, in contrast to the other Mexican trials- that showed this effect. Days out of school or day-care center may depend more on the parents criteria or in the policy of each center in this study. Similarly, there was a trend toward reduced otitis media in the OM-85 BV group regarding the placebo group. The protection against otitis was found in the other trials.” The small sample size is a major shortcoming of this study. The safety of OM-85 BV was good; only one patient suffered an adverse event, a rash that was related to the capsule administration.
It would be important to conduct multicenter trials to validate the benefits of OM-85 BV treatment in younger children, those with viral RTI, and children prone to otitis, including an adequate number of patients in each month. The use of immunostimu-lation may be considered as an important tool to reduce the incidence of ARTI and its complications, such as otitis media, and therefore to diminish the costs associated with ARTIs. We conclude that OM-85 BV is an important option for the prevention of ARTI. Further larger multicenter investigations in the prevention of otitis and other RTI complications are suggested.