Fifty-four of 100 children were selected to enter the trial. The nonincluded children suffered seasonal or food-related wheezing or nasal itchiness. Patients were reminded of follow-up visits. Only one boy in the OM-85 BV group was unavailable for follow-up in the last assessment, and the rest of the trial participants completed the scheduled clinical assessments.
All the envelopes containing the double-blind code for the treatment numbers were collected after the end of the study. Based on the empty blisters, compliance was > 90% in all the patients. In the OM-85 BV group, 18 children received powder and 8 children received capsules; in the placebo group, 16 children received powder and 12 children received capsules.
Both groups had similar demographics at the beginning of the trial (p > 0.05; Table 1). The reported ARTIs incidence the year before was > 12 in both groups. Most of these ARTIs were from mild-to-moderate severity. The risks factors for ARTIs were similar (p > 0.05), except the number of siblings in the school that was higher in the placebo group (Table 2). Twenty children in the OM-85 BV group and 17 in the control group had antecedents of otitis with moderate severity; they suffered 2.45 ± 1.1 and 2.53 ± 2.03 otitis episodes in the last year, respectively. Treatment thrombosis
During the trial, 131 ARTIs were recorded in the OM-85 BV group and 224 in the placebo group (Table 3). The patients in the OM-85 BV group had a lower relative risk of one or more otitis episodes of 0.323 (95% confidence intervals [CI], 0.100 to 1.046; a trend for a lower risk), as well as lower relative risks for six or more, seven or more, or eight or more ARTIs of 0.374 (95% CI, 0.205 to 0.684), 0.323 (95% CI, 0.154 to 0.677), and 0.287 (95% CI, 0.109 to 0.754), respectively.
Figure 1 represents the mean incidence of ARTIs from data organized in calendar months. There were significant lower incidences of ARTIs in the months of May, June, July, and August in the OM-85 BV group (p < 0.05 by Mann-Whitney U test), and a trend from January to March and from September to December. Figure 2 represents the percentage of patients having less than six ARTIs throughout the consecutive 12-month period. The OM-85 BV group had fewer ARTIs than the placebo group.
We explored the possible effect of time of inclusion in the ARTIs incidence. We performed a multiple ANOVA for repeated measures for the monthly consecutive incidence of ARTIs considering drug treatment and month of inclusion as factors; there was no effect of the time of inclusion, nor interaction between the time of inclusion and the treatment group in the global incidence of ARTIs (p > 0.05). In the same way, when incidence data were ordered in calendar months and tested by multivariate ANOVA, there was no effect of the time of inclusion, nor interaction between the time of inclusion and the treatment group in the global incidence of ARTIs (p > 0.05).
Figure 1. Number of ARTIs by calendar month. The graphic represents the mean ± SE ARTIs by group monthly. The bold figures and bars correspond to the OM-85 BV group and the open figures and bars to the placebo group. * = p < 0.05 by Mann-Whitney U test.
Figure 2. Percentage of patients having less than than six ARTIs throughout the consecutive 12-month period. This graphic represents the occurrence of the event of six ARTIs in the Kaplan-Meier survival plot fashion and statistics. The bold line corresponds to the OM-85 BV group and the broken line to the placebo group. The evolution of the groups was statistically different (p < 0.001 by test log rank, Breslow and Tarone-Ware).
Table 1—Demographic Characteristics of the Groups
|Characteristics||OM-85 BV (n = 26)||Placebo (n = 28)|
|Age, yr||3.86 ± 2.49||4.52 ± 2.75t|
|median (percentiles 25, 75)||3.21 (2.08, 5.52)||4.33 (2.37, 6.1)|
|Sex, No. (%)||
|Male||13 (50)||18 (64.3)|
|Female||13 (50)||10 (35.7)|
|Weight, kg||15.65 ± 4.95||17.49 ± 6.55t|
|Height, cm||100.57 ± 22.13||104.25 ± 20.94t|
|ARTIs in the last year||12.33 ± 4.7||12.26 ± 3.99t|
|Antibiotic courses in the last||9.87 ± 3.26||8.85 ± 3.05t|
Table 2—Risks Factors for the Groups
|Gestational age, mo||8.85 ± 0.37||8.86 ± 0.33t|
|Birth weight, kg||3.2 ± 0.57||3.3 ± 0.55t|
|Breast feeding time, mo||5.69 ± 4.79||5.89 ± 3.0т|
|Children living at home!|
|Two or more||3||8|
|Persons living at home||3.15 ± 0.78||3.39 ± 0.87т|
|Siblings in day-care center!|
|Siblings in school|
|Two or more||—||6|
|Time of attendance at day-|
|care center or school!|
|> 24 mo||9||9|
|Persons smoking at home!|
Table 3—No. and Kind of ARTIs During the Trial
|OM 85 BV||Placebo|
|Variables||(n = 26)||(n = 28)|