Table 2.
Description of clinical trials performed in the adult population
| Study/year | Number of patients/treatment | Age | Population | Intervention | Follow up | Results |
|---|---|---|---|---|---|---|
| Cvoriscec B et al. 1989 [24] |
52 OM-85 BV vs 52 placebo |
20-69 |
Chronic brobnchitis |
1 capsule/day for 1 mo; 1 capsule/10 days for mos 3, 4 and 5 |
6 mos including administration period |
Decrease of duration of acute episodes and of fever (p<0.001); decrease of antibiotic consumption (p<0.05); increase of T lymphocyte count until 3rd mo after exacerbation (p<0.05); increased serum IgA levels (p<0.05) |
| Orcel B et al. 1994 [36] |
147 OM-85 BV vs 143 placebo |
>65 |
Chronic bronchitis |
1 capsule 10 days/mo for 3 mo |
6 mos including administration period |
28% reduction of lower RTIs entirely due to 40% reduction in the number of episodes of bronchitis (p<0.01) |
| Collet JP et al. 1997 [37] |
191 OM-85 BV vs 190 placebo |
OM-85 BV: 65.3±7.7 Placebo: 66.9±7.7 |
COPD |
1 capsule 10 days/mo for 3 mo |
6 mos including administration period |
No effect in occurrence of acute exacerbation; reduction in number of hospital admissions; decrease in duration of hospitalisation (p=0.037) |
| Li et al. 2004 [38] |
49 OM-85 BV vs 41 placebo |
55-82 |
Chronic bronchitis and COPD |
1 capsule 10 days/mo for 3 mo |
12 mos including administration period |
Decrease in incidence, duration, and severity of acute exacerbation (p<0.01); decrease in consumption of antibiotics |
| Solér et al. 2007 [39] |
142 OM-85 BV vs 131 placebo |
22-78 |
Chronic bronchitis/ mild COPD |
1 capsule/day for 1 mo; 1 capsule/10 days for mos 3, 4 and 5 |
6 mos including administration period |
Decrease of acute exacerbations at the end of study (p=0.014). Difference between treatments higher in patients with current or past smoking history |
| Capetti et al. 2010 [42] |
130 OM-85 BV |
Not reported |
HIV infection- high risk of RTI |
1 capsule 10 days/mo for 3 mo |
12 mos-comparison performed between year w/o and with treatment |
Decrease of antibiotic cycles from 297 to 55. Decrease of hospitalisation from 23 to 6. |
| Tang et al. 2012 [40] | 192 OM-85 BV vs 192 placebo | Not reported | Chronic bronchitis or COPD | 1 capsule 10 days/mo for 3 mo | 10 wks | Decrease in occurrence of exacerbation (p<0.05); decrease in antibiotic consumption (p<0.05) |
In all cases adult dosage was administered.