The quality of evidene is downgraded by study limitations (unclear allocation concealment and lack of blinding), and by imprecise results (few patients).
A Cochrane review included 5 studies with a total of 341 children. Aim of the review was to assess the effectiveness of medical and surgical interventions for treating BCG-induced disease in children. The studies were from Turkey, Iran, and the Caribbean (Jamaica, Dominica). All trials included infants with local/regional lymphadenitis, while two of them also included infants with abscessed lymphadenitis. None of the studies included infants with HIV or other immunodeficiencies. No studies were found including patients with distant/disseminated disease. Four arms compared oral antibiotics to no intervention or placebo, one arm evaluated needle aspiration compared to no intervention, and another evaluated the use of locally instilled isoniazid versus oral erythromycin.
Oral isoniazid, oral erythromycin, or oral isoniazid plus rifampicin did not have an effect on clinical failure. In patients with lymphadenitis abscess, needle aspiration reduced clinically persistent BCG-induced disease at 6 to 9 months of follow-up. In another study of patients with the same condition, aspiration plus local instillation of isoniazid reduced time to clinical cure compared to aspiration plus oral erythromycin (Table ).
| Outcome | Participants (studies) | No intervention | Oral isoniazid (INH) | Relative effect (95% CI) |
|---|---|---|---|---|
| Clinical failure | 54 (2) | 36 per 100 | 53 per 100 (28 to 100) | RR 1.48 (0.79 to 2.78) |
| Outcome | Participants (studies) | Placebo or no intervention | Oral erythromycin | Relative effect (95% CI) |
| Clinical failure | 148 (3) | 48 per 100 | 47 per 100 (36 to 62) | RR 1.03 (0.70 to 1.53) |
| Outcome | Participants (studies) | No intervention | Oral isoniazid plus rifampicin | Relative effect (95% CI) |
| Clinical failure | 35 (1) | 33 per 100 | 43 per 100 (22 to 82) | RR 1.20 (0.51 to 2.83) |
| Outcome | Participants (studies) | No intervention | Needle aspiration | Relative effect (95% CI) |
| Clinical failure | 77 (1) | 35 per 100 | 5 per 100 (1 to 19) | RR 0.13 (0.03 to 0.55) |
| Outcome | Participants (studies) | Oral erythromycin | Locally instilled isoniazid | |
| Time to resolution of illness | 27 (1) | The mean time to clinical resolution in the erythromycin group was 5.2 months | The mean time to clinical resolution in the isoniazid group was 1.3 months less (95% CI 2.21 less to 0.39 less) |
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