Summary of findings 2.
Oral erythromycin versus placebo or no intervention for BCG adverse reactions
| Oral erythromycin compared to placebo or no intervention for BCG vaccine adverse reactions | ||||||
| Patient or population: patients with BCG adverse reactions Settings: ambulatory setting Intervention: erythromycin Comparison: placebo or no intervention | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo or no intervention | Erythromycin | |||||
| Clinical failure clinical observation Follow‐up: 1 to 6 months | 48 per 100 | 47 per 100 (36 to 62) | RR 1.03 (0.70 to 1.53) | 148 (3 studies1) | ⊕⊝⊝⊝ very low2,3,4 | |
| *The basis for the assumed risk (eg the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1Caglayan 1987, Noah 1993 and Kuyucu 1998. Include patients with regional ipsilateral subclavicular or axillary lymphadenitis >1.5 cm in diameter without fluctuation. 2 Sequence generation, allocation concealment not described. Only one study (Noah 1993) was blinded and used placebo in the control group. 3 Different doses (10, 40, and 50 mg/kg/day); different length of follow‐up. 4 Wide 95% CIs among different important clinical thresholds with moderate heterogeneity.