Summary of findings for the main comparison. Anti‐TB therapy versus placebo for maintenance of remission in Crohn's disease.
Anti‐TB therapy versus placebo for maintenance of remission in Crohn's disease | ||||||
Patient or population: patients with maintenance of remission in Crohn's disease Settings: Intervention: Anti‐TB therapy versus placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Control | Anti‐TB therapy versus placebo | |||||
Relapse | 670 per 10001 | 389 per 1000 (302 to 503) | RR 0.58 (0.45 to 0.75) | 206 (4 studies) | ⊕⊝⊝⊝ very low2,3 | |
Adverse events | 86 per 10001 | 221 per 1000 (125 to 391) | RR 2.57 (1.45 to 4.55) | 322 (4 studies) | ⊕⊝⊝⊝ very low2,4,5 | |
Withdrawals due to adverse events | 67 per 10001 | 87 per 1000 (40 to 187) | RR 1.29 (0.6 to 2.77) | 322 (4 studies) | ⊕⊝⊝⊝ very low2,6 | |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) 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. |
1 Control group risk estimates come from control arm of meta‐analysis, based on included trials. 2 Downgraded two levels due to unknown risk of bias for random sequence generation and allocation concealment for all 4 studies in the pooled analysis and unknown risk of bias for blinding for 3 studies in the pooled analysis. 3 Downgraded one level due to sparse data (107 events) 4 Downgraded one level due to unexplained heterogeneity (I2 = 64%) 5 Downgraded one level due to sparse data (51 events) 6 Downgraded two levels due to very sparse data (25 events)