Summary of findings for the main comparison. Azathioprine versus placebo for maintenance of remission in ulcerative colitis.
| Azathioprine versus placebo for maintenance of remission in ulcerative colitis | ||||||
| Patient or population: Patients with quiescent ulcerative colitis Settings: Outpatient Intervention: Azathioprine or 6‐Mercaptopurine 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 | AZA versus PBO | |||||
| Failure to maintain remission | 650 per 10001 |
442 per 1000 (351 to 559) |
RR 0.68 (0.54 to 0.86) |
232 (4 studies) | ⊕⊕⊝⊝ low2,3 | |
| Any adverse events | 26 per 10001 |
65 per 1000 (21 to 201) |
RR 2.51 (0.82 to 7.74) |
232 (4 studies) | ⊕⊝⊝⊝ very low2,4 | |
| Withdrawal due to adverse event | 0 per 10001 |
0 per 1000 (0 to 0) |
RR 7.00 (0.38 to 128.87) |
152 (3 studies) | ⊕⊝⊝⊝ very low2,5 | |
| *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; AZA: azathioprine; PBO: placebo | ||||||
| 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 one level due to high risk of bias in one study in the pooled analysis (single‐blind). 3 Downgraded one level due to sparse data (127 events). 4 Downgraded two levels due to very sparse data (12 events). 5 Downgraded two levels due to very sparse data (3 events).