Summary of findings for the main comparison. Budesonide 6 mg versus placebo for maintenance of remission in Crohn's disease.
| Budesonide 6 mg versus placebo for maintenance of remission in Crohn's disease | ||||||
| Patient or population: patients with quiescent Crohn's disease Settings: outpatients Intervention: budesonide 6 mg 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 | Budesonide 6 mg versus placebo | |||||
| Continued remission at 3 months | 522 per 10001 | 652 per 1000 (522 to 825) | RR 1.25 (1.00 to 1.58) | 540 (6 studies) | ⊕⊕⊝⊝ Low2,3 | |
| Continued remission at 6 months | 524 per 10001 | 603 per 1000 (498 to 728) | RR 1.15 (0.95 to 1.39) | 420 (5 studies) | ⊕⊕⊕⊝ Moderate4 | |
| Continued remission at 12 months | 476 per 10001 | 538 per 1000 (447 to 643) | RR 1.13 (0.94 to 1.35) | 420 (5 studies) | ⊕⊕⊕⊝ Moderate5 | |
| *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 Unexplained heterogeneity (I2 = 56%). 3 Sparse data (315 events). 4 Sparse data (238 events). 5 Sparse data (215 events).