Summary of findings for the main comparison. Budesonide MMX® 9 mg versus placebo for induction of remission in ulcerative colitis.
| Budesonide MMX® 9 mg versus placebo for induction of remission in ulcerative colitis | ||||||
| Patient or population: Adult patients with active ulcerative colitis Settings: Outpatient Intervention: Budesonide MMX® 9 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 MMX® 9 mg versus placebo | |||||
| Remission (combined clinical and endoscopic remission) | 68 per 10001 | 154 per 1000 (103 to 232) | RR 2.25 (1.5 to 3.39) | 900 (3 studies) | ⊕⊕⊕⊝ moderate2 | |
| Clinical improvement | 286 per 1000 | 371 per 1000 (283 to 486) | RR 1.3 (0.99 to 1.7) | 442 (2 studies) | ⊕⊕⊕⊝ moderate3 | |
| Endoscopic improvement | 324 per 1000 | 418 per 1000 (327 to 538) | RR 1.29 (1.01 to 1.66) | 442 (2 studies) | ⊕⊕⊕⊝ moderate4 | |
| Histologic remission | 123 per 1000 | 186 per 1000 (137 to 254) | RR 1.51 (1.11 to 2.06) | 900 (3 studies) | ⊕⊕⊝⊝ low5,6 | |
| Endoscopic remission | 143 per 1000 | 223 per 1000 (161 to 309) | RR 1.56 (1.13 to 2.16) | 695 (2 studies) | ⊕⊕⊕⊝ moderate7 | |
| Serious adverse events | 31 per 1000 | 27 per 1000 (10 to 74) | RR 0.88 (0.33 to 2.4) | 513 (2 studies) | ⊕⊕⊝⊝ low8 | |
| Adverse events | 412 per 1000 | 449 per 1000 (391 to 519) | RR 1.09 (0.95 to 1.26) | 971 (3 studies) | ⊕⊕⊕⊝ moderate9 | |
| *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 estimate come from the control arm of meta‐analysis, based on included trials 2 Downgraded one level due to sparse data (101 events) 3 Downgraded one level due to sparse data (147 events) 4 Downgraded one level due to sparse data (165 events) 5 Downgraded one level due to moderate heterogeneity (I2 = 47%) 6 Downgraded one level due to sparse data (139 events) 7 Downgraded one level due to sparse data (128 events) 8 Downgraded two levels due to very sparse data (15 events) 9 Downgraded one level due to moderate heterogeneity (I2 = 54%)