Summary of findings 3. Budesonide 10 mg versus prednisolone 40 mg for induction of remission in ulcerative colitis.
| Budesonide 10 mg versus prednisolone 40 mg for induction of remission in ulcerative colitis | ||||||
| Patient or population: Adult patients with active ulcerative colitis Settings: Multicentre study in Sweden (outpatients) Intervention: Budesonide 10 mg/day versus prednisolone 40 mg/day | ||||||
| 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 versus prednisolone | |||||
| Endoscopic improvement | 658 per 10001 | 618 per 1000 (434 to 875) | RR 0.94 (0.66 to 1.33) | 72 (1 study) | ⊕⊕⊝⊝ low2,3 | |
| Endoscopic remission | 158 per 10001 | 118 per 1000 (36 to 382) | RR 0.75 (0.23 to 2.42) | 72 (1 study) | ⊕⊝⊝⊝ very low2,4 | |
| Histologic remission | 158 per 10001 | 88 per 1000 (24 to 325) | RR 0.56 (0.15 to 2.06) | 72 (1 study) | ⊕⊝⊝⊝ very low2,5 | |
| Adverse event ‐ Reduction in plasma cortisol below lower reference limit | 758 per 10001 | 15 per 1000 (0 to 227) | RR 0.02 (0 to 0.3) | 67 (1 study) | ⊕⊝⊝⊝ very low2,6 | Per‐protocol analysis7 |
| Study withdrawals | 211 per 10001 | 236 per 1000 (99 to 558) | RR 1.12 (0.47 to 2.65) | 72 (1 study) | ⊕⊝⊝⊝ very low2,8 | |
| Withdrawal due to adverse event | 211 per 10001 | 207 per 1000 (84 to 508) | RR 0.98 (0.40 to 2.41) | 72 (1 study) | ⊕⊝⊝⊝ very low2,9 | |
| *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 because sequence generation and allocation concealment were unclear 3 Downgraded one level due to sparse data (46 events) 4 Downgraded two levels due to very sparse data (10 events) 5 Downgraded two levels due to very sparse data (9 events) 6 Downgraded two levels due to very sparse data (25 events) 7 Suppression of plasma cortisol below baseline at 2 weeks. Cortisol levels improved over time in the prednisolone‐treated group, with no significant difference in levels compared to budesonide at 9 weeks 8 Downgraded two levels due to very sparse data (16 events) 9 Downgraded two levels due to very sparse data (15 events)