Summary of findings 3. Budesonide versus mesalazine for treating collagenous colitis.
| Budesonide versus mesalazine for treating collagenous colitis | ||||||
| Patient or population: Patients with collagenous colitis Setting: Outpatient Intervention: Budesonide Comparison: Mesalazine | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with mesalazine | Risk with Budesonide | |||||
| Clinical response | 440 per 10001 | 801 per 1000 (497 to 1000) | RR 1.82 (1.13 to 2.93) | 55 (1 RCT) | ⊕⊕⊝⊝ low2 | |
| Histological response | 440 per 10001 | 867 per 1000 (546 to 1000) | RR 1.97 (1.24 to 3.13) | 55 (1 RCT) | ⊕⊕⊝⊝ low3 | |
| Adverse events | 680 per 10001 | 469 per 1000 (292 to 748) | RR 0.69 (0.43 to 1.10) | 55 (1 RCT) | ⊕⊕⊝⊝ low4 | |
| Withdrawals due to adverse events | 160 per 10001 | 14 per 1000 (2 to 264) | RR 0.09 (0.01 to 1.65) | 55 (1 RCT) | ⊕⊕⊝⊝ low5 | |
| Serious adverse events | 120 per 10001 | 14 per 1000 (1 to 265) | RR 0.12 (0.01 to 2.21) | 55 (1 RCT) | ⊕⊕⊝⊝ low6 | |
| *The risk in the intervention group (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; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Control group risk comes from control arm of the included study. 2 Downgraded two levels due to very sparse data (35 events). 3 Downgraded two levels due to very sparse data (37 events). 4 Downgraded two levels due to very sparse data (31 events). 5 Downgraded two levels due to very sparse data and wide confidence interval (4 events). 6 Downgraded two levels due to very sparse data and wide confidence intervals (3 events).