Summary of findings 4. Mesalamine versus placebo for treating collagenous colitis.
Mesalamine versus placebo for treating collagenous colitis | ||||||
Patient or population: Patients with collagenous colitis Setting: Outpatient Intervention: Mesalamine Comparison: Placebo | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with placebo | Risk with Mesalamine | |||||
Clinical response | 595 per 10001 | 440 per 1000 (262 to 737) | RR 0.74 (0.44 to 1.24) | 62 (1 RCT) | ⊕⊕⊝⊝ low2 | |
Histological response | 514 per 10001 | 442 per 1000 (257 to 755) | RR 0.86 (0.50 to 1.47) | 62 (1 RCT) | ⊕⊕⊝⊝ low3 | |
Adverse events | 541 per 10001 | 681 per 1000 (454 to 1000) | RR 1.26 (0.84 to 1.88) | 62 (1 RCT) | ⊕⊕⊝⊝ low4 | |
Withdrawals due to adverse events | 27 per 10001 | 160 per 1000 (19 to 1000) | RR 5.92 (0.70 to 49.90) | 62 (1 RCT) | ⊕⊕⊝⊝ low5 | |
Serious adverse events | 27 per 10001 | 120 per 1000 (13 to 1000) | RR 4.44 (0.49 to 40.29) | 62 (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 (33 events). 3 Downgraded two levels due to very sparse data (30 events). 4 Downgraded two levels due to very sparse data (37 events). 5 Downgraded two levels due to very sparse data and wide confidence interval (5 events). 6 Downgraded two levels due to very sparse data and wide confidence interval (4 events).