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. 2017 Nov 11;2017(11):CD003575. doi: 10.1002/14651858.CD003575.pub6

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 evidenceHigh 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).