4. Clarithromycin (1 g/day) compared to placebo for induction of remission in Crohn's disease.
| Clarithromycin compared to placebo for induction of remission in Crohn's disease | ||||||
| Patient or population: Participants with active CD Setting: Outpatient Intervention: Clarithromycin 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 Clarithromycin | |||||
| Failure to enter clinical remission Follow‐up:12 weeks |
818 per 1,000 | 843 per 1,000 (638 to 1,000) | RR 1.03 (0.78 to 1.36) | 41 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Clinical remission was defined as CDAI ≤150 |
| Failure to maintain clinical remission | Not reported | This outcome was not reported | ||||
| Failure to have clinical response Follow‐up: 12 weeks |
818 per 1,000 | 736 per 1,000 (532 to 1,000) |
RR 0.90 (0.65 to 1.26) |
41 (1 RCT) |
⊕⊕⊝⊝ LOW 2 | Clinical response was defined by CDAI reduction by ≥ 70 from baseline |
| Failure to maintain endoscopic remission | Not reported | This outcome was not reported | ||||
| Adverse events Follow‐up: 12 weeks |
45 per 1,000 | 210 per 1,000 (26 to 1,000) | RR 4.63 (0.57 to 37.96) | 41 (1 RCT) | ⊕⊕⊝⊝ LOW 3 | Adverse events included gastrointestinal symptoms |
| Serious adverse events | Not reported | This outcome was not reported | ||||
| Withdrawal due to adverse events Follow‐up: 12 weeks |
500 per 1,000 | 370 per 1,000 (180 to 760) | RR 0.74 (0.36 to 1.52) | 41 (1 RCT) | ⊕⊕⊝⊝ LOW 4 | Withdrawal due to adverse events was most often due to gastrointestinal symptoms |
| *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 Downgraded two levels due to very sparse data (34 events)
2 Downgraded two levels due to very sparse data (32 events)
3Downgraded two levels due to very sparse data (5 events)
4 Downgraded two levels due to very sparse data (18 events)