Summary of findings 2. Oral 5‐ASA versus SASP for induction of remission in ulcerative colitis.
| Oral 5‐ASA versus SASP for induction of remission in ulcerative colitis | ||||||
| Patient or population: People with active mild‐to‐moderate ulcerative colitis Settings: Outpatient Intervention: Oral 5‐ASA | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| SASP | Oral 5‐ASA | |||||
|
Failure to induce global or clinical remission Follow‐up: 4 ‐ 8 weeks |
583 per 1000a | 525 per 1000 (449 to 606) | RR 0.90 (0.77 to 1.04) | 526 (8 studies) | ⊕⊕⊕⊝ MODERATEb | Global or clinical remission was defined as the return to stool frequency (2 ‐ 3 stools or fewer a day) without the presence of blood |
|
Failure to induce global or clinical improvement Follow‐up: 4 ‐ 8 weeks |
467 per 1000a | 411 per 1000 (355 to 472) | RR 0.88 (0.76 to 1.01) | 1053 (14 studies) | ⊕⊕⊕⊕ HIGH | Clinical improvement was defined as reduction in their clinical activity index |
| Failure to induce endoscopic remission | See comment | 2 studies reported this outcome but meta‐analysis not performed as they used different measurement indices. Neither study showed significant differences in complete endoscopic remission between 5‐ASA and SASP | ||||
| Failure to adhere to medication regimen | See comment | Outcome not reported | ||||
|
Adverse events Follow‐up: 4 ‐ 8 weeks |
287 per 1000a | 138 per 1000 (103 to 181) | RR 0.48 (0.36 to 0.63) | 909 (12 studies) | ⊕⊕⊕⊝ MODERATEc | Adverse events included nausea, headache, dyspepsia, vomiting, abdominal pain and rash |
|
Serious adverse events Follow‐up: 4 ‐ 8 weeks |
38 per 1000 |
51 per 1000 (11 to 246) |
RR 1.36 (0.28 to 6.52) |
107 (2 studies) |
⊕⊕⊝⊝ LOWd | Serious adverse events included erythematous rash, venous thrombosis, carcinoma, acute pancreatitis, rheumatoid arthritis and erythema nodosum |
|
Withdrawal due to adverse events Follow‐up: 4 ‐ 8 weeks |
129 per 1000a | 52 per 1000 (31 to 88) | RR 0.40 (0.24 to 0.68) | 640 (10 studies) | ⊕⊕⊕⊝ MODERATEe | Common adverse events leading to withdrawal included nausea, headaches and rashes |
| *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. | ||||||
aControl group risk estimates come from control arm of meta‐analysis, based on included trials. bDowngraded one level due to sparse data (294 events). cDowngraded one level due to sparse data (190 events). dDowngraded two levels due to very sparse data (5 events). eDowngraded one level due to sparse data (54 events).