Sandborn 2012.
| Methods | Phase 3, multicenter, randomized, double‐blind, double dummy, placebo‐controlled trial | |
| Participants | Adult patients (18 to 75 years of age) with active, mild to moderate ulcerative colitis for at least 6 months, with an ulcerative colitis disease activity index (UCDAI) score of 4‐10 points (N = 489). | |
| Interventions | Budesonide MMX 9 mg/day (n = 123), budesonide MMX 6 mg/day (n = 121), mesalamine (Asacol 2.4 g/day, as reference, n = 124), or placebo (n = 121) for 8 weeks | |
| Outcomes | Primary outcome: combined clinical and endoscopic remission at week 8. Remission was defined as combined clinical and endoscopic remission with a UCDAI score < 1 point, with subscores of 0 for both rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a > 1‐point reduction from baseline in the endoscopic index score Secondary outcomes: clinical improvement (> 3‐point reduction in UCDAI), endoscopic improvement (> 1‐point reduction in the UCDAI mucosal appearance subscore), symptom resolution (score of 0 for both rectal bleeding and stool frequency subscores from the UCDAI), histologic healing (histologic score of < 1 (corresponding to a histologic activity grade of 0) according to the Saverymuttu scale and adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization for this study was developed by an external contractor and administered centrally |
| Allocation concealment (selection bias) | Low risk | The interactive voice response system was used to centrally randomize patients to study drug |
| Blinding (performance bias and detection bias) All outcomes | Low risk | A double‐dummy procedure was used to maintain blinding, with patients in each treatment group receiving their blinded study drug 3 times daily. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 140 patients were unable to complete the study (34 from budesonide 9mg QD, 32 from budesonide 6mg QD, 29 from Asacol 2.4 g/day, and 45 from placebo group) |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported in the published study |
| Other bias | Low risk | The study appears to be free of other sources of bias |