| Methods |
Multi‐centre, double‐blind, double‐dummy, randomized, non‐inferiority trial comparing the efficacy and safety of once daily MMX mesalamine (2.4 g/day) with twice daily mesalamine (Asacol, 1.6 g/day) in patients with ulcerative colitis who were in endoscopic remission |
| Participants |
Adult patients (> 18 years) with a diagnosis of UC (confirmed by histology) that was considered to be in remission for ≥ 30 days on a stable dose of mesalamine (≤ 2.4 g/ day) or the equivalent dose of sulfasalazine (≤ 6.2 g/ day), with an endoscopy score of ≤ 1; and had a combined symptom score (stool frequency and rectal bleeding) of ≤ 1. All patients were to have had experienced at least one acute flare of UC (defined as a documented episode of increased bowel frequency with rectal bleeding for which UC therapy was intensified) in the past 12 months, with at least two acute flares in their medical history (N = 826) |
| Interventions |
MMX mesalamine (2.4 g/day) dosed once daily (n = 415) versus Asacol (1.6 g/day) dosed twice daily (n = 411) for 6 months |
| Outcomes |
Primary outcome was endoscopic remission at 6 months defined as a modified UC‐DAI endoscopy subscore of < 1 point. Secondary outcomes included: maintenance of mucosal healing with no or mild symptoms (combined modified UC‐DAI‐defined stool frequency and rectal bleeding subscores of ≤ 1 point) at 6 months; time to relapse (relapse was defined as withdrawal due to lack of efficacy), measured from the date of randomization to the date the patient withdrew due to relapse; the modified UC‐DAI score and its components (rectal bleeding, stool frequency, endoscopy, and Physician’s Global Assessment scores); and safety and tolerability of study treatments |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Low risk |
The randomization was performed centrally via an interactive voice response system |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy (matched placebos) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
