Kamm 2007.
| Methods | Randomised, phase III, double‐blind, double‐dummy, parallel‐group, placebo‐controlled, multicenter study (N = 343) | |
| Participants | Adult patients (> 18 years) with active, mild‐to‐moderate UC who had recently been diagnosed or relapsed
Patients had a modified UCDAI score between 4‐10, with a sigmoidoscopy score > 1 and a PGA score < 2 During the screening period, patients could continue taking a stable dose of mesalamine (52.0 g/day), but mesalamine was withdrawn at baseline if the patient was eligible for inclusion |
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| Interventions | Group 1: MMX mesalamine 2.4 g/day (n = 86) Group 2: MMX mesalamine 4.8 g/day (n = 85) Group 3: Asacol 2.4 g/day (n = 86) Group 4: Placebo (n = 86) Treatment administered for 8 weeks All patients received 4 tablets and 2 capsules in the morning, 2 capsules at lunchtime, and 2 capsules in the evening |
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| Outcomes | Primary outcome: proportion of patients in clinical and endoscopic remission Secondary outcomes: clinical remission, clinical improvement, changes in modified UC‐DAI score, changes in sigmoidoscopic (mucosal) appearance (baseline to week 8), changes in rectal bleeding and stool frequency (from baseline to any study visit), treatment failure rate, and time to withdrawal |
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| 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 | Patients were randomised centrally via an interactive voice response system |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Asacol tablets contained 400 mg mesalamine and were enclosed in a capsule for blinding purposes Double‐dummy design: all patients received 4 tablets and 2 capsules in the morning, 2 capsules at lunchtime, and 2 capsules in the evening |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐outs were balanced across intervention groups with similar reasons for withdrawal 52/86 patients in the placebo group, 70/86 patients in the MMX 2.4 g group, 72/85 patients in the MMX 4.8 g group, and 70/86 patients in the Asacol group completed the study All analyses were performed according to the ITT principle |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |