Musch 2005.
| Methods | Randomised, double‐blind, placebo‐controlled, multicenter trial | |
| Participants | 91 adult patients with active UC defined by a Rachmilewitz CAI score of at least 8 points Group 1: n=32, M:F = 21:11, median age = 38.0 yrs, median disease duration 7.5 yrs, median Rachmilewitz CAI score = 10, mean endoscopic index score = 10 Group 2: n=30, M:F = 18:12, median age = 34.5 yrs, median disease duration 6.7 yrs, median Rachmilewitz CAI score = 10, mean endoscopic index score = 9 Group 3: n=29, M:F = 15:14, median age = 38.0 yrs, median disease duration 3.2 yrs, median Rachmilewitz CAI score = 10, median endoscopic index score = 9 | |
| Interventions | Group 1: 3 MIU IFN‐β‐1a by SC injection t.i.w Group 2: 1 MIU by SC injection IFN‐β‐1a t.i.w Group 3: placebo injections Duration of treatment 8 weeks | |
| Outcomes | Primary outcome was response rate at the end of treatment. Response was defined as reduction of 6 or more CAI points at week 8 compared with baseline Secondary endpoints: 1. Number of patients with complete response ‐ reduction of CAI to 4 points of less after 8 weeks of treatment; 2. Time until response; 3. Reduction of CAI after 4 and 8 weeks; 4. Reduction of the endoscopic index after 8 weeks; 5. Number of patients receiving colectomy; 6. Reduction of steroid dose |
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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 assigned by a centralised randomisation schedule |
| Blinding (performance bias and detection bias) All outcomes | Low risk | The study was double‐blind in design Supervision of the clinical trial was performed by a steering committee of investigators who were blinded from the results throughout the trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4/32 patients in 3 MIU group, 5/30 patients in 1 MIU group, 7/29 patients in placebo group dropped out during treatment |
| Selective reporting (reporting bias) | Low risk | All pre‐defined outcomes were reported |
| Other bias | Low risk | No other issues were identified |