Prantera 2012.
| Methods | Randomized, double blind, placebo controlled Intention to treat not performed Twenty‐four week trial |
|
| Participants | Patients aged 18‐75, active ileal or colonic CD (CDAI 220‐400) (N = 402) | |
| Interventions | Randomized to oral rifaximin 400 mg BID (n = 104), oral rifaximin 800 mg BID (n = 98), oral rifaximin 1200 mg BID (n = 99) or oral placebo (n = 101) | |
| Outcomes |
Primary outcome: Clinical remission (CDAI < 150) at 12 weeks Secondary outcomes: Number of patients who achieved clinical response at week 12 (reduction in CDAI score of 100 points), number of patients who maintained clinical remission at week 14 and 24 and number of patients with treatment failure (failure to achieve loss of at least 70 in CDAI score after 1 month, or an increase in CDAI score of >100 points from the baseline) |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerized randomisation procedure |
| Allocation concealment (selection bias) | Low risk | Centralized randomization using an Interactive Voice Response System |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Questionaires used to collect outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | High rate of withdrawal from the study in each treatment group. (rifaximin 400 mg BID (41/106), rifaximin 800 mg BID (33/99), rifaximin 1200 mg BID (41/103) or placebo (43/102) |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |