Thia 2009.
| Methods | Randomized placebo controlled trial. Blinded participants and investigators Intention to treat Ten week trial |
|
| Participants | Patients aged 16 and older with confirmed CD with 1 or more actively draining perianal fistulas (N = 25) | |
| Interventions | Patients were randomised to receive oral ciprofloxacin 500 mg BID (n = 10), oral metronidazole 500 mg BID (n = 7) or oral placebo (n = 8) | |
| Outcomes |
Primary outcome: Closure of fistulas, meaning that they were no longer draining Secondary outcomes:Clinical remission at weeks 2 and 6, improvement in fistula symptoms at weeks 2, 6, and 10 (defined as 50% reduction in draining fistulas from baseline), short‐term durability of fistula closure defined as maintaining remission for at least 4 weeks, patient and physician global assess‐ ment measured at weeks 2, 6, and 10, PDAI at weeks 2, 6, and 10, IBDQ at weeks 2, 6, and 10; and CDAI at weeks 2, 6, and 10 |
|
| Notes | Patients 16 years and older | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was done using computer randomisation |
| Allocation concealment (selection bias) | Low risk | Medication distrubution was done by the investigational pharmacist service |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both patients and investigators were blinded to treatment assignments Patients took tablets with similar appearance |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Specific efforts to maintain blinding among study physicians not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Seven subjects had left the study early, more in the metronidazole group (5/7) compared to others (1/10 in ciprofloxacin group and 1/8 in placebo group) Reasons for discontinuation included lost to follow‐up, withdrawal of consent, adverse events, and other reasons |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |