Rahimpour 2016.
Methods | Randomised clinical trial. | |
Participants | Country: Iran.
Number randomised: 29.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 29.
Average age: 36 years.
Females: 12 (41.4%).
Separate data for the subgroup with ulcerative colitis: no. Inclusion criteria:
Exclusion criteria:
Follow‐up: 12 weeks after 12 weeks of treatment. |
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Interventions | Participants were randomly assigned to 2 groups. Group 1: vancomycin 125 mg QDS (n = 18). Group 2: placebo (n = 11). | |
Outcomes |
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Notes | Trial authors provided additional information on outcomes in February 2017. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "An independent investigator who was blinded to the treatment group made random allocation cards by using computer‐generated random numbers". |
Allocation concealment (selection bias) | Low risk | Quote: "Another investigator who was also blinded was responsible for the patients’ enrolments and data collection". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "We used the triple blinding method which meant that patients, investigators who were responsible for the patients’ enrolment and the analyzer of the data at the end of the study were unaware of identities to reduce the chance of bias occurrence in the study". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "We used the triple blinding method which meant that patients, investigators who were responsible for the patients’ enrolment and the analyzer of the data at the end of the study were unaware of identities to reduce the chance of bias occurrence in the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No post‐randomisation drop‐outs were reported. |
Selective reporting (reporting bias) | Low risk | Comment: No published protocol was available; mortality and morbidity were reported. |
For‐profit bias | Low risk | Quote: "This study was supported by a grant from the Tehran University of Medical Sciences". |
Other bias | Low risk | Comment: no other bias. |