Sterling 2004.
Methods | Randomised clinical trial. | |
Participants | Country: USA.
Number randomised: 25.
Post‐randomisation drop‐outs: 9 (36%).
Revised sample size: 16.
Mean age: 44 years.
Females: 10 (62.5%). Separate data for the subgroup with ulcerative colitis: no. Inclusion criteria:
Exclusion criteria:
Follow‐up: 24 months. |
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Interventions | Participants were randomly assigned to 1 of 2 groups. Group 1: mycophenolate mofetil 1000 mg twice/d and low‐dose UDCA (13–15 mg/kg/d) combined treatment over the period of follow‐up of the study (n = 6). Group 2: low‐dose UDCA (13–15 mg/kg/d) over the period of follow‐up of the study (n = 10). | |
Outcomes | No outcomes of interest were reported. | |
Notes | Reasons for post‐randomisation drop‐out:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: This information was not available. |
Allocation concealment (selection bias) | Low risk | Quote: "Concealed randomisation via investigational pharmacy or by concealed envelopes" (study author's reply). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Neither patient nor investigator was blinded to study medication". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Neither patient nor investigator was blinded to study medication". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "All data were analysed by the intention‐to‐treat method". Comment: Post‐randomisation drop‐outs were reported. |
Selective reporting (reporting bias) | High risk | Comment: No published protocol was available; no outcomes of interest were reported. |
For‐profit bias | High risk | Quote: "Supported in part by a NIH grant to the General Clinical Research Center of Virginia Commonwealth University Medical Center, M01‐RR‐00065‐35 and by the generous support of Roche Laboratory, Nutley, NJ and Axcan Scandipharm, Birmingham, AL, USA". Comment: The trial was funded by a party with vested interest in the results (Roche produces mycophenolate mofetil). |
Other bias | Low risk | Comment: no other bias. |