Rasmussen 1998.
Methods | Cross‐over randomised clinical trial. | |
Participants | Country: Denmark.
Number randomised: 13.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 13.
Mean age: not stated.
Females: not stated. Separate data for the subgroup with ulcerative colitis: no. Inclusion criteria:
Exclusion criteria: not stated. Follow‐up: 24 months. |
|
Interventions | Participants were randomly assigned to 1 of 2 groups. Group 1: methotrexate (10 mg/m2 body area/wk) for the first year followed by placebo (n = 5). Group 2: placebo followed by methotrexate (10 mg/m2 body area/wk) (n = 8). | |
Outcomes | No outcomes of interest were reported before cross‐over. | |
Notes | ||
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) | Unclear risk | Comment: This information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Trial authors stated double‐blind and have used placebo. However, the groups blinded were not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Trial authors stated double‐blind and have used placebo. However, the groups blinded were not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: This information was not available. |
Selective reporting (reporting bias) | High risk | Comment: No published protocol was available; no outcomes of interest were reported. |
For‐profit bias | Unclear risk | Comment: This information was not available. |
Other bias | Low risk | Comment: no other bias. |