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. 2017 Mar 28;2017(3):CD011343. doi: 10.1002/14651858.CD011343.pub2

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:
  1. Diagnosis of primary sclerosing cholangitis.

  2. Raised alkaline phosphatase.

  3. Symptoms such as pruritus, pain, jaundice.


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.