Beuers 1992.

Methods	Study design: a prospective, randomised, double‐blind, placebo‐controlled trial.
Participants	Country: Germany. Publication language: English. Inclusion criteria: ‐ diagnosis of PSC by endoscopic retrograde cholangiography, hepatobiliary histological appearance, and a cholestatic serum enzyme pattern in the absence of evidence of secondary sclerosing cholangitis, hepatobiliary malignancies, or other viral, metabolic, or autoimmune liver disease; ‐ ALP level at least 1.5 times the normal value. Exclusion criteria ‐ pregnancy; ‐ therapy of PSC within the last three months with UDCA, azathioprine, chlorambucil, colchicine, cyclosporine, methotrexate, D‐penicillamine, or corticosteroids; ‐ serum bilirubin level > 15 mg/dl; ‐ other liver diseases in addition to PSC. Participants: ‐ UDCA group (n = 6) Mean age (years): 29 (range 17 to 46); Ratio of sex (M/F): 6/0; Concurrent IBD no.: 5/6 (83%); Symptoms: fatigue: 3/6 (50%); ascites: 1/6 (17%). ‐ Placebo group (n = 8) Mean age (years): 46 (range 24 to 62); Ratio of sex (M/F): 5/3; Concurrent IBD no.: 5/8 (63%); Symptoms: fatigue: 5/8 (63%); RUQ pain: 1/8 (12.5%); pruritus: 2/8 (25%); jaundice: 1/8 (12.5%)
Interventions	UDCA group: ‐ Dose: 13 to 15 mg/kg body weight/day in two divided doses. ‐ Route: orally. ‐ Duration: one year. Placebo group: ‐ identical‐appearing capsules administered in the same quantity and manner.
Outcomes	Biochemical changes at the end of treatment; Clinical signs and symptoms at the end of treatment; Liver histology at the end of treatment; and adverse events.
Notes	Letter was sent to the authors in August 2010. A reply with additional information was received shortly after.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	A computer‐generated block randomisation was used.
Allocation concealment?	Unclear risk	Method of allocation concealment not described.
Blinding? All outcomes	Low risk	Identical appearing placebo in 250 mg capsules were used.
Incomplete outcome data addressed?	Low risk	Follow‐up time: 1 year. Numbers and reasons for withdrawal were stated.
Free of selective reporting?	Low risk	Study outcomes clearly pre‐specified and data reported.
Sample size calculation	Low risk	Stated and used.
Intention‐to‐treat analysis	High risk	Not stated and not used. According to the principal author contacted during August 2010, two patients from the control group were excluded from data analysis.