Stiehl 1994.
| Methods | Study design: a 3‐year pilot study with a placebo‐controlled study period. | |
| Participants | Country: Germany.
Publication language: English. Inclusion criteria ‐ a typical endoscopic retrograde cholangiographic investigation, which showed multiple stenoses; ‐ a serum alkaline phosphatases level at least twice the normal range; ‐ a negative antimitochondrial antibody; ‐ and a liver biopsy compatible with the diagnosis of PSC. Exclusion criteria ‐ decompensation of cirrhosis; ‐ a history of neoplastic disease; ‐ and/or coexisting hepatic disease. Participants ‐ UDCA group (n = 10) Mean age (years): 36 (range 18 to 58); Ratio of sex (M/F): 8/2; Concurrent IBD no. : 9 (90%); Ratio of intra‐ and extra‐hepatic in ERCP: 10:9. ‐ Placebo group (n = 10) Mean age (years): 41 (range 22 to 57); Ratio of sex (M/F): 7/3; Concurrent IBD no. : 8 (80%); Ratio of intrahepatic and extrahepatic PSC in ERCP: 10:9. |
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| Interventions | UDCA group:
‐ Dose: 750 mg/day.
‐ Route: orally.
‐ Duration: three months. Placebo group: ‐ identical‐appearing capsules administered in the same quantity and manner. |
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| Outcomes | Liver histological changes at the end of treatment; Endoscopic cholangiography changes at the end of treatment; Biochemical parameters at the end of treatment; and clinical symptom changes at the end of treatment. | |
| 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 computerised randomisation list was used. |
| Allocation concealment? | Unclear risk | No information provided. |
| Blinding? All outcomes | Unclear risk | Not adequately described. |
| Incomplete outcome data addressed? | Low risk | We contacted the principal author during August 2010 and he stated that no dropouts occurred during the study period. |
| Free of selective reporting? | Unclear risk | Study outcomes were not pre‐specified. |
| Sample size calculation | Low risk | Stated and used. The trial attained the calculated sample size. |
| Intention‐to‐treat analysis | High risk | Not stated and not used. |
ALP: alkaline phosphatases. AST: aspartate aminotransferase. ERCP: endoscopic retrograde cholangiopancreatography. IBD: inflammatory bowel disease. PSC: primary sclerosing cholangitis. UDCA: ursodeoxycholic acid. RUQ: right upper quadrant. INR: international normalized ratio.