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. Author manuscript; available in PMC: 2013 Nov 2.
Published in final edited form as: Gastroenterology. 2013 Jul 1;145(3):10.1053/j.gastro.2013.06.052. doi: 10.1053/j.gastro.2013.06.052

Table 2.

Key Randomized Placebo-Controlled Trials of UDCA for PSC

Year (reference) Dose UDCA Follow up Number of Patients Outcomes
1997 (99) 13–15 mg/kg/day 2.2 years 105

  • No difference in treatment failure (time to transplant, histology, etc)

  • Liver tests improved in UDCA group.
2001 (100) 20 mg/kg/day 2 years 26

  • UDCA had improvement in liver tests, histology and cholangiography.
2001 (101) 25–30 mg/kg/day 1 year 30

  • UDCA group had improved liver tests, improved Mayo Risk Score at 1 year and better predicted 4 year survival than placebo.

  • Higher dose UDCA had improved Mayo Risk score compared to patients enrolled in lower dose UDCA trial 99.
2005 (102) 17–23 mg/kg/day 5 years 219

  • No difference in death or liver transplant, cholangiocarcinoma or liver tests.
2009 (103) 28–30 mg/kg/day 6 years 150

  • UDCA improved liver tests but was associated with more adverse events including time to death or liver transplant.