Table 4.

UDCA in Combination Therapy for PSC

Author/Year/Type of Trial	No. of Patients	Dose of UDCA/Duration	Biochemical Response	Symptom Improvement	Histologic Response
Lindor et al[31] 1996 Uncontrolled	19	13-15 mg/kg/day of UDCA + MTX 0.25 mg/kg/week 2 years	Yes, but not different than the UDCA alone group	No	No
Stiehl et al[36] 1997 Uncontrolled	65	750 mg/day of UDCA + endoscopic intervention Mean 45 months	Yes	NA, but showed improved survival	NA
Schramm et al[32] 1999 Uncontrolled	15	UDCA 500-750 mg/day + azathiopurine 1-1.5 mg/kg/day + prednisolone 1 mg/kg/day initially, then tapering to 5-10 mg/day Median of 41 months	Yes	Yes	Yes
Van Hoogstraten et al[33] 2000 Randomized, Double-blind Non Placebo-controlled		12 mg/kg/day UDCA + budesonide (3 mg/day or 9 mg/day) or prednisone 10 mg/day 8 weeks	Yes in the prednisone group, but no change in the budesonide group	Yes in the prednisone group, but no change in the budesonide group	NA
Sterling et al[34] 2004 Randomized Controlled Pilot Study	25	13-15 mg/kg/day UDCA ± MMF 2000 mg/day 2 years	Yes, but not different than the UDCA alone group	NA	No
Farkkila et al[35] 2004 Randomized, Placebo-controlled	80	UDCA 15 mg/kg/day ± MTZ 600-800 mg/day 36 months	Yes in both groups, but AP decreased more in the combination group	NA, but improved Mayo risk score occurred in the combination therapy group	No

UDCA = ursodeoxycholic acid; PSC = primary sclerosing cholangitis; NA = not available; MTX = methotrexate; MMF = mycophenolate mofetil; MTZ = metronidazole; AP = alkaline phosphatase