Controversies in the management of primary sclerosing cholangitis

Table 3 Important studies involving ursodeoxycholic acid

Ref.	Dose and study design	Number UDCA (number placebo)	Follow up	Parameter	Outcome
Chazouillères et al[51]	8-16 mg/kg	15	6 mo	Liver enzymes	Improved
	UDCA alone
O'Brien et al[52]	10 mg/kg	12	37 mo	Liver enzymes	Improved
	UDCA alone
Beuers et al[53]	13-15 mg/kg	6 (8)	12 mo	Liver enzymes	Improved
	UDCA vs placebo			Histology	Improved
Lindor et al[54]	13-15 mg/kg	51 (51)	2.2 yr	Liver enzymes	Improved
	UDCA v placebo			Time to treatment failure	No change
				Time to liver transplant	No change
Olsson et al[55]	17-23 mg/kg	110 (109)	5 yr	Liver enzymes	No change
	UDCA vs placebo			Transplant free survival	No change
Lindor et al[56]	28-30 mg/kg	76 (74)	Terminated	Liver enzymes	Improved
	UDCA vs placebo			Primary end-point	Increased
				Serious adverse events	Increased

UDCA: Ursodeoxycholic acid.