Multicenter randomized prospective controlled study of ursodeoxycholic acid and s-adenosyl-l-methionine in the treatment of intrahepatic cholestasis of pregnancy.

Objectives: To compare the efficacy of the ursodeoxycholic acid (UDCA) and S-adenosyl-L-methionine (SAMe) monotherapy with their combined effect on intrahepatic cholestasis of pregnancy (ICP). Materials: ICP patients at 28 weeks to 35 weeks of singleton pregnancy. Methods: Based on the multicenter randomized controlled study method, five centers were set up in Sichuan and Chongqing in China, where ICP frequently occurs. ICP patients at 28 weeks to 35 weeks of singleton pregnancy were divided randomly into three groups: Group A given 250 mg po Qid of UDCA, Group B given 1000 mg ivgtt Qd of SAMe, and Group C given UDCA+SAMe. The symptoms, improvement in biochemical indicators, and perinatal outcomes of the mothers and babies were also compared. Results: (1) From July 2009 to March 2011, 138 cases were gathered from the five centers. Among them, 18 cases were eliminated. Thus, only 120 cases with complete data were included in the experiment (41, 38, and 41 cases for Groups A, B, and C, respectively). (2) The differences in the maternal ages, gestational periods before the treatment and diagnosis of ICP, pruritus scores, total bile acid (TBA), alanine aminotransferase, aspartate aminotransferase, and total bilirubin before medication were not statistically significant among the three group. (3) The results show evident improvements in the pruritus symptoms in the three groups (P < 0.05). However, the differences could not be considered statistically significant. The TBA levels in all groups significantly decreased after treatment (P < 0.05). Group A had better curative effects than Group B. The statistical significance of the differences between the curative effects in Groups B and C and Groups A and C were indeterminable. The ALT, AST and TB levels in all groups significantly decreased after treatment (P < 0.05). Group A and C had better curative effects than Group B. The statistical significance of the differences between the curative effects in Groups A and C was indeterminable. The comparison of gestational ages, delivery modes, the 1 and 5 min Apgar scores of newborn babies, and amniotic fluid properties also showed no statistical significance. No perinatal death or adverse drug reactions were observed. Conclusions: UDCA and SAMe are both effective and safe on ICP treatments. The use of UDCA alone and UDCA+SAMe achieved better effects on the biological indicators of ICP than SAMe only. The use of UDCA alone may be more economic and convenient.