Randomized prospective comparative study of ursodeoxycholic acid and S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis of pregnancy.

AIM: 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). PATIENTS AND METHODS: We studied singleton pregnancies at <36 weeks with a moderate or severe form of ICP between January 1999 and March 2004. Patients were randomized to either oral UDCA 3x250 mg daily or 500 mg SAMe twice daily in slow running infusion for twelve days followed by oral administration of 500 mg twice daily until delivery. Intensive hematological, biochemical and fetal monitoring were carried out.
RESULTS: Of the 78 women enrolled, 25 received SAMe monotherapy, 26 received UDCA, and 27 received combined therapy. Groups were initially comparable in terms of gestational age, duration of therapy, parity and biochemical characteristics. All therapies improved the pruritus. The combined therapy and the monotherapy with UDCA (later) led to improving of the serum concentrations of bile acids and transaminases compared with SAMe monotherapy (P<0.01). Combined therapy led to a faster decrease of serum concentrations of bile acids and transaminases compared with UDCA monotherapy (borderline significance). Gestational ages were similar in all groups. No adverse effects were noted on the fetuses or neonates with either therapy.
CONCLUSIONS: UDCA is an effective drug in the treatment of ICP, and combined with SAMe, has probably a synergistic effect on biochemical parameters. This mode of treatment seems more effective but the effect of the successful treatment on the fetus is unclear. Therefore, the ante- and intrapartum monitoring of the fetus should be part of the management of severe forms of ICP. The project is supported by IGA MZ CR (No. NH/7376-3).

RCT Entities:   Population Interventions Outcomes