Clinical–liver, pancreas, and biliary tractEfficacy and Safety of Ursodeoxycholic Acid Versus Cholestyramine in Intrahepatic Cholestasis of Pregnancy
Section snippets
Study Design
An open, randomized, parallel group study was performed comparing the efficacy and safety of UDCA and cholestyramine in intrahepatic cholestasis of pregnancy. The study was approved by the ethics committee of the Kaunas Medical University. The study was conducted in accordance with the ethical guidelines of the Declaration of Helsinki.
Patients
Patients with a diagnosis of ICP as defined by the criteria below were prospectively evaluated for inclusion in this study between October 1999 and September 2002.
Results
Eighty-four patients, aged 18–41 years, between 25 and 39 weeks of gestation, who fulfilled the inclusion criteria were enrolled in the present study. After randomization, 42 patients received UDCA, 8–10 mg/kg body weight/day, and 42 patients received cholestyramine, 8 g/day, for 14 days. Median time of onset of treatment was 35.0 weeks (range, 22.0–39.0 weeks); delivery was at 37–38 weeks. Therefore, most of the patients were not offered continued medical treatment until delivery when the
Discussion
The present study indicates that treatment of ICP with UDCA for 14 days is superior to treatment with cholestyramine regarding relief of pruritus, delivery near term, and improvement of maternal serum liver tests. Pruritus is frequently considered a concomitant to pregnancy and is often not recognized as a key symptom of ICP and treated expectantly. However, pruritus is not the major threat to mother and fetus, although its intensity may severely debilitate the mother. More seriously, ICP may
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Supported in part by a grant from the Science Foundation of Kaunas University of Medicine and by Dr. Falk, Pharma GmbH, Freiburg, Germany.