COMPARATIVE EFFICACY AND SIDE-EFFECTS OF URSODEOXYCHOLIC AND CHENODEOXYCHOLIC ACIDS IN DISSOLVING GALLSTONES - A DOUBLE-BLIND CONTROLLED-STUDY

  • 1 January 1983
    • journal article
    • research article
    • Vol. 85  (6) , 1257-1264
Abstract
In a double-blind controlled study of ursodeoxycholic acid [UDCA] (400 and 800 mg/day) and chenodeoxycholic acid [CDCA] (375 and 750 mg/day), in comparison with placebo, UDCA was significantly more effective than CDCA in dissolving gallstones after 12 mo. of treatment. Although there continued to be better dissolution during UDCA treatment (dissolution complete in 30% and partial in another 30% of the patients) than during CDCA treatment (dissolution complete in 7% and partial in 40%) at 24 mo., this difference between the treatment groups was no longer statistically significant. The incidence of floating stones was significantly higher in the patients who dissolved their stones than in those who did not (P < 0.001). The 3 failures of dissolution of floating stones during bile acid treatment were associated with CDCA therapy-2 of them with the 750-mg and the 3rd with the 375-mg doses. Gallstone dissolution with UDCA occurred in spite of a rise in biliary cholesterol saturation, which was consistent with a nonmicellar mechanism of cholelitholysis. Furthermore, > 3-fold serum elevations of L-alanine aminotransferase were observed only during CDCA therapy. They occurred in 2 patients treated with 375 and 750 mg/day, respectively. The enzyme levels normalized after discontinuation of CDCA and have remained normal for 13 and 8 mo., respectively, after the institution of treatment with 800 mg/day of UDCA. There was no correlation between the liver tests and biliary levels of lithocholic acid. Of all the symptoms studied, only constipation showed changes that approached statistical significance (P = 0.0681). There was a significant improvement of constipation in the combined CDCA groups when they were compared with the combined UDCA groups. The total bile acid pool expanded significantly in both the CDCA and in the 800-mg UDCA treatment groups. The marked increases of biliary UDCA and CDCA, respectively, indicated complicance with the treatment in all but 1 bile acid-treated patient. Neither serum triglycerides nor serum cholesterol showed significant changes in any of the treatment groups. UDCA dissolves gallstones faster and with fewer side effects than CDCA. The results of the study are also consistent with the view that UDCA is cholelitholytic at a lower dose than is CDCA.