Efficacy and indications of ursodeoxycholic acid treatment for dissolving gallstones

A multicenter double-blind trial
  • Tokyo Cooperative Gallstone Study Group
  • Author Footnotes
    1 Members of the Tokyo Cooperative Gallstone Study Group are as follows: Chairman: Haruo Kameda, M.D. (The Jikei University School of Medicine, Tokyo). X-ray film interpreting commitee: Haruo Kameda, M.D., Fumio Sugata, M.D. (Fujigaoka Hospital, Showa University, Kanagawa Pref.), Taiji Matsumoto, M.D. (Sanraku Hospital, Tokyo), Norio Katsuta, M.D. (Nihon Medical School, Tokyo). Manuscript preparation: Toshiaki Osuga, M.D. (The University of Tsukuba School of Medicine, Ibaraki Pref.). Controller: Yutaka Dohi, M.D. (Saitama Medical School, Saitama Pref.). Coinvestigators (alphabetically): S. Ashizawa, M.D., R. Fujita, M.D., Y. Hasegawa, M.D., S. Hatsushiba, M.D., Y. Hatta, M.D., H. Hirabayashi, M.D., T. Honda, M.D., F. Ishihara, M.D., N. Ishii, M.D., Y Ito, M.D., H. Kaneda, M.D., K. Kashima, M.D., M. Kono M.D., F. Kumura, M.D., R. Kurihara, M.D., H. Kuroda, M.D., Y. Murakami, M.D., T. Nagai, M.D., K. Nakazawa, M.D., T. Namihisa, M.D., M. Nambu, M.D., Y. Nao, M.D., Y. Nitta, M.D., M. Nomura, M.D., M. Ogasawara, M.D., S. Omata, M.D., H. Osawa, M.D., T. Sajima, M.D., T. Sakai, M.D., M. Shimizu, M.D., M. Takahashi, M.D., Y. Takahasi, M.D., S. Tsujimura, M.D., K. Tsuneoka, M.D., Y. Ueno, M.D., J. Yamamoto, M.D. and M. Yamanaka, M.D.
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      The cholelitholytic action of ursodeoxycholic acid (UDCA) was investigated by a double-blind clinical trial. The trial started with 151 subjects all confirmed by radiographic examination as having radiolucent gallstones in a functioning gallbladder. The subjects were divided into three groups receiving 600 mg/day of UDCA, 150 mg/day of UDCA, and placebo (lactose) per day, respectively. Seventy-nine cases were classed as dropouts or were excluded due to incomplete follow-up or inadequate patient selection, and the data on the remaining 72 cases were analyzed. After 6–12 mo of treatment, dissolution or decrease in size or number of stones occurred in 10 of the 29 cases in the 600 mg/day group (34.5%), 4 of 23 cases in the 150 mg/day group (17.4%), and 1 of 20 cases in the control group (5.0%). For those cases with noncalcified, less than 15 mm in diameter, and floating stones, efficacy increased to 83.3% in the 600 mg/day group. Lithogenic index of bile defined by Thomas and Hofmann became unsaturated after treatment in the 600 mg/day group. Neither diarrhea nor hepatic toxicity was noted. The results indicate that UDCA is a safe and effective litholytic agent.
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