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The Effect of Ursodesoxycholic Acid on Duodenal Adenomas in Familial Adenomatous Polyposis: A Prospective Randomized Placebo-Control Trial
source: Colorectal Disease
authors: Parc Y, Desaint B, Fléjou J F, Lefèvre J H, Serfaty L, Vienne A, Kotti S, Simon T, Tiret Esummary/abstract:
Duodenal adenomas occur in about 90% of patients with familial adenomatous polyposis (FAP) and are the second cause of death of patients who have had a prophylactic proctocolectomy. Studies suggest that biliary acids have a role in the development of duodenal adenomas. The aim of this study was to evaluate the impact of ursodesoxycholic acid (UDCA) on duodenal adenoma formation in patients with FAP.
A randomized, double-blinded, placebo-controlled study was carried out of 71 patients (20-65 years) who already had a restorative proctocolectomy. Subjects received either 10 mg/kg of UDCA orally per day or a placebo tablet for 24 months. The Spigelman severity score was determined after duodenal axial and lateral view endoscopy at 12 and 24 months.
At 2 years 55 patients had completed the entire period of treatment. At the end of the follow-up period, nine (25%) patients in the UDCA group and seven (20%) in the placebo group had a decrease in the Spigelman score (P = 0.6142). Patients receiving UDCA had no side-effects (0%) compared with four (14%) in the placebo group (P = 0.0392).
UDCA had no effect on the development of duodenal adenomas in FAP patients (NCT: 00134758).
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