title: The effect of ursodesoxycholic acid on duodenal adenomas in familial adenomatous polyposis: a prospective randomized placebo-control trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  UDCA had no effect on the development of duodenal adenomas in FAP patients (NCT: 00134758).
authors: Department of Digestive Surgery, Hôpital Saint-Antoine, AP-HP, Université Pierre et Marie Curie, Paris, France. yann.parc@sat.aphp.fr
authors: Y
authors: Y
authors: Parc
authors: B
authors: B
authors: Desaint
authors: J-F
authors: JF
authors: Fléjou
authors: J H
authors: JH
authors: Lefèvre
authors: L
authors: L
authors: Serfaty
authors: A
authors: A
authors: Vienne
authors: S
authors: S
authors: Kotti
authors: T
authors: T
authors: Simon
authors: E
authors: E
authors: Tiret
mesh_terms: D000236:Adenoma / Q000150:complications / Q000473:pathology / Q000517:prevention & control*; D011125:Adenomatous Polyposis Coli / Q000150:complications*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004379:Duodenal Neoplasms / Q000150:complications / Q000473:pathology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016737:Proctocolectomy, Restorative; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D017211:Treatment Failure; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid