title: A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia.
abstract: OBJECTIVE
  The efficacy of hormonal therapy for recurrent bleeding from gastrointestinal angiodysplasia remains uncertain. We investigated the efficacy of long-term estrogen-progestagen therapy in the prevention of rebleeding from gastrointestinal angiodysplasia.
  
  
  METHODS
  Seventy-two noncirrhotic patients bleeding from gastrointestinal angiodysplasia confirmed by endoscopy or angiography were randomized to receive in double-blind conditions treatment with ethinylestradiol (0.01 mg) plus norethisterone (2 mg) (1 tablet/d), or placebo (1 tablet/d) for a minimum period of 1 year (range: 1-2 years).
  
  
  RESULTS
  Four patients could not be assessed because they did not attend the first follow-up visit. Failure of treatment occurred in 13 of 33 (39%) patients in the treatment group and in 16 of 35 (46%) patients in the placebo group (P = NS). No significant differences between groups were found according to number of bleeding episodes (0.7 +/- 1.0 vs. 0.9 +/- 1.5) and transfusional requirements (0.9 +/- 1.9 vs. 0.7 +/- 1.5 units). Treatment received was not an independent predictor for rebleeding prevention in the multivariate regression analysis. Severe adverse events (2 vs. 1) and mortality (0 vs. 1 patient, respectively) were similar between the treatment and placebo groups.
  
  
  CONCLUSIONS
  Continuous estrogen-progestagen treatment is not useful in the prevention of rebleeding from gastrointestinal angiodysplasia.
authors.affiliation: Digestive System Research Unit, Hospital General Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Junquera
authors.forename: F
authors.initials: F
authors.lastname: Feu
authors.forename: M
authors.initials: M
authors.lastname: Papo
authors.forename: S
authors.initials: S
authors.lastname: Videla
authors.forename: J R
authors.initials: JR
authors.lastname: Armengol
authors.forename: J M
authors.initials: JM
authors.lastname: Bordas
authors.forename: E
authors.initials: E
authors.lastname: Saperas
authors.forename: J M
authors.initials: JM
authors.lastname: Piqué
authors.forename: J R
authors.initials: JR
authors.lastname: Malagelada
mesh_terms: D000328:Adult; D000368:Aged; D016888:Angiodysplasia / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence
chemical_list: D004997:Ethinyl Estradiol; D009640:Norethindrone