A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia.

Abstract

BACKGROUND & AIMS:

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: F Junquera, F Feu, M Papo, S Videla, J R Armengol, J M Bordas, E Saperas, J M Piqué, J R Malagelada
• Journal: Gastroenterology (Gastroenterology) Vol. 121 Issue 5 Pg. 1073-9 (Nov 2001) ISSN: 0016-5085 [Print] United States
• PMID: 11677198 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Ethinyl Estradiol
• Norethindrone

Topics

• Adult
• Aged
• Angiodysplasia (complications, drug therapy)
• Double-Blind Method
• Ethinyl Estradiol (administration & dosage, adverse effects)
• Female
• Gastrointestinal Hemorrhage (prevention & control)
• Humans
• Male
• Middle Aged
• Norethindrone (administration & dosage, adverse effects)
• Recurrence