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SECOND INTERNATIONAL SYMPOSIUM
ON THE ROLE OF SOY
IN PREVENTING AND TREATING CHRONIC DISEASE

September 15-18, 1996
Brussells, Belgium

SCIENTIFIC PROGRAM
(Oral Abstracts)

Soy and Cancer
Soy Consumption and Cancer Risk : Human Studies

A Pilot Study of Genistein/Soy Protein Isolate in the Treatment of Hereditary Hemorrhagic Telangiectasia; Possible Efficacy in HHT-Associated Epistaxis, Gastrointestinal Hemorrhage and Migrane
Joshua R. Korzenik, Stephen Barnes, Yale University School of Medicine, New Haven, Connecticut.

Background. Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disorder with diverse manifestations including epistaxis (nosebleeds), gastrointestinal (GI) bleeding and migraine. Therapeutic options are limited. The pathophysiology of HHT has been suggested to be due to a dysregulation of angiogenesis. Genistein, an isoflavone and component of soy, has been demonstrated to inhibit angiogenesis which is the basis for this pilot study of soy in HHT.

Aims. To evaluate the efficacy of soy protein isolate (SPI) in the treatment of chronic epistaxis and GI hemorrhage in patients with HHT.

Methods. Patients were enrolled if diagnosed with HHT and epistaxis (at least 2x/wk), GI bleeding (requiring transfusions or IV iron to maintain hg<10) or both. Patients were given 29 grams of SPI twice daily (SUPRO) provided by Protein Technologies International containing approximately 40 mg genistein daily) for three months. Patients maintained a daily diary throughout the study including a two-week observational period prior to treatment. Hemoglobin levels were obtained in all patients with GI bleeding monthly. Urinary genistein levels were measured before SPI and after the first month.

Results. Nine patients were enrolled and a tenth took an alternate soy product off protocol. Of the 8 completing three months, six had epistaxis (2x/week-6x/day lasting 1-20 minutes), three had GI bleeding. Of the six with epistaxis, three had complete or near complete (nosebleeds<1 minute/day) resolution. A fourth had significant improvement. Response was see in 1-4 weeks. One of three patients with GI bleeding had a marked response (increase in hematocrit from 22 to 32 without transfusions after one month on SPI), one had an equivocal response and the third showed no benefit. Four patients had migraines at least three times a month for >5 years. All four reported complete relief from migraines, an unanticipated result. SPI was well tolerated with no adverse effects, though one patient noted a significant increases in menses. Genestein levels did not correlate with clinical response.

Conclusion. SPI merits further investigation to evaluate its use as a therapy for epistaxis, GI bleeding and migraines in patients with HHT. Randomized, controlled trials are underway.

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