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Effect of leuprolide acetate in patients with moderate to severe functional bowel disease

Double-blind, placebo-controlled study

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Abstract

Moderate to severe functional bowel disease results in debilitating abdominal pain, nausea, intermittent vomiting, early satiety, bloating, abdominal distension, and/or altered bowel habits. Because it occurs ∼20–30 times more frequently in women than in men and its symptoms often coincide with the menstrual cycle, we hypothesized that reproductive steroids may antagonize diseased nerves of the gastrointestinal tract, enhancing the expression of symptoms. No effective or consistent therapy has existed for these patients. We prospectively investigated the effect of a gonadotropin-releasing hormone analog, leuprolide acetate, in 30 women with symptoms of moderate to severe functional bowel disease. The study was phase II, randomized, double blind, and placebo controlled. Lupron Depot 3.75 mg (which delivers a continuous low dose of drug for one month) or placebo were given intramuscularly monthly for three months. Symptom scores were assessed at each four-week visit. Follicle-stimulating hormone, luteinizing hormone, estradiol, and progesterone levels were assessed before and after therapy. Patients treated with low-dose leuprolide improved progressively and significantly in scores for nausea, vomiting, bloating, abdominal pain, and early satiety, and for overall symptoms (P<0.01–0.05). All hormone levels decreased significantly (P<0.05) except luteinizing hormone (P=0.054).

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Authors and Affiliations

  1. TAP Pharmaceuticals Inc., 60015, Deerfield, Illinois

    John R. Mathias MD, Mary H. Clench PhD, Vonda G. Reeves-Darby MD, Lisa Mehelich Fox RN, Ping H. Hsu PhD, Patricia H. Roberts RN, Lesa L. Smith PA-C & Norma J. Stiglich MD

  2. Abbott Laboratories, 60064, Abbott Park, Illinois

    John R. Mathias MD, Mary H. Clench PhD, Vonda G. Reeves-Darby MD, Lisa Mehelich Fox RN, Ping H. Hsu PhD, Patricia H. Roberts RN, Lesa L. Smith PA-C & Norma J. Stiglich MD

  3. From the Department of Internal Medicine, Division of Gastroenterology, and the Department of Obstetrics and Gynecology, The University of Texas Medical Branch, 77555-0764, Galveston, Texas

    John R. Mathias MD, Mary H. Clench PhD, Vonda G. Reeves-Darby MD, Lisa Mehelich Fox RN, Ping H. Hsu PhD, Patricia H. Roberts RN, Lesa L. Smith PA-C & Norma J. Stiglich MD

Authors
  1. John R. Mathias MD
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  2. Mary H. Clench PhD
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  3. Vonda G. Reeves-Darby MD
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  4. Lisa Mehelich Fox RN
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  5. Ping H. Hsu PhD
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  6. Patricia H. Roberts RN
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  7. Lesa L. Smith PA-C
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  8. Norma J. Stiglich MD
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Additional information

This material was published in abstract form inGastroenterology 104:A548, and presented at the annual meeting of the American Gastroenterological Association, Boston, Massachusetts, May 15–21, 1993.

This study was supported by a grant from TAP Pharmaceuticals Inc., Deerfield, Illinois.

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Mathias, J.R., Clench, M.H., Reeves-Darby, V.G. et al. Effect of leuprolide acetate in patients with moderate to severe functional bowel disease. Digest Dis Sci 39, 1155–1162 (1994). https://doi.org/10.1007/BF02093778

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  • DOI: https://doi.org/10.1007/BF02093778

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