title: Effect of leuprolide acetate in patients with moderate to severe functional bowel disease. Double-blind, placebo-controlled study.
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 approximately 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).
authors.affiliation: Department of Internal Medicine, University of Texas Medical Branch, Galveston 77555-0764.
authors.forename: J R
authors.initials: JR
authors.lastname: Mathias
authors.forename: M H
authors.initials: MH
authors.lastname: Clench
authors.forename: V G
authors.initials: VG
authors.lastname: Reeves-Darby
authors.forename: L M
authors.initials: LM
authors.lastname: Fox
authors.forename: P H
authors.initials: PH
authors.lastname: Hsu
authors.forename: P H
authors.initials: PH
authors.lastname: Roberts
authors.forename: L L
authors.initials: LL
authors.lastname: Smith
authors.forename: N J
authors.initials: NJ
authors.lastname: Stiglich
mesh_terms: D000328:Adult; D000595:Amino Acid Sequence; D003109:Colonic Diseases, Functional / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D008969:Molecular Sequence Data; D011374:Progesterone / Q000097:blood; D011446:Prospective Studies
chemical_list: D003692:Delayed-Action Preparations; D011374:Progesterone; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D016729:Leuprolide