Effect of leuprolide acetate in treatment of abdominal pain and nausea in premenopausal women with functional bowel disease: A double-blind, placebo-controlled, randomized study

John R. Mathias, Mary H. Clench, Thomas L. Abell, Kenneth L. Koch, Glen Lehman, Malcolm Robinson, Robin Rothstein, William J. Snape

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

We have previously reported impressive results in using a gonadotropin- releasing hormone analog, leuprolide acetate (Lupron), in the treatment of moderate to severe symptoms (especially abdominal pain and nausea) in patients with functional bowel disease (FBD). Pain is the hallmark of patients with FBD, and there is no consistent therapy for the treatment of these patients. The purpose of the present study was to expand the investigation to study similar patients (menstruating females) in a multicenter, double-blind, placebo-controlled, randomized study using Lupron Depot (which delivers a continuous dose of drug for one month), 3.75 mg (N = 32) or 7.5 mg (N = 33), or placebo (N = 35) given intramuscularly every four weeks for 16 weeks. Symptoms were assessed using daily diary cards to record abdominal pain, nausea, vomiting, early satiety, anorexia, bloating, and altered bowel habits. Additional assessment tools were quality of life questionnaires, psychological profile, oralto-cecal transit using the hydrogen breath test, antroduodenal manometry, reproductive hormone levels, and global evaluations by both patient and investigator. Patients in both Lupron Depot-treated groups showed consistent improvement in symptoms; however, only the Lupron Depot 7.5 mg group showed a significant improvement for abdominal pain and nausea compared to placebo (P <0.001). Patient quality of life assessments and global evaluations completed by both patient and investigators were highly significant compared to placebo (P <0.001). All reproductive hormone levels significantly decreased for both Lupron Depot-treated groups by week 4 and were significantly different compared to placebo at week 16 (P <0.001). This study shows that leuprolide acetate is effective in controlling the debilitating symptoms of abdominal pain and nausea in patients with FBD.

Original languageEnglish (US)
Pages (from-to)1347-1355
Number of pages9
JournalDigestive Diseases and Sciences
Volume43
Issue number6
DOIs
StatePublished - 1998
Externally publishedYes

Fingerprint

Leuprolide
Nausea
Abdominal Pain
Placebos
Therapeutics
Quality of Life
Research Personnel
Hormones
Breath Tests
Manometry
Anorexia
Gonadotropin-Releasing Hormone
Habits
Vomiting
Hydrogen
Psychology
Pain

Keywords

  • Abdominal pain
  • Functional bowel disease
  • Gonadotropin- releasing hormone
  • Leuprolide acetate
  • Lupron Depot
  • Nausea

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Effect of leuprolide acetate in treatment of abdominal pain and nausea in premenopausal women with functional bowel disease : A double-blind, placebo-controlled, randomized study. / Mathias, John R.; Clench, Mary H.; Abell, Thomas L.; Koch, Kenneth L.; Lehman, Glen; Robinson, Malcolm; Rothstein, Robin; Snape, William J.

In: Digestive Diseases and Sciences, Vol. 43, No. 6, 1998, p. 1347-1355.

Research output: Contribution to journalArticle

Mathias, John R. ; Clench, Mary H. ; Abell, Thomas L. ; Koch, Kenneth L. ; Lehman, Glen ; Robinson, Malcolm ; Rothstein, Robin ; Snape, William J. / Effect of leuprolide acetate in treatment of abdominal pain and nausea in premenopausal women with functional bowel disease : A double-blind, placebo-controlled, randomized study. In: Digestive Diseases and Sciences. 1998 ; Vol. 43, No. 6. pp. 1347-1355.
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