Effect of leuprolide acetate in patients with moderate to severe functional bowel disease. Double-blind, placebo-controlled study

What Was Tested

This randomized controlled trial paper looks at Leuprolide.

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, the researchers hypothesized that reproductive steroids may antagonize diseased nerves of the gastrointestinal tract, enhancing the expression of symptoms.

Who Took Part

According to the abstract, 30 women were involved.

By PubMed's age tags, the people studied were adults and middle-aged adults, women only.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Blinding on both sides kept the women and researchers unaware of who received Leuprolide.

Some women received a placebo instead of Leuprolide, giving a reference point.

A time span of one month appears in the methods.

What Was Measured

Because it occurs approximately 20-30 times more frequently in women than in men and its symptoms often coincide with the menstrual cycle, the researchers hypothesized that reproductive steroids may antagonize diseased nerves of the gastrointestinal tract, enhancing the expression of symptoms.

The subject headings attached to it are Amino Acid Sequence, Colonic Diseases, Functional, Estradiol, Follicle Stimulating Hormone, Leuprolide, Molecular Sequence Data and Progesterone.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Leuprolide in 30 women over one month.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 1994 (Digestive diseases and sciences), a journal based in United States.

More context: the Leuprolide compound page, all human trials.