Treatment with itopride can reduce the pain and fullness associated with functional dyspepsia, also referred to as indigestion, according to the results of a new study.

In Japan, itopride is commonly prescribed for functional dyspepsia, which includes nonspecific abdominal discomfort, bloating and an early sense of fullness with meals. However, large, definitive trials to verify its effectiveness have not been done, lead author Dr. Gerald Holtmann, from the Royal Adelaide Hospital in Australia, and colleagues note. It was also unclear if the dose commonly used in Japan - 50 mg three times daily - is optimal.

The findings, which appear in The New England Journal of Medicine, are based on a study of 523 patients who were randomly assigned to one of three doses of itopride (50, 100, or 200 mg three times daily) or placebo for 8 weeks.

Forty-one percent of patients in the placebo group reported resolution or marked improvement of their symptoms compared with 57 percent, 59 percent, and 64 percent with each successively higher dose of itopride. Further analysis confirmed that the two higher doses of itopride provided the greatest relief.

“The exact mechanisms by which itopride improves symptoms remain to be established, and further clinical trials are needed to assess the efficacy and optimal duration of treatment in various populations,” the authors conclude.

While calling the results “important,” editorialist Dr. George F. Longstreth, of Kaiser Permanente in San Diego, California, comments that “until therapy for functional dyspepsia is more dependable, our most effective approach is to maximize the physician-patient relationship to help patients cope with their symptoms.”

SOURCE: The New England Journal of Medicine, February 23, 2006.