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Drug Helps Fight Functional Dyspepsia
February 22, 2006

(The New York Times News Service) -- Functional dyspepsia, a condition characterized by unexplained abdominal pain, is a common, often frustrating disorder with few treatment options.

But research from Australia suggests that a new medication called itopride may offer a slightly more effective option to people with dyspepsia. This study found the drug to be about 23 percent more effective in treating functional dyspepsia than a placebo.

Results of the study appear in the Feb. 23 issue of The New England Journal of Medicine.

"There wasn't a dramatic response (to itopride) over the placebo," says Dr. Roshini Rajapaksa, a gastroenterologist at New York University Medical Center in New York City. "But it's good to have something new to add to our armamentarium."

Functional dyspepsia is a very common disorder. As many as one-quarter to one-third of Americans reported having dyspepsia within the past twelve months, according to Dr. George Longstreth, the author of an accompanying editorial in the same issue of the journal. Longstreth is a gastroenterologist for Kaiser Permanente in San Diego.

Dyspepsia is the word doctors use to describe upper abdominal pain, usually in the center of the abdomen. Functional dyspepsia is abdominal pain with no known cause. Other symptoms include bloating, heartburn, nausea and a feeling of fullness.

Doctors first try to rule out obvious causes of the pain, such as an ulcer or gallstones, Longstreth says. Unexplained abdominal pain that continues for longer than 12 weeks is considered chronic functional dyspepsia.

Both Longstreth and Rajapaksa say there aren't many treatment options available for functional dyspepsia. Lifestyle changes may be suggested, and sometimes proton pump inhibitor drugs, such as Prilosec or Nexium, are prescribed, but Rajapaksa says these measures often have little effect.

Longstreth agrees. "Treatments so far have not been very impressive," he concludes.

In this study, 523 people diagnosed with functional dyspepsia were randomly assigned to receive either itopride or a placebo.

Those given itopride received one of three different doses -- 50, 100 or 200 milligrams -- taken three times a day for eight weeks.

At the end of the eight weeks, 64 percent of those receiving 200 milligrams of itopride reported being symptom-free or having significant symptom improvement. Fifty-nine percent of those on 100 milligrams of itopride and 57 percent of those on 50 milligrams of itopride reported the same improvements.

However, the researchers noted that 41 percent of those taking a placebo also reported being either symptom-free or significantly improved.

In a separate analysis focused on symptoms of either abdominal pain or feeling full, the researchers found itopride was helpful 73 percent of the time, compared to 63 percent of the time for the placebo.

No significant side effects from the treatment were reported.

"Even though this study was well done and showed a statistically significant benefit," Longstreth says, "the authors point out that the number-to-treat to cure one person was six (patients). That means five out of six people didn't get better."

Rajapaksa says the study highlights the need for better treatments for functional dyspepsia. "This is a real condition.

It's not just in someone's mind. We need a better understanding of this disease so we can develop better treatments for it," she says.

Copyright 2006 The New York Times News Service. All rights reserved.

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