Cooling the burn

Procedure provides long-term relief from acid reflux

As part of a multi-center clinical trial, U-M Medical School physicians are evaluating a simple, outpatient procedure that could provide long-term relief to the 14 million Americans who suffer from severe, chronic heartburn. Called the Stretta procedure, it was approved by the U.S. Food and Drug Administration in April 2000 to treat gastroesophageal reflux disease.

"In nearly all patients, the procedure gave partial or complete relief from symptoms of gastroesophageal reflux disease," says Timothy T. Nostrant, M.D., professor of internal medicine in the U-M Medical School. Nostrant is lead researcher for the U-M Health System's part of the study. Stanford University coordinated the multi-center trial.

"Patients reported increased quality of life, decreased medication use and continued improvement in symptoms even 12 months after treatment," Nostrant says.

The disease may develop from a combination of factors, says Nostrant, "but the most important is that the valve, or sphincter, separating the stomach from the esophagus is too weak to keep acid in the stomach."

The Stretta procedure uses an intense pulse of radio waves to tighten muscle control at the point where the esophagus, or food pipe, meets the stomach. This prevents acid from traveling upward. U-M gastrointestinal specialists are now offering it to patients whose heartburn has progressed far beyond the occasional post-dinner upset. The procedure uses equipment made by Curon Medical, which sponsored the clinical trial that led to FDA approval.

"It doesn't strengthen the muscles, but instead produces a little bit of scarring between the esophagus and the stomach, which makes the valve less likely to open," Nostrant says.

On May 23 at the Digestive Diseases Week meeting in Atlanta, results were presented on 119 patients — 72 men and 47 women — who received the Stretta procedure. Sixteen of them were U-M patients. All patients were between the ages of 22 and 75 and all had chronic heartburn or regurgitation, chronic acid exposure in the esophagus, minor hiatal hernia (a condition where part of the stomach protrudes through the dia-phragm from the abdomen into the chest) or esophagitis, an inflammation of the esophagus.

At 12 months, two-thirds of patients no longer needed the anti-reflux medications they were taking before the Stretta procedure. Esophagitis was present in 33 patients at the start of the study and in 25 patients six months after the procedure.

Nostrant added that those with severe hiatal hernias, or patients who only experience heartburn occasionally — as much as half the American population — are not candidates for the treatment.

The next step is to continue monitoring patients who received the Stretta procedure to determine its long-term effectiveness. A double-blind study also is planned to rule out the placebo effect.

-Valerie Gliem

See the complete story online at:
www.med.umich.edu/opm/newspage/stretta.htm

For more information on Dr. Nostrant, visit:
www.med.umich.edu/intmed/gastroenterology/

Patient information on GERD is available at: www.niddk.nih.gov/health/digest/pubs/heartbrn/heartbrn.htm