Results from a multi-center trial show that a simple, outpatient procedure may provide long-term relief to the millions of Americans who suffer from severe heartburn.
The research, presented at the recent Digestive Diseases Week meeting in Atlanta, shows that the procedure significantly eased symptoms of gastroesophageal reflux disease (GERD), or heartburn, with continued improvement even 12 months after treatment.
In nearly all patients, the procedure gave partial or complete relief, says Timothy T. Nostrant, professor of internal medicine. Nostrant was the lead researcher for the Health Systems part of the study, which Stanford University coordinated.
Called the Stretta procedure, the operation has been tested at the U-M and other locations over the past several years and could help many of Americas estimated 14 million GERD sufferers. It was approved by the Food and Drug Administration in April 2000 to treat chronic heartburn.
GERD may arise from a combination of factors, says Nostrant, but the most important factor is that the valve, or sphincter, that separates the stomach from the esophagus is too weak to keep the acid in the stomach.
The Stretta procedure uses an intense pulse of radio waves to tighten the muscle control at the point where the esophagus meets the stomach, preventing acid from traveling upward. The U-Ms gastrointestinal specialists are now offering it to many of their patients whose heartburn has progressed far beyond the occasional post-dinner upset.
In the study, 119 patients72 men and 47 womenunderwent the Stretta procedure. Sixteen of them were patients at the U-M. All of the patients were between 22 and 75, and all had chronic heartburn or regurgitation, chronic acid exposure in the esophagus, minor hiatal herniaa condition where part of the stomach protrudes through the diaphragm from the abdomen into the chestor esophagitis, an inflammation of the esophagus.
While the patient is under mild anesthesia, a catheter is fed through the mouth, down the throat and into the esophagus, stopping just at the muscular valve that separates the esophagus from the stomach. Inside the catheter is a narrow instrument with electrodes that can emit powerful but carefully aimed radio waves. This heats the muscles of the esophagus, causing them to contract.
It doesnt strengthen the muscles, but instead produces a little bit of scarring between the esophagus and the stomach, which makes the valve a little less easy to open up and makes it less likely that the acid will come up, Nostrant says.
At 12 months, two-thirds of patients no longer were taking the anti-reflux medications they were 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.
Most important was that most of the patients assessment of their own mental and physical conditions improved, Nostrant says. They said they had an improved quality of life, decreased medication use, and they generally felt better.
U-M researchers caution that those with severe hiatal hernias, or patients who only experience heartburn occasionallyas much as half the American populationare not candidates for the treatment.