BY RUTHANN RICHTER
Heartburn will be a minor annoyance for many who overindulge this holiday season. For them a little "plop, plop, fizz, fizz" or other over-the-counter remedy may bring relief.
But for the 14 million Americans who suffer from gastroesophageal reflux disease (GERD), a daily effort is required to keep this condition at bay. Now, researchers at Stanford and the Veterans Affairs Palo Alto Health Care System may be able to offer a new treatment.
Some 85 percent of patients with GERD have experienced relief and have been able to discontinue their daily medications after treatment with a new minimally invasive technique that Stanford and Palo Alto VA researchers are evaluating.
The technique uses radiofrequency energy to tighten the lower esophageal sphincter, a valve designed to prevent stomach acid and digestive enzymes from flowing backward from the stomach into the esophagus. In people with reflux, this valve may be defective, allowing these irritating substances to drift into the throat and mouth, producing symptoms of chronic heartburn, persistent sore throat, regurgitation, difficulty swallowing, chronic cough, laryngitis, difficulty sleeping and even asthma.
Researchers have tested the approach on some 100 patients nationwide -- including 38 at Stanford -- with encouraging results, said David Utley, MD, clinical instructor of surgery at Stanford and the developer of the technique. Among patients who have been followed for at least four months, 85 percent no longer take any medication for heartburn and have shown significant improvement in their quality of life, Utley said. Preliminary data suggest increased relief of symptoms in patients who have been followed for six months, he said.
"The advantage of the procedure is that it doesn't involve surgery," said George Triadafilopoulos, MD, a Stanford professor of medicine (gastroenterology) and the principal investigator in the clinical trial. "If it doesn't work, the procedure can be repeated or can be followed by surgery. It's cheaper, it [doesn't require hospitalization], it takes one hour and the patient can play golf the next morning."
Some 14 million American adults suffer daily from reflux, one of the most common and most costly conditions in the United States today, said Utley, an otolaryngologist and plastic and reconstructive surgeon. Some $7 billion is spent on antacids and other drugs to treat the symptoms of the disease, which is a condition found principally in Western nations.
Until recently, reflux sufferers have had to rely on medications or surgery to control the disease. They've also had to limit their activities, sleep with the upper body elevated and avoid consumption of fatty foods, chocolate, coffee, alcohol and other substances.
While medication may effectively squelch symptoms, it doesn't prevent the continued regurgitation of bile and digestive enzymes into the esophagus, which can cause further injury, Utley said. Moreover, most patients must contend with the need to take medications daily on a permanent basis, he said.
Some patients may opt for a one-time surgical procedure -- known as Nissen fundoplication -- in which doctors wrap a portion of the stomach around the esophagus, like a doughnut, to tighten the valve and prevent backflow into the esophagus. Although this four-hour procedure now is done through a laparascope, requiring six tiny incisions in the stomach, it has the risks associated with general surgery and may result in complications, such as difficulty swallowing, Utley said.
Recognizing the limitations of current therapy, Utley approached Triadafilopoulos more than two years ago with the idea of strengthening the valve using radiofrequency energy. Utley had worked with Stanford colleagues who had effectively used this form of energy to reshape the tongue and soft palate to treat sleep apnea.
The two researchers brought Mark Vierra, MD, assistant professor of surgery, into the project and began by testing the approach in pigs. In November 1998, they applied the technique to their first patient under an approved Stanford Human Subjects Protocol.
After the investigators presented their preliminary results in May at the Digestive Disease Week conference, they began to receive calls from gastroenterologists around the country seeking to test the therapy at their own medical centers, Triadafilopoulos said.
The method is now being offered at 17 other sites in a multicenter clinical trial approved by the federal Food and Drug Administration, Utley said. All of the Stanford patients have been treated at the VA Palo Alto Health Care System, where Utley and Triadafilopoulos are based.
The procedure is performed much like a standard endoscopy, in which the patient remains awake but receives a mild sedative. Doctors insert a catheter, a small tube about the size of a pen, into the mouth and down into the esophagus and stomach. They position the catheter at the sphincter valve and then inflate a balloon to anchor the tube in place. The muscle then is heated by tiny electrodes on the tip of the catheter. The electrodes may reach a temperature of 85 degrees Celsius, although the heat rapidly dissipates as it gets further from the heated area, Utley said.
The heat effectively tightens the valve to make it more resistant to reflux events, Utley said. Patients have experienced no significant complications, Triadafilopoulos said. A few patients have had mild difficulty swallowing or have experienced fevers, symptoms that went away after a day, Utley said.
He said the technique is believed to work through several different mechanisms. It's thought that some patients experience reflux as a result of misfiring nerves in and around the sphincter that signal the brain to relax the muscle. Heat may disrupt those nerves and prevent these misguided signals from getting through, Utley said.
The technique also has been found to effectively shrink the collagen in the valve to make it tighter and less stretchy, he said. Through the natural process of wound healing, thermal hot spots also attract new collagen to the site so that by six months the area is completely healed and the greatest improvement is seen, he said.
The investigators expect to follow patients for several years to see if the results hold up over time, Triadafilopoulos said.
"If you can avoid the use of drugs for five or 10 years with a procedure that takes about an hour to do, that's good news," he said.
The clinical trial is supported by
Conway Stuart Medical in Sunnyvale, a company Utley founded to
support the basic science research and development of the
technique. SR