Paula Moyer, MA

October 30, 2006

October 30, 2006 (Las Vegas) — A medical approach consisting of 3 agents ("triple therapy") can reverse Barrett's esophagus and the dysplasia that often follows, eliminating the risk for esophageal adenocarcinoma, according to investigators who presented their findings here at the 71st annual meeting of the American College of Gastroenterology (ACG).

The treatment consists of a proton pump inhibitor to treat acid reflux, sucralfate suspension to treat bile and pepsin reflux, and folic acid as chemoprevention against dysplasia.

"Medical therapy with these 3 modalities reverses dysplasia and Barrett's esophagus in clinical and endoscopic follow-up," said principal investigator Stephen P. Stowe, MD. Dr. Stowe is medical director of the Lake Norman Center for Digestive and Liver Disease in Mooresville, North Carolina. "We saw no difference in dysplasia clearance in men and women or in those with and without a family history of Barrett's esophagus. We saw no progression to cancer in 301 patient-years of follow-up."

Dr. Stowe and his coinvestigator conducted the phase 2 study in 81 patients with Barrett's esophagus who were selected from 3495 consecutive patients in a single practice who were scheduled to undergo esophageal endoscopy. Of these 81 patients, 44 were men and 37 were women. The investigators categorized patients by the presence of dysplasia and stratified their treatment accordingly. Those with no dysplasia received daily treatment with a proton pump inhibitor of choice, 1 mg daily of folic acid, and 10 cc of sucralfate at bedtime. Those with dysplasia were on doubled therapy: twice-daily doses of the proton pump inhibitor and folic acid, and 10 cc of sucralfate upon rising and at bedtime.

Follow-up regimens were also based on patients' dysplasia status. Those with no dysplasia underwent conventional endoscopy and chromo-endoscopy beginning 12 months after the initiation of treatment. Those with mild dysplasia underwent these studies beginning 9 to 12 months after treatment started. Those with moderate to severe dysplasia underwent these studies beginning 3 to 6 months after initiating therapy. Patients were assigned a score based on endoscopy findings as well as clinical findings, such as symptoms of reflux and choking; the affected length of the esophagus, the presence of scarring; stenosis or ulcer; the severity of dyspepsia.

"Healing was evident starting at 9 months after treatment began, and most were healed by 48 months with some stragglers at 72 to 80 months," said Dr. Stowe. "We documented full healing in 72% of very short and short segments, 75% of intermediate segments, and 17% of long segments." Long segments were defined as more than 6 cm in length. Although healing of Barrett's esophagus was slightly better in women and those with a family history of Barrett's esophagus, there was no statistically significant difference by sex or family history for reversal of dysplasia, he said.

When they analyzed their data by the severity of dysplasia, the investigators found that 4 of 5 patients with moderate dysplasia had both reversal of dysplasia and healing of Barrett's esophagus, as did 8 of 15 patients with mild dysplasia and 8 of 23 patients with indefinite dysplasia.

No patients in the overall group progressed to cancer after 301 years of patient follow-up. Similarly, they documented no progression among the 48 patients with dysplasia and 177 years of patient follow-up.

"To my knowledge this is the first study showing a reversal of Barrett's with noninvasive methods. We find this intriguing and interesting," said Phillip E. Jaffe, MD, in a phone interview. Dr. Jaffe, who was not involved in thestudy, is an associate professor of medicine at Yale University School of Medicine in New Haven, Connecticut, and he practices in Hamden, Connecticut. He spoke as a member of the ACG public relations committee.

"Do remember that is a single-center, retrospective study, and it needs to be replicated on a prospective manner, but it gives us hope that people with Barrett's and dysplasia may benefit from a noninvasive intervention," Dr. Jaffe added. "We don't want people to adopt this as a primary mode of therapy until we have a lot more data, but we think it's interesting."

ACG 71st Annual Meeting: Abstract 683. Presented October 23, 2006.

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