Pam Harrison

October 29, 2014

PHILADELPHIA — Endoscopic fundoplication is better for treating regurgitation than a maximum-dose proton pump inhibitor (PPI) in patients with gastroesophageal reflux disease, results from the RESPECT trial show.

The study, known as Randomized Esophyx vs Sham Placebo-Controlled Transoral Fundoplication, is a multicenter comparative trial conducted at eight academic and community centers in the United States. Results were presented here at the American College of Gastroenterology 2014 Annual Scientific Meeting.

"I can't emphasize enough that this is the first trial of any sort — meaning medical, surgical, or endoscopic — that has used regurgitation as its primary end point," said Peter Kahrilas, MD, from the Northwestern University Feinberg School of Medicine in Chicago.

"We found that troublesome regurgitation resolved in a greater proportion of patients treated with transoral fundoplication than with omeprazole," he told Medscape Medical News. "The procedure should therefore be considered in gastroesophageal reflux patients with small or absent hernia who suffer from regurgitation despite PPI therapy."

Inclusion criteria were the daily use of a PPI for more than 6 months, bothersome regurgitation — with or without heartburn — while receiving at least 40 mg of omeprazole or its equivalent, and abnormal esophageal acid exposure after 7 days off PPI therapy.

 
Regurgitation is unpleasant on many levels; it limits physical activity a lot more than heartburn does, and it's a lot less treatable.
 

On the Reflux Disease Questionnaire, patients indicated that they experienced either an acid taste in their mouth or an unpleasant movement of material upward from the stomach, or they experienced both symptoms daily or on multiple days a week. It was typically moderate to severe in intensity.

Of the 696 patients screened as potential candidates for the study, 129 were eventually randomized in a 2:1 ratio to transoral fundoplication plus placebo or to sham surgery plus twice-daily omeprazole 40 mg.

During the transoral fundoplication procedure, physicians aim to restructure the gastroesophageal junction using small fasteners to plicate the tube and restrict the amount of fluid refluxing out of the stomach and entering the esophagus.

In the study, the average procedure lasted 49 minutes and an average of 23 fasteners was used.

The 6-month study was completed by 76 patients in the transoral fundoplication group and 28 in the PPI group. Before the final analysis, patients were all reassessed symptomatically and underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy.

In the final intent-to-treat analysis, more patients in the transoral fundoplication group than in the PPI group reported the elimination of troublesome regurgitation (67% vs 45%; P = .023).

There was a significant reduction in intraesophageal acid exposure for all parameters measured in the transoral fundoplication group (P < .01), but no improvement in pH control in the PPI group.

Bloating and dysphagia, unwanted sequelae associated with surgical fundoplication, improved in both groups.

"Adverse events were minimal, so transoral fundoplication appears to be safe without the side effects of surgical fundoplication," said Dr Kahrilas.

"You don't want to completely eliminate the ability to vent the esophagus, because then patients wouldn't be able to burp. If the procedure is overly done, you have too restrictive an outflow," he explained.

"Regurgitation is unpleasant on many levels," said Dr Kahrilas. "It limits physical activity a lot more than heartburn does, and it's a lot less treatable with medicinal therapies. It comes down to whether or not a patient's anatomy is 'fixable' by the intervention because the more distorted the anatomy, the less likely you are going to be able to effectively treat with this technique."

Regurgitation is one of the most difficult reflux symptoms physicians have to treat, said Nicholas Shaheen, MD, from the University of North Carolina School of Medicine at Chapel Hill.

"Medical therapy generally does a poor job of controlling this symptom; a mechanical barrier is optimal," he told Medscape Medical News.

In fact, the field needs an effective, durable, minimally invasive alternative to surgery for the large number of patients who experience regurgitation, he added.

"Transoral fundoplication shows promise as an alternative," said Dr Shaheen. However, he added, more data, especially regarding durability, will be necessary to position the procedure in the correct place in treatment algorithms.

This study was supported by a grant from EndoGastric Solutions. Dr Kahrilas reports serving as a consultant for Reckitt Benckiser, AstraZeneca, and Pfizer. Dr Shaheen has disclosed no relevant financial relationships.

American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting: Abstract 41. Presented October 21, 2014.

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