Gastroenterology

Gastroenterology

Volume 125, Issue 3, September 2003, Pages 668-676
Gastroenterology

Clinical-alimentary tract
Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial

Presented during the Digestive Disease Week meetings, May 22, 2002, at the plenary session of the American Society of Gastrointestinal Endoscopy.
https://doi.org/10.1016/S0016-5085(03)01052-7Get rights and content

Abstract

Background & Aims: Gastroesophageal reflux disease is a prevalent disorder that often requires long-term medical therapy or surgery. The United States Food and Drug Administration recently cleared new endoluminal gastroesophageal reflux disease treatments; however, no controlled trials exist. Methods: We randomly assigned 64 gastroesophageal reflux disease patients to radiofrequency energy delivery to the gastroesophageal junction (35 patients) or to a sham procedure (29 patients). Principal outcomes were reflux symptoms and quality of life. Secondary outcomes were medication use and esophageal acid exposure. After 6 months, interested sham patients crossed over to active treatment. Results: At 6 months, active treatment significantly and substantially improved patients’ heartburn symptoms and quality of life. More active vs. sham patients were without daily heartburn symptoms (n = 19 [61%] vs. n = 7 [33%]; P = 0.05), and more had a >50% improvement in their gastroesophageal reflux disease quality of life score (n = 19 [61%] vs. n = 6 [30%]; P = 0.03). Symptom improvements persisted at 12 months after treatment. At 6 months, there were no differences in daily medication use after a medication withdrawal protocol (n = 17 [55%] vs. n = 14 [61%]; P = 0.67) or in esophageal acid exposure times. There were no perforations or deaths. Conclusions: Radiofrequency energy delivery significantly improved gastroesophageal reflux disease symptoms and quality of life compared with a sham procedure, but it did not decrease esophageal acid exposure or medication use at 6 months. This procedure represents a new option for selected symptomatic gastroesophageal reflux disease patients who are intolerant of, or desire an alternative to, traditional medical therapies.

Section snippets

Methods

We conducted a randomized, double-blinded, sham-controlled trial of radiofrequency energy to the gastroesophageal junction for the treatment of GERD. Reporting methods comply with the CONSORT (consolidated standards of reporting trials) statement.17

Results:

A total of 64 patients were randomized (35 to active treatment and 29 to sham) between May 2000 and February 2001 (Figure 1). All patients received conscious sedation, and the median active treatment procedure time (from starting the initial endoscopy to catheter removal) was 51 minutes. Not all sites fully enrolled their block assignments; random variation created a slight imbalance in the proportion of subjects allotted to active vs. sham treatments. Partial or complete 6-month data were

Discussion

This study found that radiofrequency energy to the gastroesophageal junction significantly and substantially reduced GERD symptoms, improved GERD HRQL, and improved general quality of life at 6 months compared with a sham procedure. The mean posttreatment heartburn symptom scores and quality of life measures in the active treatment group were comparable to their pretreatment values while taking medications. The symptom improvement compared with a sham procedure was comparable to or greater than

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  • Cited by (0)

    Supported by Curon Medical, Sunnyvale, California. None of the authors act as paid consultants for, are employees of, or hold any equity interest in Curon Medical.

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