Improvement of gastroesophageal reflux symptoms after radiofrequency energy: A randomized, sham-controlled trial

Douglas A. Corley, Philip Katz, John M. Wo, Andreas Stefan, Marco Patti, Richard Rothstein, Steven Edmundowicz, Michael Kline, Rodney Mason, M. Michael Wolfe

Research output: Contribution to journalArticle

256 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)668-676
Number of pages9
JournalGastroenterology
Volume125
Issue number3
DOIs
StatePublished - Sep 1 2003
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Corley, D. A., Katz, P., Wo, J. M., Stefan, A., Patti, M., Rothstein, R., Edmundowicz, S., Kline, M., Mason, R., & Wolfe, M. M. (2003). Improvement of gastroesophageal reflux symptoms after radiofrequency energy: A randomized, sham-controlled trial. Gastroenterology, 125(3), 668-676. https://doi.org/10.1016/S0016-5085(03)01052-7