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

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

Research output: Contribution to journalArticle

250 Citations (Scopus)

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

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Gastroesophageal Reflux
Randomized Controlled Trials
Quality of Life
Heartburn
Acids
Therapeutics
Esophagogastric Junction
United States Food and Drug Administration

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Improvement of gastroesophageal reflux symptoms after radiofrequency energy : A randomized, sham-controlled trial. / Corley, Douglas A.; Katz, Philip; Wo, John; Stefan, Andreas; Patti, Marco; Rothstein, Richard; Edmundowicz, Steven; Kline, Michael; Mason, Rodney; Wolfe, M. Michael.

In: Gastroenterology, Vol. 125, No. 3, 01.09.2003, p. 668-676.

Research output: Contribution to journalArticle

Corley, DA, Katz, P, Wo, J, Stefan, A, Patti, M, Rothstein, R, Edmundowicz, S, Kline, M, Mason, R & Wolfe, MM 2003, 'Improvement of gastroesophageal reflux symptoms after radiofrequency energy: A randomized, sham-controlled trial', Gastroenterology, vol. 125, no. 3, pp. 668-676. https://doi.org/10.1016/S0016-5085(03)01052-7
Corley, Douglas A. ; Katz, Philip ; Wo, John ; Stefan, Andreas ; Patti, Marco ; Rothstein, Richard ; Edmundowicz, Steven ; Kline, Michael ; Mason, Rodney ; Wolfe, M. Michael. / Improvement of gastroesophageal reflux symptoms after radiofrequency energy : A randomized, sham-controlled trial. In: Gastroenterology. 2003 ; Vol. 125, No. 3. pp. 668-676.
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AU - Patti, Marco

AU - Rothstein, Richard

AU - Edmundowicz, Steven

AU - Kline, Michael

AU - Mason, Rodney

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