title: Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Research, Kaiser Permanente, Oakland, California, USA. Douglas.Corley@kp.org
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Corley
authors.forename: Philip
authors.initials: P
authors.lastname: Katz
authors.forename: John M
authors.initials: JM
authors.lastname: Wo
authors.forename: Andreas
authors.initials: A
authors.lastname: Stefan
authors.forename: Marco
authors.initials: M
authors.lastname: Patti
authors.forename: Richard
authors.initials: R
authors.lastname: Rothstein
authors.forename: Steven
authors.initials: S
authors.lastname: Edmundowicz
authors.forename: Michael
authors.initials: M
authors.lastname: Kline
authors.forename: Rodney
authors.initials: R
authors.lastname: Mason
authors.forename: M Michael
authors.initials: MM
authors.lastname: Wolfe
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011846:Radio Waves / Q000009:adverse effects; D000078702:Radiofrequency Therapy