title: A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD.
abstract: OBJECTIVE
  Several studies have reported symptom relief in gastro-esophageal reflux disease (GERD) patients treated with radiofrequency delivery (Stretta procedure) at the gastro-esophageal junction (GEJ), but the mechanism underlying this improvement is unclear. The objective of this study was to test the hypothesis that Stretta alters GEJ resistance.
  
  
  METHODS
  We conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. The study was conducted in a tertiary care center. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ were done before the start of the study and after 3 months.
  
  
  RESULTS
  Barostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure. In all, 22 GERD patients (17 females, mean age 47±12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contrast, symptom score was significantly improved and GEJ compliance was significantly decreased. Administration of sildenafil, an esophageal smooth muscle relaxant, normalized GEJ compliance again to pre-Stretta level, arguing against GEJ fibrosis as the underlying mechanism.
  
  
  CONCLUSIONS
  The limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance. Decreased GEJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume.
authors: Department of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.
authors: J
authors: J
authors: Arts
authors: R
authors: R
authors: Bisschops
authors: K
authors: K
authors: Blondeau
authors: R
authors: R
authors: Farré
authors: R
authors: R
authors: Vos
authors: L
authors: L
authors: Holvoet
authors: P
authors: P
authors: Caenepeel
authors: A
authors: A
authors: Lerut
authors: Jan
authors: J
authors: Tack
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D004943:Esophagogastric Junction / Q000503:physiopathology* / Q000601:surgery; D004945:Esophagoscopy; D004947:Esophagus / Q000503:physiopathology / Q000601:surgery; D005260:Female; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome