A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease

Background: Gastroesophageal reflux disease (GERD) is a prevalent disorder that often requires long-term medical therapy or surgery. Radiofrequency (RF) energy delivery (Stretta procedure) has been shown in several studies to improve GERD symptoms and quality of life for approximately two-thirds of patients. The authors proposed that increasing the dose of Stretta would further improve the response to this therapy. Methods For this study, 36 patients were randomized into three groups. In group A, 12 patients underwent a singlesession Stretta procedure. In group B, 12 patients underwent a sham Stretta procedure (mirror of the active procedure in all aspects except there was no deployment of the electrodes). In group C, 12 patients underwent a single Stretta treatment followed by repeat Stretta if GERD health-related quality of life (HRQL) was not 75% improved after 4 months. For each patient, 56 RF lesions were created per session. The principal outcome was GERD HRQL improvement. The secondary outcomes were medication use, lower esophageal sphincter (LES) basal pressure, endoscopic grade of esophagitis, and esophageal acid exposure by pH probe. Results The Stretta procedure was completed successfully for all the patients in both active treatment groups. At 12 months, the mean HRQL scores of those off medications, the LES basal pressure, the 24-h pH scores, and the proton pump inhibitor (PPI) daily dose consumption were significantly improved from baseline in both Stretta groups (p\0.01). The double Stretta was numerically but not significantly better than the single Stretta for mean HRQL, mean 24 h pH, mean LES pressure, and PPI use. Seven patients in the double Stretta treatment group had normalized their HRQL at 12 months compared with 2 patients in the single-treatment group (p = 0.035). The sham patients had a small but statistically significant decrease in their daily PPI dosages (p\0.05) and mean HRQL scores (p\0.05). No serious complications (bleeding, perforation, or death) occurred. However, two patients experienced significant delayed gastric emptying after the second Stretta treatment. Conclusions The Stretta procedure significantly reduced GERD HRQL, use of PPI drugs, esophageal acid exposure, LES pressure, and grade of esophagitis compared with the sham procedure. The double Stretta therapy had numerically superior outcomes for most parameters and a significantly more frequent normalization of HRQL scores compared with the single Stretta.