No Evidence for Efficacy of Radiofrequency Ablation for Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

BACKGROUND & AIMS: A radiofrequency ablation technique known as Stretta was recommended by the Society of American Gastrointestinal and Endoscopic Surgeons as an alternative treatment for gastroesophageal reflux disease (GERD). However, randomized controlled trials of the efficacy of Stretta have produced conflicting findings, and those from previous systematic reviews were compromised as a result of deficiencies in study conduct and reporting of findings. We performed a systematic review to evaluate all evidence on the efficacy of Stretta for the management of GERD. METHODS: We searched MEDLINE and the Cochrane Central Register of Controlled Trials (The Cochrane Library) from inception until February 28, 2014, along with other databases, for randomized controlled trials of Stretta in patients with GERD. Primary outcomes were physiologic parameters of GERD, including normalization of esophageal pH values and augmentation of lower esophageal sphincter pressure (LESP). Secondary outcomes were health-related quality of life (HRQOL) and ability to stop the use of proton pump inhibitors (PPIs). For quality assurance purposes, 2 investigators were involved throughout the study. Data were pooled under a random-effects model. The systematic review was performed as per the standards of the Cochrane collaboration. RESULTS: We collected data from 4 trials and a total of 165 patients (153 patients were analyzed). Three trials compared Stretta vs sham, and 1 trial compared Stretta with PPI therapy. The overall quality of evidence was very low. The pooled results showed no difference between Stretta and sham or management with PPI in patients with GERD for the outcomes of mean (%) time the pH was less than 4 over a 24-hour time course, LESP, ability to stop PPIs, or HRQOL. CONCLUSIONS: In a meta-analysis of trials, we found that Stretta for patients with GERD does not produce significant changes, compared with sham therapy, in physiologic parameters, including time spent at a pH less than 4, LESP, ability to stop PPIs, or HRQOL.