Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial.

BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, as PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two GERD patients \u3e21 years with moderate-to-severe regurgitation despite 8weeks of once-daily PPI therapy were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N=102) or to laparoscopic MSA (N=50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated MSA patients reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (p50% improvement in GERD-HRQL score (p CONCLUSIONS: GERD patients with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with magnetic sphincter augmentation rather than increased PPI dosing. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02505945