234. EFFECTS OF TRANSCUTANEOUS ELECTRICAL STIMULATION SYSTEM ON HEARTBURN, REGURGITATION AND ESOPHAGEAL ACID EXPOSURE IN GERD PATIENTS

Abstract Background Chronic PPI treatment in GERD is associated with high failure rate and concerns regarding PPI's side effects. In a previously published proof of concept study, a non-pharmacological, non-invasive transcutaneous, electrical stimulation system, reduced esophageal acid exposure in GERD patients unresponsive to standard dose PPI. However, in that study, a symptomatic response to electrical stimulation was not assessed. Aim To determine the effect of a transcutaneous electrical stimulation system (TESS) on symptoms (heartburn and regurgitation) and the percentage of esophageal acid exposure time in GERD patients. Methods Patients suffering from heartburn and regurgitation were recruited into this multicenter study. The first phase of this study was a one week, run-in period, off-PPI's, during which, patients completed symptoms diaries and demographic questionnaires. Thereafter, all patients underwent upper endoscopy with subsequently wireless esophageal pH capsule placement (off PPI). Based on pH analysis in the first 24-hours, (day 0) only those with increased acid exposure time (percent total time pH <4 above 6%) continued to the next phase. During phase two of the study, patients were treated for two weeks with TESS and documented their symptoms. Primary end points included the reduction of baseline (pretreatment) number of heartburn and regurgitation episodes as well as 24-hour percent total time pH <4 and/or DeMeester score by at least 50%. Results 26 GERD patients (16 male, aged 47±15 years, mean BMI 25±3 kg/m2) completed the study. At baseline, mean number of daily heartburn and regurgitation events was 2.41±0.36 and 1.38±0.35, respectively. Following TESS, mean number of daily heartburn and regurgitation events dropped to 0.69±0.16 and 0.31±0.19, respectively (p=0.01). At baseline, mean percent total time pH < 4 was 11.8±0.9. Following TESS, mean percent total time pH < 4 dropped to 7.3±0.8, 7.8±1.0, 6.7±1.1 and 5.0±0.7 for day 1, 2, 3 and 4, respectively (p=0.01). At baseline, mean DeMeester score was 31.4±2.1. Following TESS, mean DeMeester score dropped to 20.1±2.0, 20.4±2.5, 17.3±2.6 and 14.3±2.0 for day 1, 2, 3 and 4, respectively (p=0.01). Conclusions TESS is effective in reducing both symptoms (heartburn and regurgitation) and esophageal acid exposure time in GERD patients.