Abstract

BackgroundGastroesophageal reflux disease (GERD) is a common disorder. Overall, ≤35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Due to the high prevalence and low satisfaction rate with treatment failure, there is an unmet need for new treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI.MethodsWe enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. After the placement of a wireless esophageal pH capsule, all patients were treated with TESS. The primary end point was the reduction in the baseline (pretreatment) 24-hour percent total time pH <4 and/or DeMeester score by 50%.ResultsSeven GERD patients (five females and two males, aged 49.3 ± 10.1 years) completed the study. At baseline, the mean percent total time pH <4 was 12.0 ± 4.9. Following TESS, the mean percent total time pH <4 dropped to 5.5 ± 3.4, 4.5 ± 2.6, 3.7 ± 2.9, and 4.4 ± 2.5 on Days 1, 2, 3, and 4, respectively. At baseline, the mean DeMeester score was 39.0 ± 18.5. After TESS, the mean DeMeester score dropped to 15.8 ± 9.2, 13.2 ± 6.8, 11.2 ± 9.4, and 12.0 ± 6.8 on Days 1, 2, 3, and 4, respectively.ConclusionTESS is a safe and potentially effective modality in reducing esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. A larger and prospective controlled study is needed to verify these preliminary results.

Highlights

  • Gastroesophageal reflux disease (GERD) is a chronic, persistent, and common medical problem with a pooled worldwide prevalence of 13% [1, 2]

  • The combination of a very prevalent chronic problem and a high level of treatment failure has prompted a search for novel therapeutic approaches

  • Identifying validated and safe alternative therapies for GERD is clearly needed in patients who continue to experience GERD

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Summary

Introduction

Gastroesophageal reflux disease (GERD) is a chronic, persistent, and common medical problem with a pooled worldwide prevalence of 13% [1, 2]. Proton-pump-inhibitor (PPI) therapy is the most effective treatment for GERD due to its profound effect on acid secretion, resulting in symptom control, esophageal healing, and prevention of complications. Despite its effectiveness, PPI failure is very common in GERD, affecting 44% of patients [3]. 35% of GERD patients fail the standard dose of proton-pump-inhibitor (PPI) treatment. Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system (TESS) can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI. Methods: We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure (off PPIs) who failed standard-dose PPI. The mean percent total time pH

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