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. 2021 Feb 11;9(4):323-328.
doi: 10.1093/gastro/goab002. eCollection 2021 Aug.

Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study

Ram Dickman  1 , Sigal Levy  2 , Tsachi Tsadok Perets  1 , Maor Hazani-Pauker  1 , Doron Boltin  1 , Hemda Schmilovitz-Weiss  1 , Issa Nidal  3 , Matan Siterman  1 , Dan Carter  4 , Ronnie Fass  5 , Rachel Gingold-Belfer  1
Affiliations

Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor: proof-of-concept study

Ram Dickman et al. Gastroenterol Rep (Oxf). .

Abstract

Background: Gastroesophageal 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.

Methods: We 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%.

Results: Seven 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.

Conclusion: TESS 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.

Keywords: gastroesophageal reflux disease; proton-pump inhibitor; transcutaneous electrical stimulation system.

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Figures

Figure 1.
Figure 1.
Phase 1 study design. GERD, gastroesophageal reflux disease; PPI, proton-pump inhibitor; LES, lower esophageal sphincter; TESS, transcutaneous electrical stimulation system.
Figure 2.
Figure 2.
The transcutaneous electric stimulation device (TESS) is applied by a technician to the patient's abdominal wall and electrically stimulates the abdominal muscles
Figure 3.
Figure 3.
The transcutaneous electric stimulation device (TESS) stimulates the abdominal muscles with modulated asymmetrical biphasic current waveforms (sawtooth wave) with a typical controlled current level of 15–40 mA base to pick and maximum 70 mA. A high-voltage generator generates 120 V to the current contorted circuit (not shown in the figure). Each waveform includes a burst of multiple rectangular biphasic pulses with a duration of 200 µs and frequency of 35 Hz. During the study, two modulated burst frequencies of 1 and 1.6 Hz were tested.
Figure 4.
Figure 4.
The decline curve of the mean percent total time pH <4 from baseline to Day 4
Figure 5.
Figure 5.
The decline curve of the mean DeMeester score from baseline to Day 4
See this image and copyright information in PMC

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