Chronic Electrical Stimulation at Acupuncture Points Improves Dyspeptic Symptoms in Patients with Diabetic Gastroparesis

Abstract

Purpose: Treatment options for gastroparesis, especially in those who are refractory to medical therapy are very limited. The aim of this project was to assess the effects of a chronic electrical stimulation (ES) at acupuncture points on symptoms of gastroparesis in diabetic patients with refractory gastroparesis. Methods: A digital microstimulator was specially developed for this project. It was the size of a watch and could be easily attached to the wrist or leg without interfering with daily activity of the patient. Twenty-six pts with diabetic gastroparesis were enrolled and 18 of them (50.4±10.8 yrs, 5M, 13F) completed the study. In a crossover design, each pt was blindly treated at home with 4-week ES and 4-week sham-ES in a randomized order. ES was performed via surface ECG electrodes placed at acupoints PC6 and ST36 using pulse trains: train on of 2s and off of 3s, 0.5ms, 25Hz and 2-6mA (appropriate and well-tolerated). Sham-ES was performed using same parameters via non-acupoints. The pts were asked to self-apply ES/sham-ES for 2 hrs after lunch/dinner. The electrogastrogram (EGG) and ECG were recorded during 4 visits (beginning and end of each 4-week treatment). Gastroparesis cardinal symptom index (9 questions) and Quality of Life (SF-36) were assessed weekly. Results: 1) Good compliance of using the microstimulation for ES therapy was noted: the actual usage of the therapy was 300.3±82.5 min/day (requested usage: 300 min/day). 2) 4-wk ES not sham-ES significantly improved 5 of 9 gastroparesis symptoms: nausea by 29.7% (P=0.005 vs. baseline), vomiting by 39.3% (P=0.055), abdominal fullness by 21.4% (P=0.0047), bloating by 20.6% (P=0.006), and retching by 31.1% (p=0.006). A significant improvement in body pain was also noted with ES. 4) 4-week ES not sham-ES increased % of normal slow waves in both fasting (72.8±14.1% vs. 79.9±13.5%, P=0.05) and fed (69.5±12.1% vs. 77.4±16.5%, P=0.04) states. 5) 4-week ES not sham-ES resulted in a trend of increase in vagal activity in the fed state (P=0.08). Conclusion: The home-based noninvasive ES therapy is feasible and effective in treating gastroparesis symptoms and possible mechanisms involving central, gastric and autonomic functions require further elucidation. Disclosure: Jiande Chen - President: Transtimulation Research Inc; Jianfeng Chen - Vice President: Transtimulation Research Inc. This research was supported by an industry grant from This study was supported by an NIH-SBIR grant.