Abstract
Purpose
To determine the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with proton pump inhibitor (PPI) therapy on symptoms and signs of patients with suspected laryngopharyngeal reflux disease (LPRD).
Methods
This was a prospective randomized controlled study. Seventy patients with reflux symptom index (RSI) > 13 and reflux finding score (RFS) > 7 were recruited and received PPI alone (control group) or TEAS combined with PPI (experimental group) for 12 weeks. Patients in the experimental group received TEAS at Tiantu (RN22), Renying (ST9), and Neiguan (PC6) once a day, five times a week. RSI, RFS, throat pain visual analog score (VAS), and LPR–health-related quality-of-life (LPR–HRQL) scores were evaluated at baseline and after 4 and 12 weeks.
Results
The decreases in total RSI and RFS, along with several subscores, were significantly higher in the experimental group than in the control group after 12 weeks (P < 0.05). The throat pain VAS and LPR–HRQL scores decreased significantly at 4 and 12 weeks after treatment in both groups, with significant differences between the groups (P < 0.001). No severe adverse events occurred, and the rates of adverse events were similar between the two groups.
Conclusion
Compared with PPI alone, TEAS combined with PPI showed a significantly greater improvement in symptoms, signs, and quality of life in the treatment of LPRD without increasing the occurrence of adverse effects. Therefore, TEAS could serve as a useful and safe treatment method for LPRD.
Trial registration
Chinese Clinical Trial Registry, ChiCTR2100046755.
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Acknowledgements
We are grateful for the non-binding support of Tianchang Jianfa Ziran Medical Products Co. Ltd, a company working on a device for TEAS therapy, of which the corresponding author Yehai Liu is a shareholder.
Funding
This study was supported by the Scientific Research Project of the Anhui Provincial Health Commission (AHWJ2021b160) and the 2018 University Scientific Research Project (KJ2018ZD021). The sponsor played no part in the study design, collection, management, analysis, and interpretation of data, writing of the report, or the decision to submit the report for publication.
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This clinical trial adhered to the protocol of the Declaration of Helsinki 1964. This study was supported by the Clinical Medical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University (project number PJ2021-04-20). This study was registered with the Chinese Clinical Trial Registration Center (ChiCTR2100046755) on May 28, 2021. This study was conducted in accordance with the approved protocol.
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Shen, H., Han, Y., Yao, C. et al. Transcutaneous electrical acupoint stimulation for suspected laryngopharyngeal reflux disease. Eur Arch Otorhinolaryngol 280, 1815–1825 (2023). https://doi.org/10.1007/s00405-022-07698-9
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DOI: https://doi.org/10.1007/s00405-022-07698-9