Efficacy and safety of Chinese Herbal Medicine (Shugan-Hewei Decoction) combined with vonoprazan for refractory gastroesophageal reflux disease: A study protocol for a Double-Blind Randomized controlled trial

Introduction: Refractory gastroesophageal reflux disease (rGERD) therapy is always lack of effective treatment in recent medical procedures. The potassium-competitive acid blocker (PCAB) vonoprazan has greater potency of acid inhibition than PPIs. The Chinese herbal medicine (CHM) Shugan-Hewei Decoction (SHD) has also demonstrated its efficacy in relieving symptoms and improving quality of life, but data on its efficacy combined with vonoprazan for rGERD are limited. This trial aims to evaluate the efficacy and safety of SHD combined with vonoprazan in the treatment of rGERD. Methods and analysis: This is a pilot, randomized, parallel-arm, placebo-controlled, multi-center clinical trial. A total of 124 participants will be allocated to the SHD group and control group randomly. The SHD group will receive SHD granules with vonoprazan (20mg/day). The control group will receive vonoprazan (20mg/day) plus an SHD granule placebo. Each group will be treated for 8 weeks. The primary outcome of the study is the score of the gastroesophageal reflux disease health-related quality of life questionnaire (GERD-Q). Secondary outcomes include healing rate, Acid exposure time (AET), oesophageal high-resolution manometry (HRM), frequency scale for the symptoms of GERD (FSSG), evaluation criteria of TCM syndrome efficacy, SF-36 quality of life scale (SF-36) and somatization symptom checklist (SSS). This trial aims to investigate the efficacy and safety of SHD combined with vonoprazan in the treatment of rGERD. Ethics and dissemination: This study has been approved by the Institutional Review Board of Human Research of Yueyang Hospital (approval number:2022-050). We will report the results of this study in a peer-reviewed journal and academic conference. Trial registration: ChiCTR2200061651, Registered 30 June 2022, https://www.chictr.org.cn/showproj.html?proj=171492