Author:
Zhang Xiaosi,Cheng Yuan,Li Xiaohong,Tan Xiang,Shi Lei,Shi Xiaojun,Zhang Xiancui,Xie Chun’e,Li Junxiang
Abstract
Abstract
Background
Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chinese medicine (TCM) can relieve the symptoms of reflux and improve the quality of life. The purpose of this study is to evaluate the safety and efficacy of Hewei Jiangni recipe (HWJNR) in the treatment of NERD with cold-heat complex syndrome, and clarify the mechanism of HWJNR on NERD based on the correlation analysis of intestinal flora and metabolites.
Methods
This is a single-center, randomized controlled, double-blind, placebo-controlled clinical trial in which 72 eligible participants with NERD and TCM syndrome of intermingled heat and cold will be randomly allocated in the ratio of 1:1 to two groups: TCM group and western medicine group. The TCM group will receive HWJNR with omeprazole enteric-coated tablets placebo, while the western medicine group will receive omeprazole enteric-coated tablets with HWJNR placebo. Each group will be treated for 8 weeks. The primary outcome is the score of gastroesophageal reflux disease (GERD) health-related quality of life questionnaire (GERD-Q). Secondary outcomes include SF-36 quality of life scale (SF-36), patient-reported outcomes (PRO) self-rating scale score, syndrome score of TCM, and adverse events. Mechanistic outcome is the correlation analysis of intestinal flora and metabolites from healthy individuals and NERD participants before and after the treatment respectively.
Discussion
The goal of this trial is to investigate the efficacy and safety of HWJNR in the treatment of NERD with cold-heat complex syndrome, and to study the composition structure and metabolite expression profile of intestinal flora in patients with NERD through 16SrRNA sequencing and metabolomic correlation analysis of fecal flora, which makes us identify the dominant links of treatment and reveal the potential mechanism of HWJNR.
ChiCTR2000041225. Registered on 22 December 2020
Funder
National Natural Science Foundation of China
Fundamental Research Funds for the Central Universities
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference26 articles.
1. Mehta Raaj S, Staller K, Chan Andrew T. Review of gastroesophageal reflux disease. JAMA. 2021;325(14):1472. https://doi.org/10.1001/jama.2021.1438.
2. Savarino E, de Bortoli N, De Cassan C, et al. The natural history of gastro-esophageal reflux disease: a comprehensive review. Dis Esophagus. 2017;30:1–9.
3. El-Serag HB, Sweet S, Winchester CC, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review[J]. Gut. 2014;63(6):871–80. https://doi.org/10.1136/gutjnl-2012-304269.
4. Spechler SJ. Proton pump inhibitors: what the internist needs to know. Med Clin North Am. 2019;103:1–14.
5. Strand Daniel S, Kim D, Peura David A. 25 years of proton pump inhibitors: a comprehensive review. Gut Liver. 2017;11:27–37.
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