JMIR Publications

ABSTRACT

Background:

Chronic atrophic gastritis(CAG) is a prevalent digestive system disorder, and patients presenting with low-grade dysplasia(LGD) face a significantly elevated risk of malignant transformation. Current clinical management primarily relies on regular endoscopic surveillance, as no definitive treatment addressing the underlying pathogenesis or effectively reversing disease progression has been established. Traditional Chinese Medicine(TCM) has demonstrated distinct advantages in managing CAG. This study aims to evaluate the clinical efficacy and safety of Shenye Xiaozheng Formula(SYXZ), a compound Chinese herbal formula, in treating CAG with LGD.

Objective:

This study aims to evaluate the clinical efficacy and safety of Shenye Xiaozheng Formula (SYXZ) in treating chronic atrophic gastritis (CAG) with low-grade dysplasia (LGD), and to provide high-level evidence supporting its clinical application.

Methods:

This multicenter, randomized, double-blind, placebo-controlled clinical trial will enroll 280 participants equally randomized to receive either SYXZ granules or its matched placebo (SYXZ granules simulator) for a 24-week intervention period, followed by 24 weeks of post-treatment follow-up. The primary endpoints are histopathological reversal and progression rates of gastric dysplasia, evaluated through standardized pathological review. Secondary outcomes include changes in serum biomarkers, TCM syndrome scores, endoscopic gastric cancer risk score, OLGA/OLGIM, as well as longitudinal assessments of psychological status (anxiety/depression scales) and systemic inflammatory markers to comprehensively evaluate therapeutic effects and potential mechanisms. A multi-center, randomized, double-blind, placebo-controlled clinical trial will be established. A total of 280 participants in 4 centers with CAG with LGD and TCM syndrome of liver depression and blood stasis This multicenter, randomized, double-blind, placebo-controlled clinical trial will enroll 280 participants with chronic atrophic gastritis accompanied by low-grade dysplasia and liver depression-blood stasis syndrome (as per TCM diagnosis) across four centers. Participants were randomly allocated in a 1:1 ratio to receive either Shenye Xiaozheng granule or its matched placebo for 24 weeks of intervention, followed by 24 weeks of observation. Primary endpoints included histological regression and progression rates of gastric dysplasia. Secondary endpoints comprised serological parameters, TCM syndrome scores, endoscopic gastric cancer risk assessment (OLGA/OLGIM staging), along with evaluations of anxiety/depression scales and inflammatory biomarkers to elucidate potential mechanisms.

Results:

This multicenter, randomized, double-blind, placebo-controlled trial will rigorously assess the histopathological reversal effects of SYXZ on gastric dysplasia, alongside improvements in serum biomarkers, TCM syndrome scores, endoscopic risk stratification, psychological status, and systemic inflammation, thereby clarifying its therapeutic potential and safety profile for CAG with LGD.

Conclusions:

This study aims to rigorously evaluate the clinical efficacy and safety of SYXZ for CAG with LGD, generating evidence to guide its clinical implementation and protocol optimization. Key words：chronic atrophic gastritis with low-grade dysplasia, Shenye Xiaozheng Formula, randomized controlled trial, Traditional Chinese medicine Clinical Trial: chronic atrophic gastritis with low-grade dysplasia; Shenye Xiaozheng Formula; randomized controlled trial; Traditional Chinese medicine