The effect of the fortifying the spleen, clearing heat, activating blood method on chronic atrophic gastritis: a real-world study
Authors: Zheng Zhihua , Wen Yi , Yan Yanhua , Xu Zhiheng , Nie Kechao , Chen Xu , Liu Fengbin , Pan Jinglin , Li Peiwu 
Published: January 2020

Introduction

Chronic atrophic gastritis (CAG) is a precancerous disease that is difficult to treat. Even after eradication of the Helicobacter pylori (HP) infection, complete resolution of the symptoms is difficult to achieve. The fortifying the spleen, clearing heat, activating blood method (FSCHABM) has an excellent curative effect in the treatment of CAG. A real-world study is particularly suitable for researching the treatment of CAG, but there are currently no reports on CAG trials. Our aim is to design a high-quality trial to investigate the efficacy and safety of FSCHABM in treating CAG patients.

Methods and analysis

This protocol is designed as a real-world study for 10 years. A total of 5000 participants will be assigned to a FSCHABM treatment group or a non-FSCHABM treatment group at a 1:1 ratio at the first Affiliated Hospital of Guangzhou University of Chinese Medicine. Patients are given 1-2 courses of a 24-week-long treatment. The participants will be followed up for observation and measurement of the following indicators: the primary outcome is the histopathological indicator; the secondary outcome includes evaluation of gastric lesions, syndrome curative effect, evaluation of symptoms, evaluation of quality of life, evaluation of anxiety and depression, economic evaluation and other indicators. This is the first real-world study evaluating the therapeutic effect of FSCHABM in the treatment of CAG in clinical practice. This protocol can provide a reference for future multi-center, randomized, controlled trials.

Strengths and limitations of this study

it is the first time to carry out TCM study related to CAG by using the real-world study. A large number of patients and a long-term study can effectively reflect the effect of TCM treatment and reduce the bias. The precise research protocol makes the whole research more accurate and reliable. The limitations of implementing this protocol are expending a lot of time, manpower and economic resources inevitably.

Ethics and dissemination

this study was approved by Ethical committee of the first Affiliated Hospital of Guangzhou University of Chinese Medicine. Study findings will be shared with participants, healthcare providers, and policymakers through research reports, conference presentations, and the Internet. The results will also be disseminated through publication in peer reviewed journals.

Trial registration

The registration number, ChiCTR1900027177, was assigned by the Chinese Clinical Trial Registry on 3 November 2019.

Funding

This work was supported by Guangdong natural science fund project, China (2019),No.2019A1515011145; Major research project of Guangzhou University of Chinese medicine, China (2019), No.A1-2606-19-110-007; The first affiliated hospital of Guangzhou University of Chinese medicine “innovation foster hospital” clinical research project, China (2019), No.2019IIT19; Guangdong natural science foundation (PhD) project, China (2017), No.2017A030310121; The first affiliated hospital of Guangzhou University of Chinese medicine “innovation foster hospital” innovation research team project, China (2017), No.2017TD05; The first affiliated hospital of Guangzhou University of Chinese medicine “innovation foster hospital” Youth scientific research talent training program, China (2015), No.2015QN09.