The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis

Follow-up Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis Based on Histological Evaluation

The purpose of this study is to evaluate efficacy of Chinese medicine treatment for chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.

A prospective, double-blind, randomized, placebo-controlled, multi-center trial is carried out in this study.The sample size is 468 patients ( 312 in treatment group, 156 in control group). The investigators will screen the patients for inclusion according to the inclusion and exclusion criteria. All patients detect of H.pylori, undergo upper digestive endoscopy and biopsies for histological investigation. Patients infected of H.pylori must receive H.pylori eradication therapy under the guidance of Kyoto global consensus report on H.pylori gastritis. Then they are assigned to treatment group or control group with an allocation ratio of 2:1. Patients intreatment group take the traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Treatment duration lasts 24 weeks. Investigators also follow up another 24 weeks. Histological changes are used as the primary outcome index. Endoscopy findings, symptoms are assessed. Serum level of pepsinogen and patient-reported outcome instrument are also administered during the study. All biopsy specimens are collected to build the biological specimen bank. Central blinded histological assessment (Histological diagnosis is determined independently by three experienced pathologists who are blinded to the information of the patients.) are used to insure the accuracy and consistency. Tele-medicine and information management system is established to help achieve follow-up interviews.

Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.

Inclusion criteria

1. Patients diagnosed with chronic atrophic gastritis.
2. Patients whose pathological diagnosis was atrophy (reduction glands) of mild/moderate grade，with or without intestinal metaplasia, with or without mild/moderate dysplasia.
3. Aged between 40 to 65 years old, male or female.
4. Patients who agree to participate in the clinical study through informed consent.
5. Local residents ensuring regular treatment and follow-up.
6. Not taking aspirin, warfarin and other anticoagulants and those without coagulation disorders.

Exclusion criteria

1. Autoimmune gastritis.
2. The combined gastric and duodenal ulcers, upper gastrointestinal bleeding.
3. Dysplasia of severe degree,or suspicious of gastric malignancy.
4. Serious comorbidities of heart, lung, liver, kidney or blood system (such as cardiac function above grade II, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal, creatinine (Cr) greater than the upper limit of normal and so on) or having a life-threatening illness .
5. Psychiatric disorders or a history of alcohol or drug abuse.
6. Pregnant or lactating women.
7. Allergic to the trial drug.
8. Patients judged inappropriate to participate in the trial by investigators.
9. Patients enrolled in another clinical trial last two months.