Evaluation of the Efficacy of Electroacupuncture in the Treatment of Chronic Atrophic Gastritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Total pathological response rate after 24 weeks of intervention
研究概览
简要总结
Brief Summary Template for the Study:
This clinical trial aims to evaluate whether electroacupuncture can treat chronic atrophic gastritis (CAG) in adult subjects aged 18 to 75 years (including both males and females), all of whom have been diagnosed with CAG based on endoscopic and histopathological criteria. The primary objectives of this study are to answer the following questions:
- Can 5 Hz electroacupuncture therapy reverse the pathological state of the gastric mucosa in patients with chronic atrophic gastritis?
- Can 5 Hz electroacupuncture therapy improve gastrointestinal symptoms in patients with chronic atrophic gastritis?
- Is there a difference in efficacy between the combination of 5 Hz electroacupuncture therapy and gastric mucosa protectants versus the use of gastric mucosa protectants alone in the treatment of chronic atrophic gastritis?
Researchers will compare the effects of 5 Hz electroacupuncture combined with gastric mucosal protectants versus gastric mucosal protectants alone to determine which method can reverse the pathological state of gastric mucosa and provide more significant symptom relief.
Participants will:
- Receive acupuncture treatment at specific acupoints (such as Shangwan(CV13), Zhongwan (CV12) ,Xiawan(CV10), Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39).) Electroacupuncture is administered at the abdominal points 'CV13-CV12' and 'ST21-ST21', alongside bilateral lower limb points 'ST36-ST39', using an SDZ-IIB handheld electroacupuncture device (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.). Receive electroacupuncture treatment at 5Hz.for 30-minute sessions, three times weekly for 1-8 weeks; twice weekly from weeks 9 to 16, once weekly from weeks 17 to 24, for a total of 24 weeks, comprising 48 treatment sessions.
- Be randomly assigned to one of the following groups: 5 Hz electroacupuncture combined with gastric mucosal protective agent group or gastric mucosal protective agent group (control group).
- Have their dyspepsia symptoms, quality of life, and any adverse reactions continuously monitored and assessed throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for chronic atrophic gastritis (CAG) (at the time of enrolment, participants must provide reports from endoscopic and pathological examinations conducted within the past year prior to the study start date, both of which indicate chronic atrophic gastritis)
- •Age between 18 and 75 years old, no gender restrictions;
- •Has not received acupuncture treatment within the past month;
- •Not participated in any other ongoing studies within the past 2 months.
- •Understand and agree to participate in this study and sign the informed consent form.
排除标准
- •Autoimmune gastritis (type A chronic atrophic gastritis);
- •Participants with a positive C-13 urea breath test at baseline (Helicobacter pylori infection);
- •Patients diagnosed with high-grade intraepithelial neoplasia based on upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
- •Patients with confirmed or unresolved malignant tumours, particularly oesophageal cancer and gastric cancer; patients with other upper gastrointestinal lesions such as peptic ulcers or Barrett's oesophagus;
- •Patients with severe lesions in major organs (heart, liver, kidney, lung, etc.) or other autoimmune diseases (rheumatic diseases, Crohn's disease, autoimmune pancreatitis, etc.); Persons with cardiac pacemakers;
- •Pregnant and lactating women;
- •Patients with infectious diseases such as tuberculosis, hepatitis, or HIV/AIDS;
- •Individuals with a history of alcohol abuse, drug use, or illicit drug use;
- •Individuals who have used other prokinetic agents, mucosal protectants, acid-suppressing medications, or related traditional Chinese medicines within the past two weeks;
- •Individuals currently participating in or who have participated in other clinical trials within the past two months; individuals unable to tolerate acupuncture or with contraindications for acupuncture treatment; and individuals deemed unsuitable for participation in this clinical trial by the research team.
研究组 & 干预措施
Electroacupuncture combined with tipronone capsules group
Participants will receive acupuncture at seven acupoints: Shangwan(CV13), Zhongwan (CV12) ,Xiawan(CV10), Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Disposable needles will be inserted until the "deqi" sensation is achieved. Electroacupuncture is administered at the abdominal points 'CV13-CV12' and 'ST21-ST21', alongside bilateral lower limb points 'ST36-ST39', using an SDZ-IIB handheld electroacupuncture device (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.). Receive electroacupuncture treatment at 5Hz.Patients will receive acupuncture treatment three times a week for 1-8 weeks, twice a week for 9-16 weeks, and once a week for 17-24 weeks, for a total of 48 treatments.
Patients will also be administered SviShu (tipronone capsules) (Wei Cai Pharmaceutical Co., Ltd., National Drug Approval Number H20093656, dosage: 50 mg) orally, one capsule at a time, three times daily, after meals. Treatment will be continued for 24 weeks.
干预措施: 5 Hz electroacupuncture combined tipronone capsules (Other)
Simple tipronone capsules group(The basic treatment group)
Patients in the simple tipronone capsules group(basic treatment group) will receive only conventional basic drug therapy. They will be given Svi-Shu (tipronone capsules) (Eisai Pharmaceutical Co., Ltd., national drug approval number H20093656, specification: 50 mg) orally, one capsule at a time, three times a day, after meals. Treatment will be continued for 24 weeks.
干预措施: Simple tipronone capsules group(The basic treatment group) (Drug)
结局指标
主要结局
Total pathological response rate after 24 weeks of intervention
时间窗: 24 weeks after the start of treatment.
Overall reversal rate (%) = (Total number of cases with OLGA or OLGIM reversal after treatment / Total number of cases) × 100% A reversal case is defined as a case where the patient's OLGA or OLGIM stage at week 24 is lower than the baseline stage (a decrease of ≥1 stage in OLGA or OLGIM stage before and after treatment is defined as a reversal, whereas an increase of ≥1 stage is defined as progression). Any stage reversal is counted toward the total number of reversal cases.
次要结局
- Histological scoring of pathological variables(24 weeks after the start of treatment.)
- Serum pepsinogen I and II (pepsinogen I, pepsinogen II, PG I, PG II), serum pepsinogen ratio (PGR), and gastrin-17 (Gastrin-17) levels.(24 weeks after the start of treatment.)
- Global Overall Symptom (GOS) Score Change(Baseline, Week 12, Week 24)
- Hospital Anxiety and Depression Scale (HADS) Score Change(Baseline, Week 12, Week 24)
- Visual analogue scale (VAS) score for upper abdominal pain(Baseline, Week 12, Week 24)
- Upper abdominal pain diary(Baseline to Week 24)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 12, Week 24)
- Treatment Expectation Score(Prior to the first treatment (Baseline))
- Compliance evaluation(Baseline, Week 12, Week 24)
研究者
Yi Liang
Research Fellow
The Third Affiliated hospital of Zhejiang Chinese Medical University