Zhongguo quanke yixue (Jul 2024)
A Multicenter Randomized Controlled Clinical Trial Study on the Effect of Piwei Peiyuan Decoction Combined with Acupuncture in the Treatment of Chronic Atrophic Gastritis with Intestinal Metaplasia
Abstract
Background Chronic atrophic gastritis (CAG) with intestinal metaplasia (IM) is an independent risk factor for gastric cancer. Long-term inflammation and oxidative stress response stimulate the physical and mental state of patients. Under the modern medical model, proton pump inhibitors and gastric mucosal protective agents are increasingly unable to meet the high drug resistance of patients. It is urgent to seek effective new Chinese medicine treatments and multiple methods to treat CAG and IM. Objective To evaluate the clinical efficacy and safety of modified Piwei Peiyuan Decoction combined with acupuncture in the treatment of CAG with IM. Methods From January 2022 to September 2023, 202 patients with CAG and IM diagnosed by gastroscopy and pathological examination in the Department of Spleen and Stomach, the Center for Preventive Treatment of Disease, the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine and the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine were selected. The patients were divided into control group (n=67), treatment group A (n=68) and treatment group B (n=67) by random number table method. All patients participated in 6 weeks of treatment: (1) Control group: aluminum magnesium suspension combined with folic acid tablets (3 times/d) ; (2) Treatment group A: to add and subtract syndrome types of Piwei Peiyuan Decoction (2 times/d) ; (3) Treatment group B: Piwei Peiyuan Decoction (the same as group A) combined with acupuncture (1 time/d), with Zusanli, Liangqiu, Gongsun, Neiguan, Zhongwan as the main points, according to the syndrome type selection of acupoints. Before and 6 weeks after treatment, OLGA, OLGIM staging, gastric mucosal pathological efficacy, gastric mucosal pathological score, clinical symptom score, PRO scale score, drug-related adverse events (AE) and adverse drug reactions (ADR) were recorded. Results A total of 192 patients completed the 6-week course of treatment (62 in the control group, 66 in the treatment group A, and 64 in the treatment group B). The effective rate of the control group was 48.39% (30/62), the effective rate of the treatment group A was 69.70% (46/66), and the effective rate of the treatment group B was 71.88% (46/64). There was a statistically significant difference in the effective rate among the three groups (χ2=9.144, P=0.01). After treatment, the gastric mucosal pathological score, clinical symptom score and PRO scale score in the three groups were lower than those in the same group before treatment (P<0.05). Pathological score of gastric mucosa: the scores of chronic inflammation, atrophy and IM in treatment group A and treatment group B were lower than those in control group, and the scores of active inflammation and dysplasia were higher than those in control group (P<0.05). Clinical symptom score: the scores of epigastric fullness and epigastric pain in treatment group A and treatment group B were lower than those in control group (P<0.05). The PRO scale score: the treatment group A and the treatment group B were lower than the control group in acid reflux, dyspepsia, defecation, psychological state, systemic symptoms and total score (P<0.05). There was no significant difference in the incidence of AE and ADR among the three groups (P>0.05) . Conclusion The overall clinical efficacy of Piwei Peiyuan Decoction combined with acupuncture is better than that of aluminum magnesium suspension combined with folic acid tablets, which is better than that of traditional antacids and gastric mucosal protective agents.
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