ABSTRACT
OBJECTIVE: To observe the clinical efficacy and safety of electroacupuncture combined with Dalitong granule for gastroesophageal reflux disease and to explore the therapeutic mechanism. METHODS: Five hundred cases diagnosed as gastroesophageal reflux disease were randomly divided into a combination group, an electroacupuncture group, a Dalitong granule group, and a western medication group, 125 cases in each group. The electroacupuncture group was treated with acupuncture at Zusanli (ST 36), Zhongwan (CV 12), Neiguan (PC 6), Tai-chong (LR 3) and Gongsun (SP 4), once daily for 6 weeks; the Dalitong granule group was treated with oral administration of Dalitong granule 6 g, three times daily; the combination group was treated with above two methods; the western medication group was treated with oral administration of Mosapride 5 mg, three times daily, Omeprazole 20 mg, twice daily and Amitriptyline 25 mg, twice daily. The total refluxing times, times of long-term reflux, percentage of upright time, percentage of supine time, percentage of total time of the 24-hour intraesophageal pH < 4 or bilirubin absorbance value (Abs) > or = 0.14, symptom score, endoscopic score, life quality score and adverse reaction were observed before treatment, at the end of treatment and 48 weeks after treatment in four groups. RESULTS: Compared with those before treatment, esophageal acid reflux, bile reflux, endoscopic score and symptom score were decreased significantly at the end of treatment in four groups (all P < 0.01), while score of life quality was increased significantly (all P < 0.01). The improvements of above indices in the combination group were superior to other groups (all P < 0.05). Compared with the end of treatment, changes of above indices were not obvious in both of combination group and electroacupuncture group 48 weeks after treatment (all P > 0.05), but these indices all recurred significantly in other two groups (all P < 0.5). The short and long-term total effective rates in the combination group were superior to other groups (P < 0.5, P < 0.1). No serious adverse reaction occurred in four groups. CONCLUSION: Electroacupuncture and Dalitong granule can both inhibit esophageal acid reflux and bile reflux, decrease endoscopic score, alleviate the symptom of gastroesophageal reflux and improve life quality, but the effect of combination is much better with safety and long-term efficacy, which is correlated with their acid inhibition, gastrointestinal motility and antidepressant effects.
