Objective: To study the clinical curative effect, safety and mechanism of action of electroacupuncture combined with Zhizhukuanzhong capsules (ZZKZC) in treating gastroesophageal reflux disease (GERD).
Methods: A total of 480 patients with confirmed GERD were randomly divided into four groups: the electroacupuncture group, the ZZKZC group, the combined therapy group, and the control group, with 120 cases in each group. Each case in the electroacupuncture group was treated with electroacupuncture on Zusanli (ST 36), Zhongwan (CV 12), Neiguan (PC 6),Taichong (LR 3) and Gongsun (SP 4) once daily for 6 weeks. Each case in the ZZKZC group was treated with oral administration of 1.29 g ZZKZC three times daily. The combined therapy group had electroacupuncture and ZZKZC. The control group was given oral administration of 5 mg mosapride three times and 20 mg pantoprazole twice daily. The 24-hour intraesophageal total number of reflux episodes with pH <4 (or bilirubin absorbance > or = 0.14), the number of long-term (> or = 5 min) reflux episodes, the percentage of upright time, the percentage of supine time, the percentage of total time of pH <4 (or bilirubin absorbance > or = 0.14), endoscopic grading score, symptom score, quality of life score, and adverse reactions were observed before treatment, at the end of treatment and 54 weeks after treatment in the four groups.
Results: The 24-hour intraesophageal pH and bile reflux, endoscopic grading score and symptom score were all significantly decreased at the end of treatment in every group, while the scores of 8 dimensions of quality of life were all increased compared with those before treatment (P<0.01). All of these indices were better in the combined therapy group than those in the other groups (P<0.05). These indices did not significantly deteriorate in the combined therapy group and electroacupuncture group 54 weeks after treatment compared with the end of treatment (P>0.05); however, these indices all significantly deteriorated in the ZZKZC and control groups (P>0.05). The short and long-term total efficacy rates in the combined therapy group showed significant superiority to those in the other groups (P<0.05 or P<0.01). No serious adverse reactions were found in the four groups.
Conclusion: Electroacupuncture and ZZKZC play an important role in inhibiting intraesophageal acid and bile reflux, decreasing the endoscopic grading score, and alleviating the symptoms of gastroesophageal reflux to improve the quality of life. However, the effect of combined treatment is more effective, with better security and long-term efficacy, and therefore, this combination treatment is appropriate for clinical use.