[Long-term efficacy and safety research on functional dyspepsia treated with electroacupuncture and Zhizhu Kuanzhong capsule].

OBJECTIVE: To observe the long-term efficacy and safety on functional dyspepsia treated with electroacupuncture and Zhizhu Kuanzhong capsule and explore the therapeutic mechanism. METHODS: Three hundreds and twenty patients with confirmed diagnosis as functional dyspepsia were randomly divided into 4 groups: an electroacupuncture group, a Zhizhu Kuanzhong capsule group, a combined therapy group and a western medication group, 80 cases in each group. In electroacupuncture group, acupuncture was applied to Zusanli (ST 36), Zhongwan (CV 12), Neiguan (PC 6), Taichong (LR 3) and Gongsun (SP 4), twice per day, continuously for 5 days each week. In Zhizhu Kuanzhong capsule group, Zhizhu Kuanzhong capsule, 1.29 g was administered for oral application, three times each day. In combined therapy group, the therapeutic programs in the above-mentioned groups were applied in combination. In western medication group, Mosapride 5 mg, three times per day; Omeprazole 20 mg, twice per day and Amitriptyline 25 mg, twice per day were administered for oral application. Six weeks treatment was required in each group. The symptoms score, the Nepean Dyspepsia Symptom Index (NDSI), the Nepean Dyspepsia Life Quality Index (NDLQI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), electrogastrography, plasma motilin, gastric emptying by B-sonography and adverse reactions were observed before and after treatment, as well as 4 weeks after treatment separately. RESULTS: Compared with those before treatment, the symptom score and NDSI decreased apparently after treatment (all P < 0.01), NDLQI, SF-36, electrogastrographic frequency, plasma motilin and gastric emptying were up-regulated apparently (all P < 0.01) after treatment in each group. The results of the above-mentioned indices in combined therapy group were superior to the other groups (all P < 0.05). As compared with the condition at the end of treatment, in 4 weeks after treatment, the above indices were not rebound apparently in electroacupuncture group and combined therapy group (all P > 0.05). But they were rebound obviously in Zhizhu Kuanzhong capsule group and western medication group (all P < 0.05). The short-term and long-term efficacies in combined therapy group were significantly higher than the total effective rates in the other groups (P < 0.05, P < 0.01). No serious adverse reaction was reported in each group. CONCLUSION: Electroacupuncture and Zhizhu Kuanzhong capsule all up-regulate plasma motilin and electrogastrographic frequency, promote gastric emptying, alleviate the symptom of functional dyspepsia and improve NDLQI. But the combined medication achieves much better efficacy and presents better safety and long-term therapeutic effect.