ABSTRACT
Objective: To evaluate the clinical efficacy and long-term efficacy of Shunwei Jiangni Fang in treating the liver- spleen- stomach disharmony and cold- dampness- heat recurrent reflux esophagitis. Methods: A total of 100 recurrent RE patients were divided into treatment group and control group by the random and control principle, with 50 cases in each group. Patients of 2 groups were treated with Shunwei Jiangni Fang and pantoprazole sodium entericcoated capsules respectively for 8 weeks. By comparing TCM syndrome scores and esophagus 24 h- pH parameters improvement, the clinical efficacy and safety of Shunwei Jiangni Fang in treating the liver-spleen-stomach disharmony and cold-dampness-heat recurrent reflux esophagitis, and perform statistics on the recurrence 6 months after treatment ending were evaluated. Results: ① For the patients with TCM syndromes in the treatment group, 4 cases were recovered, 17 cases were improved, 22 cases were effective, and the total effective rate was 86％; for the patients with TCM syndromes in the control group, 2 cases were recovered, 8 cases were improved, 14 cases were effective, and total effective rate was 48％. Difference of total effective rate for 2 groups was significant (P ＜ 0.05). The heartburn, belching, dry mouth, bitter taste, tiredness, distended abdomen and sticky stool in treatment group were more improved than those of control group (P ＜ 0.05); ② In the control group, the patient's 24 h-pH parameters could be improved, especially, the 24h gastric reflux times and times of reflux ＞ 5min could be reduced more than the control group, and difference was significant (P ＜ 0.05). ③ The treatment group was able to improve the patients' esophageal mucosal inflammation, with no statistically significant difference from the control group (P ＞ 0.05). ④ At 6 months after treatment, the recurrence rate of treatment group and control group was 6.0％ and 28％ respectively, and difference was significant (P ＜ 0.05). Conclusions: Shunwei Jiangni Fang can treat the liver-spleen-stomach disharmony and cold-dampness-heat recurrent reflux esophagitis, with apparently efficacy. It can effectively improve the clinical symptoms, reduce the reflux occurrence times, reduce esophageal mucosal inflammation, lower the recurrence rate, prevent apparent adverse reactions, thus, it shall be widely promoted.