RESUMO
Objective:To evaluate the clinical efficacy of Zhiwei pill for bile reflux gastritis （BRG） with symptoms of disharmony of liver and stomach， evaluate the safety after treatment by three-arm study， and investigate the regulatory action to gastrointestinal hormones. Method:One hundred and eighty patients were randomly divided into placebo group （60 cases）， control group （60 cases） and observe group （60 cases） by random number table. Patients in three groups got lifestyle intervention of non-drug therapy. Patients in control group got hydrotalcite tablets 1-2 hours after meal or untimely bedtime or in case of stomach pain， 2 tablets/time， 3 times/day. Patients in placebo group got simulated medicine of Zhiwei pill 1 hour after meal， 6 g/time， 3 times/day. Patients in observe group got Zhiwei pill 1 hour after meal， 6 g/time， 3 times/day. The treatment continued for 4 weeks in all 3 groups. Before and after treatment， scores were graded for symptoms of disharmony of liver and stomach and patient reported outcome （PRO） scale for patients with chronic gastrointestinal diseases. Gastroscopy was taken to grade the scores of bile reflux and mucosa under gastroscope. Levels of gastrin （GAS）， motilin （MTL）， cholecystokinin （CCK）， substance P （SP） and gastrointestinal hormones were detected. Efficacy for traditional Chinese medicine（TCM） syndrome and efficacy under gastroscope were compared， and safety after treatment was evaluated. Result:After treatment， the total scores of the main symptoms and 7 secondary symptoms of disharmony of liver and stomach in observe group were all lower than those in placebo group and control group （<italic>P</italic><0.01）， and scores of symptoms of disharmony of liver and stomach and PRO were all lower than those in control group and placebo group （<italic>P</italic><0.01）. After treatment， scores of degree of bile reflux and mucosa under gastroscope in observe group were all lower than those in placebo group and control group （<italic>P</italic><0.01）. Level of CCK was lower than that in placebo group and control group （<italic>P</italic><0.01）， while levels of MTL， GAS and SP were higher than those in placebo group and control group （<italic>P</italic><0.01）. Total effective rate of TCM syndrome was 91.38%（53/58）， higher than 71.93%（41/57） in control group and 34.62%（18/52） in placebo group. The total effective rate in gastroscopy was 93.10%（54/58）， higher than 78.95%（45/57） in control group and 28.85%（15/52） in placebo group （<italic>P</italic><0.05 or <italic>P</italic><0.01）. No adverse reactions related to Zhiwei pill were found. Conclusion:Zhiwei pill can improve bile reflux， promote the healing of mucosa under gastroscope， regulate gastrointestinal hormones， improve gastrointestinal motor function， significantly alleviate clinical symptoms， and improve quality of life， with better efficacy for TCM syndrome and efficacy in gastroscopy， and it is safe for clinical use.