ABSTRACT
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.
ABSTRACT
Objective::To evaluate theclinical efficacy of Zhiwei pills combined with Hperadication programme for gastritis with liver and stomach Qi stagnation syndrome caused by helicobacter pylori (Hp) and to investigate its effect on antioxidant stress. Method::One hundred and sixty patients were randomly divided into control group (80 cases) and observation group (80 cases) by random number table. Patients in control group gotHperadication programme, and esomeprazole magnesium enteric-coated tablets, 20 mg/time, 1 time/day. Bismuth potassium citrate tablets, 0.3 g/time, 2 times/days. Amoxicillin capsules, 1.0 g/time, 2 times/days. Furazolidone tablets, 0.1 g/time, 2 times/days, all for 14 days. Based on the treatment in control group, the patients in observation group additionally got Zhiwei pills, 6 g/time, 3 times/day. The course of treatment was 8 weeks in both groups. After treatment, eradication of Hp was detected. Before and after treatment, scores of liver and stomach Qi stagnation syndrome were graded. After treatment, patients received gastroscopy and pathological review, and patient report outcome indicators (PRO) both before and after treatment were discussed. The levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-8, oxidative dismutase (SOD), glutathione peroxidase (GSH-Px) and malondialdehyde (MDA) were detected both before and after treatment. Result::Negative conversion rate of Hp was(70/75) 93.33% in observation group, higher than(58/71) 81.69% in control group (P<0.05). In the analysis of rank sum test, effect of traditional Chinese medical(TCM) syndrome in observation group was better than that in control group (Z=2.183, P<0.05), and clinical efficacy was also better than that in control group (Z=2.175, P<0.05). Scores of liver and stomach Qi stagnation syndrome and total PRO score in observation group were all lower than those in control group (P<0.01). Levels of TNF-α, IL-1β, IL-8 and MDA were lower than those in control group (P<0.01), while levels of SOD and GSH-Px were higher than those in control group (P<0.01). Conclusion::Zhiwei pills combined with Hperadication programme can improve the eradication rate of Hp, alleviate clinical symptoms, improve the quality of life of patients, inhibit inflammatory reaction and anti-oxidative stress, and improve the curative effect and clinical efficacy of TCM syndromes in the treatment of gastritis with liver and stomach Qi stagnation syndrome, so it is worth for further study and use.