Abstract
Objective To evaluate the efficacy and safety of sanjiuweitai particles combined with omeprazole in the treatment of functional dyspepsia (FD).Methods A multicenter,randomized,double-blind,double-dummy,parallel-controlled clinical trial was carried out.A total of 405 FD patients were divided into sanjiuweitai group,omeprazole group and combination group.There were 135 cases in each group and were treated with sanjiuweitai particle and omeprazole simulant,omeprazole and sanjiuweitai particle stimulant and sanjiuweitai particle and omeprazole respectively.The medicine was continuously taken for 14 days.The improvement of clinical symptoms of each group was evaluated before and after treatment.Kruskal-Wallis H test was performed for measurement data.Chi-square test or Fisher exact probability method was used for counting material.Pairwise comparisons among three groups,the inspection level was α'=0.0125.Results Two weeks after treatment,clinical symptoms of all the three groups improved significantly.The total efficiency of sanjiuweitai group was 69.2 ％ (90/130),omeprazole group was 65.6 ％ (86/131) and combination group was 83.7％ (103/123).The total efficiency of combination group was higher than those of sanjiuweitai and omeprazole group (x2 =7.3543 and10.9033,P=0.0067 and 0.0010).The total efficiency of sanjiuweitai group was equal with that of omeprazole group (P＞0.05).The main adverse reaction included dizziness,sleepiness,heartburn,abdominal pain and ALT increase.There were no significant differences in the incidence of adverse events among three groups (P＞0.05).Conclusion The efficacy of sanjiuweitai particles with omeprazole combination in the treatment of FD was significant and with few adverse reactions. Key words: Dyspepsia; Gastrointestinal agents (traditional Chinese medicine) ; Omeprazole; Drug therapy, combination; Multicenter study
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