Safety and clinical efficacy evaluation on Invigorating Stomach and Regulating Spleen Oral Liquid in the treatment of functional dyspepsia with syndrome of spleen deficiency and qi stagnation

Objective To explore the safety and clinical efficacy on Invigorating Stomach and Regulating Spleen Oral Liquid in the treatment of functional dyspepsia with syndrome of spleen deficiency and qi stagnation.Methods 108 patients were divided into two groups randomly.The patients(n = 53) in treatment group received Invigorating Stomach and Regulating Spleen Oral Liquid and patients(n = 55) in control group received Invigorating Stomach and Regulating Spleen Pill.The efficacies of gastrointestinal motor activity,clinical symptoms,composite and the safety evaluation were compared between two groups.Results The scores of traditional Chinese medical syndrome in two groups after treatment compared with before treatment,there were significant differences(Ptreatment group 0.01,Pcontrol group 0.05).Comparing on single clinical symptom scores,gastrectasis,abdominal distension,abdominal pain,eructation,anorexia,early satiety of two groups after treatment compared with before treatment,there were significant differences(P 0.05,P 0.01).ITT analysis: The total effective rate of treatment group was 96.21%,the total effective rate of control group was 96.36%.PPA analysis: The total effective rate of treatment group was 97.82%,the total effective rate of control group was 96.23%,there were no significant differences of ITT analysis and PP analysis in two groups(all P 0.05).There was no adverse events took place in treatment group,and 3 adverse events in control group.Conclusion Invigorating Stomach and Regulating Spleen Oral Liquid can improve the gastric emptying and has better effect on the clinical symptoms of functional dyspepsia patients with syndrome of spleen deficiency and qi stagnation.It will be the common drugs in the treatment of functional dyspepsia patients with syndrome of spleen deficiency and qi stagnation.