Objective: To investigate the clinical effect of treating functional dyspepsia (symptoms of disharmony between liver and stomach) by the method of smoothing the liver and fortifying the spleen and harmonizing the stomach. Method: Eighty-six patients with functional dyspepsia were randomly divided into the observation group and the control group with 43 cases in each group. domperidone 10 mg was taken orally 0.5 h before dinner three times per day for the control group and omeprazole enteric-coated tablets 10 mg was taken orally 0.5 h before dinner one times per day to the patients who had epigastric pain and burning. Method of smoothing the liver and fortifying the spleen and harmonizing the stomach was used to treat the observation group. The courses of two groups were both four weeks. The symptoms of disharmony between liver-stomach and evaluate the quality of life of the patients were observed. Result: The total effective rate of the observation group (90.7%) was better than that (72.1%) of the control group (P<0.05). The total effective rate for syndromes of traditional Chinese medicine in observation group (93.02%) was better than that (67.44%) in the control group (P<0.01). Scores of the syndrome of abdominal distension

early satiety

abdominal pain

epigastric burning sensation and disharmony between liver-stomach after treatment in the observation group were significantly lower than those in the control group (P<0.01). Scores of the trunk function (PF)

general health (GH)

role emotional (RE)

social function (SF)

bodily pain (BF) and mental health (MH) after treatment in the observation group were higher than those in the control group (P<0.05). Conclusion: The treatment of smoothing the liver

fortifying the spleen and harmonizing the stomach can significantly improve the clinical symptoms of functional dyspepsia

the quality of life and the clinical efficacy.