Objective

2

To explore the clinical efficacy and safety of modified Heweitang in the treatment of functional dyspepsia （FD） due to liver-stomach disharmony and its regulation of gastrointestinal hormones and brain-gut peptides.

Method

2

One hundred and twenty-six eligible patients were randomized into a control group （62 cases） and an observation group （64 cases）. Patients in the observation group took the modified Heweitang granules with warm water 30 min after meals， 10 g/time， 3 times/day， while those in the control group took the corresponding placebo granules at the same dose in the same manner. The treatment in both groups lasted for four weeks. Before and after treatment， the four main symptoms including postprandial satiety， early satiety， upper abdominal pain， and upper abdominal burning sensation were scored， followed by the examination of gastric emptying （GE） and the scoring of the functional digestive disorders quality of life questionnaire （FDDQL）， 7-point global overall symptom scale （GOSS）， and liver-stomach disharmony syndrome. The cholecystokinin （CCK）， motilin （MTL）， gastrin （GAS）， serotonin （5-HT）， vasoactive intestinal peptide （VIP）， and substance P （SP） levels before and after treatment were detected， and then the safety was evaluated.

Result

2

After treatment， the scores of the four main symptoms， GOSS， and liver-stomach disharmony syndrome in the observation group were lower than those in the control group （

P

<

0.01）， while the GE rate and FDDQL scores in the observation group were higher （

P

<

0.01）. The CCK， GAS， 5-HT， and VIP levels of the observation group declined as compared with those of the control group （

P

<

0.01）， whereas the MTL and SP levels were elevated （

P

<

0.01）. After treatment， the overall response rate in the observation group was （51/57）89.47%， higher than （15/56）26.79% in the control group （

χ

2

=45.696，

P

<

0.01）. No drug-related adverse reactions were found during the trial.

Conclusion

2

The modified Heweitang is efficient and safe in relieving the main and related symptoms and traditional Chinese medicine （TCM） syndrome， regulating the secretion of gastrointestinal hormones and brain-gut peptides， promoting GE rate， and improving the quality of life of patients with FD due to liver-stomach disharmony.