Objective  To investigate the clinical effect of Flupentixol and Melitracen Tablets combined with Shugan Jieyu Capsule in the treatment of refractory gastroesophageal reflux disease (GERD).

  Methods  A total of 90 patients with refractory GERD admitted to Department of Digestion were divided into control group and study group according to random number table method, with 45 cases in each group. The control group was treated with optimized treatment by proton pump inhibitors (PPIs), the study group was treated with Flupentixol and Melitracen Tablets combined with Shugan Jieyu Capsule on the basis of the control group, the treatments of both groups lasted for 12 weeks and the patients were followed up closely. The scores of GERD symptoms, Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) before treatment, and at 6 and 12 weeks after treatment were compared. The clinical efficacy and safety of the two groups were evaluated.

  Results  There was no dropout case in the control group and 1 case removed from the study group. The Reflux Disease Questionnaire (RDQ), HAMD and HAMA scores of the two groups showed a gradual downward trend. The RDQ, HAMD and HAMA scores at 6 and 12 weeks after treatment were significantly lower than before treatment (P < 0.05), and the study group was significantly lower than that in the control group(P < 0.05). The total effective rate of the study group was significantly higher than that of the control group (95.45% vs. 80.00%, P < 0.05). There were only a few mild discomfort symptoms in the two groups during the treatment period, which did not affect the continuous treatment.

  Conclusion  Flupentixol and Melitracen Tablets combined with Shugan Jieyu Capsule on the basis of routine optimized treatment by PPIs can effectively relieve the clinical symptoms of refractory GERD and improve the mental state, which is a reliable therapy with remarkable curative effect and high safety.