ABSTRACT
Objective:To observe the clinical efficacy modified Chaihu Shugansan combined with Xuanfu Daizhetang on anxiety and depression of patients with gastroesophageal reflux disease （GERD） and Qi stagnation and phlegm obstruction syndromes in clinic and the effect on neuropeptide factor and pro-inflammatory factor. Method:Patients 200 cases were divided into control group and observation group. Patients in control group got omeprazole enteric-coated tablets， 20 mg/time， 1 time/day， flupentixol and melitracen tablets， 1 tablet/time， 2 times/day， and Dalitong granules， 1 bag/time， 3 times/day. In addition to omeprazole enteric-coated tablets in control group， patients in observation group were also added with syndrome differentiation-based treatment of modified Chaihu Shugansan combined with Xuanfu Daizhetang， 1 dose/day. The treatment lasted for 8 weeks. Before and after treatment， scores of acid regurgitation， heartburn， poststernal pain， syndrome of Qi stagnation and phlegm obstruction， gastroesophageal reflux disease questionnaire （GerdQ）， Hamilton anxiety Scale-14 （HAMA-14） and Hamilton depression scale-17 （HAMD-17） were scored； And upper gastrointestinal endoscopy， levels of peripheral vasoactive intestinal peptide （VIP）， 5-hydroxytryptamine （5-HT）， tumor necrosis factor-<italic>α </italic>（TNF-<italic>α</italic>）， interleukin-1 （IL-1）， IL-6 were detected. All the patients （GerdQ<8） got follow-up for 16 weeks， and the recurrence and safety were recorded. Result:After treatment， scores of GerdQ， endoscope， main symptoms and syndrome of Qi stagnation and phlegm obstruction on observation group were lower than those in control group （<italic>P</italic><0.01）， and scores of HAMA-14 and HAMD-17 decreased in both groups （<italic>P</italic><0.01）， but with no statistically significant difference in both groups. The comprehensive efficacy of main symptoms in observation group was better than that in control group （<italic>Z</italic>=2.076， <italic>P</italic><0.05）. The curative effect of traditional Chinese medicine （TCM） syndrome in observation group was superior to that in control group （<italic>Z</italic>=2.151， <italic>P</italic><0.01）. The effect of endoscope was better than that in control group （<italic>Z</italic>=2.103， <italic>P</italic><0.05）. And levels of VIP， 5-HT， TNF-<italic>α</italic>， IL-1 and IL-6 in observation group were lower than those in control group. During the 16-week follow-up， the recurrence rate in observation group was 19.23% （15/78）， which was lower than 35.38% （23/65） in control group （<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/EF9122E2-D647-4d34-AB25-83CBA259DE55-M002.jpg"><?fx-imagestate width="3.30199981" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/EF9122E2-D647-4d34-AB25-83CBA259DE55-M002c.jpg"><?fx-imagestate width="3.30199981" height="3.64066648"?></graphic></alternatives></inline-formula>=4.741， <italic>P</italic><0.05）. The average recurrence time of the observation group was lower than that of the control group（<italic>P</italic><0.01）. Conclusion:Modified Chaihu Shugansan combined with Xuanfu Daizhetang can significantly improve the main symptoms and TCM syndromes， relieve depression， anxiety and other adverse emotions， promote the healing of gastroesophageal mucosa， reduce the recurrence rate and delay the recurrence time among patients with GERD and Qi stagnation and phlegm obstruction syndromes. The mechanism of action may be related to the expression of neuropeptide factor and the inhibition of pro-inflammatory factor.