Clinical Study About The Efficacy Of Sini Huoxue Decoction On Functional Dyspepsia Epigastric Pain Syndrome(Qi Stagnation And Blood Stasis Syndrome)

Objective: This study was designed to investigate the clinical efficacy and safety of Sini Huoxue decoction in the treatment of Functional Dyspepsia Epigastric Pain Syndrome(qi stagnation and blood stasis syndrome),and to provide clinical basis for the treatment of this disease with traditional Chinese medicine.Methods: 72 patients with Functional Dyspepsia Epigastric Pain Syndrome(qi stagnation and blood stasis syndrome)were diagnosed in the outpatient department of spleen and stomach diseases of Yunnan traditional Chinese medicine hospital from January to December 2019.They were randomly divided into two groups,included treatment group and control group,each groups have 36 patients.The treatment group was given Sini Huoxue Decoction,and the control group was given Qizhi Weitong granules.The course of treatment was 4 weeks.The scores of TCM syndromes and life quality before and after treatment were recorded and analyzed.Results: 65 patients completed the clinical study according to the protocol.There were 33 cases in the treatment group and 32 cases in the control group.1.Comparison of total effective rate: The total effective rate was 90.91% in Sini Huoxue Decoction treated group,and 84.38% in the control group.Sini Huoxue Decoction treatment group was better than the control group(P<0.05).2.Comparison of total score of TCM syndromes: After treatment,the total score of TCM syndromes was reduced in two groups,indicating that two treatments have an obvious therapeutic effect on improving patients’ symptoms(P<0.05),and the treatment group was better than the control group(P<0.05).3.Comparison of Single score of TCM syndromes: The single scores of TCM syndromes of two groups were reduced through treatment.indicating that two treatments can relieve patients’ symptoms(P<0.05).The efficacy of the treatment group was better than control group,especially on the following three symptoms as the gastric distending pain or tingling,pain worsens after meal or at night,and belching acid regurgitation(P<0.05).The efficacy of the treatment group was nearly equal to the control group on improving fullness in chest,symptoms worsen because of bad emotional state,no appetite or eat less and inhibited defecation(P>0.05).4.Comparison of quality of life score: After treatment,the quality of life scores at eight dimensions were increased than before,the scores in body pain,energy,social function,emotional function,mental health five dimensions were significantly improved(P<0.05),the treatment group scores were higher than the control group in body pain,energy and mental health dimensions(P<0.05).5.During the treatment,there were no obvious changes in blood routine,stool routine plus occult blood,urine routine,liver and kidney function and electrocardiogram in the two groups,the patients from two groups had no obvious adverse reactions.Conclusion: Sini Huoxue decoction is more effective than Qizhi Weitong granules in the process of treating FD-EPS(qi stagnation and blood stasis syndrome).Sini Huoxue decoction can relieve effectively patients’ symptoms of stomachache and belching acid regurgitation,improve the patients’ body pain and emotional state,thus improve their quality of life.These results suggested that Sini Huoxue decoction might be a potential therapeutic agent for FD-EPS.It might provide the references for the clinical application.