| Objective: This study objectively evaluates the efficacy and safety of Xiaopi Zhitong Decoction in the treatment of functional dyspepsia with cold-heat syndrome,and provides a new clinical idea for the treatment of functional dyspepsia with cold-heat syndrome by traditional Chinese medicine.Methods:In this study,72 patients with functional dyspepsia(miscellaneous cold and heat syndrome)were enrolled and divided into treatment group and control group according to random number table,36 cases in each group.There was no significant difference in gender,age,course of disease and main symptoms between the two groups.The treatment group was treated with Xiaopi Zhitong Decoction(decoction-free,one dose a day,warm clothes on an empty stomach in the morning and evening),and the control group was treated with Jinghua Weikang capsule(160mg each time,30 minutes before meals,three times a day).The treatment time was 4 weeks for both groups.The symptoms and TCM syndromes of all patients before and after treatment were recorded,and the safety of electrocardiogram,liver and kidney function were observed before and after treatment.Indicators,comprehensive evaluation of curative effect,analysis of Xiaopi Zhitong Decoction in the treatment of functional dyspepsia cold-heat miscellaneous syndrome clinical efficacy.And all the data collected were analyzed and compared with statistical software SPSS20.0.Results:(1)Evaluation of TCM syndromes: Of 36 patients treated with Xiaopi Zhitong Decoction,6 were cured,13 were markedly effective,13 were effective and 4 were ineffective;of 36 patients treated with Jinghua Weikang Capsule,3 were cured,6were markedly effective,13 were effective and 14 were ineffective.According to the principle of curative effect evaluation,the total effective rate of Xiaopi Zhitong Decoction group was 88.9%,and that of Jinghua Weikang capsule group was 61.1%.Rank sum test showed that the difference was statistically significant(P < 0.05),suggested that Xiaopi Zhitong Decoction is superior to Jinghua Weikang Capsule in the treatment of cold-heat syndrome of functional dyspepsia.(2)Total integral comparison of TCM syndromes: before treatment,the total integral of TCM syndromes was compared between groups,using independent sample t test,P > 0.05,the difference was not statistically significant,the two groups were comparable.After treatment,the total scores of TCM syndromes were compared by independent sample t test(P < 0.05).The difference was statistically significant,suggesting that Xiaopi Zhitong Decoction is better than Jinghua Weikang Capsule in the treatment of TCM syndromes of cold-heat miscellaneous syndrome.The total scores of TCM syndromes in the two groups before and after treatment were compared by paired sample t test,all P values were < 0.05,the difference was statistically significant,indicating that both Xiaopi Zhitong Decoction and Jinghua Weikang Jiao Pill had curative effect in improving TCM syndromes of mixed cold and heat syndrome.(3)Comparisons of symptoms scores of each single item of TCM: Comparisons of main symptoms scores before and after treatment: There was no significant difference between the two groups in the main symptoms scores at the time of admission(P >0.05),which was comparable.Xiaopi Zhitong Decoction group was significantly better than Jinghua Weikang capsule group in improving symptoms of "full stomach or pain,aggravated by cold" and "dry mouth or bitter mouth"(P < 0.01).The score of secondary symptoms before and after treatment: There was no significant difference in the score of secondary symptoms between the two groups(P > 0.05),which was comparable.The two groups had similar effect in improving symptoms of "no appetite","Gastric upset","nausea or vomiting"(P > 0.05);Xiaopi Zhitong Decoction group was better than Jinghua Weikang capsule group in improving symptoms of "borborygmus"(P < 0.05);Xiaopi Zhitong Decoction group was better than Jinghua Weikang capsule group in improving symptoms of "Loose stool"(P < 0.01).(4)There were no adverse reactions and toxic side effects in the two groups,which indicated that Xiaopi Zhitong Decoction and Jinghua Weikang Capsules were safe to use.Conclusion:From the above results,Xiaopi Zhitong Decoction has more significant advantages than Jinghua Weikang Capsule in treating functional dyspepsia with cold-heat miscellaneous syndrome.It can obviously improve the clinical symptoms of patients with functional dyspepsia.No adverse reactions are found.It is safe and effective.It has certain application value and provides a new choice for clinical treatment of functional dyspepsia with cold-heat miscellaneous syndrome. |
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