| Background:Chemotherapy-induced nausea and vomiting(CINV)is a common adverse drug reaction in patients with malignant tumors after chemotherapy,which can affect the quality of life of patients and reduce treatment compliance.At present,the prevention and treatment of CINV in modern medicine is mainly based on drug treatment,but the effect is limited.Traditional Chinese medicine has a long history and definite curative effect in the treatment of nausea and vomiting.As an important traditional Chinese medicine therapy,external treatment has the advantages of rapid action and few adverse reactions.Previous studies have confirmed that acupuncture combined with acupoint application has certain efficacy and safety in the treatment of chemotherapy-related nausea and vomiting.However,it can still be improved in experimental design and acupuncture prescription.It is necessary to further observe its efficacy and safety evaluation.Objective:The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture combined with acupoint application based on the method of regulating liver and spleen in the treatment of CINV in patients with traditional chinese medicine syndrome of liver disorders and spleen and stomach weakness.Methods:In this study,a prospective,randomized,single-blind,multi-center,placebo-controlled clinical study was conducted.From January 21,2021 to February 2,2023,84 patients who met the inclusion criteria were selected from the Department of Oncology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University and Shunyi Hospital of Beijing Hospital of Traditional Chinese Medicine.Using the random number table method,the subjects were randomly divided into the treatment group and the control group according to 1:1.Both groups were treated with ondansetron as the basic antiemetic regimen during chemotherapy.The treatment group was treated with acupuncture combined with antiemetic acupoint application.The acupuncture regimen was based on the’old ten needles ’ acupuncture prescription,went to Shangwan point(CV-13)and Xiawan point(CV-10),added Zhangmen point(LR-13),and added electroacupuncture to Zusanli point(ST-36).The control group was treated with sham acupoint shallow acupuncture combined with placebo acupoint application.Before chemotherapy and 2 to 5 days after chemotherapy,acupuncture treatment was performed once.Acupoint application began before chemotherapy,once a day for 5 days.Observe and record the nausea and vomiting,TCM syndrome scores,Eastern Cooperative Oncology Group(ECOG)physical strength scores and Simplified Nutritional Appetite Questionnaire(SNAQ)scores of the subjects before chemotherapy and on the 1st,2nd,3rd,7th,10th,14th,and 21st days after chemotherapy,as well as safety evaluation indicators such as acupuncture adverse reactions and blood,urine,and stool routines.After the study,the differences between and within the two groups were compared,and the factors that may affect the efficacy were analyzed by regression analysis.Results:A total of 84 patients were included in this study,and 80 patients completed the treatment.①Nausea and vomiting:The complete control rate of nausea in the treatment group and the control group was 66.25%and 30.94%respectively,and the effective rate was 90.00%and 65.00%respectively.The complete control rate and effective rate of nausea in the treatment group were significantly higher than those in the control group on the 1st,2nd,3rd,7th,10 th and 14 th day of chemotherapy,and the difference was statistically significant(P<0.050).The degree of nausea in the treatment group on the 1st,2nd and 3rd day after chemotherapy was significantly higher than that before chemotherapy(P<0.050).The degree of nausea in the control group on the 1st,2nd,3rd,7th,10th and 14th day after chemotherapy was significantly higher than that before chemotherapy(P<0.050).In the control of vomiting,the mean complete control rates of the treatment group and the control group were 90.31%and 56.56%,respectively,and the effective rates were 95.56%and 75.94%,respectively.Compared with the control group,the treatment group had higher complete control rates on the 1st,2nd,3rd,7th,and 10th days after chemotherapy(P<0.050),and higher effective rates on the 1st,2nd,3rd,and 7th days after chemotherapy(P<0.050).The degree of vomiting on the 1st,2nd,3rd,and 7th days after chemotherapy was significantly higher than that before chemotherapy(P<0.050).The degree of vomiting in the control group on the 1st,2nd,3rd,7th and 10th day after chemotherapy was significantly higher than that before chemotherapy(P<0.050).②TCM syndrome score,ECOG score and SNAQ score:The TCM syndrome scores of the treatment group on the 3rd,7th,10th and 14th day after chemotherapy were lower than those of the control group,and the difference was statistically significant.There was no significant difference in ECOG score before chemotherapy and on the 7th,14th and 21st day after chemotherapy(P<0.050).On the 3 rd day after chemotherapy,the ECOG score of the treatment group was significantly lower than that of the control group(P=0.015).There was no significant difference in nutritional status between the treatment group and the control group before chemotherapy(P=0.087).The SNAQ score of the treatment group was significantly higher than that of the control group on the 3rd,7th,14th and 21st days after chemotherapy(P<0.001).③Safety:No serious acupuncture-related adverse reactions occurred in this study,and the safety was good.Conclusion:Acupuncture based on the method of regulating liver and spleen and acupoint application of traditional Chinese medicine can effectively prevent and treat CINV,and has a good effect on acute and delayed CINV.It can alleviate the clinical symptoms of patients,improve physical strength and nutrition,and improve the quality of life of patients.It has high safety and good compliance. |
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