| [BACKGROUD]Cancer-related fatigue(CRF)is one of the most painful symptoms of cancer patients currently associated with cancer and cancer treatments.It is more likely to occur than other symptoms and is not easily controlled by drugs.CRP has a high incidence,especially in patients receiving radiation and/or chemotherapy,and can persist for months or even years after the end of treatment,seriously affecting the quality of life and work ability.The effective methods of modern medical treatments of CRF are limited.The NCCN guidelines in the recent 3 years all recommend nonpharmacologic interventions.However,in clinical applications,doctors mainly recommend non-pharmaceutical interventions based on patient conditions,and the relative compliance is poor.All the evidence for pharmacologic interventions is level 2A,and there is still no effective pharmacologic treatment for CRF.Traditional Chinese medicine(TCM)of CRF has been widely reported in China and has abundant treatment measures,including TCM decoction,Chinese patent medicine,TCM inj ection,acupuncture,Taiji,acupoint application,Chinese medicine foot bath,etc.Therefore,it is worthwhile to explore the effective treatment of CRF from TCM treasures.The study of TCM syndrome pattern of CRF shows that the deficiency syndrome is the main type,and the syndrome of Qi-Yin deficiency is prone to occur after radiotherapy and chemotherapy.Zhenqi Fuzheng Formula is composed of Astragalus and Ligustrum lucidum.It has the effect of tonifying Qi and nourishing Yin.It is a commonly used TCM for oncology combined with surgery,radiotherapy and chemotherapy.It has good clinical efficacy and safety.In the past 20 years,the literature analysis of the literature on the treatment of malignant tumors by Chinese medicine showed that the frequency of use of jaundice was in the first place,and the female scorpion was in the first place of the Yin medicine.Further data association rules revealed that"Huangqi-female scorpion" was one of the commonly used drug pairs in the tumor suppressing agent.On this basis,we put forward the hypothesis that Zhenqi Fuzheng Formula Addition has the effect of improving CRF with Qi-Yin Deficiency Syndrome caused by radiotherapy and/or chemotherapy.Then we adopted a prospective and parallel controlled clinical trial to explore it and potentiall provide reference data for further randomized,double-blind,placebo-controlled clinical studies in the future[OBJECTIVE]To explore the efficacy and safety of Zhenqi Fuzheng Formula Addition in the treatment of CRF with Qi-Yin Deficiency Syndrome caused by radiotherapy and/or chemotherapy,so as to provide reference for further searching for better treatment for CRF[METHODS]This study is a prospective,parallel control and open clinical trial.Fifty patients were divided into the experimental group(n=25)and the control group(n=25).The experimental group accepts basic treatment and Zhenqi Fuzheng Formula Addition while the control group only accepts basic treatment.The study lasted 8 weeks.Therapeutic evaluation indicators mainly include Multi-Dimensional Fatigue Symptom Inventory-Short Form-China(MFSI-SF-C)score,Fatigue Symptom Inventory-China(FSI-C)score,Brief Fatigue Inventory-China(BFI-C)score,European Organization for Research and Treatment Quality of life Questionnaires-Cancer30(EORTC QLQ-C30)score,etc.Safety indicators mainly include adverse events.Statistical analysis was carried out by SPSS 19.0 software.Counting data were used to calculate the number and percentage of cases under the corresponding classification.Chi-square test was used to test the effectiveness of the evaluation.If the measurement data conforms to normal distribution and has homogeneity of variance,two independent samples T test is used for comparison between groups.T' test is used for variance unevenness but conforming to normal distribution.Non-parametric test is used for comparing data that do not conform to normal distribution[RESULTS]1.Fifty patients participated in the study,and they were divided into control group(n=25)and experimental group(n=25).Four cases in the control group and one case in the experimental group failed to be followed up,two cases stopped the study for receiving cancer treatment.A total of 24 patients in the experimental group and 19 patients in the control group were included in the analysis.Before treatment,there was no significant difference between the two groups in age,sex,type of tumors,stage of tumors,time of diagnosis of tumors and previous treatment of tumors.There was no significant difference in the number of people who took Chinese medicine instead of tea,health products,had insomnia,anemia,cancer pain,depression and regular exercise2.Changes of MFSI-SF-C scores before and after treatment:At the 4th and 8th weeks of treatment,the general fatigue,vitality and MFSI-SF-C total scores of the treatment group were significantly improved when compared with those of the control group(P<0.05).In the two dimensions of physical fatigue and mental fatigue,the scores of the treatment group at the 8th week were significanly lower than those of the control group(P<0.05,P<0,05).In the dimension of emotional fatigue,the score of the treatment group at the 4th week was significantly lower than that of the control group(P<0.05),but there was no significant difference between the two groups at the 8th week.3.The changes of FSI-C scores before and after treatment:In terms of the severity of fatigue,the scores of the treatment group at the 2nd,3rd,4th,5th,6th,7th and 8th weeks were significantly lower than those of the control group(P<0.05).In terms of the effects of fatigue on daily life,activities,emotions,ability to concentrate and quality of life,and the duration of fatigue,the scores of the treatment group at the 3rd,4th,5th,6th,7th and 8th weeks were significantly lower than those of the control group(P<0.05).On the total score of FSI-C,the scores of the treatment group at the 2nd,4th,5th,6th and 8th weeks were significantly lower than those of the control group(P<0.05),but there was no significant difference between the two groups at the 3rd and 7th weeks(P>0.05).In the aspect of the most fatigued time of the day,the effect of Zhenqi Fuzheng Formula Addition was not observed4.Changes of BFI-C scores before and after treatment:At the 8th week of treatment,the total score of BFI-C in the treatment group was significantly lower than that in the control group(P=0.012),however,there was no significant difference between the two groups at the 2nd,3rd,4th,5th,6th and 7th weeks.There was no significant difference in the incidence of unusual fatigue between the two groups before and after treatment(all P>0.05)5.Before and after treatment,the symptom scores of Qi-Yin Deficiency in the treatment group were significantly lower than those in the control group(P<0.001;P<0.001).The total effective rate of the treatment group was 41.7%and 50.0%respectively in the 4th and 8th week,which was significantly higher than that of the control group(5.3%and 5.3%,P=0.006;P=0.006).6.Changes of EORTC QLQ-C30 scores before and after treatment:In the two areas of role function and social function,the scores of treatment group were significantly higher than those of control group at 4 and 8 weeks of treatment(P=0.041,P=0.002;P=0.015,P=0.011)In the field of emotional function,the score of the treatment group was significantly higher than that of the control group at the4th week of treatment(P=0.041),but there was no significant difference at the 8th week of treatment(P>0.05).In the three main symptom areas,the score of fatigue symptoms in the treatment group was significantly lower than that in the control group at the 8th week(P=0.007),and there was no significant difference in nausea,vomiting and pain symptoms between the two groups before and after treatment(P>0.05).In the field of single symptom,there was no significant difference in the scores of shortness of breath,insomnia,loss of appetite and diarrhea between the two groups before and after treatment(P>0.05).In the field of constipation symptoms,the score of the treatment group before treatment was significantly higher than that of the control group(P=0.027).However,there was no significant difference in the score of constipation symptoms between the two groups at the 4th and 8th week of treatment(P=0.138,P=0.647).In terms of economic difficulties,the scores of the treatment group were significantly lower than those of the control group at the 4th and 8th week of treatment(P=0.011,P=0.016).In terms of overall quality of life,the scores of the treatment group at the 4th and 8th week of treatment were significantly higher than those of the control group(P=0.001,P<0.001)7.Safety:During the course of the study,one patient developed dreamlike symptoms during the medication period,and then self-relieved a week later.This may have no correlation with study medication.No serious adverse events were observed in the study[CONCLUSION]The addition of Zhenqi Fuzheng Formula may have short-term effects on reducing the fatigue symptoms and improving the overall quality of life of CRF patients with deficiency of both Qi and Yin caused by radiotherapy and/or chemotherapy.In view of the small sample and low quality of this research,further in-depth studies among large population are required to confirm the effect of the medicine. |
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