Clinical Study on Fuzheng Guben Granules in Treating Cancer-Related Fatigue
Objective To evaluate the clinical efficacy and safety of Fuzheng Guben Granules(derived from Buzhong Yiqi Decoction)for the treatment of cancer-related fatigue(CRF).Methods Eighty-four patients were randomly divided into a trial group and a control group by stratified randomization method,with 42 cases in each group.Both groups were treated with standardized western medicine treatment and conventional symptomatic treatment.In addition,the trial group was treated with Fuzheng Guben Granules orally.Four weeks constituted a treatment cycle,and both groups were treated for a total of three cycles(≥3 days of continuous medication in each cycle).The changes of Piper's Fatigue Scale(PFS)scores,Karnofsky Performance Status(KPS)scores and traditional Chinese medicine(TCM)syndrome scores in the two groups before and after treatment were observed.After treatment,the efficacy for TCM syndrome and clinical safety of the two groups were evaluated.Results(1)After three cycles of treatment,the total effective rate of the trial group was 57.14%(24/42)and that of the control group was 11.90%(5/42),and the intergroup comparison showed that the overall efficacy(by rank-sum test)and the total effective rate(by chi-square test)of the trial group were significantly superior to those of the control group(P＜0.05).(2)After treatment,the scores of the four dimensions of sensory fatigue,emotional fatigue,cognitive fatigue and behavioral fatigue and the total score of PFS of the trial group were decreased when compared with those before treatment(P＜0.05),whereas the behavioral fatigue score and the total PFS score of the control group were increased when compared with those before treatment(P＜0.05).The intergroup comparison showed that the decrease of total PFS score,sensory fatigue score and behavioral fatigue score in the trial group was significantly superior to that in the control group(P＜0.05).(3)After treatment,KPS score for the quality of life in the trial group was increased(P＜0.05)while the KPS score in the control group was decreased when compared with that before treatment(P＜0.05).The intergroup comparison showed that the increase of KPS score in the trial group was significantly superior to that of the control group(P＜0.05).(4)After treatment,the TCM syndrome score of the trial group was decreased when compared with that before treatment(P＜0.05),while the TCM syndrome score of the control group showed no obvious change(P＞0.05).The intergroup comparison showed that the decrease of TCM syndrome score in the trial group was significantly superior to that of the control group(P＜0.05).(5)After treatment,no significant changes were founded in the safety indicators of the patients in the two groups(P＞0.05)except that the levels of aspartate transaminase(AST)and alanine transaminase(ALT)of the trial group,as well as the platelet(PLT)of the control group were increased(P＜0.05).In terms of the adverse events,the incidence of myelosuppression(showing as the decrease of white blood cell count and hemoglobin content)in the trial group was significantly lower than that in the control group,and the difference was statistically significant(P＜0.05).Conclusion Fuzheng Guben Granules can effectively reduce the degree of fatigue,relieve the discomforts of patients,improve their quality of life,and reduce the adverse reactions caused by anti-tumor drugs to a certain extent,with significant efficacy and high safety and exerting a positive impact on the survival of patients.
cancer-related fatigueFuzheng Guben GranulesBuzhong Yiqi Decoctionquality of lifemyelosuppressionclinical study
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