Clinical Study On Shugan Jianpi Granule In The Treatment Of Breast Cancer Due To Fatigue

This essay consists of two parts,including literature review and clinical trial.Literature review This part conducted a retrospective study about the research progress of cancer-related fatigue(CRF),and then summarized the views on definition,pathological mechanism,influence factors,diagnostic methods and therapeutic approaches of CRF.CRF is one kind of subjective feeling,mainly consisting of mental and physical fatigue and cognitive decline.CRF is one of the most common symptoms in breast cancer survivors,which can not only reduce quality of life,but also affect diagnosis,treatment and prognosis of cancer patients.At present,the pathogenesis of cancer-related fatigue is unclear,including cytokine dysregulation,5-HT levels dysregulation,hypothalamic pituitary adrenal axis dysfunction and altered ATP metabolism.Many factors may account to fatigue,including interventions on tumors,anxiety and depression,and sleep quality.Several studies have reported that the level of cytokines and C-reactive protein may affect the degree of fatigue,which can be used as one of prediction and evaluation measures.However,the proof intensity is not high,needing further study.Several scales are reported to assess fatigue,composed of Piper score scale and Brief fatigue inventory(BFI).Pharmacotherapy on CRF includes psychostimulant,antianemic agents,and antidepressant drugs,and non-drug therapy includes social psychological behavior intervention,however,treatments above still lack high-level evidence,which can even develop side effect more than benefit.Traditional Chinese Medicine(TCM)was reported in many researches to influence breast cancer-related fatigue,Shu Gan Jian Pi based-method has achieved good results,but the efficacy and safety still need further study to confirm.Clinical trial:Objective:To assess the efficacy and safety of TCM Shu Gan Jian Pi(SGJP)granules on breast cancer-related fatigue and explore its potential correlation with proinflammatory cytokine and C-reactive protein.Methods:A multicenter and single arm clinical trial was conducted in this study.Patients suffering from cancer-related fatigue and meeting the diagnostic criteria for syndrome of liver-depression and spleen-deficiency were included.Patients were treated with JPSG granules for 8 weeks.Piper fatigue scale(PFS),ECOG functional condition,TCM syndrome scale,hospital anxiety and depression scales(HAD)and Pittsburgh sleep quality index(PSQI)were evaluated before treatment and 4 weeks,8 weeks and 12 weeks after treatment.Proinflammatory cytokine,C-reactive protein(CRP)and drug safety index were assessed at the screening phase(baseline)and after treatment(week 8).Results:40 patients were recruited in this study.PFS,TCM syndrome scale and hospital anxiety scales(HAD)scores all declined 4 weeks,8 weeks and 12 weeks after treatment.ECOG and depression scale scores declined 8 weeks and 12 weeks after treatment.No significant decline was found 4 or 8 weeks after treatment.No significant correlation was observed between piper and cytokine or CRP.No significant change was found in post-treatment cytokine or CRP.Meanwhile,no patients were found to have adverse reactions or specific changes in safety index during follow-up.Conclusions:SGJP granules can improve symptoms of fatigue,anxiety and depression with good clinical efficacy and safety.Insufficient evidence about the efficacy on improving sleep quality and changing cytokine and CRP can be obtained from the study,neither the correlation between fatigue and cytokine or CRP.Hence,more strictly designed clinical study should be conducted to confirm the efficacy and safety of JPSG granules.