| Objective:To investigate the efficacy and safety of the traditional Chinese medicine decoction Bu Zhong Yi Qi tang(BZYQT)for improving cancer related fatigue(CRF)by literature review,systematic review and cohort study.Methods:For literature review,literature related to the cause of CRF,pathological mechanism of CRF in Chinese medicine,treatment of CRF in both western and Chinese medicine and the effect of anti-tumor,alleviate fatigue,and clinical trial of BZYQT were collected and integrated.For the systematic review,4 electronic databases,WanFang database,CAJ full-text database,Pudmed,Medline(Ovid),were searched and extracted the data of RCT studies related to CRF and BZYQT.Two different investigators accessed the methodological quality of the studies independently according to the Cochrane risk of bias tool.Data was synthesized by RevMan 5.3 software.For the cohort study,total 34 subjects were divided into experimental group(N=17)and control group(N=17).The patients of experimental group were given BZYQT and the control group were under Chinese herbal medicine based on syndrome differentiation except herbs which can replenish qi.Duration of observation was 4 weeks.Its outcome measurements were the severity of fatigue,quality of life,Karnofsky performance status scale,qi deficiency symptom,body constitution of Chinese medicine and its related score.Results:For CRF is very common in cancer patients,which include active treatment,post-treatment and end-of-life stages.Treatment methods of western medicine,which have sufficient clinical evidence,are physical therapy and psychostimulant.However,there is difficulty for CRF patients to insist on physical therapy and psychostimulant has side effect.Acupuncture and herbal medicine are the main treatment methods of Chinese medicine to treat CRF.Besides,BZYQT has anti-tumor and alleviate fatigue effect and it was found that it had a positive result for the treatment of CRF in several clinical trials.For the systematic review,totally 8 RCT studies of CRF and BZYQT were found.Total patients number was 475.However,the methodological quality of studies was generally poor,main reason is the missing the description of randomization procedure and blinding method.BZYQT used alone or in combination of chemotherapy or usual care showed significantly relief of CRF severity compared to the placebo,chemotherapy or usual care.Besides,the quality of life in BZYQT group and BZYQT plus chemotherapy or usual care group was also improved significantly than the placebo,chemotherapy or usual care group.The effect of BZYQT is alleviating the severity of fatigue,improving quality of life and decreasing the score of Spleen deficiency.One of the 8 studies reported a minor adverse event of BZYQT(flatulence and dyspepsia),and no serious adverse event was found.For the cohort study,the experimental group had a significant improvement of CRF severity after 4 weeks treatment of BZYQT,which CRF severity was measured by brief fatigue inventory,BFI-C.(pre-treatment vs pro-treatment:4.40±2.28 vs 3.62±1.99,p=0.033)For the quality of life,the experimental group was also significantly better after the treatment in physical functioning(PF)and fatigue symptom(FA),which was measured by EORTC quality of life questionnaire C30,QLQ-C30.(pre-treatment vs pro-treatment:PF:70.59± 16.68 vs 80.00± 11.30,p=0.012;FA:45.10± 19.03 vs 35.29±14.29,p=0.027)For the Karnofsky performance status scale,the experimental group was also significantly better after 4 weeks treatment.(pre-treatment vs pro-treatment:87.65±4.37 vs 94.12±6.18,p=0.000)after 4 weeks of BZYQT,experimental group had a better quality of life than control group in pain(PA)and appetite loss(AP)symptom.(experimental group vs control group:PA:17.65±13.78 vs 34.31±27.30,p=0.032;AP:5.88±13.10 vs 19.61±20.61,p=0.027)For the Karnofsky performance status scale,the experimental group was also significantly better than the control group.(experimental group vs control group:94.12±6.18 vs 87.06±5.88,p=0.002)Besides,the number of patients improved in the qi deficiency symptom in experiential group was significantly more than that of the control group.(experimental group vs control group:17 vs 6,p=0.000)For the body constitution of Chinese medicine was measured by Constitution of Chinese medicine Questionnaires(CCMQ)(Hong Kong version),after 4 weeks of treatment,the number of experimental group patients in phlegm-wetness decreased significantly(p=0.005)and the score of blood-stasis also decreased significantly(p=0.041)when compared with the control group.However,the increase of numbers in yin-deficiency and wetness-heat experimental group patients should be concerned.There was no adverse event.Conclusion:For the literature review,the effect of Chinese medicine decoction BZYQT to CRF is effective and BZYQT has anti-tumor,alleviate fatigue effect.For the systematic review,from the limited findings,BZYQT seems to be effective,such as alleviating the severity of CRF,improving quality of life and Spleen deficiency symptom,and also safe in the CRF treatment.However,due to the poor methodological quality of the studies,current evidence is not sufficient to support draw a confirmative conclusion and some suggestion for improving the quality of RCT was provided.For the cohort study,BZYQT was found that it can relived the CRF severity,improved the Karnofsky performance status,the quality of life,qi deficiency symptom and the body constitution of cancer patients.But more rigorous studies are needed to confirm the efficacy of BZYQT. |
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