Clinical Research Of Traditional Chinese Medicine (TCM) Syndrome Differentiation And Acupuncture Treatment On Cancer Related Fatigue (CRF)

ObjectiveThe main objective of the research is to investigate the efficacy of acupuncture treatment on cancer related fatigue and other cancer related symptoms; so as to find out the feasibility of administering acupuncture as an adjunctive therapy to cancer patients.MethodsThis is a prospective, randomized controlled trial (RCT). The study was carried inGuangzhou and Hong Kong during June 2013 to December 2014. A total of 48 cases who suffered from cancer related fatigue, andmet the inclusion and exclusion criteria were recuited. The subjects were randomized and allocated into the treatment group or control groupin the ratio of 1:1. The treatment group receivedthe original Chinese medicine treatment, supportive care and symptomatic treatment; in addition, they were offered acupuncture and moxibustion treatment three times per week for two weeks. The control group received onlythe original Chinese medicine treatment, supportive care and symptomatic treatment. The primary outcome measuredwas the difference in fatigue score by using brief fatigue inventory-Chinese (BFI-C). Secondary outcomes included the quality of life, by usingthe Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Hospital Anxiety and Depression Scale (HADS-14), Palliative Performance Scale (PPS) and Chinese Medicine Symptoms Quantitative Criteria Table. Any adverse events or serious adverse events were recorded to access the safety aspect. Data obtained from different study sites will be centralized and analyzed. Categorical variables, including demographics, management patterns and incidence of adverse events will be examined using Chi-square (χ2) test. Continuous variables, including scoring of BFI-C, FAACT and HADS-14, will be evaluated using t-test. Statistical significance is defined as p< 0.05 with two-sided test. All statistical analysis will be conducted with SPSS program.ResultsThere were no significant difference baseline characteristics of the study subjects (P>0.05) which indicates that the two groups were well balanced with comparability. The statistical results showed: ①There was significant difference (P<0.05) in the aspect of BFI-C (difference in the score:post-pre) including the average, Ql, Q2, Q3, Q4, Q5, Q6, Q7, Q8 and Q9 before and after treatment in the treatment group. There was significant difference (P<0.05) in the aspect of BFI-C (difference in the score:post-pre) including the average, Q1, Q2, Q3, Q4, Q6, Q8 and Q9 before and after treatment in the control group. There was significant difference (P<0.001) in the aspect of BFI-C (difference in the score:post-pre) including the average, Ql, Q2, Q3, Q4, Q5, Q6, Q7, Q8 and Q9) before and after treatment between treatment group and control group.②There was significant difference (P<0.05) in the aspect of FAACT (difference in the score:post-pre) including GP, GS, GE, GF, ACT and total score before and after treatment in the treatment group; while there was no significant difference (P>0.05) in the same aspect of FAACT in the control group. There was significant difference (P<0.001) in the aspect of FAACT (difference in the score:post-pre) including GP, GS, GE, GF, ACT and" Total score before and after treatment between the treatment group and control group. ③There was significant difference (P<0.05) in the aspect of HADS-14 (difference in the score:post-pre) before and after treatment in the treatment group; while there was no significant difference (P>0.05) in that of the control group. There was significant difference (P<0.001) in the aspect of HADS-14 (difference in the score:post-pre) before and after treatment between the treatment group and control group. ④There was significant difference (P<0.05) in the aspect of PPS (difference in the score:post-pre) before and after treatment in the treatment group. There was also significant difference (P<0.05) in that of the control group. There was significant difference (P=0.005) in the aspect of PPS (difference in the score:post-pre) before and after treatment between the treatment group and control group. ⑤There were some changes in the quantity of TCM syndrome before and after treatment in the treatment group. The number of patients diagnosed as "liver stagnation and spleen deficiency"(肝郁脾虚型)changed from 7 (32%, before treatment) to 11 (50%, after treatment). The number of patients diagnosed as "spleen and kidney yang deficiency"(脾肾阳虚型)changed from 15 (68%, before treatment) to 11 (50%, after treatment). On the other hand, there was no obvious change in that of the control group.ConclusionThe study result shows that acupuncture and moxibustion treatment can relieve cancer-related fatigue (CRF) and improve the quality of life in cancer patients. By summarizing the TCM syndrome differentialamong the patients, and setting uptheguideline of acu-points selection for CRF treatment, the clinical efficacy can also be raised. With its safety, mild side effects, simple operation and low costing, acupuncture and moxibustion treatment is worth for promotion in public health care system.