Dai-han Zhou1, Li-zhu Lin, Yi-qiang Zhou. 1. First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou (510405). zdh@oncology.org.cn
Abstract
OBJECTIVE: To observe the short-term therapeutic efficacy of integrated traditional and Western medicine (ITWM) in treating non-small cell lung cancer (NSCLC) in III and IV phase. METHODS: Adopting the prospective, multi-centered, randomized and controlled method for clinical research, 324 patients who conformed to the enrolling standard were divided by ratio of 1:1:1 into the Chinese medicine (CM) group (n= 99), the ITWM group (n 03) and the Western medicine (WM) (n=92) group. The excluded or dropping off cases were 10 in CM, 6 in ITWM and 14 in WM. Clinical trials were conducted in 6 hospitals and 3 months of treatment was taken as one therapeutic course. The main observation indexes were tumor size, Karnofsky scores, body weight, adverse reaction, etc. RESULTS: The total effective rate of tumor remission in the 3 groups was 4.0%, 26.2%, and 14.1%, respectively, statistical significance was shown in the difference among them (chi = 21.72, P = 0.000 < 0.017). The total tumor stabilization rate was 66.7 , 81.6%, and 76.1 , respectively, by rectification test, no significance was shown in difference among them (chi2 = 6.052, P = 0.049 > 0.017). Karnofsky scoring showed that after 90 days of treatment, Karnofsky score raised in the CM and ITWM group, but lowered in the WM group, paired t-test showed significant difference in the ITWM group before and after treatment. The Karnofsky score in IWTM was higher than that in CM and WM with significant difference (H = 10.572, P = 0.000 < 0.05). The patients' body weight in the 3 groups were all reduced. The reduction in the CM and ITWM group was lower than that in WM group, among which, significant difference was shown in CM and WM group when compared with the same group before treatment (P < 0.05). The effect in the ITWM and CM group was better than that in WM group in aspects of improving such tumor related symptoms as cough, short breath, anorexia, fatigue, etc. Observation of adverse reaction showed that lesser hemotoxicity of III and IV grade appeared in the CM and ITWM group than that in the WM group, and significant difference was shown in counts of white blood cells, granulocytes, platelets hemoglobin, etc. among the 3 groups (P < 0.01). CONCLUSION:ITWM therapy showed better short-term efficacy in treating patients with NSCLC than CM or WM alone, showing the superiority of ITWM therapy. It can be adopted as an effective therapeutic program with low-toxicity.
RCT Entities:
OBJECTIVE: To observe the short-term therapeutic efficacy of integrated traditional and Western medicine (ITWM) in treating non-small cell lung cancer (NSCLC) in III and IV phase. METHODS: Adopting the prospective, multi-centered, randomized and controlled method for clinical research, 324 patients who conformed to the enrolling standard were divided by ratio of 1:1:1 into the Chinese medicine (CM) group (n= 99), the ITWM group (n 03) and the Western medicine (WM) (n=92) group. The excluded or dropping off cases were 10 in CM, 6 in ITWM and 14 in WM. Clinical trials were conducted in 6 hospitals and 3 months of treatment was taken as one therapeutic course. The main observation indexes were tumor size, Karnofsky scores, body weight, adverse reaction, etc. RESULTS: The total effective rate of tumor remission in the 3 groups was 4.0%, 26.2%, and 14.1%, respectively, statistical significance was shown in the difference among them (chi = 21.72, P = 0.000 < 0.017). The total tumor stabilization rate was 66.7 , 81.6%, and 76.1 , respectively, by rectification test, no significance was shown in difference among them (chi2 = 6.052, P = 0.049 > 0.017). Karnofsky scoring showed that after 90 days of treatment, Karnofsky score raised in the CM and ITWM group, but lowered in the WM group, paired t-test showed significant difference in the ITWM group before and after treatment. The Karnofsky score in IWTM was higher than that in CM and WM with significant difference (H = 10.572, P = 0.000 < 0.05). The patients' body weight in the 3 groups were all reduced. The reduction in the CM and ITWM group was lower than that in WM group, among which, significant difference was shown in CM and WM group when compared with the same group before treatment (P < 0.05). The effect in the ITWM and CM group was better than that in WM group in aspects of improving such tumor related symptoms as cough, short breath, anorexia, fatigue, etc. Observation of adverse reaction showed that lesser hemotoxicity of III and IV grade appeared in the CM and ITWM group than that in the WM group, and significant difference was shown in counts of white blood cells, granulocytes, platelets hemoglobin, etc. among the 3 groups (P < 0.01). CONCLUSION: ITWM therapy showed better short-term efficacy in treating patients with NSCLC than CM or WM alone, showing the superiority of ITWM therapy. It can be adopted as an effective therapeutic program with low-toxicity.