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[A randomized clinical trial for the evaluation of head and neck squamous cell carcinoma treating with traditional Chinese medicine]

This paper described the research design,research process and statistical analysis of randomized clinical trial by treatment with traditional Chinese medicine in patients with squamous cell carcinoma of the head and neck.At first we found there was no significant difference between treating group and contral group(P>0.05) using log-rank test on Kaplan-Meier survival curves. With further multivariate analysis Cox model and after adjusting for sex,age,legth of taking the assigned medication,grade of tumor differentiation and using of chemotherapy,the rate of tumor-related death for control group was significantly higher than that for treating group :hazards ratio estimate was 1.939(95% confidence interval 1.008-3.729,(P<0.05).The length of taking Chinese medicine was one of the most important prognostic factors(P<0.001).The results suggest that the prescribed medication contributed to the improved survival,and it was an independent prognostic factor.