a six-month crossover chemoprevention clinical trial of tea in smokers and non-smokers methodological issues in a feasibility study六个月交叉化学预防的临床试验的茶在吸烟者和不吸烟者在可行性研究方法论的问题.pdfVIP

Dash et al. BMC Complementary and Alternative Medicine 2012, 12:96 /1472-6882/12/96 RESEARCH METHODOLOGY Open Access A six-month crossover chemoprevention clinical trial of tea in smokers and non-smokers: methodological issues in a feasibility study 1 1 1 1 3 Chiranjeev Dash , Fung-Lung Chung , Joy Ann Phillips Rohan , Emily Greenspan , Patrick D Christopher , 1 4 2 2 1,5* Kepher Makambi , Yukihiko Hara , Kenneth Newkirk , Bruce Davidson and Lucile L Adams-Campbell Abstract Background: Chemoprevention crossover trials of tea can be more efficient than parallel designs but the attrition and compliance rates with such trials are unknown. Methods: Attrition (dropouts) and compliance with treatment were assessed in a 25-week randomized, placebo controlled, crossover, feasibility clinical trial of four tea treatments to investigate the effect of tea on oral cancer biomarkers. Each treatment lasted 4 weeks with 2 weeks of washout in between. Participants were 32 smokers and 33 non-smokers without any evidence of premalignant oral lesions. The interventions consisted of packets of green tea, black tea, caffeinated water, or placebo. Participants were assigned to each treatment for four weeks, and were instructed to drink five packets per day while on the treatment. Dropout from the trial and compliance (consumption of ≥ 85% of the prescribed treatment packets) are the main outcome measures reported. Results: There was a high rate of dropout (51%) from the study, and the rates were significantly higher among smokers (64%) than non-smokers (36%). Among participants who comp