randomized, placebo-controlled, double-blind trial of swedish snus for smoking reduction and cessation随机、安慰剂对照、双盲试验的瑞典鼻烟减少吸烟和戒烟.pdfVIP

Joksić et al. Harm Reduction Journal 2011, 8:25 /content/8/1/25 RESEARCH Open Access Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation 1 1 2 2 3* Gordana Joksić , Vera Spasojević-Tišma , Ruza Antić , Robert Nilsson and Lars E Rutqvist Abstract Background: Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods: We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81%) expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ≥ 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits. Results: At the week 24 visit, the proportion of participants who achieved the protocol defi