Commentary on Ward et al. (2013): Failure to find a treatment effect for NRT in a low-income country -implicationsKenneth Ward and his colleagues assessed the additional impact of nicotine replacement therapy (NRT) for smoking cessation in Syria in a two arm, parallel group, randomized placebo-controlled, double-blind trial [1]. Patients were seen in one of four primary care clinics and in addition to random allocation to active or placebo nicotine patch received brief physician advice and behavioral counseling. No incremental effect was found for active over placebo patch at end of treatment or at follow up. The authors note that this lack of a treatment effect is inconsistent with a large literature derived primarily from efficacy trials. They rule out several possible explanations for their results. Although their statistical power to observe an effect was somewhat limited with a total N of 269, they note that their observed effect was so small as to call into question lack of power as an explanation for their null finding.The overall 1-year prolonged abstinence rates (11.9% for place and 12.7% for active patch) appear relatively low [2]. However, this study appears to be more of effectiveness than an efficacy trial. Given the limited available cessation literature in low-and middle-income countries [3,4], it would be difficult to conclude that these overall long-term abstinence rates are disappointing. The investigators achieved what appears to be a surprising level of engagement by physicians. The five physicians who served as cessation coordinators underwent two hours of initial training in the study protocol and brief intervention strategies followed by six hours of additional training to deliver multiple sessions of behavioral cessation counseling both in person and by telephone. Overall adherence by both physicians and patients was excellent. One would not expect a similar level of engagement by physicians in a high-resource setting [2].Although this relatively small trial cannot prove the null hypothesis that NRT is ineffective in low-resource settings, it does introduce a note of caution. For quite some time, I have had doubts about how extensive a role pharmacotherapy is likely to play as part of cessation treatment in low-and middle-income countries. Cost is an obvious barrier, although there are additional barriers of access and distribution [5]. If behavioral interventions are proven to be effective as a stand-alone approach in low resource settings, this could have important implications.Publication of these results is timely in light of the recent adoption of Article 14 of the WHO Framework Convention on Tobacco Control at the fourth session of the Conference of the Parties in November 2010 [6,7]. Article 14 addresses tobacco dependence and cessation and calls in part for collaborating 'with other Parties to facilitate accessibility and affordability for treatment of tobacco dependence including pharmaceutical products . . .' (emphasis added). Detailed guidelines for implementation of Article 14...