A new study published online ahead of print in the journal Addiction reports that over-the-counter nicotine is ineffective in helping smokers quit, resulting in outcomes no better than for smokers who quit without the aid of medication.
(See: Kotz D, Brown J, West R. 'Real-world' effectiveness of smoking cessation treatments: a population study. Addiction. Published online ahead of print on December 20, 2013. doi:10.1111/add.12429.)
The study involved a cross-sectional survey of more than 10,000 adult smokers in England who had made at least one quit attempt in the previous year. The main predictor variable was the method used in the most recent quit attempt: (1) medication and counseling; (2) medication and brief advice; (3) medication only [over-the-counter NRT]; and (4) no medication. The no medication group was the referent group. The main outcome variable was sustained smoking cessation from the last quit attempt until the time of the survey.
The study controlled for multiple potential confounding variables, including the individuals' level of cigarette dependence, time since last quit attempt, and number of prior quit attempts.
The results were as follows: "Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the survey were 3.25 [95% confidence interval (CI) = 2.05–5.15] greater in users of prescription medication in combination with specialist behavioural support, 1.61 (95% CI = 1.33–1.94) greater in users of prescription medication combined with brief advice and 0.96 (95% CI = 0.81–1.13) in users of NRT bought over the counter."
While the study concludes that behavioral counseling and advice in addition to medication are effective, it also concludes that NRT alone is ineffective: "smokers who buy nicotine replacement therapy over the counter with no behavioural support have similar odds of success in stopping as those who stop without any aid."
The Rest of the Story
This study adds to the evidence that although nicotine replacement therapy (NRT) performs well in clinical trials, it appears to have little or no effectiveness in real world settings, outside of clinical trials or counseling programs. In other words, for smokers who attempt to quit on their own using NRT, this medication appears to be no more effective than unaided smoking cessation.
Of note, these findings come from a research group that acknowledges multiple conflicts of interest with pharmaceutical companies that manufacture smoking cessation drugs. Thus, there is an inherent (subconscious) bias to report positive effects of medication. This conflict gives the results of this study even more credibility, as a Big Pharma-funded study is now reporting that over-the-counter NRT may be ineffective for smoking cessation.
The results are problematic, especially given the tobacco control movement's obsession with nicotine replacement therapy. Promoting the use of NRT and mandating that insurance companies cover over-the-counter NRT purchase have become the centerpiece of most health departments' strategies to encourage smoking cessation. An NIH expert panel has insisted that every smoker be treated with medication. And a panel that sets standards for hospital accreditation has insisted that every smoker must be prescribed smoking cessation medication.
These strategies and recommendations appear to fly in the face of evidence suggesting that in the real world, NRT is not particularly effective
This study also calls into question the recommendations of public health agencies such as the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and World Health Organization (WHO), which have advised smokers against using electronic cigarettes, urging them instead to use traditional methods such as over-the-counter NRT.
Even if NRT were effective, it would still represent public health malpractice, in my opinion, to discourage smokers who have failed to quit using NRT to continue trying NRT rather than trying electronic cigarettes if they are excited about that idea. But in the face of evidence that the NRT that is being recommended is not particularly effective, the recommendations of the CDC, FDA, and WHO become contemptible.