Monday, March 26, 2012

Another Study Shows No Effect of NRT on Smoking Cessation in Real-Life, Population-Based Setting

A study just published online ahead of print in BMJ reports finding no effect of the provision of free nicotine replacement therapy on smoking cessation rates in a multi-pronged clinical trial.

See: Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ 2012;344:e1696 doi: 10.1136/bmj.e1696 (Published 23 March 2012)

The study was conducted in a real-world, population-based setting, using the national quitline in England to recruit participants. Callers to the quitline who agreed to set a quit date were randomized to one of the following groups:

1. Usual care: standard quitline assistance
2. Intervention A: standard quitline assistance plus free NRT
3. Intervention B: standard quitline assistance plus more intense and frequent counseling

The participants were randomized in a 2 by 2 design. Thus, one group was usual care only. One group was intervention A only. One group was intervention B only. And the fourth group received Intervention A and Intervention B.

The findings were as follows: The six-month prolonged cessation rate for those who received free NRT was 17.7%, compared to a rate of 20.1% among those who did not receive free NRT. This difference was not statistically significant.

For validated smoking cessation at six months (confirmed by carbon monoxide testing), the quit rates were 6.6% for those who received free NRT and 9.4% for those who did not receive free NRT. This difference was statistically significant.

Depending on whether one relies upon the confirmed or unconfirmed smoking cessation results, the basic finding of the study is either that NRT had no effect on quitting, or that the provision of free NRT slightly impaired smoking cessation.

The study concludes: "Among smokers who were motivated enough to call the English NHS Smoking Helpline, set a quit date, and accepted an offer of support for smoking cessation, offering either additional free nicotine replacement therapy or higher intensity proactive telephone support did not increase quit rates over and above those obtained using standard quitline care."

The Rest of the Story

The most important finding of this story is that under the best real-life conditions of free nicotine replacement therapy and frequent counseling, a chemically-confirmed six-month smoking cessation rate of only 6.6% was achieved. Even the non-confirmed (self-reported) quit rate of 17.7% at six months among those who received free NRT is quite dismal.

Compare these findings with those of the first electronic cigarette trial. In that study, the sustained six-month abstinence rate was 22.5%.

There was a major difference, however. In this study, the smokers were highly motivated to quit and had gone so far as to call the quitline. In the Polosa study, subjects were enrolled only if they had "no interest in quitting."

Thus, we have a real-world six-month prolonged cessation rate of 17.7% with NRT among highly motivated smokers compared to a 22.5% prolonged six-month cessation rate with electronic cigarettes among smokers with very low motivation to quit.

Do anti-smoking practitioners look at the evidence anymore? In light of these data, what would possibly prompt anti-smoking groups to highly encourage NRT, highly discourage electronic cigarettes, and even go so far as to advise electronic cigarette users who have successfully quit to return to "proven" methods of cessation?

Moreover, what is the difference between this research and the previous research which purportedly showed how effective NRT is?

I assert that there are two major differences:

1. The previous research was not conducted in a real-life setting. It was conducted in the settings of clinical trials which in no way simulate people's actual experience outside of those trials. Here, the research involved a clinical trial, but it was conducted in a real-life, population-based setting which represents actual practice.

2. The previous research was conducted largely by researchers with financial conflicts of interest with Big Pharma. This research was conducted by investigators with no financial conflicts of interest.

As the evidence continues to build that NRT is not all that it was cracked up to be, the established tobacco control institutions are not budging because they are too financially entrenched in Big Pharma. As I have pointed out in just the last week, their conferences are sponsored by Big Pharma, their organizations are heavily funded by Big Pharma, and their major reports and recommendations giving national advice or setting national policy are written largely by experts who have financial conflicts of interest with Big Pharma.

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