December 21, 2017

Stanton A. Glantz, PhD

More evidence that NRT without counseling does not work

Eric Leas, John Pierce and their colleagues at UC San Diego just published “Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers” in the Journal of the National Cancer Institute, which adds to the case that NRT used over-the-counter without being part of an organized smoking cessation effort that includes counselling does not work. 
 
This is, of course, something that the tobacco industry has known for a long time, ever since shortly after NRT was introduced.  As Dorie Apollonio and I pointed out in our paper “Tobacco Industry Research on Nicotine Replacement Therapy: ‘If Anyone Is Going to Take Away Our Business It Should Be Us,’” that is why the tobacco companies don’t fight spending money giving away NRT and and why they are now selling their own recreational NRT.
 
It also points to the folly of the FDA adopting the tobacco industry’s “harm reduction” approach of simply seeking alternative delivery systems for nicotine other than conventional cigarettes.
 
Here is the UCSD press release on the study.
 
Study: Medications Alone Don’t Help Smokers Quit
 
December 20, 2017  |  Yadira Galindo
 
Pharmaceutical interventions are routinely prescribed to help people quit smoking. However, a new study by University of California San Diego School of Medicine researchers suggests that, despite promising results in clinical trials, smoking cessation drugs alone may not be improving the chances of successful quitting among smokers in general.
 
“Thirty four percent of people who are trying to quit smoking use pharmaceutical aids and yet most are not successful,” said senior study author John P. Pierce, PhD, Professor Emeritus in the Department of Family Medicine and Public Health at UC San Diego School of Medicine and Moores Cancer Center. “The results of randomized trials that tested these interventional drugs showed the promise of doubling cessation rates, but that has not translated into the real world.”
 
The study, published online in the Journal of the National Cancer Institute on December 21, assessed the effectiveness of three first-line medications recommended by clinical practice guidelines: varenicline, bupropion and nicotine replacement therapy (patch). The data was collected from the Current Population Survey-Tobacco Use Supplement — a U.S. Census survey of adults 18 years or older conducted to obtain information about the country’s use of tobacco products.
 
Studying two cohorts surveyed approximately one decade apart, the team used a method known as "matching" to help balance comparison groups on factors that could lead individuals to be more likely to use a cessation aid but simultaneously make it more difficult for them to quit. For example, one factor was the amount of cigarettes someone regularly consumed.
 
“In these analyses, matching helped reduce bias,” said first author Eric Leas, PhD, who conducted the research while a graduate student researcher at UC San Diego and is now a postdoctoral scholar at the Stanford University School of Medicine. “Still, we found no evidence that the pharmaceutical cessation aids that we assessed improved the chances of successfully quitting. This was both surprising, given the promise of smoking cessation seen in randomized trials, and disappointing because of the need for interventions to help smokers quit.”
 
In the findings, the researchers point to the use of intensive behavioral counseling in combination with pharmaceutical aids as a factor that may have contributed to an increase in smoking cessation rates during clinical trials.
 
Prior research that studied the effect of free behavioral counseling offered by phone has shown improvement in smoking cessation rates when combined with pharmaceutical interventions.
 
“Smokers who are committed to quitting and want to use a pharmaceutical aid should also enroll in a program that could help them track their progress and support them in their attempt,” said Leas.
 
Many states offer free behavioral counseling over the phone, including in California. The California Smokers’ Helpline , operated by UC San Diego Moores Cancer Center, offers counselors who are fluent in the six most commonly spoken languages in California. Smokers can call 1-800-NO-BUTTS.
 
“Evidence is pointing to an important role of behavioral counseling when prescribing pharmaceutical aids,” said Pierce. “If the products were approved with counseling we may have better success rates. As it is, less than 2 percent of smokers who use a pharmaceutical aid are using any behavioral counseling. In both of these longitudinal studies, this was a recipe for relapse to smoking.”
 
Co-authors include: Tarik Benmarhnia, Martha M. White, Madison L. Noble, Dennis R. Trinidad and David R. Strong, all at UC San Diego.
 
This research was funded, in part, by the Tobacco Related Disease Research Program (24ST-0050, 21RT-0135, 24RT-0036) and the National Heart, Lung and Blood Institute (T32HL007034).
 
Here is the abstract for the paper:
 

Background.  Despite strong efficacy in randomized trials, the population effectiveness of pharmaceutical aids in long-term smoking cessation is lacking, possibly because of confounding (factors that are associated with both pharmaceutical aid use and difficulty quitting). Matching techniques in longitudinal studies can remove this confounding bias.
Methods.  Using the nationally representative Tobacco Use Supplement to the Current Population Survey (TUS-CPS), we assessed the effectiveness of medications to aid quitting among baseline adult smokers who attempted to quit prior to one year of follow-up in two longitudinal studies: 2002–2003 and 2010–2011. Pharmaceutical aid users and nonusers with complete data (n = 2129) were matched using propensity score models with 12 potential confounders (age, sex, race-ethnicity, education, smoking intensity, nicotine dependence, previous quit history, self-efficacy to quit, smoke-free homes, survey year, and cessation aid use). Using matched data sets, logistic regression models were fit to assess whether use of any individual pharmaceutical aid increased the proportion of patients who were abstinent for 30 days or more at follow-up.
Results.  Propensity score matching markedly improved balance on the potential confounders between the pharmaceutical aid use groups. Using matched samples to provide a balanced comparison, there was no evidence that use of varenicline (adjusted risk difference [aRD] = 0.01, 95% confidence interval [CI] = –0.07 to 0.11), bupropion (aRD = 0.02, 95% CI = –0.04 to 0.09), or nicotine replacement (aRD = 0.01, 95% CI = –0.03 to 0.06) increased the probability of 30 days or more smoking abstinence at one-year follow-up.
Conclusions.  The lack of effectiveness of pharmaceutical aids in increasing long-term cessation in population samples is not an artifact caused by confounded analyses. A possible explanation is that counseling and support interventions provided in efficacy trials are rarely delivered in the general population.

 
The citation to the paper is Leas, EC et al, Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers.  JNCI: Journal of the National Cancer Institute, djx240, https://doi.org/10.1093/jnci/djx240.  Published: 21 December 2017.  It is available for free here.

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