Nicotine Replacement Therapy Study: A Closer Look

A report published online Jan. 10 in the journal Tobacco Control is receiving lots of publicity, with many headlines suggesting it shows nicotine replacement therapy (NRT) to be ineffective for treating tobacco dependence.

The study focused on relapse among people who had stopped smoking using NRT (with or without professional counseling) or without using NRT. The 787-person cohort, the size of which diminished as time went on, was established in 2001 and telephone interviews were conducted in 2003 and 2006.

The report consists of the individuals who, by the first or follow-up survey, had stopped smoking during the prior two years and had completed the interview at the subsequent wave. Investigators concluded that people who’ve quit smoking relapse at equivalent rates regardless of whether they used NRT to help them in their quit attempts.

Limitations of the study

A deeper look at this study reveals several serious limitations.

First, in most randomized tobacco cessation clinical trials, there is a similar relapse rate for those in the active or placebo group after the medications are stopped. The difference in smoking abstinence after one year is related to higher efficacy at the end of treatment with medication compared with placebo. So, it’s not surprising that there was no difference in relapse in this study.

Two biases are also at play:

  • Selection bias. People who select to use NRT and/or counseling are more likely to be more addicted and therefore more likely to relapse.
  • Recall bias. Smokers who report quitting cold turkey recall quit attempts that have lasted longer and yielded more success, while forgetting those of shorter duration. Those quitting with medications tend to better recall all assisted quit attempts — both those that didn’t last long and those that succeeded. Failure to adjust for recall bias could lead to the erroneous conclusion that there’s no difference in smoking abstinence between those quitting cold turkey and those quitting with medications.

Practical considerations

A number of population-based studies have found that NRT has positive effects in the population, though others don’t show such effects. However, randomized controlled trials of all approved medications for treating tobacco dependence have shown better safety and efficacy compared with placebo.

Given this, we could conclude that when used properly — at the proper dosage and for the proper length of time — nicotine replacement products do indeed help people stop smoking. Preventing relapse is a different issue that is complicated by many factors.

As health care professionals, we can increase the chances of a person stopping smoking and maintaining smoking abstinence over time by tailoring medications to his or her needs and offering appropriate follow-up.

Treatment pays off

One other argument made by the study’s investigators is that government insurance programs shouldn’t offer coverage for medications at the expense of tobacco control initiatives. But, new research from The George Washington University School of Public Health and Health Services published Jan. 6 in the journal PLoS ONE shows that coverage of tobacco dependence treatment in Massachusetts’ Medicaid program resulted in substantial savings — for every $1 spent toward treatment, the program saved an average of $3.12.

This indicates that investing in treatment programs can help smokers to stop, which in turn can lead to reductions in hospital admissions for tobacco-related problems and significant savings for Medicaid. These savings could be applied to increase availability of treatment and for other tobacco control activities.