Questions raised over nicotine replacement therapy: Study

Smokers have been advised a host of choices for nicotine replacement like gums, patches and nasal sprays to help them quit. But a new U.S. study says that these do not help people quit cigarettes over the long term any better than going it alone.

The research by the Harvard University School of Public Health followed 787 adults in the state of Massachusetts who had recently quit smoking, and found that over time just as many relapsed after nicotine replacement therapy (NRT) as without - about a third. “This study shows that using NRT is no more effective in helping people stop smoking cigarettes in the long term than trying to quit on one's own,” said lead author Hillel Alpert, a research scientist at Harvard.

Study participants were surveyed over three periods: 2001-2002, 2003-2004, and 2005-2006. Not only were relapse rates about the same among those who used NRT and those who did not, the study found that heavily dependent smokers who took NRT without professional therapy were twice as likely to relapse as those who did not use NRT.

The participants told whether they had used a patch, gum, inhaler, or spray. They told how long they used the product continuously. The recommended practice is to use the product for eight weeks. Most did not use the products. For instance, at the first interview, 77% did not use them. Those who did use them did so for various time periods. At the first interview, the 33% of those who used the products did so for more than six weeks. About one-third of the quitters had relapsed at each of the three time periods.

“This may indicate that some heavily dependent smokers perceive NRT as a sort of 'magic' pill, and upon realizing it is not, they find themselves without support in their quitting efforts, doomed to failure,” said the study in the journal Tobacco Control.

This study refutes earlier randomized controlled studies that have shown NRT to be effective in helping smokers quit. These authors show the weakness of those trials among the general population in a real-life setting. The study also showed that very few people follow the recommendations of using NRT for eight weeks, with many opting for shorter periods of use.

The NRT industry has boomed since nicotine gum was introduced in 1984, according to background information in the article. Back then, NRT products were a $US45 million industry in the United States. Since over-the-counter sales of NRT were approved in 1996, the industry has soared to $US800 million ($787 million) per year. On top of that, sales of prescription drugs to stop smoking reached $US841 million in 2007. More public funds are also helping to subsidize stop-smoking therapies to low-income Americans, with 39 state Medicaid programs covering one or more kinds of NRT in 2011, compared to 17 states in 1996.

Meanwhile, rates of smoking in the United States have leveled off at about 20 per cent of the population in the past five years after a steady period of decline. “What this study shows is the need for the Food and Drug Administration...to approve only medications that have been proven to be effective in helping smokers quit in the long-term and to lower nicotine in order to reduce the addictiveness of cigarettes,” said co-author Gregory Connolly, director of Harvard's Center for Global Tobacco Control.

GlaxoSmithKline Consumer Healthcare, whose US products include the NicoDerm CQ patch and Nicorette gum, responded to the study by saying, “There remains strong support for NRT's efficacy and its positive impact on public health.” In a statement, it cited the World Health Organization, leading experts and world governments which “agree that NRT products have a crucial role to play in helping to reduce the devastating toll of disease caused by tobacco dependence”. It also referenced “numerous studies (that) show smokers who use NRT products per the dosing recommendations, combined with support, can double their chances of successfully quitting over ‘cold turkey’”.

The study is “seriously biased,” says Saul Shiffman, professor of psychology at the University of Pittsburgh and a longtime researcher in the field. He serves as a consultant to GlaxoSmithKline, which markets the nicotine replacement products Nicorette and NicoDerm CQ. He, too, cites the limited use of the products as a problem. He believes clinical trials, such as those that compare using the medications to not using them, give a truer picture. Numerous clinical trials, he says, “show that these medications double your chances of quitting.”

Connolly does not advocate abandoning the nicotine replacement medication. Instead, he suggests understanding its use. “In the short term, what it is designed for is treatment of withdrawal,” he says. “Long term, our study would not say it would prevent relapse.”
Steven Schroeder professor of medicine and director of the Smoking Cessation Leadership Center at the University of California, San Francisco, reviewed the study findings for WebMD. “It's a useful reminder that there are many ways to help smokers quit and we shouldn't over-emphasize nicotine replacement therapy,” he explained. However, he sees some limitations to the study. He questions whether more participants were needed to find the true effects of the medication with or without counseling. Another limitation, he says, is that few took the treatment as recommended.

His bottom line, “I tell [smokers] it's important to quit. Some do it cold turkey. But data show if you get counseling and one or more of the medications, it will increase your chances of quitting long-term.” He is referring to previous studies showing that the combination approach helps people quit.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

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