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Nicotine Replacement Treatments May Not Work Long-Term

 

Jan. 9, 2012 — Nicotine replacement therapies such as gums or patches may not help smokers kick the habit long-term, a new study shows.

 

Relapse rates of the quitters were similar during the study period, whether they used the products alone or with counseling, or they did not use them.

 

“Nicotine replacement therapies … do not show any long-term effect on quitting even when combined with counseling,” says researcher Gregory Connolly, DMD, director of the Center for Global Tobacco Control and professor of public health at the Harvard School of Public Health. Behavioral counseling is widely recommended, with medication, to help smokers quit.

 

The results of the new study are published online in Tobacco Control. The findings are at odds with clinical trials, Connolly says. The new study, however, draws from the population. It gives a more ”real world” picture, he tells WebMD.

 

Smoking cessation experts and a maker of nicotine replacement therapies took issue with the findings.

 

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.” Better strategies are needed to prevent relapse, he tells WebMD.

 

13 Best Quit-Smoking Tips Ever

Nicotine Replacement Study Details

 

Connolly followed 787 adult smokers who had recently quit in Massachusetts. The participants were interviewed over three time periods: In 2001 to 2002, 2003 to 2004, and 2005 to 2006. Of the 787 people, 480 finished the second interview and 248 the third interview.

 

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, Connolly says.

 

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.

 

The chances of relapse were not affected by use of the nicotine replacement products for more than six weeks or whether the program included counseling. The relapse odds were highest for those who had been heavily dependent on nicotine and used the products but did not get counseling.

 

In the past five years, the declines in adult smoking seen in previous years have stalled, Connolly says.

 

Deciding how best to get smokers to quit for good is a public health challenge. Sales of the nicotine replacement products have risen, Connolly says. Sales totaled $45 million in 1984, when nicotine gum was introduced. Since 1997, sales have totaled more than $800 million annually. “The findings of this study cast doubt on the relative effectiveness of NRT [nicotine replacement therapy] as a population strategy” the researchers write. The money now spent on coverage for the medications, Connolly says, should be balanced by ongoing public health programs that encourage smokers to quit.

Professor: ‘We Shouldn’t Over-Emphasize Nicotine Replacement Therapy’

hand crushing cigarettes

 

Steven Schroeder MD, 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 tells WebMD.

 

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.

 

The study is ”seriously biased,” says Saul Shiffman, PhD, 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.”

Nicotine Replacement: Industry Weigh-In

 

”When it comes to smoking cessation, there is no ‘magic pill,’” says Deborah Bolding, a spokesperson for GlaxoSmithKline, in an emailed statement to WebMD.

 

She cites ”hundreds of clinical trials” showing the products work when used as directed. NRT products, she writes, have ”helped millions of smokers quit by gradually weaning them off their tobacco addiction and [the approach] is recommended as a [primary] therapy for quitting.”

 

SOURCES:

 

Gregory N. Connolly, DMD,  professor of public health; director, Center for Global Tobacco Control, Harvard School of Public Health, Boston.

 

Alpert, H. Tobacco Control, published online Jan. 9, 2012.

 

Steven Schroeder, MD, professor of medicine; director, Smoking Cessation Leadership Center, University of California, San Francisco.

 

Saul Shiffman, PhD, professor of psychology, University of Pittsburgh.

 

Deborah Bolding, spokeswoman, GlaxoSmithKline.

© 2012 WebMD, LLC. All rights reserved.

©2005-2007 WebMD, Inc. All rights reserved.

WebMD does not provide medical advice, diagnosis or treatment.

Rating

5 Star

Categories

Nicotine Replacement Treatments May Not Work Long-Term

Our Review Summary

This story managed to address nearly all of our criteria in this clearly written piece. We always wish stories had a little more detail about costs, and this one, like the other two reviewed, also missed information about harms. The main drawback to this story, though, was that it relied too heavily on people connected to GlaxoSmithKline, which makes some of the most popular nicotine replacement products.

 

Why This Matters

As this story points out, the research on nicotine therapy has been evolving. Because of the strength of so many clinical trials, people assume that patches, gum and other nicotine products work, but this study indicates that under real world conditions, these medicines might actually not show much benefit. The story says, “In the past five years, the declines in adult smoking seen in previous years have stalled”. Jump starting those efforts is crucial giving the impact smoking has on population health.

A Cochrane Report  in 2008 reported on trials involving more than 40,000 subjects and concluded that nicotine replacement therapy improves the likelihood of smoking cessation in the short term.  Although many people stop smoking, the return to smoking within a year is common. This study looks at the long term benefits over a 5 year period in the real world. Although there are limitations to the study, the conclusions bring the relative value of the hundreds of millions of dollars spent annually into question.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

This story discussed costs in the context of overall sales figures. “Deciding how best to get smokers to quit for good is a public health challenge. Sales of the nicotine replacement products have risen, Connolly says. Sales totaled $45 million in 1984, when nicotine gum was introduced. Since 1997, sales have totaled more than $800 million annually.” We wish the story had included some examples of the costs of the individual products compared to cigarettes.

The cost of 8 weeks of the nicotine patch is approximately $160-200.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story, like the others, provides no hard numbers for quantifying the benefits, but we thought it did an adequate job explaining what the study found. Unlike the NY Times and LA Times stories, this one provided accurate information about the number of subjects who started and completed the study.

All three of the stories have the same problem of not explaining whether ultimately two-thirds of the study participants relapsed or the same one-third relapsed at two different intervals.

Nonetheless, we’ll give the story the benefit of the doubt with a satisfactory score on this.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

None of the stories mentioned the potential harms from taking nicotine, as opposed to quitting cold turkey. Nor did they mention the additional risks associated with continuing to smoke instead of making use of a more successful smoking cessation program that would actually help a smoker quit. As the leading risk factor for early death, smoking should be stopped as quickly and effectively as possible.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story, like the others, did a fair job explaining the study design. This one excelled by explaining a key fact about the study. “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.” This gets to both a potential problem with how comprehensive the study might be and whether it is a good measure of the products’ effectiveness. This isn’t just a question of whether people were compliant. It’s a question of whether the study could adequately judge the products’ effectiveness given the size of the cohort and varying lengths of time people took the drugs. The New York Times story indicates that the lengths of time did not matter, but none of the stories fully addressed this point.

Does the story commit disease-mongering?

Satisfactory

No disease mongering.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

We give the story a pass here because it includes one independent source with good perspective on both the study’s strengths and drawbacks. Half of the people quoted in the story, though, either work for Glaxo or receive funding from Glaxo.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story gave a good, independent perspective about the fact that the preponderance of evidence is leaning toward a combination therapy of drugs and counseling.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

We like that this story was very specific on what types of nicotine products were studied. “The participants told whether they had used a patch, gum, inhaler, or spray. They told how long they used the product continuously.”

Does the story establish the true novelty of the approach?

Satisfactory

The story says that the new study gives a more “real world” picture of nicotine replacement therapies.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story did not rely on any press release.

Total Score: 9 of 10 Satisfactory

Comments (3)

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ken derow

February 15, 2012 at 5:01 am

Is it any wonder that NRT treatments are not highly effective when use of NRT as a stand-alone therapy only addresses the physical dependency related to nicotine addiction, and not the more intractable issues related to psychological dependency, whereby psychosocial cues often trigger the “light-up” porcess. The most effective smoking cessation tools must directly address both parts of the problem, both the physical and the psychological.

Reply

James Guthrie Merickel

July 27, 2012 at 9:08 pm

I am skeptical about the overall seriousness of attempts to get people to change behaviors that have been chosen (or appear to have been). In the large, economists indicate that it is better for those without serious behavioral issues and for ‘the economy’ for those with them to destroy themselves slowly than to try to help them, though the assumptions economists make about what an ideal state of the economy is are disputable. So, the subject dealt with here concerns an industry to help people that is overmatched by countervailing forces at present.

Reply