Nicotine Replacement Therapies May Not Be as Effective When Purchased Over-The-Counter
Every year, more than one third of US smokers try to quit smoking. Since nicotine replacement therapies (NRT) became available in the early 1990s, nicotine gums, patches and inhalers have been popular smoking cessation aids. Research has shown that they help moderate to heavy smokers (15 or more cigarettes per day) quit, but evidence that they help light smokers (less than 15 cigarettes per day) quit is lacking. Initially, NRT was prescribed by physicians to supplement behavioral therapies and self-help materials they were dispensing in the office. By the second half of 1996, NRT had become widely available without a prescription (e.g., Nicorette, Nicotrol), so smokers could obtain them without guidance from their physicians.
Research published in the September 11, 2002 Journal of the American Medical Association suggests that the effectiveness of NRT may have declined after it became available without a prescription. The researchers speculate that this reduced effectiveness may be due to light smokers using the products and an overall reduction in behavioral and self-help efforts.
About the Study
Researchers at the University of California, San Diego analyzed data from the California Tobacco Surveys (CTS) of 1992, 1996, and 1999. The 1992 survey included 5247 smokers, the 1996 survey included 9725, and the 1999 survey included 6412. Although the CTS was not designed to measure the effectiveness of NRT, these surveys included information about number of quit attempts in the previous year, use of NRT, use of behavioral therapy or self-help materials, and successful quit attempts. In addition, the 1999 survey included information on use of the prescription antidepressant bupropion (Wellbutrin, Zyban) as a smoking cessation aid.
For this recent analysis of the CTS data, researchers looked at only the most recent quit attempt. They analyzed use of NRT, bupropion, behavioral therapy, and self-help materials, as well as success in quitting.
Researchers compared the successful quit rates of NRT users among the 1992, 1996, and 1999 surveys.
From 1992 to 1999, attempts to quit smoking increased by more than 60% and use of cessation aids (NRT or antidepressant) increased by 50%. However, long-term success of NRT was only evident in the 1992 and 1996 surveys. By 1999, when NRT had been available over-the-counter for several years, the long-term smoking cessation rate among NRT users was no better than the cessation rate among quit attempters not using NRT.
Of interest is that in 1996 and 1999, duration of NRT use was only 14 days, which is much less than the recommended minimum of six weeks, and use of behavioral therapies was only 20%. In addition, by 1999 significantly more light smokers, for whom NRT has not been shown effective, were using NRT.
Although these results raise questions about the long-term effectiveness of NRT, this study has its limitations. First, the researchers analyzed data from the most recent quit attempt only, which excludes a number of previous quit attempts that may or may not have involved NRT. Second, participants in this study who were classified as “successful quitters” could have relapsed after the last survey in 1999, thus moving them into the unsuccessful category. However, the researchers used sophisticated statistical techniques to try to minimize this concern. Third, smokers in this study were not randomly assigned to take or not to take NRT; rather they made that decision themselves. It’s possible that some factor related to their decision to use or not use NRT (for example, their determination or their fear of illness) affected their chances of success. Finally, the fact that the CTS study in which this information was collected was not designed to measure the long-term effectiveness of NRT weakens the strength of these findings.
How Does This Affect You?
Does this mean NRT doesn’t work? Not necessarily. This study simply raises concerns that NRT may not be as effective in the general population as it was in the controlled clinical studies supporting its effectiveness.
The findings also remind us that NRT’s effectiveness has only been verified among moderate to heavy smokers but not among light smokers. In addition, NRT was always intended for use in conjunction with behavioral therapy and self-help materials to help smokers quit. The authors of this study speculate that when physicians prescribed NRT, the products were more likely to be prescribed to appropriate candidates and within the context of other smoking cessation efforts, such as counseling and written self-help materials.
Before you head down to the drug store to buy yourself nicotine gum or patches, consider talking to your health care provider about your plans to quit. He or she can suggest an appropriate plan of action or direct you to a smoking cessation program. In addition to your nicotine addiction, you’ll need to address the behavioral factors that affect your smoking habits. (See the Resources section below for links to smoking cessation websites.)
“Freedom From Smoking” Smoking Cessation Program
American Lung Association
Tobacco Information and Prevention Resource
Centers for Disease Control and Prevention
Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002;288:1260-1264.
Last reviewed Sep 12, 2002 by
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