The use of nicotine replacement therapy (NRT) for smoking cessation is no longer effective in helping moderate and heavy smokers quit for the long term, and it has no benefit for light smokers, according to a report released in the Sept. 11 Journal of the American Medical Association (Vol. 288, No. 10: 1260-1264).

Researchers from the University of California San Diego said the number of people trying to quit has gone up dramatically, and so has the use of NRT. John P. Pierce, PhD, and Elizabeth A. Gilpin, MS, studied smokers in California by looking at the California Tobacco Surveys conducted each year during the 1990s.

The scientists looked at surveys from 1992, 1996, and 1999. They found that the percentage of smokers trying to quit increased more than 60% (from 28% to 61%).

During this time NRT use, such as the nicotine patch and nicotine gum, increased more than threefold: in 1992, 116,209 smokers used NRT; in 1996, 337,142 smokers used NRT; and in 1999, 423,290 smokers used NRT.

The cessation therapies became available over-the-counter in 1996. Pierce and Gilpin said that in 1999 compared to 1996, 37% of those people trying to quit were light smokers. The researchers said that these smoking cessation aids have never proven beneficial for lighter smokers.

Pierce and Gilpin said that unlike in 1992 and 1996, smoking abstinence in moderate to heavy smokers in 1999 was only short term, and after three months, the effect was about the same as for those who used no aids.

This contrasted to 1992 and 1996 surveys, where it appeared that moderate to heavy smokers using NRT were able to abstain longer than similar smokers who did not use NRT.

"Since becoming available without prescription in mid-1996, these products have been heavily promoted to the public," said Pierce. "Unfortunately, advertising does not distinguish between light smokers and those in the medium-to-heavy smoking category."

The authors suggested that NRT should be used in combination with other types of smoking cessation help, such as behavioral counseling.

Gilpin said, "These products are designed to help with the cravings associated with smoking, but not the behavioral aspects."

Some of the changes noted in the study may be related to the fact that these products became available over-the-counter in 1996. "In 1992," write the authors, "NRT was prescribed by physicians only, and physicians or pharmacists may have provided counseling about product use. By mid-August 1996, NRT was widely available over-the-counter."

The result, said the authors, was that it appears there was some long-term benefit to the possible role of doctors and pharmacists in prescribing and counseling patients that disappeared once the products became easily available in 1996.

The report concluded that what goes on in a clinical study may not reflect what happens in real life when a medication is no longer closely monitored. How a study's results are measured, the enthusiasm of the people participating in the study, and a lack of counseling, which had been provided in many trials, are all factors that make the results of clinical trials of smoking cessation look better than they are outside of research programs.

The researchers recommended that there is a "need for more research nationwide concerning barriers to more appropriate use of NRT in the nonclinical setting."

Not all of the information in the report is negative, according to Len Lichtenfeld, MD, a medical editor with the American Cancer Society.

"Interestingly," says Lichtenfeld, "an examination of the survey results suggests that about 15% to 20% of the people surveyed each year who try to stop smoking actually were able to do for at least nine months."

This finding is significant, noted Lichtenfeld. "It is important to remember that failing on one attempt does not mean you shouldn’t try again," he said. "Sometimes, when you are trying to stop smoking, the second, third, or fourth time may be the charm."

"Of course," Lichtenfeld emphasized, "the best strategy is to not start smoking in the first place."