A new study, conducted in the “real world” as opposed to under clinical conditions, finds that nicotine patches and gum and other nicotine replacement products designed to help people quit smoking, are no more effective in the long term than quitting without their help, even when combined with counseling.

The researchers, from Harvard School of Public Health (HSPH) and the University of Massachusetts Boston, said their findings show the importance of conducting studies in the general population and not just relying on clinical studies, which tend to support the idea that nicotine replacement therapies are effective.

A report on their findings is due to appear online this week in the BMJ journal Tobacco Control.

The US Food and Drug Administration (FDA) approved nicotine replacement products in the 1990s, since when they have been available over the counter. The approval came after randomized clinical trials showed that participants who quit with the aid of such products were up to three times more likely to be successful.

Gregory Connolly is director of the Center for Global Tobacco Control at HSPH and co-authored this latest study. He told the press their findings show the US regulating authorities should only approve products that have been proven to work in the long term:

“What this study shows is the need for the Food and Drug Administration, which oversees regulation of both medications to help smokers quit and tobacco products, 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.”

For their study, Connolly, lead author Hillel Alpert, a research scientist at HSPH, and co-author Lois Biener of the University of Massachusetts Boston’s Center for Survey Research, followed 787 adult smokers living in Massachusetts and asked them to complete surveys. The recruits joined the study after they had recently quit smoking.

The researchers surveyed the participants at three time periods after quitting: in 2001-2002, in 2003-2004, and in 2005-2006. They asked them whether they had used any nicotine replacement therapies such skin patches, gum, inhalers or nasal sprays to help them give up, and if they had, then what was the longest time they had used them for without a break.

They also asked them if they had received any support or professional help, such as from a doctor or counselor, or if they had attended a smoking cessation program.

When the researchers analyzed the data they found for each time period, that nearly one third of recent quitters said they had taken up smoking again, and those who had used nicotine replacement products were just as likely to relapse as the ones who had given up without the use of those aids.

The researchers also found no difference in relapse rate between heavy and light smokers who used nicotine replacement products.

Alpert said their study showed that using nicotine replacement therapy is “no more effective in helping people stop smoking cigarettes in the long-term than trying to quit on one’s own”.

He said even though clinical trials had shown nicotine replacement therapies to be effective, their findings highlight the importance of doing empirical studies that look at how effective these aids are in the general population (in the “real world” as opposed to under controlled conditions).

Biener said perhaps we should reconsider putting so much public money behind nicotine replacement therapies, especially if it means less money is available for efforts that research shows to be effective, such as increasing the price of tobacco products, promoting no smoking policies and media campaigns.

According to the US Centers for Disease Control and Prevention (CDC), the previous decline in adult smoking rates has levelled out in the last five years.

Funds from the National Cancer Institute, State and Community Tobacco Control Interventions Research Grant Program helped pay for the study.

Written by Catharine Paddock PhD