Smokers are no more likely to give up cigarettes for good by using nicotine replacement products such as patches and gum than if they did not use those quit-smoking aids, a prospective cohort study showed.

Compared with people who did not use nicotine replacement products, the likelihood that they'd take up smoking again was no lower among individuals who used patches or gum for the recommended time of more than six weeks, regardless of whether they also had counseling by a healthcare professional (P=0.117) or not (P=0.159), according to Hillel R. Alpert, ScM, of Harvard University in Boston, and colleagues.

Action Points Explain that the use of nicotine replacement products such as patches and gum failed to help former smokers in their efforts to stay off cigarettes.

Point out that the likelihood of smoking relapse was no lower among individuals who used nicotine replacement for the recommended time of more than six weeks, regardless of whether they also had counseling by a healthcare professional.

Nor were the odds of smoking relapse changed by use of the nicotine products for any length of time -- less than or more than six weeks -- either with counseling (P=0.398) or without help from a professional (P=0.073), the researchers reported online in Tobacco Control.

"The results of this representative study of recent quitters raise serious questions regarding the population-level effectiveness of widely popular smoking cessation medications used with or without behavioral counseling," Alpert and colleagues stated.

Smoking cessation aids have been available over the counter for more than 15 years, and their use has been recommended by the Department of Health and Human Services, based on successful short-term results in randomized studies.

However, the decline in smoking prevalence has leveled off in the past few years, and the ratio of ex-smokers to ever-smokers has been unchanged for almost the entire time these products have been available.

Because cross-sectional studies have suggested that the benefits seen in randomized trials may not hold up over time, Alpert and colleagues conducted a series of telephone interviews at two-year intervals with a sample of 6,739 adults in Massachusetts.

During the first wave of interviews, which took place in 2001-2002, 787 participants reported that they had stopped smoking within the previous two years.

But among the 61% of these recent quitters who participated in the second wave of interviews in 2003-2004, 30.6% had relapsed.

And of the 68.1% of those interviewed in the second wave who then participated in the third wave in 2005-2006, 31.3% were once again smoking.

Among those who reported having recently quit in wave one, 22.6% had used a nicotine replacement product, as did 20.4% of those who reported quitting in wave two.

But the product had been used for longer than six weeks by only 7.5% and 13.3% in wave one and two, respectively.

Between waves one and two, the rate of relapse was doubled for those who had remained abstinent for less than six months (35% versus 17%, P<0.001), Alpert and colleagues found.

Between wave two and wave three, relapse was higher, at 52%, among participants who used the nicotine products for any amount of time without any counseling, compared with those who used the products for any amount of time with counseling (30%) or those who never used the products (22%, P=0.015).

Further analysis found that the highest risk of relapse was for individuals who previously had been heavy smokers, had used nicotine products for any length of time, and had no professional help (OR 2.68, 95% CI 1.40 to 5.11).

Heavy smokers were those who had their first cigarette within one half-hour of rising and smoked more than 20 cigarettes daily.

The lowest risk was for those who had remained abstinent for at least six months (OR 0.46, 95% CI 0.29 to 0.73).

The findings of this study, according to the authors, highlight the shortcomings of reliance on randomized clinical trial (RCT) data for the formulation of health policy guidelines.

"While the RCT design provides the best control for confounding and isolating causal mechanisms and is essential for determining clinical effectiveness, the cohorts and clinical settings in which they are conducted may not be generalizable to the population in the real world," they noted.

For instance, a review of eligibility criteria for clinical trials of smoking cessation found that two-thirds of nicotine-dependent patients were excluded.

The findings also have important implications for healthcare costs, with $800 million being spent each year for over-the-counter smoking cessation products and $841 million for prescription aids.

The authors pointed out that comprehensive, population-based tobacco control programs led to major reductions in smoking in the U.S. prior to the growth of cessation medications. For instance, Massachusetts and California saw 50% to 60% decreases in consumption with these programs.

Funding ineffective services, such as cessation medications, that aim to change individual behavior has meant a steep decline in money spent on public programs that have been demonstrably effective, such as mass-media campaigns and no-smoking laws, they said.

The authors noted that the U.S. healthcare reform legislation plans to expand coverage for smoking cessation in both public and private insurance.

"As the nation moves to expand coverage of healthcare services, policies addressing the design, marketing, and use of cessation medications should be made in the larger context of public health. Increases in coverage for individual treatment must not be at the expense of public health programs and policy interventions that have proven effective in promoting cessation," they concluded.