Study Finds Nicotine Gum and Patches Don't Help Smokers Quit The nicotine gum and patches that millions of smokers use to help kick their habit have no lasting benefit and may backfire in some cases, according to the most rigorous long-term study to date of so-called nicotine replacement therapy. The study, released Monday, followed nearly 2,000 people over a period of years, and is likely to inflame a long-running debate about the value of nicotine alternatives. In medical studies, the products appear effective, making it easier for people to quit, at least in the short term. Those earlier, more encouraging findings were the basis for federal guidelines that recommended the products for smoking cessation. But in surveys, smokers who have used the over-the-counter products, either as part of a program or on their own, have reported little benefit. The new study followed one group of smokers to see whether nicotine replacement affected their odds of kicking the habit over time. It did not, even if they also received counseling with the nicotine replacement. The market for nicotine replacement products has taken off in recent years, rising to more than $800 million annually in 2007 from $129 million in 1991. The products were approved for over-the-counter sale in 1997, and many state Medicaid programs cover at least one of them. "We were hoping for a very different story," said Dr. Gregory N. Connolly, director of Harvard's Center for Global Tobacco Control and a co-author of the study. I ran a treatment program for years, and we invested some $6 million in treatment services. Doctors who treat smokers said that the study findings were not unexpected, given the haphazard way many smokers use the products. "Patient compliance is a very big issue," said Dr. Richard Hurt, director of the nicotine dependence center at the Mayo Clinic, who was not involved in the study. Dr. Hurt said products like nicotine gum and patches "are absolutely essential, but we use them in combinations and doses that match treatment to what the individual patient needs," unlike smokers who are self-treating. The products have been controversial since at least 2002, when researchers at the University of California, San Diego, reported from a large survey that they appeared to offer no benefit. A government-appointed panel that included nicotine replacement as part of federal guidelines for treatment also came under fire, because panel members had received payments from the products" manufacturers. In the study, conducted in Massachusetts, the researchers followed a representative sample of 1,916 adults made up of smokers, recent quitters and young adults. They interviewed the participants three times, once in 2001 or 2002, again in 2003 or 2004, and finally in 2005 or 2006, asking the smokers and quitters about their use of gum, patches and other such products, their periods of abstinence and their relapses. At each stage, about one-third of the people trying to quit had relapsed, the study found. The use of replacement products made no difference, whether they were taken for the recommended six-week period, or with the guidance of a professional cessation counselor. Heavy smokers (a pack a day or more) who used replacement products without counseling were twice as likely to relapse as heavy smokers who did not use them. "Our study essentially shows what happens in the real world is very different" from what happens in clinical trials, said Hillel R. Alpert of Harvard, a co-author with Dr. Connolly and Lois Biener, of the University of Massachusetts.