Health Care Zone

Do Nicotine Patches Work? Are Nicotine Gums Effective?

Harvard study suggests nicotine patches, gums don’t work. Do nicotine patches work? If we go by the results of recent findings from the most rigorous long-term study of nicotine replacement therapy (NRT) products so far, the answer is, no.

The study, which looked at thousands of smokers, including nearly 800 people trying to quit smoking over a period of several years, shows that nicotine gum and patches have no lasting benefit and may even backfire in some cases.

The new study, published Jan. 9 in the journal Tobacco Control, runs counter to previous medical studies that showed the products effectively helped people quit, at least in the short term.

The World Health Organization and government drug regulators like the United States Food and Drug Administration used those earlier findings as a basis for their recommending NRTs.

For many years now, WHO has recommended the use of NRT products together with smoking cessation counseling as effective means to help smokers quit. Smoking cessation, in turn, is part of a six-fold strategy of the global health organization to address what it calls the “tobacco epidemic.”

“The tobacco epidemic is one of the biggest public health threats the world has ever faced,” says WHO in its website, “killing nearly six million people a year—five million are users and ex-users and more than 600,000 are nonsmokers exposed to secondhand smoke.”

At least half of all the people who smoke or use tobacco will eventually die of lung cancer or any other tobacco-related disease. Tobacco users who die prematurely deprive their families of income, jack up the costs of health care for entire communities and collectively, hinder the overall economic development of whole countries.

Tobacco is a leading cause of death, illness and impoverishment in almost all countries of the world today. Because of this, public health authorities have joined hands with doctors and communities in building a growing global tobacco control movement.

The movement, backed by WHO, has been urging governments to adopt six measures that, taken together, have been proven to cut smoking rates drastically.

The measures include:
• banning smoking in public places to protect people from secondhand smoke
• enforcing bans on tobacco advertising, promotion and sponsorship
• requiring companies to place graphic warnings on labels of cigarettes and other tobacco products
• raising tobacco taxes
• monitoring tobacco use and prevention policies
• providing smoking cessation help like putting up clinics that provide counseling and NRT products for smokers who want to quit

“We were hoping for a very different story,” Dr. Gregory N. Connolly, director of Harvard’s Center for Global Tobacco Control and a co-author of the study tells the New York Times. “I ran a treatment program for years, and we invested” millions in treatment services.

But in the study of Dr. Conolly and colleagues, smokers who used the replacement products, either on their own or as part of a program, reported in surveys that they received little benefit from the gums and patches.

The new study also followed one particular group of smokers to see if nicotine replacement affected their odds of kicking the habit over time. It didn’t, even if they also received counseling with the nicotine replacement.

Stopping addiction
About two in every three smokers want to stop smoking. But without help, many will fail. The main reason why so few smokers succeed, even though they want to stop, is that they’re addicted to nicotine—and nicotine addiction is strong and difficult to break.

Nicotine is a drug that is inhaled from the tobacco in cigarettes. From the lung, it gets into the bloodstream and stimulates the brain.

In regular smokers, when blood level of nicotine falls, they usually develop withdrawal symptoms like restlessness, increased appetite, inability to concentrate, irritability, dizziness, constipation, nicotine craving, depression and anxiety.

These symptoms begin within a few hours after having the last cigarette and when they aren’t relieved by the next cigarette, they get worse.

This is where nicotine replacement therapy (NRT) is supposed to help. NRT products get nicotine into the bloodstream without smoking. When used as indicated, they are supposed to stop, or reduce, the symptoms of nicotine withdrawal.

Aside from nicotine gums and patches, there are inhalers, tablets, lozenges and sprays. Mostly, they’re available over-the-counter, but for some NRTs, you need a prescription.

When they were first released on the market, nicotine patches were available by prescription only. But since 1996, many nicotine gums and patches for use as “stop-smoking aids” have been available OTC. In October 2002, the FDA approved a lozenge containing nicotine. Because they’re approved and allowed OTC, many state Medicaid programs cover at least one of these NRTs.

Global sales of these replacement products has soared in recent years, rising to more than US$800 million annually in 2007 in the U.S. alone, from US$129 million in 1991.

Noncompliance
But since they’ve been created, there’s been a debate over the value of nicotine alternatives.

In 2002, researchers at the University of California, San Diego, conducted a large survey that showed the products seemed to offer no benefit. But the study did not follow people over time.

“Some studies have questioned these treatments, but the bulk of clinical trials have unequivocally endorsed them,” Dr. Michael Fiore, director of the University of Wisconsin’s Center for Tobacco Research and Intervention and one of the most recognized American experts on tobacco control, tells the New York Times.

Dr. Fiore was the chairman of the panel that wrote the U.S. Public Health Service Clinical Practice Guideline: Treating Tobacco Use and Dependence in 2008.

“There are millions of smokers out there desperate to quit, and it would be a tragedy if they felt—because of one study—that this option is ineffective,” he tells the NY Times, which reports, however that he has admitted receiving payments from drug makers.

In fact, the panel he led that recommended including nicotine replacement as part of federal guidelines for tobacco treatment had come under fire in the past, because panel members had received payments from the product manufacturers.

But some doctors don’t blame the replacement products, but the smokers who use these NRTs in a haphazard way. “Patient compliance is a very big issue,” says Dr. Richard Hurt, director of the Mayo Clinic’s Nicotine Dependence Center, who was not involved in the study.

According to him, 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.

Mainly a large survey
In the new study, Harvard researchers followed a representative sample of 1,916 adults, including 787 people who, at the start of the study, had recently quit smoking. Participants were interviewed three times, about once every two years in the 2000s.

During interviews, researchers asked the smokers and quitters about their use of gum, patches and other such products, their periods of not smoking and their relapses. The study was conducted in Massachusetts.

The researchers found that about one-third of the people trying to quit had relapsed at each stage. They also found the use of replacement products made no difference, whether they were taken with the guidance of a cessation counselor or for the recommended two-month period (they usually weren’t).

Using NRTs also backfired in one subgroup of heavy smokers. Defined as smokers who smoked their first cigarettes within 30 minutes after waking, these heavy smokers used replacement products without counseling. At the end of the study, they were found to be twice as likely to relapse as heavy smokers who did not use NRTs.

“Our study essentially shows that what happens in the real world is very different” from what happens in clinical trials, study co-author Hillel R. Alpert of Harvard University tells the New York Times. Other co-authors of the study are Dr. Connolly and Lois Biener of the University of Massachusetts, Boston.

The researchers argue that while nicotine replacement appears to help people quit, it is not enough to prevent relapse in the longer run.

“Motivation matters a lot; so does a person’s social environment, the amount of support from friends and family, and the rules enforced at the workplace. Media campaigns, increased tobacco taxes and tightening of smoking laws have all had an effect as well,” the NY Times report concluded.

Indeed, in many developing countries where resources aren’t enough to fund NRT products, smoking rates have been slashed mainly by adopting national policies that changed the environment of smokers. These policies include raising cigarettes prices by increasing their taxes and preventing the smuggling of cheaper goods, creating smoke-free workplaces, banning smoking in public spaces and enforcing graphic warnings on cigarette packs. Ukraine is one country that has successfully slashed its smoking rates without much use of nicotine replacement products.

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