Smoking cessation pill no better than nicotine patches or lozenges

FILE - In this Saturday, March 2, 2013, photo, a cigarette burns in an ashtray at a home in Hayneville, Ala. (AP)

Smoking cessation pills aren't any better than nicotine patches or lozenges at helping people successfully quit, a U.S. study suggests.

Researchers gave more than 1,000 smokers counseling to help them quit and randomly assigned them to receive three months of treatment with either lozenges plus patches, patches alone or varenicline, a cessation drug sold as Chantix in the U.S. and Champix in many other countries including Canada and Europe.

After a year, roughly one in five smokers successfully kicked the habit regardless of which treatment they used, the researchers report in JAMA, though there were more side effects such as insomnia, nausea, and constipation with varenicline.

"The results suggest that the widely available, simple to use, nicotine patch can produce long-term smoking cessation rates that are similar to those produced by more intense treatments," said lead study author Timothy Baker, a public health researcher at the University of Wisconsin.

At the start of the study, participants were around 48 years old and had been smokers for about two decades. They smoked 17 cigarettes a day on average, a bit less that a typical pack in the U.S.

After 26 weeks, researchers asked them if they had smoked at all in the previous seven days and did lab tests to see if the level of carbon monoxide in their breath was low enough to confirm they had indeed refrained from smoking.

Among 241 people assigned to use nicotine patches, 55 of them, or about 23 percent, were confirmed non-smokers at 26 weeks.

In the group of 424 people given varenicline, 100 of them, or about 24 percent, were confirmed abstinent at that point in the study. So were 113 of the 421 people who used a combination of patches and lozenges, or about 27 percent of this group.

The differences between the groups were too small to be statistically meaningful.

After one year, 21 percent of the people using patches had quit, as had 19 percent of people taking varenicline and 20 percent of individuals given a combination of patches and lozenges. At this point, too, the differences weren't statistically significant.

Some side effects were more common with varenicline, with about 29 percent of people on the drug reporting nausea, 23 percent reporting vivid dreams and 22 percent reporting insomnia. The drug label carries warnings of serious psychiatric side effects and suicidal thoughts; people with a history of psychosis, serious depression or suicide attempts were excluded from the study.

The most common side effects with the patch were itching, vivid dreams, and insomnia. Itching, nausea and vivid dreams were the most common side effects with combined patch and lozenge use.

One shortcoming of the study is that more than half of the patients in each treatment group stopped therapy before the 12-week regimen was completed, the authors note.

It's also possible that the intense counseling participants received and their less than a pack-a-day smoking habits made it harder to uncover differences between the treatments that might be seen without counseling or with heavier smokers, Dr. Neal Benowitz, a nicotine addiction researcher at the University of California San Francisco, said by email.

Some previous research has found both varenicline and combination nicotine replacement therapy more effective than patches alone, the study authors note.

"For high dependence smokers, I would give the choice of varenicline or combined nicotine replacement therapy," added Benowitz, who wasn't involved in the study but has advised Pfizer, the company that makes the drug.

One advantage of nicotine patches and lozenges is that unlike varenicline, they don't require a prescription, noted Dr. Carlos Roberto Jaen of the University of Texas Health Science Center in San Antonio. Some patients still might prefer a pill, particularly if they have skin conditions or allergies.

"The benefits of nicotine replacement are access and cost," Jaen, who wasn't involved in the study, said by email. "This study provides important evidence to use varenicline as a second-line medication or at least hold it as an option after patients have attempted to use nicotine replacement first."

The study was supported by the U.S. National Heart, Lung, and Blood Institute.