NEW YORK, Nov 01 (Reuters Health) -- When the nicotine patch first became available for smokers who wanted to quit, it was a prescription medication. In 1996, the patch became available as an over-the-counter item, available without a prescription. A report published in the November issue of the American Journal of Public Health confirms that this over-the-counter method of smoking cessation is both safe and effective.
Researchers led by Dr. J. Taylor Hays of the Mayo Clinic in Rochester, Minnesota, recruited 958 subjects for two studies. In the first study, participants were provided with either a nicotine patch or a placebo (inactive) patch for free, and followed for 24 weeks. Subjects were randomly assigned to groups in this double-blind study, in which neither they nor the researchers knew who had which patch.
In the second study, participants were not given the patches for free, but were required to purchase nicotine patches, and were also followed for 24 weeks. These subjects were randomly assigned to either the double-blind or the open label parts of the study. All subjects were asked to keep weekly journals and to visit the study center weekly for patches and for a carbon monoxide breath test.
At 6 weeks, 13% of placebo subjects reported abstinence from smoking compared with 20.2% of those wearing the "free" active patch. For subjects who bought their patches, 23.2% reported abstinence. Breath tests confirmed abstinence in slightly smaller percentages for each group.
There were no significant differences in abstinence between the subjects who received nicotine patches for free and those who paid for them. The differences between the placebo group and the two active nicotine patch groups were significant.
At 24 weeks, all three groups reported lower rates of abstinence than at 6 weeks, with those who paid for their patches continuing to do slightly better. Again, the breath tests confirmed abstinence in smaller proportions.
Side effects from the patch were mild and included skin reactions, sleep disturbances, nausea, and headache. Sixteen subjects had cardiovascular side effects, including heart attack in two. The authors note that "any increased risk of cardiovascular events appears to be tied more closely to smoking than to nicotine patch therapy."
The researchers report that these findings on smoking cessation rates are similar to, although lower than, results from similar studies. They suggest that this may be because their study did not provide counseling or other behavioral intervention, which is considered helpful in smoking cessation programs.
Hays and his team conclude that although "an important public health benefit may result from over-the-counter nicotine patch use... (h)ealthcare providers will still need to take an active role in smoking cessation intervention by advising that smokers who want to stop should use nicotine patches and by providing support for smoking cessation attempts."
