Researchers demonstrate that smoking cessation clinical trial results translate effectively into the “real world,” reports Mayo Clinic Proceedings.
Numerous randomized clinical trials have shown the effectiveness of the two major forms of smoking cessation treatment – behavioral support and medication – in helping smokers quit. Researchers have now demonstrated that this approach can successfully translate to the “real world” and that a combination of the two treatments offers almost a threefold chance of success over attempts to quit without using a cessation aid. Their findings are published in Mayo Clinic Proceedings.
“Randomized clinical trials have a high internal validity, but because they are conducted under very strict conditions, they do not reflect the real world in which these treatments are supposed to be used,” explains Daniel Kotz, PhD, from the University of Maastricht in the Netherlands. “We therefore conducted a study to compare the various smoking cessation methods in the real world.”
Investigators conducted a prospective cohort study in a random sample of 1,560 adult smokers who took part in an English national household survey between November 2006 and March 2012. They used data from the Smoking Toolkit Study, an ongoing research program designed to provide information about smoking cessation and factors that promote or inhibit it at a population level.
Smokers were included in the study when they were smoking tobacco at the time of an initial interview, responded to a questionnaire six months later, and made at least one quit attempt during the study period. The smokers each used one of the following four cessation aids: prescription medication (nicotine replacement therapy, bupropion, or varenicline) in combination with specialist behavioral support delivered by a UK National Health Service Stop Smoking Service (4.8%); prescription medication with brief advice (20.8%); nicotine replacement therapy bought over the counter (29.9%); or none of these (44.5%).
A total of 23% reported not smoking at the end of the six-month period. The investigators found that smokers who used a combination of specialist behavioral support and medication in their quit attempts reported higher levels of urges to smoke than did smokers who tried to quit unaided. After adjusting for this, they found smokers using the combination approach had almost three times the odds of success than did those who used neither medication nor behavioral support. A combination of prescription medication along with limited behavioral support was also more effective than unaided quitting. They found however that smokers who bought nicotine replacement therapy (NRT) over the counter with no behavioral support had a reduced success rate.
“As far as we are aware, our study is the first prospective cohort study comparing prescription medication when offered with specialist behavioral support with prescription medication offered without such support. A major strength of our study is the use of a representative sample of the English population that was sufficiently large to detect an effect of specialist behavioral support despite its low prevalence,” says Dr. Kotz. “The results clearly show that the combination of prescription medication with behavioral support is the most successful method. More smokers should be guided towards these forms of treatment.”
“Tobacco use continues to be prevalent and deadly in the United States and worldwide. Further, smoking cessation is one of the most important health behavior changes that we can encourage in our patients. Hundreds of clinical trials that included thousands of patients have demonstrated the efficacy of combined behavioral therapy and pharmacotherapy for tobacco-dependence treatment,” comments J. Taylor Hays, MD, Director of the Mayo Clinic Nicotine Dependence Center in Rochester, Minnesota “The research by Dr. Kotz and his colleagues demonstrates that this approach can be translated to the real world and provide real benefit. This is a case where there is happily little difference between ‘theory and practice.’ Health systems, hospitals, clinics, and providers now need to practice the well-established standard of care to save real lives in their real world.”