Bupropion plus nicotine replacement no better than replacement alone

Journal of Family Practice, Dec, 2004

Simon JA, Duncan C, Carmody TP, Hudes ES. Bupropion for smoking cessation. Arch Intern Med 2004; 164:1797-1803.

* CLINICAL QUESTION

Does the addition of bupropion to nicotine replacement and counseling improve cessation rates?

* BOTTOM LINE

The addition of bupropion (Zyban) does not further increase long-term quit rates in those who receive nicotine replacement and cognitive-behavioral counseling. Quit rates at 1 year were similarly high in both groups--22% and 28% (P=NS). (LOE=1b)

* STUDY DESIGN

Randomized controlled trial (double-blinded)

* ALLOCATION

Uncretain

* SETTING

Outpatient (any)

* SYNOPSIS

The investigators conducting this study enrolled 209 men and 34 women who were receiving care at a Veterans Affairs Medical Center in the United States. These smokers were mainly unmarried middle-aged white men recruited by hospital-based advertising, as well as from lists of patients who previously had participated in smoking cessation clinical studies. Presumably, the patients in the latter group had failed previous smoking cessation attempts, although they may have taken up smoking to participate in the study (ie, professional study participants).

The patients were randomized (allocation concealment uncertain) to receive either placebo or bupropion 150 mg twice daily for 7 weeks. Patients in both groups also received cognitive-behavioral counseling for 30 to 60 minutes with 5 telephone follow-up counseling sessions. They also received nicotine replacement therapy using transdermal nicotine patches.

As is typical in smoking cessation studies, quit rates were high initially: 81% at 1 week. The clinically relevant outcome for smoking cessation is the quit rate at 1 year. In this study, biochemically confirmed quit rates at 1 year were not statistically different between the 2 groups: 19% in the bupropion-treated group compared with 24% in the placebo-treated group (P=NS). These results were in the intention-to-treat analysis. Results were higher in the patients who were compliant, but not different between the 2 groups: 28% of compliant bupropion-treated patients and 22% of compliant placebo users. Although the study was large, as were the quit rates, the researchers did not provide a power calculation.