A pilot randomized, placebo-controlled, double-blind trial of a multistep herbal program for assisting smokers to...

This pilot randomized-controlled trial was designed to evaluate the effectiveness of an over-the-counter multistep herbal smoking cessation regimen, SmokeRx, that employs four different herbal formulations taken at different times during the program. Twenty-two subjects were randomized to a placebo group and 20 to the SmokeRx program. The results show that the odds of reduced or validated cessation of smoking were not significantly different between the groups at any juncture over the 6 months of the trial but that there was a trend for higher odds in the SmokeRx group. Subjects were also more likely to drop out of the placebo group (p = .06), suggesting a possible positive effect of the SmokeRx regimen. Overall, early dropouts (at 2 week follow-up) appeared less motivated to quit smoking, as they were more likely to be younger, had smoked more than 5 years, had greater difficulty refraining from smoking in places where it is forbidden, had fewer previous quit attempts, did not intend to quit smoking in the next month, and exercised fewer hours per week. These results suggest that a larger trial of SmokeRx may be warranted and that more studies that assess the efficacy of herbal formulas are needed to provide valid data for non-nicotine smoking cessation options.