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Background: Vernonia cinerea and Boesenbergia rotunda are beneficial for cigarette smokers, therefore, systematic investigation is encouraged.
Objective: To assess the efficacy and safety of two oral spray formulations, one with V. Cinerea extracts alone and another with combined extracts of V. cinerea and B. rotunda compared to the placebo oral spray, as a supplement for smoking cessation behavioral counseling.
Methods: The randomized, placebo-controlled trial was conducted at the Outpatient Department of Chao Phya Abhaibhubejhr Hospital, Prachinburi Province, Thailand. The eligible smokers were randomly assigned to three groups to receive the oral sprays with the extracts of V. cinerea, V. cinerea combined with B. rotunda, or placebo. The percentages of reduction in number of cigarettes smoked per week, the smoking abstinence status, the Fagerstrom Tests for Nicotine Dependence (FTND) score, and the adverse reactions were determined for six weeks.
Results: By the sixth week, the percentages of reduction of cigarettes smoked among the smokers with the V. cinerea spray (n=18), the V. cinerea combined with B. rotunda spray (n=21), and the placebo spray (n=17) compared to the first week were 67.09% vs. 28.19%, 73.90% vs. 35.97%, and 46.65% vs. 26.20%, respectively. The reduction in the intervention groups compared to the placebo group was significantly higher since the second week (p<0.05). There were no significant differences in the abstinence status (p>0.05). The FTND score before and after the study in all groups were significantly decreased. Both spray formulations were well-tolerated compared to the placebo. No serious adverse events were observed.
Conclusion: Both oral spray formulations appear to be very promising to support smoking cessation pharmacotherapy. Further studies with larger group of smokers and longer duration of the interventions may be needed to provide more robust knowledge of these findings
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