Efficacy and Safety of Vernonia Cinerea Pastilles for Smoking Cessation in Low and Moderate Nicotine Dependence

Abstract

Vernonia cinerea (VC) is a Thai medicinal plant that has higher efficacy for smoking cessation than placebo but the difference is not statistically significant. The previous studies have mostly focused on the 2-4 weeks treatment of various forms of VC such as infusion tea, lozenges, and capsules. Therefore, this study has developed a 12-weeks treatment with VC pastilles in smokers. Objective: To compare the efficacy of VC pastilles for smoking cessation in low and moderate nicotine dependence by measuring the continuous abstinence rate (CAR) and the 7-days prevalence abstinence rate (PAR) prior to an assessment at week 12 and the adverse events at the end of study treatment (week 12). Materials and Method: This study was a randomized, double-blind, placebo‐controlled trial of VC pastilles and placebo by block randomization technique, included intention at preparation level to quit smoking, aged 18-60 years. All of subjects received counseling to smoking cessation. The VC group received 2 pastilles; 3 times daily of 575.34 mg VC pastilles extracted from VC powder per day which reference from VC capsule study. Both groups were followed up to evaluate their smoking cessation and any adverse events at Weeks 2, 4, and 12 at the community pharmacy of the Faculty of Pharmaceutical Science, Khon Kaen University. Result: 68 subjects had low nicotine dependence (VC pastilles group: 33 subjects, control group: 35 subjects) 43 subjects had moderate nicotine dependence (VC pastilles group: 21 subjects, control group:  22 subjects). At the end of study treatment (week 12), it found that the CAR and PAR of the subjects with low nicotine dependence between the VC pastilles group and control group were 24.24% and 20.00% (OR=1.28, 95%CI: 0.41-4.04); and 36.36% and 37.14% (OR=0.97, 95%CI: 0.36-2.59) respectively. For the moderate nicotine dependence, it found that the CAR and PAR of the VC pastilles group and control group were 42.86% and 13.64% (OR=4.75, 95%CI: 1.07-21.14); and 52.38% and 22.73% (OR=3.74, 95% CI: 1.00-13.92) respectively. There was no difference of adverse events between the VC pastilles group and control group in both low and moderate nicotine dependence. Conclusion: VC pastilles has more efficacy than placebo for smoking cessation in moderated nicotine dependence, the finding has show statistic significant in CAR and PAR at week 12 so VC pastilles may be effect to nicotine dependence smoker. In addition, no serious adverse event was found.