Abstract:
The primary objective of this study was to compare the efficacy of Vernonia cinerea lozenge and placebo on 7-days point prevalence abstinence rate (PAR) in week 4 of the study period. The secondary objectives were to compare the efficacy of Vemonia cinerea lozenge and placebo on PARs at week 2, 8 and 12, continuous abstinence rates (CARs) at week 2, 4, 8, and 12, the mean change of number of cigarettes smoked per day between baseline vs week 4 and baseline vs week 12 in subjects who were smoking, and the incidences and characteristics of adverse events throughout the 4-week treatment phase. A 12-week, randomized, double blinded, placebo-controlled trial was conducted in 67 subjects who were current smokers with not less than 6 months history of smoking, aged at least 15 years, and being in the preparation or action (not more than 7 days) stage of the Transtheoretical Model stages of change. They also did not receive any medicine or other therapy for smoking cessation except cognitive and behavioral therapy. They were then block-randomized into two groups (experimental and control. Experimental group (34 smokers) received a 4-week Venonia cinerea lozenge taken 1 tablet every 4-6 hours, totally 3 tablets per day. Control group (33 smokers) received a 4-week identical placebo in the same manner as the experimental group. Both groups were given individual counseling by a pharmacist at week 0, 1, 2, 4, 8 and 12 and telephone follow-up during each clinic visit. A target quit date was scheduled at day 8 of study period. Smoking status was determined by self-report and confirmed by the urine cotinine. Then number of cigarettes smoked per day were assessed by interview and self-report at clinic visits. Adverse events were assessed by self-report, interview, vital sign measurement, and laboratory data. This study was conducted in an outpatient clinic at Sichon bospital in Nakhon Sri Thamaraj, Thailaod. Data were collected between March 1, 2011 and October 31, 2011. The results showed that the PAR in experimental group (38.2%) were higher than there of the control group (27.3%) at week 4 of the study, but with no statistically significant difference (P=0.339, RR=1.40, 95% CI: 0.69-2.83). The PARs in the experimental group and the control group at week 2, 8 and 12 achieved 41.2% vs 24.2% (P=0.140, RR=1.70, 95% CI: 0.82- 3.51), 41.2% vs 33.3% (P=0.507, RR=1.24, 95% CI: 0.66-2.31) and 47.1% Vรs 27.3% (P=0.094, RR= 1. 73, 95% CI: 0.89-3.34), respectively. The CARs in the experimental group and the control group at week 2, 4, 8 and 12 achieved 41.2% vs 24.2% (P=0. 140, RR=1. 70, 95% CI: 0.82-3.51),32.4% vs 21.2% (P=0.304, RR=1.53, 95% CI: 0.67-3.46), 29.4% vs 21.2% (P=0.441, RR=1.39, 95% CI: 0.60-3.21) and 29.4% s 15.2% (P=0.162, RR=1.94, 95% CI: 0.74-5.07), respectively. The CARs for heavy (> 10 cigarettes per day) smokers significantly higher in the experimental group at all clinic visits, 40% vs 6.3% at week 2, 26.7% vs 6.3% at week 4 and 8, 26.7% vs 0% at week 12. The subjects who were smoking in both groups bad reduced the number of cigarettes smoked per day from baseline throughout the study, but no significant difference between the groups (P=0.645 and 0.541 at week 4 and 12, respectively). The most commonly reported adverse events in the experimental group were drowsiness (38.2%), tongue numbness, dislike the odor of cigarette smoke, dizziness (26.5% equally), and craving reduction (20.6%). There w was 10 difference in the frequency of adverse events between the experimental group and control group except for drowsiness incidence which was statistically significantly higher among the experimental group than the control group (38.2% vs 12.1%, P=0.014). No serious adverse events were noted. The results of this study indicate that Vernonia cinerea lozenge when used as an adjunct to pharmacist counseling does not appear to increase s smoking abstinence rates, but these may be an advantage to using it in heavy smokers (>10 cigarettes smoked per day). Larger scale and longer duration studies are needed to verify the efficacy of Vemnonia cinerea lozenge for smoking cessation.
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