Efficacy and Safety of Vernonia cinerea for Smoking Cessation: An Open-Label Randomized Controlled Trial.

2023-01-01
Asian Pacific journal of cancer prevention : APJCP 24(1)
- Krissanaporn Tuenthosarn
- Jiratha Budkaew
- Nithikorn Sorncha
- Bandit Chumworathayi

PubMed: 36708558
DOI: 10.31557/apjcp.2023.24.1.101

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 84
Population: 84 patients
Methods: Randomized, active-comparator, open-label trial; 84 patients equally randomized to VC or nortriptyline; 12 weeks of treatment followed by follow-up to week 24.
Blinding: Open-label
Duration: 24 weeks
Funding: Unclear

This study aimed to compare the efficacy and safety of Vernonia cinerea (VC) and nortriptyline for smoking cessation. A randomized, active-comparator, open-label trial was conducted in 2019. A total of 84 patients participated in the study, and equally randomized with 42 participants in each group. Overall, there was no statistically significant difference of continuous abstinence rate (CAR) between VC and nortriptyline group (Odd ratio 0.68, 95%CI 0.25-1.85, P=0.451). After week 12, the end of treatment, CAR between both groups was not different (44.44% vs 45.95%, Odd ratio 0.77, 95%CI 0.23-2.54, P>0.999). After follow up by the end of research at week 24, the CAR in both groups was not different (41.67% vs 43.24%, Odd ratio 0.76, 95%CI 0.23-2.55, P>0.999). After week 24, relapse rate between VC and nortriptyline group was not different (13.89% vs 10.81%, P=0.923). In addition, both groups were effective in reducing the number of cigarettes per day compared to baseline. However, there was no difference between the groups. Overall, the VC group had an 8% smoking rate less than nortriptyline group, but not statistically significant (IRR 0.92, 95%CI 0.59-1.43, P=0.702). They also resulted in reducing the exhaled CO level at treatment period and wash out period (at week 12; 7(-17-20) vs 7(-12-16), mean difference 0.78, 95%CI -3.07-4.63, P>0.999, at week 24; 8(-5-22) vs 8.5(-5-17), mean difference 0.39, 95%CI -3.46-4.24, P>0.999). Overall, there was no difference between either group (mean difference -0.31, 95%CI -3.10-2.47). For safety data, adverse events including tongue bitter taste or numbness were found in VC group to be greater than in nortriptyline group (61.9% vs 30.95%, P=0.004), whereas dry mouth and drowsiness were greater found in nortriptyline group (35.71% vs 90.48%, P<0.001 and 16.67% vs 90.48%, P<0.001, respectively). Serious adverse events were not found. In smoking cessation, efficacy and safety of either VC or nortriptyline showed no difference.

Research Insights

ironweed→Increased Smoking Cessation Rate
there was no statistically significant difference of continuous abstinence rate (CAR) between VC and nortriptyline group (Odd ratio 0.68, 95%CI 0.25-1.85, P=0.451). After week 12, the end of treatment, CAR between both groups was not different (44.44% vs 45.95%, Odd ratio 0.77, 95%CI 0.23-2.54, P>0.999). After follow up by the end of research at week 24, the CAR in both groups was not different (41.67% vs 43.24%, Odd ratio 0.76, 95%CI 0.23-2.55, P>0.999).
Effect
Neutral
Effect size
Small
ironweed→Reduced Cigarette Consumption
both groups were effective in reducing the number of cigarettes per day compared to baseline. However, there was no difference between the groups. Overall, the VC group had an 8% smoking rate less than nortriptyline group, but not statistically significant (IRR 0.92, 95%CI 0.59-1.43, P=0.702).
Effect
Neutral
Effect size
Small
ironweed→Reduced Exhaled Carbon Monoxide Level
They also resulted in reducing the exhaled CO level at treatment period and wash out period (at week 12; 7(-17-20) vs 7(-12-16), mean difference 0.78, 95%CI -3.07-4.63, P>0.999, at week 24; 8(-5-22) vs 8.5(-5-17), mean difference 0.39, 95%CI -3.46-4.24, P>0.999). Overall, there was no difference between either group (mean difference -0.31, 95%CI -3.10-2.47).
Effect
Neutral
Effect size
Small
ironweed→Reduced Relapse Rate
After week 24, relapse rate between VC and nortriptyline group was not different (13.89% vs 10.81%, P=0.923).
Effect
Neutral
Effect size
Small

Adverse Events Reported

ironweed→drowsiness
dry mouth and drowsiness were greater found in nortriptyline group (35.71% vs 90.48%, P<0.001 and 16.67% vs 90.48%, P<0.001, respectively)
Finding
Increased risk
Magnitude
16.67% vs 90.48%, P<0.001
Significant
Yes
ironweed→dry mouth
dry mouth and drowsiness were greater found in nortriptyline group (35.71% vs 90.48%, P<0.001 and 16.67% vs 90.48%, P<0.001, respectively)
Finding
Increased risk
Magnitude
35.71% vs 90.48%, P<0.001
Significant
Yes
ironweed→tongue bitter taste or numbness
adverse events including tongue bitter taste or numbness were found in VC group to be greater than in nortriptyline group (61.9% vs 30.95%, P=0.004)
Finding
Increased risk
Magnitude
61.9% vs 30.95%, P=0.004
Significant
Yes
ironweed→Overall tolerability
Serious adverse events were not found.
Finding
Reported