Effect of Vernonia cinerea (L.) Less. lozenges as a smoking cessation aid in patients with non-communicable diseases

Context: Smoking is the leading cause of premature death or severe disability. Vernonia cinerea (VC) is an herb that is used in traditional Thai medicines for quitting smoke and is inexpensive. Aims: To assess the efficacy and safety of VC lozenges for smoking cessation compared with a placebo in non-communicable diseases (NCD) patients. Methods: This study was a multicenter randomized, paralleled, double-blind, controlled trial (Clinicaltrial.gov Identifier: NCT06268002). Five hospitals and two community pharmacies in Thailand participated between September 2017 and December 2021. The inclusion criteria were smokers aged at least 18 years and smoking at least 10 cigarettes per day for at least one month who had the desire to quit smoking and had established NCD. All eligi-ble patients were randomly assigned to receive either VC lozenges or a placebo. The primary outcome was a lower continuous abstinence rate (CAR) after four weeks. Results: Ninety-three smokers with NCD were enrolled. After four weeks, there were more CAR events in the VC lozenges group than in the control group (6 vs. 1; odds ratio [OR] 10.74, 95% confidence interval [CI] 0.82-140.28) but with no statistically significant differences (p=0.083). When compared to the baseline, the number of cigarettes smoked per day and exhaled carbon monoxide levels decreased significantly in patients who received VC lozenges. No serious adverse events or abnormal laboratory data were reported during the use of VC lozenges. Conclusions: In smokers with NCD, the CAR rate at four weeks in the VC lozenges group was not different from the placebo group. NCD patients who received VC lozenges were well tolerated, and no serious side effects were found.