Efficacy and Safety of Cytisine in Combination with a Community Pharmacists' Counselling for Smoking Cessation in Thailand: A Randomized Double-Blinded Placebo-Controlled Trial.

BACKGROUND: Cytisine is a prospective pharmacological alternative for community pharmacy smoking cessation services. However, it has not yet been licensed because of a lack of efficacy and safety information in Thailand. OBJECTIVE: The aim of this study was to evaluate the efficacy of cytisine in combination with community pharmacists' counselling on smoking cessation in a community pharmacy in ThailandDesign. Setting, participants, and interventions: A double-blinded randomized placebo-controlled trials was carried out. Participants aged >18 years old who smoked >10 tobaccos/day were randomly assigned to receive cytisine or placebo and five sessions of counselling by a community pharmacist. The primary outcome was a continuous abstinence rate (CAR) at week 48. The CAR was also measured at weeks 2, 4, 12, and 24. Adverse events were monitored. RESULTS: A total of 132 participants were included, with 67 receiving cytisine and 65 receiving a placebo. Approximately 95% of participants were male. The CARs were determined to be 14.93% and 6.15% for cytisine and placebo, respectively, at week 48. The relative risk (RR) was 2.41 (95% confidence interval (CI); 0.80-7.35, p = 0.102). The RRs for CAR at weeks 2, 4, 12, and 24 were 2.43, 2.91, 2.50, and 1.78, respectively. Only the RRs for weeks 2, 4, and 12 were statistically significant. Common and non-serious gastrointestinal and neurological adverse events were observed. CONCLUSION: Cytisine, when combined with community pharmacists' counselling, did not statistically improve the CAR at week 48, although it did improve the CAR at weeks 2, 4, and 12. Adverse events of cytisine were common and non-serious (registration number: TCTR20180312001).

Vernonia cinerea pastilles is effective for smoking cessation.

BACKGROUND AND AIM: Vernonia cinerea (VC) is a herb that can alleviate nicotine addiction, potentially aiding in smoking cessation. Previous studies have examined four-to eight-week treatments using VC, but have found it to be ineffective. This study aimed to evaluate the smoking cessation effects of VC in addicted smokers over a longer treatment duration with pastilles. EXPERIMENTAL PROCEDURE: This was a randomized double-blinded controlled trial conducted at a community pharmacy. The inclusion criteria were age between 18 and 60 years, intention to quit smoking, and low to moderate level of nicotine addiction. All eligible participants were stratified according to nicotine addiction level and then randomly assigned either VC treatment or placebo. The VC group received two pastilles three times daily, while the control group received a placebo for 12 weeks. The outcomes were continuous abstinence rate (CAR) and point abstinence rate (PAR) at four and 12 weeks. RESULTS: There were 121 eligible participants; 10 participants were not willing to participate. In total, there were 111 eligible participants, 54 of whom were treated with VC (48.65%) and 57 of whom were given a placebo (51.35%). Baseline characteristics were comparable between the two groups. The VC group had a significantly higher chance of smoking cessation at 2.01 (95% CI of 1.03, 3.92) compared with the placebo group at the end of the study. There were no significant side effects in either group. CONCLUSION: The VC pastille group had significantly higher CAR than the placebo group at week 12.