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

Pum Phusahat, Piyameth Dilokthornsakul, Watchara Boonsawat, Uraiwan Zaeoue, Nadthatida Hansuri, Nirachara Tawinkan, Ampornpan Theeranut and Sunee Lertsinudom ()
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Pum Phusahat: Division of Pharmacy, Somdej Phra Yupparat Sa Kaeo Hospital, Sa Kaeo 27000, Thailand
Piyameth Dilokthornsakul: Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand
Watchara Boonsawat: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Uraiwan Zaeoue: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Nadthatida Hansuri: Community Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand
Nirachara Tawinkan: Community Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand
Ampornpan Theeranut: Faculty of Nursing, Khon Kaen University, Khon Kaen 40002, Thailand
Sunee Lertsinudom: Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand

IJERPH, 2022, vol. 19, issue 20, 1-12

Abstract: 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).

Keywords: cytisine; efficacy; safety; smoking cessation; community pharmacist (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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