A new study published in Addiction has found that cytisine, a low-cost, generic stop-smoking aid that has been used in eastern Europe since the 1960s, increases the chances of successful smoking cessation by more than two-fold compared with placebo and may be more effective than nicotine replacement therapy. It has a benign safety profile, with no evidence of serious safety concerns. Sounds perfect for your New Year resolution, doesn’t it? But there’s a catch: Cytisine is not licensed or marketed in most countries outside of central and eastern Europe, making it unavailable in most of the world, including many low- and middle-income countries where it could make a big difference to global health.

Cytisine is a plant-based compound that eases smoking withdrawal symptoms. It was first synthesised in Bulgaria in 1964 as Tabex® and later spread to other countries in eastern Europe and Asia, where it is still marketed. In 2017, the Polish pharmaceutical company Aflofarm began selling it as Desmoxan®, a prescription-only medicine, and Canada approved it as an over-the-counter natural health product, Cravv®.

Because cytisine is a low-cost drug, it could form part of a plan to increase accessibility to drug therapy for smokers, which tends to be limited in low- and middle-income (LAMI) countries.

Lead author Dr. Omar De Santi elaborates: "Our study adds to the evidence that cytisine is an effective and inexpensive stop-smoking aid. It could be very useful in reducing smoking in LAMI countries where cost-effective smoking cessation drugs are urgently needed. World-wide, smoking is considered the main cause of preventable death. Cytisine has the potential to be one of the big answers to that problem."

This study pooled the results of eight randomised controlled trials comparing cytisine with placebo, with nearly 6,000 patients. The combined results showed that cytisine increases the chances of successful smoking cessation by more than twofold compared with placebo.

The study also looked at two randomised controlled trials comparing cytisine with nicotine replacement therapy, with modest results in favor of cytisine, and three trials comparing cytisine with varenicline, without a clear benefit for cytisine.

De Santi O, Orellana M, Di Niro CA, Greco V.
Evaluation of the effectiveness of cytisine for the treatment of smoking cessation: A systematic review and meta-analysis.
Addiction. 2023 Dec 31. doi: 10.1111/add.16399