Comparison of Efficacy and Safety of Cytisine against Nicotine Replacement Treatment

Cytisine is a plant-derived alkaloid that has gained attention as a cost-effective pharmacotherapy for smoking cessation. This study aimed to compare the real-world effectiveness and safety of cytisine versus nicotine replacement therapy (NRT) among individuals enrolled in a smoking cessation program.

This non-randomized observational study included 476 patients who received pharmacological treatment for smoking cessation between January 2024 and January 2025 at a tertiary smoking cessation clinic. Patients were grouped according to treatment modality: cytisine or NRT. The primary outcome was continuous abstinence at 6 months, based on self-reported smoking status without biochemical verification. Secondary outcomes included tolerability and factors associated with cessation success.

Of the 229 patients treated with cytisine, 124 (54.1%) achieved 6-month abstinence, compared to 77 of 247 patients (31.2%) in the NRT group (p<.001). Female sex and the presence of diabetes mellitus were independently associated with higher cessation success. Both treatments were generally well tolerated; no serious adverse events were reported. Cytisine users most commonly reported mild gastrointestinal symptoms and sleep disturbances.

Cytisine was significantly more effective than NRT in achieving 6-month continuous abstinence in a real-world setting, with a comparable safety profile. Certain subgroups, such as women and patients with diabetes, may benefit more from pharmacologic cessation support.

This study provides supportive evidence for the routine clinical use of cytisine as a first-line smoking cessation treatment, especially in low- and middle-income countries. Its affordability, tolerability, and short treatment duration offer distinct advantages for public health implementation.