The Multi-Component Smoking Cessation Support Programme (McSCSP) is effective in patients with severe mental disorder...

High prevalence of smoking in people with severe mental disorders (SMD) contributes to their medical morbidity and reduced life expectancy. Despite the evidence of gender differences in smoking cessation, few studies have tested those differences among people with SMD. This is a non-randomized, open-label, prospective, 9-month follow-up multicentre trial to examine gender differences in the efficacy, safety and tolerability of a Multi-Component Smoking Cessation Support Programme (McSCSP). The results showed that there were no significant differences in short- (males 44.9% vs females 57.7%, chi-square = 1.112, p = 0.292) or long-term efficacy (week 24: males 40.8%, females 42.3%, chi-square = 0.016, p = 0.901; week 36: males 36.7%, females 38.5%, chi-square = 0.022, p = 0.883) between gender, neither controlled by diagnosis or treatment. Regarding safety and tolerability, there was significant increase in abdominal perimeter in males [from 105.98 (SD 13.28) to 108.52 (SD 14.01), t = -3.436, p = 0.002)], but not in females. However, there were no significant gender differences in adverse events (constipation, abnormal/vivid dreams, nausea/vomiting or skin rash/redness around patch site). In conclusion, we have demonstrated that is effective and safe to help either male or female patients with stabilized SMD to quit smoking. However, it might be a tendency in females to respond better to varenicline treatment in the short-term. Future research with larger samples is required to more clearly determine whether or not the there are differences, in addition to their reliability and robustness.