Abstract:
Introduction: The treatment for nicotine dependence in clinical practice is limited. The objec-tive of this study was to evaluate the effectiveness of nortriptyline (the study group) and nicotine gum (the control group) in nicotine dependent smokers. Methods: The experimental study with a control group was designed. Both groups received counseling and monitoring by pharmacists. The allocation was controlled by a career and an underlying disease. The study was performed during February - December, 2013. All smokers in this study were male. There were 103 smokers in the treatment group and 102 smokers in the control group. Endpoint were the rate of smoking cessation, number of ciga-rettes smoked per day, levels of carbon monoxide (CO), adherence and adverse drug reactions (ADRS) which were collected every month for four months. All the endpoints were analyzed using multiple logistic regression when compared between groups, except the number of cigarettes smoked per day which multiple linear regression was used. All comparisons controlled by age, education, career and income per month. The level of statistical significance was set at α = 0.05. Results: The cessation rates with nortriptyline were 16.8%, 39.4%, 73.7% and 75.0% and with nicotine gum were 18.1%, 34.0%, 67.4% and 70.5% at month 1, 2, 3 and 4, respectively (p=0.995 at month 4). The decremental proportion of cigarettes smoked per day at month 4 compared with the number on the quitting date were 13.1+5.7 cigarettes/day with nortriptyline and 12.8+6.5 cigarettes/day with nicotine gum, there was no difference between two groups (p=0.730). The incremental proportion of exhaled carbon mon-oxide (CO)<10 ppm were 17.4% with nortriptyline and 24.4% with nicotine gum (p=0.758). Adverse drug reactions with nortriptyline and nicotine gum were found 70.3% and 30.5%, respectively (p<0.001). The top three adverse drug reactions with nortriptyline were drowsiness (56.4%), dry mouth (34.7%) and bitter taste (8.9%). With nicotine gum were flatulence (15.8%), stomach pain (8.4%) and tight jaw (6.3%). Adherence rate was not different between groups (59.2% with nortriptyline and 68.6% with nicotine gum, p=0.314). Conclusion: There was no difference between the effectiveness of nortriptyl-ine and nicotine gum, adverse drug reactions were higher with nortriptyline than nicotine gum, but there were no serious adverse events within 3 months of the treatment.
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