OBJECTIVE@#To evaluate the clinical effect of acupuncture on smoking cessation and withdrawal symptoms and to explore the influence factors of acupuncture on smoking cessation.@*METHODS@#A total of 500 subjects with tobacco dependence were randomized into an acupuncture group, an auricular therapy group, an acupuncture plus auricular therapy group, a TENS group and a nicotine replacement therapy group (NRT group), 100 cases in each one. In the acupuncture group, acupuncture was applied at Baihui (GV 20), Lieque (LU 7), Hegu (LI 4) and Zusanli (ST 36). The treatment was given 5 times a week, once a day in the first 2 weeks. The treatment was given once every 2 days in the week 3 and 4, 3 times a week, and twice a week, once every 3 days in the week 5 to 8. In the auricular therapy group, the ear point pressure therapy was used at shenmen (TF), neifenmi (CO), pizhixia (AT) and jiaogan (AH), 3 times a week. In the acupuncture plus auricular therapy group, acupuncture and auricular therapy were adopted with the same points and manipulation as the previous two groups. Acupuncture was given 3 times a week and the auricular therapy was given twice a week. In the TENS group, SDZ-Ⅱ B type electric acupuncture apparatus was used to stimulate Lieque (LU 7) and Zusanli (ST 36), once a day. In the NRT group, the nicotine patch was used on the chest, back and the upper arms of the subjects, once a day. The duration of treatment was 8 weeks as one course in every group. Afterwards, the 16-week follow-up was conducted. The time-point withdrawal rate was evaluated by the level of urine cotinine in 8 weeks of treatment and in the follow-up in the subjects of 5 groups. The persistent withdrawal rate was evaluated by the self-report of the subjects in 8 weeks of treatment as well as in the follow-up in the 5 groups. The withdrawal effect, the score of the fagerstrom test for nicotine dependence (FTND) and the score of the heaviness of smoking index (HSI) were compared among the groups. Twenty indexes were selected as the potential influence factors, the 72 h withdrawal rate based on the level of urine cotinine in 8 weeks of treatment and in the follow-up was taken as the dependent variable. Using the two categories of Logistic regression analysis, the influence factors of therapeutic effect of acupuncture were screened for smoking cessation.@*RESULTS@#After 8 weeks of treatment, the time-point withdrawal rate in the subjects among the groups was NRT group > acupuncture plus auricular therapy group > auricular therapy group > acupuncture group > TENS group. In the follow-up, the time-point withdrawal rate was acupuncture plus auricular therapy group > NRT group > acupuncture group > TENS group > auricular therapy group, but without statistical significance in comparison (>0.05). After 8 weeks of treatment, the persistent withdrawal rate in the subjects among the groups was auricular therapy group > TENS group > acupuncture group > acupuncture plus auricular therapy group > NRT group. In the follow-up visit, the persistent withdrawal rate was auricular therapy group > TENS group > acupuncture plus auricular therapy group > acupuncture group > NRT group. The result in the auricular therapy group was better than all of the other 4 groups (0.05). The regression analysis showed that the factors, i.e. nationality, educational background, drinking frequency, pre-treatment FTND score, pre-treatment HSI score and smoking cessation for physical reason in family, were correlated significantly with the withdrawal result after 8-week treatment (<0.05). The factors, i.e. education background, smoking age, pre-treatment FTND score and different therapeutic methods, were correlated significantly with the withdrawal result in the follow-up (<0.05).@*CONCLUSION@#Acupuncture combined with auricular therapy effectively reduce nicotine dependence and smoking intensity and relieve withdrawal symptoms. There are many factors that affect the withdrawal effect in smoking cessation. Hence, the influence factors in smoking cessation with acupuncture should be clearly determined so as to develop the individual regimen for smoking cessation and improve the clinical therapeutic effect of acupuncture on smoking cessation.