Abstract Objective: This study examined factors associated with successful/unsuccessful smoking cessation in nicotine-dependent patients treated with the following herbal medicines in addition to varenicline or nicotine patch, to address symptoms occurring in the course of treatment: Gorei-San (nausea and headache), Toukaku-Jouki-Tou and Dai-Ken-Chu-Tou (constipation), Yoku-Kan-San (headache, irritability, and insomnia), and Bakumondou-Tou (cough). Although herbal medicines have been reported to be solely effective for smoking cessation, the association between their addition to non-smoking adjuvants and successful/unsuccessful smoking cessation has rarely been examined. In this study, the addition of herbal medicines markedly improved the smoking cessation rate. Methods: A single-center retrospective cohort study was conducted, involving 179 outpatients who had participated in a smoking cessation program in our facility within the period between April 26, 2008 and February 26, 2016. The smoking cessation rate 12 weeks after the start of the program was examined as a primary endpoint, with additional herbal prescriptions for the outpatients as the main factor, and the age, sex, Brinkman Index, hospital visit frequency, and Fagerström Test for Nicotine Dependence score as adjustment factors. Results: The smoking cessation rates of those treated with and without herbal medicines were 89.3 (25/28) and 62.9% (95/151), respectively, revealing a marked improvement in the former (P=0.008). On multivariate logistic regression analysis, the hospital visit frequency showed a close association with successful smoking cessation (P=0.000). The difference was non-significant, but herbal prescriptions also tended to be associate with it (P=0.086). Discussion: The more favorable outcome with the addition of herbal medicines may also be explained by an increased hospital visit frequency as a result of establishing trust-based relationships through more attentive consultation and treatment than usual when prescribing herbal medicines. It is expected that the association between the addition of herbal medicines and smoking cessation outcomes will be further clarified in future studies involving increased numbers of subjects.