Objective To assess the efficacy, safety, and clinical feasibility of traditional Chinese medicine formula, based on Qufeng Liqi Huoxue, combined with conventional Western medicine in the treatment of vitiligo, so as to provide a basis for the promotion of this therapeutic strategy.

Methods A total of 218 patients with vitiligo were divided into 2 groups, of which 126 were treated by traditional Chinese medicine basic formula combined with conventional Western medicine orally (case group), and 92 treated only with conventional Western medicine (control group). The efficiency, leukoplakia regression rates, and adverse effects between the two groups were compared, and stratification analysis was performed.

Results The total efficiency rate of 62.70% (79/126) in the case group was higher than that in the control group(41.30%, 38/92; P=0.001). The rate of leukoplakia regression of (38.62±19.11)% in the case group was higher than that in the control group (%, P < 0.001). Stratification analysis showed that the rates of the total efficiency and leukoplakia regression both in the progressive and stable stages in the case group were higher than those in the control group (P < 0.05). But in the patients using glucocorticoid, there was no significant difference in the total efficiency and the rate of leukoplakia regression between the two groups. The adverse effect rate was 7.14% in the case group and 6.52% in the control group, and there was also no significant difference between the two groups. The adverse effects were mainly gastrointestinal effects and could be tolerated.

Conclusions For the treatment of vitiligo, oral traditional Chinese medicine formula combined with conventional Western medicine has definite curative effect, good safety, and strong feasibility, and is worthy of clinical promotion.