Abstract: PURPOSE: To investigate the clinical effect and safety of modified Xiaoyao pill on the treatment of oral lichen planus (OLP) patients with anxiety or depression. Methods: Sixty OLP patients with anxiety and depression were randomly divided into 2 groups, treated separately with hydroxychloroquine(HCQ, control group) and HCQ+modified Xiaoyao pill(experimental group). The results were measured with semi quantitative reticular erosive and ulcerative lesion (REU) and visual analogue scale（VAS） scoring system at the first visit, the second week, the fourth week and the eighth week, respectively. Data analysis was performed using SPSS 18.0 software package. Results: The clinical effect of HCQ+modified Xiaoyao pill was better than that of the HCQ. The REU, VAS scores were lower after treatment in both groups (P<0.05), but the effect of the experimental group was more remarkable in reducing the pain indexes, accelerating the healing of erosive lesion and preventing recurrence than the control group. There was no significant difference in the overall effective rate between the two groups (P>0.05). Conclusions: Modified Xiaoyao pill was effective and safe in the treatment of OLP patients with anxiety or depression, especially for EOLP.

Key words: Oral lichen planus, Liver-qi syndrome, Modified Xiaoyao pill, Self-rating anxiety scale, Self-rating depression scale