[Efficacy of Chinese herbal medicine Mailuo Shutong Granule and Hirudoid cream for chronic venous disorder-induced pigmentation in lower extremities: a prospective, randomized controlled trial].

Background: Chronic venous disorder (CVD) of the lower extremities generally induces dermatologic complications in lower extremity skin, such as hyperpigmentation. If not treated effectively, the lesions may develop into severe outcomes, including dermal ulcer or necrosis.

Objective: To evaluate the clinical efficacy of Mailuo Shutong Granule, a compound traditional Chinese herbal medicine, and Hirudoid cream (heparinoid), in treatment of patients with dermal hyperpigmentation of skin caused by CVD.

Design, Setting, Participants And Interventions: A total of 108 CVD outpatients with pigmentation from Department of Vascular Surgery, Shanghai Changhai Hospital were randomly divided into Mailuo Shutong group, Hirudoid group and combined therapy group, with 36 patients in each group. Patients in the Mailuo Shutong group and the Hirudoid group were treated with Mailuo Shutong Granule or Hirudoid cream, respectively, while those in the combined therapy group were treated with Mailuo Shutong Granule plus Hirudoid cream. They were all treated for 28 d.

Main Outcome Measures: Before and after the 28-day treatment, area and average gray value of pigmentation lesions were measured and evaluated.

Results: Thirty-three cases in the Mailuo Shutong group, 34 cases in the Hirudoid group and 31 cases in the combined therapy group were included for analysis. After treatment, area of pigmentation decreased and average gray value of pigmentation declined in all the 3 groups (P<0.05). The reductions of area and average gray value in the combined therapy group were more significant than those in the Mailuo Shutong group and Hirudoid group (P<0.05). There were no differences in improvement of pigmentation between the Mailuo Shutong group and Hirudoid group (P>0.05).

Conclusion: These data suggest that both Mailuo Shutong Granule and Hirudoid cream can improve CVD-induced hyperpigmentation, and combined treatment of the two drugs results in better clinical efficacy.