OBJECTIVE: To evaluate the efficacy and safety of a Chinese herbal formula, Xiao-Feng-San (XFS), in the treatment of atopic dermatitis (AD) using a randomised, double-blind, placebo-controlled trial.METHODS: The trial consisted of an eight-week treatment period and a four-week follow-up period. A total of 71 subjects with refractory, extensive and non-exudative AD were enrolled and randomised at a ratio of 2:1, to receive XFS (n = 47) or placebo (n = 24) in powder form. The XFS herbal formula consisted of the herbs Saposhnikovia divaricata (Fang Feng), Schizonepeta tenuifolia (Jing Jie), Angelica sinensis (Dang Gui), Rehmannia glutinosa {Sheng Di Huang), Saphora flavescens (Ku Shen), Atractylodes lancae (Cang Zhu), Crypto tympana pustulata (Chan Tui), Linum usitatissimum (Hu Ma), Anemarrhena asphodeloides (Zhi Mu), Gypsum fibrosum (Shi Gad), Clematis armandii (Chuan Mu Fong), Glycyrrhiza uralensis (Gan Cao) and Articum lappa (Niu Bang); while the placebo consisted of caramel, lactose and starch. The powders were to be mixed in 120 ml of warm water, and taken three times a day during the treatment period. Thedosages varied according to age group of subjects: 3 g per dose for those aged 3-7 years; 6 g per dose for those aged 8-12; and 9 g per dose for those above 13 years. Subjects were asked to maintain current diet and dermatological treatments during the trial. Assessments were carried out at the beginning of the trial and in weeks four, eight, and 12. The assessments include total lesion score, erythema score, surface damage score, pruritus score and sleep score; blood chemistry/laboratory examinations were done as part of the safety assessment. Subjects were required to keep a daily diary to record treatment compliance and occurrence of side-effects.
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