Background: Severe and widespread atopic dermatitis often fails to respond adequately to topical steroids and oral antihistamines and requires immunomodulatory drugs which, although effective, have undesirable toxic effects. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, 71 patients with severe intractable atopic dermatitis were given an 8-week treatment with oral Xiao-Feng-San (XFS; 47 patients) or placebo (24 patients). Total lesion score, erythema score, surface damage score, pruritus score and sleep score were measured at 4-week intervals. Results: Fifty-six patients completed both the treatment and follow-up periods. The decrease in the total lesion score in the treatment group at 8 weeks was significantly greater than that of the placebo group (79.7 ± 5.8% vs. 13.5 ± 7.64%; p < 0.001). There was also a statistically significant difference between the treatment and placebo groups with regard to erythema, surface damage, pruritus and sleep scores. The difference between the 2 groups was still significant for all outcome measures except the erythema score at the 12-week follow-up, 4 weeks after the 8-week treatment had ended. Patients reported no side effects from treatment, although some commented on the unpalatability of the medication. Conclusion: Our study results suggest that the traditional Chinese herbal medicine XFS may be an alternative choice of therapy for severe, refractory, extensive and nonexudative atopic dermatitis.

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