The Efficacy and Safety of a Chinese Herbal Product (Xiao-Feng-San) for the Treatment of Refractory Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
PURPOSE OF THE STUDY.
To determine if the Chinese herbal product Xiao-Feng-San (XFS) taken orally could significantly improve symptoms of severe intractable atopic dermatitis.
A total of 71 Taiwanese subjects (age range: 8.4–22.6 years [median: 13.1 years]) with history of severe, refractory atopic dermatitis and poor response to eczema medications (topical steroids, oral antihistamines) were enrolled.
This was a prospective, double-blind, placebo-controlled trial in which patients were randomly assigned at a ratio of 2:1 to receive XFS or placebo over 8 weeks. There were 47 (median age: 12.2 years) given XFS and 24 (median age: 13.6 years) given placebo. Participants were matched according to gender, height, weight, BMI, age, duration of illness, and symptom scores. Patients were given varying doses depending on age. Laboratory studies were performed and total lesion score, erythema score, surface damage score, pruritis score, and sleep scores were calculated at 4-week intervals up to 12 weeks.
A total of 56 subjects completed the entire study. There was a statistically significant improvement in total lesion scores among those in the treatment group compared to those of the placebo group (79.7 ± 5.8% vs 13.5± 7.64%; P < .001). There was also statistically significant improvement in all symptom scores for those on treatment compared to those on placebo. Four weeks after the treatment was discontinued, the mean improvement in the clinical lesion score for the XFS group was still significantly better than that of the placebo group. Patients reported no adverse effects except unpalatability for some. Treatment did not affect total serum immunoglobulin E level, eosinophil counts, or interleukin 5, interleukin 13, or eosinophil cationic protein levels.
The traditional Chinese herbal medication XFS might be an alternative choice of therapy for severe, refractory, extensive, nonexudative atopic dermatitis.
Severe and widespread atopic dermatitis can be frustrating to treat for patients, parents, and physicians. Patients often ask their physicians if there are alternative approaches to controlling atopic diseases. XFS is a common Chinese herbal preparation of 12 herbs, some with known anti-inflammatory effects, that might provide a complementary option for adults and children who require systemic steroids to control their eczema flares. However, more scientific evaluation of XFS to determine its mechanism of action, safety profile, applicability, and palatability need to be considered before widespread use is accepted.
- Copyright © 2011 by the American Academy of Pediatrics