Efficacy and Safety of Ginseng & Astragalus Combination (Bu Zhong Yi Qi Tang) on Patients with Atopic Dermatitis
Efficacy and Safety of a Traditional Herbal Medicine, Hochu-ekki-to in the Long-term Management of Kikyo (Delicate Constitution) Patients with Atopic Dermatitis: A 6-month, Multicenter,Double-blind, Randomized, Placebo-controlled Study
Hiromi Kobayashi1, Masamitsu Ishii1, Satoshi Takeuchi2, Yoichi Tanaka3,
Takahiro Shintani4, Atsushi Yamatodani5, Tadashi Kusunoki6 and Masutaka Furue2
1Department of Dermatology, Osaka City University Graduate School of Medicine, Osaka,
2Department ofDermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka,
3Tanaka Clinic, Nagasaki, 4Research Institute of Oriental Medicine, Kinki University, Osaka-Sayama,
5Department of Medical Physics and Engineering, Graduate School of Allied Health Sciences, Faculty of Medicine, Osaka University, Osaka and
6Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo, Tokyo, Japan
Abstract
Hochu-ekki-to is a traditional herbal (Kampo) medicine that has been shown to be effective for patients with Kikyo (delicate, easily fatigable, or hypersensitive) constitution. Previous case reports have suggested that this herbal drug was effective for a certain subgroup of patients with atopic dermatitis (AD).
We aimed to evaluate the efficacy and safety of Hochu-ekki-to in the long-term management of Kikyo patients with AD. In this multicenter, double blind, randomized, placebo-controlled study, 91 Kikyo patients with AD were enrolled. Kikyo condition was evaluated by a questionnaire scoring system. All patients continued their ordinary treatments (topical steroids, topical tacrolimus, emollients or oral antihistamines before and after their protocol entry. Hochu-ekki-to or placebo was orally administered twice daily for 24 weeks. The skin severity scores, total equivalent amount (TEA) of topical agents used for AD treatment, prominent efficacy (cases with skin severity score=0 at the end of the study) rate and aggravated rate (more than 50% increase of TEA of topical agents from the beginning of the study) were monitored and evaluated.
Seventy-seven out of 91 enrolled patients completed the 24-week treatment course (Hochu-ekki-to: n=37, placebo: n=40). The TEA of topical agents (steroids and/or tacrolimus) was significantly (P<0.05) lower in the Hochu-ekki-to group than in the placebo group, although the overall skin severity scores were not statistically different. The prominent efficacy rate was 19% (7 of 37) in the Hochu-ekki-to group and 5% (2 of 40) in the placebo group (P=0.06). The aggravated rate was significantly (P<0.05) lower in the Hochu-ekki-to group (3%; 1 of 37) than in the placebo group (18%; 7 of 39). Only mild adverse events such as nausea and diarrhea were noted in both groups without statistical difference.
This placebo-controlled study demonstrates that Hochu-ekki-to is a useful adjunct to conventional treatments for AD patients with Kikyo constitution. Use of Hochuekki-to significantly reduces the dose of topical steroids and/or tacrolimus used for AD treatment without aggravating AD.
This article is an Open Access article published in Oxford Journal: Evidence-based Complementary and Alternative Medicine.
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