Article thumbnail

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

By Hiromi Kobayashi, Masamitsu Ishii, Satoshi Takeuchi, Yoichi Tanaka, Takahiro Shintani, Atsushi Yamatodani, Tadashi Kusunoki and Masutaka Furue

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 Hochu-ekki-to significantly reduces the dose of topical steroids and/or tacrolimus used for AD treatment without aggravating AD

Topics: Original Articles - Clinical Analyses
Publisher: Oxford University Press
OAI identifier: oai:pubmedcentral.nih.gov:2887326
Provided by: PubMed Central

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.

Suggested articles

Citations

  1. (1996). A case with atopic dermatitis in whom Keigai-rengyo-to related formula was effective. Curr Ther
  2. (1999). A controlled trial of traditional Chinese herbal medicine in Chinese patients with recalcitrant atopic dermatitis.
  3. (1992). A controlled trial of traditional Chinese medicine plants in widespread non-exudative atopic eczema.
  4. (1999). Accelerated recovery from cyclophosphamideinduced leukopenia in mice administered a Japanese ethical herbal drug, Hochu-ekki-to. Immunopharmacology
  5. (2004). An alternative approach to atopic dermatitis: part I—caseseries presentation. Evid based Complement Alternat Med
  6. (2004). An alternative approach to atopic dermatitis: part II—Summary of cases and discussion. Evid based Complement Alternat Med
  7. Clinical dermatology 7, eczema and dermatitis II, atopic dermatitis. The Kampo 1986;4:2–17
  8. (1990). Clinical effectiveness of Sairei-to for atopic dermatitis. Nishinihon Hifu
  9. (1999). Combination therapy with diet and traditional Japanese medicine for intractable adult atopic dermatitis—Interpretation of dietary influence. In:
  10. (1980). Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockholm) Suppl
  11. Dichotomous effect of a traditional Japanese medicine, bu-zhong-yiqi-tang on allergic asthma in mice.
  12. (2004). Diet and Japanese herbal medicine for recalcitrant atopic dermatitis: efficacy and safety. Drugs Exp Clin Res
  13. (1998). Effect of a traditional Chinese medicine, Bu-Zhong-Yi-Qi-Tang on the protection against an oral infection with Listeria monocytogenes.
  14. (1992). Effect of a traditional Chinese medicine, Bu-zhong-yiqi-tang (Japanese name: Hochu-ekki-to) on the protection against Listeria monocytogenes infection in mice. Immunopharmacol Immunotoxicol
  15. (1998). Effect of Kampo medicines on IgEmediated biphasic cutaneous reaction in mice.
  16. Effect of Saiko-seikan-to on atopic dermatitis. Hifuka kiyo 1983;78:145–50
  17. (1992). Efficacy of traditional Chinese herbal therapy in adult atopic dermatitis. Lancet
  18. (2004). Evidence-based reconstruction of Kampo medicine: part II—the concept of Sho. Evid based Complement Alternat Med
  19. Experience of Shishi-hakuhi-to in the treatment of dermatitis. Kampo kenkyu 1999;326:38–42
  20. Four cases report of atopic dermatitis successfully treated with Tokaku-joki-to.
  21. (2004). Guidelines for therapy for atopic dermatitis
  22. (2003). Hochu-ekki-to suppresses development of dermatitis and elevation of serum IgE level in NC/Nga mice. Drugs Exp Clin Res
  23. ICCAD II faculty. International consensus conference on atopic dermatitis II (ICCAD II): clinical update and current treatment strategies.
  24. (1998). Immunopharmacological effects of Hochu-ekki-to and its clinical application. Prog Med
  25. (2000). Increase of adult atopic dermatitis (AD) in recent Japan. Environ Dermatol
  26. (1999). Inhibition of eosinophil infiltration into the mouse peritoneal cavity by a traditional Chinese medicine, Bu-zhong-yi-qi-tang (Japanese name: Hochu-ekki-to). Immunopharmacol Immunotoxicol
  27. (1992). Is the prevalence of atopic dermatitis increasing? Clin Exp Dermatol
  28. (1997). Japanese herb treatments of adult atopic dermatitis by diet and Japanese herb remedy—evaluation of disappearance of disease phases. In:
  29. Kampo for adult atopic dermatitis. Gendai Toyo igaku 1988;9:162–5
  30. Kampo medicine for atopic dermatitis. Allerugi no Rinsho 1989;9:711–4
  31. (2005). Kampo medicines for mite antigen-induced allergic dermatitis in NC/Nga Mice. Evid Based Complement Alternat Med
  32. Kampo therapies for atopic dermatitis: the effectiveness of Hochu-ekki-to. Nishinihon Hifu 1989;51:1003–13
  33. (1998). Kampo therapy for eczema and dermatitis. Derma
  34. (1994). Kampo therapy in dermatology. In: Dermatological Oriental Medicine Study Group (eds).
  35. Metabolism of constituents in Huangqin-tang, a prescription in traditional Chinese medicine, by human intestinal flora.
  36. On the indication of Shishi-zai.
  37. (1994). One-year follow up of children treated with Chinese medicinal herbs for atopic eczema.
  38. Prevalence of atopic dermatitis determined by clinical examination in Japanese adults.
  39. Study of clinical efficacy of Hochu-ekki-to for child patients with atopic dermatitis. Rinsho Kenkyu 1993;70:4012–21
  40. (1997). Suppression of IgE production in mice treated with a traditional Chinese medicine, Bu-zhong-yi-qi-tang (Japanese name: Hochu-ekki-to). Immunopharmacology
  41. (2000). Systematic review of treatments for atopic eczema. Health Technol Assess
  42. (1998). Tacrolimus ointment does not affect collagen synthesis: results of a single-center randomized trial.
  43. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety.
  44. The effects of Hochu-ekki-to in patients with atopic dermatitis resistant to conventional treatment.
  45. (2007). The efficacy of traditional Chinese herbal therapy in atopic eczema. Int Arch Allergy Immunol 1994;104:222–6. Received August 9, 2007; accepted
  46. (1999). The treatment of eczema with Chinese herbs: a systemic review of randomized clinical trials.
  47. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol 2000;142:931–6. 372 Randomized controlled trial of Hochu-ekki-to for atopic dermatitis13.
  48. (2002). Topical tacrolimus protopic. Drugs Today
  49. (1995). Unkei-to related Kampo formulas for atopic dermatitis. Curr Ther
  50. (1999). Worldwide variations in the prevalence of symptoms of atopic eczema in the international study of asthma and allergies in childhood.