Identification of a Predictive Biomarker for the Beneficial Effect of Keishibukuryogan, a Kampo (Japanese Traditional) Medicine, on Patients with Climacteric Syndrome

Takao Namiki,Maki Kihara,Koichi Ueno,Hiromi Sato,Katsutoshi Terasawa,Atsushi Chino,Toshiaki Kita,Akiyo Kaneko,Hideki Okamoto,Makio Shozu,Yukari Matsumoto,Haruka Kakikura,Akito Hisanaga

doi:10.1155/2014/962109

Abstract

Keishibukuryogan (KBG; Guizhi-Fuling-Wan in Chinese) is one of the Kampo (Japanese traditional) medicines used to treat patients with climacteric syndrome. KBG can be used by patients who cannot undergo hormone replacement therapy due to a history of breast cancer. We evaluated whether cytosine-adenine (CA) repeat polymorphism of the estrogen receptor β gene can be a predictor of the beneficial effect of KBG on climacteric syndrome. We also investigated the relationship between CA repeat polymorphism, the patients' profiles, and the therapeutic effect. We found that CA was an SS, SL, or LL genotype according to the number of repeats. We studied 39 consecutive patients with climacteric disorders who took KBG for 12 weeks. The diagnosis of climacteric disorders was made on the basis of the Kupperman index. KBG significantly improved the patients' climacteric symptoms (i.e., vasomotor symptoms in the patients with the LL genotype and melancholia in the patients with the SL genotype). No relationship between the patients' profiles and CA repeat polymorphism was recognized. CA repeat polymorphism could thus be a potential biomarker to predict the efficacy of KBG in climacteric syndrome, and its use will help to reduce the cost of treating this syndrome by focusing the administration of KBG on those most likely to benefit from it.

Highlights

Climacteric syndrome, which is caused by a decrease of the estrogen level during menopause, often severely impairs a woman’s quality of life [1, 2]
We evaluated whether the contribution of the CA repeat polymorphism of the ERβ gene has a role in the effectiveness of KBG in women with climacteric syndrome
There were no significant differences between these groups except in age and height (Table 1)

Summary

Introduction

Climacteric syndrome, which is caused by a decrease of the estrogen level during menopause, often severely impairs a woman’s quality of life [1, 2]. Many climacteric women suffer from vasomotor symptoms, mood disorders, vaginal dryness, headache, shoulder stiffness, and other problems. Hormone replacement therapy (HRT) is one of the most effective treatments for climacteric symptoms, especially for vasomotor symptoms, mood problems, and vaginal dryness. In Japan, the use of Kampo medications (Japanese herbal medicine) is one alternative for controlling these symptoms in women who reject HRT or who cannot receive HRT due to a history of breast cancer [7]. In a recent randomized study in the United States, patients with hot flashes did not show improvement as a result of KBG treatment, suggesting that the inclusion criteria of patients in clinical trials are important in showing the efficacy of Kampo medicine [8]

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Conclusion