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Evidence-Based Complementary and Alternative Medicine
Volume 2011, Article ID 192381, 9 pages
http://dx.doi.org/10.1155/2011/192381
Research Article

Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission

1Consolidated Research Institute for Advanced Science and Medical Care, Waseda University (ASMeW), 513 Wasedatsurumaki-cho, Shinjuku-ku, Tokyo 162-0041, Japan
2Department of Obstetrics and Gynecology, Graduate School of Medical Science, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8640, Japan
3Department of Urology, Gengendo Kisarazu Clinic, 4737 Takayanagi, Kisarazu, Chiba 292-0014, Japan
4Department of Urology, Shikoku Cancer Center, 160 Ko, Minamiumemoto-machi, Matsuyama, Ehime 791-0280, Japan

Received 31 October 2009; Revised 27 September 2010; Accepted 17 February 2011

Copyright © 2011 Satoshi Ohno et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Although many cancer patients use complementary and alternative medicine, including Agaricus blazei Murill (ABM), safety is not yet well understood. Cancer survivors took 1.8, 3.6, or 5.4 g ABM granulated powder (Kyowa Wellness Co., Ltd., Tokyo, Japan) per day orally for 6 months. Adverse events were defined by subjective/objective symptoms and laboratory data according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Seventy-eight patients were assessed for safety of ABM (30/24/24 subjects at 1/2/3 packs per day, resp.). Adverse events were observed in 9 patients (12%). Most were digestive in nature such as nausea and diarrhea, and one patient developed a liver dysfunction-related food allergy, drug lymphocyte product. However, none of these adverse events occurred in a dose-dependent manner. This study shows that ABM does not cause problems in most patients within laboratory parameters at the dosages tested over 6 months. This trial supports previous evidence that the ABM product is generally safe, excluding possible allergic reaction.