title: Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission.
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.
authors.affiliation: Consolidated Research Institute for Advanced Science and Medical Care, Waseda University (ASMeW), 513 Wasedatsurumaki-cho, Shinjuku-ku, Tokyo 162-0041, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ohno
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Sumiyoshi
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Hashine
authors.forename: Akitomi
authors.initials: A
authors.lastname: Shirato
authors.forename: Satoru
authors.initials: S
authors.lastname: Kyo
authors.forename: Masaki
authors.initials: M
authors.lastname: Inoue