Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission. (18th April 2011)

• Record Type: Journal Article
• Authors: Ohno, Satoshi; Sumiyoshi, Yoshiteru; Hashine, Katsuyoshi; Shirato, Akitomi; Kyo, Satoru; Inoue, Masaki
• Is Part Of: Evidence-based complementary and alternative medicine. Volume 2011(2011)
• Publication Date: 2011-04-18
• Subjects: Alternative medicine -- Periodicals; 615.505
• DOI: 10.1155/2011/192381
• Languages: English
• ISSNs: 1741-427X

Abstract

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.