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

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 wer...

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Autores principales: Ohno, Satoshi, Sumiyoshi, Yoshiteru, Hashine, Katsuyoshi, Shirato, Akitomi, Kyo, Satoru, Inoue, Masaki
Formato: Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092499/
https://www.ncbi.nlm.nih.gov/pubmed/21584278
http://dx.doi.org/10.1155/2011/192381
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author Ohno, Satoshi
Sumiyoshi, Yoshiteru
Hashine, Katsuyoshi
Shirato, Akitomi
Kyo, Satoru
Inoue, Masaki
author_facet Ohno, Satoshi
Sumiyoshi, Yoshiteru
Hashine, Katsuyoshi
Shirato, Akitomi
Kyo, Satoru
Inoue, Masaki
author_sort Ohno, Satoshi
collection PubMed
description 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.
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spelling pubmed-30924992011-05-16 Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission Ohno, Satoshi Sumiyoshi, Yoshiteru Hashine, Katsuyoshi Shirato, Akitomi Kyo, Satoru Inoue, Masaki Evid Based Complement Alternat Med Research Article 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. Hindawi Publishing Corporation 2011 2011-04-18 /pmc/articles/PMC3092499/ /pubmed/21584278 http://dx.doi.org/10.1155/2011/192381 Text en Copyright © 2011 Satoshi Ohno et al. https://creativecommons.org/licenses/by/3.0/ 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.
spellingShingle Research Article
Ohno, Satoshi
Sumiyoshi, Yoshiteru
Hashine, Katsuyoshi
Shirato, Akitomi
Kyo, Satoru
Inoue, Masaki
Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title_full Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title_fullStr Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title_full_unstemmed Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title_short Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission
title_sort phase i clinical study of the dietary supplement, agaricus blazei murill, in cancer patients in remission
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092499/
https://www.ncbi.nlm.nih.gov/pubmed/21584278
http://dx.doi.org/10.1155/2011/192381
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