title: Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.
abstract: BACKGROUND
  Myelodysplastic syndromes (MDS) are characterized by ineffective erythropoiesis with dysplastic bone marrow leading to peripheral cytopenia, risk of infection, and progression to acute myelogenous leukemia. Maitake mushroom beta-glucan, a dietary supplement, stimulates hematopoietic progenitor cell differentiation, granulocyte colony-stimulating factor production, and recovery of peripheral blood leukocytes after bone marrow injury. This phase II trial examined the effects of Maitake on innate immune function in MDS.
  
  
  METHODS
  Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease received oral Maitake extract at 3 mg/kg twice daily for 12 weeks. Primary endpoints included neutrophil count and function tested as endogenous or stimulated neutrophil production of reactive oxygen species (ROS) by flow cytometry compared with age-matched healthy controls (HC). ROS activators were Escherichia coli, phorbol ester, and the bacterial peptide N-formylmethionyl-leucyl-phenylalanine (fMLP). Complete blood counts, chemistry panels, iron studies, and monocyte function were evaluated.
  
  
  RESULTS
  Of 21 patients enrolled, 18 completed the study and were evaluable. Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021). Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03). Asymptomatic eosinophilia occurred in 4 patients (p = 0.014). Other changes in albumin, hemoglobin, and total protein were not clinically relevant.
  
  
  CONCLUSIONS
  Maitake was well tolerated. Enhanced in vitro neutrophil and monocyte function following treatment demonstrate that Maitake has beneficial immunomodulatory potential in MDS. Further study is warranted.
authors.affiliation: Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, 1429 First Avenue, New York, NY, 10021, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Wesa
authors.forename: Susanna
authors.initials: S
authors.lastname: Cunningham-Rundles
authors.forename: Virginia M
authors.initials: VM
authors.lastname: Klimek
authors.forename: Emily
authors.initials: E
authors.lastname: Vertosick
authors.forename: Marci I
authors.initials: MI
authors.lastname: Coleton
authors.forename: K Simon
authors.initials: KS
authors.lastname: Yeung
authors.forename: Hong
authors.initials: H
authors.lastname: Lin
authors.forename: Stephen
authors.initials: S
authors.lastname: Nimer
authors.forename: Barrie R
authors.initials: BR
authors.lastname: Cassileth
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood / Q000378:metabolism; D001853:Bone Marrow / Q000473:pathology; D001854:Bone Marrow Cells / Q000378:metabolism; D016022:Case-Control Studies; D045424:Complex Mixtures / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D048691:Grifola / Q000737:chemistry*; D006801:Humans; D059785:Karyotype; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000276:immunology / Q000378:metabolism; D009190:Myelodysplastic Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D009504:Neutrophils / Q000276:immunology / Q000378:metabolism; D017382:Reactive Oxygen Species / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D045424:Complex Mixtures; D017382:Reactive Oxygen Species