Maitake (Grifola frondosa) Clinical Trials

2022

Effect of Maitake D-fraction in advanced laryngeal and pharyngeal cancers during concurrent chemoradiotherapy: A randomized clinical trial

Authors: Qinglei Hu and Binli Xie

Journal: Acta Biochimica Polonica

Study Design: Randomized clinical trial

Intervention: During CCRT, Maitake capsules were taken orally 3 times a day, each time 4 capsules, one hour before meals.

Participants: 141 patients with advanced laryngeal or pharyngeal cancer undergoing concurrent chemoradiotherapy (CCRT)

Duration: The median observation time was 42.3 \u00b1 22.5 months for the Maitake D-Fraction group and 39.6 \u00b1 27.2 months for the placebo group.

Outcome Measures: Adverse events, quality of life (QOL) assessed by EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires, and overall survival (OS)

This study investigated the effects of Maitake D-Fraction on CCRT-related adverse events and quality of life (QOL) in patients with advanced laryngeal and pharyngeal cancer. The results showed that Maitake D-Fraction reduced the frequency of severe adverse events and improved QOL scores compared to the placebo

2015

Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study

Authors: Kathleen M. Wesa, Susanna Cunningham-Rundles, Virginia M. Klimek, Emily Vertosick, Marci I. Coleton, K. Simon Yeung, Hong Lin, Stephen Nimer, and Barrie R. Cassileth

Journal: Cancer Immunology Immunotherapy

Study Design: Phase II, open-label, non-randomized trial

Intervention: 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.

Participants: 21 patients with low or intermediate-1-risk myelodysplastic syndromes (MDS)

Duration: 12 weeks

Outcome Measures: Absolute neutrophil count (ANC), neutrophil function (respiratory burst response), changes in blood counts, cytokine levels, monocyte function, and iron studies

This study investigated the effects of Maitake extract on innate immune function in MDS patients. The results showed that Maitake extract was well-tolerated and enhanced neutrophil and monocyte function in vitro. It also increased endogenous neutrophil and monocyte function and improved the monocyte response to E. coli stimulation. These findings suggest that Maitake extract may have beneficial immunomodulatory effects in MDS.

2010

Maitake Mushroom (Grifola frondosa) Extract Induces Ovulation in Patients with Polycystic Ovary Syndrome: A Possible Monotherapy and a Combination Therapy After Failure with First-Line Clomiphene Citrate

Authors: Jui-Tung Chen, Kunihiko Tominaga, Yoshiaki Sato, Hideo Anzai, and Ryo Matsuoka

Journal: The Journal of Alternative and Complementary Medicine

Study Design: Open trial

Intervention: Subjects were administered MSX on the first day of menses, which was continued for up to 12 weeks or 3 cycles, or CC at a daily dose of 50 mg from days 5 to 9 of menses, and repeated up to 3 cycles. Subjects who did not respond to either MSX or CC were further subjected to combination therapy.

Participants: 80 patients with polycystic ovary syndrome (PCOS)

Duration: Up to 12 weeks for monotherapy, up to 16 weeks for combination therapy

Outcome Measures: Ovulation rate

This study investigated the effects of Maitake extract (MSX) on ovulation in PCOS patients. The results showed that MSX alone could induce ovulation in some patients, and it was also effective as an adjunct therapy for patients who did not respond to clomiphene citrate (CC). The combination therapy of MSX and CC showed promising results in inducing ovulation in patients who failed monotherapy with either MSX or CC.

2009

A phase I/II trial of a polysaccharide extract from Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects

Authors: Gary Deng, Hong Lin, Andrew Seidman, Monica Fornier, Gabriella D’Andrea, Kathleen Wesa, Simon Yeung, Susanna Cunningham-Rundles, Andrew J. Vickers, and Barrie Cassileth

Journal: Journal of Cancer Research and Clinical Oncology

Study Design: Phase I/II dose-escalation trial

Intervention: Maitake liquid extract was taken orally at 0.1, 0.5, 1.5, 3, or 5 mg/kg twice daily for 3 weeks.

Participants: 34 postmenopausal breast cancer patients

Duration: 3 weeks

Outcome Measures: Safety, tolerability, and immunological parameters

This study investigated the safety, tolerability, and immunological effects of Maitake extract in breast cancer patients. The results showed that Maitake extract was well-tolerated, with only two patients withdrawing due to mild side effects. The study also found a statistically significant association between Maitake extract and immunological function, with varying effects depending on the dose and specific immune parameter. Some immune parameters were enhanced, while others were suppressed, suggesting that Maitake extract acts as an immunomodulator rather than simply an immune enhancer.

2004

Safety of Maitake D-Fraction in Healthy Patients Assessment of Common Hematologic Parameters

Authors: Smadelli Glauco, Freddo Jano, Giordo Paolo, and Sensuke Konno

Journal: Alternative & Complementary Therapies

Study Design: Randomized, double-blinded trial

Intervention: Fifteen (15) participants were instructed to take 1 drop of D-fraction per kg in body weight per day, equally distributed at each meal (3 times per day) in water. Thirteen (13) participants received a placebo preparation and were told to follow the same instructions as the subjects in the D-fraction group.

Participants: 28 healthy subjects

Duration: 1 month

Outcome Measures: Hematologic parameters (complete blood count, serum glucose, total cholesterol, HDL, bilirubin, creatinine, hepatic enzymes, iron, etc.)

This study assessed the safety and effects of Maitake D-Fraction on hematologic parameters in healthy individuals. The results showed no adverse effects or significant changes in most parameters after one month of D-fraction intake. However, there were minor statistical differences in hemoglobin, hematocrit, and GPT/ALT levels, suggesting a potential for D-fraction to influence these parameters with long-term use.

Effect of Maitake (Grifola frondosa) D-Fraction on the Activation of NK Cells in Cancer Patients

Author: Noriko Kodama, Kiyoshi Komuta, and Hiroaki Nanba

Journal: Journal of Medicinal Food

Study Design: Not explicitly stated, but appears to be a clinical trial

Intervention: Maitake D-Fraction was administered to cancer patients. The dose and frequency are not specified in this abstract.

Participants: 10 cancer patients

Duration: Not explicitly stated

Outcome Measures: CD4 and CD8 cell counts, NK cell activity, serum soluble interleukin-2 receptor (sIL-2R) levels, and tumor marker expression

This study investigated the effect of Maitake D-Fraction on NK cell activity in cancer patients. The results showed that Maitake D-Fraction increased NK cell activity and hindered metastatic progress while lessening the expression of tumor markers. The changes in CD4 and CD8 cell counts were not related to disease severity or stage. These findings suggest that Maitake D-Fraction may repress cancer progression through the stimulation of NK activity.

2000

Effects of Maitake (Grifola frondosa) glucan in HIV-infected patients

Authors: Hiroaki Nanba, Noriko Kodama, Douglas Schar, and Denise Turner

Journal: Mycoscience

Study Design: Non-controlled clinical trial

Intervention: Patients received either 6 grams of dried Maitake in tablets or 20 mg of maitake D-Fraction + 4 grams of Maitake tablets. 

Participants: 35 HIV-infected patients

Duration: 360 days

Outcome Measures: CD4+ cell counts, viral load, symptoms of HIV infection, status of secondary diseases, and sense of well-being

This study investigated the effects of Maitake D-Fraction, a beta-glucan extracted from Maitake mushrooms, on HIV-infected patients. The results showed that Maitake D-Fraction positively affected CD4+ cell counts and viral load in most patients. Additionally, 85% of participants reported an increased sense of well-being, suggesting potential benefits for Maitake D-Fraction in managing HIV infection.