NICEVIVA
MONOGRAPH SPEC LATEST 2026

Agaricus blazei

BOTANICALS · Evidence Monograph

Agaricus blazei is an evidence-graded botanicals monograph evaluated across 36 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 8 randomized controlled trials, encompassing n = 225 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 36 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 8 RCTs (5 Double-Blind)
Cumulative Participants n = 225
Reported Trial Dosages 1.8 g · 3.6 g · 5.4 g
Trial Duration Range 21 days · 6 months · 12 weeks
Reading Time ~18 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 36 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (1.8 g · 3.6 g · 5.4 g) over a structured 21 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (36 PubMed studies)
Quantitative biomarker & outcome analysis (10 studies with effect-size/sample data)
Randomized controlled trial verification (8 RCTs · 5 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Agaricus blazei & Why Does Form Matter?

Agaricus blazei is classified under BOTANICALS and has been investigated across 36 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (1.8 g, 3.6 g, 5.4 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Agaricus blazei frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (8 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Agaricus blazei acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Agaricus blazei an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 36 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 8 randomized controlled trials (5 double-blind, n = 225 total participants).

Representative peer-reviewed findings include: • PMID:21132265 (2011) — "Agaricus blazei Murill enhances doxorubicin-induced apoptosis in human hepatocellular carcinoma cells by NFκB-mediated increase of intracellular doxorubicin accumulation." (These findings suggest that ABM, when combined with low doses of Dox, has the potential to provide more efficient therapeutic effects against drug-resistant human hepatocellular carcinoma.) • PMID:7869611 (1994) — "Inhibitory action of a (1-->6)-beta-D-glucan-protein complex (F III-2-b) isolated from Agaricus blazei Murill ("himematsutake") on Meth A fibrosarcoma-bearing mice and its antitumor mechanism." (Furthermore, the L3T4+/Lyt2+ ratio showed a tendency to increase, and the Lyt2+ ratio was markedly decreased.) • PMID:32274562 (2020) — "Mushroom extracts and compounds with suppressive action on breast cancer: evidence from studies using cultured cancer cells, tumor-bearing animals, and clinical trials." (Antineoplastic effectiveness in human clinical trials and mechanism of anticancer action have been reported for Antrodia camphorata, Cordyceps sinensis, Coriolus versicolor, Ganoderma lucidum, Grifola frondosa, and Lentinula edodes.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 1.8 g · 3.6 g · 5.4 g · 1500 mg over 21 days · 6 months · 12 weeks · 4 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Agaricus blazei, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (1.8 g · 3.6 g · 5.4 g) and re-evaluate efficacy after 21 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (36 Studies) · 10 Quantitative Analyses

01
CLINICAL STUDY International journal of oncology (2011) PMID: 21132265 ↗
Agaricus blazei Murill enhances doxorubicin-induced apoptosis in human hepatocellular carcinoma cells by NFκB-mediated increase of intracellular doxorubicin accumulation.
Clinical Trial Synthesis 2011 Clinical Study published in International journal of oncology. Key conclusion: These findings suggest that ABM, when combined with low doses of Dox, has the potential to provide more efficient therapeutic effects against drug-resistant human hepatocellular carcinoma.
View Original PubMed Abstract ↓

It has been demonstrated that the Agaricus blazei Murill (ABM) mushroom, which primarily consists of polysaccharides, possesses anti-tumor activities. However, the mechanisms by which ABM inhibits human hepatocellular carcinoma growth remain unknown. Our study demonstrates that ABM acts as an enhancer to sensitize doxorubicin (Dox)-mediated apoptotic signaling, and this sensitization can be achieved by enhancing intracellular Dox accumulation via the inhibition of NFκB activity. These findings suggest that ABM, when combined with low doses of Dox, has the potential to provide more efficient therapeutic effects against drug-resistant human hepatocellular carcinoma.

02
CLINICAL STUDY Japanese journal of pharmacology (1994) PMID: 7869611 ↗
Inhibitory action of a (1-->6)-beta-D-glucan-protein complex (F III-2-b) isolated from Agaricus blazei Murill ("himematsutake") on Meth A fibrosarcoma-bearing mice and its antitumor mechanism.
Clinical Trial Synthesis 1994 Clinical Study published in Japanese journal of pharmacology. Key conclusion: Furthermore, the L3T4+/Lyt2+ ratio showed a tendency to increase, and the Lyt2+ ratio was markedly decreased.
View Original PubMed Abstract ↓

The effects of F III-2-b (Agaricus blazei Murill polysaccharide) with or without 5-fluorouracil (5-FU) on immune responses were investigated in Meth A tumor-bearing and normal mice. The i.p. administration of F III-2-b (10 mg/kg/day x 30) moderately inhibited the growth of Meth A tumor cells implanted s.c. in mice. Development of implanted tumors was strongly inhibited by the combination of F III-2-b and 5-FU. The picryl chloride-induced delayed type hypersensitivity (PC-DTH) response in mice was depressed after the implantation of tumor and treatment with 5-FU. F III-2-b restored the suppression of PC-DTH by 5-FU, but did not increase the PC-DTH of normal mice. F III-2-b not only enhanced the degree of spleen cell-mediated sheep red blood cells (SRBC) hemolysis (quantitative hemolysis of SRBC), the indexes of the spleen and thymus, and the number of spleen cells but also restored the suppressive effect of 5-FU. In the group receiving F III-2-b, the percentages of splenic Thy1.2-, L3T4- and asialo GM1-positive cells were significantly increased as compared with the tumor-bearing mice treated with saline. Furthermore, the L3T4+/Lyt2+ ratio showed a tendency to increase, and the Lyt2+ ratio was markedly decreased. These results suggest that the antitumor effect of F III-2-b may be correlated with the changing pattern of the Thy1.2-, L3T4- and asialo GM1-positive cells.

03
CLINICAL STUDY Applied microbiology and biotechnology (2020) PMID: 32274562 ↗
Mushroom extracts and compounds with suppressive action on breast cancer: evidence from studies using cultured cancer cells, tumor-bearing animals, and clinical trials.
Clinical Trial Synthesis 2020 Clinical Study published in Applied microbiology and biotechnology. Key conclusion: Antineoplastic effectiveness in human clinical trials and mechanism of anticancer action have been reported for Antrodia camphorata, Cordyceps sinensis, Coriolus versicolor, Ganoderma lucidum, Grifola frondosa, and Lentinula edodes.
View Original PubMed Abstract ↓

This article reviews mushrooms with anti-breast cancer activity. The mushrooms covered which are better known include the following: button mushroom Agaricus bisporus, Brazilian mushroom Agaricus blazei, Amauroderma rugosum, stout camphor fungus Antrodia camphorata, Jew's ear (black) fungus or black wood ear fungus Auricularia auricula-judae, reishi mushroom or Lingzhi Ganoderma lucidum, Ganoderma sinense, maitake mushroom or sheep's head mushroom Grifola frondosa, lion's mane mushroom or monkey head mushroom Hericium erinaceum, brown beech mushroom Hypsizigus marmoreus, sulfur polypore mushroom Laetiporus sulphureus, Lentinula edodes (shiitake mushroom), Phellinus linteus (Japanese "meshimakobu," Chinese "song gen," Korean "sanghwang," American "black hoof mushroom"), abalone mushroom Pleurotus abalonus, king oyster mushroom Pleurotus eryngii, oyster mushroom Pleurotus ostreatus, tuckahoe or Fu Ling Poria cocos, and split gill mushroom Schizophyllum commune. Antineoplastic effectiveness in human clinical trials and mechanism of anticancer action have been reported for Antrodia camphorata, Cordyceps sinensis, Coriolus versicolor, Ganoderma lucidum, Grifola frondosa, and Lentinula edodes.

04
RANDOMIZED TRIAL (RCT) PloS one (2016) PMID: 27415795 ↗
Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study.
Clinical Trial Synthesis 2016 Randomized Controlled Trial (RCT) published in PloS one involving n = 25 participants; statistical significance reported at p = 0.106. Key conclusion: CONCLUSIONS: The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups.
View Original PubMed Abstract ↓

BACKGROUND: Ingestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn's disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects. METHODS AND FINDINGS: 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64-6.40), 4.48 (3.69-5.27) and 4.08 (3.22-4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected. CONCLUSIONS: The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication. TRIAL REGISTRATION: ClinicalTrials.gov NCT01496053.

05
RANDOMIZED TRIAL (RCT) PloS one (2016) PMID: 26933886 ↗
Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan™, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study.
Clinical Trial Synthesis 2016 Randomized Controlled Trial (RCT) published in PloS one involving n = 24 participants; statistical significance reported at p = 0.002. Key conclusion: CONCLUSIONS: Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis.
View Original PubMed Abstract ↓

BACKGROUND: Ingestion of AndoSan™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan™ also resulted in clinical effects. METHODS AND FINDINGS: 50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan™ or placebo for the 21 days' experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92-6.83), 4.71 (3.90-5.52) (p = 0.002) and 4.50 (3.70-5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan™ group. There were no alterations in general blood samples and fecal calprotectin. CONCLUSIONS: Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan™ in this study. TRIAL REGISTRATION: ClinicalTrials.gov NCT01496053.

06
CLINICAL STUDY Complementary therapies in medicine (2013) PMID: 24050580 ↗
Quality of life improvements among cancer patients in remission following the consumption of Agaricus blazei Murill mushroom extract.
Clinical Trial Synthesis 2013 Clinical Study published in Complementary therapies in medicine involving n = 23 participants. Key conclusion: CONCLUSION: This preliminary longitudinal clinical study demonstrated that daily intake of ABM appears to improve both physical and mental components based on SF-8 qualimetric analysis.
View Original PubMed Abstract ↓

OBJECTIVES: The aim of this preliminary clinical study was to assess if the daily intake of Agaricus blazei Murill (ABM) granulated powder (SSI Co., Ltd., Tokyo, Japan) for 6 months improved the quality of life (QOL) in cancer patients in remission. DESIGN: Open study. SETTING: Subjects diurnally took 1 (1.8 g; N=23), 2 (3.6 g; N=22), or 3 (5.4 g; N=22) packs/day orally for 6 months. MAIN OUTCOME MEASURES: The SF-8 Health Survey questionnaire was used to evaluate the QOL. The differences between the SF-8 baseline scores at the time of entry and 6-months after ABM treatment were evaluated. RESULTS: The results showed a significant improvement in QOL in both physical and mental components. More specifically, QOL effects of ABM in different genders showed males improved physical components, while females improved only mental components. QOL effects in the different age groups showed that ages 65 and under improved mental components, while ages 66 and older improved physical components. Furthermore, with respect to optimal dose effects of ABM with respect to QOL improvement, two packs per day for 6 months showed improvements in both physical and mental components. CONCLUSION: This preliminary longitudinal clinical study demonstrated that daily intake of ABM appears to improve both physical and mental components based on SF-8 qualimetric analysis.

07
RANDOMIZED TRIAL (RCT) Journal of alternative and complementary medicine (New York, N.Y.) (2007) PMID: 17309383 ↗
The mushroom Agaricus Blazei Murill in combination with metformin and gliclazide improves insulin resistance in type 2 diabetes: a randomized, double-blinded, and placebo-controlled clinical trial.
Clinical Trial Synthesis 2007 Randomized Controlled Trial (RCT) published in Journal of alternative and complementary medicine (New York, N.Y.) involving n = 29 participants; statistical significance reported at p = 0.04. Key conclusion: The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect.
View Original PubMed Abstract ↓

BACKGROUND: Complementary and alternative medicine use in adults with type 2 diabetes is popular. Although most of the herbs and supplements appear to be safe, there is still insufficient evidence that demonstrates their definitive beneficial effects. This study was done to determine whether the supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes. MATERIALS AND METHODS: This study was a clinical randomized, double-blind, placebo-controlled trial. Of a population of 536 registered diabetes patients with 72 subjects (1) aged between 20 and 75 years, (2) being Chinese, (3) having type 2 diabetes for more than 1 year, and (4) having been taking gliclazide and metformin for more than 6 months were enrolled in this study. The enrolled patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement. RESULTS: At the end of the study, subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index (3.6[standard deviation, 2.5] versus 6.6[standard deviation, 7.4], p = 0.04) than the control group (n = 31). The plasma adiponectin concentration increased 20.0(standard deviation, 40.7)% in the ABM group after 12 weeks of treatment, but decreased 12.0(20.0)% among those taking the placebo (p < 0.001). CONCLUSIONS: Supplement of ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.

08
CLINICAL STUDY Research in veterinary science (2007) PMID: 16624357 ↗
Effect of supplementation of Agaricus mushroom meal extracts on enzyme activities in peripheral leukocytes of calves.
Clinical Trial Synthesis 2007 Clinical Study published in Research in veterinary science. Key conclusion: It was concluded that supplementation of Agaricus mushroom meal extract was effective in activation of enzymes related to energy metabolism in peripheral leukocytes of calves.
View Original PubMed Abstract ↓

To investigate the effect of Agaricus mushroom meal on the energy metabolism in animal tissues; plasma glucose, triglyceride, cholesterol and immunoreactive insulin (IRI) concentrations and activities of enzymes related to energy metabolism in plasma and peripheral leukocytes were measured in Japanese Black WagyuxHolstein F1 calves supplemented with Agaricus blazei Murill (A. blazei) extract in milk-replacer at the dose of 60g/head/day for 4 weeks. Activities of malate dehydrogenase and aspartate aminotransferase in cytosol and glutamate dehydrogenase in mitochondria, and the malate dehydrogenase/lactate dehydrogenase ratio in cytosol in peripheral leukocytes of calves with A. blazei were significantly higher than those in control calves without A. blazei. It was concluded that supplementation of Agaricus mushroom meal extract was effective in activation of enzymes related to energy metabolism in peripheral leukocytes of calves.

09
RANDOMIZED TRIAL (RCT) Nutrients (2019) PMID: 31581605 ↗
Agaricus blazei-Based Mushroom Extract Supplementation to Birch Allergic Blood Donors: A Randomized Clinical Trial.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: Hence, the prophylactic effect of oral supplementation before the season with the AbM-based AndosanTM extract on aeroallergen-induced allergy was associated with reduced specific IgE levels during the season and basophils becoming less sensitive to allergen activation.
View Original PubMed Abstract ↓

Since Agaricus blazei Murill (AbM) extract reduced specific IgE and ameliorated a skewed Th1/Th2 balance in a mouse allergy model, it was tested in blood donors with self-reported, IgE-positive, birch pollen allergy and/or asthma. Sixty recruited donors were randomized in a placebo-controlled, double-blinded study with pre-seasonal, 7-week, oral supplementation with the AbM-based extract AndosanTM. Before and after the pollen season, questionnaires were answered for allergic rhino-conjunctivitis, asthma, and medication; serum IgE was measured, and Bet v 1-induced basophil activation was determined by CD63 expression. The reported general allergy and asthma symptoms and medication were significantly reduced in the AbM compared to the placebo group during pollen season. During the season, there was significant reduction in specific IgE anti-Bet v 1 and anti-t3 (birch pollen extract) levels in the AbM compared with the placebo group. While the maximal allergen concentrations needed for eliciting basophil activation before the season, changed significantly in the placebo group to lower concentrations (i.e., enhanced sensitization) after the season, these concentrations remained similar in the AndosanTM AbM extract group. Hence, the prophylactic effect of oral supplementation before the season with the AbM-based AndosanTM extract on aeroallergen-induced allergy was associated with reduced specific IgE levels during the season and basophils becoming less sensitive to allergen activation.

10
RANDOMIZED TRIAL (RCT) Scandinavian journal of immunology (2016) PMID: 27588816 ↗
Cytokine Levels After Consumption of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan(™) , in Patients with Crohn's Disease and Ulcerative Colitis in a Randomized Single-Blinded Placebo-Controlled Study.
Clinical Trial Synthesis 2016 Randomized Controlled Trial (RCT) published in Scandinavian journal of immunology. Key conclusion: Generally, the effect on reduction in systemic cytokine levels by consumption of AndoSan™ was limited and supported only marginally anti-inflammatory effects in these patients.
View Original PubMed Abstract ↓

Ingestion of the Agaricus blazei Murill-based mushroom extract AndoSan™ has been shown in randomized placebo-controlled studies to improve symptoms in Crohn's disease (CD) and ulcerative colitis (UC) and also fatigue and quality of life in the latter patients. The aim was to examine whether this clinical impact of AndoSan™ intake could be explained by influence on foremost pro-inflammatory cytokines in the patients. Fifty patients with symptomatic UC and CD were randomized and blinded for oral daily intake of AndoSan™ or placebo. Blood samples taken before (visit 1) and after 21 days' (visit 3) consumption were analysed for cytokines IL-1ß, IL-2, IL-4-8, IL-10, IL-12-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1ß and TNF-α. Baseline cytokine levels were similar in CD and UC. In CD, cytokine levels at visit 1 versus visit 3 were unaltered within the AndoSan™ and the placebo groups. Only IL-2 was significantly reduced at visit 3 in the Andosan™ compared with the placebo group. However, when combining IL-1ß, IL-6 and G-CSF in the patients with CD, the cytokine levels were significantly lower in the AndoSanTM - versus the placebo group, visit 3. In UC, levels of IL-2, IL-5 and MIP-1ß were reduced within the AndoSan™ group. IL-5 was also reduced at visit 3 compared with placebo. Generally, the effect on reduction in systemic cytokine levels by consumption of AndoSan™ was limited and supported only marginally anti-inflammatory effects in these patients. Therefore, other explanations behind the clinical anti-inflammatory effects than the contribution of cytokines seem more pertinent, including anti-allergic and antioxidant activities. © 2016 The Foundation for the Scandinavian Journal of Immunology.

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