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

Abstract

BackgroundIngestion 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 Findings50 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.ConclusionsBeneficiary 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 RegistrationClinicalTrials.gov NCT01496053

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

“…In a recent similar placebo-controlled study [ 23 ] of patients with UC consuming AndoSan TM , the improvements in addition to symptoms irrefutably also were evident for fatigue and HRQoL. Obviously, clinical improvement due to intake of this mushroom extract in patients with CD was more limited vs. those with UC.…”

“…We have in a recent single-blinded randomized placebo controlled study, in which patients with ulcerative colitis received this mushroom extract (AndoSan TM ) for three weeks [ 23 ], demonstrated improvements in symptoms, fatigue and HRQoL compared with patients in the placebo group.…”

Agaricus blazei-Based Mushroom Extract Supplementation to Birch Allergic Blood Donors: A Randomized Clinical Trial

“…It was determined from a similar randomized clinical trial with Andosan TM in 50 patients with ulcerative colitis or Crohn’s disease that 50 patients were needed for significant differences at the p = 0.05 level in symptoms and plasma cytokine levels [25,26].…”

“…Since Andosan TM has an anti-inflammatory effect in blood donors and inflammatory bowel disease (IBD) patients [23,24,25,26] and aeroallergy and asthma can be defined as local inflammatory conditions in the airways, it was pertinent to investigate this mushroom extract in an allergy and asthma intervention study. We examined whether the AbM-based mushroom extract Andosan TM , taken orally before the pollen season, could reduce allergy and asthma symptoms, medication, and specific IgE basophil sensitization to t3 (birch pollen extract) and Bet v 1 (major component from birch) and could influence the Th1/Th2 cytokine balance in otherwise healthy humans as found in mouse models for allergy and asthma [9,10].…”

Antitumor, Anti-inflammatory and Antiallergic Effects of Agaricus blazei Mushroom Extract and the Related Medicinal Basidiomycetes Mushrooms, Hericium erinaceus and Grifola frondosa: A Review of Preclinical and Clinical Studies

“…In another clinical trial 50 patients with UC and 50 patients with CD were randomized to receive either 60 mL of Andosan TM or placebo for 21 days. Plasma levels of IL-5 (UC group) and IL-2 (CD group) were reduced in patients receiving Andosan TM [82], and patients in both groups enjoyed an improvement in clinical symptoms and quality of life [83,84]. When looking at IL-1ß, IL-6 and granulocyte-colony stimulating factor (G-CSF) combined in the patients with CD, the cytokine levels were significantly lower in the Andosan TM group.…”