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

Stig Palm Therkelsen, Geir Hetland, Torstein Lyberg, Idar Lygren, Egil Johnson, Stig Palm Therkelsen, Geir Hetland, Torstein Lyberg, Idar Lygren, Egil Johnson

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.

Conflict of interest statement

Competing Interests: Two of the authors (GH and EJ) have patent/patent applications and financial interests relating to material (AndoSan™) pertinent to this article: i) WO2005065063 A2, Appl. No.:10/585600, NO- and PCT-filed Jan 2004 and Jan 2005, respectively, by Inventor Hetland Geir, and ii) NO20090003383, Appl. No.: NO20090003383 20091119, by Inventors Hetland Geir and Johnson Egil and filed by Applicant Immunopharma AS in Nov 2009 and financial interest of Geir Hetland as shareholder in Immunopharma AS of Norway, commercializing AndoSan™. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. An algorithm showing the scheme…
Fig 1. An algorithm showing the scheme for inclusion of the patients in the study.

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