Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan(TM), on Symptoms, Fatigue and Quality of Life in Patients with Crohn’s Disease in a Randomized Single-Blinded Placebo Controlled Study

BACKGROUND: Ingestion of AndoSan(TM), 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 AndoSan(TM) also resulted in clinical effects. METHODS AND FINDINGS: 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSan(TM) 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 AndoSan(TM) 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 AndoSan(TM) 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 AndoSan(TM) 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 AndoSan(TM) 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 AndoSan(TM). CD patients with mild to moderate symptoms may have beneficiary effects of AndoSan(TM) as a safe supplement in addition to conventional medication. TRIAL REGISTRATION: ClinicalTrials.gov NCT01496053