Stig Palm Therkelsen, Geir Hetland, Torstein Lyberg, Idar Lygren, Egil Johnson
Journal: PloS one 2017;11(7):e0159288
PMID: 27415795
AndoSanTM is a medicinal mushroom supplement based on Agaricus Blazei Murrill (ABM), but also contains Hericium erinaceus (lion’s mane, 14.7%) and Grifola frondosa (Maitake, 2.9), and contains immune modulatory beta-glucans as well as other bioactive compounds. This single-centre randomised two-armed patient-blinded study was designed to determine whether daily oral intake of AndoSanTM could improve clinical symptoms, fatigue and quality of life in patients with Crohn’s Disease (CD). Patients received either AndoSanTM 60ml per day or placebo for 21 days and were evaluated before start of treatment and at day 14 and 21. Outcome measures were the Crohn’s Disease Activity Index (SCDAI), the self-reported health-related quality of life (HRQoL), a fatigue questionnaire, blood parameters and faecal calprotectin (a marker for intestinal inflammation). 25 patients in each study arm completed the trial and were included in study analysis. There was a statistically significant improvement inf SCDAI in the AndoSanTM group, in particular for number of liquid stools and pain, but not the placebo group, although the difference between the groups was not statistically significant. There were no statistically significant differences for fatigue, quality of life, blood tests or calprotectin. No adverse effects were reported. The authors conclude that AndoSanTM could be safe to complement conventional medication to relieve symptoms in CD patients.
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.
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