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

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

Journal: PLOS ONE

Study Design: Randomized, single-blinded, placebo-controlled trial

Participants: 50 patients with symptomatic Crohn’s disease (CD)

Intervention:

• AndoSan™ extract (Agaricus blazei-based, 82% AbM, 15% Hericium erinaceus, 3% Grifola frondosa): 30 ml twice daily for 21 days
• Placebo: Equivalent volume of a color-matched, inert liquid
• Symptoms, fatigue, and health-related quality of life (HRQoL) were assessed at days 0, 14, and 21.

Outcome Measures:

• Symptom score improvement (Harvey-Bradshaw Index for Crohn’s disease)
• Fatigue levels (total, physical, and mental fatigue scores)
• Health-related quality of life (HRQoL) (SF-36 questionnaire)
• Fecal calprotectin and general blood parameters

Summary:
This study investigated the potential clinical benefits of AndoSan™, a medicinal mushroom extract, in patients with Crohn’s disease. Patients in the AndoSan™ group showed significant symptom improvement over 21 days, particularly in stool frequency and abdominal pain reduction. However, when compared to placebo, no statistically significant differences were observed between groups, except for stool frequency improvement favoring AndoSan™.

Fatigue scores improved similarly in both AndoSan™ and placebo groups, and HRQoL improvements were minor, with bodily pain decreasing in the AndoSan™ group and social functioning improving in the placebo group. No significant changes were detected in fecal calprotectin or blood parameters. Importantly, no adverse effects were reported, suggesting that AndoSan™ may be a safe supplement to conventional therapy for symptom relief in Crohn’s disease patients.