title: 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.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01496053.
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Oslo, Norway.
authors.forename: Stig Palm
authors.identifier: http://orcid.org/0000-0001-7104-0403
authors.initials: SP
authors.lastname: Therkelsen
authors.affiliation: Immunology and Transfusion Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Hetland
authors.affiliation: Medical Biochemistry, Oslo University Hospital, Ullevål, Oslo, Norway.
authors.forename: Torstein
authors.initials: T
authors.lastname: Lyberg
authors.affiliation: Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.
authors.forename: Idar
authors.initials: I
authors.lastname: Lygren
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Oslo, Norway.|Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: Egil
authors.initials: E
authors.lastname: Johnson
mesh_terms: D000328:Adult; D000364:Agaricus / Q000737:chemistry; D000368:Aged; D045424:Complex Mixtures / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C579023:AndoSan; D045424:Complex Mixtures