title: 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.
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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01496053.
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Norway.
authors.forename: Stig Palm
authors.initials: SP
authors.lastname: Therkelsen
authors.affiliation: Immunology and Transfusion Medicine, Oslo University Hospital, Ullevål, Norway.|Faculty of Medicine, University of Oslo, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Hetland
authors.affiliation: Medical Biochemistry, Oslo University Hospital, Ullevål, Norway.
authors.forename: Torstein
authors.initials: T
authors.lastname: Lyberg
authors.affiliation: Medicine, Oslo University Hospital, Ullevål, Norway.
authors.forename: Idar
authors.initials: I
authors.lastname: Lygren
authors.affiliation: Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Norway.|Faculty of Medicine, University of Oslo, Norway.
authors.forename: Egil
authors.initials: E
authors.lastname: Johnson
mesh_terms: D000328:Adult; D000364:Agaricus / Q000737:chemistry; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000737:chemistry / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D045424:Complex Mixtures / Q000737:chemistry / Q000627:therapeutic use*; D005221:Fatigue / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011788:Quality of Life; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: C579023:AndoSan; D000893:Anti-Inflammatory Agents; D045424:Complex Mixtures; D039841:Leukocyte L1 Antigen Complex