Clinical Effects and Cytokine Responses from Ingestion of AndoSanTM in Patients with Ulcerative Colitis and Crohn´s Disease. A Randomized Placebo Controlled Study

Inflammatorisk tarmsykdom (IBD) er betennelsestilstander i tarmen med hovedsakelig ukjent sykdomsårsak, og består av sykdomsgruppene morbus crohn (CD) og ulcerøs kolitt (UC). Medisinsk behandling har som mål å dempe symptomer og sykdomsaktivitet, men er beheftet med varierende effekt og en del bivirkninger. Tidligere studier har vist interessante resultater for soppen Agaricus blazei Murill (AbM) på blant annet betennelse og infeksjon. Medisinsk behandling med bruk av sopp er svært vanlig i Asia, hvor for eksempel AbM brukes som behandling hos ca 500.000 mennesker i Japan. AndoSanTM er en soppekstrakt som inneholder 82% AbM, 15% Hericeum erinaceum og 3% Grifola frondosa. Dette soppekstraktet ble funnet mest potent i et utvalg av soppekstrakter i studier på blodforgiftning i mus, og ble derfor foretrukket i videre studier av vår forskningsgruppe. Stig Palm Therkelsen har i sitt doktorarbeid gjennomført studier på IBD pasienter hvor effekten av AndoSanTM ble sammenliknet med placebo. Alle pasientene hadde mild til moderat sykdomsaktivitet. Pasientene rapporterte tilbake om kliniske parametere som symptomer, livskvalitet og fatigue. Resultatene viste bedring av symptomer i AndoSanTM-gruppen sammenliknet med placebo, både for CD og UC, og i tillegg livskvalitet og fatigue for UC. Det ble også gjort analyse av signalproteiner (cytokiner) i immunforvaret fra blodprøver. Resultater fra disse undersøkelsene viste kun en marginal effekt i retning av betennelsesreduksjon, og kunne dermed ikke forklare mekanismene til at pasientene følte seg bedre. Behandling med AndoSanTM på IBD pasienter kan etter vår vurdering anbefales som et supplement til ordinær medisinsk behandling, spesielt for pasienter med UC. Det ble ikke rapportert om bivirkninger etter inntak av AndoSanTM i våre studier

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

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. Methods and Findings 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. Trial Registration ClinicalTrials.gov NCT0149605

Effect of the Medicinal <i>Agaricus blazei</i> 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

<div><p>Background</p><p>Ingestion of AndoSan^TM, based on the mushroom <i>Agaricus blazei</i> 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.</p><p>Methods and Findings</p><p>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.</p><p>Conclusions</p><p>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.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT01496053" target="_blank">NCT01496053</a></p></div

Mean SF-36 scale scores (n = 24 AndoSan^™ and n = 26 placebo) UC.

<p>Mean SF-36 scale scores (n = 24 AndoSan^™ and n = 26 placebo) UC.</p

Fatigue scores for the patients with (n = 25 AndoSan^TM and n = 25 placebo) CD.

<p>Fatigue scores for the patients with (n = 25 AndoSan^TM and n = 25 placebo) CD.</p

Mean SF-36 scale scores (n = 25 AndoSan^TM and n = 25 placebo) CD.

<p>Mean SF-36 scale scores (n = 25 AndoSan^TM and n = 25 placebo) CD.</p

Symptom score (SCDAI) for the CD patients.

<p>Symptom score (SCDAI) for the CD patients.</p

Mean fatigue scale scores.

<p>Normative data in the Norwegian population compared with the included CD patients.</p

Mean SF-36 scale scores.

<p>Age-adjusted Normative Data from the Norwegian Population compared with patients with UC on inclusion.</p

Symptom score for the UC patients.

<p>Symptom score for the UC patients.</p