Evidence map›Paper›PMID 27415795›Full record

Trial reportPloS one2016

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.

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

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01496053 (Anti-inflammatory Effect of a Mushroom Extract), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01496053 phase2 / phase3completednot on this map

Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study

TypeinterventionalSponsorOslo University HospitalRan2011 to 2016Enrolled100ConditionsUlcerative Colitis, Crohn's Disease, Inflammatory Bowel DiseaseArmsAndoSan, Sugar Extract
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Frontiers in immunology · 2020
    Article
  9. Review
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Stig Palm TherkelsenDepartment of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Oslo, Norway.ORCID http://orcid.org/0000-0001-7104-0403
Geir HetlandImmunology and Transfusion Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.
Torstein LybergMedical Biochemistry, Oslo University Hospital, Ullevål, Oslo, Norway.
Idar LygrenMedicine, Oslo University Hospital, Ullevål, Oslo, Norway.
Egil JohnsonDepartment of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIngestion 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

findings50 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.

conclusionsThe 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 registrationClinicalTrials.gov NCT01496053.

Indexed as

AgaricusAdultAgedComplex MixturesCrohn DiseaseFatigueFemaleHumansMaleMiddle AgedQuality of LifeSingle-Blind MethodTreatment OutcomeYoung AdultAndoSanComplex Mixtures

Identifiers

PMID27415795
PMCPMC4944955

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.