Evidence map›Paper›PMID 26933886›Full record

Trial reportPloS one2016

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.

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 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Psychometric validation of the SF-36Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    Pooled it
  3. Nutrients · 2019
    Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. The Health and Clinical Benefits of Medicinal Fungi.Advances in biochemical engineering/biotechnology · 2023
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. 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, Norway.
Geir HetlandImmunology and Transfusion Medicine, Oslo University Hospital, Ullevål, Norway.
Torstein LybergMedical Biochemistry, Oslo University Hospital, Ullevål, Norway.
Idar LygrenMedicine, Oslo University Hospital, Ullevål, Norway.
Egil JohnsonDepartment of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIngestion 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

findings50 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.

conclusionsBeneficiary 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 registrationClinicalTrials.gov NCT01496053.

Indexed as

Quality of LifeAdultAgaricusAgedAnti-Inflammatory AgentsColitis, UlcerativeComplex MixturesFatigueFecesFemaleHumansLeukocyte L1 Antigen ComplexMaleMiddle AgedPlacebo EffectSingle-Blind MethodAndoSanAnti-Inflammatory AgentsComplex MixturesLeukocyte L1 Antigen Complex

Identifiers

PMID26933886
PMCPMC4774976

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.