Effect of Andosan in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to
      significant pain, joint destruction and functional decline, and has a substantial economic
      impact both for sufferers and society. Although the etiology of RA is unknown, it is
      generally accepted that it arises from an interplay of genetic predisposition (in particular,
      HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g.
      autoantibody production), and environmental factors. The prevalence and incidence of RA in
      Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are
      2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA
      and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6).
      RA is also associated with significant comorbidity; the most important is premature
      cardiovascular disease that significantly contributes to increased mortality. Compared with
      the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden,
      and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of
      RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids,
      traditional disease modifying antirheumatic drugs (including methotrexate) and biologic
      therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy).
      Also, a considerable portion of the patients are in need of joint replacement surgery and in
      need of rehabilitation.

      However, the treatment opportunities are still not optimal. In a large proportion of the
      patients, full control of the disease is not possible due to limited effect of available
      therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new
      therapeutic alternatives to treat RA.

      Since studies on healthy volunteers and IBD-patients support that the mushroom extract
      AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a
      pilot study whether this effect also was evident in patients with RA. A potential
      anti-inflammatory effect could prove beneficial in these seriously ill patients, who
      accordingly could experience less side effects (edema, granulocytopenia, diminished tissue
      repair) due to potential reduction number and dose of disease modifying drugs.
    

Detailed description: 
      Main aim: Examine whether daily oral ingestion of a immunomodulatory mushroom extract
      (AndoSanTM) leads to a clinical, biochemical and genetical improvement in RA. The experiment
      will be carried out for 21 days in 15 eligible RA patients. In order to increase the
      scientific value of the project we will use, a as far as possible, an age matched control
      group of RA patients with steady medication and no intervention. The control group of 10-15
      patients will be answering the same questionnaires and give the same samples of blood and
      feces.

      Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of
      Andosan the effect of this therapy on:

        -  general blood samples (leucocytes, CRP, liver and renal function tests), including
           erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)

        -  level of blood cytokines and analytes
           (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/
           17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB,
           RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in
           patients

        -  genetic expression in blood leukocytes (microarray) -number of swollen and tender
           joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA
           impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue
           scale (VAS) for patient's and physician's global assessment of disease activity, life
           quality (SF-36 version 2), fatigue score.

      Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of
      Andosan the effect of this therapy on:

        -  general blood samples (leucocytes, CRP, liver and renal function tests), including
           erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)

        -  level of blood cytokines and analytes
           (IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/
           17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB,
           RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in
           patients

        -  genetic expression in blood leukocytes (microarray) -number of swollen and tender
           joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA
           impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue
           scale (VAS) for patient's and physician's global assessment of disease activity, life
           quality (SF-36 version 2), fatigue score.
    

Intervention name(s): Mushroom extract
Intervention type(s): Dietary Supplement
Intervention description(s): The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rheumatoid arthritis; symptom score; fatigue; life quality; cytokines; mRNA expression; Quality of Life; Signs and Symptoms; Indication for Modification of Patient Physical Status