Therkelsen Stig Palm, Hetland Geir, Lyberg Torstein, Lygren Idar, Johnson Egil
Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Ullevål, Oslo, Norway.
Immunology and Transfusion Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.
PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.
Ingestion 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.
50 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.
The 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.
ClinicalTrials.gov NCT01496053.
先前的研究表明，摄入基于姬松茸的AndoSanTM可通过降低健康个体和克罗恩病（CD）患者体内的促炎细胞因子发挥抗炎作用。在这项随机单盲安慰剂对照研究中，我们检验了摄入AndoSanTM是否也会产生临床效果。
在这项符合方案的研究中，50例有症状的CD患者被随机分为两组，在为期21天的试验期内，一组每日口服AndoSanTM，另一组口服安慰剂。患者在第0、14和21天报告了经过验证的症状、疲劳及健康相关生活质量（HRQoL）评分。同时也分析了粪便钙卫蛋白和一般血液参数。在AndoSanTM组（n = 25）中，症状从基线（第0天）到第14天和第21天有所改善，相应的平均评分（95%CI）分别为5.52（4.64 - 6.40）、4.48（3.69 - 5.27）和4.08（3.22 - 4.94）（p<0.001）。我们发现AndoSanTM组中男女的症状评分均有显著改善，而安慰剂组（n = 25）无显著变化。然而，两组之间无显著差异（p = 0.106），尽管男性的症状评分有边际效应（p = 0.054）。两组在身体、精神和总体疲劳方面都有类似的改善。与基线相比，AndoSanTM组在第21天时身体疼痛和活力方面的HRQoL有所改善，安慰剂组在活力和社会功能方面有所改善。未检测到一般血液样本和粪便钙卫蛋白有关键变化。
这项单盲随机临床试验的结果显示，AndoSanTM组中男女的症状均有显著改善，但研究组之间无显著差异。与安慰剂相比，在疲劳、HRQoL、粪便钙卫蛋白和血液样本方面的结果相当相似。患者未报告AndoSanTM有任何危害或意外影响。对于症状较轻至中度的CD患者，除传统药物治疗外，AndoSanTM作为一种安全的补充剂可能具有有益作用。
ClinicalTrials.gov NCT01496053
