The Gerard K H, Bleijenberg Gijs, van der Meer Jos W M
Department of General Internal Medicine, Nijmegen Expert Centre Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
PLoS Clin Trials. 2007 May 18;2(5):e19. doi: 10.1371/journal.pctr.0020019.
It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio).
A randomized, placebo-controlled, double-blind clinical trial.
Radboud University Nijmegen Medical Centre, The Netherlands.
Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals.
Acclydine or placebo for 14 wk.
Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis.
There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI -4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI -201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio -0.5 (95% CI -2.8 to +1.7, p = 0.63).
We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS.
目前尚不清楚胰岛素样生长因子（IGF）功能是否参与慢性疲劳综合征（CFS）的病理生理过程。未发表的数据以及患者组织时事通讯中的报告表明，一种食品补充剂Acclydine可能通过提高生物活性IGF1水平来有效治疗CFS。在此，我们旨在测量与年龄和性别匹配的社区对照相比，CFS患者的IGF1和IGF结合蛋白（IGFBP）3状态，并评估Acclydine对疲劳严重程度、功能损害和生物活性IGF1水平（IGFBP3/IGF1比值）的影响。
一项随机、安慰剂对照、双盲临床试验。
荷兰拉德堡德大学奈梅亨医学中心。
57名符合美国疾病控制与预防中心CFS标准的成年患者。将22名CFS患者的IGF状态与22名年龄和性别匹配的健康社区对照个体的IGF状态进行比较。
服用Acclydine或安慰剂，为期14周。
观察指标包括疲劳严重程度（个人力量清单，疲劳严重程度子量表 [CIS-疲劳]）、功能损害（疾病影响概况-8 [SIP-8]）以及生物活性IGF1血清浓度。分析采用意向性分析。
与年龄和性别匹配的健康对照个体相比，22名CFS患者的IGF状态没有差异。在任何观察指标上，Acclydine治疗组与安慰剂组相比均未产生显著差异：CIS-疲劳 +1.1（95%置信区间 -4.4至 +6.5，p = 0.70），SIP-8 +59.1（95%置信区间 -201.7至 +319.8，p = 0.65），以及IGFBP3/IGF1比值 -0.5（95%置信区间 -2.8至 +1.7，p = 0.63）。
我们发现与健康匹配的社区对照相比，CFS患者的IGF1状态没有差异。此外，该临床试验结果并未表明Acclydine在治疗CFS方面比安慰剂有任何优势。
