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Chronisch Vermoeidheidssyndroom: diagnose, behandeling en ...

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KCE Reports 88 Chronic Fatigue Syndrome 47<br />

2.5.3.6 Supplem<strong>en</strong>t treatm<strong>en</strong>ts<br />

Elev<strong>en</strong> studies were reviewed in CRD Report 35 that investigated supplem<strong>en</strong>t<br />

treatm<strong>en</strong>ts for CFS pati<strong>en</strong>ts. Only three of these studies investigating either ess<strong>en</strong>tially<br />

fatty acids or magnesium were of high quality (1A).<br />

No significant effects were noted in RCTs of g<strong>en</strong>eral supplem<strong>en</strong>ts, poll<strong>en</strong> extract and<br />

medicinal mushrooms. A RCT of acclydine and amino acids reported significantly more<br />

improvem<strong>en</strong>t in IGF-1 levels in the interv<strong>en</strong>tion than control group, but no significant<br />

differ<strong>en</strong>ce in global improvem<strong>en</strong>t or symptoms (p < 0.0001).<br />

Studies that examined ess<strong>en</strong>tial fatty acid supplem<strong>en</strong>ts were conflicting, with one high<br />

quality RCT (1A; n=50) reporting no improvem<strong>en</strong>t and one slightly larger controlled<br />

trial (1A; n=63) conducted in pati<strong>en</strong>ts with post-viral fatigue syndrome (PVFS) reporting<br />

an overall b<strong>en</strong>eficial effect. This trial showed greater shifts towards normal levels of cell<br />

fatty acid conc<strong>en</strong>tration in treatm<strong>en</strong>t groups, most of which were statistically significant,<br />

as well as improvem<strong>en</strong>ts in symptom measures.<br />

One small RCT (1A; n=34) showed that magnesium supplem<strong>en</strong>ts had an overall positive<br />

effect of improvem<strong>en</strong>t in measures of <strong>en</strong>ergy and pain, emotional reactions, g<strong>en</strong>eral<br />

health and laboratory measures, but not in sleep, physical mobility or social isolation.<br />

However, two of 34 participants in this study dropped out, 1 because of g<strong>en</strong>eralised<br />

rash.<br />

One very small RCT (1B) assessed the effects of liver extract in pati<strong>en</strong>ts with CFS but<br />

found no differ<strong>en</strong>ce in outcomes (activity and <strong>en</strong>ergy, m<strong>en</strong>tal health, symptoms)<br />

betwe<strong>en</strong> the interv<strong>en</strong>tion and control groups.<br />

A RCT of acetyl-L-carnitine and propionyl-L-carnitine (1A) found significant<br />

improvem<strong>en</strong>ts in fatigue and cognitive function associated with treatm<strong>en</strong>t. Adverse<br />

effects of supplem<strong>en</strong>t trials are not well reported as well as reasons for dropping out of<br />

the studies (except for magnesium).<br />

Beyond RCTs included in Bagnall’ systematic review, McDermott et al. 130 compared a<br />

food supplem<strong>en</strong>t, the arabinoxylane (BioBran MGN-3) versus placebo for 8 weeks in 71<br />

CFS adult pati<strong>en</strong>ts. Data were complete in 64/71 pati<strong>en</strong>ts. Both groups showed marked<br />

improvem<strong>en</strong>t over the study duration, but without significant differ<strong>en</strong>ces, except for the<br />

social well-being subscale of the WHOQOL-BREF, where improvem<strong>en</strong>t was significantly<br />

better in the placebo group. There was no significant differ<strong>en</strong>ce betwe<strong>en</strong> groups in<br />

fatigue severity (change in Chalder physical fatigue subscale from baseline to 8 weeks: -<br />

1.5 with BioBran v -1.8 with placebo; differ<strong>en</strong>ce -0.3, 95% CI -3.2 to + 2.6; p = 0.84). No<br />

serious adverse effects were reported. Three people on active treatm<strong>en</strong>t withdrew<br />

because of minor side-effects (mild nausea, exacerbation of fatigue, and irritable bowel<br />

symptoms, respectively) and one person withdrew from the placebo group because of<br />

wors<strong>en</strong>ing fatigue (p value not provided).<br />

Another rec<strong>en</strong>t RCT assessed the effect of Acclydine on fatigue severity, functional<br />

impairm<strong>en</strong>t, and biologically active IGF1 level (IGFBP3/IGF1 ratio) in CFS adult<br />

pati<strong>en</strong>ts. 131 No differ<strong>en</strong>ces were found in IGF1 status in CFS pati<strong>en</strong>ts compared to<br />

healthy matched neighbourhood controls. In addition, the results of this clinical trial do<br />

not demonstrate any b<strong>en</strong>efit of Acclydine over placebo in the treatm<strong>en</strong>t of CFS. The<br />

negative results of this trial are important: Acclydine is exp<strong>en</strong>sive and is available<br />

without prescription on the Internet, making it available to pati<strong>en</strong>ts pot<strong>en</strong>tially without a<br />

doctor’s oversight.<br />

Evid<strong>en</strong>ce is insuffici<strong>en</strong>t to support a b<strong>en</strong>eficial effect of dietary supplem<strong>en</strong>ts,<br />

including ess<strong>en</strong>tial fatty acids in CFS (Evid<strong>en</strong>ce quality 1A).<br />

2.5.3.7 Other treatm<strong>en</strong>ts<br />

One controlled trial of combination treatm<strong>en</strong>t (including medical treatm<strong>en</strong>t of<br />

symptoms plus anxiety/affective disorder and CBT) in pati<strong>en</strong>ts with CFS was also<br />

included in the CRD Report 35. 1 This controlled trial included 71 pati<strong>en</strong>ts, but only 22<br />

of the 71 original participants were followed up (17 in the interv<strong>en</strong>tion group and 5 in<br />

the control group).

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