Double-blind randomized controlled trial to assess the efficacy of intravenous gammaglobulin for the management of Chronic Fatigue Syndrome (CFS) in adolescents

A double blind randomized controlled trial was conducted in 71
adolescents aged 11-18 years. Inclusion in the trial required
fulfilment of the diagnostic criteria, (Fukuda et al., 1994).
Three infusions of 1 gm/kg (max 1 litre of 6 gm/100 ml in 10%
w/v maltose solution) were given one month apart. The dummy
solution was a 10% w/v maltose solution with 1% albumin of
equivalent volume for weight. Efficacy was assessed by
difference in a mean functional score including school
attendance, school work, social activity and physical
activity, between baseline, three months and six months after
the final infusion.

There was a significant mean functional improvement at
the six month follow-up of 70 adolescents with Chronic
Fatigue Syndrome of average duration 18 months. There
was also a significant improvement for both groups from the
beginning of the trial to the six month post infusion
follow-up. Adverse effects were common with both solutions but
not predictive of response. Neither solution could be
identified by recipients.

MCM: From 1994 AACFS meeting in Ft. Lauderdale

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