Department of Paediatrics, Royal Children's Hospital, Vic.
5 Year Follow-Up of Young People with CFS Following the Double Blind Randomised Controlled Intravenous Gammaglobulin Trial
A five year follow of young people involved in the double blind randomised controlled trial of intravenous gammaglobulin has been conducted to determine whether the improvement following the intravenous gammaglobulin was sustained. A 78% contact and follow up was achieved on an intention to treat basis, and 84% (74) of those who completed the study were traced. A questionnaire that assessed functional outcomes was used and delayed type skin hypersensitivity reaction was measured (using CMI Multitest) in those who were anergic in the initial study.
The initial study demonstrated a significant difference between the baseline functional score and 6 month follow up for both groups, and between the mean functional outcomes (t = -2.12, p < 0.04, df 68) at 6 months. For the young people who were categorised as anergic (no response) using the CMI Multitest, or hypoergic (response less than 2-9 mm in total) there was a highly significant difference between treatment with gammaglobulin or placebo on functional outcome, whereas there was no difference between placebo and gammaglobulin in improvement rate for those with normal cell mediated immunity as measured by the CMI Multitest. At follow up there was no deterioration in function in any young person i.e. they all remained improved or continued to improve. Sixteen per cent of those who responded were still moderately unwell with another 16% 'not back to normal yet'. The remainder were well and active. Delayed type hypersensitivity had returned to normal over the five years in those who were 'well'.
There was no deterioration in function over the 5 years following participation in the gammaglobulin trial, and young people continued to improve although a significant number were still disabled. The significance of the abnormal delayed type hypersensitivity reaction for the response to gammaglobulin is uncertain and warrants further investigation.
Alison Hunter Memorial Foundation
PO Box 6132 North Sydney 2059 Australia
Phone/Fax +61 2 9958 6285
All material on the site © AHMF