The report is available in English with a French summary - KCE

70 Plasma KCE Reports 120
Chronic fatigue syndrome
The Chronic fatigue syndrome (CFS) is a condition characterised by severe, disabling
fatigue in the absence of exertion, and is marked by a dramatic decline in activity level.
Currently, the aetiology of CFS remains unknown.
The beneficial effect of IG for CFS patients is controversial. Three RCTs obtained mixed
results: a RCT conducted in 1990 found improvements in symptom scores and
functional capacity at three months; 143 a second found improvement in immune
indicators but not in symptom and functional measures, 144 the third trial was more
recent and larger (involving 99 adult patients). 145 It found no effect of treatment, but
reported adverse reactions in 70-80% patients, with no relationship to IG treatment. It
concluded that IG cannot be recommended as a therapy for CFS.
There is conflicting evidence on the effect of IG in CFS, but the larger and more
recent trial showed no effect, with a high rate of adverse events.
3.3 CONSUMPTION OF IMMUNOGLOBULINS
3.3.1 Consumption in other countries
Few studies investigating IG use and its trends are available. No study has been found on
IG consumption in European countries. However, eight studies with quantitative data
on recent IG use per indication were found from Australia, Canada, New Zealand and
the US. 146,147,148,149,150,151,152,153 .
3.3.1.1 Consumption by medical speciality and indication
The results of the four studies analyzing prescription data after 2000 are described
below. 146,147-149 . The distribution of the total quantities of IG used, by indication and
major specialty, is shown in Table 22, based on the four studies analyzing IG use per
indication. Though variations are observed across studies, the majority of IG was
prescribed by two clinical specialities: neurology, which consume in average one third of
total IG amount; and immuno-haematology, which consume around half of the total
amount. An exception to this pattern was the Massachusset general hospital (US) where
a very high consumption in neurology (71%) is biasing other relative estimates.
Table 22: Distribution of the total amount of immunoglobulin used per
disease in four studies in three countries, 2000-2004 (New Zealand, Canada,
US). Weighted average of the four studies.
Studies New Zealand Toronto
Massach
US
Canada
Atlantic
Weighted
average
Diseases/year 2004 2000 2004 2003-04
Guillain-Barré syndrome 6% 5% 3% 4% 5%
Chronic inflammatory demyelinating polyneuropathy 13% 9% 12% 19%
Multifocal motor neuropathy 3% 3% 62%
8% 4%
Relapsing-remitting multiple sclerosis 3% 3%
Myasthenia gravis 2% 1% 4% 5% 3%
Dermatomyositis 2% 2% 2% 2%
Total neurology - muscular 25% 20% 71% 35% 32%
Idiopathic thrombocytopenic purpura 9% 16% 8% 17% 13%
Primary immune deficiencies 32% 15% 9% 15% 19%
Secondary immune deficiency in general 15% 19% 9% 10% 14%
- Chronic lymphocytic leukaemia 5% 1% 4%
- Multiple myeloma 1% 1%
- Bone marrow / stem cell transplant 8% 19% 4% 11%
- Children with HIV 1% 1%
- solid organ transplants 2% 1% 4% 2%
Acute leukaemia in childhood 4% 4%
Autoimmune haemolytic anaemia 2% 1% 2%
Total immuno-hemato 60% 51% 27% 42% 48%
Kawasaki disease in children 0% 1% 0%
Toxic shock syndrome 3% 2% 1% 2%
Others 15% 27% 1% 22% 17%
Total amount IG 101.496 g 100.208 g 48.230 g 65.240 g 315.174 g