Brain, Vol 120, Issue 7 1123-1130, Copyright © 1997 by Oxford University Press
V Govoni, E Granieri, MR Tola, E Paolino, I Casetta, E Fainardi and VC Monetti
A retrospective study was carried out in the Ferrara Local Health District,
Italy, for the period 1981-1993 (average resident population: 177,235
inhabitants) to establish whether people exposed to exogenous gangliosides
had a higher risk of Guillain-Barre syndrome. The incidence of
Guillain-Barre syndrome of 1.9/100,000 population/year [95% confidence
interval (CI): 1.3-2.5] reported in Ferrara Local Health District in the
same period was used as a reference for comparison. The data bank of
Ferrara Local Health District made it possible, first to estimate the
number of individuals exposed to gangliosides in the resident population of
Ferrara Local Health District (3.7%), the number of ganglioside
prescriptions and the number of cases of Guillain-Barre syndrome who had
treatment with gangliosides (nine patients, 20.9%), and, secondly, to
verify the sequence of events between the ganglioside injection and the
onset of the disease. Seven of the nine patients (77.8%) received
gangliosides as treatment for peripheral neuropathy (Guillain-Barre
syndrome onset before gangliosides were prescribed). For the other two
patients (22.2%) a possible appropriate temporal sequence between
ganglioside injection and onset of Guillain-Barre syndrome was found. Based
on two possible ganglioside-related cases, the risk of Guillain-Barre
syndrome was higher in the exposed (0.53/100,000 population/month following
ganglioside injection; 95% CI: 0.06-1.91) compared with the unexposed
population, but the difference was not significant. When only individuals
prescribed with mixed gangliosides were considered (both possible
ganglioside-related Guillain-Barre syndrome cases received mixed
gangliosides), the risk of Guillain-Barre syndrome was higher (0.64/100,000
population/month following ganglioside injection; 95% CI: 0.08-2.31) but
the difference from the risk in unexposed individuals was not statistically
significant. The relative risk for the exposure to mixed gangliosides was
borderline (relative risk = 4.3; 95% CI: 1.0- 17.8). The wide 95%
confidence intervals were a consequence of sample size limitations.
Considering also that the exposed and unexposed groups differed in age
(those exposed were older than those unexposed and the age-specific
incidence of Guillain-Barre syndrome in the study population increased with
increasing age), the present findings question either a strong increased
risk of Guillain-Barre syndrome in people exposed to exogenous gangliosides
or an immunogenic role of these agents in humans. However, because of the
limited sample size, the results are not conclusive.
ARTICLES
Exogenous gangliosides and Guillain-Barre syndrome. An observational study in the local health district of Ferrara, Italy
Dipartimento di Discipline Medico-Chirurgiche della Comunicazione, Universita degli Studi di Ferrara, Italy.
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