Cases of Guillain-Barre syndrome (GBS) associated with parenteral use
of gangliosides have been reported in several European countries. To e
valuate the hypothesis of association between ganglioside exposure and
occurrence of GBS, a case-control study was conducted. GBS cases disc
harged during 1989 from public and private hospitals in three Italian
provinces were identified: 42 GBS cases and 420 controls matched on ag
e and gender were enrolled. Data of onset of symptoms of GBS was taken
from clinical records. Exposure status of subjects was ascertained th
rough the regional computerized drug prescription monitoring system. T
he odds ratio of association between ganglioside use, in the 30 days p
rior to onset of symptoms, and GBS was 9.1 (95% confidence interval 2.
8-29.4). Although there are formidable difficulties in distinguishing
prodromal therapy of GBS from drug causation, the association with gan
glioside therapy is strong and supportive of the hypothesis of a role
of ganglioside preparations in the occurrence of GBS.