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Abstract
Introduction: In the early ninety a severe form of acute motor neuropathy presenting clinically as Guillain-Barre syndrome (GBS) was described in a number of patients within 2 weeks of starting parenteral treatment with gangliosides. Such cases were originally reported in Germany and later in the United States, Italy, and Spain. After these reports gangliosides were banded in Europe in late 1993. However, epidemiological studies failed to demonstrate an association between gangliosides therapy and GBS. The risk of this therapy should be assessed as gangliosides are still under investigation for spinal cord injuries and marketed in South-America.
Objectives: To conduct a systematic review of randomised controlled trials (RCT) on parenteral gangliosides to evaluate whether such therapy is associated with an increase of GBS within 2 weeks of starting treatment.
Methods: The estimated number of cases necessary to reveal a statistically significant increase in GBS, from a GBS rate of 0.01% in the control group to 0.1% in the gangliosides group within 2 weeks of starting treatment, is about 25,000 (l-beta=0.95). We performed an explorative search in the Cochrane Library (issue 1, 1999), combining the terms "GM1" or "ganglioside(s)" or "Cronassial" or "Sygen", to look for complete reviews and RCTs on gangliosides.
Results: We identified only three complete Cochrane reviews: "Gangliosides in acute stroke" (2077 patients randomised), "Pharmacology for spinal cord injury" (only 37 patients randomised GM1 vs placebo) and "Tardive diskinesia: miscellaneous treatments" (no relevant trials on gangliosides). In the Cochrane Controlled Trials Register we found 64 RCTs on gangliosides. The diseases in which the efficacy of gangliosides was tested, included stroke, subarachnoid haemorrhage, tardive diskinesia, Parkinson's disease, Chagas cardioneuropathy, spinal cord injury, diabetic, uremic and alcoholic polineuropathy, motoneuron disease, retinitis pigmentosa, keratoconjunctivitis. The Collaborative Review Groups (CRGs) cover almost all the above pathologies. We planned to contact CRGs in order to favour systematic reviews on gangliosides and to look for cases of GBS. The review will be performed if the estimate sample size could be reached.
Discussion: Collaboration among different CRGs of the Cochrane network may be of crucial importance in case of rare but potentially severe adverse effect of treatments.
Objectives: To conduct a systematic review of randomised controlled trials (RCT) on parenteral gangliosides to evaluate whether such therapy is associated with an increase of GBS within 2 weeks of starting treatment.
Methods: The estimated number of cases necessary to reveal a statistically significant increase in GBS, from a GBS rate of 0.01% in the control group to 0.1% in the gangliosides group within 2 weeks of starting treatment, is about 25,000 (l-beta=0.95). We performed an explorative search in the Cochrane Library (issue 1, 1999), combining the terms "GM1" or "ganglioside(s)" or "Cronassial" or "Sygen", to look for complete reviews and RCTs on gangliosides.
Results: We identified only three complete Cochrane reviews: "Gangliosides in acute stroke" (2077 patients randomised), "Pharmacology for spinal cord injury" (only 37 patients randomised GM1 vs placebo) and "Tardive diskinesia: miscellaneous treatments" (no relevant trials on gangliosides). In the Cochrane Controlled Trials Register we found 64 RCTs on gangliosides. The diseases in which the efficacy of gangliosides was tested, included stroke, subarachnoid haemorrhage, tardive diskinesia, Parkinson's disease, Chagas cardioneuropathy, spinal cord injury, diabetic, uremic and alcoholic polineuropathy, motoneuron disease, retinitis pigmentosa, keratoconjunctivitis. The Collaborative Review Groups (CRGs) cover almost all the above pathologies. We planned to contact CRGs in order to favour systematic reviews on gangliosides and to look for cases of GBS. The review will be performed if the estimate sample size could be reached.
Discussion: Collaboration among different CRGs of the Cochrane network may be of crucial importance in case of rare but potentially severe adverse effect of treatments.