A Cochrane review [Abstract] 1 included 16 small and 2 larger RCTs. These 18 studies looked at a total of 916 patients treated with a total of 12 different pharmaceutical agents. Overall, studies were of poor methodological quality, partly because of ethical dilemmas concerning placebo injections. Two studies showed that placebo was not as good as active treatment in resolving the spasms. The strongest evidence suggested that hormonal treatment (prednisolone or tetracosactide depot) leads to resolution of spasms faster and in more infants than does vigabatrin. Responses without subsequent relapse may be no different. The same study suggests that hormonal treatments might improve the long-term developmental outcome compared with vigabatrin in infants not found to have an underlying cause for their infantile spasms.
Comment: The quality of evidence is downgraded by limitations in study quality (inadequate or unclear allocation concealment, lack of blinding), by inconsistency (heterogeneity in interventions and outcomes) and by imprecise results (limited study size for each comparison).
Primary/Secondary Keywords