Why the study?
Does nitrazepam reduce spasm frequency compared to corticotropin in infants with infantile spasms?
Does nitrazepam reduce spasm frequency compared to corticotropin in infants with infantile spasms?
Nitrazepam and corticotropin are similarly effective in reducing infantile spasms, but corticotropin is associated with more severe adverse effects.
Supports nitrazepam as alternative to corticotropin; confirms equivalent efficacy for infantile spasms.
Fifty-two patients were enrolled in a four-week randomized multicenter study comparing nitrazepam and corticotropin in the treatment of infantile spasms. The drugs' efficacy was evaluated in 48 patients, all less than 2 years of age. Both treatments resulted in a statistically significant reduction in spasm frequency from that at baseline, but the difference between treatments was not significant. The number of patients who experienced side effects was similar in the two treatment groups, but the adverse effects encountered among the patients treated with corticotropin were qualitatively more severe and required the discontinuation of treatment in six patients.
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Fritz E. Dreifuss (1986) studied this question.
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