Affiliations: Department of Pharmacy, West China Second University
Hospital, Sichuan, China | School of Pharmacy, West China College, Sichuan
University, Sichuan, China | Department of Pediatric Neurology, West China Second
University Hospital, Sichuan, China
Note: [] Correspondence: Dr. Lingli Zhang, Department of Pharmacy, West
China Second University Hospital, No 20, Section~3, South Renmin Road, Cheng
du, Sichuan, China. Tel.: +86 (028) 85501012; Fax: +86 (028) 85501012; E-mail:
[email protected]
Abstract: To determine the influence of dose on the efficacy and safety of
adrenocorticotropic hormone (ACTH) for infantile spasms. We searched six
relative databases. Randomized controlled trials and crossover studies, which
meet our inclusion criteria were considered for inclusion. The quality of
included trials was evaluated with respect to sequence generation, allocation
concealment, blinding and incomplete data. We performed both direct and
indirect meta-analysis to evaluate the efficacy and safety of high-dose and
low-dose of ACTH. Results: A total of 168 reports were retrieved, and after
scrutiny seven reports of trials containing three head to head comparisons, two
vigabatrin comparisons and two prednisone comparisons were included. In direct
comparison meta-analysis, studies were homogenous (P > 0.10). There was a
trend towards more complete cessation of spasms in the low-dose ACTH treated
group (RR: 0.86, 95% confidence interval [CI]: 0.57–1.31), though
statistically not significant. Relapse was more frequent in low-dose ACTH
groups (RR: 0.69, 95% CI: 0.22–2.19) but without demonstrating statistic
difference. No difference was present for disappearance of hypsarrhythmia
between high and low-dose ACTH (RR: 0.93, 95% CI: 0.57–1.54). In indirect
meta-analysis the comparison of complete cessation of spasms between high-dose
and low-dose ACTH from indirect meta failed to show any significant difference.
There was no significant difference between two dosages with respect to relapse
rates. High-dose ACTH produced more adverse effects than low-dose group. A
low-dose ACTH therapy might be preferable for its comparative efficacy and
lower risk of adverse effects.
