Introduction

Role of hormonal therapy in short term control of epileptic spasms (ES) is well established.  Currently recognized two forms of hormonal therapies are intra-muscular long acting tetracosactrine (ACTH) (costly, invasive) and prednisolone (cheap, oral). However, the more efficacious form of these two for early spasm control is not yet described.

Method

A prospective randomized, single blind clinical trial is underway in Sri Lanka presently. Eighty eight newly diagnosed, previously untreated children with documented ES, who demonstrated hypsarrhythmia on EEG, were randomized to receive oral prednisolone (PNL) or ACTH for 14 days according to doses used in UKISS protocol. Spasm load was assessed on day 0, day 14 and day 42 using a spasm diary. Primary outcome for day 14 was “no spasms for more than 48 hours”.  Sustained spasm control was defined as “no spasms within 14 day followed by continued spasm freedom for 28 days”.

Results

Forty six (PNL) and 42(ACTH) completed 14 days of treatment. Spasm cessation by D14 occurred in 60.9% with PNL in comparison to only 38% with ACTH (p=0.03). Mean number of days for spasm cessation was 3.85(SD=2.42) for PNL and 8.47(SD=3.83) for ACTH (p=0.00). Sustained seizure freedom was seen in 44% on PNL vs 22% (p=0.03).

Conclusion

These findings confirm that early spasm cessation, complete cessation of spasms on D14, and subsequent sustained spasm control are achieved better with oral prednisolone than with ACTH therapy.  This is the first-ever documentation of therapeutic supremacy of oral prednisolone over ACTH for ES.