Table 1 Prospective ACTH studies: Short-term results

Ref.nClassType of ACTH (dose)No. wk of full doseTotal Rx, wkOther Rx
* The studies by Hrachovy et al.18 and Baram et al.16 are considered class I studies when one is comparing high-dose vs low-dose ACTH or ACTH vs prednisone but class III studies when considering whether either medication was effective in decreasing the number of infantile spasms because neither study contained a placebo-controlled group.
† Total of 42 adverse events.
‡ Results prior to crossover (phase I).
§ Progressive dosage regimen starting at 0.2 IU/kg and increasing to 1.0 IU/kg.
∥ No statistically significant difference between etiologic subgroups.
¶ After crossover (at the end of phase II).
# p ≤ 0.02 compared to prednisone group.
** Short-term outcome at 10 mo. Numbers of patients differ in Methods and Results.
†† Results combined for ACTH alone and ACTH plus PNL treatment groups in CIS patients.
ACTH = adrenocorticotropic hormone; Rx = treatments; F/U = follow-up; SIS = symptomatic infantile spasm; CIS = cryptogenic infantile spasm; N = natural; NS = not stated; RH = reversal of hypsarrhythmia; HPT = hypertension; Irrit = irritability; S = synthetic; Sed = sedation; VGB = vigabatrin; CN = completely normal; Var = variable; Hypo-K+ = hypokalemia; Pneum = pneumonia.
1859I/III*N312No
    High doseN (150 IU/m2)312No
    Low doseN (20 IU/m2)312No
1615I/III*N (150 IU/m2)24No
14Prednisone (2 mg/kg/d)24No
1712IIN (20 IU/m2)67No
12Prednisone (2 mg/kg/d)No
2025IIIS§66Yes
    Low dose12(0.2 IU/kg)2–44–6Yes
    High dose13(1.0 IU/kg)4–64–6Yes
1919IIIS (10 IU/d)5.75.7No
23VGB (100–150 mg/kg/d)5.75.7No
215IIIN (20–40 IU)NS6–10No
23**IIINVarVarNS
    SIS69N (110 IU/m2)38NS
    CIS36N (110 IU/m2)38NS
    CIS37ACTH, prednisolone8, 14–20VarNS
2415IVN (150 IU/m2)112Yes
2218IVACTH, 1–24 (0.8 mg/kg)46Yes
Mean (range) F/U, mo% Spasms stoppedSIS vs CIS, %Resolution of hypsarrhythmia, %Relapse, %Side effects, %Time to improved
NS5449 vs 7822 RH1918% HPT, 42% IrritNS
NS5045 vs 75231531% HPT, 46% IrritNS
NS5852 vs 8021214% HPT, 37% IrritNS
1587#92 vs 6787 RH15NS1 wk
16.92930 vs 2529 RHNSNS
NS42NS42 RH3324% HPT75% in 2 wk
NS33NS33 RH2925% HPT, 63% Atrophy33% in 2 wk
128075 vs 8875 SIS/88 CIS45 SIS/16 CISNS
7575 vs 7575 SIS/75 CIS50 SIS/0 CIS7% Atrophy, 92% Sed, 100% IrritNS
8575 vs 10075 SIS/100 CIS40 SIS/33 CIS12% Atrophy, 83% Sed, 100% IrritNS
(9–44)7464 vs 8878 CN/100 RH2437% HPT, 5% Irrit12 d
(9–44)4844 vs 5736 CN/48 RH813% Drowsy, Hypotonia, Irrit14 d
10100NS100 CN2040% HPT1 wk
6 y19% HPT, 12% Hypo-K+, 3 diedNS
103929 CNNSNS
1058††59 CNNSNS
1058††59 CNNSNS
43.393NR9336100% Irrit, 13% serious side effects3 wk
63321 vs 7533NS11% HPT, 6% Pneum, 11% died