SUMATRIPTAN FOR MIGRAINE ATTACKS IN CHILDREN - A RANDOMIZED PLACEBO-CONTROLLED STUDY - DO CHILDREN WITH MIGRAINE RESPOND TO ORAL SUMATRIPTAN DIFFERENTLY FROM ADULTS
Ml. Hamalainen et al., SUMATRIPTAN FOR MIGRAINE ATTACKS IN CHILDREN - A RANDOMIZED PLACEBO-CONTROLLED STUDY - DO CHILDREN WITH MIGRAINE RESPOND TO ORAL SUMATRIPTAN DIFFERENTLY FROM ADULTS, Neurology, 48(4), 1997, pp. 1100-1103
Oral sumatriptan is an effective acute treatment for migraine in adult
s, but its efficacy in children is still undetermined. Twenty-three ch
ildren, aged 8.3 to 16.4 years, took both sumatriptan and placebo in a
randomized, double-blind, placebo-controlled, crossover trial. The pr
imary endpoint was a greater than or equal to 50% decrease in pain int
ensity on a 100-mm visual analogue scale at 2 hours. Other endpoints o
f efficacy were pain intensity difference (PID), showing pain relief a
t each time point; summed pain intensity differences (SPIDs), estimati
ng overall pain relief; and preference. Two hours after sumatriptan, 7
of 23 reached the primary endpoint, and after placebo, 5 of 23 (diffe
rence 9%, 95% CI for difference, -21 to 38%; p = ns). Within 2 hours,
the headache disappeared completely in 5 of 23 children after sumatrip
tan and in 2 of 23 children after placebo (p = ns). Median PIDs were s
lightly better for sumatriptan between 0.5 and 4 hours (p = ns). Media
n SPIDs increased almost identically up to 2 hours. Thereafter, median
SPIDs for placebo remained practically constant, whereas for sumatrip
tan, the improvement continued. At 4 hours, the median SPID for sumatr
iptan was 2.4 times as high as for placebo. However, the maximum diffe
rences between median SPIDs at 4 hours (38.5, 95% CI, -75.8 to 57.5; W
ilcoxon signed rank test, p = 0.4) or at any other point were not stat
istically significant. Of the 23 children, 13 preferred sumatriptan an
d 2 placebo (sign test, p = 0.004). The failure of this and previous c
ontrolled studies suggests that the response of children to sumatripta
n may be different from adults.