Laser Acupuncture in Children with Headache: A double-blind, randomized, bicenter, placebo-controlled trial

To investigate whether laser acupuncture is efficacious in children with headache and if active laser treatment is superior to placebo laser treatment in a prospective, randomized, double-blind, placebo-controlled trial of low level laser acupuncture in 43 children (mean age [SD] 12.3 [+/–2.6] years) with headache (either migraine [22 patients] or tension type headache [21 patients]). Patients were randomized to receive a course of 4 treatments over 4 weeks with either active or placebo laser. The treatment was highly individualised based on criteria of Traditional Chinese medicine (TCM). The primary outcome measure was a difference in numbers of headache days between baseline and the 4 months after randomization. Secondary outcome measures included a change in headache severity using a 10 cm Visual Analogue Scale (VAS) for pain and a change in monthly hours with headache. Measurements were taken during 4 weeks before randomization (baseline), at weeks 1–4, 5–8, 9–12 and 13–16 from baseline. The mean number of headaches per month decreased significantly by 6.4 days in the treated group (p ≤ 0.001) and by 1.0 days in the placebo group (p = 0.22). Secondary outcome measures headache severity and monthly hours with headache decreased as well significantly at all time points compared to baseline (p ≤ 0.001) and were as well significantly lower than those of the placebo group at all time points (p ≤ 0.001).