Laser acupuncture in children with headache: A double-blind, randomized, bicenter, placebo-controlled trial

This multicenter, double-blind, randomized study was the first to rigorously evaluate the efficacy of laser acupuncture in the treatment of pediatric headache. Conducted between October 2006 and March 2007 in Germany, it included 43 children with a mean age of 12.3 years who suffered from migraine (22 patients) or tension-type headache (21 patients). The methodological design was exemplary, using concealed central randomization and blinded outcome assessment, ensuring high quality of the evidence produced. Patients were randomized to receive active laser (30 mW, 830 nm) or placebo, with devices identical in appearance and sound.

Treatment was highly individualized based on traditional Chinese medicine (中醫) criteria, including pulse and tongue diagnosis, differing positively from studies that use standardized protocols. Basic points included LI-4 and ST-36 for frontal headache, TE-5 and GB-34 for lateral pain, SI-3 and BL-60 for occipital pain, and GV-20 for holocephalic pain, with the possibility of additional points and auriculotherapy. Each point received 30 seconds of irradiation (~0.9 J per point). The primary outcome was the difference in the number of headache days between baseline and 4 months after randomization.

Secondary outcomes included pain severity (visual analog scale 0-10 cm) and monthly hours with headache. Results were clinically significant and statistically robust. The active laser group showed a mean reduction of 6.4 headache days per month (p < 0.001), while placebo reduced only 1.0 day (p = 0.22). The difference between groups was 5.4 days per month (p < 0.001).

It is important to note that the benefits of active laser persisted throughout the entire 16-week follow-up, while placebo effects diminished after 8 weeks. Pain severity and monthly headache duration also improved significantly in the active group compared to placebo. No adverse events were reported, confirming the safety profile of the technique. The clinical implications are substantial, considering that traditional acupuncture can cause anxiety in children and laser acupuncture offers a painless and nontraumatic alternative.

The authors suggest that children may be more sensitive to acupuncture than adults, explaining the superior results with relatively low dosage. Individualized treatment according to TCM, rather than standardized protocols, may have contributed to the observed efficacy.