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The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (≥18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 ± 12.3; 22.6% men, 47.2 ± 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [€857.47; 95% confidence interval 790.86, 924.07, vs. €527.34 (459.81, 594.88), P < 0.001, mean difference: €330.12 (235.27 …