A large German study has compared the effectiveness of acupuncture in addition to routine care in patients with primary headache, to routine care alone. In a randomised controlled trial plus non-randomised cohort study, patients with headache were allocated to receive up to 15 acupuncture sessions over three months or no acupuncture (control group) during the first three months. Patients who did not consent to randomisation received acupuncture treatment immediately. All subjects were allowed to continue usual medical care. Of 15,056 headache patients (mean age 44, 77% female), 1613 were randomised to acupuncture and 1569 to control, while 11,874 were included in the non-randomised acupuncture group. At three months, the number of days with headache decreased from 8.4 to 4.7 in the acupuncture group and from 8.1 to 7.5 in the control group. Intensity of pain and quality of life improvements were also more pronounced in the acupuncture vs. control groups. Treatment success was maintained at six months and the outcome changes in non-randomised patients were similar to those in randomised patients. The authors conclude that acupuncture plus routine care in patients with headache is associated with marked clinical improvements compared with routine care alone. (Acupuncture in patients with headache. Cephalalgia. 2008 Jul 2. [Epub ahead of print]).