Migraine prophylaxis: randomised controlled trial

Methods Adult patients diagnosed with migraine without aura who had previously not had prophylactic treatment were recruited from fi ve hospital outpatient departments. They were randomised to two groups in equal numbers: (1) the treatment group had verum acupuncture plus placebo medication and (2) the control group had sham acupuncture plus fl unarizine, a drug recommended as a fi rstline preventive treatment of migraine. The study period of 20 weeks included a baseline observation period of 4 weeks, a treatment period of 4 weeks, and follow-up period of 12 weeks. Both verum and sham acupuncture groups had three treatment sessions lasting 30 min each week for 4 weeks which were conducted by experienced acupuncture practitioners. In both groups, needles were stimulated manually to achieve a sensation of de qi. Obligatory acupuncture points used in the verum acupuncture group included scalp points GV20, GV24, GB13, GB8 and GB20. Additional acupuncture points could be chosen according to the features of the headache according to traditional Chinese medicine (TCM) headache types. Sham acupuncture points were chosen on the basis of having no known association with headache according to TCM. They were selected over the elbows and knees and were 3 mm away from the correct site of the actual acupuncture points. The primary outcome measure was the proportion of patients with at least 50% reduction in the number of migraine days (responders). Secondary outcomes included the Visual Analogue Scale (VAS) for pain, a general health survey, acute medication use and adverse events.