Evaluation of acupuncture efficacy for migraine attacks prophylaxis - a phase III trial

INTERVENTION: The 67 patients were randomized into two differents groups: real and sham acupuncture groups. Both groups were treated with 16 acupuncture sessions in twelve weeks. Eight in the first four weeks of the treatment period, seven in the next four weeks of the treatment period and one in the four weeks of the treatment period. Treatment was individualized in the real acupuncture group following the Traditional Chinese Medicine (TCM) principles and minimal acupuncture was used in the sham acupuncture group not respecting the TCM rules. CONDITION: Migraine ; Nervous System Diseases ; Migraine PRIMARY OUTCOME: The percentage of patients with a reduction of =50% in migraine attack frequency and the total of the migraine days compared with the baseline period. SECONDARY OUTCOME: 1. The percentage of patients with a reduction of =40% in migraine attacks frequency; 2. Frequency of migraine attacks; 3. Average duration of a migraine attack; 4. Average headache severity; 5. Total duration of migraine pain in hours per diary; 6. Rate of rescue medication used; 7. Nausea and vomiting frequency; All of them comparing the first diary (baseline period) with the other group's headache diaries. INCLUSION CRITERIA: 1. Patients suffering from migraine with or without aura for at least one year were diagnosed according to criteria of the International Headache Society 2. Male or female, aged 18‐50 years 3. Patients with only one type of headache (exclusively migraine) 4. Patients who had not used acupuncture or drugs with migraine prophylactic effects within the last three months 5. Patients who could come to the hospital for 17 times in the following twelve weeks (acupuncture evaluation and acupuncture treatment period)