Study of electroacupuncture with different frequencies for the treatment of headache and anxiety-depression symptoms in patients with migraine: A randomized clinical trial

To observe the effects of electroacupuncture (EA) with varied frequencies on headache and anxiety-depression symptoms in patients with migraine and to screen optimal frequency of EA for patients with such conditions. Single-center, randomized, controlled clinical trial was designed, and the outcome assessors and statisticians were blinded. The patients with migraine were randomized into 2 Hz EA group, 100 Hz EA group and sham-stimulation group. In each group, the changes in migraine attacks, days with headache, the scores of visual analogy scale (VAS), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and migraine-specific quality-of-life questionnaire (MSQ), as well as the dosage of analgesics were observed at the baseline, during treatment, in 1, 2 and 3 months of follow-up separately. Patients were enrolled in the Third Affiliated Hospital of Zhejiang Chinese Medical University, between 1st August 2018 and 31st July 2021. Sixty-five migraine patients with or without aura. In the EA groups, the acupoints were bilateral Fengchi (GB20), Gongxue (Extra), Sizhukong (TE23), Taiyang (EX-HN5), Shuaigu (GB8), Waiguan (TE5) and Yanglingquan (GB34). Electric stimulation was exerted at GB20 and Gongxue (Extra), with 2 Hz and 100 Hz separately. In the sham-stimulation group, the shallow acupuncture was operated at the sites 1 cm lateral to GB20 and Gongxue (Extra), and on the radial side of TE5 and GB34. The output wires were cut off after attached to the acupoints. The patients in each group received the treatment 3 times weekly, once every two days, for consecutive 4 weeks. The complete intervention was composed of 12 treatments. Changes in numbers of migraine attacks at treatment phase (week 1 to week 4) from the baseline(week -4 to week 0) in patients of each group (1) Changes in migraine attacks and days with headache: In the 2 Hz EA and 100 Hz EA groups, the changes for migraine attacks and days of headache were higher significantly when compared with that in the sham-stimulation group at the same time stage (P < 0.05). There was no statistical difference between two EA groups. (2) Changes of VAS score: In the 2 Hz EA and 100 Hz EA groups, the changes of VAS score were significantly higher when compared with that in the sham-stimulation group at the same time stage (P < 0.05). There was no statistical difference between two EA groups. (3) Assessment of anxiety and depression: The differences in the changes of SAS and SDS scores had no statistical significance in patients of each group at each assessment stage (P > 0.05). (4) Assessment on the quality of life: Compared with the sham-stimulation group at the same time stage, the improvement in MSQ score was increased significantly during treatment in patients of the 2 Hz EA group (P < 0.05). There was no statistical difference between two EA groups. (5) Assessment on safety and compliance: The patients of each group had sound compliance. There was no adverse events during trial, suggesting promising safety of treatment. EA may effectively reduce the migraine attacks, and the days and intensity of headache, presenting promising safety. However, there was no significant improvement on anxiety-depression symptoms, and no significant difference between high and low frequencies of EA treatment in relieving headache and anxiety/depression symptoms in the patients with migraine. ChiCTR1800017259