Evaluating the Prophylaxis and Long-term Effectiveness of Meridian-based Acupuncture for Migraine:a Randomized,Controlled TrialCN
Abstract：Aim:This research aims to observe the clinical efficacy of acupuncture at the acupoints along the meridian for patients suffering migraine without aura. We hope the findings will explore the persistence and regularity of acupuncture therapy at acupoints along the meridian according to syndrome differentiation and provide scientific evidence on migraine treatment.Methods:A multi-center, randomized and controlled trial was designed.227patients who met the inclusion criteria were divided into3groups at the ratio of1:1:1by the central randomization system:the individualized acupoint treatment group （Group A）, the non-acupoint control group （Group B） and the waiting-list control group （Group C）. Group A took GB20and GB8as the primary acupoints, and then select corresponding matching acupoints according to syndrome differentiation of meridians. Group B underwent insertion of acupuncture needles at four bilateral non-points in locations not corresponding to acupuncture points. Group C didn’t recieve any intervention during the observation period, but instead receive20acupuncture treatments for free after a waiting period of24weeks. Both Group A and B were punctured at the unilateral acupoints and each side was punctured alternatively. Participants in Group A and Group B received20sessions over4weeks, once a day, five times continuously with2days’interval in a week, then all participants will receive20weeks of follow-up. The outcome were assessed at the baseline,4th,8th,12th,16th,20th and24th week after randomization. The primary outcomes were the frequency of migraine attacks during the16th week after randomization, while secondary outcomes included frequency of migraine attacks and differences from baseline, number of days with migraine and differences from baseline, visual analogue scale （VAS） score and differences from baseline, grade of headache intensity （0-3）, SAS and SDS scores. Results:1. The frequency of migraine attacks during the16th week after randomization, Group A revealed significant improvements comparing to that of Group B and Group C （P<0.05）, but there was no statistical differences between Group B and Group C （P>0.05）.2. At the fourth week after randomization, all outcomes except SAS and SDS, Group A revealed significant inprovements comparing to that of Group B and Group C（P<0.05）, and these difference persisted to the following5follow-up visits.3. The statistical difference of all outcomes except SDS was obeserved between Group B and Group C （P＜0.05）, but it tended to dwindle with time passing.Conclusions:1. Compared to non-acupoints control group and waiting-list control group, the individualized acupoint treatment group was better on migraine management in following aspects:reducing the frequency of migraine, relieving the extent of pain and improvement of participants’emotional status. This difference persisited till the24th week. Thus we can conclude that the efficacy of acupuncture is sustainable.2. Compared to wating-list control group, the non-acupoint was better on migraine management in following aspects:reducing the frequency of migraine, relieving the extent of pain and improvement of participants’emotional status, the difference was dwindling gradually and disappeared on the24th week, which showed the placebo effect of non-acupoints was fading and it’s not sustainable.