| Objective:In this study, we recruited patients with migraine without aura to evaluate the differences of time-dependent effect of meridian-involved acupoint and non-acupoint by conducting this standard randomized controlled trials. We also will investigate the long-term traits of its clinical effect of acupuncture therapy in migraine treatment and prophylaxis, and further provide good quality evidence to support the selection of acupoint in clinical practice.Methods:The present study is a multi-center, randomized, controlled trial.166 eligible patients with migraine without aura were recruited from three clinical centers in Chengdu, Hunan, Chongqing, respectively. By central randomization, all patients were averagely allocated to two groups, acupoint selection along meridians group (group A) and non-acupoint group (group B). Patients of group A received acupuncture treatment of stimulating at GB20 and GB8 as the primary acupoints.and corresponding acupoints according to syndrome differentiation of the meridians as arbitrary point set. While group B received sham acupuncture of stimulating four non-points in locations not related to acupuncture points that confirmed by previous clinical trials. All stimulating sites were punctured unilaterally in each treatment and both sides were stimulated in turn. Both groups were stimulated by HANS-LH200 nerve stimulator with monophasic wave of 2 Hz and 0-2 mA electrical current. Treatment time and frequency is 30 min and 5 times a week for 4 weeks. The entire study period lasts for 28 weeks, including 4 weeks of baseline period,4 weeks of treatment period and 20 weeks of follow-up period. Outcomes were measured at the week 0,4,8,12,16,20,24 respectively. The primary outcomes of our experiment were the frequency of migraine attacks during the 16th week after randomization, while secondary outcomes included frequency of migraine attacks,, visual analogue scale (VAS) score, comprehensive scores and MSQ scores.Results:1. For headache attack frequency, compared with the baseline period (in 0 w eeks) both patients in group A and group B experienced significant reduction of migraine attacks in 16 weeks after randomization; there’s also a significant d ifference between group A and group B in reducing migraine attacks(P<0.05).2. After treatment, there were significant differences in 16-week headache attack frequency, VAS score, MSQ score and comprehensive score for both group A and group B. Compared with group B, headache frequency, VAS score, MS Q score and emotional assessment of comprehensive score were significantly impr oved (P＜0.05) in group A. The difference in clinical effect lasts for 5 subsequen t follow-ups; But at 4-week, there’s no significant difference in the functional li mitation domain and dysfunction domain of MSQ between group A and group B (P>0.05).Conclusion:1. In each measuring timepoint after treatment, patients in both groups exper ienced significant alleviation in headache attack frequency, VAS score, MSQ scor e and comprehensive score, suggesting that acupuncture at both acupoints and no n-acupoints is effective for treating migraine;2. In each measuring timepoint after treatment, the clinical effect of acupoi nt selection along meridians is significantly superior to that of non-acupoint i n migraine attack frequency, VAS score, MSQ score and the emotional domain of comprehensive score. The difference in effect lasts from the 4-week until the 24-w eek, indicating the existence of long-term therapeutic effect of acupoint selection along meridian. |
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