A Randomized,Double-Blind,Controlled Trial Study On Pingganqianyang Tianning Decoction In Treatment Of Migraine Wind-Phlegm And Blood Stasis With Hyperactivity Of Liver-Yang

Objective:To investigate the clinical efficacy,safety and possible mechanism of Pinggan qianyang Tianning(PGQY)Decoction by observing its impact on headache,hemodynamics and 5-hydroxytryptamine(5-HT)levels in migraine patients with wind-phlegm and blood stasis and hyperactivity of liver-yang syndrome.Methods:The 90 migraine patients of this syndrome were divided randomly into the trial group(n=45,treated with PGQY Tianning Decoction+Yuanhu simulator)and the control group(n=45,treated with Yuanhu+PGQY Tianning Decoction simulator).Both group were continuously treated for 2 courses,and 15d for each course.The scores of clinical symptom,visual analogue scale(VAS)and headache impact test-6(HIT-6),changes of peak systolic velocity(Vs),mean systolic velocity(Vm)and 5-HT content were observed.Results:1.A total of 82 patients completed the trial,43 in the trial group and 39 in the control group.2.Comparison of the efficacy:the total effective rate of the trial group was 83.72%,which was significantly higher than that of the control group of 23.08%(P<0.01).3.Compared with pre-treatment:①The clinical symptom,VAS and HIT-6 scores of the trial group were decreased(P<0.01),the VAS score of the control group was decreased(P<0.01)and the other two were no change(P>0.05).The trial group was better than control group(P<0.01).②The Vs and Vm of the anterior,middle,posterior and basilar arteries of the brain in trial group were decreased(P<0.01),and the control group was not statistically changed(P>0.05).The trial group was better than control group(P<0.01,P<0.05).③The 5-HT content in trial group was increased(P<0.01),and in control group was decreased(P>0.05).the trial group was superior to the control group(P<0.01).4.No serious adverse reactions and adverse events occurred in either group during the trial.Conclusion:PGQY Tianning Decoction can significantly improve the symptoms of migraine in patients with wind-phlegm and blood stasis and hyperactivity of liver-yang syndrome,and the mechanism is correlating with the regulation of patients’ intracranial blood flow velocity and 5-HT content.