Clinical Study Of Lai's Tong-Yuan Therapy In Migraine Without Aura With Excessive Rising Of Liver-Yang

ObjectivTo observe the clinical effect of Lai' s Tong-Yuan therapy in migraine without aura with excessive rising of Liver-Yang by randomized controlled trials(RCT)versus sham acupuncture and flunarizine.Lai' s Tong-Yuan therapy reached a more satisfied effect than sham acupuncture and flunarizine in migraine without aura with excessive rising of Liver-Yang,which could be the liable clinical evidence.Method1.20 patients from June 2013 to December 2015 at the First Affiliated Hospital of Guangzhou University of Traditional Chinese acupuncture clinic,Hong Kong Tung Wah Chinese medicine clinic diagnosed mobile vehicle were randomized into 3 groups for Lai's Tong-Yuan therapy,sham acupuncture or flunarizine.They were previously diagnosed as migraine without aura in modern medicine and Head-wind syndrome with excessive rising of Liver-Yang in Chinese medicine.Each patient was under observation for 16 weeks in total.Patients received Lai's Tong-Yuan therapy were stimulated by acupoints of Baihui,Yintang,Qianding,Houding,Shuigou,Hegu,Taichong,Tianshu,Guanyuan,Qihai,Zhongji,Guilai,30 minutes per visit,3 times per week for 12 week.Patients received sham acupuncture were stimulated by 5 different sham acupoints for 30 minutes per visit,3 times per week for 12 week.Sham acupoints include ?2 cun above lateral malleolus,on the posterior edge of tibia.2.or 6 cun above malleolus medialis,at the middle line frompatella to anterior superior spine.? peak of biceps femoris.? on the lateral edge of femurs,1-2cm away from Zusanli.?medial margin of upper arms,junction of deltoid and biceps.?medial side of elbow,at the middle line of armpit to elbow tip.Inserting the needles to sham acupoints the same way like use Lai' s Tong-Yuan therapy,but only into 3-5mm,twirling and lifting3.times to avoid Deqi.Patients received flunarizine capsule 10mg per night by warm water for 12 weeks.All patients were followed up once4.weeks later after they received the last treatment.We evaluated each patient for 5 times:collected baseline data at the first day of treatment.Collected data at the 4th week,8th week,12th week and 16th week since recruit.ResultsAll patients were relieved in the onset days,degree and life qualities.Patients received Lai's Tong-Yuan therapy or flunarizine benefited more than those received sham acupuncture.Patients received Lai's Tong-Yuan therapy versus sham acupuncture:migraine onset days of patients received Lai's Tong-Yuan therapy were less than those received sham acupuncture at 4th week,8th week and 16th week(P<0.05).Patients received Lai' s Tong-Yuan therapy started feeling milder pain than those received sham acupuncture since 8th week,and lasted to 16th week,which showed significant difference.Patients received Lai's Tong-Yuan therapy reached better score in life quality scale HIT-6 than those received sham acupuncture since 8th week,and lasted to 16th week,which showed significant difference(P<0.05).Patients received Lai's Tong-Yuan therapy versus flunarizine:migraine onset days of patients received Lai' s Tong-Yuan therapy were less than those received flunarizine since 4th week(P<0.05).However,effect of flunarizine started rising since 8th week and showed no significant difference with Lai' s Tong-Yuan therapy.migraine onset days of patients received Lai's Tong-Yuan therapy were less than those received flunarizine since 12th week till 16th week,which showed significant difference(P<0.05).Patients received flunarizine were unsteady during follow up,however,patients received Lai' s Tong-Yuan therapy were still improved than before,which showed significant difference(P<0.05),indicated that Lai' s Tong-Yuan therapy is good at reducing migraine onset days and keeping it stable.When evaluated pain degree in migraine,Lai' s Tong-Yuan therapy and flunarizine can both reducing pain mildly.Since 4th week of treatment till 12th week,Lai' s Tong-Yuan therapy and Sham acupuncture has no significant difference in reducing migraine pain.During follow up,patients receivedLai' s Tong-Yuan therapy has milder migraine pain than those who received flunarizine,indicated that Lai's Tong-Yuan therapy is good at reducing migraine pain and keeping it stable.When evaluated life quality by scale HIT-6,patients received Lai's Tong-Yuan therapy reached better score in life quality scale HIT-6 than those received sham acupuncture since 4th week,and lasted to 16th week,which showed significant difference(P<0.05),indicated Lai' s Tong-Yuan therapy is good at improving life quality of patients with migraine without aura with excessive rising of Liver-Yang and keeping it stable.Adverse events:There were 7 cases of adverse events in this study,including 1 patient fainted when receiving Lai's Tong-Yuan therapy once,6 cases of adverse events when taking flunarizine,including 1 case of tremor,2 cases of depression,3 cases of drowsiness and mental fatigue.There was significant difference between Lai's Tong-Yuan therapy and flunarizine(P<0.05),suggesting that the safety of Lai' s Tong-Yuan therapy is higher than flunarizine.In summary,Lai's Tong-Yuan therapy shows advantages in safety,both short-term and long-term efficacy,and deserves promotion in treating migraine without aura with excessive rising of Liver-Yang.