Objective: To observe the clinical efficacy and safety of Tianning decoction in the treatment of migraine with Yin defieiency and Yang hyperativity syndrome. Method: Altogether 64 eligible migraine patients with Yin defieiency and Yang hyperativity syndrome were randomly divided into the treatment group (Tianning decoction group) and the control group (Flunarizine group). Each group included 32 patients and continuously treated for 8 weeks. The clinical efficacy was evaluated on the basis of the headache index score and the change in the traditional Chinese medicine (TCM) syndrome score. Result: After the treatment

the total effective rate of the treatment group was 93.8%

and that of the control group was 84.3%

indicating an obvious superiority between them (P<0.05). The intra-group comparison in the headache attack frequency and headache days score between the two groups before and after the treatment showed differences with statistical significance (P<0.05

P<0.01). After 8 weeks of the treatment

the inter-group comparison in scores between the two groups showed statistical significance (P<0.05). The inter-group comparison in the headache score between the two groups before and after the treatment decreased to varying degrees (P<0.05

P<0.01)

with an obvious superiority in the treatment group to the control group (P<0.05). The TCM symptom score of the treatment group was significantly lower than that of the control group after the treatment (P<0.05).The score of the control group also decreased

but with no statistical significance. The inter-group comparison showed a superiority in the treatment group to the control group after the treatment (P<0.05). The accompanying symptoms (nausea

vomiting

photophobia

tears) were relieved in both groups after the treatment

with statistical significance in difference (P<0.05

P<0.01).And the treatment group was superior to the control group in some accompanying symptoms (P<0.05). Conclusion: The clinical efficacy of Tianning decoction is obviously superior to western medicine Flunarizine

and so can be used as a safe and effective drug for migraine.