Efficacy of the traditional Chinese medicine NAOAN capsule for primary prevention of stroke in high-risk population

Objective To evaluate the efficacy of the traditional Chinese medicine NAOAN capsule in primary prevention of stroke in high-risk populations. Methods A multicenter, randomized controlled study was performed in community setting, involving 1 088 individuals at high risk of stroke, with cerebrovascular function scores<75 and 10-year Framingham stroke risk ≥ 6%. Subjects were recruited in communities at Beijing, Shanghai, Changsha, and Chengdu communities, through resident committees or the village unit. A total of 559 subjects were randomized into a group treated with the NAOAN capsule, and 529 subjects in an aspirin treatment group. Follow-up was performed every 2 months for 2 years. At the mid-point and end of the intervention, we compared cerebrovascular function differences between the 2 groups. Results During the 2-year community trial, 531 subjects in the NAOAN capsule group and 465 in the aspirin group followed the protocol. Cerebrovascular function scores increased from 45.2±19.7 at baseline to 61.7±26.5 after the 2-year trial (t=-12.931, P<0.001) in the NAOAN capsule group, and from 47.2±18.9 at baseline to 53.7±25.1 (t=-5.058, P<0.001) in the aspirin group; greater increases in cerebrovascular function scores were found in the NAOAN capsule group than that in the aspirin group (t=4.906, P<0.001). Conclusions Cerebrovascular function in individuals at high risk of stroke was improved by taking NAOAN capsule. Cerebrovascular function scores improved more with NAOAN capsules than with aspirin. Key words: Stroke; Community medicine; High-risk population; NAOAN capsule; Intervention management