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Objective:To observe the clinical efficacy of Yiqiyangxin Chinese medicine compound combined with cognitive therapy on generalized anxiety disorders. Methods: A total of 202 generalized anxiety disorders patients were randomly allocated to a control condition (Paroxetine combined with cognitive therapy) or a treatment condition (Yiqiyangxin Chinese medicine compound combined with cognitive therapy). Subsequently, scores of Hamilton Anxiety Scale (HAMA), Zung Self-rating Anxiety Scale (SAS) and blood routine, urine routine, liver function, renal function, electrocardiogram were detected before treatment, 3 months, 6 months after treatment and 6 months after medicine withdrawal, respectively. Results: HAMA and SAS scores were significantly reduced in two groups (P<0.001) after treatment, but the differences in HAMA and SAS scores, apparent effect and effectiveness were not significant (P>0.05). HAMA and SAS scores were significantly increased in two groups (P<0.05) after medicine withdrawal, and there were significant differences in HAMA and SAS scores, recurrent disease and adverse reaction (P<0.001). The incidence of recurrent disease and adverse reaction in treatment group was low. Both two groups showed no apparent abnormality in blood routine, urine routine, liver and renal function, and electrocardiogram. Conclusions: Yiqiyangxin Chinese medicine compound combined with cognitive therapy can significantly reduce the recurrence after medicine withdrawal and is effective on generalized anxiety disorders. Furthermore, the incidence of adverse reactions is low. The treatment program is worthy clinic application in the further.