OBJECTIVE: To observe the efficacy and safety of amlodipine besylate combined with Xinkeshu in the treatment of hypertension. METHODS: 100 patients with hypertension were randomly divided into control group (50 cases) and observation group(50 cases). Control group was orally given one Amlodipine besylate tablet, once a day; observation group was additionally given 4 Xinkeshu tablets, 3 times a day. The treatment course was 8 weeks. Clinical efficacy, systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after treatment in 2 groups were observed, the incidence of adverse reactions was recorded. RESULTS: The total effective rate in observation group was significantly higher than control group, the incidence of adverse reactions was significantly lower than control group, the differences were statistically significant (P<0.05). Before treatment, there were no significant differences in the SBP and DBP between 2 groups (P>0.05). After treatment, the SBP and DBP in 2 groups were significantly lower than before, the differences were statistically significant (P<0.05); but there was no significant difference between 2 groups (P>0.05). CONCLUSIONS: The efficacy of amlodipine besylate combined with Xinkeshu is superior to amlodipine besylate alone in the treatment of hypertension, with better safety.