OBJECTIVE: To evaluate the efficacy and safety of Yi’anning pills (益安宁丸) for the treatment of stable angina pectoris in coronary heart disease with Qi-blood deficiency syndrome and liver-kidney deficiency syndrome.

METHODS: This study was a multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial. Participants were randomly divided into the experimental group and the control group (3∶1) using the randomized block method. All participants received guideline-standardized treatment for stable angina pectoris associated with coronary heart disease, among whom the first 64 participants underwent the treadmill exercise test. The experimental group was also treated with Yi’anning pills and Xinyuan capsules (心元胶囊) simulant, while the control group received Yi’anning pills simulant and Xinyuan capsules, both for 8 weeks. The primary clinical outcome was the total Seattle Angina Questionnaire (SAQ) score, and the secondary clinical outcomes were the individual SAQ scores, treadmill exercise test results, rate of nitroglycerin cessation or reduction, classification of angina pectoris severity, and therapeutic effect against Traditional Chinese Medicine syndrome.

RESULTS: Overall, 158 participants were included from nine sub-centers, including 119 in the experimental group and 39 in the control group. After 8 weeks of treatment, the experimental intervention was superior to the control intervention in terms of the increase in total SAQ score (P <0.05). For the individual SAQ scores, the experimental intervention had an advantage over the control intervention in the reduction in physical activity limitation (P <0.05), the improvement in angina pectoris stability (P <0.05), and the frequency of angina pectoris attacks (P <0.05). Regarding the treadmill exercise test, the experimental intervention was superior to the control intervention for augmenting the maximum exercise heart rate (P > 0.05) and improving the angina-free rate after treatment (P > 0.05), but the differences were not statistically significant. The rate of nitroglycerin cessation or reduction was higher in the experimental group than in the control group (P <0.05). Regarding angina pectoris severity classification, the efficacy rate in the experimental group was higher than in the control group (P <0.05). Regarding the therapeutic effect against Traditional Chinese Medicine syndromes, the efficacy rates against Qi-blood deficiency syndrome and liver-kidney deficiency syndrome in the experimental group were both greater than those in the control group (both P <0.05). There was no statistically significant difference in adverse events between the two groups (P > 0.05).

CONCLUSION: Based on the standardized treatment of stable angina pectoris in coronary heart disease, Yi’anning pills outperformed Xinyuan capsules in terms of the total SAQ score, demonstrating a good clinical effect and safe application.