Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial

• Published in: Chinese journal of integrative medicine 2024-11
• Main Authors: Wang, Fan, Gao, Hai-Qing, Lyu, Zhe, Wang, Xiao-Ming, Han, Hui, Wang, Yong-Xia, Lu, Feng, Dong, Bo, Pu, Jun, Liu, Feng, Zu, Xiu-Guang, Liu, Hong-Bin, Yang, Li, Zhang, Shao-Ying, Yan, Yong-Mei, Wang, Xiao-Li, Chen, Jin-Han, Liu, Min, Yang, Yun-Mei, Li, Xiao-Ying
• Format: Article
• Language: English
• ISSN: 1672-0415; 1993-0402; 1993-0402
• DOI: 10.1007/s11655-024-4001-4

To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P