Efficacy and safety of a traditional Chinese herbal formula Xuefu Zhuyu prescription for hypertension: A meta-analysis of randomized controlled trials

Background: Hypertension is a major risk factor for cardiovascular disease, kidney disease, and stroke. Xuefu Zhuyu decoction (Xuefu Zhuyu prescription [XZP]) is a classic Chinese medicine prescription, which has been widely used in headache, vertigo, hypertension, and so on. This meta-analysis aimed at evaluating the efficacy and safety of XZP for hypertension and related risk diseases of hypertension, especially cardiovascular disease, with sufficient evidence. Methods: A comprehensive literature search was performed in 7 electronic databases from their establishment up to April 7, 2022, to examine the therapeutic effect and safety of XZP for hypertension. The primary outcome included systolic blood pressure (BP), diastolic BP, categorical BP, traditional Chinese medicine syndrome integral, and traditional Chinese medicine syndrome effect. The secondary outcomes were defined as vascular endothelial function, ventricular remodeling, and blood lipids. Poor prognosis included stroke, heart failure, and so on. Continuous variables were analyzed using mean difference and 95% confidence intervals. Relative risk and 95% confidence interval were used for dichotomous data. The data were pooled and analyzed by RevMan5.4. Results: A total of 37 studies with 3391 hypertensive patients were included for meta-analysis. All studies compared XZP and antihypertensive or lipid-lowering drugs with conventional treatment used alone. Overall, 25 studies demonstrated that XZP substantially reduced BP compared with the control group (P < .00001). A total of 11 studies showed that XZP significantly improved symptoms in patients with hypertension (P < .00001). Meanwhile, this result indicated that XZP has good effects on lowering blood lipids, improving vascular endothelial function, ventricular remodeling, and carotid intima-media thickness, so it can reverse the damage of hypertensive target organs and reduce the incidence of related risk diseases (P < .05). Encouragingly, the incidences of adverse reactions and adverse outcomes were also lower than with conventional treatment. The Z curves for the key outcome indicators cross the traditional thresholds and the trial sequential analysis boundaries, indicating that the conclusions are reliable. Conclusion: XZP shows good clinical efficacy in simultaneously reducing BP, protecting the cardiovascular system, and preventing related risk diseases of hypertension. XZP may provide a multiefficacy therapeutic method in the prevention and treatment of hypertension and its associated risk factors.