Abstract
Objective The study aimed to evaluate the efficacy and safety of Bushenjiangya-optimized (BSJYO) granule on left ventricular diastolic dysfunction (LVDD) in hypertensive (HTN) patients. Methods 120 patients diagnosed with HTN plus LVDD were randomly assigned to the BSJYO granule group and placebo group, and all patients received basal western medicine (WM) treatment. After eight weeks of treatment, we evaluated echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events. Major adverse cardiovascular events (MACEs) were collected at 6-month follow-up. Results Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P < 0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P < 0.01). There were no differences between treatment groups in kidney and liver function, early adverse events, or MACE. Conclusion BSJYO granule plus basal WM is an effective and safe therapy for HTN patients with LVDD.
Highlights
Left ventricular diastolic dysfunction (LVDD) is characterized by abnormalities in left ventricular filling, including decreased diastolic distensibility and impaired relaxation, and it may represent an important pathophysiologic link between hypertension (HTN) and heart failure (HF), in patients who have heart failure with normal or preserved ejection fraction (HFpEF) [1]
Epidemiological evidence suggested the success of possible interventions: a mortality benefit has been observed in those whose LVDD improved compared with those whose LVDD remained the same or worsened [4]
From May 2014 to May 2016, 120 patients aged 18 to 80 years were enrolled in this study and were randomly assigned to receive BSJYO granule plus basal western medicine (WM) or the placebo plus basal WM treatment. e baseline characteristics of the patients are shown in Table 1. e two groups were comparable with respect to demographic characteristics, blood pressure, blood pressure load, and indexes of echocardiography. 16 out of 120 were excluded from data analysis because of failing to follow up or finishing the treatment (Figure 1)
Summary
Left ventricular diastolic dysfunction (LVDD) is characterized by abnormalities in left ventricular filling, including decreased diastolic distensibility and impaired relaxation, and it may represent an important pathophysiologic link between hypertension (HTN) and heart failure (HF), in patients who have heart failure with normal or preserved ejection fraction (HFpEF) [1]. In a more recent prospective cohort study, a history of HTN was present in 76% of patients with DD. In this cohort, HTN was found to be an independent predictor of the transition from DD to symptomatic HF [3]. Given the true paucity of LVDD-specific treatment trials and that LVDD can progress to HFpEF, current treatments mainly focus on the LVDD of HFpEF. Many studies, such as the Heart Outcomes Prevention Evaluation (HOPE) study [5] and the Antihypertensive and Lipid-Lowering Treatment to Prevent
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