QiShen YiQi dripping pills combined with basic therapy significantly improved 6-minute walk distance compared to basic therapy alone (difference 20.38 meters; 95% CI 1.74-39.02; P=0.035).
RCT (n=84)
Open-label, evaluator-blinded
Randomized
Does the addition of QiShen YiQi dripping pills to standard therapy improve 6-minute walk distance in elderly patients with HFpEF?
The addition of QiShen YiQi dripping pills to standard therapy may improve exercise tolerance and physical function in elderly patients with HFpEF over 12 weeks.
Estimación del efecto: Difference 20.38 meters (95% CI 1.74-39.02)
valor p: p=0.035
Objective: Decreased exercise tolerance and impaired physical function in elderly patients with heart failure with preserved ejection fraction (HFpEF) are key issues affecting the quality of life, with limited enhancement from available treatments. QiShen YiQi (QSYQ) dripping pills have the effect of benefiting qi and activating blood. The aim of this study was to investigate its effects on the improvement of exercise tolerance, physical function and cardiac function in elderly patients with HFpEF. Methods: This study is an open-label, evaluator-blinded randomized controlled trial., which included 84 elderly HFpEF patients ≥ 65 years old from January 2023 to March 2025, and randomly divided into a control group (42 patients) and a treatment group (42 patients). The control group was treated with basic HFpEF therapy (following the 2022 ESC and 2023 Chinese Heart Failure Guidelines), and the treatment group was treated with QSYQ dropping pills (0.5 g/trip, 3 times daily for 12 weeks) in combination with basic therapy. The primary endpoint was 6-minute walk distance (6MWD) at 12 weeks, and secondary endpoints included physical function indices (4-meter walking speed, grip strength, SPPB total score, etc.), quality of life score (KCCQ, etc.), laboratory index (NT-proBNP), and echocardiographic parameters (LVEF, LAVI, etc.). Results: The baseline characteristics of the two groups were comparable (P > 0.05). After 12 weeks of treatment, 6MWD increased significantly in the treatment group compared with the control group (difference between groups: 20.38 meters, 95% CI 1.74-39.02, P = 0.035), and showed a trend of continuous improvement with the duration of treatment (baseline vs 12 weeks, P = 0.010). Among the secondary endpoints, the treatment group showed significantly better improvement in SPPB total score (P < 0.001), KCCQ score (P < 0.001), and LAVI (P = 0.039) than the control group, and there was a trend of decreasing NT-proBNP, but the difference was not statistically significant between the groups (P = 0.096). After adjusting for confounders, the improvement of 6MWD in the treatment group was still significantly better than that in the control group (P = 0.035). Conclusion: The combination of QSYQ dripping pills with standard therapy may yield limited improvements in exercise tolerance, physical function, and quality of life for elderly patients with HFpEF, and may potentially mitigate left atrial remodeling. However, given the sample size and design limitations of this study, these findings are exploratory. Their precise clinical value and long-term safety require validation through further large-scale studies.
Li et al. (Mon,) conducted a rct in Heart failure with preserved ejection fraction (HFpEF) (n=84). QiShen YiQi (QSYQ) dripping pills vs. Basic HFpEF therapy was evaluated on 6-minute walk distance (6MWD) at 12 weeks (Difference 20.38 meters, 95% CI 1.74-39.02, p=0.035). QiShen YiQi dripping pills combined with basic therapy significantly improved 6-minute walk distance compared to basic therapy alone (difference 20.38 meters; 95% CI 1.74-39.02; P=0.035).