Background: Qishentaohong Granule (QSG) is a traditional Chinese medicine (TCM) prescription for the treatment of chronic heart failure (CHF). The objective is to confirm the improvement of QSG on cardiac function and quality of life (QOL) in patients with CHF.
Methods: This is a single-center, prospective, randomized controlled clinical trial. Seventy-six patients (forty-four male and twenty-six female) from 27 to 84 years old with diagnosed CHF New York Heart Association (NYHA) classⅡ or Ⅲ in stage C were enrolled and randomly assigned in a 1:1 ratio to receive the QSG (9 g, twice daily) or trimetazidine (TMZ) (10 mg, thrice daily) in addition to their standard medications for the treatment of CHF. The study period was 4 weeks. The primary outcomes (cardiac function and QOL) and secondary outcomes were measured at the baseline and end of the trial.
Results: Thirty-five patients completed the study in each group. At the 4-week follow-up, the efective rate in NYHA classification in the QSG group was better than that in the TMZ group (74.29% vs. 54.29%, P < 0.05). Chronic heart failure integrated traditional Chinese and Western medicine survival scale (CHFQLS) scores were improved by 13.82 ± 6.04 vs. 7.49 ± 2.28 in the QSG and TMZ groups respectively (P < 0.05). Subgroup analysis of the CHFQLS results showed that physiological function, role limitation and vitality were significantly higher in the QSG group (15.76 ± 7.85 vs. 7.40 ± 3.36, P < 0.05; 16.00 ± 8.35 vs. 10.53 ± 4.64, P < 0.05; 15.31 ± 8.09 vs. 7.89 ± 4.60, P < 0.05). Treatment with QSG also demonstrated superior performance in comparison to the TMZ with respect to 6-minute walking test (6MWT), TCM syndrome, shortness of breath, fatigue, gasp, general edema and the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level. No significant adverse reactions (ARs) and adverse cardiac events (ACEs) occurred during treatment in either group.
Conclusion: In addition to conventional treatments, QSG as an adjuvant therapy significantly improved cardiac function and QOL in patients with CHF class Ⅱ or Ⅲ in stage C.
Trial registration: This trial is registered with ChiCTR, No. ChiCTR-TRC-12002857. Registered March 21, 2019. (retrospectively registered)