The effects of qishen granules for patients with chronic heart failure: A multicenter randomized double-blind placebo-controlled trial.

Despite advancements in chronic heart failure (CHF) treatment, the effect often remains unsatisfactory and unstable. More effective therapies are needed. Qishen granules (QSG) are a novel Chinese botanical drug effective in treating CHF in animal models, but clinical evidence remains inadequate. This study aims to evaluate the effects of QSG on patients with CHF. We enrolled CHF patients in this 12-week, randomized, double-blind, placebo-controlled trial and randomly assigned them to the QSG (twice a day, 6.8 g granules at once) or placebo group. The primary endpoint was a change in the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level after treatment. The secondary outcome consists of the New York Heart Association (NYHA) functional classification, 6-min walking distance (6MWD), TCM syndrome integral scale, quality of life, and echocardiographic index. A total of 191 patients completed the 12-week follow-up period, with 94 in the QSG group and 97 in the placebo group. The Qishen granules group demonstrated a considerably greater reduction in NT-proBNP than the placebo group (50% vs 32% for QSG vs placebo, respectively; = 0.011). Patients who received QSG performed better in the NYHA functional rank, 6MWD, TCM syndrome integral scale, and quality of life ( < 0.05). The QSG group performed better in HFrEF patients regarding the efficiency of NT-proBNP. There was no statistical significance in the change in evaluated safety parameters, such as blood routine and biochemistry. Based on standard treatment, Qishen granules further reduced the levels of NT-proBNP when compared with placebo. Together with other outcomes, our findings suggest that QSG could be used in combination therapy for CHF. : www.clinicaltrials.gov, identifier NCT03027375. Registered 9 October 2017.