PMID- 36618925 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230111 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 13 DP - 2022 TI - The effects of qishen granules for patients with chronic heart failure: A multicenter randomized double-blind placebo-controlled trial. PG - 1017734 LID - 10.3389/fphar.2022.1017734 [doi] LID - 1017734 AB - Background: 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. Objective: This study aims to evaluate the effects of QSG on patients with CHF. Methods: 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. Results: 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; p = 0.011). Patients who received QSG performed better in the NYHA functional rank, 6MWD, TCM syndrome integral scale, and quality of life (p < 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. Conclusion: 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. Clinical Trial Registration: www.clinicaltrials.gov, identifier NCT03027375. Registered 9 October 2017. CI - Copyright (c) 2022 Du, Liu, Tan, Huang, Wang, Zhao and Wang. FAU - Du, Kangjia AU - Du K AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. FAU - Liu, Junjie AU - Liu J AD - Department of Cardiology, Nanjing Pukou Hospital of Traditional Chinese Medicine, Nanjing, China. FAU - Tan, Nannan AU - Tan N AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. FAU - Huang, Xinyi AU - Huang X AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. FAU - Wang, Juan AU - Wang J AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. FAU - Zhao, Huihui AU - Zhao H AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. FAU - Wang, Wei AU - Wang W AD - Department of Chinese medicine, Beijing University of Chinese Medicine, Beijing, China. LA - eng SI - ClinicalTrials.gov/NCT03027375 PT - Journal Article DEP - 20221223 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC9822771 OTO - NOTNLM OT - NT-probnp OT - chronic heart failure OT - detoxification OT - qi shen granules OT - randomized controlled trial COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/01/10 06:00 MHDA- 2023/01/10 06:01 PMCR- 2022/12/23 CRDT- 2023/01/09 03:41 PHST- 2022/08/12 00:00 [received] PHST- 2022/12/08 00:00 [accepted] PHST- 2023/01/09 03:41 [entrez] PHST- 2023/01/10 06:00 [pubmed] PHST- 2023/01/10 06:01 [medline] PHST- 2022/12/23 00:00 [pmc-release] AID - 1017734 [pii] AID - 10.3389/fphar.2022.1017734 [doi] PST - epublish SO - Front Pharmacol. 2022 Dec 23;13:1017734. doi: 10.3389/fphar.2022.1017734. eCollection 2022.