PMID- 33360345 OWN - NLM STAT- MEDLINE DCOM- 20210224 LR - 20210224 IS - 1618-095X (Electronic) IS - 0944-7113 (Linking) VI - 81 DP - 2021 Jan TI - Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial. PG - 153419 LID - S0944-7113(20)30250-6 [pii] LID - 10.1016/j.phymed.2020.153419 [doi] AB - BACKGROUND: Salvia Miltiorrhiza Depside Salt (SMDS) was extracted from Salvia miltiorrhiza with high-quality control of active principles. In 2005, China's FDA approved the use of SMDS for stable angina pectoris (SAP), but the evidence of SMDS combined with aspirin remains unclear. PURPOSE: The aim of this study was to assess the clinical effectiveness and safety of SMDS combined with aspirin in patients with SAP. METHODS: A multicenter, pragmatic, three-armed parallel group and an individually randomized controlled superiority trial was designed. Participants aged 35 to 75 years old with SAP were recruited from four "Class Ⅲ Grade A" hospitals in China. Participants who were randomized into the SMDS group were treated with SMDS by intravenous drip. Participants in the control group received aspirin enteric-coated tablets (aspirin). Participants who were randomly assigned to the combination group received SMDS combined with aspirin. All participants received standard care from clinicians, without any restrictions. The primary outcome measure was thromboelastography (TEG). Secondary outcome measures included symptom score of the Seattle Angina Questionnaire (SAQ), visual analogue scale (VAS) score of traditional Chinese medicine (TCM) symptoms, platelet aggregation measured by light transmittance aggregometry (LTA), and fasting blood glucose. Effectiveness evaluation data were collected at baseline and ten days after treatment. Researchers followed up with participants for one month after treatment to determine whether adverse events (AEs) or adverse drug reactions (ADRs) such as bleeding tendency occurred. All statistical calculations were carried out with R 3.5.3 statistical analysis software. RESULTS: A total of 135 participants completed follow-up data on the primary outcome after ten days of treatment. Participants in the SMDS combined aspirin group had the highest improvement rate of sensitivity in AA% [p < 0.001, 95% CI (0.00-0.00)], from 30.6% before treatment to 81.6% after treatment. Participants with drug resistance (AA% < 20%) in the SMDS combined with aspirin group also had the highest sensitivity rate [p < 0.001, 95% CI (0.00-0.00)] after treatment (accounting for 81.0% of the combination group and 60.7% of the sensitive participants). The improvement of TCM symptoms in participants treated with SMDS combined with aspirin was significantly better than that of the aspirin group [MD = 1.71, 95% CI (0.15-3.27), p = 0.032]. There were no significant differences in other indexes (R, TPI, MA, K, CI, alpha value) of TEG, SAQ, platelet aggregation and fasting blood glucose among the three groups. No bleeding tendency or ADRs occurred in all participants. CONCLUSION: SMDS combined with aspirin is a clinically effective and safe intervention to treat adults aged 35 and older with SAP. This trial shows that SMDS combined with aspirin can significantly improve the sensitivity rate of AA% in TEG and the VAS score of TCM symptoms. Further large samples and high-quality research are needed to determine if certain participants might benefit more from SMDS combined with aspirin. The study protocol was registered in the Clinical Trials USA registry (registration No. NCT02694848). CI - Copyright (c) 2020. Published by Elsevier GmbH. FAU - Lyu, Jian AU - Lyu J AD - Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Inner Dongzhimen, Beijing 100700, China. FAU - Xue, Mei AU - Xue M AD - XiYuan Hospital, China Academy of Chinese Medical Sciences, No.1 Xiyuan playground Road, Haidian District, Beijing 100091, China. FAU - Li, Jun AU - Li J AD - Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.5, North Line Pavilion, Xicheng District, Beijing 100053, China. FAU - Lyu, Weihui AU - Lyu W AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, No.111 Dade Road, Yuexiu District, Guangzhou 510120, China. FAU - Wen, Zehuai AU - Wen Z AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, No.111 Dade Road, Yuexiu District, Guangzhou 510120, China. FAU - Yao, Ping AU - Yao P AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, No.111 Dade Road, Yuexiu District, Guangzhou 510120, China. FAU - Li, Junxia AU - Li J AD - General Hospital of Beijing PLA Military Region, No.5, Nan men Cang, Dongsishitiao, Dongcheng District, Beijing 100700, China. FAU - Zhang, Yanling AU - Zhang Y AD - General Hospital of Beijing PLA Military Region, No.5, Nan men Cang, Dongsishitiao, Dongcheng District, Beijing 100700, China. FAU - Gong, Yumiao AU - Gong Y AD - General Hospital of Beijing PLA Military Region, No.5, Nan men Cang, Dongsishitiao, Dongcheng District, Beijing 100700, China. FAU - Xie, Yanming AU - Xie Y AD - Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Inner Dongzhimen, Beijing 100700, China. Electronic address: ktzu2018@163.com. FAU - Chen, Keji AU - Chen K AD - XiYuan Hospital, China Academy of Chinese Medical Sciences, No.1 Xiyuan playground Road, Haidian District, Beijing 100091, China. Electronic address: kjchenvip@163.com. FAU - Wang, Lianxin AU - Wang L AD - Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Inner Dongzhimen, Beijing 100700, China. Electronic address: wlxing@126.com. FAU - Chai, Yan AU - Chai Y AD - Department of Epidemiology, University of California-Los Angeles, 405 Hilgard Avenue, California 90095, USA. Electronic address: chaiyanhi@hotmail.com. LA - eng SI - ClinicalTrials.gov/NCT02694848 PT - Journal Article PT - Multicenter Study PT - Pragmatic Clinical Trial PT - Randomized Controlled Trial DEP - 20201210 PL - Germany TA - Phytomedicine JT - Phytomedicine : international journal of phytotherapy and phytopharmacology JID - 9438794 RN - 0 (Cardiovascular Agents) RN - 0 (Depsides) RN - 0 (Drugs, Chinese Herbal) RN - AYI8EX34EU (Creatinine) RN - R16CO5Y76E (Aspirin) SB - IM MH - Aged MH - Angina, Stable/*drug therapy/etiology MH - Aspirin/adverse effects/*therapeutic use MH - Cardiovascular Agents/adverse effects/*therapeutic use MH - Creatinine/blood MH - Depsides/therapeutic use MH - Drug Therapy, Combination MH - Drugs, Chinese Herbal/adverse effects/chemistry/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Salvia miltiorrhiza/*chemistry MH - Thrombelastography MH - Treatment Outcome OTO - NOTNLM OT - Effectiveness and safety OT - Randomized controlled trial OT - Salvia miltiorrhiza depside salt OT - Stable angina pectoris OT - Traditional Chinese medicine EDAT- 2020/12/29 06:00 MHDA- 2021/02/25 06:00 CRDT- 2020/12/28 11:12 PHST- 2020/09/18 00:00 [received] PHST- 2020/11/12 00:00 [revised] PHST- 2020/11/19 00:00 [accepted] PHST- 2020/12/29 06:00 [pubmed] PHST- 2021/02/25 06:00 [medline] PHST- 2020/12/28 11:12 [entrez] AID - S0944-7113(20)30250-6 [pii] AID - 10.1016/j.phymed.2020.153419 [doi] PST - ppublish SO - Phytomedicine. 2021 Jan;81:153419. doi: 10.1016/j.phymed.2020.153419. Epub 2020 Dec 10.