AUTHOR=Li Pengqi , Xin Qiqi , Hui Jiaqi , Yuan Rong , Wang Ya , Miao Yu , Lee Simon Ming-Yuen , Leng Sean X. , Cong Weihong ,  BPNMI Consortium 

TITLE=Efficacy and Safety of Tongxinluo Capsule as Adjunctive Treatment for Unstable Angina Pectoris: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 12 - 2021

YEAR=2021

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.742978

DOI=10.3389/fphar.2021.742978

ISSN=1663-9812

ABSTRACT=Tongxinluo capsule (TXLC) is a commonly used Chinese medicine for unstable angina pectoris (UA). This manuscript aims to clarify the safety and efficacy of TXLC as an adjunctive treatment for UA.Two reviewers searched 7 databases from inception to August 2021, and performed literature screening and information extraction independently. The meta-analysis was implemented after evaluating the methodological quality of RCTs by the Cochrane bias risk assessment tool. Sensitivity analyses were conducted for testing the stability of the results, and the Begg and Egger tests were performed to any potential publication bias. After eligibility assessment, 42 RCTs with a total of 5421 participants were included. Evidence showed that TXLC reduced the rate of cardiovascular events [RR=0.29, 95% CI (0.19, 0.45), I2=0%] (including composite cardiovascular mortality [RR=0.16, 95% CI (0.03, 0.88), I2=20%], the incidence of acute myocardial infarction (AMI) [RR=0.27, 95% CI (0.13, 0.57), I2=0%] and the occurrence of revascularization [RR=0.28, 95% CI (0.15,0.54), I2=0%]), all-cause mortality[RR=0.25, 95% CI (0.06, 0.99), P=0.05, I2= 19%], recurrence of angina [RR=0.25, 95% CI (0.11, 0.61), P=0.002, I2= 0%], the number of ST-segment depression (NST) [MD=-0.45, 95% CI (-0.69, -0.20), P=0.0005, I2 = 0%], the total values of ST-segment depression (∑ST) [MD=-0.70, 95% CI (-1.08, -0.32), P=0.0003, I2=70%] and the level of hypersensitive C-reactive protein (hs-CRP) [MD=-2.86, 95% CI (-3.73, -1.99), I2=86%], increased serum nitric oxide (NO) concentration [MD=11.67, 95% CI (8.33, 15.02), I2=33%], improved the electrocardiogram (ECG) abnormalities [RR=1.23, 95% CI (1.16, 1.30), I2=0%], and relieved the symptoms of angina pectoris (including chest pain or tightness [RR=1.13, 95% CI (0.97, 1.32), I2=30%], palpitations [RR=1.47, 95% CI (1.18, 1.84), I2=0%], shortness of breath [RR=1.53, 95% CI (1.24, 1.88), I2=0%], and asthenia [RR=1.69, 95% CI (0.83, 3.43), I2=90%]). The most common adverse effect were gastrointestinal symptoms which could be eliminated through dose reduction, medication time adjustment and symptomatic remedy. Collectively, TXLC was effective and considerably safe for UA. However, due to the unavoidable risk of bias, these results must be interpreted with caution. We look forward to large-scale, high-quality RCTs to update and verify the results in future.