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Review
. 2021 Oct 11:12:742978.
doi: 10.3389/fphar.2021.742978. eCollection 2021.

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

Pengqi Li  1   2 , Qiqi Xin  1   2 , Jiaqi Hui  1   2 , Rong Yuan  1   2 , Ya Wang  1   2 , Yu Miao  1   2 , Simon Ming-Yuen Lee  3 , Sean X Leng  4 , Weihong Cong  1   2 ; BPNMI Consortium
Affiliations
Review

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

Pengqi Li et al. Front Pharmacol. .

Abstract

Tongxinluo capsule (TXLC) is a commonly used Chinese medicine for unstable angina pectoris (UA). This article aimed 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 each randomized controlled trial (RCT) by the Cochrane Risk of Bias tool. Sensitivity analyses were conducted for testing the stability of the results, and the Begg and Egger tests were performed for any potential publication bias. After eligibility assessment, 42 RCTs with a total of 5,421 participants were included. Evidence showed that TXLC reduced the rate of cardiovascular events [RR = 0.29, 95% CI (0.19, 0.45), p < 0.00001, I 2 = 0%] {including cardiovascular mortality [RR = 0.16, 95% CI (0.03, 0.88), p = 0.03, I 2 = 20%], the incidence of acute myocardial infarction [RR = 0.27, 95% CI (0.13, 0.57), p = 0.0006, I 2 = 0%] and the occurrence of revascularization [RR = 0.28, 95% CI (0.15,0.54), p = 0.0001, I 2 = 0%]}, all-cause mortality [RR = 0.25, 95% CI (0.06, 0.99), p = 0.05, I 2 = 19%], recurrence of angina [RR = 0.25, 95% CI (0.11, 0.61), p = 0.002, I 2 = 0%], the number of ST-segment depression [MD = -0.45, 95% CI (-0.69, -0.20), p = 0.0005, I 2 = 0%], the summation of ST-segment depression [MD = -0.70, 95% CI (-1.08, -0.32), p = 0.0003, I 2 = 70%] and the hypersensitive C-reactive protein level [MD = -2.86, 95% CI (-3.73, -1.99), p < 0.00001, I 2 = 86%], increased the nitric oxide level [MD = 11.67, 95% CI (8.33, 15.02), p < 0.00001, I 2 = 33%], improved the electrocardiogram change [RR = 1.23, 95% CI (1.16, 1.30), p < 0.00001, I 2 = 0%] and the clinical efficacy in UA [RR = 1.26, 95% CI (1.21, 1.32), p < 0.00001, I 2 = 24%], and relieved the symptoms of angina pectoris {including chest pain or tightness [RR = 1.13, 95% CI (0.97, 1.32), p = 0.12, I 2 = 30%], palpitations [RR = 1.47, 95% CI (1.18, 1.84), p = 0.0007, I 2 = 0%], shortness of breath [RR = 1.53, 95% CI (1.24, 1.88), p < 0.0001, I 2 = 0%], and asthenia [RR = 1.69, 95% CI (0.83, 3.43), p = 0.15, I 2 = 90%]}. The most common adverse effect was gastrointestinal symptoms which could be relieved and 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 and further verified by large-scale and high-quality RCTs. Systematic Review Registration: www.crd.york.ac.uk/PROSPERO/, identifier CRD42021232771.

Keywords: Chinese medicine; Tongxinluo capsule; efficacy; meta-analysis; safety; systematic review; unstable angina pectoris.

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Conflict of interest statement

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.

Figures

FIGURE 1
FIGURE 1
Flow chart of literature search.
FIGURE 2
FIGURE 2
Risk of bias graph.
FIGURE 3
FIGURE 3
Risk of bias summary.
FIGURE 4
FIGURE 4
Meta-analysis of the rate of cardiovascular events (including cardiovascular mortality incidence of AMI, and incidence of revascularization) using TXLC Plus CT vs. CT.
FIGURE 5
FIGURE 5
Meta-analysis of the all-cause mortality using TXLC Plus CT vs. CT.
FIGURE 6
FIGURE 6
Meta-analysis of recurrence of angina using TXLC Plus CT vs. CT.
FIGURE 7
FIGURE 7
Meta-analysis of NST using TXLC Plus CT vs. CT.
FIGURE 8
FIGURE 8
Meta-analysis of ∑ST using TXLC Plus CT vs. CT.
FIGURE 9
FIGURE 9
Meta-analysis of ECG improvement using TXLC Plus CT vs. CT.
FIGURE 10
FIGURE 10
Meta-analysis of the clinical efficacy in UA using TXLC Plus CT vs. CT.
FIGURE 11
FIGURE 11
Meta-analysis of symptom improvement (including chest pain or tightness, palpitation, shortness of breath, asthenia) using TXLC Plus CT vs. CT.
FIGURE 12
FIGURE 12
Meta-analysis of hs-CRP level using TXLC Plus CT vs. CT.
FIGURE 13
FIGURE 13
Meta-analysis of NO level using TXLC Plus CT vs. CT.
FIGURE 14
FIGURE 14
Funnel plot, Begg’s funnel plot and Egger’s publication bias plot of the ECG improvement.
FIGURE 15
FIGURE 15
Funnel plot, Begg’s funnel plot and Egger’s publication bias plot of the clinical efficacy in UA.
See this image and copyright information in PMC

References

    1. Begg C. B., Mazumdar M. (1994). Operating Characteristics of a Rank Correlation Test for Publication Bias. Biometrics. 50, 1088–1101. 10.2307/2533446 - DOI - PubMed
    1. Cai Z. L., Li M. F. (2010). Tongxinluo Capsule in Treating 61 Cases of Unstable Angina Pectoris. Chin. Forgn. Med. 29, 107. 10.3969/j.issn.1674-0742.2010.33.081 - DOI
    1. Cannon C. P., Battler A., Brindis R. G., Cox J. L., Ellis S. G., Every N. R., et al. (2001). American College of Cardiology Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes. A Report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J. Am. Coll. Cardiol. 38, 2114–2130. 10.1016/s0735-1097(01)01702-8 - DOI - PubMed
    1. Chang G. D., Chen Y. W., Xu X. S., Wang Y. (2018). Study on the Efficacy and Mechanism of Tongxinluo Capsule in the Treatment of Coronary Heart Disease. Chin. J. Evid. Bas. Cardiol. Med. 10, 729–732. 10.3969/j.issn.1674-4055.2018.06.24 - DOI
    1. Chang S. F., Zhao M. (2004). Clinical Observation on Treatment of 68 Cases of Unstable Angina With Tongxinluo Capsule. Mod. J. Int. Tradit. Chin. West. Med. 13, 189. 10.3969/j.issn.1008-8849.2004.02.040 - DOI