Efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction

Yang, Yan; Gao, Songtao; Fang, Qiuju; Zhu, Mei Ling

doi:10.1097/md.0000000000024246

“…Due to the inadequacy of the total sample size and the existence in some studies of a greater number of adverse reactions in the intervention group; however, we still need to be cautious about the outcome of the drug safety analysis. Nevertheless, it is encouraging to see that in recent years, a growing number of studies have shown the clinical safety of proprietary Chinese medicines [ 35 , 36 ].…”

Section: Resultsmentioning

confidence: 99%

Effect of Proprietary Chinese Medicine on Coronary Microvascular Dysfunction in Patients with Microvascular Angina: A Systematic Review and Meta‐Analysis

Yu

¹

,

Xu

²

,

Wang

³

et al. 2023

Evidence-Based Complementary and Alternative Medicine

2

0

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Background. Microvascular angina (MVA) has received increasing attention and interest in recent years, but there are still some shortcomings in the diagnosis and treatments at current stage. In recent years, several studies have confirmed the efficacy of proprietary Chinese medicines (PCMs) in improving MVA symptoms; however, there is no systematic review and meta-analysis to comprehensively assess the efficacy of PCMs in this area. Objective. Investigating the clinical efficacy of proprietary Chinese medicines for treating MVA and coronary microvascular function. Methods. We looked up articles from January 1, 2012, to the present from eight databases. Then, we screened the literature and followed the 2019 version 2 of Cochrane risk of bias tool for systematic review. The Stata/SE 15.0 software was used for the meta-analysis. Results. There are 21 studies, including 1,641 patients who were included in this review. According to the results, the combination of PCMs and conventional MVA treatment was able to further enhance clinical efficacy [RR = 1.28, 95% CI (1.20, 1.36), p < 0.001], prolong the time of duration on the treadmill exercise testing (TET) [SMD = 1.49, 95% CI (0.63, 2.36), p = 0.001] and improve levels of NO [SMD = −1.77 95% CI (−2.11, −1.43), p < 0.001]. At the same time, PCMs could also decrease the microvascular resistance index (IMR) [SMD = −1.79, 95% CI (−2.58, −1.00), p < 0.001)], serum level of hs-CRP [SMD = −1.21, 95% CI (−1.84, −0.58), p < 0.001] and ET-1 [SMD = −1.77 95% CI (−2.11, −1.43), p < 0.001]. Regards to medication safety, a total of 27 adverse events occurred, including 10 cases in the intervention group and 17 cases in the control group. Conclusion. The study suggests that the combination of PCMs and conventional MVA treatment enhances clinical efficacy and could better improve coronary microvascular function. In the future, we expect more high-quality, randomized, double-blind clinical studies to validate the safety, and efficacy of PCMs to provide valuable evidence-based medicine (EBM) for the treatment of MVA with PCMs.

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“…Nine RCTs [ 27 – 29 , 31 – 33 , 35 , 37 , 40 ] reporting a clinical efficacy rate were pooled. Among the subgroup analysis ( Figure 2 ), SBP plus RT showed a better clinical efficacy rate than RT alone (RR = 1.15, 95% CI [1.06, 1.25], p < 0.05) with low heterogeneity ( Q (6) = 8.17, p = 0.23, I 2 = 35.00%).…”

Section: Resultsmentioning

confidence: 99%

“…Seven RCTs [ 26 , 30 , 32 , 33 , 35 , 39 , 41 ] reported recurrent AMI, and nine RCTs [ 24 , 26 – 28 , 30 – 33 , 35 ] reported complication cases. SBP adjunctive to RT significantly reduced the AMI recurrent rate than RT alone (RR = 0.30, 95% CI [0.15, 0.59], p < 0.05; Q (4) = 1.45, p = 0.84, I 2 = 0, low heterogeneity), but SBP adjunctive to RT plus PCI did not present significant difference (RR = 0.64, 95% CI [0.20, 2.09], p > 0.05; Q (1) = 0.76, p = 0.38, I 2 = 0, low heterogeneity) ( Figure 6(a) ).…”

Section: Resultsmentioning

confidence: 99%

Shexiang Baoxin Pill for Acute Myocardial Infarction: Clinical Evidence and Molecular Mechanism of Antioxidative Stress

Guo

¹

,

Qin

²

,

He

³

et al. 2021

Oxidative Medicine and Cellular Longevity

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Acute myocardial infarction (AMI) has been a preclinical and clinical concern due to high hospitalization rate and mortality. This study was aimed at evaluating the effectiveness and safety of Shexiang Baoxin Pill (SBP) for AMI and exploring the possible mechanism of oxidative stress. Six databases were searched on March 26, 2021. Twenty-four studies were included and accessed by the RoB 2.0 or SYRCLE tool. Compared with routine treatment (RT), SBP showed the effectiveness in the clinical efficacy ( RR = 1.15 , 95% CI [1.06, 1.25]), left ventricular ejection fraction (LVEF) ( SMD = 0.73 , 95% CI [0.62, 0.95]), glutathione (GSH) ( SMD = 2.07 , 95% CI [1.51, 2.64]), superoxide dismutase (SOD) ( SMD = 0.92 , 95% CI [0.58, 1.26]), malondialdehyde (MDA) ( SMD = − 4.23 , 95% CI [-5.80, -2.66]), creatine kinase-myocardial band (CK-MB) ( SMD = − 4.98 , 95% CI [-5.64, -4.33]), cardiac troponin I (cTnI) ( SMD = − 2.17 , 95% CI [-2.57, -1.76]), high-sensitivity C-reactive protein (Hs-CRP) ( SMD = − 1.34 , 95% CI [-1.56, -1.12]), interleukin-6 (IL-6) ( SMD = − 0.99 , 95% CI [-1.26, -0.71]), triglycerides (TG) ( SMD = − 0.52 , 95% CI [-0.83, -0.22]), flow-mediated dilation (FMD) ( SMD = 1.39 , 95% CI [1.06, 1.72]), von Willebrand Factor (vWF) ( SMD = − 1.77 , 95% CI [-2.39, -1.15]), nitric oxide (NO) ( SMD = 0.89 , 95% CI [0.65, 1.13]), and recurrent rate ( RR = 0.30 , 95% CI [0.15, 0.59]). But SBP adjunctive to RT plus PCI had no improvements in almost pooled outcomes except for the Hs-CRP ( SMD = − 1.19 , 95% CI [-1.44, -0.94]) and TG ( SMD = − 0.25 , 95% CI [-0.48, -0.02]). Laboratory findings showed that SBP enhanced the endothelial nitric oxide synthase (eNOS) activity and regulated laboratory indexes especially for homocysteine. In conclusion, SBP has adjunctive effects on AMI via the mechanism of antioxidative stress. The current evidence supports the use of SBP for mild and moderate AMI patients.

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“…In this study, following screening more than 100 kinds of clinical commonly used Chinese medicines, Styrax is found with the most potent CYP3A4 inhibitory effect (almost completely inhibit CYP3A4 at 100 μg/ml). Considering that Styrax and Styrax-related herbal products are frequently used in combination with a panel of marketed cardiovascular drugs (such as warfarin, digoxin and simvastatin) to treat cardiovascular diseases ( Zhu, 2009 ; Tao et al, 2016 ; Yang et al, 2021 ). It is well-known that Styrax/Styrax-related herbal products are often taken orally for the treatment of human diseases, while a number of studies have reported that the local distribution of herbal constituents in the intestine is much higher than that in the liver ( Lai et al, 2009 ; Wang et al, 2018 ).…”

Section: Discussionmentioning

confidence: 99%

“…Notably, Styrax is often used as a key material for preparing some marketed herbal products (such as Suhexiang Pill, Shexiang Baoxin Pill, Subing Dropping Pill, Guanxin Suhe Pill, Shixiang fansheng Pill), owing to the high safety profiles and beneficial effects of this herb in preventing and treating cardiovascular diseases ( Bian and Zhang, 2016 ; Guo et al, 2021 ). In Asia countries, Styrax and Styrax-related herbal products are frequently used in combination with a panel of marketed cardiovascular drugs (such as warfarin, digoxin and simvastatin) to treat cardiovascular diseases ( Zhu, 2009 ; Tao et al, 2016 ; Yang et al, 2021 ). As an important ester spice, Styrax is also used for making a variety of foods ( Yu, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

The Chinese herb Styrax triggers pharmacokinetic herb-drug interactions via inhibiting intestinal CYP3A

Zhang

¹

,

Zhang

²

,

Gong

³

et al. 2022

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Human cytochrome P450 3A4 (hCYP3A4) is a predominant enzyme to trigger clinically relevant drug/herb-drug interactions (DDIs or HDIs). Although a number of herbal medicines have been found with strong anti-hCYP3A4 effects in vitro, the in vivo modulatory effects of herbal medicines on hCYP3A4 and their potential risks to trigger HDIs are rarely investigated. Herein, we demonstrate a case study to efficiently find the herbal medicine(s) with potent hCYP3A4 inhibition in vitro and to accurately assess the potential HDIs risk in vivo. Following screening over 100 herbal medicines, the Chinese herb Styrax was found with the most potent hCYP3A4 inhibition in HLMs. In vitro assays demonstrated that Styrax could potently inhibit mammalian CYP3A in liver and intestinal microsomes from both humans and rats. In vivo pharmacokinetic assays showed that Styrax (i.g., 100 mg/kg) significantly elevated the plasma exposure of two CYP3A-substrate drugs (midazolam and felodipine) when midazolam or felodipine was administered orally. By contrast, the plasma exposure of either midazolam or felodipine was hardly affected by Styrax (i.g.) when the victim drug was administered intravenously. Further investigations demonstrated that seven pentacyclic triterpenoid acids (PTAs) in Styrax were key substances responsible for CYP3A inhibition, while these PTAs could be exposed to intestinal tract at relatively high exposure levels but their exposure levels in rat plasma and liver were extremely low. These findings well explained why Styrax (i.g.) could elevate the plasma exposure of victim drugs only when these agents were orally administrated. Collectively, our findings demonstrate that Styrax can modulate the pharmacokinetic behavior of CYP3A-substrate drugs via inhibiting intestinal CYP3A, which is very helpful for the clinical pharmacologists to better assess the HDIs triggered by Styrax or Styrax-related herbal products.

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Efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction

Cited by 6 publications

References 19 publications

Effect of Proprietary Chinese Medicine on Coronary Microvascular Dysfunction in Patients with Microvascular Angina: A Systematic Review and Meta‐Analysis

Effect of Proprietary Chinese Medicine on Coronary Microvascular Dysfunction in Patients with Microvascular Angina: A Systematic Review and Meta‐Analysis

Shexiang Baoxin Pill for Acute Myocardial Infarction: Clinical Evidence and Molecular Mechanism of Antioxidative Stress

The Chinese herb Styrax triggers pharmacokinetic herb-drug interactions via inhibiting intestinal CYP3A

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