Updated evidence of the Naoshuantong capsule against ischemic stroke: a systematic review and meta-analysis of randomized controlled trials

Cuilin Que; Yupeng Wei; Guanxiang Yin; Congren Zhou; Zhenhong Liu; Xinxing Lai; Mingzhen Qin; Xuejiao Xiong; Xiangyi Zheng; Xinglu Dong; Ying Gao

doi:10.3389/fphar.2024.1434764

Updated evidence of the Naoshuantong capsule against ischemic stroke: a systematic review and meta-analysis of randomized controlled trials

Front Pharmacol. 2024 Sep 26:15:1434764. doi: 10.3389/fphar.2024.1434764. eCollection 2024.

Authors

Cuilin Que^#^{1

2

3}, Yupeng Wei^#^{1

2

3}, Guanxiang Yin³, Congren Zhou^{1

2

3}, Zhenhong Liu^{1

2}, Xinxing Lai^{1

2}, Mingzhen Qin^{1

2

3}, Xuejiao Xiong^{1

2

3}, Xiangyi Zheng^{1

3}, Xinglu Dong^{1

2}, Ying Gao^{1

2

4}

Affiliations

¹ Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
² Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.
³ Beijing University of Chinese Medicine, Beijing, China.
⁴ Chinese Medicine Key Research Room of Brain Disorders Syndrome and Treatment of the National Administration of Traditional Chinese Medicine, Beijing, China.

^# Contributed equally.

Abstract

Background: Stroke is a serious health issue that can result in death or disability, leading to a significant economic strain on society and families. A growing number of studies have shown that the Naoshuantong capsule (NSTC) is beneficial as a treatment for ischemic stroke (IS) in recent years. Our study aims to provide an update on the safety and efficacy of the NSTC in IS patients.

Methods: We thoroughly searched eight databases to identify suitable randomized controlled trials (RCTs) assessing the effectiveness of the NSTC in the treatment of IS. The National Institute of Health Stroke Scale (NIHSS) for an acute period and modified Rankin Scale (mRS) at 3 months for a non-acute period were considered the primary outcome, and secondary outcomes included the NIHSS for a non-acute period, mRS, Barthel Index (BI), modified Barthel Index (MBI), Stroke-specific Quality of life (SS-QOL), and the recurrence rate of cerebrovascular events. Subsequently, its quality was assessed using the Cochrane risk assessment scale. Statistical analysis was conducted using RevMan 5.3 and Stata 14.0.

Results: A total of 27 RCTs were included, which involved 3,139 patients. The results showed that the NSTC improved neurological function not only in the acute period (MD = -2.53; 95% CI: -2.91, -2.15; p < 0.00001) but also in the non-acute period (MD = -3.70; 95% CI: -5.82, -1.58; p = 0.0006) and improved the long-term functional outcomes with lower mRS scores (MD = -0.68; 95% CI: -1.09, -0.26; p = 0.001). At the same time, the NSTC decreased the risk of cerebrovascular disease recurrence (RR = 0.43; 95% CI: 0.27, 0.70; p = 0.0006) and increased the quality of life in the acute period (MD = 23.88; 95% CI: 16.63, 31.13; p < 0.00001). Significant disparities in the incidence of adverse events between the NSTC and control groups were not observed. The certainty of evidence was estimated as moderate to very low.

Conclusion: The NSTC emerges as a potentially efficacious and safe treatment option for IS. NSTC could improve neurological function in different period of IS, and it has certain clinical value in secondary prevention. As a result of the poor quality and heterogeneity of the included trials, larger and standardized RCTs are needed to validate NSTC in IS treatment.

Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=482981, identifier CRD42023482981.

Keywords: Chinese patent medicine; Naoshuantong capsule; ischemic stroke; meta-analysis; systematic review.

Publication types

Systematic Review

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by the 2019 Major Difficult Diseases Clinical Collaboration Capacity Building Project of Traditional Chinese and Western Medicine—Cerebral Infarction (YW082); the Construction Project of the Cerebral Vascular Disease Prevention and Treatment Office of Traditional Chinese Medicine in Beijing (YW083); and the Pilot Project of Clinical Research and Achievement Transformation Capacity Improvement (DZMG-MLZY-23002).