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Randomized Controlled Trial
. 2023 Jun 1;6(6):e2317574.
doi: 10.1001/jamanetworkopen.2023.17574.

Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial

Longfei Wu  1 , Haiqing Song  1 , Chi Zhang  2 , Anxin Wang  3   4 , Bowei Zhang  1 , Chiyu Xiong  5 , Xianbo Zhuang  6 , Yingzhuo Zang  7 , Chenghao Li  8 , Qi Fang  9 , Chuanqiang Qu  10 , Lihua Wang  11 , Mei Zhang  12 , Hao Li  13 , Xiaoli Wang  14 , Yanan Li  15 , Lei Xia  16 , Zhigang Yao  17 , Zhi Nie  18 , Ying Gao  2 , Xunming Ji  19
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial

Longfei Wu et al. JAMA Netw Open. .

Abstract

Importance: Preclinical and clinical studies have suggested the neuroprotective effect of Panax notoginseng saponins (Xuesaitong soft capsules). However, robust evidence in patients with ischemic stroke is lacking.

Objective: To assess the efficacy and safety of Xuesaitong soft capsules in patients with ischemic stroke.

Design, setting, and participants: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 67 tertiary health centers in China from July 1, 2018, to June 30, 2020. Included patients were aged 18 to 75 years with a diagnosis of ischemic stroke and a National Institutes of Health Stroke Scale score between 4 and 15.

Interventions: Eligible patients were randomly assigned within 14 days after symptom onset to receive either treatment with Xuesaitong soft capsules (120 mg orally twice daily) or placebo (120 mg orally twice daily) for 3 months.

Main outcomes and measures: The primary outcome was functional independence at 3 months, defined as a modified Rankin Scale score of 0 to 2.

Results: Among 3072 eligible patients with ischemic stroke who were randomized, 2966 (96.5%) were included in the modified intention-to-treat cohort (median [IQR] age, 62 [55-68] years; 1982 male [66.8%]). The number of patients who achieved functional independence at 3 months was 1328 (89.3%) in the Xuesaitong group and 1218 (82.4%) in the control group (odds ratio, 1.95; 95% CI, 1.56-2.44; P < .001). In the safety cohort, serious adverse events occurred in 15 of 1488 patients (1.0%) in the Xuesaitong group and 16 of 1482 (1.1%) in the control group (P = .85).

Conclusions and relevance: In this randomized clinical trial, Xuesaitong soft capsules significantly increased the likelihood of functional independence at 3 months in patients with ischemic stroke, indicating that this may be a safe and effective alternative therapy to improve prognosis in this population.

Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR1800016363.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Participant Flow Diagram
Figure 2.
Figure 2.. Distribution of the Modified Rankin Scale (mRS) Scores at 3 Months
Figure 3.
Figure 3.. Subgroup Analyses
OR indicates odds ratio; TOAST, Trial of Org 10172 in Acute Stroke Treatment.
See this image and copyright information in PMC

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References

    1. Zhou M, Wang H, Zhu J, et al. . Cause-specific mortality for 240 causes in China during 1990-2013: a systematic subnational analysis for the Global Burden of Disease Study 2013. Lancet. 2016;387(10015):251-272. doi:10.1016/S0140-6736(15)00551-6 - DOI - PubMed
    1. Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2003;(3):CD000213. doi:10.1002/14651858.CD000213 - DOI - PubMed
    1. Goyal M, Menon BK, van Zwam WH, et al. ; HERMES Collaborators . Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016;387(10029):1723-1731. doi:10.1016/S0140-6736(16)00163-X - DOI - PubMed
    1. Dirks M, Niessen LW, van Wijngaarden JD, et al. ; PRomoting ACute Thrombolysis in Ischemic StrokE (PRACTISE) Investigators . Promoting thrombolysis in acute ischemic stroke. Stroke. 2011;42(5):1325-1330. doi:10.1161/STROKEAHA.110.596940 - DOI - PubMed
    1. Li F, Zhao H, Han Z, et al. . Xuesaitong may protect against ischemic stroke by modulating microglial phenotypes and inhibiting neuronal cell apoptosis via the STAT3 signaling pathway. CNS Neurol Disord Drug Targets. 2019;18(2):115-123. doi:10.2174/1871527317666181114140340 - DOI - PubMed

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