Mengnan Liu1, Yuting Pu2, Juan Gu2, Qida He3, Yan Liu4, Yiwei Zeng5, Jingchi Li6, Xingru Long7, Sijin Yang8, Qibiao Wu9, Hua Zhou10. 1. Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China; National Traditional Chinese Medicine Clinical Research Base and Department of Cardiovascular, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China. 2. Department of Neurology, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China. 3. Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China. 4. National Traditional Chinese Medicine Clinical Research Base and Department of Cardiovascular, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China. 5. Acupuncture and Tuina College, Chengdu University of Traditional Chinese Medicine, Chengdu, China. 6. Department of Spine Surgery, Affiliated Hospital of Integrated Traditional Chinese, and Western Medicine for Nanjing University of Chinese Medicine, Nanjing, China. 7. Medical Imaging Department, Southwest Medical University, Luzhou, Sichuan, China. 8. Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China; National Traditional Chinese Medicine Clinical Research Base and Department of Cardiovascular, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China. Electronic address: ysjimn@sina.com. 9. Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China. Electronic address: qbwu@must.edu.mo. 10. Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China. Electronic address: hzhou@must.edu.mo.
Abstract
BACKGROUND: Zhilong Huoxue Tongyu capsule (ZL) is a Chinese patent medicine and used for the treatment of acute cerebral infarction (ACI) and its clinical application has gradually been widely recognized in China. However, the effects of ZL for patients with ACI have never been systematically evaluated. PURPOSE: A systematic review and meta-analysis was performed to evaluate the efficacy of ZL in ACI. STUDY DESIGN: A systematic review and meta-analysis of randomized clinical trials (RCTs). MATERIALS AND METHODS: A systematic review and meta-analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The comprehensive literature search was accomplished in 6 electronic databases to find relevant randomized controlled trials from their inception until October 31, 2020. The Cochrane Handbook for Systematic Reviews of Interventions was used for methodological quality and independent evaluation. Review Manager 5.3 was used to analyze all the data obtained. The Clinical Effective Rate (CER) was the primary outcome, and the National Institutes of Health Stroke Score (NIHSS), Barthel Index (BI), and Modified Rankin Scale (MRS) were the secondary outcomes. RESULTS: Seven clinical studies recruiting 571 eligible patients were included in this meta-analysis. The results of meta-analysis suggested that compared with conventional treatment alone, ZL combined with conventional treatment significantly improved CER (RR = 1.20, 95% CI: 1.12-1.29, p < 0.00001), decrease National Institutes of Health Stroke Scale Score (NIHSS) (MD = -2.60, 95% CI: -3.41-1.79, p < 0.00001), Barthel Index (BI) (MD = -9.75, 95% CI: 7.15-12.36, p < 0.00001) and Modified Rankin Scale (MRS) (MD = -0.57, 95% CI: -0.84-0.30, p < 0.00001). There were no reported adverse events in the studies. Most results were robust and the quality of evidence was from moderate to low. CONCLUSION: ZL combined with conventional treatment can improve the short-term outcomes of ACI patients, indicating ZL is a promising treatment choice for ACI and may be used as adjunctive treatment to the conventional treatment of ACI. However, due to the limitations of included clinical trials, high-quality clinical trials with longer follow-ups are still needed to further assess the effectiveness and safety of ZL for ACI patients.
BACKGROUND: Zhilong Huoxue Tongyu capsule (ZL) is a Chinese patent medicine and used for the treatment of acute cerebral infarction (ACI) and its clinical application has gradually been widely recognized in China. However, the effects of ZL for patients with ACI have never been systematically evaluated. PURPOSE: A systematic review and meta-analysis was performed to evaluate the efficacy of ZL in ACI. STUDY DESIGN: A systematic review and meta-analysis of randomized clinical trials (RCTs). MATERIALS AND METHODS: A systematic review and meta-analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The comprehensive literature search was accomplished in 6 electronic databases to find relevant randomized controlled trials from their inception until October 31, 2020. The Cochrane Handbook for Systematic Reviews of Interventions was used for methodological quality and independent evaluation. Review Manager 5.3 was used to analyze all the data obtained. The Clinical Effective Rate (CER) was the primary outcome, and the National Institutes of Health Stroke Score (NIHSS), Barthel Index (BI), and Modified Rankin Scale (MRS) were the secondary outcomes. RESULTS: Seven clinical studies recruiting 571 eligible patients were included in this meta-analysis. The results of meta-analysis suggested that compared with conventional treatment alone, ZL combined with conventional treatment significantly improved CER (RR = 1.20, 95% CI: 1.12-1.29, p < 0.00001), decrease National Institutes of Health Stroke Scale Score (NIHSS) (MD = -2.60, 95% CI: -3.41-1.79, p < 0.00001), Barthel Index (BI) (MD = -9.75, 95% CI: 7.15-12.36, p < 0.00001) and Modified Rankin Scale (MRS) (MD = -0.57, 95% CI: -0.84-0.30, p < 0.00001). There were no reported adverse events in the studies. Most results were robust and the quality of evidence was from moderate to low. CONCLUSION:ZL combined with conventional treatment can improve the short-term outcomes of ACI patients, indicating ZL is a promising treatment choice for ACI and may be used as adjunctive treatment to the conventional treatment of ACI. However, due to the limitations of included clinical trials, high-quality clinical trials with longer follow-ups are still needed to further assess the effectiveness and safety of ZL for ACI patients.