BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design

Frontiers in Pharmacology - Tập 12
Weidi Liu1,2, Li Zhou1, Luda Feng1, Dandan Zhang1,2, Chi Zhang1, Ying Gao1,2
1Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
2Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China

Tóm tắt

Background: BuqiTongluo (BQTL) granules are herbal phenotypic drugs for Qi deficiency and blood stasis (QDBS) syndrome. Its discovery relied primarily on knowledge of observable phenotypic changes associated with diseases. Although BQTL granules have been widely advocated by Chinese Medicine (CM) practitioners, its use lacks empirical support.Aim of the study: In this basket trial, the efficacy of BQTL granules in multiple diseases that have the QDBS syndrome in common will be compared with placebo.Materials and Methods: The BuqiTongluo granule for Qi deficiency and blood stasis syndrome (BOSS) study is a basket herbal trial (ClinicalTrials.gov, NCT04408261). It will be a double-blinded, randomized, placebo-controlled, parallel, multicenter, clinical trial. In total, 432 patients (1:1:1 ischemic stroke, stable angina pectoris, and diabetic peripheral neuropathy), who meet the operationalized diagnostic criteria for QDBS syndrome, have been recruited and randomized in a ratio of 1:1 to receive 6 weeks’ treatment with BQTL granules or placebo. The primary outcome is the change in the QDBS syndrome score at week 6 from baseline. Secondary outcomes include objective outcome measures for the three diseases and adverse events. Omics will help to understand these responses by molecular events.Conclusion: QDBS syndrome is a common phenotypic marker that was hypothesized to predict whether patients with multiple diseases would respond to this targeted therapy. No previous basket trial has assessed the potential efficacy of an herbal intervention for multiple diseases. The unique promise of the trial is its ability to exploit a disease phenotype to discover novel treatments for three diseases for which the root cause is unknown, complex, or multifactorial, and for which scientific understanding is insufficient to provide valid molecular targets.

Từ khóa


Tài liệu tham khảo

Bijur, 2001, Reliability of the Visual Analog Scale for Measurement of Acute Pain, Acad. Emerg. Med., 8, 1153, 10.1111/j.1553-2712.2001.tb01132.x

Bril, 2002, Validation of the Toronto Clinical Scoring System for Diabetic Polyneuropathy, Diabetes Care, 25, 2048, 10.2337/diacare.25.11.2048

Chan, 2013, SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials, BMJ, 346, e7586, 10.1136/bmj.e7586

Cunanan, 2017, An Efficient Basket Trial Design, Stat. Med., 36, 1568, 10.1002/sim.7227

Dong, 2013, Phytochemicals and Biological Studies of Plants in Genus Hedysarum, Chem. Cent. J., 7, 124, 10.1186/1752-153x-7-124

2014, Standards of Medical Care in Diabetes--2014, Diabetes Care, 37, S5, 10.2337/dc14-S005

Fan, 2014, Study Progress on Stroke with Syndrome of Qi Deficiency and Blood Stasis, World Chin. Med., 9, 257, 10.3969/j.issn.1673-7202.2014.02.036

Hao, 2017, The Protective Effect of the Active Components of ERPC on Diabetic Peripheral Neuropathy in Rats, J. Ethnopharmacol, 202, 162, 10.1016/j.jep.2017.03.015

Jiang, 2014, Traditional Chinese Medicine Zheng in the Era of Evidence-Based Medicine: A Literature Analysis, Evidence-Based Complementary Alternative Medicine, 2012, 9, 10.1155/2012/409568

Kasner, 2006, Clinical Interpretation and Use of Stroke Scales, Lancet Neurol., 5, 603, 10.1016/s1474-4422(06)70495-1

Knuuti, 2020, 2019 ESC Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes, Eur. Heart J., 41, 407, 10.1093/eurheartj/ehz425

Li, 2007, Metabonomics Analysis of the Urine of Rats with Qi Deficiency and Blood Stasis Syndrome Based on NMR Techniques, Chin. Sci. Bull., 52, 3068, 10.1007/s11434-007-0389-4

Miao, 2003, Clinical Observation on Treatment of Diabetic Peripheral Neuropathy with Qi-Supplementing and Blood-Activating Therapy, Zhongguo Zhong Xi Yi Jie He Za Zhi, 23, 826

Miao, 2012, Syndrome Differentiation in Modern Research of Traditional Chinese Medicine, J. Ethnopharmacology, 140, 634, 10.1016/j.jep.2012.01.033

Park, 2020, An Overview of Precision Oncology Basket and Umbrella Trials for Clinicians, CA Cancer J. Clin., 70, 125, 10.3322/caac.21600

Sacco, 2013, An Updated Definition of Stroke for the 21st century: a Statement for Healthcare Professionals from the American Heart Association/American Stroke Association, Stroke, 44, 2064, 10.1161/STR.0b013e318296aeca

2002, Guideline for Clinical Research of New Chinese Medicine

Uyttenboogaart, 2005, Optimizing Cutoff Scores for the Barthel Index and the Modified Rankin Scale for Defining Outcome in Acute Stroke Trials, Stroke, 36, 1984, 10.1161/01.STR.0000177872.87960.61

Wan, 2009, Panax Notoginseng Reduces Atherosclerotic Lesions in ApoE-Deficient Mice and Inhibits TNF-Alpha-Induced Endothelial Adhesion Molecule Expression and Monocyte Adhesion, J. Agric. Food Chem., 57, 6692, 10.1021/jf900529w

Wang, 2007, Yi Lin Gai Cuo (Correcting the Errors in the Forest of Medicine) (Chinese and English Edition

Wang, 2015, Item Selection Analysis of Qi Deficiency and Blood Stasis Syndrome Evaluation Scale, Jilin J. Traditional Chin. Med., 35, 656, 10.13463/j.cnki.jlzyy.2015.07.003

Wang, 2013, Hedysari Extract Improves Regeneration after Peripheral Nerve Injury by Enhancing the Amplification Effect, PLoS One, 8, e67921, 10.1371/journal.pone.0067921

Wei, 2009, Effects of Hedysari Polysaccharides on Regeneration and Function Recovery Following Peripheral Nerve Injury in Rats, Am. J. Chin. Med., 37, 57, 10.1142/S0192415X09006618

Xie, 2020, Wang Yongyan's Experience in Treating Stroke: Case Series of Chinese Medicine Tonify Qi and Promote Blood Circulation, J. Beijing Univ. Traditional Chin. Medicine(Clinical Medicine), 27, 4

Yuan, 2021, Towards a Clinical Efficacy Evaluation System Adapted for Personalized Medicine, Pharmgenomics Pers Med., 14, 487, 10.2147/pgpm.S304420

Zhai, 2020, Treating Different Diseases With the Same Method-A Traditional Chinese Medicine Concept Analyzed for its Biological Basis, Front. Pharmacol., 11, 946, 10.3389/fphar.2020.00946

Zhang, 2010, Buyang Huanwu Decoction Ameliorates Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome by Reducing CRP and CD40 in Rats, J. Ethnopharmacol, 130, 98, 10.1016/j.jep.2010.04.017

Zhou, 2021, Xuesaitong Exerts Long-Term Neuroprotection for Stroke Recovery by Inhibiting the ROCKII Pathway, In Vitro and In Vivo, J. Ethnopharmacol, 272, 113943, 10.1016/j.jep.2021.113943

Zhou, 2014, A Network-Based Analysis of the Types of Coronary Artery Disease from Traditional Chinese Medicine Perspective: Potential for Therapeutics and Drug Discovery, J. Ethnopharmacol, 151, 66, 10.1016/j.jep.2013.11.007

Thông tin
Thông tin xuất bản

Frontiers in Pharmacology

Tập 12

Thông tin tác giả