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      Current Status and Major Challenges to the Safety and Efficacy Presented by Chinese Herbal Medicine

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          Abstract

          Traditional Chinese medicine (TCM) is not only used prevalently in Asian countries but has also gained a stable market globally. As a principal form of TCM, Chinese herbal medicine (CHM) is comprised of treatments using multiple Chinese herbs which have complex chemical profiles. Due to a lack of understanding of its modality and a lack of standardization, there are significant challenges associated with regulating CHM’s safety for practice and understanding its mechanisms of efficacy. Currently, there are many issues that need to be overcome in regard to the safety and efficacy of CHM for the further development of evidence-based practices. There is a need to better understand the mechanisms behind the efficacy of CHM, and develop proper quality standards and regulations to ensure a similar safety standard as Western drugs. This paper outlines the status of CHM in terms of its safety and efficacy and attempts to provide approaches to address these issues.

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          Aristolochic acid nephropathy: a worldwide problem.

          Frédéric Debelle, Jean-Louis Vanherweghem, Joëlle Nortier (2008)
          Aristolochic acid nephropathy (AAN), a progressive renal interstitial fibrosis frequently associated with urothelial malignancies, was initially reported in a Belgian cohort of more than 100 patients after the intake of slimming pills containing a Chinese herb, Aristolochia fangchi. Although botanicals known or suspected to contain aristolochic acid (AA) were no longer permitted in many countries, several AAN cases were regularly observed all around the world. The incidence of AAN is probably much higher than initially thought, especially in Asia and the Balkans. In Asian countries, where traditional medicines are very popular, the complexity of the pharmacopoeia represents a high risk for AAN because of the frequent substitution of the botanical products by AA-containing herbs. In the Balkan regions, the exposure to AA found in flour obtained from wheat contaminated with seeds of Aristolochia clematitis could be responsible for the so-called Balkan-endemic nephropathy. Finally, despite the Food and Drug Administration's warnings concerning the safety of botanical remedies containing AA, these herbs are still sold via the Internet.
          Article 0 comments Cited 192 times – based on 0 reviews     Review now
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            Synergistic Effects of Chinese Herbal Medicine: A Comprehensive Review of Methodology and Current Research

            Xian Zhou, Sai-Wang Seto, Dennis Chang … (2016)
            Traditional Chinese medicine (TCM) is an important part of primary health care in Asian countries that has utilized complex herbal formulations (consisting 2 or more medicinal herbs) for treating diseases over thousands of years. There seems to be a general assumption that the synergistic therapeutic effects of Chinese herbal medicine (CHM) derive from the complex interactions between the multiple bioactive components within the herbs and/or herbal formulations. However, evidence to support these synergistic effects remains weak and controversial due to several reasons, including the very complex nature of CHM, misconceptions about synergy and methodological challenges to study design. In this review, we clarify the definition of synergy, identify common errors in synergy research and describe current methodological approaches to test for synergistic interaction. We discuss the strengths and weaknesses of these models in the context of CHM and summarize the current status of synergy research in CHM. Despite the availability of some scientific data to support the synergistic effects of multi-herbal and/or herb-drug combinations, the level of evidence remains low, and the clinical relevancy of most of these findings is undetermined. There remain significant challenges in the development of suitable methods for synergistic studies of complex herbal combinations.
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              Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin.

              R Isbrucker, George A Burdock (2006)
              Licorice (or 'liquorice') is a plant of ancient origin and steeped in history. Licorice extracts and its principle component, glycyrrhizin, have extensive use in foods, tobacco and in both traditional and herbal medicine. As a result, there is a high level of use of licorice and glycyrrhizin in the US with an estimated consumption of 0.027-3.6 mg glycyrrhizin/kg/day. Both products have been approved for use in foods by most national and supranational regulatory agencies. Biochemical studies indicate that glycyrrhizinates inhibit 11beta-hydroxysteroid dehydrogenase, the enzyme responsible for inactivating cortisol. As a result, the continuous, high level exposure to glycyrrhizin compounds can produce hypermineralocorticoid-like effects in both animals and humans. These effects are reversible upon withdrawal of licorice or glycyrrhizin. Other in vivo and clinical studies have reported beneficial effects of both licorice and glycyrrhizin consumption including anti-ulcer, anti-viral, and hepatoprotective responses. Various genotoxic studies have indicated that glycyrrhizin is neither teratogenic nor mutagenic, and may possess anti-genotoxic properties under certain conditions. The pharmacokinetics of glycyrrhizin have been described and show that its bioavailability is reduced when consumed as licorice; this has hampered attempts to establish clear dose-effect levels in animals and humans. Based on the in vivo and clinical evidence, we propose an acceptable daily intake of 0.015-0.229 mg glycyrrhizin/kg body weight/day.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicines (Basel)
                Journal ID (iso-abbrev): Medicines (Basel)
                Journal ID (publisher-id): medicines
                Title: Medicines
                Publisher: MDPI
                ISSN (Electronic): 2305-6320
                Publication date (Electronic): 18 January 2019
                Publication date Collection: March 2019
                Volume: 6
                Issue: 1
                Electronic Location Identifier: 14
                Affiliations
                NICM Health Research Institute, Western Sydney University, Penrith, NSW 2751, Australia; c.li@ 123456westernsydney.edu.au (C.-G.L.); d.chang@ 123456westernsydney.edu.au (D.C.); a.bensoussan@ 123456westernsydney.edu.au (A.B.)
                Author notes
                Author information
                https://orcid.org/0000-0001-8766-8158
                https://orcid.org/0000-0002-7433-667X
                Article
                Publisher ID: medicines-06-00014
                DOI: 10.3390/medicines6010014
                PMC ID: 6473719
                PubMed ID: 30669335
                SO-VID: cac48331-534b-4589-a03d-da79297f9a44
                Copyright © © 2019 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 19 December 2018
                Date accepted : 15 January 2019
                Categories
                Subject: Review

                Keywords: traditional chinese medicine,chinese herbal medicine,safety,efficacy,herb–drug interaction,synergy,herbal formulae
                Data availability:
                Keywords: traditional chinese medicine, chinese herbal medicine, safety, efficacy, herb–drug interaction, synergy, herbal formulae

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