Safety Surveillance of Traditional Chinese Medicine: Current and Future

Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli; Cheng, Yung‐Chi

doi:10.1007/s40264-014-0250-z

Cited by 215 publications

(155 citation statements)

References 74 publications

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“…Similar problems are evident for most herbs used in the context of TCM [8,12,15,17,62,63,64,65,66,67,119,120,121,122,123,124,181,185,229,230,231,232,233], which were discussed by the Chinese FDA, presenting details of the current status and future perspectives of the pharmacovigilance practice and risk control of TCM drugs in China [12]. …”

Section: Diagnostic Challengesmentioning

confidence: 59%

“…A variety of reports and analyses focused on important issues related to the use of herbal TCM [8,9,10,41,42,43,44,45,46,47,48,49,50,51,52,53]. In particular, its integration into modern Western medicine will not easily be accomplished due to differences in philosophy and approaches of diagnoses and therapy.…”

Section: Herbal Traditional Chinese Medicine Its History Philosomentioning

confidence: 99%

“…Some efforts appear promising [12], provided the principles of current Good Agricultural Practices (cGAP) and current Good Manufacturing Practices (cGMP) are fulfilled [8,12,50,60]. In essence, herbal TCM products intended for medicinal purposes and fulfilling regulatory requirements of efficacy and safety, should all be classified as regulated herbal drugs [50].…”

Section: Herbal Traditional Chinese Medicine Its History Philosomentioning

confidence: 99%

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Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

et al. 2016

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Background: Traditional Chinese Medicine (TCM) with its focus on herbal use is popular and appreciated worldwide with increased tendency, although its therapeutic efficacy is poorly established for most herbal TCM products. Treatment was perceived as fairly safe but discussions emerged more recently as to whether herb induced liver injury (HILI) from herbal TCM is a major issue; Methods: To analyze clinical and case characteristics of HILI caused by herbal TCM, we undertook a selective literature search in the PubMed database with the search items Traditional Chinese Medicine, TCM, alone and combined with the terms herbal hepatotoxicity or herb induced liver injury; Results: HILI caused by herbal TCM is rare and similarly to drugs can be caused by an unpredictable idiosyncratic or a predictable intrinsic reaction. Clinical features of liver injury from herbal TCM products are variable, and specific diagnostic biomarkers such as microsomal epoxide hydrolase, pyrrole-protein adducts, metabolomics, and microRNAs are available for only a few TCM herbs. The diagnosis is ascertained if alternative causes are validly excluded and causality levels of probable or highly probable are achieved applying the liver specific RUCAM (Roussel Uclaf Causality Assessment Method) as the most commonly used diagnostic tool worldwide. Case evaluation may be confounded by inappropriate or lacking causality assessment, poor herbal product quality, insufficiently documented cases, and failing to exclude alternative causes such as infections by hepatotropic viruses including hepatitis E virus infections; Conclusion: Suspected cases of liver injury from herbal TCM represent major challenges that deserve special clinical and regulatory attention to improve the quality of case evaluations and ascertain patients’ safety and benefit.

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Section: Diagnostic Challengesmentioning

confidence: 59%

Section: Herbal Traditional Chinese Medicine Its History Philosomentioning

confidence: 99%

Section: Herbal Traditional Chinese Medicine Its History Philosomentioning

confidence: 99%

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Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

et al. 2016

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“…The WHO reported that the annual sales of herbal medicine in Germany for the year 2002 have reached US$2.432 billion [14]. Nahin et al [15] also reported that the market of HMPs in USA has expanded tremendously from US$2.9 billion to US$4.8 billion from 1995 to 2008.…”

Section: Introductionmentioning

confidence: 99%

“…After a period of 3 years, the sales of herbal medicine in China increased tremendously as reported by National Bureau of Statistics [14]. They reported that the sale value in herbal industries has reached US$68 billion (RMB418 billion) with an annual growth rate of 37.9%.…”

Section: Introductionmentioning

confidence: 99%

Review: DNA Barcoding and Chromatography Fingerprints for the Authentication of Botanicals in Herbal Medicinal Products

Abubakar

Salleh²,

Shamsir³

et al. 2017

Evidence-Based Complementary and Alternative Medicine

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In the last two decades, there has been a tremendous increase in the global use of herbal medicinal products (HMPs) due to their claimed health benefits. This has led to increase in their demand and consequently, also, resulted in massive adulteration. This is due to the fact that most of the traditional methods cannot identify closely related species in a process product form. Therefore the urgent need for simple and rapid identification methods resulted in the discovery of a novel technique. DNA barcoding is a process that uses short DNA sequence from the standard genome for species identification. This technique is reliable and is not affected by external factors such as climates, age, or plant part. The difficulties in isolation of DNA of high quality in addition to other factors are among the challenges encountered using the DNA barcoding in the authentication of HMP. These limitations indicated that using DNA barcoding alone may ineffectively authenticate the HMP. Therefore, the combination of DNA barcoding with chromatographic fingerprint, a popular and generally accepted technique for the assessment and quality control of HMP, will offer an efficient solution to effectively evaluate the authenticity and quality consistency of HMP. Detailed and quality information about the main composition of the HMPs will help to ascertain their efficacy and safety as these are very important for quality control.

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Analysis of Herbicide and/or Pesticide Residues in Dietary Botanical Supplements

Raina‐Fulton

Aborkhees

Behdarvandan

2018

Encyclopedia of Analytical Chemistry

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Analysis of pesticides in nutraceuticals, particularly dietary botanical supplements, is challenging owing to the low water content of powder or tablet samples and potentially higher concentration of co‐extracts produced during the drying and manufacturing processes. These co‐extracts can cause signal suppression or enhancement in mass spectrometric (MS) detection. Poor chromatographic stability and peak shapes can also be observed from co‐eluting matrix components. Sample preparation is critical to the detection of pesticides in extracts, and the major sample preparation methods used for dietary botanical supplements included modified QuEChERS (quick, easy, cheap, effective, rugged, and safe) methods, dilute‐and‐shoot, and pressurized liquid extraction (PLE) with in‐cell (on‐line) cleanup. Additional cleanup of extracts was completed by dispersive solid‐phase extraction (dSPE) or solid‐phase extraction (SPE). Recoveries of individual pesticides from a variety of chemical classes of varying polarities were evaluated using the major sample preparation approaches utilized for analysis of pesticides since 2010. Major chemical classes of pesticides included those predominately analyzed by GC‐MS/MS (pyrethroid insecticides) or LC‐MS/MS (carbamates, sulfonyl ureas, phenyl ureas, and neonicotinoid insecticides) and those that have greater flexibility to be analyzed by GC‐MS/MS or LC‐MS/MS (azole and strobilurin fungicides). Other selected herbicides including cyclohexene oxime herbicides, aryloxyphenoxy propionic herbicides, or fungicides that were included in multiresidue analysis methods were also examined. Common dSPE sorbents included primary secondary amine (PSA), octyldecyl silane (C18), graphitized carbon black (GCB), and zirconia and C18 bonded to silica (Z‐Sep + ), while carbon‐based sorbents were used for SPE along with Florisil ® . C18 and PSA were also used for SPE often in combination with a carbon‐based sorbent. Highlighted are the issues with different chemical classes or sample matrix types.

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Safety Surveillance of Traditional Chinese Medicine: Current and Future

Cited by 215 publications

References 74 publications

Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

Review: DNA Barcoding and Chromatography Fingerprints for the Authentication of Botanicals in Herbal Medicinal Products

Analysis of Herbicide and/or Pesticide Residues in Dietary Botanical Supplements

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