Adulterants and Contaminants in Psychotropic Herbal Medicines Detected with Mass Spectrometry and Next-Generation DNA Sequencing
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The role of herbal medicine in the treatment of common psychiatric disorders such as anxiety, depression and insomnia has become more established over the past decade. Some herbal preparations such as St John’s wort (Hypericum perforatum) have demonstrated clinical evidence but have also been included in recent reports of widespread adulteration and contamination. Herbal medicines sold in Australia are required to be listed on the Therapeutic Goods Administration’s (TGA) Australian Register of Therapeutic Goods (ARTG) and must comply with strict ingredient and manufacturing guidelines to assure quality and safety.
The aim of this research was to assess whether pharmaceutical adulterants and contaminants were present in psychotropic herbal medicines available in Australia, as a measure of quality, and the effectiveness of regulation.
A two-pronged approach combining next-generation DNA sequencing and small-molecule analysis techniques was undertaken to audit a subset of herbal medicines for the presence of prescription medications, illicit drugs, pesticides, herbicides, heavy metals and contaminant DNA. Small-molecule analysis included liquid chromatography with quadrupole time-of-flight mass spectrometer (LC-QTOF-MS) detection, liquid chromatography with UV/vis diode array (LC-UV) detection, gas chromatography with nitrogen–phosphorus and mass spectrometer detection (GC-NPD/MS) and heavy metal analysis using inductively coupled plasma with mass spectrometer (ICP-MS) detection.
In total, 49% (29 of 59) of the investigated herbal medicines had one or more materials not listed on their labels or ARTG registration, including Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)-listed material (one medicine), heavy metals (12%) or components that could trigger food sensitivity, such as wheat (12%). In contrast to previous studies, no prescription pharmaceutical adulterants were detected, although 10% had undeclared caffeine. Twenty-four percent of herbal medicines had DNA from animal species, including mice and bats, indicating poor quality control. The surveyed herbal medicines included both traditional Chinese medicines (TCM) and Western herbals. Ninety-four percent of TCMs were contaminated or adulterated, compared with 37% of the Western herbals. Only two of the 59 samples contained the listed active ingredient(s) without additional adulterants and contaminants, or missing ingredients.
The high levels of contamination found in this study suggests that closer surveillance of herbal medicines is needed in order to assure the required level of quality of herbal medicines available in Australia. The results suggest that the TGA’s low-/high-risk system for regulation coupled with post-market auditing is not keeping unapproved and/or unsafe herbal medicines from the market.
Compliance with Ethical Standards
This study was funded by the Australian National Health and Medical Research Council (NHMRC) (grant #1061329).
Conflict of interest
Claire L. Hoban, Ian F. Musgrave, Megan L. Coghlan, Matthew W.P. Power, Roger W. Byard, Christine Nash, Rachael Farrington, Garth Maker, Elly Crighton, Robert Trengove and Michael Bunce report no known conflicts of interest.
This article does not contain any studies with human participants or animals performed by any of the authors.
- 25.Therapeutic Goods Administration, Australian Regulatory Guidelines, Good Manufacturing Practice (GMP) clearance for overseas manufacturers. 17th ed. Version 1.0 May 2011. https://www.tga.gov.au/sites/default/files/manuf-overseas-medicines-gmp-clearance-17.pdf. Accessed 22 Jun 2017.
- 26.Grantley J, McPherson F, Petroeschevsky A. Recognising water weeds: plant identification guide. The State of New South Wales Industry & Investment; 2009. http://www.dpi.nsw.gov.au/__data/assets/pdf_file/0007/329308/041209-DPI-RWW-PLANT-GUIDE.pdf. Accessed 22 Jun 2017.
- 28.Convention on International Trade in Endangered Species of Flora and Fauna, The CITES Appendices. https://www.cites.org/eng/app/index.php. Accessed Jul 2016.
- 29.Australian Government. Therapeutic Goods Order No. 69 general requirements for labels for medicines (27/08/2001)Google Scholar
- 32.Churchill S. Australian bats. 2nd ed. Crows Nest: Allen & Unwin; 2008.Google Scholar
- 33.Zhou J, Xie G, Yan X. Encyclopedia of traditional Chinese medicines. Molecular structures, pharmacological activities, natural sources and applications. Berlin: Springer; 2011.Google Scholar
- 42.Blödt S, Mittring N, Schützler L, Fischer F, Holmberg C, et al. A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study. BMC Cancer. 2016;16:843.CrossRefGoogle Scholar