A herbal treatment for type 2 diabetes adulterated with undisclosed drugs

CORRESPONDENCE| VOLUME 391, ISSUE 10138, P2411, JUNE 16, 2018 PDF [629 KB] Figures Mia Steyn Lewis Couchman Gemma Coombes Kenneth A Earle Atholl Johnston David W Holt DOI:https://doi.org/10.1016/S0140-6736(18)31134-6 Donald W Seldin Next Article Endpoints in diabetes cardiovascular outcome trials Supplementary Material References Article Info Figures Patients might be drawn to the use of herbal remedies because they are encouraged to think of them as natural remedies, free from adverse effects. We describe a case in which a patient purchased a purported herbal remedy that was found to be adulterated with commonly prescribed drugs. A 58-year-old woman of south Asian origin, with a 30-year history of type 2 diabetes, together with hypertension, hypercholesterolaemia, chronic kidney disease, retinopathy, and a painful peripheral neuropathy, attended our clinic in November, 2017. Her drug therapy included metformin 850 mg three times a day, insulin (Levemir) 16 units at night, atorvastatin 20 mg at night, lisinopril 40 mg once daily, and lacidipine 2 mg once daily. She had moderate to severe chronic kidney disease (stage 3b), with an estimated glomerular filtration rate of 40 mL/min/1·73m2. Her glucose control was relatively tight with an HbA1c of 55 mmol/mol (7·2%) and home blood glucose measurements ranging from 3·6 to 11 mmol/L. The patient volunteered that from November, 2015, until May, 2017, she had replaced some of her diabetic medicine prescribed at the time with a herbal remedy purchased in India, which the manufacturers claimed was a cure, rather than a treatment, for diabetes. The patient noted some of her Indian acquaintances were taking the same herbal remedy. She stopped taking the product after experiencing recurrent hypoglycaemia. A gradual decline in her renal function, along with hypoalbuminaemia and peripheral oedema, although no albuminuria, was also noted from the time the supplement was started. The patient agreed to supply the herbal product for analysis. It was a crudely formed, irregular, ball-shaped tablet of 6–8 mm diameter, and came in three colours, weighing 191–309 mg (figure). We crushed the tablets and shook the resulting chalky material in methanol. We analysed the methanolic extracts using liquid chromatography with quadrupole time-of-flight mass-spectrometry, and we quantified the compounds identified using liquid chromatography with tandem mass-spectrometric detection (appendix). The pink and green tablets both contained glibenclamide (1·0–2·2 mg) and metformin (89–153 mg). The brown tablets did not contain an identifiable active pharmaceutical ingredient. Figure thumbnail gr1 FigureTablets supplied to patient View Large Image Figure ViewerDownload Hi-res image Download (PPT) A study1 of Indian or Pakistani patients with diabetes living in Edinburgh noted the reluctance of some patients to adhere to medication with allopathic medicines; instead, patients favoured herbal remedies, which were seen as less toxic. Our data, supported by analytical findings, suggest that the use of such preparations might carry the risk of adverse effects from undisclosed additives. The product we analysed was laced with undisclosed antidiabetic compounds of doubtful provenance, and the doses varied significantly in between tablets. Thus, the tablets could potentially lead to poor and unpredictable diabetic control and exposure to adverse effects of substandard adulterants. The clinical risks posed by falsified and substandard medicines are well documented,2, 3 but clearly clinicians must also be aware of preparations purporting to treat illnesses by means of a natural remedy that are actually adulterated with unknown doses of pharmacological drugs. The problem is probably more widespread than appreciated. Our analytical data support the findings of a study,4 which found a wide range of proprietary Chinese medicines and health products had been adulterated with drug classes, such as non-steroidal anti-inflammatories, corticosteroids, and oral antidiabetics, and that a significant proportion of patients exposed to these products had suffered adverse effects attributable to the adulterants. We suggest that doctors treating patients with diabetes should enquire if their patients are using any herbal or alternative remedies if they note unexpectedly poor diabetic control or adverse events, and that the same approach might be necessary in other clinical settings. We declare no competing interests. Supplementary Material Download .pdf (.18 MB) Help with pdf files Supplementary appendix References Porqueddu T Herbal medicines for diabetes control among Indian and Pakistani migrants with diabetes. Anthropol Med. 2017; 24: 17-31 View in Article Scopus (2) PubMed Crossref Google Scholar Abril JL Holt DW Wilson RR Falsified medicines in the European Union and North America: what are we doing to protect public health?. J Pharmacovigil. 2016; 4: 213 View in Article Google Scholar Johnston A Holt DW Substandard drugs: a potential crisis for public health. Br J Clin Pharmacol. 2014; 78: 218-243 View in Article Scopus (37) PubMed Crossref Google Scholar Ching CK Chen SPL Lee HHC et al. Adulteration of proprietary Chinese medicines and health products with undeclared drugs: experience of a tertiary toxicology laboratory in Hong Kong. Br J Clin Pharmacol. 2018; 84: 172-178 View in Article Scopus (4) PubMed Crossref Google Scholar Article Info Publication History Published: 16 June 2018 IDENTIFICATION DOI: 10.1016/S0140-6736(18)31134-6 Copyright © 2018 Elsevier Ltd. All rights reserved. ScienceDirect Access this article on ScienceDirect Figures Figure thumbnail gr1 FigureTablets supplied to pa