Adulterated herbal supplement shows unexpected efficacy

Reviewed: Karioti A, Giocaliere E, Guccione C, et al. Combined HPLC-DAD-MS, HPLC-MSⁿ and NMR spectroscopy for quality control of plant extracts: The case of a commercial blend sold as dietary supplement. J Pharm Biomed Anal. 2014;88:7-15. Abstract available at http://www.sciencedirect.com/science/article/pii/S0731708513003464.

During the last four years, the pharmacovigilance system at Florence University in Italy received several reports from patients referring to the unexpected effectiveness of Olivis® (marketed in Italy by the company Ser-Vis) as an adjunct to hypertension therapy. The declared components of this liquid preparation were extracts of olive (Olea europaea, Oleaceae) leaves and buds, hawthorn (Crataegus laevigata, Rosaceae; syn. C. oxyacantha) leaves, flowers, and fruits, fumitory (Fumaria officinalis, Papaveraceae) herb, and shepherd's purse (Capsella bursa-pastoris, Brassicaceae) herb. The authors of the paper from the University of Florence used a combination of analytical techniques (HPLC-UV/MS, HPLC-MS/MS, and NMR) to evidence the absence of olive leaf extracts and to show that the concentrations of the other herbal materials in the final product were so low that their presence could by no means explain the efficacy or the occurrence of serious adverse events (bradycardia, hypotension) after administration of the product. Based on the analytical data, the researchers were able to determine that Olivis contained an extract of a Rauvolfia spp (Apocynaceaea). and that the observed effects and adverse events could be attributed to the non-declared Rauvolfia alkaloid-containing material. The authors conclude that chemical fingerprint analysis for all herbal products should be required by authorities to ensure safety of herbal medicinal products.

Comment: Fraudulent adulteration is a global issue as this report exemplifies. According to Vannacci et al.,¹ the official label of Olivis in the database of the Italian Ministry of Health declared the presence of Dissolena verticillata, which is a synonym for Rauvolfia verticillata. This plant is known for containing reserpine and other alkaloids whose presence in dietary supplements is banned. However, the Rauvolfia extract was not declared on product labels in stores. Based on this information, the manufacturer knowingly added the Rauvolfia extract to his product, and therefore even a chemical fingerprint analysis, as requested by the authors, would not have prevented the product from reaching the shelves.

Reference

1.       Vannacci A, Giocaliere E, Paoletti A, et al. An anti-hypertensive herbal supplement containing not-declared reserpine: a possible risk for patients’ health. Poster presentation: 34° Congresso Nazionale della Società Italiana di Farmacologia. Rimini, Italy; 2009.