Adverse Events of Traditional Medicines and Herbal Products in the Thai Health Product Vigilance Center Database and the Ayurved Clinic of Applied Thai Traditional Medicine, Siriraj Hospital

Abstract

Objective: The aim of this study was to categorize adverse events (AEs) and symptoms related to traditional medicines (TMs) and herbal products (HPs) using the Thai Vigibase program (TVP). Materials and Methods: TVP collected spontaneous AE reports including causality assessment of medical products in Thailand. For prospective data, Naranjo’s algorithm (NJA) was used to determine the level of causality. Results: There were a total of 1,133 AE case reports extracted from TVP and featured 1,229 TMs/HPs (310 TMs/ HPs names) and 1,592 symptoms (204 symptom names). Andrographis paniculata was the product most frequently linked to AEs, with six cases of confirmed urticaria, 37 probable cases, and 24 possible causalities, 15 patients were given 23 TMs/HPs and this related to 33 AEs. The Ya Hom No.24 Tablets had the most reported AEs at 17.4% with only one causality, which was most probably linked to chest burning pain. There was also one case of herbal decoction relieving menopausal symptoms that was certainly related to chest fullness, feeling hot and cold, suffocation feeling, and sweating increase. Ayurved Siriraj Brand Ya Lom No.65 Pills, also reported one case that was linked to fatigue and drowsiness. Conclusion: Reports from both data sources found a similar pattern in AE type and TMs/HPs. Naranjo’s algorithm might be one of useful tools to help assess the causality between TMs/HPs and AEs. The results of this study serve as a good reference for causality between TMs/HPs and their AEs for all Thai traditional medicine practitioners.