Is Duhuo Jisheng Tang containing Xixin safe? A four-week safety study

Abstract

BackgroundThough the nephrotoxicity and carcinogenicity of aristolochic acid (AA) are known, its safety in clinical usage is not clear. This study aims to evaluate the safety of Duhuo Jisheng Tang (DJT) in a four-week study to treat osteoarthritis (OA) of the knee.MethodsA qualitative and quantitative investigations on DJT were conducted. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were measured for participants with knee OA at their scheduled hospital visits. Each detected AEs was independently assessed for severity and causality by site investigators (Chinese medical doctors) and study nurses.ResultsA total of 71 eligible subjects were included in the clinical study where 287 AEs were reported. DJT did not contain detectable aristolochic acid (AA) under thin-layer chromatography (TLC) analysis and gas chromatography coupled with mass spectrometry (GC-MS). There were no significant changes in liver or kidney functions.ConclusionIn four-week use of DJT, no renal tubular damage, no severe incidences of AEs and adverse drug reactions (ADRs) were observed. The present study obtained safety data from active surveillance of DJT.

The Role of Chinese Medicine in the Treatment of Chronic Diseases in China

“…CM products (including CMM) could be applied according to the principles of diagnosis and treatment in CM, and based on that, CM practice can be considered as safe. There are various studies reporting the good safety of CM decoctions in the treatment of some chronic diseases [35][36][37][38][39]. Our survey also showed that both CM practitioners and patients believe that decoction is effective and safe (unpublished data).…”

Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

“…No acute renal tubular damage was observed after receiving four weeks of DJS (possibly a total of 1.34–2.01  μ g of AAI) during the study period [43]. Possibly, as compared to the reported case of the AA-related nephropathy that involved a patient ingesting 400 g of DJT for over four months, the ingestion levels of AA in our observational study were very low.…”

Frequencies and prescription patterns of traditional Chinese medicine use among elderly patients in Taiwan: A population-based study

“…An experimental study showed that Du-Huo-Ji-Sheng-Tang could regulate the expression of the vascular endothelial growth factor mRNA and hypoxia-inducible factor -1α mRNA and inhibit chondrocyte apoptosis in an animal model (Chen et al, 2011a). Although no drug reactions or adverse events were observed during the study period (Hsieh et al, 2010), further research is required to provide more evidence for establishing its efficacy and safety.…”