Research
Is Duhuo Jisheng Tang containing Xixin safe? A four-week safety study
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* Corresponding author: Jung-Der Wang jdwang@ntu.edu.tw
1 Division of Health Technology Assessment, Center for Drug Evaluation, Taipei 100, Taiwan
2 Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University, Taipei 100, Taiwan
3 Department of Obstetrics and Gynecology, Department of Chinese Medicine, Taipei City Hospital, Yangming Branch, Taipei 100, Taiwan
4 Institute of Traditional Medicine, School of Medicine, National Yangming University, Taipei 100, Taiwan
5 Division of Traumatology, Chinese Medicine Branch, Taipei City Hospital, Taipei 100, Taiwan
6 Division of Chinese Internal Medicine, Chinese Medicine Branch, Taipei City Hospital, Taipei 100, Taiwan
7 Department of Internal Medicine, National Taiwan University Hospital, Taipei 100, Taiwan
8 Department of Environmental and Occupational Medicine, National Taiwan University Hospital, Taipei 100, Taiwan
Chinese Medicine 2010, 5:6 doi:10.1186/1749-8546-5-6
Published: 11 February 2010Abstract
Background
Though 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.
Methods
A 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.
Results
A 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.
Conclusion
In 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.