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Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 697893, 9 pages
Review Article

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

1Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taipei City 112, Taiwan
2Department of Chinese Medicine, Taipei City Hospital, Yangming Branch, Taipei City 111, Taiwan
3Center for Evidence Based Medicine, Peking University Health Science Centre, Peking University, Beijing 100871, China
4Division of Epidemiology, School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong
5Department of Public Health, College of Medicine, National Cheng Kung University, Tainan City 701, Taiwan

Received 7 April 2013; Revised 23 June 2013; Accepted 10 August 2013

Academic Editor: Lixing Lao

Copyright © 2013 Jung-Nein Lai et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM). Methods. We have proactively monitored the safety profiles of Duhuo Jisheng Tang (DJT), Suan Zao Ren Tang (SZRT), and TMN-1. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens. Results. A total of 221, 287, and 203 AEs were detected after SZRT, DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related to SZRT treatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such as Mu Tong and an increased risk of CKD, ESRD, and urinary tract cancer. Conclusion. Prospective and retrospective observational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies.