PMID- 24159351 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140624 LR - 20220408 IS - 1741-427X (Print) IS - 1741-4288 (Electronic) IS - 1741-427X (Linking) VI - 2013 DP - 2013 TI - Observational studies on evaluating the safety and adverse effects of traditional chinese medicine. PG - 697893 LID - 10.1155/2013/697893 [doi] LID - 697893 AB - 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. FAU - Lai, Jung-Nein AU - Lai JN AD - Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taipei City 112, Taiwan ; Department of Chinese Medicine, Taipei City Hospital, Yangming Branch, Taipei City 111, Taiwan. FAU - Tang, Jin-Ling AU - Tang JL FAU - Wang, Jung-Der AU - Wang JD LA - eng PT - Journal Article PT - Review DEP - 20130914 PL - United States TA - Evid Based Complement Alternat Med JT - Evidence-based complementary and alternative medicine : eCAM JID - 101215021 PMC - PMC3789390 EDAT- 2013/10/26 06:00 MHDA- 2013/10/26 06:01 PMCR- 2013/09/14 CRDT- 2013/10/26 06:00 PHST- 2013/04/07 00:00 [received] PHST- 2013/06/23 00:00 [revised] PHST- 2013/08/10 00:00 [accepted] PHST- 2013/10/26 06:00 [entrez] PHST- 2013/10/26 06:00 [pubmed] PHST- 2013/10/26 06:01 [medline] PHST- 2013/09/14 00:00 [pmc-release] AID - 10.1155/2013/697893 [doi] PST - ppublish SO - Evid Based Complement Alternat Med. 2013;2013:697893. doi: 10.1155/2013/697893. Epub 2013 Sep 14.