PMID- 17078102
OWN - NLM
STAT- MEDLINE
DCOM- 20070226
LR  - 20061130
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 15
IP  - 12
DP  - 2006 Dec
TI  - Development of active safety surveillance system for traditional Chinese 
      medicine: an empirical study in treating climacteric women.
PG  - 889-99
AB  - PURPOSE: Traditional Chinese medicines (TCM) prescribed by doctors are regularly 
      reimbursed by the National Health Insurance (NHI) in Taiwan. The safety of TCM 
      should undergo the same scrutiny that most western medicines do. This study was 
      to monitor adverse events (AEs) associated with a new mixture of TCM, TMN-1, used 
      to treat climacteric symptoms. METHODS: For this multi-center, prospective 
      observational study, we recruited 134 women with climacteric symptoms. During 
      this 12-week study, the subjects made nine visits, took TMN-1 three times a day, 
      and received routine hematologic tests, biochemical tests, and tests for 
      gynecologically relevant hormones at baseline and after 4 and 12 weeks of 
      beginning medication. At every visit, the subjects were asked by questionnaire 
      about any AEs. All AEs were examined through a process of causality assessment 
      (CA) by a research team. RESULTS: In total, we recorded 203 AEs, in order of 
      decreasing incidences--cough, pharyngitis, rhinitis, abdominal pain, abdominal 
      fullness, diarrhea, and pruritus with incidence rates of 2.57, 2.47, 1.88, 1.78, 
      1.68, 1.58, and 1.58 per 10(3) person-days, respectively. Most AEs were 
      tolerable. Five of the AEs were judged to be "probable" adverse drug reactions 
      (ADRs): Two events of diarrhea and one event each of nausea, abdominal pain, and 
      abdominal fullness. CONCLUSION: This study demonstrates the effectiveness using 
      active safety surveillance to document safety of TCMs. This surveillance system 
      could probably be useful to document the safety of other alternative or 
      complementary medicines.
FAU - Hsieh, Shu-Ching
AU  - Hsieh SC
AD  - Institute of Occupational Medicine and Industrial Hygiene, National Taiwan 
      University College of Public Health, Taipei, Taiwan.
FAU - Lai, Jung-Nien
AU  - Lai JN
FAU - Chen, Pau-Chung
AU  - Chen PC
FAU - Chen, Huey-Jen
AU  - Chen HJ
FAU - Wang, Jung-Der
AU  - Wang JD
LA  - eng
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Hormones)
SB  - IM
MH  - Adult
MH  - Climacteric/*drug effects
MH  - Drugs, Chinese Herbal/adverse effects
MH  - Female
MH  - Hormones/blood
MH  - Humans
MH  - Medicine, Chinese Traditional/*adverse effects/*standards
MH  - Nurses
MH  - *Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Taiwan
EDAT- 2006/11/02 09:00
MHDA- 2007/02/27 09:00
CRDT- 2006/11/02 09:00
PHST- 2006/11/02 09:00 [pubmed]
PHST- 2007/02/27 09:00 [medline]
PHST- 2006/11/02 09:00 [entrez]
AID - 10.1002/pds.1340 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2006 Dec;15(12):889-99. doi: 10.1002/pds.1340.