Development of active safety surveillance system for traditional Chinese medicine: An empirical study in treating climatic women

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 10³ 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.