Safety Surveillance on Traditional Chinese Herbal Medicine and the Related Empirical Studies
Date Issued
2008
Date
2008
Author(s)
Shu-Ching, Hsieh
Abstract
Despite the absence of safety data, the worldwide use of Chinese herbal products (CHPs) is on the increase; the rising number of reports of herb-related toxic events therefore indicates an urgent need to establish safety profiles for such products. In this thesis, we tried to establish an active safety surveillance system and take use of databases analysis to supplement the current pharmacovigilance function on traditional Chinese medicine. We also conducted four empirical studies to test the feasibilities of these two approaches. tudy 1: his is a multi-center and prospective observational study. We recruited 134 women with climacteric symptoms. During 12-week study period, the subjects made 9 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 adverse events. All adverse events were examined through a process of causality assessment by a research team. n total, we recorded 203 adverse events, 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 adverse events were tolerable. Five of the adverse events were judged to be “probable” adverse drug reactions: 2 events of diarrhea and 1 event each of nausea, abdominal pain, and abdominal fullness. tudy 2: n this study, we conducted a qualitative/quantitative investigation on Dwu-Hwo-Jih-Sheng-Tang (DHJST) along with a prospective observational study. During the study period, we actively monitor adverse events (AE) and adverse drug reactions (ADR) amongst patients who took 2.5 grams of DHJST twice a day for four weeks. A list of AEs and complete blood counts, liver and kidney function tests were measured at the scheduled visits.Although containing Xi xin, DHJST did not contain detectable aristolochic acid under thin-layer chromatography analysis and gas chromatography coupled with mass spectrometry. A total of 71 eligible subjects were included in the clinical study. 287 AEs were reported, all of which seemed tolerable. The incidence rates (per 103 person-days) for the most often reported AEs were: rashes (14.5), abdominal fullness (12.9), coughs (12.4), somnolence (11.9), muscle cramps (10.3) and diarrhea (10.3). The probable ADRs included single events of change in skin color, flush, tachycardia and diarrhea. There were no significant changes in liver or kidney functions. oth studies demonstrate the effectiveness using active safety surveillance to document safety of traditional Chinese medicines. This surveillance system could probably be useful to document the safety of other alternative or complementary medicines. tudy 3:e carried out a cross-sectional analysis on a cohort of 200,000 patients, based on 2004 data from the National Health Insurance (NHI) reimbursement database. Data mining techniques were applied to explore CHP co-prescription patterns. total of 46,938 patients had been prescribed CHPs on at least one occasion in 2004. Patients using CHPs were generally female and middle-aged, made more outpatient visits, had fewer hospitalizations and consumed more medical resources than non-users of CHPs. A total of 1,073,030 CHPs were contained within 220,123 prescriptions, for which acute nasopharyngitis was the most common indication. Yan hu suo and Jia Wei Xiao Yao San were the most frequently prescribed single herb (SH) and herbal formula (HF), respectively. The results of the data mining showed that the best predictions were provided by co-prescriptions of ‘Mo yao and Ru xiang’, ‘Ye jiao teng and Suan Zao Ren Tan’ and ‘Dang Gui Nian Tong Tang and Shu Jing Huo Xue Tang’ in the groups of SH-SH, SH-HF and HF-HF, respectively. Such combination prescriptions of more than two herbal formulas warrant future studies to secure their efficacy and safety.tudy 4: longitudinal analysis was carried out on a randomly sampled cohort of 200,000 patients using 1997-2003 data obtained from the Taiwan NHI reimbursement database. uring the seven-year study period, a total of 78,644 patients had been prescribed with SAA (suspected aristolochic acid containing) CHPs on at least one occasion, the majority of whom were females and/or middle-aged. A total of 526,867 prescriptions were issued containing 1,218 licensed SAA CHP items. Over 85 per cent of SAA-exposed patients took less than 60gms of SAA herbs; however, about seven per cent were exposed to a cumulative dose in excess of 100gms of Xi xin, Mu tong or Ma dou ling. Diseases of the respiratory and musculoskeletal system were the most common indications for the SAA CHP prescriptions. The most frequently prescribed SAA CHPs were Shu jing huo xie tang, Chuan qiong cha diao san, and Long dan xie gan tang, respectively containing Fang ji, Xi xin, and Mu tong.n study 3, it provides national-level CHP prescription profiles and utilization rates, and documents, for the first time, HF-HF combination prescriptions in Chinese medicine practices in Taiwan. To further target the CHPs of concern, the study 4 showed that about one-third of people in Taiwan have, at some time, been prescribed with SAA CHPs, and although the cumulated dosages may not be large.t is therefore concluded that future studies are indicated to safeguard CHP usage.
Subjects
active safety surveillance
adverse event
aristolochic acid
prescription patterns
cohort database analysis
Chinese herbal products
data mining
SDGs
Type
thesis
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