Increased risks of chronic kidney disease associated with prescribed Chinese herbal products suspected to contain aristolochic acid.

AIM: Nephropathy associated with aristolochic acid (AA) has been documented by human and animal studies. Ancient Chinese herbology claimed to reduce toxicity in their mixtures. It was the objective of this study to determine the risk of chronic kidney disease (CKD) associated with AA-related Chinese herbal products (CHP) or mixtures of herbs in a national cohort. METHODS: A retrospective follow-up study was conducted, using a systematic random sample (200 000 people) in the National Health Insurance reimbursement database during 1997-2002. The incidence rates of CKD and end-stage renal disease (ESRD) were calculated for the whole sample and those that had used CHP suspected to contain AA. Cox regression models were constructed to control potential confounders, including age, sex, hypertension, diabetes mellitus, and use of non-steroidal anti-inflammatory drugs and acetaminophen. RESULTS: A total of 199 843 persons were included in the final analysis, 102 464 (51.3%) men and 97 379 (48.7%) women, with an average incidence rate of 1964/10(6) person-years for CKD and 279/10(6) person-years for ESRD. After controlling other risk factors, the hazard ratios for development of CKD seemed to increase for patients that had consumed more than 30 g Mu-Tong, and more than 60 g Fangchi. CONCLUSION: Prescription of more than 30 g Mu-Tong or more than 60 g Fangchi CHP was associated with an increased risk of developing CKD. In addition to prohibiting the use of Guan-Mu-Tong and Guang-Fangchi, patients who have used these CHP should continue to be followed up.

Prescription profile of potentially aristolochic acid containing Chinese herbal products: an analysis of National Health Insurance data in Taiwan between 1997 and 2003.

BACKGROUND: Some Chinese herbal products (CHPs) may contain aristolochic acid (AA) or may be adulterated by the herbs suspected of containing AA which is nephrotoxic and carcinogenic. This study aims to identify the risk and the prescription profile of AA-containing CHPs (AA-CHPs) in Taiwan. METHODS: A longitudinal analysis was conducted on a randomly sampled cohort of 200,000 patients using the data from the National Health Insurance (NHI) in Taiwan between 1997 and 2003. RESULTS: During the 7-year study period, 78,644 patients were prescribed with AA-CHPs; most patients were females, or middle-aged, or both. A total of 526,867 prescriptions were made to use 1,218 licensed AA-CHPs. Over 85% of the AA-exposed patients took less than 60 g of AA-herbs; however, about 7% were exposed to a cumulated dose of over 100 g of Radix et Rhizoma Asari (Xixin), Caulis Akebiae (Mutong) or Fructus Aristolochiae (Madouling). Patients of respiratory and musculoskeletal diseases received most of the AA-CHP prescriptions. The most frequently prescribed AA-CHPs Shujing Huoxie Tang, Chuanqiong Chadiao San and Longdan Xiegan Tang, containing Radix Stephaniae Tetrandrae, Radix et Rhizoma Asari and Caulis Akebiae, respectively. CONCLUSION: About one-third of people in Taiwan have been prescribed with AA-CHPs between 1997 and 2003. Although the cumulated doses were not large, further actions should be carried out to ensure the safe use of AA-CHPs.

The prescribing of Chinese herbal products in Taiwan: a cross-sectional analysis of the national health insurance reimbursement database.

PURPOSE: The consumption of Chinese herbal products (CHPs) is increasing exponentially. However, the scientific evidence is lacking and there is an urgent requirement for detailed pharmacoepidemiological information on CHP usage. This study was to investigate CHP prescription patterns in Taiwan. METHODS: We 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. RESULTS: A 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. CONCLUSIONS: This study provides national-level CHP prescription profiles and utilization rates, and documents, for the first time, HF-HF prescription combinations in Chinese medicine (CM) practices in Taiwan. We conclude that more studies are needed to validate the safety and effectiveness of CHP prescriptions.