Jung-Nien Lai

Risks of Kidney Failure Associated With Consumption of Herbal Products Containing Mu Tong or Fangchi: A Population-Based Case-Control Study

BACKGROUND Taiwan has a remarkably high incidence of end-stage renal disease (ESRD). The objective of this study is to determine the association between prescribed herbal products containing aristolochic acid and ESRD. STUDY DESIGN Population-based case-control study. SETTING & PARTICIPANTS All new ESRD cases in Taiwan and a simple random sample (200,000 people) drawn from the national health insurance reimbursement database in 1997-2002. PREDICTOR Age; sex; hypertension; diabetes; cumulative doses of nonsteroidal anti-inflammatory drugs, acetaminophen, and adulterated herbal supplements potentially containing aristolochic acid before the development of chronic kidney disease; and indications for prescribing such herbs, including chronic hepatitis, chronic urinary tract infection, chronic neuralgia, or chronic musculoskeletal diseases. OUTCOMES & MEASUREMENTS Occurrence of ESRD through construction of multiple logistic regression models. RESULTS There were 36,620 new ESRD cases from 1998 through 2002. After exclusion of cases with chronic kidney disease diagnosed before July 1, 1997, there were 25,843 new cases of ESRD and 184,851 controls in the final analysis. Women, older age, hypertension, and diabetes were significantly associated with increased risks of the development of ESRD. After adjustment for known risk factors, cumulative doses >60 g of Mu Tong (OR, 1.47 [95% CI, 1.01-2.14] for 61-100 g; OR, 5.82 [95% CI, 3.89-8.71] for >200 g) or Fangchi (OR, 1.60 [95% CI, 1.20-2.14] for 61-100 g; OR, 1.94 [95% CI, 1.29-2.92] for >200 g) were associated with increased risk of the development of ESRD with a dose-response relationship. This relationship persisted when analyses were limited to participants who consumed <500 pills of nonsteroidal anti-inflammatory drugs and those without diabetes. LIMITATIONS No measurement of renal function, no contact with patients, over-the-counter sales were not recorded, and potential underestimation of exposure dose for cases and ORs. CONCLUSIONS Consumption of >60 g of Mu Tong or Fangchi from herbal supplements was associated with an increased risk of developing kidney failure.

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

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.

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.

Herbal medicines used during the first trimester and major congenital malformations : An analysis of data from a pregnancy cohort study

AbstractBackground: Major congenital malformations place a considerable burden on the affected child, the family and society. Any kind of medicine used during pregnancy might have a harmful impact; therefore, such practice has raised concerns. The objective of the current study was to explore the relationship between the use of herbal medicines by pregnant women during the first trimester of pregnancy and the risk of major congenital malformation in their live born infants. Methods: This was a cross-sectional analysis of data from a prospective pregnancy cohort, which was established between 1984 and 1987. To assemble the cohort, pregnant women of ≥26 weeks of gestation who came to the Taipei Municipal Maternal and Child Hospital in Taiwan for prenatal care were enrolled in the study and interviewed using a structured questionnaire. Detailed information, including herbal medicine use during different periods of pregnancy, was obtained during the interview. Past medical history, current obstetric data and details on conventional medicines used during pregnancy were abstracted from medical records. Data on birth weight, gestational duration and characteristics of live born infants were gathered from the Taiwan national birth register. Congenital malformation information was obtained from multiple sources: the newborn examination record (1984–7); the national death register (1984–2003); and Taiwan National Health Insurance data (1996–2000). Multiple logistic regression was used to estimate the odds ratio [OR] of major congenital malformation by herbal medicines used during the first trimester. Results: A total of 14 551 live births were analysed. After adjustment for confounding factors, taking huanglian during the first trimester of pregnancy was found to be associated with increased risk of congenital malformations of the nervous system (adjusted OR 8.62, 95% CI 2.54, 29.24). An-Tai-Yin was associated with an increased risk of congenital malformations of the musculoskeletal and connective tissues (adjusted OR 1.61, 95% CI 1.10, 2.36) and the eye (adjusted OR 7.30, 95% CI 1.47, 36.18). Conclusion: We found evidence for a possible link between the use of specific herbal medicines during the first trimester of pregnancy and increased risks of specific groups of congenital malformations. We could not investigate whether the adverse effects were related to direct toxicity from the herbal medicines, or were from misuse, contamination or uncontrolled confounding. Nonetheless, we would advise caution regarding use of herbal medicines during pregnancy, and we suggest that further investigation of these findings is warranted.

Integrating traditional Chinese medicine healthcare into diabetes care by reducing the risk of developing kidney failure among type 2 diabetic patients: a population-based case control study.

ETHNOPHARMACOLOGICAL RELEVANCE Our previous study indicated that the traditional Chinese medicine (TCM) formula Liu-Wei-Di-Huang-Wan, which consists of six type of herbs, namely Rehmannia glutinosa (Gaertn.) DC., root, dried; Cornus officinalis Siebold & Zucc., fructus, dried; Dioscorea oppositifolia L., root, dried; Alisma plantago-aquatica subsp. orientale (Sam.) Sam., tuber, dried; Paeonia × suffruticosa Andrews, bark, dried; Poria cocos (Fr.) Wolf., sclerotium, dried, is the most frequently prescribed herbal formula used to treat type 2 diabetes patients. The aim of the study was to evaluate the integration of TCM into diabetes care in terms of how it reduces the risk of developing kidney failure. MATERIALS AND METHODS The Taiwan׳s National Health Insurance Research Database (NHIRD) provided detailed information of health care services for each patient and covers 98% of all Taiwan residents as of 2007. Case and control subjects were selected from the NHIRD. Two multivariable logistic regression models were constructed in order to explore two types of exposure assessments including prescription of TCMs (model 1) and prescription of different estimated dosages of Liu-Wei-Di-Huang-Wan (model 2). RESULTS Using logistic regression model 1, having used TCMs was independently associated with a decreased risk of kidney failure by multivariable analysis (OR=0.69, 95% CI: 0.61-0.77). Using logistic regression model 2, there was no difference between non-Liu-Wei-Di-Huang-Wan TCM users and Liu-Wei-Di-Huang-Wan TCM users in terms of the risk of developing kidney failure. Furthermore, there was also no linear dose-response trend when we used exposure to prescribed Liu-Wei-Di-Huang-Wan as a continuous variable (for non-Liu-Wei-Di-Huang-Wan TCM users, OR=0.68, 95% CI: 0.60-0.77; for TCM users consuming 1-30 g of Liu-Wei-Di-Huang-Wan, OR=0.69, 95% CI: 0.54-0.87; for >30 g of Liu-Wei-Di-Huang-Wan, OR=0.84, 95% CI: 0.49-1.44). CONCLUSIONS Integrating TCM healthcare into diabetes care was found to be associated with a decreased risk of developing kidney failure. Having recognized the use of TCM, exploring any potential interactions and adverse effects, and integrating both technologies into a holistic treatment system may be beneficial to the relief of diabetic nephropathy on patients with type 2 diabetes.

Duhuo Jisheng Tang for treating osteoarthritis of the knee: a prospective clinical observation

BackgroundLittle scientific evidence supports the efficacy of herbal medicines in the treatment of degenerative arthritis of the knee. The purpose of this study is to evaluate both the efficacy and safety of a finished Chinese herbal preparation Duhuo Jisheng Tang (DJT) in reducing symptoms of degenerative osteoarthritis of the knee.MethodsA prospective follow-up study was carried out in two hospitals in Taipei between April and October 2005. Sixty-eight osteoarthritis patients, with symptoms diagnosed by radiologists, received DJT at a rate of 2.5 g, twice daily for four weeks. Baseline scores were measured on the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, followed by further measures at the end of weeks 1, 2 and 4. The World Health Organization Quality of Life (WHOQOL) assessment was undertaken as a secondary outcome, with pattern identification questionnaires being adopted. Regression models were constructed to explore the score differences between the baseline and at weeks 2 and 4 by various determinants including age, gender, body mass index (BMI), severity at baseline, use of rescue medication, aversion to cold and flaccidity of the lower back and knees.ResultsAmong the 68 participants, there were statistically significant reductions in the WOMAC index scores for pain, stiffness and physical functioning in the second and fourth weeks, with effects first appearing during week 2. By week 4, the mean WOMAC index scores had fallen from 22.2 (± 19.2) to 16.1 (± 16.2) for pain, from 28.1 (± 24.9) to 18.5 (± 20.3) for stiffness, and from 22.6 (± 18.0) to 18.2 (± 17.8) for physical functioning, while the global score for pain under the visual analogue scale (VAS) was reduced from 38.7 (± 21.5) to 27.8 (± 19.8).ConclusionIn the treatment of degenerative osteoarthritis of the knee, a 4-week therapy with the Chinese herbal preparation DJT reduced pain and stiffness and improved physical functioning, but it was less effective in treating flaccidity and aversion to cold.

Increased risk of hospitalization related to motor vehicle accidents among people taking zolpidem: a case-crossover study.

Background Several epidemiological and experimental studies have found a positive association between the risk of motor vehicle accidents (MVAs) and use of zopiclone and benzodiazepines. There is, however, little evidence of any risk of MVA attributable to the use of zolpidem 1 day before such accidents. We attempted to determine whether the use of zolpidem 1 day before is associated with an increased risk of an MVA. Methods Using a 1-million-person randomly sampled cohort from the Taiwan National Health Insurance reimbursement database, 12 929 subjects were identified as having been hospitalized between 1998 and 2004 due to an MVA. Using a case–crossover design, we selected the day before an MVA as the case period for each subject, and the 91st, 182nd, and 273rd days before the case period as 3 retrospective control periods. Conditional logistical regression models were constructed to calculate the odds ratio (OR) of having an MVA and the exposure of zolpidem 1 day before. We calculated doses of benzodiazepines, zopiclone, and zolpidem based on their defined daily dose. Results The adjusted OR for involvement in an MVA after taking 1 defined daily dose of zolpidem was 1.74 (95% confidence interval: 1.25–2.43). There were also positive effects for different washout periods and cumulative doses at 7, 14, 21, and 28 days before the occurrence of an MVA. Conclusions Use of zolpidem 1 day before might be associated with an increased risk of MVA. Thus, precautionary warnings should be provided when prescribing zolpidem.

Malignant ovarian germ cell tumors

Objectives: Fifty patients with malignant ovarian germ cell tumors, which accounts for 10.8% of all ovarian malignancies, were treated from 1977 through 1994. Their cases are reviewed. Methods: The histology includes endodermal sinus tumor (EST) in 15 patients, immature teratoma in 14, dysgerminoma in 13, and mixed germ cell tumor in eight. The mean age at presentation was 21.5 years and mean primary tumor diameter was 16 cm. All patients underwent surgery as the initial treatment, and 10 received more than one operation. Postoperative adjuvant chemotherapy was not given to cases with stage Ia immature teratoma and dysgerminoma. VAC (vincristine, actinomycin D, cyclophosphamide) and BVP (bleomycin, vinblastine, cisplatin) regimens were utilized in early 1980s for EST and advanced‐stage tumors of immature teratoma and dysgerminoma. BEP (bleomycin, etoposide, cisplatin) and EP (etoposide, cisplatin) regimens were applied in advanced‐stage disease and some stage I disease since 1990. VIP (VP‐16, ifosfamide, cisplatin) regimen was employed as salvage regimen in cases where other combinations failed. Results: α‐Fetoprotein (AFP) was elevated in every tumor containing endodermal sinus element, and AFP served as a good indicator for prediction of tumor recurrence. The follow‐up time ranged from 5 to 144 months with the mean of 54.5 months. Conclusions: The survival rate for EST was 54%, that for immature teratoma and dysgerminoma was 85% and 90%, respectively.

The Traditional Chinese Medicine Prescription Pattern of Endometriosis Patients in Taiwan: A Population-Based Study

Background. Traditional Chinese medicine (TCM), when given for symptom relief, has gained widespread popularity among women with endometriosis. The aim of this study was to analyze the utilization of TCM among women with endometriosis in Taiwan. Methods. The usage, frequency of service, and the Chinese herbal products prescribed for endometriosis, among endometriosis patients, were evaluated using a randomly sampled cohort of 1,000,000 beneficiaries recruited from the National Health Insurance Research Database. Results. Overall, 90.8% (N = 12, 788) of reproductive age women with endometriosis utilized TCM and 25.2% of them sought TCM with the intention of treating their endometriosis-related symptoms. Apart from the usage of either analgesics or more than one type of medical treatment, the odds of using TCM and Western medicine were similar in all types of conventional endometriosis treatment. However, endometriosis patients suffering from symptoms associated with endometriosis were more likely to seek TCM treatment than those with no symptoms. There were 21,056 TCM visits due to endometriosis and its related symptoms, of which more than 98% were treated with Chinese herbal products (CHPs). Conclusion. Gui-Zhi-Fu-Ling-Wan (Cinnamon Twig and Poria Pill) containing sedative and anti-inflammatory agents is the most commonly prescribed Chinese herbal formula mainly for the treatment of endometriosis-related symptomatic discomfort and the effects of these TCMs should be taken into account by healthcare providers.

The traditional Chinese medicine prescription pattern of patients with primary dysmenorrhea in Taiwan: a large-scale cross sectional survey.

ETHNOPHARMACOLOGICAL RELEVANCE Traditional Chinese medicine (TCM), when given for symptom relief, has gained widespread popularity among women with primary dysmenorrhea (PD). The aim of this study was to analyze the utilization of TCM among PD women in Taiwan. METHODS The use, service frequency and Chinese herbal products prescribed for PD women were evaluated using a cross sectional survey of 23,118 beneficiaries who were recruited from the National Health Insurance Research Database. The logistic regression method was employed to estimate the odds ratios (ORs) for utilization of TCM. RESULTS Overall, 53.4% (N=12,349) of PD women utilized TCM and 92.2% of them sought TCM with the intention of treating their menstruation-related pain symptoms. PD women who do not take prescription painkillers (aOR=35.75, 95% CI:33.20-38.49) were more likely to seek TCM treatment than those who took pain medication (aOR=1.00). There were a total of 213,249 TCM visits due to PD, of which more than 99% were treated with Chinese herbal products (CHPs). Dang-gui-shao-yao-san (Tangkuei and Peony Powder) was the most frequently prescribed formula for treating PD. CONCLUSION Primary dysmenorrhea women tended to use Chinese herbal products to deal with pain-related symptoms, rather than use acupuncture. Dang-gui-shao-yao-san, which containing both sedative and anti-inflammatory agents, is the most commonly prescribed Chinese herbal formula for the treatment of PD. A well designed, double-blind, randomized, placebo-controlled study to further evaluate the efficacy of Dang-gui-shao-yao-san as a treatment women with primary dysmenorrhea is warranted.