scholarly journals Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Jung-Nein Lai ◽  
Jin-Ling Tang ◽  
Jung-Der Wang
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Effects ◽  
Observational Studies ◽  
Aristolochic Acid ◽  
National Health Insurance System ◽  
Tract Cancer ◽  
Increased Risk ◽  
Reimbursement Database ◽  
Complete Blood Counts

Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM).Methods. We have proactively monitored the safety profiles ofDuhuo Jisheng Tang (DJT),Suan Zao Ren Tang (SZRT), and TMN-1. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens.Results. A total of 221, 287, and 203 AEs were detected afterSZRT,DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related toSZRTtreatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such asMu Tongand an increased risk of CKD, ESRD, and urinary tract cancer.Conclusion.Prospective and retrospectiveobservational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies.

Development of Rapid Advice Guidelines for the Treatment of Coronavirus Disease 2019 with Traditional Chinese Medicine

2020 ◽  
Vol 48 (07) ◽  
pp. 1511-1521
Author(s):  
Ning Liang ◽  
Huizhen Li ◽  
Jingya Wang ◽  
Liwen Jiao ◽  
Yanfang Ma ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Observational Studies ◽  
The Body ◽  
Assessment Development ◽  
Evidence Collection ◽  
Novel Coronavirus ◽  
Grade Methodology ◽  
Evidence Based Guidelines

The worldwide spread of the 2019 novel coronavirus has become a profound threat to human health. As the use of medication without established effectiveness may result in adverse health consequences, the development of evidence-based guidelines is of critical importance for the clinical management of coronavirus disease (COVID-19). This research presents methods used to develop rapid advice guidelines on treating COVID-19 with traditional Chinese medicine (TCM). We have followed the basic approach for developing WHO rapid guidelines, including preparing, developing, disseminating and updating each process. Compared with general guidelines, this rapid advice guideline is unique in formulating the body of evidence, as the available evidence for the treatment of COVID-19 with TCM is from either indirect or observational studies, clinical first-hand data together with expert experience in patients with COVID-19. Therefore, our search of evidence not only focuses on clinical studies of treating COVID-19 with TCM but also of similar diseases, such as pneumonia and influenza. Grading of recommendations assessment, development and evaluation (GRADE) methodology was adopted to rate the quality of evidence and distinguish the strength of recommendations. The overall certainty of the evidence is graded as either high, moderate, low or very low, and to give either “strong” or “weak” recommendations of each TCM therapy. The output of this paper will produce the guideline on TCM for COVID-19 and will also provide some ideas for evidence collection and synthesis in the future development of rapid guidelines for COVID-19 in TCM as well as other areas.

scholarly journals Traditional Chinese medicine: Pivotal role of the spleen in the metabolism of aristolochic acid I in rats is dependent on oatp2a1

2016 ◽  
Vol 14 (4) ◽  
pp. 3243-3250 ◽  
Author(s):  
Ting Xiang ◽  
Zhangbin Yang ◽  
Baoguo Sun ◽  
Haoxuan Luo ◽  
Shijun Zhang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Aristolochic Acid ◽  
Pivotal Role ◽  
Aristolochic Acid I

scholarly journals Traditional Chinese Medicine Decreases the Stroke Risk of Systemic Corticosteroid Treatment in Dermatitis: A Nationwide Population-Based Study

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Kao-Sung Tsai ◽  
Chia-Sung Yen ◽  
Po-Yuan Wu ◽  
Jen-Huai Chiang ◽  
Jui-Lung Shen ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Stroke Risk ◽  
Systemic Corticosteroid ◽  
Strong Association ◽  
Corticosteroid Treatment ◽  
Epidemiological Studies ◽  
Population Based ◽  
Rank Test ◽  
Increased Risk

Epidemiological studies have shown a strong association between dermatitis and stroke. Systemic corticosteroid, the mainstay treatment for dermatitis, could enhance the atherosclerotic process. Traditional Chinese Medicine (TCM) has been used for dermatitis to decrease the side effects of corticosteroid. However, the different stroke risk in dermatitis patients treated with systemic corticosteroid or TCM remains unclear. This study identified 235,220 dermatitis patients and same comorbidity matched subjects between 2000 and 2009 from database of NHRI in Taiwan. The two cohorts were followed until December 31, 2011. The primary outcome of interest was new diagnosis of stroke. The crude hazard ratio (HR) for future stroke among dermatitis patients treated with systemic corticosteroid was 1.40 (95% CI, 1.34–1.45;P<0.0001) and TCM was 1.09 (95% CI, 1.05–1.13;P<0.0001). The log-rank test showed a higher cumulative incidence of ischemic stroke in the patient treated with only systemic corticosteroid group than that treated with systemic corticosteroid and TCM, only TCM, and neither systemic corticosteroid nor TCM in the matched cohort during the follow-up period (P<0.0001). We demonstrated that patients treated with systemic corticosteroid had an increased risk of stroke and that the risk probably decreased by TCM treatment.

scholarly journals Nephroprotective Role of Zhibai Dihuang Wan in Aristolochic Acid-Intoxicated Zebrafish

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Ping-Hsun Lu ◽  
Hsun-Yao Lee ◽  
Yan-Liang Liou ◽  
Sheng-Fen Tung ◽  
Ko-Li Kuo ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Aristolochic Acid ◽  
Transgenic Zebrafish ◽  
Herbal Formula ◽  
Zebrafish Model ◽  
Green Fluorescent ◽  
Nephroprotective Effect ◽  
Kidney Malformations

Zhibai Dihuang Wan (ZDW) is an eight-herbal formula of traditional Chinese medicine. Clinically, it regulated immune activity and was used to treat diabetes and renal disease. In this study, we aimed to explore the nephroprotective effect of ZDW in an aristolochic acid- (AA-) intoxicated zebrafish model. We used a green fluorescent kidney transgenic zebrafish to evaluate the nephroprotective effects of ZDW by recording subtle changes in the kidney. Our results demonstrated that ZDW treatment can attenuate AA-induced kidney malformations (60% for AA-treated, 47% for pretreatment with ZDW, and 17% for cotreatment ZDW with AA, n = 50 ). Furthermore, we found that the expression levels of tnfα and mpo were decreased either in pretreatment or cotreatment groups. In conclusion, our findings revealed that AA-induced nephrotoxicities can be attenuated by ZDW. Therefore, we believe that zebrafish represent an efficient model for screening AA-protective Chinese medicine.

scholarly journals Systemic adverse effects from inhaled corticosteroid use in asthma: a systematic review

2020 ◽  
Vol 7 (1) ◽  
pp. e000756
Author(s):  
Roshni Patel ◽  
Sumrah A Naqvi ◽  
Chris Griffiths ◽  
Chloe I Bloom
Keyword(s):  
Adverse Effects ◽  
Observational Studies ◽  
Respiratory Infections ◽  
Bone Fractures ◽  
Risk Of Bias ◽  
Systemic Effects ◽  
Inhaled Corticosteroid ◽  
Mineral Density ◽  
Increased Risk ◽  
Ocular Disorders

BackgroundOral corticosteroid use increases the risk of systemic adverse effects including osteoporosis, bone fractures, diabetes, ocular disorders and respiratory infections. We sought to understand if inhaled corticosteroid (ICS) use in asthma is also associated with increased risk of systemic effects.MethodsMEDLINE and Embase databases were searched to identify studies that were designed to investigate ICS-related systemic adverse effects in people with asthma. Studies were grouped by outcome: bone mineral density (BMD), respiratory infection (pneumonia or mycobacterial infection), diabetes and ocular disorder (glaucoma or cataracts). Study information was extracted using the PICO checklist. Risk of bias was assessed using the Cochrane Risk of Bias tool (randomised controlled trials) and Risk of Bias In Non-randomised Studies of Interventions-I tool (observational studies). A narrative synthesis was carried out due to the low number of studies reporting each outcome.ResultsThirteen studies met the inclusion criteria, 2 trials and 11 observational studies. Study numbers by outcome were: six BMD, six respiratory infections (four pneumonia, one tuberculosis (TB), one non-TB mycobacteria), one ocular disorder (cataracts) and no diabetes. BMD studies found conflicting results (three found loss of BMD and three found no loss), but were limited by study size, short follow-up and lack of generalisability. Studies addressing infection risk generally found positive associations but suffered from a lack of power, misclassification and selection bias. The one study which assessed ocular disorders found an increased risk of cataracts. Most studies were not able to fully adjust for known confounders, including oral corticosteroids.ConclusionThere is a paucity of studies assessing systemic adverse effects associated with ICS use in asthma. Those studies that have been carried out present conflicting findings and are limited by multiple biases and residual confounding. Further appropriately designed studies are needed to quantify the magnitude of the risk for ICS-related systemic effects in people with asthma.

scholarly journals Relationship betweenEGF,TGFA, andEGFRGene Polymorphisms and Traditional Chinese Medicine ZHENG in Gastric Cancer

2013 ◽  
Vol 2013 ◽  
pp. 1-13 ◽  
Author(s):  
Junfeng Zhang ◽  
Zhen Zhan ◽  
Juan Wu ◽  
Chunbing Zhang ◽  
Yaping Yang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Stasis ◽  
Syndrome Differentiation ◽  
Nucleotide Polymorphisms ◽  
Important Principle ◽  
Increased Risk ◽  
Genetic Mechanisms ◽  
Herbal Formulae

In traditional Chinese medicine (TCM), correct syndrome differentiation is the most important principle guiding the prescription of Chinese herbal formulae for the treatment of gastric cancer (GC). We aimed to reveal the genetic mechanisms underlying GC syndrome differentiation (ZHENG) in a population of 387 GC patients. Twenty-nine single nucleotide polymorphisms (SNPs) inEGF,TGFA, andEGFRwere investigated. Two SNPs, rs11466285 inTGFAand rs884225 inEGFR, were significantly associated with the distribution of ZHENG(P<0.05). The rs11466285 TT genotype increased the risk of damp heat with toxin (DHT) and deficiency of bothQiandyin(DQY) compared with obstruction of blood stasis (OBS). The rs884225 AA genotype could increase the risk of DQY and deficiency of bothQiand blood (DQB) compared withyindeficiency due to stomach heat (YDSH). Parallel comparison among the SNPs and syndrome types revealed that DQB was distinct from YDSH, disharmony between the liver and stomach, stagnation of phlegm muddiness (SPM), OBS, and other syndromes at several SNP loci(P<0.05). The rs11466285 TT and rs884225 AA genotypes exhibit increased risk of DQB compared with OBS and SPM(P<0.05), respectively. In conclusion, the formation of GC ZHENG was related toEGF,TGFA, andEGFRgene polymorphisms.

scholarly journals Rapid Analysis of Aristolochic Acid Analogues in Traditional Chinese Patent Medicine by LC-MS/MS

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Jing Liu ◽  
Yang Liu ◽  
Yingxue Wu ◽  
Zhong Dai ◽  
Shuangcheng Ma
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Aristolochic Acid ◽  
Gene Mutations ◽  
Aristolochic Acids ◽  
Potential Safety ◽  
Akebiae Caulis ◽  
The One ◽  
Traditional Chinese Patent Medicine ◽  
Aristolochic Acid I

Aristolochic acids have been demonstrated to have renal toxicity, cause carcinogenesis, and may cause gene mutations. A series of risk control measurements have been adopted worldwide since 1990s. Some varieties of traditional Chinese medicine with high content of aristolochic acids have been banned in China. However, some species containing aristolochic acids in microscale are still in use. In recent years, with the continuous awareness of drug safety, the aristolochic acid analogues were generally considered to be of potential safety risks. Among these constituents, aristolochic acid I is still the one with most studies. Therefore, in addition to aristolochic acid I, it is necessary to establish an accurate and rapid method to determine other aristolochic acid analogues. LC-MS/MS methods based on multireaction monitoring mode was established to simultaneously determine 9 aristolochic acid analogues including 5 aristolochic acids and 4 aristolactams for the first time. Furthermore, the method was applied for Long dan Xie gan Pill, a traditional complex compound preparation with a long history for treatment of diseases including hepatochlic hygropyrexia, dizziness, tinnitus, and deafness. It has attracted widespread attention because of the aristolochic acid nephropathy. The crude drug Caulis Aristolochiae manshuriensis (Guanmutong) collected in the prescription was replaced by Akebiae Caulis (Mutong), and the established method helps to understand the product safety on market. As a result, aristolochic acid I, aristolochic acid Iva, and aristolactam I were detected and determined in one batch of Long dan Xie gan Pill among 25 batches of samples. It provided practical approach to demonstrate trace aristolochic acids and aristolactams. It was beneficial to control the safety of related traditional Chinese medicine products.

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