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Accumulation of Arsenic Speciation and In Vivo Toxicity Following Oral Administration of a Chinese Patent Medicine Xiao-Er-Zhi-Bao-Wan in Rats.

ABSTRACT: Realgar-containing traditional Chinese medicines such as Xiao-Er-Zhi-Bao-Wan (XEZBW), have been widely used for thousands of years. However, events associated with arsenic-induced ailments have increasingly become a public concern. To address the toxicity of XEZBW, we studied the histopathology and blood biochemistry of rats exposed to XEZBW using technology like high-performance liquid chromatography-inductively coupled mass spectrometry to determine arsenic speciation. Our results demonstrated that dimethylarsinic acid (DMA) increased from 18.57 ± 7.45 to 22.74 ± 7.45 ng/g in rat kidney after oral administration for 7 and 14 days, which was 10-fold higher than the levels observed in controls. Trivalent arsenite As(III) showed a large increase on day 7 (26.99 ± 1.98 ng/g), followed by a slight decrease on day 14 (13.67 ± 6.48 ng/g). Total arsenic levels on day 7 (185.52 ± 24.56 ng/g) and day 14 (198.57 ± 26.26 ng/g) were nearly twofold higher than that in the control group (92.77 ± 14.98 ng/g). Histopathological analysis showed mild injury in the liver and kidney of rats subjected to oral administration of realgar for 14 days. As in the XEZBW groups, a mild injury in these organs was observed after administration for 14 days. This study inferred that the toxicity of arsenic was concentration- and time-dependent. The accumulation of DMA, a byproduct of choline metabolism, was responsible for inducing higher toxicity. Therefore, we concluded that measuring the levels of DMA, instead of total arsenic, might be more suitable for evaluating the toxicity of realgar-containing traditional Chinese medicines.

SUBMITTER: Luo J

PROVIDER: S-EPMC5524916 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Project description:ObjectivesBy performing an overview of systematic reviews and meta-analyses of the efficacy and safety of oral Chinese patent medicine combined with conventional therapy in the treatment of heart failure, to evaluate the reliability and applicability of the conclusions of the current studies and provide evidence for clinical decision-making.MethodsSystematic reviews and meta-analyses of oral Chinese patent medicine combined with conventional therapy treating heart failure were searched based on standardized search strategy in six electronic databases including PubMed, Embase, Cochrane Library (No. 2 of 2020), China National Knowledge Infrastructure (CNKI), Wanfang Database (Wanfang), and Chinese Scientific Journal Database (VIP) from inception to February 2020. The literature was independently screened and extracted by two researchers. The methodological quality of the included literature was evaluated using the AMSTAR-2 (A Measurement Tool to Assess Systematic Review 2). If necessary, we would summarize the original research data and further perform data synthesis using RevMan software (version 5.3), and the evidence quality of the included literature was graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.ResultsA total of 38 systematic reviews and meta-analyses were included, involving 11 kinds of oral Chinese patent medicines, including Qili Qiangxin Capsules (11/38), Qishen Yiqi Dropping Pills (9/38), Shexiang Baoxin Pills (4/38), Wenxin Keli (2/38), Tongxinluo Capsules (2/38), Compound Danshen Dripping Pills (2/38), Zhenyuan Capsules (3/38), Buyi Qiangxin Tablets (2/38), Yangxinshi Tablets (1/38), Xuezhikang (1/38), and Yixinshu Capsules (1/38). The methodological quality of all literature was rated as critically low. The grading of the quality of evidence was 43 moderate, 101 low, and 40 very low. The main reason for the degradation of evidence quality was the risk of bias. In the evaluation of efficacy, there was no statistically significant difference between the two groups in terms of mortality, which is a piece of low-quality evidence. Qili Qiangxin Capsules or Qishen Yiqi Dripping Pills combined with conventional therapy can significantly reduce the hospitalization rate of patients with chronic heart failure, and the quality of the evidence is moderate. The overall efficacy of oral Chinese patent medicine combined with conventional therapy in improving the clinical symptoms, quality of life, exercise endurance, laboratory tests, physical examination, and other indicators of patients with heart failure is confirmed. In the evaluation of safety, there was no significant difference between the two groups.ConclusionsOral Chinese patent medicine combined with conventional therapy has good clinical efficacy and safety in the treatment of heart failure. However, due to its low level of methodological quality and evidence quality, the current evidence-based conclusions need to be further verified.

Project description:ObjectiveTo access the comparative effectiveness and safety of different oral Chinese patent medicine (OCPM) versus oxaliplatin-based chemotherapy regimen (C) alone for colorectal cancer (CRC) through network meta-analysis (NMA).MethodsSeveral electronic databases were searched for randomized controlled trials (RCTs) concentrated on the use of OCPM to treat CRC with C from the inception of the databases to January 10, 2021. We performed frequentist NMA and indirect comparison to compare study outcomes from the included RCTs. The risk of bias of each study was assessed using the Cochrane risk of bias tool. Confidence in evidence was assessed using Confidence in Network Meta-Analysis (CINeMA).ResultsA total of 31 RCTs with 1985 participants comparing 10 OCPM, namely, Antike (ATK), Shenyi (SY), Huachansu (HCS), Boerning (BEN), Xiaoaiping (XAP), Jinlong (JL), Compound matrine (CC), Pingxiao (PX), Xihuang pill (XHW), Kangaiping (KAP) were identified. The methodological quality of included RCTs was not very high. The results of the NMA showed that the comparisons were all indirect. Among diverse OCPM, ATK + C had the highest objective response rate (ORR) with a P-score of .63 with risk ratio (RR) of 1.37 (95% CI 1.12-1.66); with a RR of 1.96 (1.26-3.05), SY + C had the highest performance status with a P-score of .73; KAP + C had the lowest nausea and vomiting with a P-score of .91 and with a RR of 0.29 (0.10-0.79); and JL + C had lowest leukopenia with a P-score of .95 with a RR of 0.47 (0.31-0.72). The results of pairwise comparison suggested no difference in outcomes among 10 kinds of OCPM + C. The comparison-adjusted funnel plots suggested that there might not be small-study effects for outcomes. According to the CINeMa approach, the confidence rating of this NMA ranged from "very low" to "low" for various comparisons.ConclusionBased on the NMA, ATK + C, SY + C, KAP + C and JL + C were associated with more preferable and options for CRC patients when referring to ORR, performance status, nausea and vomiting, and leukopenia, respectively. However, owing to the limitations of this research, the above conclusions require further verification by more high-quality RCTs.Prospero registrationCRD42020160658.

Project description:Background:Traditional Chinese Patent Medicine (TCPM) is now being used more and more extensively for primary hypertension in China. However, the comparative efficacy and safety of it need more clarified evidence. Thus, we conducted a Bayesian network meta-analysis to compare TCPMs with other interventions. Methods:We searched China National Knowledge Infrastructure (CNKI), WanFang Data, PubMed, Embase, and Cochrane Library from inception to April 2019 for randomized controlled trials (RCTs) with diagnosis of primary hypertension that compared the efficacy of TCPMs with antihypertension drugs (ADs). Two researchers screened literature, extracted data, and evaluated risk of bias independently. The primary outcomes were systolic blood pressure (SBP) and diastolic blood pressure (DBP). The secondary outcomes were adverse effects (AEs), total cholesterol (TC), and triglyceride (TG). We used the Bayesian network meta-analysis to compare interventions and described the categorical variable and the continuous variable as odds ratio (OR) and mean difference (MD), respectively. Besides, we ranked all interventions via the Surface Under the Cumulative Ranking (SUCRA) values and conducted metaregression with nine covariates as additional analysis. Results:We included 192 studies with 23366 patients diagnosed as primary hypertension in total. For SBP reduction, eighteen interventions were significantly better than AD. Among them, Yinxingye (YXY) + AD (MD = -12, 95% CrI [-16, -8.5]) was superior to others in the rank plot with SUCRA 0.91. For DBP reduction, sixteen interventions were significantly better than AD. Among them, Qinggan Jiangya (QGJY) + AD (MD = -8.7, 95% CrI [-12, -5.5]) and Qiju Dihuang (QJDH) + AD (MD = -8.8, 95% CrI [-12, -5.2]) were superior to others in the rank plot with SUCRA 0.89. To summarize the SUCRA values, we found that QGJY + AD and YXY + AD had the most significant reductions for both SBP and DBP. YXY + AD was the best one for both TC (MD = -1.3, 95% CrI [-1.9, -0.64]) and TG (MD = -0.52, 95% CrI [-0.92, -0.11]) reductions. Considering adverse effects, we found two interventions had significant differences comparing with AD. Among them, YXY + AD was the best one with SUCRA of 0.01. Conclusion:In all TCPMs, QGJY + AD and YXY + AD may be the best options for hypertension. Meanwhile, YXY + AD can improve blood lipids in patients with hypertension. However, due to the vague reports of adverse effects and other limitations, more evidence, especially that provided by high-quality studies, is needed to prove the advantages of TCMPs.

Project description:IntroductionChinese patent medicine (CPM) is an indispensable part of traditional Chinese medicine. Coronavirus Disease 2019 (COVID-19) manifests is an acute respiratory infectious disease. This systematic review aimed to evaluate the therapeutic effects and safety of oral CPM for COVID-19.MethodsWe included randomized controlled trials (RCTs) that tested oral CPM for the treatment of COVID-19 identified from publications in CNKI, Wanfang, VIP, Web of Science, SinoMed, PubMed, Embase, BioRxiv, MedRxiv and arXiv before November 2nd, 2020. The risk of bias for each trial was assessed using the Cochrane Risk of Bias Tool 2.0. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool.ResultsSeven RCTs including 1079 participants were identified. The overall bias was assessed as "-high risk of bias" for all included trials. Oral CPM investigated were: Lianhua Qingwen capsule/granules (LHQW), Jinhua Qinggan granules (JHQG), Huoxiang Zhengqi dripping pills (HXZQ), Toujie Quwen granules (TJQW) and Lianhua Qingke granules (LHQK). Compared with conventional western therapy alone for people with COVID-19: regarding the main outcomes, the results showed that oral CPM combined with conventional western therapy improved cure rate (RR = 1.20, 95 % CI 1.04-1.38, involving LHQW and TJQW), reduced aggravation rate (RR = 0.50, 95 % CI 0.29 - 0.85, involving LHQW, JHQG, LHQK and TJQW); with regard to additional outcomes, the results showed that add-on oral CPM shortened the duration of fever, cough and fatigue, improved the recovery rate of cough and fatigue, and increased the improvement and recovery rate of chest CT manifestations. There were some differences in therapeutic effects among various CPMs for the same COVID-19 outcome. The use of TJQW and LHQG appeared not to increase the risk of adverse events, but JHQG may cause mild diarrhea.ConclusionLow-certainty or very low-certainty evidence demonstrated that oral CPM may have add-on potential therapeutic effects for patients with non-serious COVID-19. These findings need to be further confirmed by well-designed clinical trials with adequate sample sizes.

Project description:BackgroundSi-Mo-Tang oral liquid (SMT) has been widely used to treat functional dyspepsia (FD), but the effectiveness is still controversial. A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to assess the efficacy and adverse effects of SMT for FD.MethodsInvestigators searched for articles with publication dates to June 21, 2016, from 9 English and Chinese electronic databases. Comparisons were SMT alone or SMT in combination with western medicine as experimental intervention, and western medicine or placebo as the control. We used the Cochrane collaboration tool for assessing risk of bias to evaluate methodologies. Data were synthesized with RevMan 5.3 software. (PROSPERO Registration #CRD42016042003).ResultsTwenty-seven RCTs were included in the review, involving 2,713 participants: 1,383 subjects were in the experimental group and 1,330 in the control group. SMT showed a significant improvement in clinical efficacy (RR 1.14; 95% CI 1.09, 1.20; P<0.00001), but the heterogeneity was also significant (P = 0.0002, I2 = 56%). Because of the different interventions in the 2 groups, we performed subgroup and sensitivity analyses to investigate potential sources of heterogeneity. The heterogeneity was smaller after subgroup analysis and the exclusion of a study by Zhu from 2009. The corresponding pooled RR has no obvious change (RR 1.17; 95% CI 1.13, 1.21; P<0.00001). Subgroup analysis by age and drugs administered in control interventions between SMT and western medicine also showed improvement in the efficacy rate. But a data synthesis that excluded high risk of bias in the blinding of participants and personnel showed no significant difference (RR 1.14; 95% CI 0.97, 1.35; P = 0.12). Three studies measured gastric emptying. Two of these studies reported no significant difference between the experimental and control groups, while 1 study showed that SMT reduced the time of gastric emptying. The relapse rate and adverse effects had no difference between 2 groups.ConclusionsThis meta-analysis suggests that SMT is an effective and safe therapy option for patients with FD. However, because of the high clinical heterogeneity, poor quality, high risk of bias and small sample size of some included studies, further standardized large-scale and strictly designed studies are needed.

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Accumulation of Arsenic Speciation and In Vivo Toxicity Following Oral Administration of a Chinese Patent Medicine Xiao-Er-Zhi-Bao-Wan in Rats.

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