CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version)

Cheng, Chung Wah; Wu, Taixiang; Shang, Hongcai; Li, Youping; Altman, Douglas G.; Moher, David; Bian, Zhaoxiang

doi:10.7326/istranslatedfrom_m17-2977_2

Cited by 25 publications

(9 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Consort Extension for Chinese Herbal Medicine Formulas 2017: Recommendation, Explanation, and Elaboration (CONSORT CHM Formula for short) was published in Annals of Internal Medicine in simplified Chinese, traditional Chinese, and English at the same time together with the editorial notes (the checklist is shown in Table ) in 27 June, 2017. Except for the Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): Extending the Consort Statement (abbreviated as CONSORT‐STRICTA), it is the first time our Chinese scholars lead and the second time participate in establishing CONSORT CHM Formula among the series of TCM CONSORT standards on the clinical trials report of acupuncture and Chinese herbal medicine.…”

Section: Checklist Of Items For Reporting Trials Of Chinese Herbal Mementioning

confidence: 99%

Innovation of clinical trials in China: Commentary on the publication of “CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration”

Bian

Shang

et al. 2017

J Evidence Based Medicine

View full text Add to dashboard Cite

Section: Checklist Of Items For Reporting Trials Of Chinese Herbal Mementioning

confidence: 99%

Innovation of clinical trials in China: Commentary on the publication of “CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration”

Bian

Shang

et al. 2017

J Evidence Based Medicine

View full text Add to dashboard Cite

“…26 However, the risk assessment of the pharmacokinetic interaction between TCMs and conventional drugs is insufficient, leading to safety and efficacy issues in contemporary pharmacotherapy. 27 As mentioned above, there is a high likelihood of concomitant use of ZJP and VEN for treating depression with gastrointestinal disorders or gastrointestinal diseases with depression in clinical practice in China. 16,28 Since ZJP has already been reported to be a potent CYP2D6 inhibitor in both in vitro 18 and clinical studies, 19 increased systemic exposure and reduced clearance to VEN, a CYP2D6 substrate, were expected in concomitant clinical use, which implied the potential risk of pharmacokinetic HDI.…”

Section: Discussionmentioning

confidence: 99%

Effects of Zuojin Pill (Rhizoma CoptidisandFructus Evodiaepreparation) on the pharmacokinetics and side effects of venlafaxine in humans

Yan

et al. 2022

Basic Clin Pharma Tox

View full text Add to dashboard Cite

Venlafaxine (VEN), a first-line antidepressant, and Zuojin Pill (ZJP), a common herbal medicine consisting of Rhizoma Coptidis and Fructus Evodiae, are high likely co-administered in China. ZJP could significantly inhibit VEN pharmacokinetics in vitro and in rats through suppression of CYP2D6 activity.To date, however, no clinical study has demonstrated the clinical relevance.Here, the VEN pharmacokinetics at a single dose of VEN with or without coadministration of ZJP was compared. ZJP had a weak herb-drug interactions (HDI) on the pharmacokinetics of VEN. The geometric means of C max and AUC 0-∞ of VEN increased by 36.7% and 34.6%, respectively, and the corresponding 90% confidence intervals (CIs) of geometric mean ratios (GMRs) exceed outside bioequivalent range of 0.80-1.25. However, the corresponding 90% CIs of GMRs of these parameters for ODV were within the range. Since ODV exposure (AUC), approximately 3.4-fold higher than that of VEN, hardly changed, the systemic exposure of VEN active moiety (VEN + ODV) with ZJP increased slightly (≤8.5%) compared with that of VEN alone. In addition, the incidence of VEN-related side effects, especially gastrointestinal relevance, was significantly reduced with ZJP. Therefore, rational concomitant use of VEN and ZJP might have low risk of HDI and be promising in clinical practice. Dongmin Yan and Ming Wu contributed equally to the work.

show abstract

“…Future researchers are urged to design experiments based on a rigorous methodology, including appropriate sample sizes and adequate follow-up with long-term duration, and the standardized report will be carried out according to the guidelines of SPIRIT-TCM Extension 2018 [74] and CONSORT-CHM formulas 2017 [75]. In terms of safety analysis, researchers must assess whether the adverse events are related to drug use.…”

Section: Implications For Futurementioning

confidence: 99%

Systematic Review and Meta-Analysis on Randomized Controlled Trials on Efficacy and Safety of Panax Notoginseng Saponins in Treatment of Acute Ischemic Stroke

Wang

Liang

et al. 2021

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

Importance. Panax Notoginseng Saponins (PNS) are proven to have antiplatelet effects in patients with acute ischemic stroke (AIS). Objective. To assess the efficacy and safety of PNS on antiplatelet therapy in the treatment of AIS. Methods. We searched 7 literature databases and 2 clinical studies databases for randomized controlled studies (RCTs) evaluating PNS as an adjuvant therapy for AIS. Relevant studies were retrieved and screened, and data were extracted independently by two reviewers. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool. Meta-analysis was carried out with the Rev Man 5.4 software. Results. Of 8267 records identified, 43 RCTs met our inclusion criteria (n = 4170 patients). Patients assigned to PNS with conventional treatments (CTs) had improved functional independence at 90 days compared with those assigned to CTs alone (RR = 1.87, 95% CI = 1.37, to 2.55, P < 0.0001 ). Patients who received PNS combined with CTs showed significantly high improvements in neurological function among individuals with AIS on the neurologic deficit score (NDS) (MDCSS = −5.71, 95% CI = −9.55 to −1.87, P = 0.004 ; MDNIHSS = −3.94, 95% CI = −5.65 to −2.23, P < 0.00001 ). The results also showed PNS contributed to a betterment in activities of daily living (ADL) on the Barthel index (MDday10 BI = 4.86, 95% CI = 2.18, to 7.54, P < 0.00001 ; MDday 14 BI = 13.92, 95% CI = 11.46 to 16.38, P < 0.00001 ; MDday 28 BI = 7.16, 95% CI = 0.60, to 13.72, P < 0.00001 ). In addition, PNS, compared with CTs alone, could significantly improve overall response rate (ORR) (RRNIHSS = 1.20, 95% CI = 1.16, to 1.24, P < 0.00001 ; RRCSS = 1.15, 95% CI = 1.08, to 1.24, P < 0.0001 ), hemorheological parameters, maximum platelet aggregation rate (MPAR) (MD = −6.82, 95% CI = −9.62 to −4.02, P < 0.00001 ), platelet parameters (MDPLT = 4.85, 95% CI = 1.82 to 7.84, P = 0.002 ; MDMPV = −0.79, 95% CI = −1.09 to −0.48, P < 0.00001 ), and serum CD62P (MD = −0.21, 95% CI = −0.29 to −0.13, P < 0.00001 ). The incidence of adverse reactions in PNS was lower than that in the control group (RR = 0.62, 95% CI = 0.39 to 0.97, P = 0.04 ). Adverse reactions in the PNS were mild adverse reactions. Conclusion. PNS may be effective and safe in treating AIS on ameliorating neurological deficit, improving activities of daily living function, and enhancing antiplatelet effects. However, more high-quality evidence is needed before it can be recommended for routine antiplatelet therapy in patients with AIS.

show abstract

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version)

Cited by 25 publications

References 0 publications

Innovation of clinical trials in China: Commentary on the publication of “CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration”

Innovation of clinical trials in China: Commentary on the publication of “CONSORT extension for Chinese herbal medicine formulas 2017: Recommendations, explanation, and elaboration”

Effects of Zuojin Pill (Rhizoma CoptidisandFructus Evodiaepreparation) on the pharmacokinetics and side effects of venlafaxine in humans

Systematic Review and Meta-Analysis on Randomized Controlled Trials on Efficacy and Safety of Panax Notoginseng Saponins in Treatment of Acute Ischemic Stroke

Contact Info

Product

Resources

About