Tags

Type your tag names separated by a space and hit enter

Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.
Zhong Xi Yi Jie He Xue Bao. 2008 Sep; 6(9):881-6.ZX

Abstract

Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Editorial

Language

eng

PubMed ID

18782527

Citation

Cheng, Chung-Wah, et al. "Transparently Reporting Adverse Effects of Traditional Chinese Medicine Interventions in Randomized Controlled Trials." Zhong Xi Yi Jie He Xue Bao = Journal of Chinese Integrative Medicine, vol. 6, no. 9, 2008, pp. 881-6.
Cheng CW, Bian ZX, Li YP, et al. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. Zhong Xi Yi Jie He Xue Bao. 2008;6(9):881-6.
Cheng, C. W., Bian, Z. X., Li, Y. P., Moher, D., Wu, T. X., Dagenais, S., Li, J., & Li, T. Q. (2008). Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. Zhong Xi Yi Jie He Xue Bao = Journal of Chinese Integrative Medicine, 6(9), 881-6. https://doi.org/10.3736/jcim20080901
Cheng CW, et al. Transparently Reporting Adverse Effects of Traditional Chinese Medicine Interventions in Randomized Controlled Trials. Zhong Xi Yi Jie He Xue Bao. 2008;6(9):881-6. PubMed PMID: 18782527.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. AU - Cheng,Chung-Wah, AU - Bian,Zhao-Xiang, AU - Li,You-Ping, AU - Moher,David, AU - Wu,Tai-Xiang, AU - Dagenais,Simon, AU - Li,Jing, AU - Li,Ting-Qian, PY - 2008/9/11/pubmed PY - 2010/8/20/medline PY - 2008/9/11/entrez SP - 881 EP - 6 JF - Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine JO - Zhong Xi Yi Jie He Xue Bao VL - 6 IS - 9 N2 - Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report. SN - 1672-1977 UR - https://www.unboundmedicine.com/medline/citation/18782527/Transparently_reporting_adverse_effects_of_traditional_Chinese_medicine_interventions_in_randomized_controlled_trials_ DB - PRIME DP - Unbound Medicine ER -