Skip to main content
Top
Published in: BMC Medical Informatics and Decision Making 1/2018

Open Access 01-12-2018 | Research article

Traditional Chinese medicine pharmacovigilance in signal detection: decision tree-based data classification

Authors: Jian-Xiang Wei, Jing Wang, Yun-Xia Zhu, Jun Sun, Hou-Ming Xu, Ming Li

Published in: BMC Medical Informatics and Decision Making | Issue 1/2018

Login to get access

Abstract

Background

Traditional Chinese Medicine (TCM) is a style of traditional medicine informed by modern medicine but built on a foundation of more than 2500 years of Chinese medical practice. According to statistics, TCM accounts for approximately 14% of total adverse drug reaction (ADR) spontaneous reporting data in China. Because of the complexity of the components in TCM formula, which makes it essentially different from Western medicine, it is critical to determine whether ADR reports of TCM should be analyzed independently.

Methods

Reports in the Chinese spontaneous reporting database between 2010 and 2011 were selected. The dataset was processed and divided into the total sample (all data) and the subsample (including TCM data only). Four different ADR signal detection methods-PRR, ROR, MHRA and IC- currently widely used in China, were applied for signal detection on the two samples. By comparison of experimental results, three of them—PRR, MHRA and IC—were chosen to do the experiment. We designed several indicators for performance evaluation such as R (recall ratio), P (precision ratio), and D (discrepancy ratio) based on the reference database and then constructed a decision tree for data classification based on such indicators.

Results

For PRR: R1-R2 = 0.72%, P1-P2 = 0.16% and D = 0.92%; For MHRA: R1-R2 = 0.97%, P1-P2 = 0.20% and D = 1.18%; For IC: R1-R2 = 1.44%, P2-P1 = 4.06% and D = 4.72%. The threshold of R,Pand Dis set as 2%, 2% and 3% respectively. Based on the decision tree, the results are “separation” for PRR, MHRA and IC.

Conclusions

In order to improve the efficiency and accuracy of signal detection, we suggest that TCM data should be separated from the total sample when conducting analyses.
Literature
1.
go back to reference Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.CrossRefPubMed Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.CrossRefPubMed
2.
go back to reference Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–6.CrossRefPubMed Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–6.CrossRefPubMed
3.
go back to reference Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. J Clin Pharmacol. 2003;57(2):127–34.CrossRef Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. J Clin Pharmacol. 2003;57(2):127–34.CrossRef
4.
go back to reference Van Puijenbroek EP, Diemont WL, Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf. 2003;26(5):293–301.CrossRefPubMed Van Puijenbroek EP, Diemont WL, Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf. 2003;26(5):293–301.CrossRefPubMed
5.
go back to reference Hauben M, Zhou XF. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf. 2003;26(3):159–86.CrossRefPubMed Hauben M, Zhou XF. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf. 2003;26(3):159–86.CrossRefPubMed
7.
go back to reference Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Saf. 2002;25(6):393–7.CrossRefPubMed Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Saf. 2002;25(6):393–7.CrossRefPubMed
8.
go back to reference Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, De Freitas RM. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54:315–21.CrossRefPubMed Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, De Freitas RM. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54:315–21.CrossRefPubMed
9.
go back to reference DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.
10.
go back to reference Sakaeda T, Tamon A, Kadoyama K, et al. Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci. 2013;10(7):796–803.CrossRefPubMedPubMedCentral Sakaeda T, Tamon A, Kadoyama K, et al. Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci. 2013;10(7):796–803.CrossRefPubMedPubMedCentral
11.
go back to reference Li C, Xia J, Deng J, et al. A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China. Pharmacoepidemiol Drug Saf. 2008;17(6):593-600. Li C, Xia J, Deng J, et al. A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China. Pharmacoepidemiol Drug Saf. 2008;17(6):593-600.
12.
go back to reference Jing J, Yongfang H, Xiujuan L, Jingtian R, Shaohong J. Application of different signal detection methods in ADR self-reporting systems in China. Chinese Journal of Pharmacovigilance. 2010;3:154–5. Jing J, Yongfang H, Xiujuan L, Jingtian R, Shaohong J. Application of different signal detection methods in ADR self-reporting systems in China. Chinese Journal of Pharmacovigilance. 2010;3:154–5.
13.
go back to reference Jingtian R, Wang S, Yongfang H, Xiaoxi D, Liming L. Comparative research of common ADR signal detection methods. Chinese Journal of Pharmacovigilance. 2011;6:356–9. Jingtian R, Wang S, Yongfang H, Xiaoxi D, Liming L. Comparative research of common ADR signal detection methods. Chinese Journal of Pharmacovigilance. 2011;6:356–9.
14.
go back to reference Wu J, Lin X, Lijun J, et al. Developmental status and case study of traditional Chinese medicine ADR monitoring. Pharmaceutical Analysis. 2014;1:22–5. Wu J, Lin X, Lijun J, et al. Developmental status and case study of traditional Chinese medicine ADR monitoring. Pharmaceutical Analysis. 2014;1:22–5.
16.
go back to reference Barnes J. Pharmacovigilance of herbal medicines : a UK perspective. Drug Saf. 2003;26(12):829–51.CrossRefPubMed Barnes J. Pharmacovigilance of herbal medicines : a UK perspective. Drug Saf. 2003;26(12):829–51.CrossRefPubMed
17.
go back to reference Tian YJ, Jiao B, Xie JZ, et al. The programming and application of analysis system for adverse drug reactions of traditional chinese medicine. Chin J Pharmacovigilance. 2007;4(4):217-21. Tian YJ, Jiao B, Xie JZ, et al. The programming and application of analysis system for adverse drug reactions of traditional chinese medicine. Chin J Pharmacovigilance. 2007;4(4):217-21.
18.
go back to reference Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;140(3):519–25.CrossRefPubMed Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;140(3):519–25.CrossRefPubMed
19.
go back to reference Bate A, Ericsson J, Farah M. International data mining for signals of herbal ADRs. Drug Saf. 2006;29(4):353. Bate A, Ericsson J, Farah M. International data mining for signals of herbal ADRs. Drug Saf. 2006;29(4):353.
20.
go back to reference Puijenbroek EPV, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiology & Drug Safety. 2002;11(1):3–10.CrossRef Puijenbroek EPV, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiology & Drug Safety. 2002;11(1):3–10.CrossRef
Metadata
Title
Traditional Chinese medicine pharmacovigilance in signal detection: decision tree-based data classification
Authors
Jian-Xiang Wei
Jing Wang
Yun-Xia Zhu
Jun Sun
Hou-Ming Xu
Ming Li
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2018
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-018-0599-5

Other articles of this Issue 1/2018

BMC Medical Informatics and Decision Making 1/2018 Go to the issue