PMID- 31693665
OWN - NLM
STAT- MEDLINE
DCOM- 20200320
LR  - 20200320
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 14
IP  - 11
DP  - 2019
TI  - Comparison of drug safety data obtained from the monitoring system, literature, 
      and social media: An empirical proof from a Chinese patent medicine.
PG  - e0222077
LID - 10.1371/journal.pone.0222077 [doi]
LID - e0222077
AB  - OBJECTIVES: To investigate the consistency of adverse events (AEs) and adverse 
      drug reactions (ADRs) reported in the literature, monitoring and social media 
      data. METHODS: Using one Chinese patent medicine-Cordyceps sinensis extracts 
      (CSE) as an example, we obtained safety data from the national monitoring system 
      (July 2002 to February 2016), literature (up to November 2016) and social media 
      (May 2019). For literature data, we searched the Chinese National Knowledge 
      Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology 
      Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), 
      PubMed, Embase and the Cochrane Library. Social media data was from the Baidu 
      post bar and Sina micro-blog. Two authors independently screened the literature 
      and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were 
      coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). 
      AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. 
      Frequencies, relative frequencies and rank were used as metrics. Radar chart was 
      used to manifest the features of the distributions and proportions. RESULTS: 610 
      AEs reported in CFDA monitoring data were associated with CSE, of which 537 
      (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 
      papers (63% RCTs, 37% other types of studies including case series, case reports, 
      ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% 
      certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and 
      their affected system-organ classes, looked largely similar, but different in 
      every aspect when looking at details. Data from RCTs demonstrated the most 
      disparity. CONCLUSIONS: In our study, the most prevalent AEs and ADRs, mainly 
      gastro-intestinal system disorders including nausea, diarrhea and vomiting, in 
      monitoring system were largely similar with those in literature and social media. 
      But data from different sources varied if looked at details. Multiple data 
      sources (the monitoring system, literature and social media) should be integrated 
      to collect safety information of interventions. The distributions of AEs and ADRs 
      from RCTs were least similar with the data from other sources. Our empirical 
      proof is consistent with other similar studies.
FAU - Hu, Ruixue
AU  - Hu R
AUID- ORCID: 0000-0002-1333-0485
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Golder, Su
AU  - Golder S
AD  - Department of Health Sciences, University of York, York, England, United Kingdom.
FAU - Yang, Guoyan
AU  - Yang G
AD  - NICM Health Research Institute, Western Sydney University, Penrith, NSW, 
      Australia.
FAU - Li, Xun
AU  - Li X
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Wang, Di
AU  - Wang D
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Wang, Liqiong
AU  - Wang L
AD  - School of acupuncture-Moxibustion and Tuina, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Xia, Ruyu
AU  - Xia R
AD  - Department of Health Sciences, University of York, York, England, United Kingdom.
FAU - Zhao, Nanqi
AU  - Zhao N
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Fang, Sainan
AU  - Fang S
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Lai, Baoyong
AU  - Lai B
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Liu, Jianping
AU  - Liu J
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Fei, Yutong
AU  - Fei Y
AUID- ORCID: 0000-0003-3051-0581
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese 
      Medicine, Beijing, China.
LA  - eng
SI  - figshare/10.6084/m9.figshare.10006679.v1
SI  - figshare/10.6084/m9.figshare.10006679
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191106
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Cordyceps
MH  - Databases, Pharmaceutical
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Drugs, Chinese Herbal/*adverse effects
MH  - Gastrointestinal Diseases/chemically induced
MH  - Humans
MH  - Publications
MH  - *Social Media
PMC - PMC6834258
COIS- The authors have declared that no competing interests exist.
EDAT- 2019/11/07 06:00
MHDA- 2020/03/21 06:00
PMCR- 2019/11/06
CRDT- 2019/11/07 06:00
PHST- 2019/01/16 00:00 [received]
PHST- 2019/08/21 00:00 [accepted]
PHST- 2019/11/07 06:00 [entrez]
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/03/21 06:00 [medline]
PHST- 2019/11/06 00:00 [pmc-release]
AID - PONE-D-18-37120 [pii]
AID - 10.1371/journal.pone.0222077 [doi]
PST - epublish
SO  - PLoS One. 2019 Nov 6;14(11):e0222077. doi: 10.1371/journal.pone.0222077. 
      eCollection 2019.