title: Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies.
abstract: OBJECTIVE
  To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination.
  
  
  METHODS
  We systematically searched three electronic databases for eligible studies. In the studies included (n=18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used.
  
  
  RESULTS
  We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR)=1.07 (95% confidence interval (CI): 0.79-1.46, P=0.66) for RCTs, and RR=0.77 (95% CI: 0.58-1.04, P=0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females.
  
  
  CONCLUSIONS
  We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed.
authors.affiliation: Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul, South Korea. Electronic address: sselmul@hanmail.net.
authors.forename: Heeyoung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul, South Korea. Electronic address: tmddus0121@hotmail.com.
authors.forename: Seungyeon
authors.initials: S
authors.lastname: Song
authors.affiliation: Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul, South Korea; Department of Pharmacy, Konkuk University Medical Center, Seoul, South Korea. Electronic address: rky221@hanmail.net.
authors.forename: Yun-Kyoung
authors.initials: YK
authors.lastname: Oh
authors.affiliation: College of Pharmacy, Chung-Ang University, Seoul, South Korea. Electronic address: wkang@cau.ac.kr.
authors.forename: WonKu
authors.initials: W
authors.lastname: Kang
authors.affiliation: Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul, South Korea; College of Pharmacy, Chung-Ang University, Seoul, South Korea. Electronic address: eykimjcb777@cau.ac.kr.
authors.forename: Eunyoung
authors.initials: E
authors.lastname: Kim
mesh_terms: D003287:Contrast Media / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D064887:Observational Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D012727:Sex Characteristics; D014057:Tomography, X-Ray Computed
chemical_list: D003287:Contrast Media
keywords: Adverse drug reaction; Contrast media; Gender; Meta-analysis; Systematic review