Sex and gender in health research: updating policy to reflect evidence

Wainer, Zoe; Carcel, Cheryl; Hickey, Martha; Schiebinger, Londa; Schmiede, Annette; McKenzie, Briar; Jenkins, Christine; Webster, Jacqui; Hehir, Angela; Solomon, Benjamin; Costa, Caroline de; Lukaszyk, Caroline; Colville, Deb; Dempsey, E.J.; Wright, Gavin; Mishra, Gita D.; Fisher, Jane; Kulkarni, Jayashri; Mitchell, Jordan; Hutchison, Katrina; Thompson, Kelly; Jorm, Louisa; Chappell, Louise; Meulen, Maarinke van der; Henry, Amanda; DiGiacomo, Michelle; Huxley, Rachel R.; Ivers, Rebecca; Peters, Sanne; Rogers, Wendy; Wang, Xia; Norton, Robyn

doi:10.5694/mja2.50426

Cited by 48 publications

(31 citation statements)

References 14 publications

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“…Sex is an important factor in epidemiology, pathophysiology, clinical manifestations, disease progression, and response to treatment [ 22 ]. We have not addressed the equally important aspect of sociocultural gender, which has recently been reviewed elsewhere [ 22 , 23 , 98 ]. The field of sex and gender research is slowly gaining speed, but fundamental evidence gaps still need to be addressed to better understand the way these characteristics function independently and together to influence health, disease, and health care [ 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Farkouh

Baumgärtel

Gottardi³

et al. 2021

JCM

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There is increasing evidence of sex differences in the action of anti-inflammatory drugs, with women being at significantly higher risk of adverse effects. Nevertheless, clinicians’ awareness of the implications of these sex differences on dosing and adverse event monitoring in routine practice is still in need of improvement. We reviewed the literature evaluating sex differences in terms of pharmacokinetics and pharmacodynamics of anti-inflammatory drugs. The anti-thrombotic activity of selective and non-selective COX-inhibitors tends to be stronger in men than women. Side effect profiles differ with regards to gastro-intestinal, renal and hepatic complications. Glucocorticosteroids were found to be more effective in men; women were more sensitive to corticosteroids when their oestradiol levels were high, a finding important for women taking hormonal contraception. TNF-alpha inhibitors have a longer half-life in men, leading to stronger immunosuppression and this a higher incidence of infections as side effects. Although research on sex differences in the effectiveness and safety of drugs is increasing, findings are often anecdotal and controversial. There is no systematic sex-differentiated reporting from clinical trials, and women are often under-represented. As personalized medicine is gaining in importance, sex, and gender aspects need to become integral parts of future research and policy making.

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Section: Discussionmentioning

confidence: 99%

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Farkouh

Baumgärtel

Gottardi³

et al. 2021

JCM

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“…Females in the lower range of intermediate G6PD activity are at risk of potentially clinically significant haemolysis from high dose 14-day primaquine (0.5mg/kg daily) and tafenoquine (300mg single dose) (Kozenis® and Krintafel®) 9,13,19,39,40 . In a systematic review comparing treatment with chloroquine versus chloroquine and primaquine, G6PD "normal" (classified using qualitative tests) females taking primaquine had significantly greater haemoglobin reductions than males 41 .…”

Section: G6pd Deficiency In Femalesmentioning

confidence: 99%

“…In a systematic review comparing treatment with chloroquine versus chloroquine and primaquine, G6PD "normal" (classified using qualitative tests) females taking primaquine had significantly greater haemoglobin reductions than males 41 . Recent studies exploring the efficacy of a high dose short course (7-day) primaquine regimen (1mg/kg) have shown consistently that females classified as normal by the fluorescent spot test are at risk for clinically significant primaquine-induced haemolysis 19,40 . One of the studies was carried out in an area with a high prevalence (15-18%) of G6PD deficiency; heterozygous females showed a significantly greater drop in haematocrit as compared to wild type homozygous females given the same treatments, and 2/16 females receiving dihydroartemisinin-piperaquine with the 7-day primaquine regimen needed a blood transfusion 18,40 .…”

Section: G6pd Deficiency In Femalesmentioning

confidence: 99%

“…One of the studies was carried out in an area with a high prevalence (15-18%) of G6PD deficiency; heterozygous females showed a significantly greater drop in haematocrit as compared to wild type homozygous females given the same treatments, and 2/16 females receiving dihydroartemisinin-piperaquine with the 7-day primaquine regimen needed a blood transfusion 18,40 . In the second study, 2 females from the site in Hanura, Indonesia had clinically significant haemolysis (a 31-40% haemoglobin reduction from pre-treatment) where 229 total participants were treated with the 7-day primaquine regimen 19 . Prevalence of G6PD deficiency in the area was unknown but previous reports in West Timor region gave a prevalence of 3.2% among males 42 .…”

Section: G6pd Deficiency In Femalesmentioning

confidence: 99%

“…As countries prepare to increase access to P. vivax radical cure with the curative regimens of primaquine 18,19 and tafenoquine (Kozenis® and Krintafel®) 11,12 , respectively, there are several opportunities that should be considered within broader national health systems for expanding the acceptability, utility, and concurrently, the cost-effectiveness of G6PD testing beyond malaria case management 15 . In this article, we discuss an important opportunity to reduce sex-related health disparities in an era of new tools and initiatives that improve the diagnosis of G6PD deficiency.…”

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confidence: 99%

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Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter

et al. 2020

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Safe access to the most effective treatment options for Plasmodium vivax malaria are limited by the absence of accurate point-of-care testing to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency, the most common human genetic disorder. G6PD-deficient patients are at risk of life-threatening hemolysis when exposed to 8-aminoquinolines, the only class of drugs efficacious against P. vivax hypnozoites. Until recently, only qualitative tests were available in most settings. These can identify patients with severe G6PD deficiency (mostly male) but not patients with intermediate G6PD deficiency (always female). This has led to and reinforced a gap in awareness in clinical practice of the risks and implications of G6PD deficiency in females—who, unlike males, can have a heterozygous genotype for G6PD. Increasing recognition of the need for radical cure of P. vivax, first for patients’ health and then for malaria elimination, is driving the development of new point-of-care tests for G6PD deficiency and their accessibility to populations in low-resource settings. The availability of user-friendly, affordable, and accurate quantitative point-of-care diagnostics for the precise classification of the three G6PD phenotypes can reduce sex-linked disparities by ensuring safe and effective malaria treatment, providing opportunities to develop supportive counseling to enhance understanding of genetic test results, and improving the detection of all G6PD deficiency phenotypes in newborns and their family members.

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Evidence-Based Medicine in Theory and Practice: Epistemological and Normative Issues

Rogers,

Hutchison

2024

Handbook of the Philosophy of Medicine

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Sex and gender in health research: updating policy to reflect evidence

Cited by 48 publications

References 14 publications

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter

Evidence-Based Medicine in Theory and Practice: Epistemological and Normative Issues

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