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Repair common Windows errors and clear accumulated junk for a smoother, more stable PC - no reinstall needed.Free scan · no reinstallPain research needs to include women—and analyze and report results in ways that reveal meaningful differences—because pain burden, pain mechanisms and responses to treatment can vary across populations. Without representative studies and transparent results, researchers cannot tell when findings generalize, when they do not, or whether an apparent difference is real. That is a case for better evidence, not for assuming that every woman feels pain the same way or needs a different treatment.
What inclusion can show—and why it matters
Pain is not one outcome. Researchers may be studying how common chronic pain is, how long it lasts, how people respond to an experimental stimulus, whether a treatment relieves pain, or what side effects occur. A difference in one of these areas does not automatically establish a difference in the others.
The International Association for the Study of Pain (IASP) reports that women generally experience more chronic pain across the lifespan and are more likely to attend pain clinics, while emphasizing that patterns vary by condition, country, age and socioeconomic circumstances. In one study spanning 17 countries, chronic pain prevalence was 45% among women and 31% among men. That is the result of that study, not a universal rate.
Experimental pain studies have also reported lower average pain thresholds and tolerance among women in some testing methods. The size and consistency of those differences depend on how pain is measured. Social expectations and context can shape pain expression and measured responses as well, so biology alone is not a complete explanation.
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IASP identifies two risks in research and care: overlooking a difference by assuming one group’s findings apply to another, and presuming a difference when groups’ needs are similar. The point of including women is to test which differences matter—and which do not—rather than to assume the answer.
Where the evidence gaps have appeared
Preclinical research
IASP’s 2024 fact sheet summarizes reviews of papers published in the journal Pain. In a review of preclinical pain studies from 1996–2005, 79% used male rodents exclusively, while 3% did not specify the animals’ sex. A review of Pain papers from 2015 also found that 79% used males only. In a later review covering 2015–2019, the male-only share had fallen to 50% by 2019. These figures describe particular reviews and publication periods, not all pain or biomedical research.
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Human research
A systematic review of Pain publications from 2012–2021, as summarized by IASP, found that fewer than 20% presented data disaggregated by sex. This reporting gap can persist even when women and men are both enrolled: if results are not analyzed or reported by sex, readers cannot see whether outcomes differed.
Enrollment patterns also depend on the setting. IASP notes that women may be overrepresented in clinical pain studies, while men may be more numerous in experimental pain samples. It is therefore inaccurate to say women are underrepresented in every pain study. The relevant questions are which kind of study, which population and period, and whether the sample and reporting suit the question.
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Enrollment alone is not enough
A study can include women yet still fail to answer whether a finding applies to them. Researchers need to define what they are measuring, design a sample appropriate to the question, and report results in a way that allows meaningful comparisons.
- Define the question: Specify whether it concerns biological sex, gender, or both. Sex and gender are related but distinct; they should not be treated as interchangeable labels.
- Measure appropriately: Explain how sex and gender are recorded. A simple “female/woman, male/man, other” classification can obscure differences in sex characteristics and gender identities.
- Justify the sample: Recruit participants or use research models suited to the scientific question, and state the reasons for exclusions.
- Plan analysis: Where relevant, plan analyses that can identify meaningful group differences. Treating sex only as a variable to adjust away can hide a difference central to the question.
- Report results clearly: Present sex-disaggregated findings when the design and data support them, and explain limitations. Gender-diverse people should not be erased by broad categories or automatically collapsed into a single group.
These steps help distinguish a genuine difference from an artifact of sampling, measurement or context. They also make it easier to compare studies of different pain types, settings and interventions.
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What treatment evidence does—and does not—say
IASP’s overview describes differences in clinical pain, experimental sensitivity and response to some interventions, but findings vary by pain type and treatment. Medication response can depend on the drug class and individual characteristics. The evidence is not strong enough to support sex-specific treatment tailoring as a general rule.
That means group averages should not be used to predict an individual patient’s pain or response, and the findings do not justify medical advice based on sex alone.
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A small study illustrates why the question remains worth studying. On 29 October 2024, NIH Research Matters described an analysis of two previously collected clinical trials in which meditation-associated pain relief appeared to involve different mechanisms in males and females. The report called for more studies that directly measure sex differences across other pain-reduction strategies. It is an early finding, not a basis for clinical recommendations: NIH Research Matters: “Sex differences in how the body reduces pain”.
What U.S. research policy requires
In the United States, NIH’s inclusion policy applies to NIH-funded clinical research. NIH says women and racial and ethnic minority groups must be included in a manner appropriate to the scientific question, with the goal of making findings generalizable to the population. Applications must address inclusion plans; exclusions need scientific or ethical justification. For NIH-defined Phase III trials, applications must address valid analysis of group differences unless clear evidence indicates differences are unlikely. These are NIH rules, not a description of every country’s or funder’s requirements.
In December 2025, the U.S. Food and Drug Administration published draft Level 1 guidance titled Study of Sex Differences in the Clinical Evaluation of Medical Products. It recommends increasing female enrollment in clinical trials and non-interventional studies, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions. FDA labels the document “Not for implementation” and says it contains non-binding recommendations; it is draft guidance, not a binding requirement.
How to judge a claim about sex differences in pain
When comparing studies or evaluating a claim about a treatment, check whether it specifies:
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- the setting and population—preclinical, experimental or clinical;
- the pain condition, duration and outcome being measured;
- how sex and gender were defined and recorded;
- whether the sample was suited to the comparison;
- whether group analyses were planned and informative; and
- whether results were reported separately, including the particular intervention and outcome.
These details determine what a finding can support. A difference in an experimental threshold, for example, is not by itself evidence that a particular treatment works differently in everyday clinical care.
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