Diagnosis of the menopause: NICE guidance and quality standards Original paper

What was reviewed?

This editorial summarizes and contextualizes the 2017 National Institute for Health and Care Excellence (NICE) guidelines and quality standards regarding the diagnosis of menopause and premature ovarian insufficiency (POI). The guidance, based on systematic reviews, critically evaluates the diagnostic utility of clinical indicators, ultrasound, and biochemical tests (particularly FSH, AMH, oestrogen, inhibin A and B), emphasizing appropriate diagnostic strategies for different age groups and clinical scenarios. The article also discusses the cost-saving implications and practical recommendations for clinical biochemistry laboratories in the UK, focusing on reducing unnecessary biochemical testing and streamlining diagnostic pathways.

Who was reviewed?

The review draws on evidence synthesized for NICE guideline development, including systematic reviews of studies involving perimenopausal and menopausal women, as well as those at risk for or suspected of POI. The population includes women over 45 presenting with menopausal symptoms, women aged 40–45 with possible menopausal features, and women under 40 with suspected POI, such as those with a history of cancer treatment or genetic syndromes like Turner syndrome. The referenced studies include a range of clinical cohorts and laboratory assessments across these age groups.

Most important findings

The NICE guideline, as summarized in this editorial, asserts that menopause in women over 45 should be diagnosed clinically—based on symptoms like vasomotor instability and menstrual irregularity—without reliance on laboratory or imaging tests. The evidence indicates that no single symptom or biochemical marker (including FSH, AMH, oestrogen, or inhibins) is sufficiently reliable in isolation for diagnosing menopause in this group. FSH is particularly unreliable due to its physiological fluctuations and interference from hormonal therapies. However, FSH measurement retains a role in diagnosing POI in women under 40, where elevated levels (>30 mIU/mL on two occasions) support the diagnosis, though a single test is inadequate due to hormonal variability. The review also emphasizes that AMH, despite its use as a marker of ovarian reserve, is not recommended for routine POI diagnosis due to assay variability and insufficient evidence for its diagnostic accuracy in this context.

Key implications

For clinical practice, the NICE guidance recommends diagnosing menopause in women over 45 based on symptoms alone, which reduces unnecessary and uninformative laboratory testing. This has significant resource-saving implications for healthcare systems. In women under 40 with suspected POI, FSH testing is appropriate, but diagnosis should be based on persistent elevations in FSH and compatible symptoms. Laboratories and clinicians should align their practice with these guidelines, minimizing inappropriate FSH testing in older women and focusing resources where diagnostic yield is greatest. This approach is expected to improve patient care, expedite appropriate referrals, and enhance long-term health outcomes while maximizing cost-effectiveness. The editorial provides actionable advice for laboratories, including audit and educational interventions to reduce unwarranted testing.