IMS updates its recommendations on HRT.

Abstract

The 13th World Congress on Menopause held in Rome in June saw publication of yet another International Menopause Society (IMS) statement on postmenopausal hormone therapy (HRT), this latest version at a time ‘when the atmosphere around the issue of postmenopausal HRT is much more rational’. The recommendations note that ‘the pendulum has swung back from its peak negative sentiment’ following publication of detailed data from the Women’s Health Initiative (WHI) showing the importance of age at the start of therapy and the ‘good safety profile’ of HRT in women younger than 60 years. Indeed, the recommendations state categorically that the ‘safety of HRT largely depends on age’, adding that healthy women under 60 years ‘should not be unduly concerned about the safety profile of HRT’. New data and re-analyses of older studies according to age show that, for most women, the potential benefits of HRT given for a clear indication are many and the risks are few when treatment is initiated within a few years of menopause. Thus, the benefits of HRT are most likely to be the relief of vasomotor symptoms and urogenital atrophy. Other menopause-related complaints, such as joint and muscle pains, mood swings, sleep disturbances and sexual dysfunction (including reduced libido) ‘may improve’ with HRT. On the contentious question of breast cancer risk, the report emphasizes the contributing role of progestogen; thus, say the recommendations, ‘it seems prudent to minimize progestogen use where safely possible’. And on cardiovascular risk, the recommendation is that in women under 60 years, or in those recently menopausal and without evidence of cardiovascular disease, ‘the initiation of HRT does not cause early harm and may reduce morbidity and mortality’. Continuation of HRT beyond the age of 60 should be decided as part of the overall risk– benefit analysis. The fall-out from the first WHI publication in 2002 was a massive swing away from HRT, as regulatory agencies sought cover under the protection of ‘shortest duration’ and ‘lowest effective dose’. Yet, within the 19-page detail of the IMS recommendations, many of these hyper-precautions are formally rejected, or at least rationally modified. Thus, as a ‘governing principle’, the IMS reports that ‘there are no reasons to place mandatory limitations on the duration of HRT.’ Continuation of therapy should be decided ‘at the discretion of the well-informed woman and her health professional’, dependent upon the specific goals and an objective estimation of ongoing benefits and risks. The IMS thus makes it clear that HRT cannot be prescribed according to an all-embracing formula; necessary for its prescription is a clear indication for use, which remains vasomotor symptoms or ‘the physical effects of estrogen deficiency’. Otherwise, HRT should be ‘individualized and tailored according to symptoms and the need for prevention, as well as personal and family history, results of relevant investigations, the woman’s preferences and expectations’. This same conclusion on the timing of HRT was also made in a report in April in the American Journal of Medicine from several leading US figures reviewing data on HRT and cardiovascular risk. They concluded: ‘The current analysis and data reviewed do not support any specific limit on the duration of menopausal hormone treatment’. Emerging data suggest that the decision to prescribe menopausal hormone treatment and how long to continue should be flexible, based on patient characteristics (e.g. age and time since menopause) and the balance of benefits (symptom relief, coronary heart disease and bone fractures) and risks (breast cancer, thromboembolic disease and stroke). We believe that guidelines from the Food and Drug Administration and other official sources should be reconsidered and revised to reflect this personalized approach to the patient.