EMEA Public statement regarding hormone replacement therapy

Hormone Replacement Therapy (HRT) is used by women after the menopause, particularly to prevent osteoporosis. There is public health concern regarding risks relating to Hormone Replacement Therapy (HRT). The EMEA (he European Agency for the Evaluation of Medicinal Products) has reviewed the available literature and formulated recommendations. For this purpose an Expert Group was set up by the EMEA for advice. The Expert Group conducted a review of data about the benefits and risks of Hormone Replacement Therapy. They investigated data from medicines containing estrogens or estrogens with progestogens (combined Hormone Replacement Therapy).

Conclusions regarding Hormone Replacement Therapy

  • Hormone Replacement Therapy provides effective relief of menopause symptoms and prevents loss of bone mass or increases bone density. Hormone Replacement Therapy can give prevention of bone fractures in women with or without risk factors for osteoporosis. A similar effect of HRT is observed in women with low bone density and/or established osteoporosis. When the HRT stops, the bone loss preventive effect of Hormone Replacement Therapy disappears within a few years.
  • There are a number of risks associated with the use of HRT. There is evidence for an increased risk of breast and endometrial cancer especially with increasing duration of HRT with all types of estrogens. The breast cancer risk is increased by addition of progestogens (= combined Hormone Replacement Therapy), whereas the risk for endometrial cancer is reduced with addition of progestogens. HRT also increases the risk of blood clotting , especially during the first year of use.
  • Contrary to previous data current evidence shows no benefit of combined Hormone Replacement Therapy on the risk of heart disease. There is even some evidence for an increased risk of heart attack and stroke.
  • There is no evidence of a beneficial effect of combined HRT on cognitive function. To the contrary, there is even some evidence of an increased risk of dementia.

Recommendations regarding Hormone Replacement Therapy

  • Hormone Replacement Therapy has beneficial affects for the treatment of menopause symptoms but the minimum effective dose and shortest duration of Hormone Replacement Therapy should be used.
  • For the prevention of osteoporosis in women with risk factors or women with established osteoporosis the use of Hormone Replacement Therapy is not recommended
  • The Hormone Replacement Therapy is not recommended for healthy women without climacteric symptoms.


Effects of Estrogen-Progestin on Risk of Fracture and Bone Mineral Density. JAMA. 2003;290:1729-1738