Risks and Benefits of MHT/HRT

Key Points

  • For the majority of symptomatic women, the benefits of menopausal hormone therapy (MHT) outweigh the risks
  • Consider the risks and benefits of all MHT in the individual prior to commencing treatment.
  • Risks differ depending on the age of the woman and the route of administration.
  • Recent information clarifies and refines the original findings of the WHI studies and these findings show that some women have been inappropriately discouraged from the use of menopausal hormone therapy.
  • Utilise current evidence and be aware of the quality of the evidence you use to make a decision.
  • Optimise lifestyle factors for each patient regardless of whether you will recommend hormone therapy.

As medical practitioners, we are well aware of the benefits of MHT for the treatment of menopausal symptoms and maintenance of bone density. However, in discussing this with patients we may find that the patient is focused on the risks, real or perceived, of the treatment. It therefore behoves us to be able to discuss the risks and benefits in a way that is understandable to the patient.

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Level of evidence
(strongest to weakest)

Type of information on which it is based

1

Double-blind, randomised, placebo-controlled trial (frequently called an RCT)

2

Observational studies which compare users and non-users but without the benefits of random assignment or the use of placebo

3

Observational studies, but does not compare users of the drug with non-users

4

Opinions from experts, non-experts (e.g. relatives, friends) and vested interest parties

Absolute vs. relative risk

The risks and benefits of MHT: a historical perspective

Summary of WHI findings

The following table from Manson et al JAMA 2013 summarises the change in outcome in absolute numbers in the overall study by the intervention phase and the cumulative follow-up (4).

Events per 10 000 women per year – intervention v placebo

 

Oestrogen plus progestogen therapy

Oestrogen therapy

 

Intervention 
phase

Cumulative follow-up

Intervention phase

Cumulative follow-up

Coronary heart disease

6

3

-3

-4

Breast cancer

9

9

-7

-7

Stroke

9

5

11

5

Pulmonary embolism

9

4

4

2

Colorectal cancer

-6

-3

2

2

Endometrial cancer

-1

-3

NA

NA

Hip fracture

-6

-5

-6

-2

All-cause mortality

-1

-1

3

-1

NA, not applicable

The above table does not convey fully the information about differences in different formulations and delivery of MHT and of the age of the women who will use it. In particular some points to note:-

Supporting women in making a decision

Recommended reading

1. de Villiers, T. J., Gass, M. L., Haines, C. J., Hall, J. E., Lobo, R. A., Pierroz, D. D., & Rees, M. (2013). Global consensus statement on menopausal hormone therapy. Climacteric, 16(2), 203-204. doi: 10.3109/13697137.2013.771520

References

1. Grodstein F, Stampfer MJ, Colditz GA, Willett WC, Manson JE, Joffe M, et al. Postmenopausal hormone therapy and mortality. N Engl J Med. 1997 Jun 19;336(25):1769-75.

2. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33.

3. Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004;291(14):1701-12.

4. Manson JE, Chlebowski RT, Stefanick ML, Aragaki AK, Rossouw JE, Prentice RL, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013 Oct 2;310(13):1353-68.

5. Boardman HM, Hartley L, Eisinga A, Main C, Roque I Figuls M, Bonfill Cosp X, et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database of Systematic Reviews. 2015;3:CD002229.

6. Canonico M, Plu-Bureau G, Lowe GDO, Scarabin P-Y. Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis. BMJ. 2008 May 31;336(7655):1227-31.

7. Canonico M. Hormone therapy and hemostasis among postmenopausal women: a review. Menopause. 2014 Jul;21(7):753-62.

8. Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study.[Erratum appears in Breast Cancer Res Treat. 2008 Jan;107(2):307-8]. Breast Cancer Res Treat. 2008 Jan;107(1):103-11

 

AMS Empowering Menopausal Women

Note: Medical and scientific information provided and endorsed by the Australasian Menopause Society might not be relevant to a particular person's circumstances and should always be discussed with that person's own healthcare provider.

This Information Sheet may contain copyright or otherwise protected material. Reproduction of this Information Sheet by Australasian Menopause Society Members and other health professionals for clinical practice is permissible. Any other use of this information (hardcopy and electronic versions) must be agreed to and approved by the Australasian Menopause Society.  

Content Updated May 2019

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