We describe three women who developed endometrial cancer after taking “bioidentical” hormone replacement therapy (HRT) to relieve menopausal symptoms. Although pharmaceutical HRT is a well established and tested therapy, little is known about the quality control, safety and efficacy of bioidentical HRT. Women should be advised to avoid bioidentical HRT, and those who continue to use it should receive regular endometrial surveillance.
A 71-year-old non-diabetic woman had been on some form of hormone replacement therapy (HRT) since the age of 49 years. She took oral oestrone sulfate 1.25 mg daily and medroxyprogesterone acetate 10 mg for at least 10 days a month for 8 years. For the next 2 years, she used a 3.2% compounded topical progesterone cream (at a daily dose of “one level spoonful”). In December 1997, she had some irregular vaginal bleeding, which was investigated by diagnostic hysteroscopy and curettage. The tissue diagnosis was atrophic endometritis.
- 1. MacLennan A, Lester S, Moore V. Oral estrogen replacement therapy versus placebo for hot flushes: a systematic review. Climacteric 2004; 4: 58-74.
- 2. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002; 288: 321-333.
- 3. Gambacciani M, Monteleone P, Sacco A, Genazzani AR. Hormone replacement therapy and endometrial, ovarian and colorectal cancer. Best Pract Res Clin Endocrinol Metab 2003; 17: 139-147.
- 4. Center for Drug Evaluation and Research. Guidance for industry. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms — recommendations for clinical evaluation [draft guidance]. Rockville, MD: CDER, 2003. http://www.fda.gov/cder/guidance/5412dft.pdf (accessed Jul 2007).
- 5. North American Menopause Society. Understanding the controversy: hormone testing and bioidentical hormones. Proceedings of the Postgraduate Course prior to the 17th Annual Meeting of the North American Menopause Society. Nashville, Tennessee; 2006; 11 Oct. http://www.menopause.org/edumaterials/PG06monogrpah.pdf (accessed Jul 2007).
- 6. Australasian Menopause Society. Bioidentical hormones (troches) advice to consumers [media release]. 29 Nov 2003. http://www.menopause.org.au/public/media_detail.asp?ID=38 (accessed Jul 2007).
- 7. Australasian Menopause Society. Bioidentical hormones (troches) advice for doctors [media release]. 29 Nov 2003. http://www.menopause.org.au/public/media_detail.asp?ID=39 (accessed Jul 2007).
Publication of your online response is subject to the Medical Journal of Australia's editorial discretion. You will be notified by email within five working days should your response be accepted.