From the Guidelines
Tibolone should not be used as a first-line treatment for menopausal symptoms in women with a history of breast cancer due to concerns over its safety and potential increased risk of breast cancer, as suggested by the halted LIBERATE trial 1. When considering the treatment of menopausal symptoms, it's crucial to weigh the benefits against the potential risks, especially in women with a history of breast cancer.
- The role of tibolone in treating menopausal symptoms is complex, given its unique profile of weak estrogenic, progestogenic, and androgenic actions.
- Tibolone has been shown to effectively reduce hot flashes and improve vaginal dryness in healthy postmenopausal women at a dose of 2.5 mg daily 1.
- However, its use is not recommended for women with a history of breast cancer due to the uncertainty surrounding its impact on breast cancer risk, as indicated by the association found in a large observational study and the premature halt of the LIBERATE trial 1.
- Nonhormonal therapies may be considered as alternatives, although they have been reported to show only moderate efficacy in treating menopausal hot flashes 1.
- The management of menopausal symptoms, especially in women with a history of breast cancer, requires careful consideration of the available treatment options and their potential risks and benefits, emphasizing the need for personalized care plans.
From the Research
Role of Tibolone in Treating Menopausal Symptoms
Tibolone is a synthetic steroid used for the treatment of menopausal symptoms, with its efficacy based on short-term data 2, 3. The benefits and risks of tibolone need to be considered, particularly with regards to breast and endometrial cancer, as well as stroke 2.
Efficacy of Tibolone
- Tibolone is more effective than placebo in relieving vasomotor symptoms, with a significant reduction in the frequency of these symptoms 2, 3.
- Compared to combined hormone therapy (HT), tibolone is less effective in alleviating menopausal symptoms, but reduces the incidence of vaginal bleeding 2, 3.
- Tibolone has positive effects on sexual well-being, mood, and vaginal atrophy, and improves urogenital symptoms 4.
Safety of Tibolone
- There is an increased risk of breast cancer in women with a history of breast cancer who take tibolone 2, 3.
- Tibolone may increase the risk of stroke in women over 60 years of age 2, 3.
- The risk of endometrial cancer with tibolone is not well defined, but it is estimated to be low or absent 2, 3, 4.
- Tibolone does not increase mammographic density, which may make it a preferable option to estrogen/progestogen therapy (EPT) in certain women 4.
Clinical Recommendations
- Tibolone is a valuable treatment option for women with climacteric complaints, particularly those with sexual dysfunction, mood disorders, fibroids, and urogenital complaints 4.
- Tibolone may be preferable to EPT in women who have not been hysterectomised, due to its lower risk of breast cancer and endometrial proliferation 4.
- The role of tibolone in clinical practice is to provide an effective treatment for menopausal symptoms, while minimizing the risks associated with traditional hormone replacement therapies 5, 6.