Tibolone is on sale in France for the treatment of menopause-related disorders. Despite properties that give reason to suspect that it can lead to breast cancer and cancer of the uterus, this synthetic hormone was not subjected to any stringent comparative studies before being put onto the market.
In 2004, the preliminary results of one major follow-up study involving more than a million women showed a risk of breast cancer that was 1.5 times higher under tibolone, compared with women who had never taken hormone replacement therapy (HRT) during menopause. In 2005, the same study also revealed that the risk of endometrial cancer (lining of the uterus) was almost double in women treated.
Another study showed that women who had taken tibolone had almost double the risk of contracting endometrial cancer, compared with women who had taken sequential oestrogen/progestogen replacement therapy.
When treatment for menopause-related disorders is necessary, there is no justification for exposing women to tibolone, which has no proven benefits in terms of effectiveness or safety compared with combined oestrogen and progestogen therapy. Furthermore, it exposes the patient to the risk of stroke.
©Prescrire March 2006
Source:
"Tibolone : cancers du sein et cancers de l'endomètre" Rev Prescrire 2006 ; 26 (270) : 192-193.
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