section name header

Evidence summaries

Effects of Tibolone in Postmenopausal Women

Tibolone, used at the daily dose of 2.5 mg, may be effective in alleviating menopausal symptoms compared with placebo but less effective than combined hormone replacement therapy in alleviating menopausal symptoms. However, it might possibly increase the risk of breast cancer recurrence. Level of evidence: "C"

Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment and incomplete assessment of outcome data in half of trials), by publication bias (most of the RCTs were sponsored and by the drug producer), and by indirectness (differences between the population of interest and those studied).

Tibolone is suggested for hot flushes and night sweats, when pharmacological treatment is needed and hormone replacement therapy cannot be used.

The recommendation is weak because tibolone is less effective oestrogen and the certainty of evidence is weak. Contraindications should be carefully discussed.

Summary

A Cochrane review [Abstract] 1 included 46 studies with a total of 19 976 women. Most RCTs evaluated tibolone for treating menopausal vasomotor symptoms. When compared to placebo, tibolone was more effective in relieving vasomotor symptoms (OR 0.33, 95% CI 0.27 to 0.41; 5 RCTs, n = 842), although only the 2.5 mg/day dose of tibolone was significantly better than placebo (OR 0.25, 95% CI 0.12 to 0.52; 2 RCTs, n = 171). Tibolone was associated with increased vaginal bleeding (OR 2.79, 95% CI 2.10 to 3.70; 9 RCTs, n=7 814). Combined hormone replacement therapy (HT) was more effective than tibolone 2.5 mg/day (OR 1.57, 95% CI 1.18 to 2.1; 4 trials, n=646; moderate quoaity evidence) but tibolone was associated with a lower rate of bleeding (OR 0.32, 95% CI 0.24 to 0.41; 16 RCTs; n=6438 women; moderate-quality evidence) .Among women with a history of breast cancer tibolone increased tumour recurrence (OR 1.50; 95% CI 1.21 to 1.85; 2 trials, n=3 165). However, there was no difference between the groups with no history of breast cancer or outcomes of endometrial cancer, cardiovascular events, venous thromboembolic events, or mortality of any cause.

A meta-analysis 2 included 8 controlled trials. Tibolone at a dose of 2.5 mg increased bone mineral density compared with non-active controls at 24 months (lumbar spine MD 4.87%, 95%CI 4.16 to-5.57, femoral neck MD 4.85%, 95%CI 1.55 to 8.15). No difference was observed when tibolone 2.5 mg dose was compared with estrogen therapy .

Clinical comments

Note

Date of latest search: 2021-10-04

References

  • Formoso G, Perrone E, Maltoni S et al. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst Rev 2016;(10):CD008536. [PubMed]
  • Castrejón-Delgado L, Castelán-Martínez OD, Clark P et al. Effect of Tibolone on Bone Mineral Density in Postmenopausal Women: Systematic Review and Meta-Analysis. Biology (Basel) 2021;10(3):.[PubMed]

Primary/Secondary Keywords