Cochrane · systematic review · CD008536

Short‐term and long‐term effects of tibolone in postmenopausal women

Formoso, G, Perrone, E, Maltoni, S, et al. · Cochrane Database of Systematic Reviews · 2016 · Cochrane Library

Gynaecology and Fertility2 versionsAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
16
current version
GRADE rated
16
No studies
0
Included studies
NR
No studies 0 · 0%Ungraded 0 · 0%Very low 11 · 68.8%Low 1 · 6.3%Moderate 4 · 25%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Current version only

Tibolone compared with placebo for treatment of vasomotor symptoms in postmenopausal women

Population: postmenopausal women with vasomotor symptoms
CD008536.PUB3 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Vasomotor symptoms (all doses)
Tibolone vs placebo
OR 0.33 [0.27, 0.41]5 studies · 842 participantsModerate
Downgraded: risk of bias

Tibolone compared with placebo for postmenopausal women: adverse events

Population: postmenopausal women with or without vasomotor symptoms
CD008536.PUB3 (current) · 7 questions
OutcomeEffectEvidenceStatus / GRADE
Endometrial cancer (all doses)
Tibolone vs placebo
OR 2.04 [0.79, 5.24]9 studies · 8504 participantsVery low
Downgraded: risk of bias
Breast cancer; women without previous breast cancer (all doses)
Tibolone vs placebo
OR 0.52 [0.21, 1.25]4 studies · 5500 participantsVery low
Downgraded: risk of bias
Unscheduled bleeding (all doses)
Tibolone vs placebo
OR 2.79 [2.1, 3.7]9 studies · 7814 participantsModerate
Downgraded: risk of bias, imprecision, indirectness
Venous thromboembolic events (clinical evaluation) all doses
Tibolone vs placebo
OR 0.85 [0.37, 1.97]5 studies · 9176 participantsVery low
Downgraded: risk of bias
Cardiovascular events (all doses)
Tibolone vs placebo
no estimate extracted4 studies · 8401 participantsVery low
Downgraded: risk of bias
Cerebrovascular events (all doses)
Tibolone vs placebo
OR 1.74 [0.99, 3.04]4 studies · 7930 participantsVery low
Downgraded: risk of bias
Mortality from any cause (all doses)
Tibolone vs placebo
OR 1.06 [0.79, 1.41]4 studies · 8242 participantsLow
Downgraded: risk of bias, imprecision, indirectness

Tibolone compared with combined HT for treatment of vasomotor symptoms in postmenopausal women

Population: postmenopausal women with vasomotor symptoms
CD008536.PUB3 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Vasomotor symptoms (tibolone 2.5 mg/d)
Tibolone vs combined HT
OR 1.57 [1.18, 2.1]4 studies · 646 participantsModerate
Downgraded: risk of bias

Tibolone compared with combined HT for postmenopausal women: adverse events

Population: postmenopausal women with or without vasomotor symptoms
CD008536.PUB3 (current) · 7 questions
OutcomeEffectEvidenceStatus / GRADE
Unscheduled bleeding (all doses)
Tibolone vs combined HT
OR 0.32 [0.24, 0.41]16 studies · 6438 participantsModerate
Downgraded: risk of bias
Endometrial cancer (all doses)
Tibolone vs combined HT
OR 1.47 [0.23, 9.33]5 studies · 3689 participantsVery low
Downgraded: risk of bias, imprecision
Breast cancer; women without previous breast cancer (all doses)
Tibolone vs combined HT
OR 1.69 [0.78, 3.67]5 studies · 4835 participantsVery low
Downgraded: risk of bias, imprecision
Venous thromboembolic events (clinical evaluation; all doses)
Tibolone vs combined HT
OR 0.44 [0.09, 2.14]4 studies · 4529 participantsVery low
Downgraded: risk of bias, imprecision
Cardiovascular events (all doses)
Tibolone vs combined HT
OR 0.63 [0.24, 1.66]2 studies · 3794 participantsVery low
Downgraded: risk of bias, imprecision
Cerebrovascular event (all doses)
Tibolone vs combined HT
OR 0.76 [0.16, 3.66]4 studies · 4562 participantsVery low
Downgraded: risk of bias, imprecision
Mortality from any cause (tibolone 2.5 mg/d)
Tibolone vs combined HT
OR 3.05 [0.12, 75.2]2 studies · 970 participantsVery low
Downgraded: risk of bias, imprecision

Unscheduled bleeding (tibolone versus placebo)

Population: women in menopause
CD008536.PUB2 · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Unscheduled bleeding (all studies)
Unscheduled bleeding (tibolone vs placebo)
OR 2.75 [1.99, 3.8]7 studies · 7462 participantsVery low
Unscheduled bleeding (tibolone 2.5 mg)
Unscheduled bleeding (tibolone vs placebo)
OR 2.51 [1.71, 3.67]6 studies · 3834 participantsVery low
Unscheduled bleeding (tibolone 1.25 mg)
Unscheduled bleeding (tibolone vs placebo)
OR 3.63 [2.37, 5.55]3 studies · 3628 participantsVery low

Unscheduled bleeding (tibolone versus combined HT)

Population: women in menopause
CD008536.PUB2 · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Unscheduled bleeding (all studies)
Unscheduled bleeding (tibolone vs combined HT)
OR 0.32 [0.24, 0.42]15 studies · 6342 participantsVery low
Unscheduled bleeding (tibolone 2.5 mg)
Unscheduled bleeding (tibolone vs combined HT)
OR 0.35 [0.26, 0.46]15 studies · 4624 participantsLow
Unscheduled bleeding (tibolone 1.25 mg)
Unscheduled bleeding (tibolone vs combined HT)
OR 0.21 [0.16, 0.26]2 studies · 1718 participantsModerate