Background
Tibolone is a synthetic steroid used for the treatment of menopausal symptoms, on the basis of short-term data suggesting its efficacy. We considered the balance between the benefits and risks of tibolone.

Objectives
To evaluate the effectiveness and safety of tibolone for treatment of postmenopausal and perimenopausal women.

Search methods
In October 2015, we searched the Gynaecology and Fertility Group (CGF) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and PsycINFO (from inception), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and clinicaltrials.gov. We checked the reference lists in articles retrieved.

Selection criteria
We included randomised controlled trials (RCTs) comparing tibolone versus placebo, oestrogens and/or combined hormone therapy (HT) in postmenopausal and perimenopausal women.

Data collection and analysis
We used standard methodological procedures of The Cochrane Collaboration. Primary outcomes were vasomotor symptoms, unscheduled vaginal bleeding and long-term adverse events. We evaluated safety outcomes and bleeding in studies including women either with or without menopausal symptoms.

Main results
We included 46 RCTs (19,976 women). Most RCTs evaluated tibolone for treating menopausal vasomotor symptoms. Some had other objectives, such as assessment of bleeding patterns, endometrial safety, bone health, sexuality and safety in women with a history of breast cancer. Two included women with uterine leiomyoma or lupus erythematosus.

Tibolone versus placebo

Vasomotor symptoms

Tibolone was more effective than placebo (standard mean difference (SMD) -0.99, 95% confidence interval (CI) -1.10 to -0.89; seven RCTs; 1657 women; moderate-quality evidence), but removing trials at high risk of attrition bias attenuated this effect (SMD -0.61, 95% CI -0.73 to -0.49; odds ratio (OR) 0.33, 85% CI 0.27 to 0.41). This suggests that if 67% of women taking placebo experience vasomotor symptoms, between 35% and 45% of women taking tibolone will do so.

Unscheduled bleeding

Tibolone was associated with greater likelihood of bleeding (OR 2.79, 95% CI 2.10 to 3.70; nine RCTs; 7814 women; I2 = 43%; moderate-quality evidence). This suggests that if 18% of women taking placebo experience unscheduled bleeding, between 31% and 44% of women taking tibolone will do so.

Long-term adverse events

Most of the studies reporting these outcomes provided follow-up of two to three years (range three months to three years).

Breast cancer

We found no evidence of differences between groups among women with no history of breast cancer (OR 0.52, 95% CI 0.21 to 1.25; four RCTs; 5500 women; I2= 17%; very low-quality evidence). Among women with a history of breast cancer, tibolone was associated with increased risk (OR 1.5, 95% CI 1.21 to 1.85; two RCTs; 3165 women; moderate-quality evidence).

Cerebrovascular events

We found no conclusive evidence of differences between groups in cerebrovascular events (OR 1.74, 95% CI 0.99 to 3.04; four RCTs; 7930 women; I2 = 0%; very low-quality evidence). We obtained most data from a single RCT (n = 4506) of osteoporotic women aged 60 to 85 years, which was stopped prematurely for increased risk of stroke.

Other outcomes

Evidence on other outcomes was of low or very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:

• Endometrial cancer: OR 2.04, 95% CI 0.79 to 5.24; nine RCTs; 8504 women; I2 = 0%.

• Cardiovascular events: OR 1.38, 95% CI 0.84 to 2.27; four RCTs; 8401 women; I2 = 0%.

• Venous thromboembolic events: OR 0.85, 95% CI 0.37 to 1.97; 9176 women; I2 = 0%.

• Mortality from any cause: OR 1.06, 95% CI 0.79 to 1.41; four RCTs; 8242 women; I2 = 0%.

Tibolone versus combined HT

Vasomotor symptoms

Combined HT was more effective than tibolone (SMD 0.17, 95% CI 0.06 to 0.28; OR 1.36, 95% CI 1.11 to 1.66; nine studies; 1336 women; moderate-quality evidence). This result was robust to a sensitivity analysis that excluded trials with high risk of attrition bias, suggesting a slightly greater disadvantage of tibolone (SMD 0.25, 95% CI 0.09 to 0.41; OR 1.57, 95% CI 1.18 to 2.10). This suggests that if 7% of women taking combined HT experience vasomotor symptoms, between 8% and 14% of women taking tibolone will do so.

Unscheduled bleeding

Tibolone was associated with a lower rate of bleeding (OR 0.32, 95% CI 0.24 to 0.41; 16 RCTs; 6438 women; I2 = 72%; moderate-quality evidence). This suggests that if 47% of women taking combined HT experience unscheduled bleeding, between 18% and 27% of women taking tibolone will do so.

Long-term adverse events

Most studies reporting these outcomes provided follow-up of two to three years (range three months to three years). Evidence was of very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:

• Endometrial cancer: OR 1.47, 95% CI 0.23 to 9.33; five RCTs; 3689 women; I2 = 0%.

• Breast cancer: OR 1.69, 95% CI 0.78 to 3.67; five RCTs; 4835 women; I2 = 0%.

• Venous thromboembolic events: OR 0.44, 95% CI 0.09 to 2.14; four RCTs; 4529 women; I2 = 0%.

• Cardiovascular events: OR 0.63, 95% CI 0.24 to 1.66; two RCTs; 3794 women; I2 = 0%.

• Cerebrovascular events: OR 0.76, 95% CI 0.16 to 3.66; four RCTs; 4562 women; I2 = 0%.

• Mortality from any cause: only one event reported (two RCTs; 970 women).

Authors' conclusions
Moderate-quality evidence suggests that tibolone is more effective than placebo but less effective than HT in reducing menopausal vasomotor symptoms, and that tibolone is associated with a higher rate of unscheduled bleeding than placebo but with a lower rate than HT.

Compared with placebo, tibolone increases recurrent breast cancer rates in women with a history of breast cancer, and may increase stroke rates in women over 60 years of age. No evidence indicates that tibolone increases the risk of other long-term adverse events, or that it differs from HT with respect to long-term safety.

Much of the evidence was of low or very low quality. Limitations included high risk of bias and imprecision. Most studies were financed by drug manufacturers or failed to disclose their funding source.

Short-term and long-term effects of tibolone in postmenopausal women.

Tibolone (TIB), a selective tissue estrogenic activity regulator (STEAR) in clinical use by postmenopausal women, activates hormonal receptors in a tissue-specific manner. Estrogenic activity is present mostly in the brain, vagina, and bone, while the inactive forms predominate in the endometrium and breast. Conflicting literature on TIB's actions has been observed. While it has benefits for vasomotor symptoms, bone demineralization, and sexual health, a higher relative risk of hormone-sensitive cancer has been reported. In the brain, TIB can improve mood and cognition, neuroinflammation, and reactive gliosis. This review aims to discuss the systemic effects of TIB on peri- and post-menopausal women and its role in the brain. We suggest that TIB is a hormonal therapy with promising neuroprotective properties.

Tibolone as Hormonal Therapy and Neuroprotective Agent.

Background: Women at high risk to develop ovarian cancer opt for risk-reducing salpingo-oophorectomy (RRSO) to reduce the risk by 80-96%. RRSO leads to a direct onset of menopause in premenopausal women. Hormone replacement therapy (HRT) can be used to mitigate menopausal symptoms after RRSO. However, it is unclear whether HRT in these women is safe in terms of breast cancer (BC) risk. Methods: We performed a literature search and investigated national guidelines on the use of HRT following RRSO in BRCA1 and BRCA2 mutation carriers. We analyzed differences and similarities between the guidelines and describe what these guidelines were based upon. Results: Seven articles regarding HRT following RRSO in BRCA1 and BRCA2 mutation carriers were identified. None of the included studies yielded any evidence that short-term use of HRT following RRSO increases the risk of developing BC or negates the protective effect of RRSO in BRCA1/2 mutation carriers without a personal history of BC. Eleven national guidelines were found and described. Conclusion: Short-term use of HRT after RRSO seems to be safe. The literature is more favorable toward estrogen alone. The ideal dosage and duration of use are unknown and remain to be investigated in future studies.

Safety of hormone replacement therapy following risk-reducing salpingo-oophorectomy: systematic review of literature and guidelines.

Hormone replacement therapy (HRT) increases the risk of endometrial and breast cancer. A strategy to reduce this incidence is the use of tibolone (TIB). The aim of this paper was to address the effects of TIB on the central nervous system (CNS). For the present review, MEDLINE (via PubMed), LILACS (via BIREME), Ovid Global Health, SCOPUS, Scielo, and PsycINFO (ProQuest Research Library) electronic databases were searched for the results of controlled clinical trials on peri- and postmenopausal women published from 1990 to September 2016. Also, this paper reviews experimental studies performed to analyze neuroprotective effects, cognitive deficits, neuroplasticity, oxidative stress, and stroke using TIB. Although there are few studies on the effect of this hormone in the CNS, it has been reported that TIB decreases lipid peroxidation levels and improves memory and learning. TIB has important neuroprotective effects that could prevent the risk of neurodegenerative diseases in postmenopausal women as well as the benefits of HRT in counteracting hot flashes, improving mood, and libido. Some reports have found that TIB delays cognitive impairment in various models of neuronal damage. It also modifies brain plasticity since it acts as an endocrine modulator regulating neurotransmitters, Tau phosphorylation, and decreasing neuronal death. Finally, its antioxidant effects have also been reported in different animal models.

/pdf/effects-of-tibolone-on-the-central-nervous-system-clinical-58f4o6elf7.pdf

Effects of Tibolone on the Central Nervous System: Clinical and Experimental Approaches

Female orgasmic disorder (FOD) is defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, as a persistent or recurrent delay in, or absence of, orgasm following a 'normal' sexual excitement phase FOD is a common problem affecting sexual function in a substantial proportion of women Studies suggest that it is prevalent in 11-41% of women worldwide and can have a tremendous impact on the individual's quality of life, relational satisfaction and general well-being The etiology of FOD tends to be multifactorial as it relates to genetics, medical conditions, medications, alcohol and drug use, other sexual dysfunctions, mental illness, life stressors, communication deficits and relationship issues It is critical that sexual functioning in patients is assessed frequently through interview and/or validated questionnaires to aid in treatment strategy and/or referral Currently, there are no approved medications to treat FOD However, there are medications and psychological treatments that have shown promise in either treating FOD or thwarting the side effects of medications that can cause FOD This chapter discusses the epidemiology and etiology of FOD and provides a comprehensive critical review of the literature on assessment and treatment of FOD

Female orgasmic disorder.

Objective To compare the effects of tibolone with those of conventional hormone replacement therapy on climacteric symptoms and sexual function in postmenopausal women.Materials and methods In a randomized, controlled trial, 140 postmenopausal women were allocated into three groups. Of the subjects included, 47 women received 2.5 mg tibolone + one Cal+D tablet (500 mg calcium and 200 IU vitamin D) daily; 46 women received 0.625 mg conjugated equine estrogen + 2.5 mg medroxyprogesterone (CEE/MPA) + one Cal+D tablet daily; and 47 women received only one Cal+D tablet as the control group. The Greene Climacteric Scale (GCS) questionnaire was used to detect the efficacy of treatment on climacteric symptoms. Rosen's Female Sexual Function Index (FSFI) was used for sexual function evaluation. Sex hormone binding globulin (SHBG), free estradiol index (FEI) and free testosterone index (FTI) were measured before and after treatment. The women were followed up for 6 monthsResults After treatment, all subscores in th...

Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women.

BACKGROUND: Childbirth preparation classes are incredibly useful for midwifery students as future medical personnel. Nowadays, given the outbreak of Covid-19 pandemic and as mobile applications are extensively welcomed, virtual space can be used for education in the area of childbirth preparation classes. Given the lack of an application for childbirth preparation classes, this study will be conducted to design, implement and validate such an application to improve the performance of midwifery students in the areas of pregnancy and safe delivery. MATERIALS AND METHODS: The present study will be conducted in three phases. In the first phase, content will be provided to Information Technology experts based on the content of the national guidelines for physiological delivery in Iran, and the application will be designed and validated for the use of midwifery students, then develop app for other medical students, midwives and physicians. In the second phase, the assessment will be based on Kirkpatrick's model. In the third stage, develop app for other medical students, midwives and physicians based on the results of the first and second phase. SPSS version 17 will be used in this phase for analysis of data through descriptive and analytical tests. CONCLUSION: Owing to the expansion of virtual space and the outbreak of Covid-19 pandemic, design, validation, and evaluation of an application for childbirth preparation classes is an exceptionally significant necessity which contributes to the process of educating midwifery students.

Design, implementation, and validation of an application for childbirth preparation classes to improve the performance of midwifery students: Study protocol

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Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women.

Design, implementation, and validation of an application for childbirth preparation classes to improve the performance of midwifery students: Study protocol