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The Cochrane Database of Systematic... Oct 2016Tibolone 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... (Meta-Analysis)
Meta-Analysis Review
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 symptomsTibolone 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 bleedingTibolone was associated with greater likelihood of bleeding (OR 2.79, 95% CI 2.10 to 3.70; nine RCTs; 7814 women; I = 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 eventsMost of the studies reporting these outcomes provided follow-up of two to three years (range three months to three years). Breast cancerWe 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; I= 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 eventsWe 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; I = 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 outcomesEvidence 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; I = 0%.• Cardiovascular events: OR 1.38, 95% CI 0.84 to 2.27; four RCTs; 8401 women; I = 0%.• Venous thromboembolic events: OR 0.85, 95% CI 0.37 to 1.97; 9176 women; I = 0%.• Mortality from any cause: OR 1.06, 95% CI 0.79 to 1.41; four RCTs; 8242 women; I = 0%. Tibolone versus combined HT Vasomotor symptomsCombined 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 bleedingTibolone was associated with a lower rate of bleeding (OR 0.32, 95% CI 0.24 to 0.41; 16 RCTs; 6438 women; I = 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 eventsMost 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; I = 0%.• Breast cancer: OR 1.69, 95% CI 0.78 to 3.67; five RCTs; 4835 women; I = 0%.• Venous thromboembolic events: OR 0.44, 95% CI 0.09 to 2.14; four RCTs; 4529 women; I = 0%.• Cardiovascular events: OR 0.63, 95% CI 0.24 to 1.66; two RCTs; 3794 women; I = 0%.• Cerebrovascular events: OR 0.76, 95% CI 0.16 to 3.66; four RCTs; 4562 women; I = 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.
Topics: Aged; Breast Neoplasms; Dyspareunia; Estrogen Receptor Modulators; Estrogen Replacement Therapy; Female; Hot Flashes; Humans; Middle Aged; Neoplasm Recurrence, Local; Norpregnenes; Postmenopause; Randomized Controlled Trials as Topic; Stroke; Sweating; Uterine Hemorrhage
PubMed: 27733017
DOI: 10.1002/14651858.CD008536.pub3 -
European Journal of Obstetrics,... Dec 2020The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).
STUDY DESIGN
Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).
RESULTS
CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).
CONCLUSIONS
Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.
Topics: Dyspareunia; Electric Stimulation Therapy; Endometriosis; Female; Humans; Pain Management; Pelvic Pain; Quality of Life
PubMed: 33129015
DOI: 10.1016/j.ejogrb.2020.10.018 -
Revista Brasileira de Ginecologia E... Jan 2017To evaluate the long-term effectiveness of perineal Thiele massage in the treatment of women with dyspareunia caused by tenderness of the pelvic floor muscles. A... (Clinical Trial)
Clinical Trial
To evaluate the long-term effectiveness of perineal Thiele massage in the treatment of women with dyspareunia caused by tenderness of the pelvic floor muscles. A total of 18 women with diagnoses of dyspareunia caused by tenderness of the pelvic floor muscles were included in the study. The women were divided in two groups: the dyspareunia (D) group - 8 women with dyspareunia caused by tenderness of the pelvic floor muscles; and the chronic pelvic pain group (CPP) group - 10 women with dyspareunia caused by tenderness of the pelvic floor muscles associated with CPP. Each patient filled out the Visual Analogue Scale (VAS), the McGill Pain Index, the Female Sexual Function Index (FSFI) and the Hospital Anxiety and Depression Scale (HADS). After an evaluation, the women underwent transvaginal massage using the Thiele technique over a period of 5 minutes, once a week for 4 weeks. All women had significant improvements in their dyspareunia according the VAS and the McGill Pain Index ( < 0,001), but the HADS scores did not show significant differences. Regarding sexual function, the D group showed improvements on all aspects of sexual function, while the CPP group showed differences only in the pain domain. Thiele massage is effective in the treatment of dyspareunia caused by tenderness of the pelvic floor muscles with a long-term pain relief.
Topics: Adult; Dyspareunia; Female; Humans; Massage; Myalgia; Pelvic Floor Disorders; Time Factors; Treatment Outcome
PubMed: 28027568
DOI: 10.1055/s-0036-1597651 -
BMJ Case Reports Oct 2023We present the case of a woman in her late 20s who consulted our gynaecology emergency department due to dyspareunia and vaginal penetration issues. She had undergone a...
We present the case of a woman in her late 20s who consulted our gynaecology emergency department due to dyspareunia and vaginal penetration issues. She had undergone a 'virginity reconstruction' procedure 10 days before her wedding in Africa. Clinical examination revealed suture of the inferior part of inner labia (labia minora), narrowing of the vaginal introitus and abnormal vaginal discharge. We performed an inferior defibulation procedure and removed the sutures under general anaesthesia. Postoperative care included systemic metronidazole, counselling, vaginal dilators and topical estrogens for 1 month. There were no complications during the postoperative follow-up, and a month later, the woman confirmed a satisfactory outcome. The aim of this paper is to discuss the practice of so-called 'virginity reconstruction', currently classified among female cosmetic genital surgeries despite being very similar to what is defined as female genital mutilation, and the care that can be provided to women in such cases.
Topics: Female; Humans; Africa; Circumcision, Female; Dyspareunia; Gynecologic Surgical Procedures; Vagina; Adult
PubMed: 37798043
DOI: 10.1136/bcr-2022-251008 -
Acta Obstetricia Et Gynecologica... Oct 2020Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to compare structured group-based multimodal physical therapy in a hospital setting (intervention group) with primary-care physical therapy (comparator group) for women with chronic pelvic pain.
MATERIAL AND METHODS
Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of "worst" and "least" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t test and Mann-Whitney U test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A P value <.05 was considered statistically significant.
RESULTS
Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% CI -2.3 to -0.2; P = .027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% CI 0.2-1.6; P = .015) and pain-related fear of movements (mean difference 2.9; 95% CI -5.5 to -0.3; P = .032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS
Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary-care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.
Topics: Adult; Chronic Pain; Dyspareunia; Fear; Female; Group Structure; Humans; Pain Measurement; Pelvic Pain; Physical Therapy Modalities; Primary Health Care; Quality of Life
PubMed: 32386466
DOI: 10.1111/aogs.13896 -
Women's Health (London, England) Aug 2015
Topics: Dysmenorrhea; Dyspareunia; Endometriosis; Female; Humans; Pelvic Pain; Women's Health
PubMed: 26343282
DOI: 10.2217/whe.15.61 -
European Journal of Obstetrics &... Sep 2023Endometriosis is a chronic oestrogen-dependent disease that affects 1 in 10 women of childbearing age. Half of these women have deep dyspareunia. The presence of this...
INTRODUCTION
Endometriosis is a chronic oestrogen-dependent disease that affects 1 in 10 women of childbearing age. Half of these women have deep dyspareunia. The presence of this symptom has been shown to negatively affect your quality of life. There are few studies in the literature that address this issue and its pathophysiology remains poorly understood.
MATERIALS AND METHODS
A case-control study has been carried out in order to assess the multi-causality of dyspareunia in patients with endometriosis. All the patients were assessed in a unit specialising in endometriosis and pelvic pain and their disease was staged using high-resolution ultrasound following the criteria of the IDEA group. The patients were divided into two groups, patients with dyspareunia n = 45 (cases) and those without it n = 55 (controls).
RESULTS
The only element that was statistically significant in explaining the dyspareunia was the presence of nodules in the retrocervical region with p = 0.000. The odds ratio of dyspareunia in the cases group was 5.3 (95 % CI 2.2-12.5).
CONCLUSIONS
Dyspareunia in patients with endometriosis is strongly dependent on the presence of nodules in the retrocervical region, although there are other factors involved that remain unknown, so more studies are still needed to understand and optimally address this symptom.
PubMed: 37608962
DOI: 10.1016/j.eurox.2023.100224 -
American Family Physician Oct 2014Dyspareunia is recurrent or persistent pain with sexual activity that causes marked distress or interpersonal conflict. It affects approximately 10% to 20% of U.S....
Dyspareunia is recurrent or persistent pain with sexual activity that causes marked distress or interpersonal conflict. It affects approximately 10% to 20% of U.S. women. Dyspareunia can have a significant impact on a woman's mental and physical health, body image, relationships with partners, and efforts to conceive. The patient history should be taken in a nonjudgmental way and progress from a general medical history to a focused sexual history. An educational pelvic examination allows the patient to participate by holding a mirror while the physician explains normal and abnormal findings. This examination can increase the patient's perception of control, improve self-image, and clarify findings and how they relate to discomfort. The history and physical examination are usually sufficient to make a specific diagnosis. Common diagnoses include provoked vulvodynia, inadequate lubrication, postpartum dyspareunia, and vaginal atrophy. Vaginismus may be identified as a contributing factor. Treatment is directed at the underlying cause of dyspareunia. Depending on the diagnosis, pelvic floor physical therapy, lubricants, or surgical intervention may be included in the treatment plan.
Topics: Diagnosis, Differential; Dyspareunia; Female; Humans; Women's Health
PubMed: 25369624
DOI: No ID Found -
Women's Health (London, England) Aug 2015Endometriosis affects a significant proportion of teenagers. Published studies suggest that laparoscopically confirmed endometriosis could be found in over 60% of... (Review)
Review
Endometriosis affects a significant proportion of teenagers. Published studies suggest that laparoscopically confirmed endometriosis could be found in over 60% of adolescent girls undergoing laparoscopic investigation for pain, in 75% of girls with chronic pelvic pain resistant to treatment and in 70% of girls with dysmenorrhea and in approximately 50% of girls with chronic pelvic pain not necessarily resistant to treatment. Both early and advanced forms, including deep endometriosis have been reported to be present in teenagers. It has recently been claimed that deep endometriosis has its roots in teenage years. Risk factors include obstructive mullerian anomalies, family history, early menarche and early onset dysmenorrhea. Both surgical and medical treatment approaches are used for treatment in this age group, but care should be taken when treatment with GnRHa and progestins is being considered due to their potential impact on bone formation. Further studies are urgently needed to determine whether early diagnosis and treatment of teenage endometriosis lead to better long term outcomes or simply increase number of interventions without preventing progression of the disease.
Topics: Adolescent; Adolescent Health; Anti-Inflammatory Agents, Non-Steroidal; Dysmenorrhea; Dyspareunia; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Menarche; Pelvic Pain; Risk Factors
PubMed: 26315257
DOI: 10.2217/whe.15.58 -
Reproductive Sciences (Thousand Oaks,... Oct 2013Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal... (Review)
Review
Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal dryness, and vaginal irritation. Currently, the only prescription options are systemic and vaginal estrogen therapies that may be limited by concerns about long-term safety and breast cancer risk. Ospemifene is a tissue-selective estrogen agonist/antagonist (a selective estrogen receptor modulator) recently approved by the US Food and Drug Administration for treatment of dyspareunia, a symptom of VVA, due to menopause. Ospemifene, the first nonestrogen oral treatment for this indication, may provide an alternative to treatment with estrogen. Animal models with ospemifene suggest an inhibitory effect on growth of malignant breast tissue, but animal data cannot necessarily be extrapolated to humans. Clinical trials, including 3 long-term studies assessing the overall safety of ospemifene, support that ospemifene is generally well tolerated, with beneficial effects on the vagina, neutral effects on the breast, and minimal effects on the endometrium.
Topics: Animals; Breast; Dyspareunia; Female; Humans; Postmenopause; Selective Estrogen Receptor Modulators; Tamoxifen; Vagina; Vulva
PubMed: 23945733
DOI: 10.1177/1933719113497290