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Climacteric : the Journal of the... Aug 2019The objective of this review is to provide an overview of existing and evolving methods of assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy A...
The objective of this review is to provide an overview of existing and evolving methods of assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy A systematic literature search was carried out on MEDLINE and Embase in order to identify studies on diagnostic instruments for vulvar, vaginal, and lower urinary tract atrophy, as well as new possibilities allowing for an improved diagnostic future. Measurement of the most bothersome symptoms, especially dyspareunia and vaginal dryness, is possibly the most useful parameter in clinical practice, even though it is a subjective measurement. Regarding objective result measurements, the two main parameters to be studied are the vaginal maturation index and vaginal pH measurement. In addition, clinical exploration has value both with the vaginal health index and with the vulvar health index. Other research tools are arising, such as a broader knowledge of the vaginal lamina propria elements, the measurement of vaginal distension, and the possibilities of having vaginal tissue 'on a chip'. Gynecologists can make a diagnosis based on the patient's symptoms and a thorough physical examination. However, in cases in which you want to be sure of the diagnosis, and when you want to evaluate and compare treatment options, we need to assess the associated symptoms, vaginal maturation index, and vaginal pH with a clinical estimation by the physician. However, there is an increasing need for new objective parameters helping in the evaluation process.
Topics: Atrophy; Female; Humans; Menopause; Urinary Tract; Vagina; Vulva
PubMed: 31157569
DOI: 10.1080/13697137.2019.1600499 -
The Cochrane Database of Systematic... Mar 2019This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has significantly improved prognosis for women with malignant and some non-malignant conditions. This treatment, however, is associated with ovarian toxicity. The use of gonadotropin-releasing hormone (GnRH) analogues, both agonists and antagonists, may have a protective effect on the ovaries. The primary mechanism of action of GnRH analogues is to suppress the gonadotropin levels to simulate pre-pubertal hormonal milieu and subsequently prevent primordial follicles from maturation and therefore decrease the number of follicles that are more vulnerable to chemotherapy.
OBJECTIVES
To assess the efficacy and safety of GnRH analogues given before or in parallel to chemotherapy to prevent chemotherapy-related ovarian damage in premenopausal women with malignant or non-malignant conditions.
SEARCH METHODS
The search was run for the original review in July 2011, and for the first update in July 2014. For this update we searched the following databases in November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Chinese Biomedicine Database (CBM).
SELECTION CRITERIA
Randomised controlled trials (RCTs), in all languages, which examined the effect of GnRH analogues for chemotherapy-induced ovarian failure in premenopausal women, were eligible for inclusion in the review.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed trial quality using the Cochrane 'Risk of bias' tool. We analysed binary data using risk ratios (RRs) with 95% confidence intervals (CI) and for continuous data, we used the standardized mean difference (SMD) to combine trials. We applied the random-effects model in our analyses. We used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.
MAIN RESULTS
We included 12 RCTs involving 1369 women between the ages of 12 and 51.1 years. Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy. The included studies were funded by a university (n = 1), research centres (n = 4), and pharmaceutical companies (n = 1). Trials were at high or unclear risk of bias.Comparison 1: GnRH agonist plus chemotherapy versus chemotherapy aloneThe incidence of menstruation recovery or maintenance was 178 of 239 (74.5%) in the GnRH agonist group and 110 of 221 (50.0%) in the control group during a follow-up period no longer than 12 months (RR 1.60, 95% CI 1.14 to 2.24; 5 studies, 460 participants; I = 79%; low-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P = 0.006). However, we observed no difference during a follow-up period longer than 12 months between these two groups (P = 0.24). In the GnRH agonist group, 326 of 447 participants had menstruation recovery or maintenance (72.9%) in comparison to the control group, in which 276 of 422 participants had menstruation recovery or maintenance (65.4%) during a follow-up period longer than 12 months (RR 1.08, 95% CI 0.95 to 1.22; 8 studies, 869 participants; I = 56%; low-certainty evidence).The incidence of premature ovarian failure was 43 of 401 (10.7%) in the GnRH agonist group and 96 of 379 (25.3%) in the control group (RR 0.44, 95% CI 0.31 to 0.61; 4 studies, 780 participants; I = 0%; moderate-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P < 0.00001).The incidence of pregnancy was 32 of 356 (9.0%) in the GnRH agonist group and 22 of 347 (6.3%) in the control group (RR 1.59, 95% CI 0.93 to 2.70; 7 studies, 703 participants; I = 0%; low-certainty evidence), with no difference between groups (P = 0.09). However, we are cautious about this conclusion because there were insufficient data about whether the participants intended to become pregnant.The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The most common adverse effects of GnRH analogues included hot flushes, vaginal dryness, urogenital symptoms, and mood swings. The pooled analysis of safety data showed no difference in adverse effects between GnRH agonist group and control group.Comparison 2: GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy aloneOnly one RCT discussed GnRH agonist-antagonist cotreatment. The limited evidence showed the incidence of menstruation recovery or maintenance was 20 of 25 (80%) in both cotreatment group and control group during a 12-month follow-up period (RR 1.00, 95% CI 0.76 to 1.32; 50 participants; very low-certainty evidence), with no difference between groups (P = 1.00). In the cotreatment group, 13 of 25 participants had menstruation recovery or maintenance (52.0%) in comparison to the control group, in which 14 of 25 participants had menstruation recovery or maintenance (56.0%) during a follow-up period longer than 12 months (RR 0.93, 95% CI 0.56 to 1.55; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.78). The incidence of pregnancy was 1 of 25 (4.0%) in the cotreatment group and 0 of 25 (0%) in the control group (RR 3.00, 95% CI 0.13 to 70.30; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.49).
AUTHORS' CONCLUSIONS
GnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of maintenance and resumption of menstruation, treatment-related premature ovarian failure and ovulation. Evidence for protection of fertility was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist and GnRH antagonist cotreatment on ovarian protection against chemotherapy. The included studies differed in some important aspects of design, and most of these studies had no age-determined subgroup analysis. Large and well-designed RCTs with longer follow-up duration should be conducted to clarify the effects of GnRH analogues in preventing chemotherapy-induced ovarian failure, especially on different age groups or different chemotherapy regimens. Furthermore, studies should address the effects on pregnancy rates and anti-tumour therapy.
Topics: Administration, Intranasal; Adolescent; Adult; Antineoplastic Agents; Child; Female; Gonadotropin-Releasing Hormone; Humans; Injections, Intramuscular; Injections, Subcutaneous; Menstruation; Middle Aged; Ovulation; Pregnancy; Pregnancy Rate; Premenopause; Primary Ovarian Insufficiency; Randomized Controlled Trials as Topic; Recovery of Function; Young Adult
PubMed: 30827035
DOI: 10.1002/14651858.CD008018.pub3 -
European Journal of Obstetrics,... Oct 2018Genitourinary syndrome of menopause (GSM) increases the probability of female sexual dysfunction (FSD). The aim of the current study is to systematically assess data... (Meta-Analysis)
Meta-Analysis
Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials.
Genitourinary syndrome of menopause (GSM) increases the probability of female sexual dysfunction (FSD). The aim of the current study is to systematically assess data regarding sexual function and use of vaginal therapies, alternative to vaginal estrogens (VE), in menopausal women with GSM. PubMed, Scopus and Cochrane Library were searched (May-September 2017) using combination keywords: "dyspareunia and vaginal therapy", "sexual function and vaginal therapy", "orgasm and vaginal therapy", "vaginal atrophy" and "genitourinary syndrome of menopause". Eligible studies were RCTs focusing on the use of vaginal therapies, alternative to VE, in menopausal women. These studies were written in English language and published in peer-reviewed journals with impact factor. Assessment of risk of bias was performed using the Cochrane Risk of Bias Tool. Outcomes involved dyspareunia, vaginal dryness, orgasm and all parameters of sexual function. Twenty-nine RCTs including 3689 menopausal women, were included. Vaginal therapies, alternative to VE included non-hormonal (vaginal laser, lubricants/moisturizers, phytoestrogens and lidocaine) and hormonal ones (Dehyadroapiandrosterone (DHEA), testosterone and oxytocin). Dyspareunia and/or vaginal dryness were assessed in 72% of the articles, while the FSD and orgasm in 45% and 28% of articles, respectively. Dyspareunia and vaginal dryness improved in all relevant studies. Sexuality scores of lubricants were inferior to estrogens [3 studies, n = 138, standardized mean difference (smd) -0.64, (95%CI -1.1, -0.2)]. Orgasm domain was the same for the DHEA 0.5% and placebo (2 studies, n = 663, smd 1.29 (95% -0.47, 3.05), I:90%). Sexual satisfaction and sexuality score were the same when testosterone was compared or added to estrogen therapy (2 studies, n = 99, smd 0.16 (95%CI-0.23,0.56), I:12% and 2 studies (n = 87), smd 0.20 (95%CI-0.23,0.62), I:0%, respectively. Available data are not adequate to provide counseling by the physicians in menopausal women regarding the efficacy of vaginal therapies as an alternative to estrogens, on all parameters of sexual function.
Topics: Female; Humans; Menopause; Randomized Controlled Trials as Topic; Sexual Dysfunction, Physiological; Vaginal Diseases
PubMed: 30103082
DOI: 10.1016/j.ejogrb.2018.08.008 -
Journal of Menopausal Medicine Apr 2018Atrophic vaginitis (AV), which is common in postmenopausal women, is characterized by vaginal dryness, dyspareunia, and discomfort. There are a variety of therapeutic...
OBJECTIVES
Atrophic vaginitis (AV), which is common in postmenopausal women, is characterized by vaginal dryness, dyspareunia, and discomfort. There are a variety of therapeutic agents for the treatment of AV, besides hormone replacement therapy. We performed this systematic review to compare the effectiveness of various therapies for symptom improvement in AV patients.
METHODS
We searched the Cochrane Library, EMBASE, MEDLINE, and other literature (Google Scholar, Web of Science, and hand search) for studies published between January 2010 and March 2015. AV was evaluated by the following outcomes: vaginal pH, dyspareunia, vaginal dryness, or cytological change (endometrial thickness, percentages of superficial cells and parabasal cells). They measured treatment efficacy with various outcomes pertaining to AV symptoms.
RESULTS
Meta-analysis suggested that ospemifene was effective against dyspareunia, vaginal dryness, endometrial thickness, and percentage changes in superficial and parabasal cells. Vaginal pH was most affected by soy isoflavone vaginal gel. Ospemifene was effective for AV symptoms.
CONCLUSIONS
This systematic review compared the effects of several therapeutic agents on symptoms of AV through a network meta-analysis. This study provides objective evidence for clinical treatment and efficacy management in AV.
PubMed: 29765921
DOI: 10.6118/jmm.2018.24.1.1 -
The Australian & New Zealand Journal of... Apr 2018Following menopause, up to 49% of women will experience genitourinary symptoms such as vaginal itching, dryness, dyspareunia and incontinence as a result of oestrogen...
Following menopause, up to 49% of women will experience genitourinary symptoms such as vaginal itching, dryness, dyspareunia and incontinence as a result of oestrogen deficiency. Treatments such as vaginal lubricants and moisturisers only temporarily relieve symptoms, while local oestrogen treatments are often unacceptable or unsafe for many women. Recently, a novel laser treatment has been proposed as a non-invasive, long-term solution to vulvo-vaginal and urinary symptoms. While preliminary histological results have been promising, its therapeutic, clinical effect has yet to be determined. However, despite the scarcity of evidence for its safety and long-term benefit, laser treatments are widely marketed for a range of genitourinary symptoms, with high uptake by both clinicians and women alike. This review aims to examine the evidence for laser treatments to the vulvo-vagina and to evaluate its safety and efficacy. Our results include 17 studies investigating the effect of laser therapy for vulvo-vaginal symptoms, seven for its effects on urinary incontinence and four for histology. These are limited to non-randomised, observational data with small sample sizes between 15 to 175 women and follow-up duration from none to two years. As such, strong evidence for laser efficacy and safety is limited and warrants more robust, placebo-controlled, randomised trials before widespread implementation.
Topics: Female; Humans; Laser Therapy; Postmenopause; Vaginal Diseases; Vulvar Diseases
PubMed: 29067688
DOI: 10.1111/ajo.12735 -
International Urogynecology Journal Apr 2018Pelvic floor disorders (PFDs) negatively affect quality of life in the general population, and their prevalence in gynecologic cancer survivors has not been... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Pelvic floor disorders (PFDs) negatively affect quality of life in the general population, and their prevalence in gynecologic cancer survivors has not been systematically described. This study aimed to determine the prevalence of PFDs in cancer survivors. We hypothesized that the prevalence of PFDs in the gynecologic cancer population would be higher than in the general female population.
METHODS
We searched PubMed (1809 to present), EMBASE (1974 to present), and the Cochrane Central Register of Controlled Trials (CENTRAL) through May 2017. The search combined subject headings, title, and abstract words for gynecologic cancer, PFDs, and prevalence. Any studies evaluating the prevalence of PFDs in gynecologic malignancies were included.
RESULTS
A total of 550 articles met the designated search criteria and 31 articles were included in this review. In cervical cancer survivors, before treatment the prevalences of stress urinary incontinence (SUI), urgency urinary incontinence (UUI) and fecal incontinence (FI) were 24-29%, 8-18% and 6%, respectively, and after treatment the prevalences of SUI, UUI, urinary retention, FI, fecal urge, dyspareunia and vaginal dryness were 4-76%, 4-59%, 0.4-39%, 2-34%, 3-49%, 12-58% and 15-47%, respectively. In uterine cancer survivors, before treatment the prevalences of SUI, UUI and FI were 29-36%, 15-25% and 3%, respectively, and after treatment the prevalences of urinary incontinence (UI) and dyspareunia were 2-44% and 7-39%, respectively. In vulvar cancer survivors, after treatment the prevalences of UI, SUI and FI were 4-32%, 6-20% and 1-20%, respectively. In ovarian cancer survivors, the prevalences of SUI, UUI, prolapse and sexual dysfunction were 32-42%, 15-39%, 17% and 62-75%, respectively.
CONCLUSIONS
PFDs are prevalent in gynecologic cancer survivors and this is an important area of clinical concern and future research.
Topics: Cancer Survivors; Female; Genital Neoplasms, Female; Humans; Pelvic Floor Disorders; Prevalence
PubMed: 28929201
DOI: 10.1007/s00192-017-3467-4 -
Menopause (New York, N.Y.) Feb 2018This systematic review of the literature was undertaken to investigate the prevalence of sexual symptoms in women in Asia in relation to their menopause status.
OBJECTIVE
This systematic review of the literature was undertaken to investigate the prevalence of sexual symptoms in women in Asia in relation to their menopause status.
METHODS
MEDLINE, EMBASE, PsycINFO, CINAHL, SCOPUS, and Google scholar were searched systematically for relevant population-based prevalence studies published between 1988 and 2016. The included studies were assessed for risk of bias using a risk-of-bias tool developed explicitly for the systematic review of prevalence studies.
RESULTS
A total of 34 articles, comprising 24,743 women, were included. In Asia, diminished sexual desire appears to be highly prevalent amongst postmenopausal women. Vulvovaginal atrophy symptoms are common after menopause in some Asian countries, but are either less common or under-reported in other Asian countries. The review highlights the paucity of data pertaining to menopause and sexual well-being in Asia, and the lack of prevalence studies that have assessed sexual function using a validated questionnaire. Most of the included studies had a high risk of bias, especially in the four items that pertain to external validity.
CONCLUSIONS
The available data, despite its limitations, suggests that after menopause, lowered sexual desire and vulvovaginal atrophy symptoms, including dryness, irritation, soreness, and dyspareunia, are common in women in Asia. The extent to which such symptoms cause women distress is not known. Studies of representative samples of premenopausal, perimenopausal, and postmenopausal women that use robustly translated and culturally appropriate validated questionnaires, and that collect detailed demographic data are still needed to determine the prevalence of sexual symptoms in relation to menopause in women in Asia.
Topics: Asia; Atrophy; Dyspareunia; Female; Humans; Libido; Postmenopause; Prevalence; Sexual Dysfunction, Physiological; Sexual Health; Vagina; Vulva
PubMed: 28858028
DOI: 10.1097/GME.0000000000000967 -
Maturitas Sep 2017This study aimed to identify and then synthesize all available data regarding the efficacy of laser therapy for postmenopausal women with genitourinary syndrome of... (Meta-Analysis)
Meta-Analysis Review
This study aimed to identify and then synthesize all available data regarding the efficacy of laser therapy for postmenopausal women with genitourinary syndrome of menopause (GSM) with/without urinary incontinence (UI). PubMed, Scopus, Web of Science, Cochrane Library and ClinicalTrials.gov were searched in October 2016. The keywords were "laser genitourinary syndrome of menopause", "laser vulvovaginal atrophy", "laser vaginal atrophy" and "laser women incontinence". Quality of reporting and risk of bias of the included studies were assessed according to STROBE and MINORs checklists, respectively. Quality of the body of evidence was evaluated with the GRADE approach. Fourteen studies involving 542 participants were included in this systematic review and meta-analysis. All GSM symptoms (dryness/dyspareunia/itching/burning/dysuria/urgency/frequency) and UI decreased significantly and consistently in all available publications. The pooled mean differences for the various symptoms were: dryness -5.5(95%CI:-6.7,-4.4;7studies;I:0%), dyspareunia -5.6(95%CI:-6.8,-4.5;7 studies;I:0%), itching -4(95%CI:-5.7,-2.2;6 studies;I:79%), burning -3.9(95%CI:-5.9,-2;6 studies;I:87%), dysuria -2.9(95%CI:-5.1,-0.7;4 studies;I:90%) and UI -4.9(95%CI:-6.4,-3.4;2 studies;I:0%). Because urgency/frequency was assessed by different methodologies the data could not be meta-analyzed. Furthermore, KHQ, UDI-6, MCS12/PCS12, FSFI, overall sexual satisfaction and measurements of the effect of laser therapy on the local pathophysiology improved significantly. In conclusion, laser therapy for postmenopausal women with GSM appears promising. It may reduce symptom severity, improve quality of life of postmenopausal women and restore the vaginal mucosa to premenopausal status. However, the quality of the body of evidence is "low" or "very low" and, thus, evidence-based modification of current clinical practice cannot be suggested.
Topics: Female; Genital Diseases, Female; Humans; Laser Therapy; Menopause; Syndrome; Urologic Diseases
PubMed: 28778337
DOI: 10.1016/j.maturitas.2017.06.029 -
American Family Physician Dec 2016The results of large clinical trials have led physicians and patients to question the safety of hormone therapy for menopause. In the past, physicians prescribed hormone... (Review)
Review
The results of large clinical trials have led physicians and patients to question the safety of hormone therapy for menopause. In the past, physicians prescribed hormone therapy to improve overall health and prevent cardiac disease, as well as for symptoms of menopause. Combined estrogen/progestogen therapy, but not estrogen alone, increases the risk of breast cancer when used for more than three to five years. Therefore, in women with a uterus, it is recommended that physicians prescribe combination therapy only to treat menopausal symptoms such as vasomotor symptoms (hot flashes) and vaginal atrophy, using the smallest effective dosage for the shortest possible duration. Although estrogen is the most effective treatment for hot flashes, nonhormonal alternatives such as low-dose paroxetine, venlafaxine, and gabapentin are effective alternatives. Women with a uterus who are using estrogen should also take a progestogen to reduce the risk of endometrial cancer. Women who cannot tolerate adverse effects of progestogens may benefit from a combined formulation of estrogen and the selective estrogen receptor modulator bazedoxifene. There is no highquality, consistent evidence that yoga, paced respiration, acupuncture, exercise, stress reduction, relaxation therapy, and alternative therapies such as black cohosh, botanical products, omega-3 fatty acid supplements, and dietary Chinese herbs benefit patients more than placebo. One systematic review suggests modest improvement in hot flashes and vaginal dryness with soy products, and small studies suggest that clinical hypnosis significantly reduces hot flashes. Patients with genitourinary syndrome of menopause may benefit from vaginal estrogen, nonhormonal vaginal moisturizers, or ospemifene (the only nonhormonal treatment approved by the U.S. Food and Drug Administration for dyspareunia due to menopausal atrophy). The decision to use hormone therapy depends on clinical presentation, a thorough evaluation of the risks and benefits, and an informed discussion with the patient.
Topics: Acupuncture Therapy; Administration, Intravaginal; Amines; Antidepressive Agents; Atrophy; Cyclohexanecarboxylic Acids; Dietary Supplements; Drug Therapy, Combination; Dyspareunia; Estrogen Replacement Therapy; Estrogens; Exercise Therapy; Female; Gabapentin; Hot Flashes; Humans; Hypnosis; Indoles; Menopause; Paroxetine; Progestins; Selective Estrogen Receptor Modulators; Tamoxifen; Vagina; Vaginal Diseases; Vasomotor System; Venlafaxine Hydrochloride; gamma-Aminobutyric Acid
PubMed: 27929271
DOI: No ID Found -
The Cochrane Database of Systematic... Aug 2016Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). This is an update of a Chochrane systematic review; the original version was first published in October 2006.
OBJECTIVES
The objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women.
SEARCH METHODS
We searched the following databases and trials registers to April 2016: Cochrane Gynaecology and Fertility Group Register of trials, The Cochrane Central Register of Controlled Trials (CENTRAL; 2016 issue 4), MEDLINE, Embase, PsycINFO, DARE, the Web of Knowledge, OpenGrey, LILACS, PubMed and reference lists of articles. We also contacted experts and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for at least 12 weeks for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial eligibility and risk of bias and extracted the data. The primary review outcomes were improvement in symptoms (participant-assessed), and the adverse event endometrial thickness. Secondary outcomes were improvement in symptoms (clinician-assessed), other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) and adherence to treatment. We combined data to calculate pooled risk ratios (RRs) (dichotomous outcomes) and mean differences (MDs) (continuous outcomes) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I(2) statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.
MAIN RESULTS
We included 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. The evidence was low to moderate quality; limitations were poor reporting of study methods and serious imprecision (effect estimates with wide confidence intervals)1. Oestrogen ring versus other regimensOther regimens included oestrogen cream, oestrogen tablets and placebo. There was no evidence of a difference in improvement in symptoms (participant assessment) either between oestrogen ring and oestrogen cream (odds ratio (OR) 1.33, 95% CI 0.80 to 2.19, two RCTs, n = 341, I(2) = 0%, low-quality evidence) or between oestrogen ring and oestrogen tablets (OR 0.78, 95% CI 0.53 to 1.15, three RCTs, n = 567, I(2) = 0%, low-quality evidence). However, a higher proportion of women reported improvement in symptoms following treatment with oestrogen ring compared with placebo (OR 12.67, 95% CI 3.23 to 49.66, one RCT, n = 67). With respect to endometrial thickness, a higher proportion of women who received oestrogen cream showed evidence of increase in endometrial thickness compared to those who were treated with oestrogen ring (OR 0.36, 95% CI 0.14 to 0.94, two RCTs, n = 273; I(2) = 0%, low-quality evidence). This may have been due to the higher doses of cream used. 2. Oestrogen tablets versus other regimensOther regimens in this comparison included oestrogen cream, and placebo. There was no evidence of a difference in the proportions of women who reported improvement in symptoms between oestrogen tablets and oestrogen cream (OR 1.06, 95% CI 0.55 to 2.01, two RCTs, n = 208, I(2) = 0% low-quality evidence). A higher proportion of women who were treated with oestrogen tablets reported improvement in symptoms compared to those who received placebo using a fixed-effect model (OR 12.47, 95% CI 9.81 to 15.84, two RCTs, n = 1638, I(2) = 83%, low-quality evidence); however, using a random-effect model did not demonstrate any evidence of a difference in the proportions of women who reported improvement between the two treatment groups (OR 5.80, 95% CI 0.88 to 38.29). There was no evidence of a difference in the proportions of women with increase in endometrial thickness between oestrogen tablets and oestrogen cream (OR 0.31, 95% CI 0.06 to 1.60, two RCTs, n = 151, I(2) = 0%, low-quality evidence).3. Oestrogen cream versus other regimensOther regimens identified in this comparison included isoflavone gel and placebo. There was no evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and isoflavone gel (OR 2.08, 95% CI 0.08 to 53.76, one RCT, n = 50, low-quality evidence). However, there was evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and placebo with more women who received oestrogen cream reporting improvement in symptoms compared to those who were treated with placebo (OR 4.10, 95% CI 1.88 to 8.93, two RCTs, n = 198, I(2) = 50%, low-quality evidence). None of the included studies in this comparison reported data on endometrial thickness.
AUTHORS' CONCLUSIONS
There was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. However, there was low-quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo. There was low-quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring; this may have been due to the higher doses of cream used. However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo.
Topics: Administration, Intravaginal; Aged; Atrophy; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Isoflavones; Middle Aged; Postmenopause; Randomized Controlled Trials as Topic; Tablets; Vagina; Vaginal Creams, Foams, and Jellies; Vaginitis
PubMed: 27577677
DOI: 10.1002/14651858.CD001500.pub3