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International Journal of Gynecological... Sep 2014Quality of life (QoL) and sexual health have become increasingly important in cervical cancer survivors (CCSs). The aims of this review were to summarize research... (Review)
Review
OBJECTIVES
Quality of life (QoL) and sexual health have become increasingly important in cervical cancer survivors (CCSs). The aims of this review were to summarize research findings of QoL and sexual function in CCSs after treatment on the basis of self-reported questionnaires and to update the current knowledge of overall QoL and sexual function in CCSs.
METHODS
Studies from electronic database between May 1966 and May 2013 were rated on their internal validity as methodological assessment. Thirty-two studies were included, wherein 15 studies had a relatively good methodology.
RESULTS
Anorectal function, urinary symptoms, and lymphedema were commonly reported as physical symptoms. As to psychosocial domains, the studies illustrated that anxiety decreased with age, whereas depression generally increased with age. Sexual function was involved in most of the studies. Vaginal dryness, dyspareunia, short vagina, and sexual dissatisfaction were prominent issues of sexual dysfunction and vaginal changes in CCSs. In terms of treatment modality, radiotherapy was thought to be associated with worse QoL and sexual function in CCSs.
CONCLUSIONS
The studies showed that QoL and sexual function in CCSs were compromised compared with the general population to different extents. Quality of life and sexual function should be paid with more attention in patients with cervical cancer after treatment.
Topics: Anxiety Disorders; Depressive Disorder; Female; Humans; Quality of Life; Sexual Dysfunction, Physiological; Sexuality; Surveys and Questionnaires; Survivors; Uterine Cervical Neoplasms
PubMed: 25033255
DOI: 10.1097/IGC.0000000000000207 -
Expert Opinion on Pharmacotherapy Apr 2014This systematic review examined the use of progestogens or oral contraceptives and gonadotropin-releasing hormone (GnRH) agonists for the treatment of endometriosis. (Comparative Study)
Comparative Study Review
OBJECTIVE
This systematic review examined the use of progestogens or oral contraceptives and gonadotropin-releasing hormone (GnRH) agonists for the treatment of endometriosis.
RESEARCH DESIGN AND METHODS
Inclusion criteria were: i) randomized controlled trials (RCTs); ii) comparison of progestogens with GnRH agonists for treatment of endometriosis; and iii) endometriosis diagnosed by laparoscopy or laparotomy.
MAIN OUTCOME MEASURES
Pelvic pain, bone mineral density, serum estradiol level, and side effects.
RESULTS
Of 128 articles identified, there were four RCTs comparing the use of progestogens and GnRH agonists. In three studies a progestogen (gestrinone, lynestrenol, or dienogest) was compared with leuprolide. In one study, ethinyl estradiol/norethindrone was compared with leuprolide/norethindrone. A meta-analysis was not possible as the studies varied markedly in their protocols, inclusion criteria, and the drugs and doses administered. Leuprolide was as effective as gestrinone, dienogest, and continuous oral contraceptives (OCs) for the relief of endometriosis-related pain, whereas it was superior to lynestrenol. Leuprolide was associated with a significant reduction in bone mineral density and estradiol levels and a higher incidence of hot flushes, headaches, mood changes, and vaginal dryness, whereas progestogens were associated with higher incidences of weight gain and acne.
CONCLUSIONS
These results suggest that progestogens or OCs may be used as first-line therapy for endometriosis.
Topics: Contraceptives, Oral; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Progestins; Randomized Controlled Trials as Topic
PubMed: 24588662
DOI: 10.1517/14656566.2014.888414 -
The Cochrane Database of Systematic... Nov 2013Heavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many women eventually will require further treatment. Endometrial ablation by hysteroscopic and more recent "second-generation" devices such as balloon, radiofrequency or microwave ablation offers a day-case surgical alternative to hysterectomy. Complete endometrial destruction is one of the main determinants of treatment success. Surgery is most effective if undertaken when endometrial thickness is less than four millimeters. One option is to perform the surgery in the immediate postmenstrual phase, which is not always practical. The other option is to use hormonal agents that induce endometrial thinning pre-operatively. The most commonly evaluated agents are goserelin (a gonadotrophin-releasing hormone analogue, or GnRHa) and danazol. Other GnRH analogues and progestogens have also been studied, although fewer data are available. It has been suggested that these agents will reduce operating time, improve the intrauterine operating environment and reduce absorption of fluid used for intraoperative uterine cavity distension. They may also improve long-term outcomes, including menstrual loss and dysmenorrhoea.
OBJECTIVES
To investigate the effectiveness and safety of pre-operative endometrial thinning agents (GnRH agonists, danazol, estrogen-progestins and progestogens) versus another agent or placebo when given before endometrial destruction in premenopausal women with heavy menstrual bleeding.
SEARCH METHODS
The following electronic databases were searched to April 2013 for published and unpublished randomised controlled trials that met the inclusion criteria: the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of controlled trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO.Other electronic sources of trials included trial registers for ongoing and registered trials; citation indexes; conference abstracts in the Web of Knowledge; the LILACS database for trials from the Portuguese- and Spanish-speaking world; PubMed; and the OpenSIGLE database and Google for grey literature.All searches were performed in consultation with the MDSG Trials Search Co-ordinator.
SELECTION CRITERIA
Randomised controlled trials (RCTs) were included if they compared the effects of these agents with one other, or with placebo or no treatment, on relevant intraoperative and postoperative treatment outcomes. Selection of trials was carried out independently by two review authors.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for risk of bias and extracted data on surgical outcomes, effectiveness outcomes, proportion of women requiring further surgical therapy during follow-up, endometrial outcome measures, acceptability of use outcomes and quality of life. Data were analysed on an intention-to-treat basis. Dichotomous data were combined for meta-analysis with RevMan software using the Mantel-Haenszel method to estimate pooled risk ratios (RRs). Continuous data were combined for meta-analysis with RevMan software using an inverse variance method to estimate the pooled mean difference (MD) with 95% confidence interval (CI). The overall quality of evidence for the main findings was assessed with the use of GRADE working group methods.
MAIN RESULTS
Twenty studies with 1969 women were included in this review. These studies compared GnRHa, danazol and progestogens versus placebo or no treatment; GnRHa versus danazol, progestogens, GnRH antagonists or dilatation & curettage; and danazol versus progestogens. Four studies performed more than one comparison.When compared with no treatment, GnRHa used before hysteroscopic resection were associated with a higher rate of postoperative amenorrhoea at 12 months (RR 1.6, 95% CI 1.2 to 2.0, 7 RCTs, 605 women, moderate heterogeneity; I(2) = 40%) and at 24 months (RR 1.62, 95% CI 1.04 to 2.52, 2 RCTs, 357 women, no heterogeneity; I(2) = 0%), a slightly shorter duration of surgery (-3.5 minutes, 95% CI -4.7 to -2.3, 5 RCTs, 156 women, substantial heterogeneity; I(2) = 72%) and greater ease of surgery (RR 0.32, 95% CI 0.22 to 0.46, 2 RCTs, 415 women, low heterogeneity; I(2) = 4%). Postoperative dysmenorrhoea was reduced (RR 0.59, 95% CI 0.40 to 0.87, 2 RCTs, 133 women, no heterogeneity; I(2) = 0%). The use of GnRHa had no effect on intraoperative complication rates (RR 1.47, 95% CI 0.35 to 6.06, 5 RCTs, 592 women, no heterogeneity; I(2) = 0%), and participant satisfaction with this surgery was high irrespective of the use of pre-operative endometrial thinning agents (RR 0.99, 95% CI 0.93 to 1.05, 6 RCTs, 599 women, low heterogeneity; I(2) = 11%). GnRHa produced more consistent endometrial atrophy than was produced by danazol (RR 1.84, 95% CI 1.23 to 2.75, 2 RCTs, 142 women, no heterogeneity; I(2) = 0%). For other intraoperative and postoperative outcomes, any differences were minimal, and no benefits of GnRHa pretreatment were noted in studies in which women underwent second-generation ablation techniques. Both GnRHa and danazol produced side effects in a significant proportion of women, although few studies reported these in detail. Few randomised data were available to allow assessment of the effectiveness of progestogens as endometrial thinning agents. When reported, the long-term effects of endometrial thinning agents on benefits such as postoperative amenorrhoea were reduced with time.The main study weaknesses were that most participants received no follow-up beyond 24 months and that the studies used a small sample size. Heterogeneity for outcomes reported ranged from none to substantial. More than half the trials had no blinding of participants or outcome assessment. Most of the trials were determined to have uncertain selection and reporting bias, as they did not report allocation concealment and evidence of selective reporting was noted. The quality of reporting of adverse events was generally poor, but, when described in the studies, they included menopausal symptoms such as hot flushes, vaginal dryness, hirsutism, decreased libido and voice changes, as well as other side effects such as headache and weight gain.
AUTHORS' CONCLUSIONS
Low-quality evidence suggests that endometrial thinning with GnRHa and danazol before hysteroscopic surgery improves operating conditions and short-term postoperative outcomes. GnRHa produced slightly more consistent endometrial thinning than was produced by danazol, although both achieved satisfactory results. The effect of these agents on longer-term postoperative outcomes was reduced with time. No benefits of GnRHa pretreatment were apparent with second-generation ablation techniques. Also, side effects were more common when these agents were used.
Topics: Danazol; Dilatation and Curettage; Dysmenorrhea; Endometrium; Female; Gonadotropin-Releasing Hormone; Humans; Menorrhagia; Preoperative Care; Progestins; Randomized Controlled Trials as Topic
PubMed: 24234875
DOI: 10.1002/14651858.CD010241.pub2 -
The Cochrane Database of Systematic... Apr 2013The delivery of combination contraceptive steroids from a transdermal contraceptive patch or a contraceptive vaginal ring offers potential advantages over the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The delivery of combination contraceptive steroids from a transdermal contraceptive patch or a contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance.
OBJECTIVES
To compare the contraceptive effectiveness, cycle control, compliance (adherence), and safety of the contraceptive patch or the vaginal ring versus combination oral contraceptives (COCs).
SEARCH METHODS
Through February 2013, we searched MEDLINE, POPLINE, CENTRAL, LILACS, ClinicalTrials.gov, and ICTRP for trials of the contraceptive patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review, we contacted known researchers and manufacturers to identify other trials.
SELECTION CRITERIA
We considered randomized controlled trials comparing a transdermal contraceptive patch or a contraceptive vaginal ring with a COC.
DATA COLLECTION AND ANALYSIS
Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the mean difference was computed. We also assessed the quality of evidence for this review.
MAIN RESULTS
We found 18 trials that met our inclusion criteria. Of six patch studies, five examined the marketed patch containing norelgestromin plus ethinyl estradiol (EE); one studied a patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials, 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE patch, ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE patch report, patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials, one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52), while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing patch reported more breast discomfort, dysmenorrhea, nausea, and vomiting. In the levonorgestrel-containing patch trial, patch users reported less vomiting, headaches, and fatigue.Of 11 ring trials with discontinuation data, two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users, ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea, acne, irritability, depression, and emotional lability than COC users.For cycle control, only one trial study showed a significant difference. Women in the patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group.
AUTHORS' CONCLUSIONS
Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the patch trials but two-thirds of ring trials. The patch could lead to more discontinuation than the COC. The patch group had better compliance than the COC group. Compliance data came from half of the patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment, the outcome assessment methods, high losses to follow up, and exclusions after randomization.
Topics: Consumer Behavior; Contraceptive Agents, Female; Contraceptive Devices, Female; Contraceptives, Oral, Combined; Drug Implants; Female; Humans; Medication Adherence; Menstrual Cycle; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 23633314
DOI: 10.1002/14651858.CD003552.pub4 -
Climacteric : the Journal of the... Jun 2013Vulvovaginal atrophy-related symptoms exert a negative impact on the quality of life of up to 50% of postmenopausal women. Many of them decline to use topical vaginal... (Review)
Review
Vulvovaginal atrophy-related symptoms exert a negative impact on the quality of life of up to 50% of postmenopausal women. Many of them decline to use topical vaginal estrogen, which is the standard effective therapy, due to the adverse publicity over recent years, and seek for alternatives. Further, there are no safety studies to support the use of topical vaginal estrogen in breast cancer survivors, and it is considered as contraindicated by many health-care professionals. Vaginal moisturizers and lubricants as well as regular sexual activity may be helpful to such women. Vaginal moisturizers may have an equivalent efficacy to topical vaginal estrogen and should be offered to women wishing to avoid the use of hormonal therapy. Lubricants are usually used during sexual intercourse to provide temporary relief from vaginal dryness and dyspareunia; however, they have no long-term therapeutic effects. We provide in this systematic review up-to-date information, for women and health-care professionals, about the use, safety and efficacy of the available vaginal moisturizers and lubricants.
Topics: Administration, Intravaginal; Aged; Atrophy; Breast Neoplasms; Coitus; Contraindications; Dyspareunia; Estrogens; Female; Humans; Lipids; Lubricants; Menopause; Middle Aged; Quality of Life; Sexual Behavior; Survivors; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva
PubMed: 23215675
DOI: 10.3109/13697137.2012.756466 -
The Cochrane Database of Systematic... Sep 2012Menopause can be a distressing and disruptive time for many women, with many experiencing hot flushes, night sweats, vaginal atrophy and dryness. Postmenopausal women... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Menopause can be a distressing and disruptive time for many women, with many experiencing hot flushes, night sweats, vaginal atrophy and dryness. Postmenopausal women are also at increased risk of osteoporosis. Interventions that decrease the severity and frequency of these menopausal symptoms are likely to improve a woman's well-being and quality of life. Hormone therapy has been shown to be effective in controlling the symptoms of menopause; however, many potentially serious adverse effects have been associated with this treatment. Evidence from experimental studies suggests that black cohosh may be a biologically plausible alternative treatment for menopause; even so, findings from studies investigating the clinical effectiveness of black cohosh have, to date, been inconsistent.
OBJECTIVES
To evaluate the clinical effectiveness and safety of black cohosh (Cimicifuga racemosa or Actaea racemosa) for treating menopausal symptoms in perimenopausal and postmenopausal women.
SEARCH METHODS
Relevant studies were identified through AARP Ageline, AMED, AMI, BioMed Central gateway, CAM on PubMed, CINAHL, CENTRAL, EMBASE, Health Source Nursing/Academic edition, International Pharmaceutical Abstracts, MEDLINE, Natural medicines comprehensive database, PsycINFO, TRIP database, clinical trial registers and the reference lists of included trials; up to March 2012. Content experts and manufacturers of black cohosh extracts were also contacted.
SELECTION CRITERIA
All randomised controlled trials comparing orally administered monopreparations of black cohosh to placebo or active medication in perimenopausal and postmenopausal women.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, extracted data and completed the 'Risk of bias' assessment. Study authors were contacted for missing information.
MAIN RESULTS
Sixteen randomised controlled trials, recruiting a total of 2027 perimenopausal or postmenopausal women, were identified. All studies used oral monopreparations of black cohosh at a median daily dose of 40 mg, for a mean duration of 23 weeks. Comparator interventions included placebo, hormone therapy, red clover and fluoxetine. Reported outcomes included vasomotor symptoms, vulvovaginal symptoms, menopausal symptom scores and adverse effects. There was no significant difference between black cohosh and placebo in the frequency of hot flushes (mean difference (MD) 0.07 flushes per day; 95% confidence interval (CI) -0.43 to 0.56 flushes per day; P=0.79; 393 women; three trials; moderate heterogeneity: I(2) = 47%) or in menopausal symptom scores (standardised mean difference (SMD) -0.10; 95% CI -0.32 to 0.11; P = 0.34; 357 women; four trials; low heterogeneity: I(2) = 21%). Compared to black cohosh, hormone therapy significantly reduced daily hot flush frequency (three trials; data not pooled) and menopausal symptom scores (SMD 0.32; 95% CI 0.13 to 0.51; P=0.0009; 468 women; five trials; substantial heterogeneity: I(2) = 69%). These findings should be interpreted with caution given the heterogeneity between studies. Comparisons of the effectiveness of black cohosh and other interventions were either inconclusive (because of considerable heterogeneity or an insufficient number of studies) or not statistically significant. Similarly, evidence on the safety of black cohosh was inconclusive, owing to poor reporting. There were insufficient data to pool results for health-related quality of life, sexuality, bone health, vulvovaginal atrophic symptoms and night sweats. No trials reported cost-effectiveness data. The quality of included trials was generally unclear, owing to inadequate reporting.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence to support the use of black cohosh for menopausal symptoms. However, there is adequate justification for conducting further studies in this area. The uncertain quality of identified trials highlights the need for improved reporting of study methods, particularly with regards to allocation concealment and the handling of incomplete outcome data. The effect of black cohosh on other important outcomes, such as health-related quality of life, sexuality, bone health, night sweats and cost-effectiveness also warrants further investigation.
Topics: Cimicifuga; Dehydration; Female; Hot Flashes; Humans; Middle Aged; Perimenopause; Phytotherapy; Postmenopause; Randomized Controlled Trials as Topic; Sweating; Trifolium; Vaginal Diseases
PubMed: 22972105
DOI: 10.1002/14651858.CD007244.pub2 -
The Cochrane Database of Systematic... Mar 2010The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance.
OBJECTIVES
To compare the contraceptive effectiveness, cycle control, adherence (compliance), and safety of the skin patch or the vaginal ring versus combination oral contraceptives (COCs).
SEARCH STRATEGY
For trials of the contraceptive patch or the vaginal ring, we searched MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP. We contacted manufacturers and researchers to identify other trials.
SELECTION CRITERIA
All randomized controlled trials comparing the skin patch or vaginal ring with a COC.
DATA COLLECTION AND ANALYSIS
Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the mean difference was computed.
MAIN RESULTS
We found 5 trials of the skin patch and 10 of the vaginal ring. Contraceptive effectiveness was similar for the patch or ring versus the comparison COC. More patch users discontinued early than COC users: ORs were 1.59 (95% CI 1.26 to 2.00), 1.56 (95% CI 1.18 to 2.06), and 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events. Compared to COC users, patch users reported more breast discomfort, dysmenorrhea, nausea, and vomiting. Patch users reported more compliant cycles than the COC users in two trials: ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). The ring trials generally showed similar discontinuation for ring and COC users. Ring users reported less nausea, acne, irritability, and depression than COC users. Ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users had similar adherence to COC users in two trials but less adherence in one. Cycle control was generally similar for the patch and COC, and was similar or better for the ring versus COC.
AUTHORS' CONCLUSIONS
Effectiveness was similar for the methods compared. The patch could lead to more discontinuation while the vaginal ring showed little difference. The patch group had better compliance than the COC group but more side effects. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. High losses to follow up can affect the validity of the results.
Topics: Consumer Behavior; Contraceptive Agents, Female; Contraceptive Devices, Female; Contraceptives, Oral, Combined; Drug Implants; Female; Humans; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 20238323
DOI: 10.1002/14651858.CD003552.pub3 -
NIH Consensus and State-of-the-science...To provide health care providers, patients, and the general public with a responsible assessment of currently available data on the management of menopause-related... (Review)
Review
OBJECTIVE
To provide health care providers, patients, and the general public with a responsible assessment of currently available data on the management of menopause-related symptoms.
PARTICIPANTS
A non-DHHS, nonadvocate 12-member panel representing the fields of obstetrics and gynecology, general internal medicine, endocrinology, rheumatology, family and health psychology, geriatric medicine, health services research, demography, biochemistry, epidemiology, clinical research, and biostatistics. In addition, 26 experts in fields related to the conference topic presented data to the panel and to the conference audience.
EVIDENCE
Presentations by experts and a systematic review of the medical literature prepared by the Oregon Evidence-based Practice Center, through the Agency for Healthcare Research and Quality's Evidence-based Practice Centers Program. Scientific evidence was given precedence over clinical anecdotal experience.
CONFERENCE PROCESS
Answering pre-determined questions, the panel drafted its statement based on scientific evidence presented in open forum and on the published scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the audience for comment. The panel then met in executive session to consider the comments received, and released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. A final copy of this statement is available, along with other recent conference statements, at the same web address of http://consensus.nih.gov.
CONCLUSIONS
Menopause is the permanent cessation of menstrual periods that occurs naturally in women, usually in their early 50s. Many women have few or no symptoms; these women are not in need of medical treatment. Premenopausal or perimenopausal women who have menopause induced by surgery, chemotherapy, or radiation are more likely to experience bothersome and even disabling symptoms. These women need safe and effective treatment. It is difficult to differentiate those symptoms that are truly associated with menopause from those due to aging. Hot flashes, night sweats, and vaginal dryness are clearly tied to the menopausal transition, and there is some positive evidence of a menopausal link for sleep disturbance. Vasomotor symptoms are reported with high frequency during the menopausal transition. Estrogen, either by itself or with progestins, is the most consistently effective therapy for these symptoms. However, the Women's Health Initiative (WHI) has identified important risk factors associated with use of these therapies. Decision making for women regarding treatment for menopausal symptoms requires personal knowledge and balancing of these risks. There are many potential alternatives to estrogen. However, their effectiveness and long-term safety need to be studied in rigorous clinical trials in diverse populations of women. Much more research is needed to clearly define the natural history of menopause, associated symptoms, and effectiveness and safety of treatments for bothersome symptoms. Natural histories are important for both science and policy. Knowing how many women transit menopause with few or no symptoms, and how many manage menopause largely on their own, can lead to public health information that empowers women and increases their self-reliance. Medical care and future clinical trials are best focused on women with the most severe and prolonged symptoms. The state of the science in management of menopausal symptoms should be reassessed periodically. Menopause is "medicalized" in contemporary U.S. society. There is great need to develop and disseminate information that emphasizes menopause as a normal, healthy phase of women's lives and promotes its demedicalization. Medical care and future clinical trials are best focused on women with the most severe and prolonged symptoms. Barriers to professional care for these women should be removed.
Topics: Behavior Therapy; Complementary Therapies; Decision Making; Estrogen Replacement Therapy; Evidence-Based Medicine; Female; Hot Flashes; Humans; Interdisciplinary Communication; Menopause; Menopause, Premature; Quality of Life; Risk Assessment; Risk Factors; Sleep Wake Disorders; United States
PubMed: 17308548
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2006Vaginal 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).
OBJECTIVES
The objective of this review was to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group Register of trials (searched January 2006), The Cochrane Library (2006,Issue 2), MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), Current Contents (1993 to January 2006, Biological Abstracts (1969 to 2006), Social Sciences Index (1980 to January 2006), PsycINFO (1972 to February 2006), CINAHL (1982 to January 2006) and reference list of articles. We also contacted manufacturers and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS
Thirty-seven trials were identified: of these 18 were excluded. Included trials were assessed for quality and two reviewer authors extracted data independently. The ratios for dichotomous outcomes and means for continuous outcomes were calculated. The outcomes analysed were categorised under the headings of: efficacy, safety and acceptability.
MAIN RESULTS
Nineteen trials with 4162 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy, with various outcome measures. When comparing the efficacy of different oestrogenic preparations (in the form of creams, pessaries, tablets and the oestradiol-releasing vaginal ring) in relieving the symptoms of vaginal atrophy, results indicated significant findings favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and seven looked at adverse effects. One trial showed significant adverse effects of the cream (conjugated equine oestrogen) when compared to tablets (oestradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by a progestagen challenge test with the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to the cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (oestradiol). Eleven studies compared acceptability to the participants by comparing: comfort of product use, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the oestradiol-releasing vaginal ring.
AUTHORS' CONCLUSIONS
Creams, pessaries, tablets and the oestradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following use of the cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the oestradiol-releasing vaginal ring for ease of use, comfort of product and overall satisfaction.
Topics: Administration, Intravaginal; Atrophy; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Middle Aged; Postmenopause; Randomized Controlled Trials as Topic; Vagina; Vaginitis
PubMed: 17054136
DOI: 10.1002/14651858.CD001500.pub2 -
The Cochrane Database of Systematic... 2003Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for... (Review)
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 estradiol releasing ring).
OBJECTIVES
The objective of this review is to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group register of trials (searched January 2003), The Cochrane Library (Issue 2, 2003), MEDLINE (1966-January 2003), EMBASE (1980-January 2003), Current Contents (1993-January 2003), Biological Abstracts (1969-2002), Social Sciences Index (1980-January 2003), PsycINFO (1972-February 2003), CINAHL (1982-January 2003) and reference list of articles. We also contacted manufacturers and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS
Twenty nine trials were identified, of these 13 were excluded. Trials were assessed for quality and two reviewers extracted data independently. Ratios for dichotomous and means for continuous outcomes were estimated. Outcomes analysed were included under the headings of efficacy, safety and acceptability.
MAIN RESULTS
Sixteen trials with 2129 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy with various outcome measures. When comparing efficacy of oestrogenic preparations (in the form of creams, pessaries, tablets and the estradiol releasing vaginal ring) with each other in relieving the symptoms of vaginal atrophy, results indicated significant differences favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and six looked at adverse effects. One trial showed significant adverse effects of cream (conjugated equine oestrogen) when compared to tablets (estradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by progestagen challenge test in the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (estradiol). Nine studies compared acceptability to the participants by comparing comfort of product, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the estradiol releasing vaginal ring.
REVIEWER'S CONCLUSIONS
Creams, pessaries, tablets and the estradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects noted following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the estradiol releasing vaginal ring for ease of use, comfort of product and overall satisfaction.
Topics: Administration, Intravaginal; Atrophy; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Randomized Controlled Trials as Topic; Vagina; Vaginitis
PubMed: 14583935
DOI: 10.1002/14651858.CD001500