ABSTRACT
Given the persistent confusion about the risks and benefits of hormone therapy since 2002 and the first publication from the Women's Health Initiative's primary findings, women and health care providers are increasingly motivated to find effective, nonhormonal approaches to treat menopause-related symptoms. Complementary and alternative medicine has grown increasingly popular in the last decade. A wide array of botanic medicines is offered as an alternative approach to hormone therapy for menopause, but data documenting efficacy and safety are limited. None of the available botanicals is as effective as hormone therapy in the management of vasomotor symptoms.
Subject(s)
Complementary Therapies , Menopause , Plant Extracts/therapeutic use , Female , Hot Flashes/drug therapy , Humans , Treatment OutcomeABSTRACT
STUDY OBJECTIVE: To investigate the systemic absorption of estradiol in partners of postmenopausal women after making skin-to-skin contact with the application sites of estradiol topical emulsion. DESIGN: Open-label, nonrandomized clinical study. SETTING: Clinical study unit. SUBJECTS: Fourteen postmenopausal women and their male partners (mean +/- SD age 57.6+/-8.7 and 49.1+/-13.3 yrs, respectively). INTERVENTION: Women applied 1.74 g/day of estradiol topical emulsion (containing 2.5 mg estradiol/g) to each leg on 2 consecutive days. Their male partners were exposed to the application sites by mean of vigorous skin-to-skin contact at 2 and 8 hours after application. MEASUREMENTS AND MAIN RESULTS: Serum concentrations of estradiol, estrone, and estrone sulfate were measured in the female subjects and their male partners. The mean +/- SD estradiol level in the women at baseline was 2.9+/-1.5 pg/ml. Their average concentration (C(average)) increased from 15.3+/-14.8 pg/ml on the first day of treatment to 27.6+/-22.7 pg/ml on the second day. Among male partners, C(average) for serum estradiol increased from 17.0+/-4.3 pg/ml at baseline to 21.0+/-4.4 pg/ml on the second exposure day. Their geometric mean fold ratio for the area under the serum concentration-time curve from 0-24 hours was 1.25 (baseline vs after second exposure, p<0.0001). CONCLUSIONS: Estradiol was transferred to male partners by means of vigorous skin-to-skin contact at application sites. Although the increase in postexposure levels of estradiol was statistically significant, all levels were still below the upper limit of the normal range for men (45 pg/ml).
Subject(s)
Estradiol/administration & dosage , Skin/metabolism , Absorption , Administration, Topical , Adult , Aged , Biological Availability , Emulsions , Estradiol/pharmacokinetics , Female , Humans , Male , Middle Aged , PostmenopauseSubject(s)
Complementary Therapies , Quackery , Women's Health , Attitude to Health , Female , Humans , Reproducibility of Results , Treatment OutcomeABSTRACT
The ageing of the US population and the recognised importance of preventative care has led to a growing body of research regarding the morbidity and mortality associated with chronic diseases in postmenopausal women. According to the National Institute of Health, postmenopausal women have a significant increase in risk for a number of debilitating diseases, including osteoporosis, breast cancer and cardiovascular disease. In addition, recently published studies prompted patients, clinicians and payers to re-examine the risks and benefits of a well-accepted therapy to treat postmenopausal symptoms. The objective of this paper is to provide a framework for assessing the economic impact of disorders affecting postmenopausal women, with a particular focus on osteoporosis, breast cancer and cardiovascular disease. This framework considers the prevalence of these conditions, the profiles of women suffering from each of them and prevailing patterns of treatment for these disorders. Taken together, these factors are used to analyse the overall economic impact of postmenopausal disorders and to provide an expert opinion in this context.
Subject(s)
Breast Neoplasms/economics , Cardiovascular Diseases/economics , Osteoporosis/economics , Postmenopause , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/therapy , Chronic Disease , Combined Modality Therapy/economics , Drug Utilization/economics , Female , Health Care Costs , Humans , Middle Aged , Osteoporosis/epidemiology , Osteoporosis/therapy , Practice Patterns, Physicians' , Prevalence , Preventive Health Services/economics , Preventive Health Services/statistics & numerical data , United States/epidemiology , Women's Health Services/economics , Women's Health Services/statistics & numerical dataABSTRACT
OBJECTIVE: The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women. DESIGN: This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint. RESULTS: A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score. CONCLUSION: Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.
Subject(s)
Depression/drug therapy , Menopause/psychology , Quality of Life , Raloxifene Hydrochloride/therapeutic use , Selective Estrogen Receptor Modulators/therapeutic use , Surveys and Questionnaires/standards , Adult , Aged , Depression/pathology , Double-Blind Method , Female , Humans , Middle Aged , Prospective Studies , Treatment Outcome , United StatesABSTRACT
In the search for alternatives to HRT--a search motivated by the yearning for "natural" treatments and, more recently, by bad news from HRT trials--herbs and botanicals, and some foods, have received much attention and wide acceptance. This acceptance is, however, based on little more than advertising and consumers' desire to believe it. The available research is mainly not of high quality, and there remains a host of products to be tested. The chief problems have been lack of standards for admission to study, unknown dosages of active principles, and unclear or lax criteria for effectiveness. So far, though, black cohosh and soy (in many forms) can be said to offer some benefits.
Subject(s)
Cimicifuga , Estrogen Replacement Therapy , Glycine max , Phytotherapy , Aged , Contraindications , Controlled Clinical Trials as Topic , Estrogen Replacement Therapy/adverse effects , Estrogen Replacement Therapy/methods , Evidence-Based Medicine , Female , Humans , Isoflavones/therapeutic use , Menopause/drug effects , Middle Aged , Plant Extracts/therapeutic use , Research Design/standards , Women's HealthABSTRACT
Alternative medicine is no longer mystical, mythical, or remote. At last 50% of the adult population has tried some sort of alternative therapy. As the population ages, and chronic illness becomes more prevalent, the use of alternatives is likely to continue to increase. CAM often targets chronic disorders that are often poorly addressed by conventional care. such as headache, arthritis. insomnia, fatigue, and so forth. Managed care, indirectly by imposing barriers to access and directly by offering riders that cover CAM services, are pushing patients away from more expensive conventional therapies. In conditions like the perimenopause, where the symptoms may wax and wane unpredictably, quality research is needed to demonstrate the efficacy of interventions. In the not so distant past, CAM practices have been given a pass, permitted to lay claim to historical uses as proof of efficacy. This exemption from the rules has been revoked. Major journals have issued a call for a new, more evenhanded approach. The editors of the prestigious New England Journal of Medicine asserted that [36]: There cannot be two kinds of medicine--conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking. Whether a therapeutic practice is 'Eastern' or 'Western', is unconventional or mainstream, or involves mind-body techniques or molecular genetics is largely irrelevant expect for historical purposes and cultural interest. Gynecologists and others who care for women need to be aware of the evidence supporting or refuting the claims made for both conventional and alternative medicine. Any therapy that provides effective and safe mitigation of the tumultuous and distressing endocrine events associated with the perimenopausal transition should be offered and used. An expanded array of therapeutic options may increase the likelihood of successful treatment and promote enhanced satisfaction and well-being for women. Such improvements can help to cement long-term relationships between providers and patients, for health and well-being now and in the future.