Melatonin osteoporosis prevention study (MOPS): a randomized, double-blind, placebo-controlled study examining the effects of melatonin on bone health and quality of life in perimenopausal women.

The purpose of this double-blind study was to assess the effects of nightly melatonin supplementation on bone health and quality of life in perimenopausal women. A total of 18 women (ages 45-54) were randomized to receive melatonin (3mg, p.o., n=13) or placebo (n=5) nightly for 6months. Bone density was measured by calcaneal ultrasound. Bone turnover marker (osteocalcin, OC for bone formation and NTX for bone resorption) levels were measured bimonthly in serum. Participants completed Menopause-Specific Quality of Life-Intervention (MENQOL) and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after treatment. Subjects also kept daily diaries recording menstrual cycling, well-being, and sleep patterns. The results from this study showed no significant change (6-month-baseline) in bone density, NTX, or OC between groups; however, the ratio of NTX:OC trended downward over time toward a ratio of 1:1 in the melatonin group. Melatonin had no effect on vasomotor, psychosocial, or sexual MENQOL domain scores; however, it did improve physical domain scores compared to placebo (mean change melatonin: -0.6 versus placebo: 0.1, P<0.05). Menstrual cycling was reduced in women taking melatonin (mean cycles melatonin: 4.3 versus placebo: 6.5, P<0.05), and days between cycles were longer (mean days melatonin: 51.2 versus placebo: 24.1, P<0.05). No differences in duration of menses occurred between groups. The overall PSQI score and average number of hours slept were similar between groups. These findings show that melatonin supplementation was well tolerated, improved physical symptoms associated with perimenopause, and may restore imbalances in bone remodeling to prevent bone loss. Further investigation is warranted.

Brief relaxation training program for hospital employees.

Employee stress leads to attrition, burnout, and increased medical costs. We aimed to assess if relaxation training leads to decreased stress levels based on questionnaire and thermal biofeedback. Thirty-minute relaxation training sessions were conducted for hospital employees and for cancer patients. Perceived Stress levels and skin temperature were analyzed before and after relaxation training.

The effects of glucosamine sulfate on intervertebral disc annulus fibrosus cells in vitro.

BACKGROUND CONTEXT: Glucosamine has gained widespread use among patients, despite inconclusive efficacy data. Inconsistency in the clinical literature may be related to lack of understanding of the effects of glucosamine on the intervertebral disc, and therefore, improper patient selection. PURPOSE: The goal of our study was to investigate the effects of glucosamine on intervertebral disc cells in vitro under the physiological conditions of inflammation and mechanical loading. STUDY DESIGN: Controlled in vitro laboratory setting. METHODS: Intervertebral disc cells isolated from the rabbit annulus fibrosus were exposed to glucosamine sulfate in the presence and absence of interleukin-1ß and tensile strain. Outcome measures included gene expression, measurement of total glycosaminoglycans, new proteoglycan synthesis, prostaglandin E2 production, and matrix metalloproteinase activity. The study was funded by NIH/NCCAM, and the authors have no conflicts of interest. RESULTS: Under conditions of inflammatory stimulation alone, glucosamine demonstrated a dose-dependent effect in decreasing inflammatory and catabolic mediators and increasing anabolic genes. However, under conditions of mechanical stimulation, although inflammatory gene expression was decreased, PGE2 was not. In addition, matrix metalloproteinase-3 gene expression was increased and aggrecan expression decreased, both of which would have a detrimental effect on matrix homeostasis. Consistent with this, measurement of total glycosaminoglycans and new proteoglycan synthesis demonstrated detrimental effects of glucosamine under all conditions tested. CONCLUSIONS: These results may in part help to explain the conflicting reports of efficacy, as there is biological plausibility for a therapeutic effect under conditions of predominate inflammation but not under conditions where mechanical loading is present or in which matrix synthesis is needed.

A pilot study of the effects of phytoestrogen supplementation on postmenopausal endometrium.

OBJECTIVE: This study was designed to assess endometrial histology in postmenopausal women not taking hormone replacement therapy, to evaluate side effects and efficacy of phytoestrogens in treating menopause-associated symptoms, and to determine whether 6 months of phytoestrogen supplementation altered endometrial histology. METHODS: We performed a prospective, double-blinded, randomized, placebo-controlled trial comparing the effects of 6 months of dietary phytoestrogen supplementation versus placebo in postmenopausal women. Baseline endometrial biopsies were performed and, if adequate, nonhyperplastic, noncancerous, and nonovulatory, subjects were randomly assigned to receive daily placebo or soy cereal supplementation for 6 months. Study subjects completed baseline and weekly dietary, symptom, and side effect logs. Repeat endometrial biopsies were obtained at 6 months. RESULTS: Subjects were recruited from January 1998 through June 2000. Twenty-seven subjects were randomized, and 19 completed the study. One (3.7%) baseline endometrial sample was weakly proliferative. All other baseline and final biopsies were consistent with atrophic, inactive endometrium. The maximum risk of endometrial stimulation with phytoestrogens is 35%. Hot flushes, night sweats, and vaginal dryness were significantly less severe at the final week of the study compared with baseline in the placebo group. Insomnia was more common in the treated group. There were no other statistically significant differences in symptoms or side effects. CONCLUSION: Phytoestrogens did not cause stimulation of the endometrium. Insomnia was more frequent over the 6-month study in the soy group, whereas hot flushes, night sweats, and vaginal dryness improved from baseline in the placebo group but not in the soy group.

What midlife women want from gynecologists: a survey of patients in specialty and private practices.

BACKGROUND: This study characterized the self-reported reason for a gynecology visit among midlife women in three different practice settings. We hypothesized that women seeking specialty care were more likely to report nonvasomotor symptoms potentially related to the menopausal transition. METHODS: Participants were 625 women aged 40-60 seen by gynecologists at three sites: an urban, academic, gynecologic menopause practice (Midlife Practice, or MLP) and urban (site A) and suburban (site B) locations of a general, nonacademic obstetrics and gynecology practice. Participants completed a self-report questionnaire asking them to choose and weigh the reason for their visit as "very much," "somewhat," or "not at all" for 15 common gynecologic and menopausal concerns. Demographic questions included age, self-rated health status, race/ethnicity, difficulty of paying for basics, and education. Comparisons between the three groups were made using parametric and nonparametric tests as appropriate. The main outcome measure was the response to the reason for participants' visit compared across the three sites. RESULTS: Women presenting to the MLP were significantly older and more likely to report vasomotor symptoms (VMS), moodiness, sexual problems, sleep problems, and weight and to learn more about menopause. When "very much" and "somewhat" reasons were combined, nearly 80% of the MLP responses listed sleep problems, 60% listed vaginal dryness or low desire, 34% listed weight gain, and 30.7% listed mood. CONCLUSIONS: Midlife women seeking care in a menopause gynecology practice had significantly more visits for vasomotor and nonvasomotor concerns than did women seeing general gynecologists. Women sought care for a broad range of concerns that are not typically in gynecologists' scope of practice, including sleep disturbances, moodiness, and weight management.

Yoga and quality-of-life improvement in patients with breast cancer: a literature review.

OBJECTIVE: Women undergoing treatment for breast cancer often turn to complementary and alternative medicine (CAM), including yoga, for improvement of mood, quality of life (QOL), sleep, and treatment-related side effects. The extant literature was reviewed to examine the clinical effects of yoga practice on QOL for patients with breast cancer. QOL was defined as physical well-being, social functioning, emotional health, and function-al adaptation. METHODS: Seven databases, including PubMed, Ovid MEDLINE, CINAHL, Embase, PsycINFO, Cochrane Library, and Web of Science were used to search for studies of patients with breast cancer that included a yoga intervention and QOL assessment. Attention was paid to assessing study population, outcome variables, the type of yoga intervention used, and methodological strengths and limitations. RESULTS: Seventy-one articles were identified that fit the search criteria. Although the literature provided evidence of QOL benefits of yoga for patients with breast cancer, no specific aspect of yoga was identified as being most advantageous. CONCLUSION: Although participation in yoga programs appeared to benefit patients with breast cancer, greater methodological rigor is required to understand the mechanisms that contribute to their effectiveness.

Pilot study of yoga for breast cancer survivors with poor quality of life.

INTRODUCTION: Studies show benefits of yoga for breast cancer patients with poor quality of life (QOL); however, none exclusively focus on survivors. This study addresses whether hatha yoga improves breast cancer survivors' QOL. METHODS: 25 breast cancer survivors completed six weeks of yoga. Outcome measures were 5 QOL categories evaluated using the FACT-B survey pre and post-intervention and after 6 months. RESULTS: Each category was evaluated independently, including: physical (PWB), social (SWB), emotional (EWB), functional (FWB), breast cancer specific well-being (BCS), Trial Outcome Index (TOI), FACT-G, and FACT-B. Significant improvement was found in all categories except social well-being (PWB p = .013, EWB p = .005, FWB p = .003, BCS p < .001, TOI p < .001, FACT-G p = .004, FACT-B p < .001). Patients with below average pre-intervention index scores (n = 13) showed greater improvement in EWB and FWB, while those with above average pre-intervention scores (n = 9) showed greater improvement in PWB. CONCLUSIONS: Yoga may be feasible and clinically useful for breast cancer survivors with poor QOL.

Effect of Sahaja yoga meditation on quality of life, anxiety, and blood pressure control.

OBJECTIVE: The present study investigates the effect of Sahaja yoga meditation on quality of life, anxiety, and blood pressure control. DESIGN: The prospective observational cohort study enrolled two study groups: those receiving treatment from the International Sahaja Yoga Research and Health Center (meditation group) and those receiving treatment from the Mahatma Gandhi Mission Hospital (control group). Researchers measured quality of life, anxiety, and blood pressure before and after treatment. RESULTS: Sixty-seven (67) participants in the meditation group and 62 participants in the control group completed the study. The two groups were comparable in demographic and clinical characteristics. At baseline, the meditation group had higher quality of life (p<0.001) than controls but similar anxiety level (p=0.74) to controls. Within-group pre- versus post-treatment comparisons showed significant improvement in quality of life, anxiety, and blood pressure in the meditation group (p<0.001), while in controls, quality of life deteriorated and there was no improvement in blood pressure. The improvement in quality of life, anxiety reduction, and blood pressure control was greater in the meditation group. The beneficial effect of meditation remained significant after adjusting for confounders. CONCLUSIONS: Meditation treatment was associated with significant improvements in quality of life, anxiety reduction, and blood pressure control.

Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of intravaginal estriol and progesterone on atrophic vaginitis in postmenopausal women. METHODS: Under a physician-sponsored Investigational New Drug application, 19 healthy postmenopausal women with atrophic vaginitis received vaginal suppositories containing estriol (1 mg) and progesterone (30 mg). The participants were instructed to insert one suppository intravaginally once daily for 2 weeks and thrice weekly for a total of 6 months. Vaginal pH, Vaginal Maturation Index, urinalysis, self-reported vaginal dryness, menopausal quality of life, and serum estriol and progesterone levels were measured at enrollment and after 3 and 6 months of suppository use. Endometrial biopsies were obtained at enrollment and at 6 months. After 2 weeks of therapy, six participants had serum estriol and progesterone measured. RESULTS: The Vaginal Maturation Index, vaginal pH, and vaginal dryness rating improved significantly at 3 and 6 months compared with baseline. Menopausal quality of life scores improved significantly in all domains, with the sexual subscale showing the most improvement. There were no cases of endometrial hyperplasia after 6 months of suppository use. Serum preinsertion estriol at week 2 and months 3 and 6 were similar to baseline levels. Serum preinsertion progesterone increased but returned to baseline preinsertion levels at month 6, and preinsertion levels were significantly less at month 6 compared with month 3. CONCLUSIONS: Intravaginal administration of a combination estriol and progesterone agent to women with atrophic vaginitis may represent a safe and effective alternative to systemic hormone replacement, although this study was not adequate to provide proof of efficacy given that it was uncontrolled.

Nutrient involvement in preeclampsia.

Preeclampsia is a pregnancy-specific condition that increases maternal and infant mortality and morbidity. It is diagnosed by new-onset increased blood pressure and proteinuria during gestation; for many years these markers were the sole targets for study. More recently, increased attention to the multisystemic nature of the syndrome with involvement of almost all organs, activation of coagulation and increased sensitivity to pressor agents has expanded understanding of the disorder. The epidemiology of preeclampsia, being more common in poor women, long ago suggested that nutrients might be involved in the disorder. Numerous conflicting hypotheses were advanced but the testing of these hypotheses has either been done poorly or not at all. Review of the available data indicates very few studies that provide useful insights. In many studies the syndrome is poorly defined and in most studies nutritional data (questionnaires or biomarkers) are obtained on women with the clinical syndrome. In overtly preeclamptic women it is impossible to decipher cause from effect. Nonetheless, current concepts of the genesis of preeclampsia that include endothelial dysfunction, inflammatory activation, oxidative stress and predisposing maternal factors provide targets for well-designed nutritional investigation. In this review the current concepts of the pathogenesis of preeclampsia are reviewed and available data are assessed in light of these concepts. Targets for nutritional investigation based on the current knowledge of pathophysiology are suggested.