MET Inhibits the Proliferation of EC Cells by Increasing MPA Sensitivity.

Context: The high resistance rate and high recurrence rate of progesterone only as a treatment for endometrial cancer (EC) limit its clinical application. Metformin (MET) may have antitumor ability. Combining MET and medroxyprogesterone acetate (MPA) may strengthen their inhibitory effects on proliferation of EC cells, but MET's mechanisms remain unclear. Objective: The study intended to identify the specific molecular mechanism that MET combined with MPA uses against EC progression. Design: The research team performed a controlled animal study. Setting: The study took place at Xuzhou Medical University in Xuzhou, China. Animals: The animals were16 female non-obese diabetic-severe combined immunodeficient (NOD-SCID) nude mice, about 12 to 16 g in weight. Interventions: The research team divided randomly, the mice into four groups and induced EC in all groups, four in each group: (1) The control group which received received normal saline, (2) the MPA group, which received 100 mg/kg of MPA; (3) the MET group, which received metformin at the rate of 200 mg/kg, each gavage volume was 0.1ml; (4) the MET+MPA group, which received 100 mg/kg of MPA and 200 mg/kg of MET. Outcome measures: The research team: (1) used a CCK-8 kit, an EdU assay, and a flow-cytometry assay to measure cancer-cell proliferation, count, and viability; determine the cell cycle; and measure apoptosis; (2) performed a Western blot analysis to determine the expression of the PR, CD133, pAkt, totalAkt, p-mTOR, and totalTOR antibodies; and (3) determined the size and volume of tumors in vivo and used immunohistochemical staining to determine expression of the Ki67 protein. Results: The MET+MPA group had a significantly lower number of cancer cells than the MET or MDA groups (both P < .001). That group also had significantly more stagnated cancer cells in the G0/G1 phase and significantly fewer cancer cells in the S phase or G2/M phase control, MET, or MPA groups (all P < .01). The MET+MPA group's PCNA and Ki-67 protein expression was significantly lower than that of the MET and MPA group. The EDU assay yielded similar results. Additionally, the MET+MPA group had significantly higher PR expression than that of to MET or MPA group (both P < .001). The MET and MPA groups' expression of CD133, p-Akt, and p-mTOR were significantly lower than those of the control group, while the MET+MPA group's levels were significantly lower than those of the MET and MPA groups. In-vivo experiments revealed that the MET and MPA groups did show decreased tumor size and volume. The MET+MPA group had tumor weights that were significantly lower and tumor volumes were significantly smaller than those of the MET and MPA groups (all P < .001). Immunohistochemical analysis revealed that the MET+MPA group's levels of the Ki-67 antigen were significantly lower than those of the MET and MPA groups. Conclusions: MET inhibited the proliferation of EC cells by increasing MPA-sensitivity, which was dependent on the inhibition of the CD133 expression and the Akt/mTOR pathway. In addition, if MET acts as an effective progestin sensitizer, it certainly offers promising therapeutic prospects for patients with early-stage EC or overgrown endometrium who have fertility requirements.

Combinatory effects of current regimens and Guizhi Fuling Wan on the development of endometriosis.

OBJECTIVE: Endometriosis, defined as the growth of endometrial glands and stromal cells in a heterotopic location under the cyclic influence of ovarian hormones, is a common gynecological disorder manifested by chronic pelvic pain and infertility. In traditional Chinese medicine, endometriosis is characterized by stagnation of vital energy (qi) and blood stasis. Guizhi Fuling Wan (GFW) was first described in Chinese canonical medicine to treat disorders associated with stagnation of qi and blood stasis, including endometriosis. Therefore, the current study aimed to test the effects of combining GFW with western medicine on the suppression of endometriosis. MATERIALS AND METHODS: Endometriosis was generated by suturing endometrial tissue on the peritoneal wall of C57BL/6JNarl mice. The mice were subsequently treated with either GFW or current hormonal therapies or in combination for 28 days. RESULTS: Endometriosis development was inhibited by GFW, Gestrinone, Visanne, GFW + Gestrinone or GFW + medroxyprogesterone acetate (MPA). The expression of intercellular adhesion molecule 1 (ICAM-1) was inhibited by GFW, Gestrinone, MPA, Visanne, GFW + Gestrinone, GFW + MPA and GFW + Visanne. Vascular endothelial growth factor (VEGF) expression was inhibited by GFW, Gestrinone, Visanne, GFW + Gestrinone and GFW + MPA. Both ICAM-1- and VEGF-reducing effects of GFW were attenuated by western medicines. Administration of GFW, MPA, Visanne, GFW + MPA and GFW + Visanne also correspondingly reduced macrophage population in peritoneal fluid. GFW, MPA, Visanne, GFW + MPA and GFW + Visanne enhanced B-cell population in peritoneal fluid. CONCLUSION: The current study reveals the therapeutic effects of GFW on endometriosis. However, the combination of GFW and current hormonal therapies potentially impedes the efficacy of each individual agent in treating endometriosis.

Comparison Of Cimicifuga foetida extract and different hormone therapies regarding in causing breast pain in early postmenopausal women.

This study aimed to compare the influence between Cimicifuga foetida extract and different hormone therapies on breast pain in early postmenopausal women. A prospective, randomized, controlled clinical trial was conducted among 96 early postmenopausal women. Participants were randomly assigned to three groups: group A received 1 mg/day estradiol valerate plus 4 mg/day medroxyprogesterone acetate on days 19-30; group B received 1 mg/day estradiol valerate plus 100 mg/day micronized progesterone on days 19-30; group C received C. foetida extract, 1talet (contains 33.3 mg extract), t.i.d. Breast pain diary and numerical rating scale was used to access the breast pain. For 6 months' treatment, the total incidence of breast pain in group A and B was significantly higher than that in group C (p < .05). The duration (day) of breast pain in each month decreased over time in group A and B while it was continuously low and without significant change in group C (p > .05). The intensity of breast pain was mild in most participants and did not differ among three groups (p > .05). During treatment of early postmenopausal women with C. foetida extract for 6 months, the incidence and duration of breast pain were lower than upon treatment with E2 plus cyclic MPA or m-P and did not change over time.

Influence of hormone therapy or C. foetida extract on breast tenderness in postmenopausal women.

OBJECTIVE: To evaluate the prevalence of breast tenderness in a population treated with menopausal hormone therapy (MHT) or Cimicifuga foetida extract. METHODS: A prospective, randomized, controlled trial was conducted. Ninety-six postmenopausal women were randomly assigned to three groups: group A, 1 mg estradiol valerate daily plus 4 mg medroxyprogesterone acetate (MPA), days 19-30; group B, 1 mg estradiol valerate daily plus 100 mg micronized progesterone (MP), days 19-30; group C, 100 mg C. foetida extract daily. Breast tenderness was evaluated daily for 12 months. RESULTS: Seventy-three patients completed the study. Group A had the highest prevalence of breast tenderness, while group C had the lowest. More than 50% of all participants reported no symptoms throughout the period. The participants in group A experienced a sharp increase in breast tenderness after treatment, but decreased after 1 month. No significant decline was found in the duration of pain in group B. The patients in group C reported no remarkable changes after 1 month. Compared to estrogen only, estrogen plus MPA/MP led to a higher incidence of prolonged breast symptoms. CONCLUSIONS: Compared to MHT groups, C. foetida extract had the lowest prevalence of breast tenderness. Most participants experienced mild or no symptoms.

Acceptability of the community-level provision of Sayana® Press by medical and nursing students in Kinshasa, Democratic Republic of the Congo.

OBJECTIVES: The objectives were to assess acceptors' attitudes toward Sayana® Press as a method and toward the mechanism of community-based distribution by medical and nursing (M/N) students, known locally as "DBCs," in Kinshasa, Democratic Republic of the Congo, and to evaluate the experience of these DBCs. STUDY DESIGN: In 2015, surveys were conducted among (1) acceptors of Sayana® Press on the day of the initial injection, (2) these same acceptors 3 months later and (3) the DBCs providing community-based services. The analysis was descriptive and involved no significance testing. RESULTS: Acceptors of Sayana® Press expressed high levels of satisfaction with the method, despite some pain experienced at injection and subsequent side effects. Although most were satisfied with the counseling and services received from the DBCs, less than one third realized that the providers were M/N students. The DBCs expressed satisfaction in serving as community-based distributors; more than 95% would recommend it to others. Their primary complaints were lack of remuneration, stockouts and need for greater supervision. CONCLUSIONS: Consistent with results from previous pilot introductions of Sayana® Press in three African countries, clients were highly satisfied with Sayana® Press as a method. The reported preference for resupply at health centers may reflect a lack of client awareness that the DBCs administering methods near the health center were not in fact staff from the health center. The pilot served to gain acceptance for the use of M/N students in community-based distribution, paving the way for additional task-shifting pilots in Kinshasa. IMPLICATIONS: Sayana® Press represents a promising new method for increasing access to modern contraception in low-income countries. The Kinshasa experience is the first to test the use of medical and nursing students as providers at the community level. The study reports high levels of satisfaction on three counts: acceptors of the contraceptive method, acceptors of the mode of service delivery, and DBCs in their role as providers of contraception at the community level. However, many clients were not aware that the DBCs were students. The study represents an important contribution to the literature on task-shifting, especially in a country with chronic shortages of healthcare personnel.

Effects of Calcium, Vitamin D, and Hormone Therapy on Cardiovascular Disease Risk Factors in the Women's Health Initiative: A Randomized Controlled Trial.

OBJECTIVE: To analyze the treatment effect of calcium+vitamin D supplementation, hormone therapy, both, and neither on cardiovascular disease risk factors. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled trial among Women's Health Initiative (WHI) participants. The predefined primary outcome was low-density lipoprotein cholesterol (LDL-C). RESULTS: Between September 1993 and October 1998, a total of 68,132 women aged 50-79 years were recruited and randomized to the WHI-Dietary Modification (n=48,835) and WHI-Hormone Therapy trials (n=27,347). Subsequently, 36,282 women from WHI-Hormone Therapy (16,089) and WHI-Dietary Modification (n=25,210) trials were randomized in the WHI-Calcium+Vitamin D trial to 1,000 mg elemental calcium carbonate plus 400 international units vitamin D3 daily or placebo. Our study group included 1,521 women who participated in both the hormone therapy and calcium+vitamin D trials and were in the 6% subsample of trial participants with blood sample collections at baseline and years 1, 3, and 6. The average treatment effect with 95% confidence interval, for LDL-C, compared with placebo, was -1.6, (95% confidence interval [CI] -5.5 to 2.2) mg/dL for calcium+vitamin D alone, -9.0 (95% CI -13.0 to -5.1) mg/dL for hormone therapy alone, and -13.8 (95% CI -17.8 to -9.8) mg/dL for the combination. There was no evidence of a synergistic effect of calcium+vitamin D+hormone therapy on LDL-C (P value for interaction=.26) except in those with low total intakes of vitamin D, for whom there was a significant synergistic effect on LDL (P value for interaction=.03). CONCLUSION: Reductions in LDL-C were greater among women randomized to both calcium+vitamin D and hormone therapy than for those randomized to either intervention alone or to placebo. The treatment effect observed in the calcium+vitamin D+hormone therapy combination group may be additive rather than synergistic. For clinicians and patients deciding to begin calcium+vitamin D supplementation, current use of hormone therapy should not influence that decision. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT00000611.

An Evidence-based Approach to the Medical Management of Fibroids: A Systematic Review.

Fibroids are the most common tumor of the female reproductive tract, but approved medical treatments are limited. Patients demand uterine-sparing treatments which preserve fertility and avoid surgery. We systematically reviewed PubMed and Cochrane databases from January 1985 to November 2015 for evidence-based medical therapies for fibroids in the context of disease prevention, treatment of early disease, treatment of symptomatic disease, and preoperative management. We identified 2182 studies, of which 52 studies met inclusion and exclusion criteria. Published data affirm the efficacy of multiple agents, which are promising avenues for the development of medical alternatives to surgery.

Non-surgical interventions for the management of chronic pelvic pain.

BACKGROUND: Chronic pelvic pain is a common and debilitating condition; its aetiology is multifactorial, involving social, psychological and biological factors. The management of chronic pelvic pain is challenging, as despite interventions involving surgery, many women remain in pain without a firm gynaecological diagnosis. OBJECTIVES: To assess the effectiveness and safety of non-surgical interventions for women with chronic pelvic pain. SEARCH METHODS: We searched the Menstrual Disorders and Subfertility Group Specialised Register. We also searched (from inception to 5 February 2014) AMED, CENTRAL, MEDLINE, EMBASE, PsycINFO, CINAHL and LILACS. We handsearched sources such as citation lists, trial registers and conference proceedings. SELECTION CRITERIA: Randomised controlled trials (RCTs) on non-surgical management of chronic pelvic pain were eligible for inclusion. We included studies of women with a diagnosis of pelvic congestion syndrome or adhesions but excluded those with pain known to be caused by endometriosis, primary dysmenorrhoea (period pain), active chronic pelvic inflammatory disease or irritable bowel syndrome. We considered studies of any non-surgical intervention, including lifestyle, physical, medical and psychological treatments. DATA COLLECTION AND ANALYSIS: Study selection, quality assessment and data extraction were performed independently by two review authors. Meta-analysis was performed using the Peto odds ratio (Peto OR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). The primary outcome measure was pain relief, and secondary outcome measures were psychological outcomes, quality of life, requirement for analgesia and adverse effects. The quality of the evidence was assessed by using GRADE methods. MAIN RESULTS: Twenty-one RCTs were identified that involved non-surgical management of chronic pelvic pain: 13 trials were included in the review, and eight were excluded. The studies included a total of 750 women-406 women in the intervention groups and 344 in the control groups. Included studies had high attrition rates, and investigators often did not blind adequately or did not clearly describe randomisation procedures. Medical treatment versus placebo Progestogen (medroxyprogesterone acetate (MPA)) was more effective than placebo at the end of treatment in terms of the number of women achieving a greater than 50% reduction in visual analogue scale (VAS) pain score immediately after treatment (Peto OR 3.00, 95% CI 1.70 to 5.31, two studies, n = 204, I(2) = 22%, moderate-quality evidence). Evidence of benefit was maintained up to nine months after treatment (Peto OR 2.09, 95% CI 1.18 to 3.71, two studies, n = 204, I(2) = 0%, moderate-quality evidence). Women treated with progestogen reported more adverse effects (e.g. weight gain, bloatedness) than those given placebo (high-quality evidence). The estimated effect of lofexidine on pain outcomes when compared with placebo was compatible with benefit and harm (Peto OR 0.42, 95% CI 0.11 to 1.61, one study, 39 women, low-quality evidence). Women in the lofexidine group reported more adverse effects (including drowsiness and dry mouth) than women given placebo (moderate-quality evidence). Head-to-head comparisons of medical treatments Head-to-head comparisons showed that women taking goserelin had greater improvement in pelvic pain score (MD 3, 95% CI 2.08 to 3.92, one study, n = 47, moderate-quality evidence) at one year than those taking progestogen. Women taking gabapentin had a lower VAS pain score than those taking amytriptyline (MD -1.50, 95% CI -2.06 to -0.94, n = 40, low-quality evidence). Study authors reported that no statistically significant difference was observed in the rate of adverse effects among women taking gabapentin compared with women given amytriptyline. The study comparing goserelin versus progestogen did not report on adverse effects. Psychological treatment Women who underwent reassurance ultrasound scans and received counselling were more likely to report improved pain than those treated with a standard 'wait and see' policy (Peto OR 6.77, 95% CI 2.83 to 16.19, n = 90, low-quality evidence). Significantly more women who had writing therapy as a disclosure reported improvement in pain than those in the non-disclosure group (Peto OR 4.47, 95% CI 1.41 to 14.13, n = 48, very low-quality evidence). No difference between groups in pain outcomes was noted when other psychological therapies were compared with standard care or placebo (quality of evidence ranged from very low to low). Studies did not report on adverse effects. Complementary therapy Distension of painful pelvic structures was more effective for pain when compared with counselling (MD 35.8, 95% CI 23.08 to 48.52 on a zero to 100 scale, one study, n = 48, moderate-quality evidence). No difference in pain levels was observed when magnetic therapy was compared with use of a control magnet (very low-quality evidence). Studies did not report on adverse effects.The results of studies examining psychological and complementary therapies could not be combined to yield meaningful results. AUTHORS' CONCLUSIONS: Evidence of moderate quality supports progestogen as an option for chronic pelvic pain, with efficacy reported during treatment. In practice, this option may be most acceptable among women unconcerned about progestogenic adverse effects (e.g. weight gain, bloatedness-the most common adverse effects). Although some evidence suggests possible benefit of goserelin when compared with progestogen, gabapentin as compared with amytriptyline, ultrasound versus 'wait and see' and writing therapy versus non-disclosure, the quality of evidence is generally low, and evidence is drawn from single studies.Given the prevalence and healthcare costs associated with chronic pelvic pain in women, RCTs of other medical, lifestyle and psychological interventions are urgently required.

Phytotherapeutic management of polycystic ovary syndrome: role of aerial parts of wood betony (Stachys lavandulifolia).

Pharmacological treatments of polycystic ovary syndrome (PCOS) have side effects. We compared the efficacy and safety of the aerial parts of wood botany (AWB) with those of Medroxyprogesterone acetate (MPA) in the management of abnormal uterine bleeding (AUB) due to PCOS. We conducted a randomized clinical trial of 66 women aged 15-45 years, with AUB. Participants were randomly assigned to either cyclical 10-mg BD MPA for three cycles or 5 g ABW TDS for three months. Clinical symptoms and paraclinical parameters were recorded before and 3 months after initiation of the treatment. Comparisons were made using generalized linear models. Age-adjusted prevalence rate of different patterns of AUB, decreased from 2.7 (95%CIs: 0.6-48.0) to 1.1 (95%CIs: 0.1-18.3) for patients taking MPA, and from 2.5 (95% CIs: 0.2-40.2) to 0.7 (95%CIs: 0.0-12.1). Decrease in prevalence rate was similar across two arms of the study (P value = 0.248). Adverse effects were observed less frequently (24.2%) among participants on MPA than among those on AWB (45.5%). The multivariate-adjusted odds for developing adverse reaction of MPA was 0.40 (95%CIs: 0.14-1.19, P value = 0.099) time odds of AWB. In conclusion, AWB may be used as an alternative for MPA in the treatment of AUB caused by PCOS.

[Clinical observation on treatment of premature ovarian failure patients of shen deficiency gan stagnation syndrome by combination of bushui roumu recipe and medroxyprogesterone acetate tablet HUA].

OBJECTIVE: To study the therapeutic efficacy of bushui roumu recipe (BRR) combined medroxyprogesterone acetate tablet (MAT) in treating premature ovarian failure (POF). METHODS: Totally 90 POF patients of Shen deficiency Gan stagnation syndrome were assigned to 3 groups by random number table, 30 in each group. Patients in the treatment group were treated with BRR and MAT, those in the Chinese medicine group were treated with BRR, and those in the Western medicine group were treated with artificial period method. All patients were treated for 3 months. The menstrual improvement was observed before and after treatment. The therapeutic efficacy was assessed using modified Kupperman scoring standard. The serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) were observed before and after treatment. RESULTS: (1) In aspect of the menstrual improvement: In the treatment group 20 patients had menstrual onset during the treatment course. Ten had normal menstruation after discontinued medication. Of them one got pregnancy one month after treatment. In the Chinese medicine group 6 patients had menstrual onset during the treatment course. Two had normal menstruation after discontinued medication. In the Western medicine group 26 patients had menstrual onset during the treatment course. Twelve had normal menstruation after discontinued medication. Better effects on the menstrual improvement were obtained in the treatment group than in the Chinese medicine group (P < 0.01), but with no statistical difference when compared with the Western medicine group (P > 0.05). (2) There was statistical difference in modified Kupperman scores of the 3 groups between before and after treatment (P < 0.01). The improvement of total modified Kupperman score was better in the treatment group than in the other two groups (P < 0.01). The improvement of palpitation was better in the treatment group than in the other two groups (P < 0.05). The improvement of tidal fever and sweat was better in the treatment group and the Chinese medicine group than in the Western medicine group (P < 0.05). (3) After treatment all patients' serum E2 was higher than before treatment, serum levels of FSH and LH were lower than before treatment. Compared pre- and post-treatment, there was statistical difference (P < 0.01). The serum E2 level in the 3 groups was higher after treatment than before treatment with statistical difference (P < 0.01). The levels of FSH and LH were lower in the 3 groups after treatment than before treatment with statistical difference (P < 0.01). The improvement of E2 was better in the treatment group than in the Chinese medicine group (P < 0.05). The improvement of FSH and LH was better in the treatment group than in the Western medicine group (P < 0.05). CONCLUSION: Combination of BRR and MAT could improve the clinical symptoms, menstruation, and serum reproductive hormones in POF patients of Shen deficiency Gan stagnation syndrome.

The effects of medroxy progesterone acetate on the pro-inflammatory cytokines, TNF-alpha and IL-1beta in the early phase of the spinal cord injury.

OBJECTIVES: Spinal cord injuries (SCIs) have high morbidity and mortality rates and currently the definitive treatment of complete SCIs are still not possible. We investigated the effects of the medroxy progesterone acetate on the pro-inflammatory cytokines, TNF-alpha and IL-1beta in the early phase of the SCI. METHODS: Forty-eight Wistar albino male rats were divided equally into four groups each consisting of 12 rats. All animals underwent T10-T12 laminectomy. We administered placebo, and 8 mg/kg medroxy progesterone acetate (MPA) intra-peritoneally into control and progesterone group at 30 minutes after the clip-compression trauma in spinal cord. We performed only T10-T12 laminectomy and clip-compression trauma in laminectomy and trauma group, respectively. Half of the rats from each group were killed at 1 hour and the other half were killed at 6 hours after the trauma. Spinal cord segments were then removed and stored at -80 °C in phosphate buffer. TNF-alpha and IL-1beta levels were determined using ELISA kit. RESULTS: We have found that there was an increase only in the TNF-alpha level at 6 hours after the trauma comparing to control group. MPA appeared to lower the TNF-alpha level significantly in the trauma group. DISCUSSION: This experimentally proven anti-inflammatory effect of MPA via acting upon TNF-alpha may offer new therapeutic options in human subjects with SCIs.

Is poor nutrition masking the effects of depomedroxyprogesterone acetate on bones in adolescent users?

INTRODUCTION: Research in the developed countries has documented bone loss in adolescents who use depomedroxyprogesterone acetate (DMPA) as a contraceptive for less than two years. DMPA use often begins during adolescence in Bangladesh, a South Asian developing country, where more than 50% of women are undernourished. Poor nutrition is also associated with low bone mineral density (BMD) in South Asian women. We investigated the effects of long-term (two or more years) DMPA use on BMD in Bangladeshi women who started its use in their adolescence. METHODS: Lumbar spine and femur neck BMD were acquired using dual energy X-ray absorptiometry for 100 adolescents (50 DMPA users and 50 non-users) in a cross-sectional study in Dhaka, Bangladesh. Multivariate analysis was used to determine the associations between BMD and DMPA use. Stratified analysis of DMPA use investigated the determinants of BMD in both groups. RESULTS: The participants (mean age 18 +/- 2 years) were generally below their ideal body weight. No significant differences in BMD were found between the two groups. Weight (odds ratio [OR] 0.96, 95 percent confidence interval [CI], 0.92-1.00) and height (OR 0.68, 95 percent CI 0.49-0.94) were independent determinants (p-value is less than 0.05) of lumbar and femur neck BMD, respectively. CONCLUSION: Poor nutritional status, indicated by a less-than-ideal body weight, may be masking the effects of DMPA on bone loss among adolescent users. Our findings suggest that nutritional supplementation may be required with DMPA prescription to promote bone health in adolescent users who are approaching peak bone mass.

The effect of low dose zinc supplementation to serum estrogen and progesterone levels in post-menopausal women.

The objective of the present study is to investigate how low-dose zinc supplementation for 2 weeks in the post-menopausal period influences levels of estrogen and progesterone in the serum. The study registered 32 natural menopause patients, who were allocated to four groups with equal number of patients. Group 1, control group, which was not subjected to any procedure. Group 2, the group that was supplemented with 15 mg/day zinc sulfate for 2 weeks. Group 3, the group that was given hormone replacement therapy (0.625 mg estrogen + 5 mg medroxyprogesterone acetate/day) for 2 weeks. Group 4, the group that received hormone replacement therapy (0.625 mg estrogen + 5 mg medroxyprogesterone acetate/day) and zinc sulfate (15 mg/day) for 2 weeks. Blood samples were collected twice from each subject, once at the beginning of the study, and once at the end of the 4-week procedure to determine estrogen (E2) and progesterone levels. Variance analysis was employed in the statistical evaluation of data. Level of significance was set at p < 0.05. No significant difference was found between the estrogen and progesterone levels of groups 1 and 2. Groups 3 and 4 had higher estrogen and progesterone levels than groups 1 and 2 (p < 0.05). Estrogen and progesterone levels in groups 3 and 4 were not different. Results of the study show that low-dose zinc supplementation to post-menopausal women for 2 weeks does not have a significant effect on the concerned parameters.

Efficacy comparison of Pueraria mirifica (PM) against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of climacteric symptoms in perimenopausal women: phase III study.

OBJECTIVE: To evaluate the efficacy comparison of Pueraria mirifica (PM), name in Thai is Kwao Kruea Khao, against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of perimenopuasal women with climacteric symptoms. MATERIAL AND METHOD: Perimenopausal women attending the Menopausal clinic of Hat Yai Regional Hospital were voluntarily recruited. The vasomotor symptoms such as hot flushes and night sweats, as well as other unpleasant symptoms, urogenital and psychological symptoms, were also assessed. Patients were voluntarily enrolled and randomly received daily 50 mg raw material of PM, Group A, or daily 0.625 mg of conjugated equine estrogen (CEE) with/without 2.5 mg of medroxyprogesterone acetate (MPA), Group B, depend on non-hysterectomized/hysterectomized condition. RESULTS: Seventy-one patients were enrolled. Eleven of those were excluded for failing to complete the initial work-up and follow-up. Sixty cases were evaluated, 30 cases in Group A and 30 cases in Group B. After medication, the mean of modified Greene climacteric scale (MGCS) in Group A/Group B had decreased from 29.0/32.26 to 17.86/18.1, 12.56/9.57 and 9.9/8.16 at 1-, 3-, and 6- month respectively. The clinical satisfaction using MGCS was not statistically significant between PM (Group A) and CEE with/without MPA (Group B) in the alleviation of climacteric symptoms (p-value > 0.05). There were no statistically significant changes of three serum markers: estradiol, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) between both groups. CONCLUSION: PM, containing phytoestrogens, has estrogenic effect as similar as CEE, and can alleviate the climacteric symptoms in perimenopausal women. PM demonstrates great promise in the treatment of climacteric symptoms. However, optimal doses should be clinically assessed to meet appropriate individual responses.

[Endometriosis]. / Endometriose.

The major symptom is dysmenorrhea. Chronic, sometimes non-cyclic pain due to pelvic adhesions is often seen in the long course of the disease. Infiltration into the blader or bowel is a rare but serious complication. A group of patients presents with sterility. Endometriosis histologically resembles endometrium. There can be ovarian cysts and foci either on the peritoneum or in the muscularis of the uterus. The etiology is unknown. There are a number of existing theories. A rare condition is an endometriosis caused iatrogen during a caesarean section. It can develop between uterus and bladder or within the suture or scar tissue. Since we know so little, the treatment options are unsatisfying. Operative resection followed by endocrine medication is the standard therapy. Alternative medicine can be an useful additional factor in the treatment concept.

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial.

BACKGROUND: Herbal supplements are widely used for vasomotor symptoms. OBJECTIVE: To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo. DESIGN: 1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004. SETTING: Group Health, Washington State. PARTICIPANTS: 351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal. MEASUREMENTS: Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale. INTERVENTIONS: 1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo. RESULTS: Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was -4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, -5.93 to -2.19 symptoms per day; P < 0.001). LIMITATIONS: The trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out. CONCLUSION: Black cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms. CLINICAL TRIALS REGISTRATION NUMBER: NCT00169299.

Effect of vitamin E supplementation with and without hormone therapy on circulatory inflammatory markers in postmenopausal women.

OBJECTIVE: To investigate the effect of vitamin E with and without estrogen replacement therapy or hormone therapy (HT) on inflammatory markers in postmenopausal women. DESIGN: Prospective, observational study, followed by a randomized, prospective, double-blind study. SETTING: Healthy volunteers in an academic medical referral center in Dallas, Texas. PATIENT(S): Seventy-five postmenopausal healthy women, ages 40 to 65 years, with follicle-stimulating hormone (FSH) levels greater > or =30 mIU/mL and a serum estradiol level < or =30 pg/mL. INTERVENTION(S): After enrollment, all women were studied at baseline and received vitamin E for 4 weeks. They were then randomized from week 4 to week 12 to receive vitamin E in conjunction with conjugated equine estrogen (CEE) (0.625 mg), CEE (0.625 mg) plus medroxyprogesterone acetate (MPA) (2.5 mg), or placebo. MAIN OUTCOME MEASURE(S): Change from baseline and between groups effects of vitamin E with and without estrogen or hormone therapy on seven circulatory inflammatory markers in postmenopausal women. RESULT(S): Vitamin E levels increased to a similar extent in all three groups compared with baseline at weeks 4 and 12. Vitamin E increased serum interleukin-6 levels. Combination CEE plus MPA significantly increased C-reactive protein levels. However, there were no consistent statistically significant effects on six other inflammatory markers. CONCLUSION(S): Vitamin E attenuated C-reactive protein increases in postmenopausal women treated with estrogen replacement therapy but not with HT. Because there was no other persistent effect on six additional inflammatory markers, it can be concluded that vitamin E and HT do not play a major role in promoting a change in cardiovascular inflammatory markers.

The Herbal Alternatives for Menopause (HALT) Study: background and study design.

We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.

Hormone use and patient concerns after the findings of the Women's Health Initiative.

OBJECTIVE: To assess behaviors and concerns related to hormone therapy after the findings of the Women's Health Initiative (WHI). DESIGN: A survey was mailed to a random sample of 1,200 women identified through the pharmacy database as taking one of two estrogen + progestogen therapies (EPT) during the 6-month period before the publication of WHI findings. Questions included hormone use history, changes in usage, an assessment of symptoms, symptom changes, health behavior changes, use of alternative therapies, and demographics. RESULTS: The response rate was 70%, with women in their 60s and those receiving hormone therapy for 5 or more years were more likely to respond (P < 0.05). The majority had started hormones for symptom relief (69%) and expected to continue use. Many reported discontinuation (63%) or modifying their medication (18%). Half of these women stopped then restarted, the other half changed products. Women in their 50s were more likely to remain on hormones than older women (P < 0.01), and those taking ethinyl estradiol and norethindrone acetate were more likely to remain on their medication than those on conjugated estrogens (43% vs 29%, P < 0.01). Little change was reported in exercise and 19% increased their calcium intake. Patient concerns fell into five major categories: long-term effects, symptom control, breast cancer risk, bone health, and cognitive function. CONCLUSIONS: Women seem to be heeding the warnings about hormones but remain concerned about the potential long-term sequelae and symptom control. More research is needed to identify safer approaches to symptom relief and to address the concerns expressed.