Weight gain in menopause: systematic review of adverse events in women treated with black cohosh.

Weight gain is a frequent problem in perimenopausal and postmenopausal women. Cimicifuga racemosa (CR) is a popular treatment option for menopausal symptoms. The aim of this review was to investigate whether there is scientific evidence that CR causes weight gain. We searched our database for medically confirmed, spontaneous adverse events regarding weight gain, literature for case reports and randomized controlled trials. Thirty cases in total were spontaneously reported in 15 years. The causality was not considered certain/likely in any of the cases. A nurse (consumer) assessed the causality as possible. Only one case was published in the literature. However, no change in body fat composition was reported, and the causality seems unlikely. Of the 31 identified studies, 17 were double-blind placebo-controlled, five were double-blind reference-controlled and nine were open reference-controlled. In total, 1839 women were treated with CR for up to 12 months. Two studies reported weight gain as an adverse event; however, no significant differences in weight changes were observed between the groups. One case of weight gain (about 2 kg) was reported, but the authors did not specify in which treatment group. In conclusion, this study provides no scientific evidence that the use of Cimicifuga racemosa causes weight gain in menopausal women.

Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Use of ossein-hydroxyapatite complex in the prevention of bone loss: a review.

BACKGROUND AND OBJECTIVE: The ossein-hydroxyapatite complex (OHC) is a microcrystalline form of calcium which provides a number of additional minerals (magnesium, phosphorus, potassium, zinc), and proteins (osteocalcin, type I collagen, type I insulin growth factor I and II, transforming growth factor beta) associated with bone metabolism. The objective of this review is to examine the role of OHC in preventing bone loss in different conditions. MATERIAL AND METHODS: A review of clinical trials assessing the relationship between OHC and bone loss was made using the following data sources: Medline (from 1966 to December 2013), the Cochrane Controlled Clinical Trials Register, Embase (up to December 2013), contact with companies marketing the supplements studied, and reference lists. RESULTS: Different randomized, clinical trials and meta-analysis suggest that OHC is more effective than calcium supplements in maintaining bone mass in postmenopausal women and in different conditions related to bone loss. In addition, OHC improves pain symptoms and accelerates fracture consolidation in patients with osteopenia or osteoporosis. CONCLUSION: The ossein-hydroxyapatite complex is significantly more effective in preventing bone loss than calcium carbonate.

Evidence-based assessment of the impact of the WHI on women's health.

Following the announcement of the first results of the Women's Health Initiative (WHI) to the media in 2002, prior to their scientific publication, the resulting panic headlines had an immediate and lasting negative effect on use of menopausal hormone replacement therapy (HRT) around the world. Rates of use dropped by 40-80%. Symptomatic women then sought multiple alternative therapies but the majority of these have no greater effect than the effect seen from placebo in well-conducted trials of HRT. Some of these therapies have risks. Although anecdotally most menopause practitioners after 2002 can attest to having to counsel large numbers of women with debilitating menopausal symptoms who were too frightened to consider HRT, it is difficult to document loss of health-related quality of life in large population studies as they were not conducted. Similarly, the positive or negative effects of the marked decline in HRT on long-term morbidities and mortality have yet to be fully assessed. Recent studies have shown an increase in postmenopausal fractures and in some, but not all, populations a small temporary decline in breast cancer. Cardiovascular outcomes may not be apparent for another decade. Short-term, randomized, placebo-controlled trials confirm that HRT is the only therapy that effectively improves health-related quality of life in symptomatic women through a reduction in vasomotor and urogenital symptoms, joint pains and insomnia, while improving sexuality. The results of the re-analyses of the WHI data and new data from other studies do not justify the continuing negative attitude to HRT in symptomatic women who start HRT near menopause.

Isoflavones: effects on bone health.

BACKGROUND: There are many effects described, both experimental and clinical, that assess the relationship between isoflavones and bone. It has been hypothesized that isoflavones may have a positive effect on bone health. OBJECTIVE: To review the effects of isoflavones on biochemical markers of bone remodeling, bone density and bone quality, and finally on fracture incidence. METHODS: A systematic review was carried out of in vitro, animal, and human studies involving isoflavones and bone health. An electronic search was made, based on Internet search engines, MEDLINE (1966-June 2010) and the Cochrane Controlled Clinical Trials Register. This search was further supplemented by a hand-search of reference lists of selected review papers. RESULTS: After crossing-cleaning the reference lists, 737 studies dealing with isoflavones and bone were identified. Of these, 36 were considered selectable. From in vitro and animal studies, isoflavones appear to stimulate osteoblastic bone formation and inhibit osteoclastic bone resorption. Reviewed data show evidence of a beneficial effect of isoflavones on bone health in peri- and postmenopausal women when high-isoflavone soy protein is incorporated in the diet. Inconsistencies observed among data from different studies are related to differences in study design, the variety of soy sources of isoflavones, time of analysis, and the variability in the bioavailability and metabolism of isoflavones. CONCLUSIONS: Most of the studies suggested a positive relationship between isoflavones and bone health. Further well-controlled, randomized, double-blind, clinical trials with a larger sample population, longer duration, and examination of various dosages are needed to better elucidate the inter-relationship between isoflavones and bone loss and to clarify whether isoflavones could prevent bone fractures.

Treatment persistence and compliance with a combination of calcium and vitamin D.

INTRODUCTION: The persistence and compliance of patients in Spain with calcium and vitamin D supplementation are unknown, and thus the purpose of the present study was to determine the current figures. METHODS: This was a multicenter, cross-sectional study. Throughout Spain, 1342 primary-care physicians and specialists were asked to recruit 7888 patients aged 45 years or over, who had been prescribed with a calcium and vitamin D combination (CaVitD) at least 1 year prior to the study. Data on biodemographics, the reason for prescription and fracture risk factors were collected. Persistence with treatment, reasons for discontinuation, and compliance among persistent patients were assessed and patients' profiles analyzed. RESULTS: From the recruited sample, a total of 7624 patients were finally analyzed. Most subjects were postmenopausal (mean age 65.7 ± 9.4 years). The main reason for CaVitD prescription was osteoporosis (56.3%), started 2-5 years earlier. A family history of osteoporosis (41.4%) and previous fractures (40.7%) occurred frequently in the patients' clinical histories. At the study visit, 27.7% had discontinued CaVitD treatment, the main reason being fatigue due to the long-term treatment. Just 31.2% of persistent patients were adherent. Non-persistent patients were more likely to be smokers, alcohol consumers, have a long immobilization history, malabsorption syndrome and previous bone fractures. CONCLUSIONS: Only two in ten patients effectively comply with CaVitD treatment after 1 year or more of its prescription.

The dilemma of menopause and hormone replacement--a challenge for women and health-care providers: knowledge of menopause and hormone therapy in Spanish menopausal women.

BACKGROUND: An important goal in menopause research is to develop knowledge and identify interventions that strive to promote, maintain and enhance well-being for women. OBJECTIVE: To evaluate the knowledge of postmenopausal Spanish women about menopause and their knowledge of and trust in hormone replacement therapy (HRT) and to identify their sources of information and how those data are related to compliance with their prescription. STUDY DESIGN: A total of 270 symptomatic postmenopausal women were personally interviewed using a structured questionnaire, which was designed to collect information on their familiarity with medical menopause studies, the menopause and the effects of HRT, their knowledge of alternative therapies, and to identify their sources of information. RESULTS: The most well-known menopausal complaints were hot flushes, sweats, irregular menstruation, cessation of menstruation, irritability and mood changes. Following suggestions of other symptoms by the interviewer, other complaints such as vaginal dryness, insomnia and depression/anxiety were also mentioned. HRT and phytoestrogens were recognized as treatments for the climacteric by most of the women. A woman's decision to seek treatment was initiated in 77% of cases by the gynecologist, in 12% by the general practitioner, in 3% by friends/family and in 3% by books/magazines. The most frequent responses of women to the onset of menopausal symptoms were to talk with their partner (39%), to discuss it with their gynecologist (33%) or with their general practitioner (14%) and to talk with their friends/family or to read books/magazines (10%). CONCLUSIONS: Vasomotor symptoms are recognized as the main complaint during the climacteric and HRT and phytoestrogens as the main therapies. Gynecologists play an important role in assuring compliance with therapies related to the menopause.

Effect of a compound containing isoflavones, primrose oil and vitamin E in two different doses on climacteric symptoms.

The object of this study was to evaluate the effect of different doses of a compound containing isoflavones 60 mg, primrose oil 440 mg and vitamin E 10 mg. (IOVE) on menopausal complaints. This was an open, multicentre, randomised, group comparative, efficacy and safety trial. A total of 1,080 postmenopausal women, with climacteric symptoms, were allocated into one of two treatment groups to receive one (Group 1; n = 562) or two IOVE capsules (Group 2; n = 518) per day. The Blatt - Kupperman scale and safety parameters including weight, body mass index, blood pressure and adverse effects were assessed at the first visit before initiating the treatment, and 3 - 6 months thereafter. In addition, cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels were measured at baseline and at the 6th month visit. Finally, at the end of follow-up, the patient's satisfaction was assessed. No differences between groups at the beginning of the study and during the follow-up were observed. A significant reduction in Blatt - Kupperman scores were observed in the two groups. In addition, the reduction of the symptoms was more intense in the first 3 months. Increasing doses of IOVE add no beneficial effects since both studied doses were equally effective in the reduction of climacteric complaints.

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

Ossein-hydroxyapatite compounds for preventing postmenopausal bone loss. Coadjuvant use with hormone replacement therapy.

OBJECTIVE: To evaluate whether the addition of an ossein-hydroxyapatite compound (OHC) may improve the effect of hormone replacement therapy (HRT) on postmenopausal bone loss. STUDY DESIGN: Of the 118 recent surgically postmenopausal women initially selected for this open study, 96 completed one-year follow-up. Patients were allocated into four groups. The first group received 50 micrograms/d of transdermal 17-beta estradiol continuously (group E, n = 23), the second received 3.32 g/d of an OHC every day (group OHC, n = 23), the third received 50 micrograms/d of transdermal 17-beta estradiol continuously plus 3.32 g/d of the OHC every day (group E-OHC, n = 26), and an additional 24 women were used as untreated controls (group C). Bone mass, assessed by dual x-ray absorptiometry, was measured prior to and at the end of treatment. Samples, including serum calcium, phosphate and osteocalcine level, were collected before therapy and during the 6th and 12th treatment months. RESULTS: All treatment groups showed an increase in bone mineral content. This increase was higher in the E-OHC group (4.7%, P < .01). Concomitant biochemical effects at 6 and 12 months were compatible with the observed effects on bone mineral. CONCLUSION: The combined regimen of OHC and HRT increased vertebral bone mass in postmenopausal women to a greater extent than did OHC or HRT alone, suggesting that this drug combination may be useful in the management of postmenopausal bone loss.

Management of osteoporosis. An overview.

Osteoporosis is a common disease associated with aging and menopause, and is becoming a major health and socioeconomic problem worldwide. The 2 major determinants of risk of osteoporosis are peak bone mass (reached in the third decade of life) and bone loss thereafter. There is substantial evidence that bone mass is of major importance for the strength of bone and the risk of fracture. The measurement of bone mass in the third decade of life is therefore a potentially useful tool in assessing the individual risk of fracture. Moreover, biochemical markers of bone formation and resorption may be of some use in predicting the rate of bone loss and the response to therapy. Since the most well-defined risk factor for osteoporosis is the cessation of ovarian estrogen production at menopause, estrogen replacement therapy (ERT) is the treatment of choice for postmenopausal bone loss. While the benefits of ERT in preventing bone loss and reducing the incidence of fractures are well established, such therapy is contraindicated in some women and is not an acceptable option for others. Other widely used treatments for osteoporosis that have been utilised to prevent bone loss include calcitonin and bisphosphonates, calcium supplementation, ossein-hydroxyapatite compound, vitamin D analogues, sodium fluoride, parathyroid hormone, anabolic steroids and growth hormone. While ERT is presently the best option for the prevention of bone loss, a regimen of ERT combined with lifestyle changes (e.g. exercise and diet) as well as other bone-preserving drugs may increase bone mass in postmenopausal women to a greater extent than ERT alone.