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Treatment of climacteric complaints with Org OD 14: a comparative study with oestradiol valerate and placebo.

Org OD 14 (7 alpha,17 alpha-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one) is a steroid possessing mixed hormonal activity, which in earlier studies has been shown to alleviate climacteric complaints and to prevent post-menopausal osteoporosis without affecting the endometrium. The effects of Org OD 14 on climacteric complaints were compared with those of oestradiol valerate (E2V) and placebo in a randomized, double-blind, cross-over study in 20 women who had been oophorectomized and hysterectomized 3-6 yr earlier as part of their treatment for cervical cancer. Each patient was treated orally for a total period of 18 wk, comprising 6 wk on each preparation. Capsules of identical appearance were given; these contained either 2.5 mg Org OD 14, 2 mg E2V or placebo. The patients' scores for symptoms and mood items on standardized rating scales were recorded at the end of each 6-wk treatment period (i.e. on days 43, 85 and 127). There were no differences between the effects of Org OD 14 and E2V on symptoms and mood items, while both compounds were more effective than placebo. Our findings confirmed that Org OD 14 is effective in ameliorating oestrogen deficiency symptoms in climacteric women.

Adult↗

Comparison of continuous and sequential oestrogen-progestogen treatment in women with climacteric symptoms.

Continuous (Kliogest) and sequential (Trisequens) oestrogen-progestogen treatment were compared in a randomized, parallel, group study in women suffering from climacteric symptoms. The subjects were treated with Trisequens for 4 mth prior to randomized assignment to 1 of 2 treatment groups, and with either Trisequens or Kliogest for 12 mth thereafter. Forty-one (41) patients were initially recruited for the study. Of these, 34 completed the study, each treatment group hence comprised 17 women. The results suggest that continuous treatment is as effective as sequential treatment in alleviating climacteric symptoms. Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels were significantly reduced after changeover from sequential to continuous treatment (LH: P less than 0.001; FSH: P less than 0.01). Breast cancer was detected in 2 women, 1 being from each treatment group. Weight, blood pressure and cholesterol concentrations were not significantly altered in either of the groups. There were no cases of endometrial hyperplasia. In the continuous-treatment group a temporary increase in breakthrough bleeding occurred at the beginning of the treatment period. It was concluded that continuous treatment seems to constitute an efficacious regimen for climacteric symptoms, which does not induce monthly bleeding.

Climacteric↗

Psychosocial determinants of climacteric complaints.

A total of 2349 Norwegian women aged 45-55 years, were investigated using postal questionnaires. Associations between menopausal development, psychosocial factors and climacteric complaints were analyzed. Factor analysis of 24 climacteric complaints identified five factors (vague somatic complaints, nervous complaints, mood lability, vasomotor and urogenital complaints) which were analyzed in relation to stage of menopausal development and a number of psychosocial variables. Five types of variable contributed to the variance in the five previously identified factors, viz. style of reacting to menstruation earlier in life, mother's climacteric complaints, negative expectations regarding the menopause, social network, sociodemographic factors, and chronological age. Menopausal development played a modest role in explaining the variance in all except vasomotor complaints, the latter being associated with current cigarette smoking. Traditional sex-role identification was associated with nervous complaints. The authors conclude that hot flushes, excessive sweating and vaginal dryness are the only complaints clearly attributable to menopausal development.

Affect↗

Climacteric complaints and their relation to menopausal development--a retrospective analysis.

The present study had two objectives: (1) to register the prevalence of a number of climacteric complaints in a Danish general population cohort and (2) retrospectively to test the validity of an association between climacteric complaints, menopausal development, occurrence of life events and social background. A postal questionnaire sent to the 51-year-old female population living in four Copenhagen suburbs, (N = 597, response rate = 88%) included information on menstrual pattern and change, hormonal treatment, socioeconomic data and a 4-year retrospective annual registration of prevalence of a number of climacteric complaints and life events. Logistic regression analyses performed on a restricted sample (women who experienced a natural menopausal development) revealed prevalence of hot flushes, moodiness and fatigue to be significantly associated with transitions in menopausal status. Fatigue, moodiness and depression were strongly associated with socio-economic variables. Life events were only occasionally associated with prevalence of the studied complaints.

Affect↗

Relations between anthropometric characteristics and degree of severity of the climacteric syndrome in Austrian women.

The connection between body-shape characteristics, namely distribution of subcutaneous fat, and the occurrence of psychic and somatic climacteric symptoms was investigated in 142 postmenopausal women from Eastern Austria. It was found that both psychic and somatic symptoms are significantly related to body-shape characteristics. With increasing breadth and circumference, i.e. a higher proportion of subcutaneous fat, the degree of severity of several symptoms increases, with the exception of hot flushes and sweating, dizziness, headache and palpitation. Since, in the climacteric, subcutaneous fat has a positive impact on the secretion of oestrogens and thus on climacteric symptoms, the results of the present study may be interpreted as an effect of the psychosocial stress to which corpulent women are exposed in our society because they do not fit the beauty ideal typical of our culture.

Adult↗

Bleeding pattern and climacteric symptoms during different sequential combined HRT regimens in current use.

Four sequential combined oestrogen and progestogen regimens were compared in terms of bleeding pattern and relief of climacteric symptoms. Treatment was with either 2 mg 17 beta-oestradiol with 1 mg norethisterone acetate [E2 + NETA]; 2 mg oestradiol valerate with 75 micrograms levonorgestrel [E2V + LNG]; 2 mg oestradiol valerate with 10 mg medroxyprogesterone acetate [E2V + MPA]; or 1.5 mg 17 beta-oestradiol with 150 micrograms desogestrel [E2 + DG]. A placebo-controlled study lasting 12-24 months was completed by 143 healthy early postmenopausal women. Bleeding lengths were not substantially different; in all regimens the majority of women were bleeding for 3-6 days. Bleeding onset showed differences when related to the 11th day of progestogen addition; in the regimen with E2V + LNG, 21% of the women women were bleeding before the 11th day of progestogen addition 26% on, and 53% after that day. In the regimen with E2V + MPA, 56% of the women were bleeding before the 11th day, 28% on, and 17% after that day, whereas in the regimen with E2 + DG, 15% of the women were bleeding before the 11th day, 5% on, and 80% after that day. All regimens reduced climacteric symptoms to the same extent. Breast tenderness occurred in all the regimens, except in the E2 + DG. Conclusively, the differences between the responses to treatment were not conspicuous. However, our data indicate that one regimen (E2 + DG) resulted in optimal bleeding control, optimal effect on climacteric symptoms, and no production of breast tenderness.

Breast↗

Climacteric symptoms in a postmenopausal Czech population.

OBJECTIVES: To assess the prevalence of climacteric symptoms and the use of hormone replacement therapy in a former eastern European country. All 55-, 57-, 59- and 61-year-old women in Kladno in the Czech Republic were asked to participate in the study. METHOD: In 1993, 1505 women in Kladno of the Czech Republic were sent a postal questionnaire concerning age at menopause and their climacteric symptoms. RESULTS: Answers were received from 799 women (53%); 98% were postmenopausal. The median age at spontaneous menopause was 50 years, 49.5 years among women smoking at least 5 cigarettes/day and 51.0 years among non-smokers (P < 0.05). About every fifth woman smoked. Totally 22% of the women had undergone hysterectomy and/or oophorectomy and 3% had been treated for a gynaecological malignancy. The majority of the women (58%) reported ongoing vasomotor symptoms; half of them had moderate to severe vasomotor symptoms. In all, 79% of the women reported ever having vasomotor symptoms. Only 3% of the women had ever tried hormone replacement therapy (HRT) and one woman had current treatment. Dysuria was reported by 22% and 4% had recurrent urinary tract infections; 70% of the women had a partner and 50% were sexually active. Reasons for not being sexually active were mostly lack of a partner, loss of sexual desire or partner's disease or impotence. CONCLUSION: Climacteric symptoms including vasomotor and urogenital symptoms had the same prevalence in the Czech Republic as previously reported in other Western Countries. Only a few women had tried HRT. Smokers had a slightly earlier menopause.

Aged↗

Ovarian function, therapy-oriented definition of menopause and climacteric.

The lack of uniformity in descriptive terminology applied to the cessation of human female menstruation and events related thereto has retarded scientific progress and resulted in confusion and, perhaps, therapeutic mismanagement. Inevitably, many published clinical studies do not clearly define the population being tested, and conclusions drawn are misleading or invalid. Although menopause refers to the final menstrual period (often defined retrospectively by 6-12 months amenorrhea) and climacteric to the transition from reproductive to nonreproductive stage of life, the event is not necessarily associated with any obvious symptom except amenorrhea. When symptoms do occur, collectively referred to as the climacteric syndrome, they are generated by an interaction between endocrine, sociocultural, and psychological factors, and perhaps concurrent aging phenomena as well. Based on the premise that some women with intact ovaries demonstrate endocrine compensatory mechanisms after menopause (i.e., that there are two types of postmenopausal ovary--one active and one essentially inert) and that women whose menses cease because of surgery (ovariectomy) or chemotherapy, they should not be included with those undergoing a natural menopause (i.e., represent an atypical group), an ovarian function, therapy-oriented definition for climacteric is proposed.

Climacteric↗

Effects of high-dose RU-486 treatment on climacteric complaints in hysterectomized postmenopausal women: a 6-week pilot study.

We investigated the effect of the anti-progestogen mifepristone (RU-486) on climacteric complaints. Four hysterectomized postmenopausal women, with at least 35 hot flushes per week, were treated with daily 200mg RU-486 for 6 weeks. RU-486 did not significantly improve climacteric complaints. Although this result does not support further clinical research with this dose of RU-486 for the treatment of climacteric complaints, potential effects of higher, but more interestingly of lower, dosages of RU-486 cannot be excluded.

Climacteric↗

Tibolone relieves climacteric symptoms in highly symptomatic women with at least seven hot flushes and sweats per day.

OBJECTIVE: To establish the potency of four dose levels of tibolone, a tissue selective estrogenic activity regulator (STEAR), to relieve climacteric symptoms in a subgroup of highly symptomatic women experiencing a minimum of seven hot flushes and sweats per day. METHODS: In a group of 770 women receiving tibolone 0.625, 1.25, 2.5 or 5.0 mg or placebo for 12 weeks, a total of 317 women experienced at least seven hot flushes and sweats per day. Frequency and intensity of climacteric symptoms were assessed at baseline and after 4, 8 and 12 weeks of treatment. Vaginal bleeding/spotting was studied using diary cards. Occurrence of adverse events was determined by active questioning. RESULTS: Tibolone induced a decrease in the frequency and intensity of climacteric symptoms, leading to statistically significant differences compared to placebo for dose levels of 1.25 mg and higher. The incidence of vaginal bleeding/spotting and of drug-related adverse events was similar in all tibolone dose groups, except for the 5.0 mg group, where the incidence was about twice as high. Dropout rate due to insufficient therapeutic effect is substantially higher in the 0.625 and 1.25 mg group (about 10%) compared to the 2.5 and 5.0 mg group (about 1%). These results are consistent with what occurred in the total study population published previously. CONCLUSION: The effects of tibolone in highly symptomatic women experiencing at least seven hot flushes and sweats per day do not differ much from that in the total study population. A daily dose of 2.5 mg is the optimal dose for both the total study population and the subgroup of highly symptomatic women. However, in order to optimise individual treatment, the 1.25 mg dose might also be taken into consideration.

Climacteric↗

Factor analysis of climacteric symptoms in Japan.

OBJECTIVES: To identify menopausal and climacteric symptoms among midlife Japanese women by factor analysis of symptom frequency and severity data. METHODS: Demographic information, anthropometric data, 2-week recalls of 82 symptoms, and assessment of epidemiological menopausal and self-defined konenki (climacteric) status were collected from 140 Japanese women living in Kyoto and Fukushima prefectures. Factor analysis was performed using symptom frequency scores and frequency-severity scores. To identify the symptoms constituting menopausal and climacteric syndromes in Japan, regression scores for individual factors were compared by menopausal and konenki status groups using non-parametric tests. RESULTS: Among 140 women aged 49.5+/-3.0 years (mean+/-S.D.), the three most prevalent symptoms were shoulder stiffness, memory loss, and stress. Analysis of frequency data resulted in an eight-factor solution, and frequency-severity data in a seven-factor solution. Anxiety and depression factors and a sexual-vasomotor factor were observed in almost all factor solutions, with additional factors comprised of psychosomatic and somatic symptoms. Anxiety scores differed by menopausal status, depression scores by konenki status, and sexual-vasomotor scores by both. Chilliness was highly correlated with sexual-vasomotor symptoms and frequency scores differed significantly between menopausal but not konenki groups. CONCLUSIONS: Sexual-vasomotor symptoms constitute a robust menopausal and konenki symptom grouping among Japanese women, but do not include night sweats or the foreign word hotto furasshu, yet do include chilliness, which may reflect thermoregulatory instability. Overlap of factors displaying significant differences between menopausal and konenki groups indicate a transition to a more medicalized concept of konenki in use by Japanese women.

Anxiety↗

Impact of climacteric on well-being. A survey based on 5213 women 39 to 60 years old.

OBJECTIVE: Our aim was to assess the influence of the severity of vasomotor complaints, menopausal status, and age on the severity of 21 general complaints considered atypical for the climacteric. STUDY DESIGN: A cross-sectional general population survey was conducted through questionnaires of 5213 women aged 39 to 60 years. Statistical analysis was performed by cross tabulation, analysis of variance, and multiple regression analysis. RESULTS: Severity of vasomotor complaints is related to the severity of all 21 general complaints, most pronounced for tenseness and tiredness. Because menstruating women report more severe atypical complaints than nonmenstruating women with similarly severe vasomotor complaints, the change in prevalence of atypical complaints according to menopausal status is rather small. Adjusted for vasomotor complaints, there is virtually no independent effect of age on atypical complaints. CONCLUSIONS: Severity of vasomotor complaints is related to an overall reduced well-being. When climacteric women are seen for atypical complaints it is vital to assess the severity of vasomotor complaints also because others have shown that the severity of vasomotor complaints is indicative of the rate of climacteric bone loss.

Adult↗

Induction of bone formation in rat osteoprogenitor cell culture by sera of climacteric women before and after hormone replacement therapy.

OBJECTIVE: To evaluate the effect of hormone replacement therapy (HRT) on growth and differentiation of cultured osteoprogenitor cells. DESIGN: Prospective clinical study. SETTING: Outpatients in a menopause clinic. PATIENT(S): Women with climacteric symptoms. INTERVENTION(S): Daily oral conjugated estrogen, 0.625 mg, and medroxyprogesterone acetate, 2.5 mg, for 7-12 months. Bone density measurement before HRT and blood sampling before and after HRT. MAIN OUTCOME MEASURE(S): Sera of climacteric women were added to the culture of rat osteoprogenitor cells, and indices of cell proliferation and differentiation (alkaline phosphatase activity and mineralization) were measured before and after HRT. RESULT(S): Sera after HRT significantly decreased cell counts but not alkaline phosphatase activity or mineralization as compared with sera before HRT. However, mineralization induced in the bioassay by both sera showed a positive correlation (r = 0.56) with E2 levels before treatment and a negative correlation (r = -0.6181) with time in menopause of serum donors. The change in mineralization showed a significant correlation with hip bone mineral density z scores (r = -0.67) but not with spine z scores (r = -0.1915), whereas the change in cell count correlated with spine bone mineral density z scores (r = 0.49) only. CONCLUSION(S): Changes in serum-induced cell proliferation and mineralization may be helpful in studying the response to HRT in climacteric women. Serum-induced mineralization is more efficient in diagnosing osteopenia than in monitoring HRT effects.

Adult↗

Subcutaneous hormone implants for the control of climacteric symptoms. A prospective study.

55 postmenopausal women on established hormone replacement therapy were treated with either oestradiol and testosterone implants or placebo at the time of return of climacteric symptoms. Their response to therapy was assessed prospectively. The statistically highly significant levels of symptom relief that followed an oestradiol and testosterone implant were contrasted sharply with the lack of any significant relief with placebo. Despite the success of oestradiol and testosterone implants in relieving symptoms of the climacteric, symptoms returned once the treatment was stopped. Evidence is presented that it is the fall in hormone levels rather than the level itself that provokes the return of climacteric symptoms.

Adult↗

A pilot study comparing the clinical effects of Jia-Wey Shiau-Yau San, a traditional Chinese herbal prescription, and a continuous combined hormone replacement therapy in postmenopausal women with climacteric symptoms.

OBJECTIVES: Interest in use of alternative remedies for managing menopausal symptoms is increasing exponentially during these years. Jia-Wey Shiau-Yau San (JWSYS), one of the traditional Chinese herbal prescriptions, is a famous herbal remedy used for the management of various menopausal-related symptoms. A randomized, controlled pilot study was performed to evaluate the clinical effects of JWSYS compared with those of a continuous combined hormone replacement therapy, Premelle, on quality of life in non-hysterectomized postmenopausal women. METHODS: The present trial compared the effect of a l6-week treatment with JWSYS or HRT (Premelle) in postmenopausal women with climacteric symptoms. The Greene Climacteric Scale was used to assess the clinical effects at baseline and after 16 weeks' treatment with either JWSYS or Premelle. The physiological parameters, such as follicle-stimulating hormone and estradiol levels, were also recorded at the same time points. RESULTS: The results showed that JWSYS had a relatively lower discontinuation rate due to adverse effects, in particular the bleeding and breast tenderness. Both JWSYS and Premelle effectively alleviated most of the menopausal symptoms with no significant differences between treatment groups, whereas the beneficial effects of JWSYS were not mediated by hormone replacement-like effects. Moreover, JWSYS showed a good compliance and safety without estrogenic effects and metabolic alterations. CONCLUSIONS: It was suggested that JWSYS was a safe and efficacious therapy and might be an alternative choice for relief of climacteric symptoms in postmenopausal women. However, the exact efficacy and clinical roles of JWSYS have not been convincingly demonstrated in this study because of the blinding approach and some statistical concerns, and only the possibility of its efficacy has been raised. Therefore, a blinding trial with more patient numbers to evaluate the efficacy of JWSYS deserves further study.

Aged↗

Experience of climacteric symptoms among 42-46 and 52-56-year-old women.

OBJECTIVE: The intensity of climacteric symptoms and their connection with sociodemographic background data were assessed among women who are or will soon be menopausal. METHODS: A sample of 5510 Finnish women who were 42-46 or 52-56-years-old was selected to this 'Quality of Life among Middle-aged Women' Study and received a menopause-specific questionnaire. RESULTS: Only 5% of the older and 36% of the younger women were totally asymptomatic. Altogether, 2% of the younger and 11% of the older women had severe climacteric symptoms. In the younger age group, a high symptom intensity was associated with living in town, having a low level of professional education, and being unemployed/laid off, whereas in the older age group, the experience of severe symptoms was associated with those having a couple relationship. CONCLUSION: Altogether 95% of women in the productive working age (52-56-years-old) surprisingly suffer from mild, moderate, or severe climacteric symptoms. Further even up to 64% of the younger women (42-46-years-old) suffered from similar symptoms.

Adult↗

Alternative drug use for the climacteric in Finland.

OBJECTIVES: To investigate the use of alternative drugs for the climacteric in Finland, which products are used, and who are the women using them. METHODS: The study was based on a population-based survey conducted in 1989 among 2000 Finnish women aged 45-64 (response rate 86%). RESULTS: 11% of the women reported the use of alternative drugs for the climacteric. Food supplements and bee products were the most common types of alternative drugs used. Some of them may have allergic or other side effects. Users differ little from other women judging by health habits and the utilization of health care services. The best predictors for alternative drug use were urban residence, more than 9 years of general education, and among 50 54-year olds, the use of prescription or OTC drugs for menopause. Over half of the users of alternative drugs had also used hormone therapy. CONCLUSIONS: Women using alternative drugs during and after the climacteric represent a large group. More information is needed about the clinical effects of alternative drugs, and the characteristics of alternative drug users.

Climacteric↗

[Climacteric arthralgia and hand arthrosis].

This study aimed at a possible classification of climacteric arthroses of the hand. 132 females suffering from arthralgias of the wrist and finger joints who had consulted our outpatient department originally because of climacteric complaints, were examined while asking them to complete a questionnaire with clinical criteria for classifying arthroses of the hand. The requisite number of criteria required for classification as ¿arthrosis of the hand¿ were attained in all three groups of females (premenopausal and postmenopausal women without operation, as well as hysterectomised and/or ovarectomised women¿, although the ex-ray showed no signs of degenerative arthritis. The subjective complaints voiced by the patients are opposed to the x-ray finding, so that it is not permissible to classify climacteric arthralgias of the wrist and finger joints as ¿arthritis¿.

Aged↗