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Comparison of four continuously administered progestogen plus oestradiol combinations for climacteric complaints.

Sixty women with climacteric complaints who had not menstruated for at least 1 year were randomly allocated to receive one of four hormonal replacement regimens. All four formulations were administered daily and continuously and each contained 2 mg of micronized oestradiol-17 beta in combination with either norethisterone acetate 1 mg (group A) or 0.5 mg (group B) or megestrol acetate 5 mg (group C) or 2.5 mg (group D). The clinical efficacy was the same although the alleviation of vasomotor symptoms was somewhat slower in those women receiving preparation A. The endometrium was atrophied in nearly all biopsies. Irregular uterine bleeding was almost entirely confined to the earlier phase of the study and was substantially less with the formulation containing 1 mg norethisterone acetate. It is concluded that a continuous oestradiol-progestogen combination can be used for long-term treatment of climacteric complaints in postmenopausal women and that after 4 months the clinical efficacy is the same irrespective of the type and dose of progestogen administered.

Adult↗

Piperazine oestrone sulphate and interrupted norethisterone in postmenopausal women: effects on bone mass, lipoprotein metabolism, climacteric symptoms, and adverse effects.

OBJECTIVE: To compare the effects of two doses of piperazine oestrone sulphate combined with interrupted norethisterone, with that of oestradiol continuously combined with norethisterone acetate, and with placebo, in postmenopausal women. DESIGN: A prospective randomised trial. PARTICIPANTS: Two hundred postmenopausal women. SETTING: Monocentre study with expertise in osteoporosis. METHODS: The participants were randomly assigned to two years of treatment with alternating three-day cycles of 1.5 mg of piperazine oestrone sulphate plus 0.7 mg of norethisterone (highEP), or alternating three-day cycles of 0.75 mg of piperaine oestrone sulphate plus 0.35 mg of norethisterone (lowEP), or 2 mg of 17beta-oestradiol continuously combined with 1 mg of norethisterone acetate (E2+NETA), or placebo. MAIN OUTCOME MEASURES: Change in bone mineral density, lipoprotein metabolism, climacteric symptoms, and adverse effects. RESULTS: One hundred and twenty-one women completed the study. Spinal bone mineral density was increased about 9% over two years by E2+NETA, about 6% by highEP, 4% by lowEP, but remained unchanged in the placebo group. The same pattern was seen in the hip and forearm. All hormone regimens decreased markers of bone turnover and alleviated climacteric symptoms. Serum lipoproteins decreased by about 10% in all hormone groups. CONCLUSIONS: All hormone regimens studied prevented bone loss completely and lowered serum lipids.

Aged↗

Dose-response analysis of effects of tibolone on climacteric symptoms.

OBJECTIVE: To assess the clinically optimal tibolone dose for the relief of climacteric complaints. DESIGN: A randomised, double blind, placebo-controlled trial. SETTING: Twenty-eight centres in Norway, The Netherlands, Sweden and Finland. POPULATION: Seven hundred and seventy-five healthy postmenopausal women were randomised to tibolone in a daily dose of 0.625, 1.25, 2.5 or 5.0 mg or placebo for 12 weeks. METHODS: At baseline, and after 4, 8 and 12 weeks, hot flushes, sweating, vaginal bleeding and adverse experiences were recorded. MAIN OUTCOME MEASURES: Change in frequency and intensity of hot flushes and sweating over 12 weeks. RESULTS: From week four onwards, 2.5 and 5.0 mg tibolone were significantly more effective than placebo, regarding the frequency of hot flushes and sweating (P < 0.001), whereas the 0.625 mg dose was not significantly different from placebo during the study. The frequency of hot flushes with the 1.25 mg dose was statistically significantly different from placebo, only from week eight onwards. The incidence of dropouts due to insufficient therapeutic effect was much higher in the tibolone 1.25 mg group (9.5%) than in the 2.5 (1.9%) and 5.0 mg (1.3%) groups. A dose-related increase in incidence of vaginal bleeding or spotting was observed (P < 0.0001). Bleeding incidence in the 5.0 mg dose group was about twice as high as in the 2.5 mg dose group. There was no difference in incidence of adverse experiences between the 2.5- and the 1.25 mg dose group. CONCLUSION: A daily dose of 2.5 mg tibolone is the clinically optimal dose for the treatment of climacteric complaints in postmenopausal women.

Adult↗

Changes in serum tumor necrosis factor (TNF-alpha) with kami-shoyo-san administration in depressed climacteric patients.

An herbal medicine (kampo) is widely used to prevent or treat climacteric symptoms. In order to investigate the potential involvement of tumor necrosis factor (TNF)-alpha in susceptibility to mood disorder in climacteric women and to clarify the relationship between immune function and the efficacy of herbal medicine, we compared serum TNF-alpha levels in two treated groups, with and without concurrent use of herbal medicine. This study included 113 consecutive depressed menopausal patients who visited the gynecological and psychosomatic medicine outpatient clinic of the Osaka Medical College Hospital in Japan. Fifty-eight patients were administered kami-shoyo-san according to the definition of above sho. In contrast, 55 patients who were different in sho of kami-shoyo-san were administered antidepressants. Hamilton Rating Scale for depression (HAM-D) scores were determined at baseline and 12 weeks after starting treatment (endpoint). TNF-alpha concentrations were analyzed before and after 12 weeks of treatment. Kami-shoyo-san significantly increased plasma concentrations of TNF-alpha after 12 weeks of treatment, to 17.22 +/- 6.13 pg/ml from a baseline level of 14.16 +/- 6.27 pg/ml (p = 0.048). The percent change in plasma concentration of TNF-alpha differed significantly between the kami-shoyo-san therapy group and the antidepressant therapy group at 4 weeks (12.0 +/- 7.8% and -1.22 +/- 0.25%, respectively, p < 0.01), 8 weeks (19.7 +/- 3.4% and -2.45 +/- 0.86%, respectively, p < 0.01), and 12 weeks (21.3 +/- 5.4% and -6.81 +/- 2.2%, respectively, p < 0.001). We found in this study that kami-shoyo-san, an herbal medicine, increased plasma TNF-alpha levels in depressed menopausal patients. Cytokines may play various roles in mood and emotional status via the central nervous system and may be regulated by herbal medicines, although the interactions are very complex.

Adult↗

Cognitive-behavioural group intervention for climacteric syndrome.

BACKGROUND: During peri- and postmenopause there is a high prevalence of psychological symptoms such as emotional instability, depressive moods, anxiety, sleep disorders, and sexual dysfunction. Aetiologically relevant factors for discomfort are decline of sex hormones and psychosocial factors such as lifestyle, attitude towards menopause, pre-menopausal mental health and sociocultural factors. In contrast to the relevance of psychosocial factors, there are few studies on psychological interventions. The present study evaluates an open trial of cognitive-behavioural group intervention consisting of psychoeducation, group discussion and coping skills training for women suffering from climacteric symptoms. METHODS: Thirty women were enrolled in this first trial. Standardised (MRS, HADS-D, Partnership Questionnaire, McCoy Female Sexuality Questionnaire) and especially developed ('Attitudes Towards the Menopause') instruments were administered 3 times, twice before (T1 and T2) and once after the group intervention (T3). General linear model repeated measures were used to analyse changes in questionnaire measures. RESULTS: Taking the average of the two pre-intervention scores, significant improvements were observed in anxiety (p < 0.01), depression (p < 0.02), partnership relations (p < 0.02), overall score of sexuality (p < 0.02), hot flashes (p < 0.01) and cardiac complaints (p < 0.01) from pre- to post-intervention. No changes were found for sexual satisfaction and stressfulness of menopausal symptoms. CONCLUSIONS: This pilot study points at a possible effectiveness of cognitive-behavioural interventions for the treatment of climacteric syndrome. Further studies will have to use randomised trials, comparing different treatments (HRT, phyto-oestrogens, relaxation training, discussion groups) for their effectiveness.

Adult↗

Oral complaints related to climacteric symptoms in oöphorectomized women.

Numerous oral complaints have been attributed to the female climacteric including altered taste, a burning sensation and xerostomia. However, the data relating these symptoms to the climacteric require elucidation as there have been no adequately controlled studies. In the present investigation, a group of 145 oöphorectomized women were followed for one year. Approximately half were treated with oestrogen replacement and the remainder with a placebo. The results indicate that the hormone had no direct effect upon the oral symptoms but that there was a general increase in somatic complaints which appeared to be related to the degree of neurosis experienced. This is turn can be attributed to vasomotor changes which are under the control of oestrogen.

Adult↗

Effects of the combined hormonal replacement drug estradiol valerate/levonorgestrel on climacteric complaints, endometrium and lipid profile of peri- and postmenopausal women.

The effects of the combined hormone replacement (HRT) drug estradiol valerate/levonorgestrel (Klimonorm) on climacteric complaints, endometrial status and lipid profile was studied in 100 peri- and postmenopausal women aged between 41 and 57 years. The duration of therapy was 6 months. The following parameters were investigated: Kuppermann index, endometrial thickness, duration of bleeding, arterial blood pressure, body weight and serum lipids and lipoproteins (total cholesterol TC, LDL cholesterol, HDL cholesterol, and triglycerides [TG]). A separate analysis was made for 27 patients who had abnormal lipid status before treatment. Total cholesterol above 6.0 mmol/l and/or LDL of more than 3.5 mmol/l was considered abnormal and those patients were labeled as "high risk". The results showed a statistically significant reduction in the severity of climacteric symptoms (Kupperman index). A large decrease in the score was observed during the first 3 months of treatment (from 27.9 at the start to mean values of 9.3, p < 0.001). A further slight decrease of the score to 4.0 (p < 0.001) was seen after 6 months of treatment. Endometrial thickness did not change. At the start of the treatment the mean duration of bleeding was 5.1 +/- 0.3 days and at the end of the 6th month it was 3.8 +/- 0.2 days (p < 0.001) Klimonorm favorably affected the lipid profile. TC decreased significantly during the therapy: by 5.2% (p < 0.05) in all women and 7.1% (p < 0.05) in the high risk group. LDL cholesterol decreased slightly: by 4.3% (p < 0.05) in all women and was more pronounced in the high risk group (7.0%, p < 0.01). HDL cholesterol increased by 12.1% (p < 0.01) in all women and by 14.7% (p < 0.001) in the high risk group. TG were elevated slightly by 9.5% (p < 0.05) in all women and 3.9% (p > 0.05) in the high risk group. LDL/HDL ratio decreased from 2.7 to 2.3 in all women and from 3.0 to 2.4 (p < 0.05) in the high risk group. No significant changes in systolic and diastolic blood pressure were recorded. Body weight did not change significantly during the treatment period.

Adult↗

[Nutritional status and food intake assessment of climacterics women].

BACKGROUND: To evaluate the nutritional status and food intake of climacterics women. METHODS: In a transversal study were evaluated 154 women matriculated in the Clinic of the Climacteric Woman of the Health Center of Public Health College of the S o Paulo University, Brazil. The analyzed variables were body mass index (BMI) and food intake (energy, percentual distribution of macronutrients, A and C vitamins, calcium and iron minerals). To analyse food caloric value and calcium and iron minerals, were utilized two age groups (35-50 y and 51-65 y). To analyse BMI, macronutrients percentage and A and C vitamins were utilized the total population (35-65 years of age). In all variables were calculated mean and standard deviation. RESULTS: The mean BMI was 29.3 kg/m2; (+/- 6.2 kg/m2;), with 75% of population above normality. About the energy, the results indicated adequacy to two age groups; about the distribution percentual of macronutrients, all were inadequate. In relation to the vitamins and minerals, all were inadequates, with exception of iron. CONCLUSION: The population studied presents risks to health owing to high value of BMI and inadequate intake of macronutrients, calcium, A and C vitamins.

Adult↗

Difference between effects of conjugated estrogen on neurotics and non-neurotics of climacteric women complaining of menopausal symptoms and its clinical application for their screening.

In order to screen the neurotics and non-neurotics of climacteric women with menopausal symptoms, conjugated estrogen was injected intravenously and the reactions were compared. Menopausal symptoms were represented by Kupperman's menopausal index. After estrogen injection the non-neurotics showed a decrease of the index, i.e., alleviation of the symptoms, while the neurotics showed no change of the index. Taking advantage of this difference, a discriminant function between neurotics and non-neurotics was calculated using, as variables, Kupperman's menopasual indices determined before and after administration of the conjugated estrogen. The calculative screening obtained from this discriminant function yielded consistency with clinical diagnosis in about 94% of the neurotics and about 87% of the non-neurotics, suggesting that this test is of value in the screening of neurotics and non-neurotics in the climacteric women with menopausal symptoms.

Adult↗

Statistical factor analysis and cluster analysis in the etiology of climacteric symptoms.

Factor analysis and cluster analysis were applied to a set of 17 climacteric symptoms data obtained from 194 premenopausal and postmenopausal women. Six distinct factors were extracted and the women were divided into 7 groups by hierarchical cluster analysis in terms of their factor scores. Only one representative factor was identified in 3 groups out of the 7. These 3 groups including 87 women were tentatively designated as vasomotor symptom, neurotic, and sensory disturbance groups. These results confirmed statistically that at least 3 simple etiological factors exist among climacteric symptoms.

Adult↗

Clinical and endocrinological features of statistical clusters of women with climacteric symptoms.

Clinical and endocrinological features of women with climacteric symptoms, who were clustered by means of factor analysis and cluster analysis, were evaluated as to serum concentrations of estradiol, progesterone, follicle-stimulating hormone and luteinizing hormone, and also as to mean ages as well as a rate of premenopausal women or that of postmenopausal women against all women in each one of the clusters. Comparison of these parameters among these clusters indicated, with statistical significance, that vasomotor symptoms, neurotic symptoms, and depressive state of the climacteric women are endocrinologically characterized by a depressed level of serum estrogen, relatively high level of serum estrogen, and an elevation of serum gonadotropin, particularly of luteinizing hormone, respectively.

Adult↗

Effects of two years' estrogen-gestagen replacement on climacteric symptoms and gonadotropins in the early postmenopausal period.

The effects of estrogen/gestagen (e/g) treatment given in a 28-day cycle (Trisequens forteR, Novo) on menopausal symptoms and plasma concentrations of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were studied in a placebo trial. 119 normal women in the early postmenopausal period with mild to moderate climacteric complaints were included. At 3-month intervals for 2 years the participants were examined and filled in questionnaires containing the 11 symptoms of the Kupperman index (10). For each symptom a score was given. In the e/g group 77% (43/56) completed the trial compared with 83% (54/63) in the control group. A total of 61% of the women complained of hot flushes and from 9% to 44% complained of the remaining 10 Kupperman symptoms. At all eight examinations e/g treatment was found to have reduced the symptom score as well as the proportion of women with hot flushes, paresthesia, insomnia, nervousness, vertigo and formication. The symptom score of hot flushes and insomnia declined significantly (p less than 0.01). In the 24 women with hot flushes and in the 19 without, e/g caused similar reduction in the mean score of the other 10 symptoms. No placebo effect was seen. E/g caused a significant (p less than 0.01) fall in the elevated plasma concentrations of FSH and LH. Vaginal bleeding was regular in 38/43 and irregular in 4/43 women during hormone treatment. No serious side effects were attributed to e/g therapy. It is concluded that e/g treatment, in addition to its beneficial effects on hot flushes and insomnia, also alleviates several other climacteric symptoms.

Bendroflumethiazide↗

Climacteric modifications in body weight and fat tissue distribution.

OBJECTIVE: To estimate the effects of climacteric modifications on body weight and fat distribution. METHODS: From 8764 women attending the authors' Menopause Clinic, 1075 untreated, normal healthy women were selected and divided into three groups: premenopausal (n = 380), perimenopausal (n = 263) and postmenopausal (n = 432). The total body fat tissue mass and distribution were analyzed using the dual energy X-ray method. RESULTS: Body weight and body mass index (BMI) were significantly higher in perimenopausal and postmenopausal than in premenopausal women. The mean total body fat and the percentage of fat with respect to soft tissue were significantly (p < 0.05) higher in the perimenopausal and postmenopausal groups than in the premenopausal group. The amount of fat tissue and the regional fat percentage with respect to total fat tissue were higher in the trunk (p < 0.05) and arm (p < 0.05) regions in perimenopausal and postmenopausal than in premenopausal women. In the postmenopausal group, the leg fat tissue was significantly (p < 0.05) less than in the premenopausal and perimenopausal groups. Total body and leg lean tissue was significantly (p < 0.01) less in postmenopausal than in premenopausal and perimenopausal women. In the premenopausal group, body weight and BMI were positively correlated with age (r = 0.37 and r = 0.54, respectively). No significant correlations were observed in the perimenopausal group. In postmenopausal women, body weight and BMI were loosely correlated with age (r = 0.13 and r = 0.11, respectively). In three groups of 63 age-matched women, with similar BMI, the percentage of total body fat with respect to soft tissue was significantly (p < 0.001) higher in the perimenopausal and postmenopausal groups than in the premenopausal group. Regarding body fat distribution, the percentage of fat with respect to total fat tissue was significantly higher in the trunk (p < 0.001) region in perimenopausal and postmenopausal women than in premenopausal women. In the leg region, the percentage of fat with respect to total fat tissue was significantly (p < 0.05) higher in the premenopausal group than in the postmenopausal group. In the arm region, a slight but not significant (p < 0.08) difference was shown in fat distribution among the three groups. CONCLUSIONS: Climacteric changes rather than the aging process are relevant for prediction of body weight and fat distribution, especially for perimenopausal and postmenopausal women, who show a shift to a central, android fat distribution.

Adipose Tissue↗

A new therapeutic method for climacteric disorders.

At the present time the administration of an exogeneous estrogen for the treatment of climacteric disorders is generally accepted both in Japan and foreign countries. However, there have been several reports to show that estrogen will promote carcinogenecity. With special attention to this point, the author performed the endocrinological treatment without estrogen for climacteric disorders. The author would like to propose the reactivation method on functionally declining ovary by the approach of induction of ovulation. In this paper the author describes a successful case treated by the new method of hormone therapy.

Administration, Oral↗

[The attitude of the woman in menopause and its influence on the climacteric].

To determine the attitude of the woman's attitude before of menopause an her relation with the climacteric symptom. Descriptive transversal, observational study through of survey structured to 425 patients in age of 50 years over, that attended to gynecology of May 1997 to July 1998, with natural menopause and antecedent of hormonoterapy for but of a year. It being investigated menopause age, at this moment appears 25 climacteric symptoms in agree to literature. Group A: patient's with positive attitude as compared to the menopause (180). The average age was 54.4 years and the age, which appears the menopause was 47.4 years. Group B: patient with negative attitude as compared the menopause (245). The average age of the patients was 53.2 years and the menopause age of 46.7 years. 57.6% of the patients expressed unfavorable concepts about the menopause. The frequent symptoms were fatigue, irritability, instability emotional, and depression. The have p > 0.001 in patient with negative attitude. The negative predisposition of the patient before the menopause favors the frequently of psychological symptoms.

Attitude to Health↗

[Combination of hormone replacement therapy with buspirone in the treatment of climacteric complaints].

At the menopause outpatient unit among 100 patients with climacteric problems 50 were treated with continuous hormone replacement therapy alone (Group A), and in 50 other cases were given a combination of a half dose hormone replacement therapy (HRT) and anxiolytic drug (Group B). After a 3 month treatment period the complaints were reduced at the same extent in both groups. The frequency of the side effects was similar in both groups. The combination of a reduced dose of HRT and an anxiolytic drug can be an alternative treatment to patients refusing HRT because of cancerophobia or side effects and to those, whom the reduced dose of HRT might be sufficient to avoid climacteric complaints.

Anti-Anxiety Agents↗

Treatment of climacteric complaints with oestriol.

150 women with serious climacteric complaints were continuously treated from January, 1970, up to April, 1972, with Ovestin¿, an orally effective preparation containing 1 mg of oestriol per tablet. After one month of treatment subjective complaints were already considerably improved. Oestrogenic activity was markedly increased, according to vaginal smears and total gonadotrophin excretion in the urine. Its high tolerance and beneficial therapeutic effect make Ovestin the preparation of choice in the treatment of the climacteric syndrome.

Adult↗

[The effects of a health promotion program on physical, mental, and dietetic health status in climacteric women].

PURPOSES: The purpose of this study was to evaluate the effects of a six months health promotion program on physical and mental health status assessments in climacteric women. METHODS: Seventy-two women, with a mean (+/- SD) age of 51.3 (+/- 3.1 yr.), body weight of 51.5 (+/- 6.3 kg), and Body Mass Index of 22.4 (+/- 2.4 kg/m2), residing in Tokyo Metropolitan area, participated as subjects in a health promotion program, completing health status assessments. Health promotion was performed once a week, two hours per session, sixteen times. The lecture and exercise program, in the first half, included basic information on diet, exercise and relaxation, and prevention of life-style related disease, and instructions for walking exercise, dancing, and dumbbell exercise. In the latter half, they performed extended walking, stretching, and autogenic training for relaxation. Healthy foods were also supplied. Before and after the program, health status was assessed, with a general medical health check, a questionnaire regarding nutrition, exercise and relaxation activities, and determination of dietary intake based on food records, eating behavior, complaints (CMI, Nichidai stress score) and physical activity levels. RESULTS: After the six months of the program: 1) Total cholesterol levels had decreased significantly, along with both systolic and diastolic blood pressure, body weight and BMI; 2) Major nutrient intake, density of nutrients and eating behavior were improved, with decrease in daily salt intake, and increase significant in daily energy expenditure; 3) Stress scores by the Nichidai stress check were decreased significantly, subjects with higher stress scores at the beginning of programs having marked change, and neurotic tendencies were decreased in CMI categories II-IV. CONCLUSION: These results suggest that, in order to maintain and/or improve the QOL of climacteric women, good dietary habits and physical activities, such as walking, and psychological support are essential. Further long-term investigations of larger populations (middle-aged to elderly) are now necessary.

Climacteric↗