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PubMed1996

Tibolone versus conjugated estrogens and sequential progestogen in the treatment of climacteric complaints.

OBJECTIVE: Tibolone has been shown to alleviate climacteric symptoms. This study was designed to compare the effect of tibolone (Livial, 2.5 mg daily) on different climacteric complaints and its impact on the endometrium, determined by vaginal ultrasound, with that of conjugated estrogens (Premarin, 0.625 mg daily) continuously for 6 months in combination with the progestogen medrogestone (Colpron, 2 x 5 mg daily for 12 days each month). METHODS: One hundred and twenty-nine postmenopausal women were recruited and the severity of climacteric symptoms as well as endometrial thickness were recorded at the pre-trial examination and after 1, 3, and 6 months. RESULTS: With the exception of vertigo, mood depression, mood disorder, loss of libido, and dryness of skin, where tibolone was found to be more effective than conjugated estrogens/medrogestone, climacteric symptoms improved significantly in both groups over the 6-month study period. Endometrial thickness did not increase significantly in the tibolone group, whereas in the conjugated estrogens/medrogestone group there was a highly significant increase after 1 month and still a trend towards significance after 6 months. Recurrence of vaginal bleeding occurred significantly less frequently in the tibolone group than in the comparison group. CONCLUSION: Tibolone seems to offer a complete treatment of the climacteric complaints whilst avoiding some of the problems associated with classical hormone replacement therapy.

Climacteric↗
PubMed2004

Influence of psycho-social factors on climacteric symptoms.

BACKGROUND: It has been suggested that psycho-social factors may be crucial in the development of climacteric symptoms. MATERIAL AND METHODS: In order to evaluate the effect of psycho-social and biological factors on menopausal symptoms, Greene (climacterical symptoms), Cooper (psychosomatic symptoms of stress), Smilkstein (family dysfunction), Duke-UNC (social support) and Israel (life events) tests were passed to 300 Chilean women between 40 and 59 years of age. Data were evaluated with ANOVA, chi2 and logistic regression using the Epi-info package. RESULTS: Perimenopausal women had a significant increase in stress and climacteric symptoms; however comparing with pre and postmenopausal women, tests for life events, family dysfunction or social support did not show any differences. A history of premenstrual syndrome was the main risk predictor f or climacteric symptoms (OR: 3.6, IC: 1.5-8.5; P < 0.03 ), followed by perimenopausal state (OR: 2.9, IC: 1.4-6.0; P < 0.001 ) and negative life events (OR: 2.3, IC: 1.0-5.3; P < 0.05 ). The psycho-social factors were predictors for anxiety and depression; on the other hand, perimenopausal state was a risk factor for somatic and vasomotor symptoms. During premenopause, women with regular cycles and vasomotor symptoms have more psychological symptoms and stress. CONCLUSION: Climacteric symptoms that appear in the perimenopause are more intense in those women who have a biological predisposition such as premenstrual syndrome and are modulated by psycho-social factors.

Adult↗
PubMed1999

Climacteric symptoms and sleep quality.

OBJECTIVE: To evaluate the effect of climacteric vasomotor symptoms on sleep quality measured by self-report and polysomnography in postmenopausal women. METHODS: Seventy-one healthy postmenopausal women were recruited, of whom 63 completed the study. Each subject recorded climacteric symptoms and subjective sleep quality for 14 days. Sleep quality was evaluated objectively by all-night polysomnography using the static charge-sensitive bed. RESULTS: During polysomnography, a high frequency of climacteric vasomotor symptoms was not associated with changes in sleep latency, percentage of sleep stages, number of arousals, sleep efficiency, or total sleep time. However, a high frequency of climacteric vasomotor symptoms (range 0-8.9, r = .60, P < .001), somatic symptoms (range 0-5.0, r = .25-.44, P < .05), and mental symptoms (range 0-5.0, r = .41-.51, P < .001) was related to impaired subjective sleep quality. In stepwise regression analysis, 32% of the impairment in subjective sleep quality was explained by vasomotor symptoms (P < .001), 14% by palpitations (P < .001), and 4% by mood instability (P = .029). High body mass index predicted impaired objective sleep quality, such as prolonged latencies to stage-2 sleep (r = .27, P = .031) and slow-wave sleep (r = .51, P = .003) and decreased oxygen saturations (r = -.54, P < .001). Older women had decreased sleep efficiency (r = -.27, P = .030) and lower oxygen saturations (r = -.36, P = .004). Serum estradiol level had only a minor effect on objective sleep quality. CONCLUSION: Impaired subjective sleep quality associated with climacteric vasomotor symptoms did not manifest as abnormalities in polysomnographic sleep recordings. Body mass index and age appeared to have the strongest effect on objective sleep quality.

Aged↗
PubMed1999

Use of health services by the climacteric women in primary health care: the need for an integral approach.

During the climacteric, women experience multiple health problems. As their needs are not catered for in an integral fashion due to the lack of any specific programme or mechanism to provide for this, they show an increased use of the health services, and an increased rate of referrals to different specialists. This study, carried out in a Basic Health Zone in San Fernando (Cádiz, Andalusía, Spain) on a sample of climacteric women who attended the Health Centre during 1995, examines these points and shows a significantly higher use of the health services in relation to the rest of the female population (those who are not in the climacteric age group) as well as a high percentage of referrals (74.6%) to specialists. It was found that both the level of knowledge about the climacteric and the use of the health services were influenced by the educational level (p < 0.001) and age (p < 0.05). Women who felt that their families provided an understanding and supportive attitude were found to have less psychological problems and, consequently, less consultations and referrals for this reason (p < 0.00001). The authors hope that their findings will provide a basis for the setting up of a programme of integral health care for climacteric women at the level of primary health care. With careful planning and the drawing up of a strategic plan, it would be possible to provide for the needs of this population group in a more satisfactory way, and it would also permit a rationalization of the resources available.

Adolescent↗
PubMed2005

Greene Climacteric Scale: norms in an Australian population in relation to age and menopausal status.

OBJECTIVES: The aim of this study was two-fold: to assess climacteric symptoms and provide normative data for the Greene Climacteric Scale during the menopause transition, and to investigate the prevalence of climacteric symptoms in a representative sample of postmenopausal Australian women. METHOD: A cohort of 500 premenopausal, perimenopausal and postmenopausal women aged 40-80 years participated in the Longitudinal Study of Ageing in Women (LAW study) at the Royal Brisbane and Women's Hospital, Brisbane, Australia. In year 1 of the study (2001), all participants completed the Greene Climacteric Scale and information regarding their menopausal status and the use of hormone therapy (HT) was obtained through a clinical interview with a qualified medical practitioner. RESULTS: The 50-59-year age group achieved the highest scores on the vasomotor and the depression scales in comparison to other age groups. Significant differences were also evident on the vasomotor and the depression scales on the basis of menopausal status, especially in perimenopausal women. Approximately 10% of women in the 60-79-year age group continued to experience vasomotor symptoms. CONCLUSION: Vasomotor symptoms, as assessed by the Greene Climacteric Scale, are common during the menopause transition and remain elevated for some years in a minority of older postmenopausal women. The norms presented in this study are appropriate for use in an Australian population.

Adult↗
PubMed2005

Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.

OBJECTIVE: Several clinical studies suggest that black cohosh may be effective in climacteric complaints. However, evidence of its efficacy based on current quality standards has been limited. METHODS: This randomized, multicenter, double-blind clinical trial compared the efficacy and tolerability of the isopropanolic black cohosh extract in the treatment of climacteric complaints compared with placebo. A total of 304 patients were randomly allocated to receive tablets corresponding to 40 mg drug or matching placebo daily for 12 weeks. The primary efficacy measure was the change from baseline on the Menopause Rating Scale I; secondary measures included changes in its subscores and safety variables. RESULTS: Patient groups did not differ in baseline characteristics. The isopropanolic black cohosh extract was more effective than placebo (P < .001) depending on time from symptom onset (P = .014) and follicle-stimulating hormone level (P = .011). The effect size was 0.03 to 0.05 Menopause Rating Scale units which is similar to recent hormone replacement therapy study results (0.036 Menopause Rating Scale units) and may therefore be considered clinically relevant. Women in the early climacteric phase benefited more than in the late phase. The hot flush subscore was the most effective measure of the isopropanolic black cohosh extract's efficacy. There were no relevant group differences in adverse events, laboratory findings, or tolerability. CONCLUSION: This isopropanolic extract of black cohosh root stock is effective in relieving climacteric symptoms, especially in early climacteric women.

Aged↗
PubMed2000

Effects of exercise experienced in the life stages on climacteric symptoms for females.

The purpose of this study is to investigate the effects of exercise experienced in the life stages on climacteric symptoms for females after menopause. Four-hundred and eight postmenopausal women completed a questionnaire. The results were as follows: (1) Mean age at menopause +/- standard deviation was 50.1 +/- 0.5 and did not show a significant relationship with the degree of exercise in the life stages. (2) The degree of climacteric symptoms had a significant relationship, or a tendency toward a significant relationship, with the degree of exercise in and after the 40's; and the greater the degree of exercise, the lesser the degree of climacteric symptoms. (3) Kupperman's index was found to be, or tended to be, significantly related to the degree of exercise in and after the 30's. Those who exercised heavily in their 30's showed a significantly lower Kupperman's index. Those who answered that they had exercised "moderately" in their "40's to menopause" and "menopause to 60 years old" tended to have the lowest index. (4) Exercise experience in the life stages was negatively correlated, in particular, to psychosomatic symptoms among the 3 climacteric symptom categories. This negative correlation tended to be higher in those who answered that they had done "less exercise" in and after their 30's. (5) A significant relationship was noted between the degree of exercise in the 30's and "weakness" in Kupperman's index, and between exercise in and after the 40's and "nervousness" and "melancholia". Therefore, it is suggested that exercising "moderately" from the subjective viewpoint in the climacteric period may alleviate psychosomatic symptoms.

Adult↗
PubMed2005

[Job performance and climacteric in female workers].

BACKGROUND: During climacteric, the presence of disabling symptoms and the higher incidence of chronic diseases, may impair the job performance of women. AIM: To relate job performance levels with the climacteric period and associated factors in working women aged from 42 to 55 years old. SUBJECTS AND METHODS: In a cross-sectional and correlative design, 64 secretaries at two public organizations at the Eighth Region of Chile, were assessed using the following instruments: Menopause-Specific Quality of Life Questionnaire (University of Toronto), adapted for Chile by PROSAM, Climacteric Self-care Questionnaire, Perceived Social Support Scale and Biodemographics Variables Questionnaire. A Perception of the Job Performance Scale was applied to the persons that superintended these woman. RESULTS: The Department Heads or persons supervising these women, determined that most workers did their work well. The best evaluations were given by older bosses. Most women under study showed a moderate alteration of the Menopause Quality of Life. A deficit of self-care during the climacteric period was detected in 92.2%. The perceived social support from friends correlated with job performance. Menopause quality of life in its different domains had no correlation with job performance variable. CONCLUSIONS: No association between changes during the climacteric period and job performance was observed among women participating in this study.

Achievement↗
PubMedDate not supplied

Blood pressure variations assessed by continuous 24-hour monitoring in menopausal and climacteric women.

Changes in the metabolic hormonal balance during the climacteric and menopause, especially surgically induced menopause, increase the risk of acute cerebrocardiovascular complications. This major risk may be linked to changes in blood pressure. In this study we performed twenty-four ambulatory blood pressure monitoring in climacteric (C), menopausal (PM), and surgically induced menopausal women (SM) to determine mean diurnal and nocturnal systodiastolic levels and percentage peaks, as variations in the pressure profile may be linked to organ damage. Our results showed that the entire series presented mainly diastolic increments (mDBP: HPM = 104.4 +/- 5.1; HSM = 106.3 +/- 2.9; HC = 100.2 +/- 3.1), and that this rise was greater in surgically induced menopausal women. In addition, these subjects presented the highest diastolic and systolic pressure peaks (HSM 37/42 versus HPM 35/36 and HC 29/31) also during the night (nocturnal peak: HSM 15/19 versus HPM 10/12 and HC 5/15). Non dippers seem more exposed to cerebrocardiovascular disease. Our results revealed that climacteric patients affected by arterial hypertension (mSBP = 162.2 +/- 4.1; mDBP = 100.2 +/- 3.1; 24 h systolic peak % = 24, diastolic peak % = 24) during the climacteric presented the same levels as observed in conclaimed menopause (mSBP 165.2 +/- 5.5; mDBP = 104.2 +/- 5.1; 24 h systolic peak % = 28, diastolic peak % = 29). Therefore, 24 h blood pressure monitoring is able to show that the pressure changes in hypertensive climacteric and menopausal women and could detect women who are at a greater risk of organ damage.

Adult↗
PubMed2001

[Complex effects of cavinton on climacteric symptoms].

The use of nonhormonal drugs in order to ameliorate climacteric symptoms makes it possible to treat also those women in whom there are some contraindications or lack of compliance for taking hormonal replacement therapy. The drugs with complex effects on the whole body functions are more widely used recently. The aim of the present study is to assess the therapeutic effect of Cavinton (vinpocetin) on the degree of climacteric symptoms and to verify its complex beneficial influence. The study comprises of three groups of women in early menopause--control group (n = 30), treatment groups with normolipidaemia (n = 32) and with hyperlipidaemia (n = 29). All women presented with moderately expressed climacteric symptoms as assessed by Kupperman menopausal index and Hamilton-Anxiety-Skala (HAMA). The women in the 2nd and 3rd groups have been taking Cavinton in an oral dose of 5 mg three times daily for 3 months. The following parameters of lipid metabolism were determined in the beginning and at the end of the study: total, HDL- and LDL-cholesterol, triglycerides, and two indexes of lipid atherogenic risk--total/HDL-cholesterol ratio and atherogenic index (AI) = total--HDL/LDL-cholesterol. The menopausal complaints were assessed by Kupperman index and HAMA. Blood vessels reactivity was determined by pulsation index (PI). Statistically significant decrease in total cholesterol and LDL-cholesterol levels as well as amelioration of atherogenic indexes was observed in the 3rd group. Kupperman index and HAMA decreased significantly on the 45th day and the 3rd month in the women under treatment. No significant changes in PI were observed but a tendency towards a decrease was seen in the 3rd group. Our data suggest that Cavinton possesses complex beneficial effects in climacteric women significantly ameliorating climacteric symptoms as well as some parameters of lipid metabolism in women with hyperlipidaemia.

Administration, Oral↗
PubMedDate not supplied

[Excretion in the urine of glucuronides of testosterone and androstenedione in women with climacteric neurosis and without neurosis].

The author elaborated a method of study of the urinary excretion of the testosterone and androstendione glucoronides and applied it in 20 women (4 healthy women of reproductive age, 10 women at the postmenopause with a climacteric neurosis, and 7 healthy women during the climacteric). In healthy women the mean values of testosterone and androstendione urinary excretion showed no significant difference from those in women of the reproductive age and during the climacteric. It is supposed that the level of urinary excretion of these hormones showed but little change with the progress of age. As to women with a climacteric neurosis, there was no significant change of the mean values of urinary excretion to testosterone and androstendione in comparison with healthy women of the same age. This suggests that the androgenic function of the adrenal glands in this neurosis showed no significant change. Patients with a climacteric neurosis displayed higher variations in the values of the urinary excretion of testosterone and androstendione glucoronides, which was possibly associated with disturbances of regulation of the production of the androgens by the hypothalamic centres.

Adult↗
PubMed1991

[The assessment of the physical work capacity of women with hypertension in the climacteric].

The author studied the hypotensive effect on women with hypertonic disease during climacteric and investigated their physical capacity for a period of one year. The object of the study was 56 women with climacteric syndrome during climacteric as 38 out of 56 women suffered from hypertonic disease (HD). A considerable reduction in the physical working capacity of women suffering from HD during climacteric 326 +/- 20 kgm/min was found. After the performed one-year treatment the physical working capacity was increased considerably to 606 +/- 23 kgm/min at p less than 0.001, to which an increase in the heart output (presented as heart frequency and arterial blood pressure) corresponded. The best manifested effect in recovery of the physical working capacity in patients with HD during climacteric was found after hypotensive therapy, but the combined (hypertensive and sedative) therapy was on the second place and the sedative therapy--on the third place.

Climacteric↗
PubMed1990

[Digital plethysmogram in women with climacteric disturbance after cold-water challenge test and effect of estrogen].

Immediately after a cold-water challenge test (C-W test) the pulse height to the digital plethysmogram descended (descent wave: D wave), and a congestion wave (C wave) occurred after the D wave. Then the recovery wave (R wave) continued after the C wave. The effects of estrogen on the digital plethysmogram under the C-W test are as follows. (1) The D wave was less than 25% in young women and women without climacteric disturbance. (2) The recovery rate of the C wave in young women was better than in climacteric women without climacteric disturbance. (3) The before value for A1B'1/B'1C1 in the C-W test of young women was 1.0, and the other values during the C-W test did not change significantly compared with the before values. (4) U-time rose only temporarily in the former case. In addition the recovery rate of the R wave after the administration of premarin in women with climacteric disturbance was 19.3%, and this was a significant improvement over the cases without administration. The recovery rate of the R wave in the same women after the administration of premarin and cercine increased to 48.3% (p less than 0.01). These data suggested that estrogen may be able to control the function of the autonomic nervous system in climacteric woman.

Adolescent↗
PubMed1982

[Clinical effect of gamma-oryzanol on climacteric disturbance -on serum lipid peroxides (author's transl)].

Though gamma-Oryzanol has been applicated as the autonomic agent in various fields for a few decades, recently its effect on lipid metabolism comes to be much more interested. We studied on the effect of gamma-Oryzanol on climacteric disturbance, and besides on the difference of lipid peroxides level which has an important and indispensable connection with mary syndromes involving aging. We obtained the following results from 40 subjects with climacteric disturbance after administration of gamma-Oryzanol Fine Particule 1.5 g (gamma-Oryzanol 300 mg included) for 4 to 8 weeks. 1. 90% of the cases improved generally; Excellent 16 (40%), Good 14 (35%), Effective 6 (15%), No change 4 (10%). 2. Effect on climacteric disturbance was judged by the Kupperman method and the Ueda method; generally recovered 85%, 80% each. 3. Significantly reduced total cholesterol, triglyceride and increased HDL-cholesterol were noted in cases with hyperlipidemia (TC greater than or equal to 220 mg/dl, TG greater than or equal to 140 mg/dl, HDL-chol. less than or equal to 45 mg/dl). Therefore, atherogenic index was excellently recovered. 4. In cases with climacteric disturbance lipid peroxides level was high, and they were significantly recovered by administration of gamma-Oryzanol. 5. During this study, no side effects have been recognized and no particular change in function test was found. Thus, we confirmed the efficacy and utility of gamma-Oryzanol on many complaints in climacteric disturbance and also on lipid metabolism.

Adult↗
PubMed1994

[The male climacteric. A responsibility for dermatologic andrology?].

Sexual impotence is considered to be the main symptom of the male climacteric, corresponding to the female menopause. While the female climacteric is routinely observed and treated by gynecologists, there are no adequate institutions for the treatment of the corresponding male complaints. Like ovarian secretion of estrogens, which declines and thus causes the female climacteric syndrome, the endocrine metabolism of the testes decreases with increasing age. The period of this decrease, however, is far more extended than that of estrogen secretion in women. Several recent studies have yielded evidence that any disease--irrespective of its kind--in the aging man influences the decrease of testosterone levels more markedly than his age. In 1986 a study group in New England inaugurated the "Massachusetts Male Aging Study" in which healthy men in different age groups were tested for hormone levels. The most prominent result of this study was a decrease in mean testosterone levels by 1% and a decrease in the mean free testosterone levels by 1.2% per year of age. The study also allows recommendations for hormone substitution. The decrease in sexual function in the aging male does not correlate with the decrease in testosterone production. In summary, however, there is no doubt that the frequency of sexual dysfunction increases with advancing age, partly because of drug interactions. As there does not seem to be any sound basis for assuming an endocrine basis for the male climacteric, other reasons must probably be sought for the male climacteric or mid-life crisis.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1997

Continuous versus cyclical transdermal estrogen replacement therapy in postmenopausal women: influence on climacteric symptoms, body weight and bleeding pattern.

OBJECTIVES: To compare continuous and cyclical transdermal estrogen replacement therapy (ERT) with or without an oral progestogen regarding climacteric symptoms, body weight and bleeding pattern. METHODS: A total of 2459 postmenopausal women were treated for three cycles of 28 days in an open, randomized, parallel group multicenter study. Patients received an estrogen matrix patch (50 micrograms 17/beta-estradiol/day) twice weekly, either continuously (eight patches/cycle) or cyclically (six patches/cycle, i.e. 3 weeks on, 1 week off). A total of 1232 patients were treated continuously and 1227 cyclically. In the study group 1150 patients had an intact uterus (543 in the continuous and 607 in the cyclical treatment arm) and received, in addition to the estrogen patch, an oral progestogen in a transformation dose for 12 days of each cycle. Hysterectomized patients totaling 1309 (689 in the continuous versus 620 in the cyclical group) did not receive progestogen. Of the 2459 patients, 771 (31.4%) participated in a follow-up study with two further treatment cycles, which was offered to the patients at the end of the main study. The main outcome measures were climacteric symptoms, measured at the end of cycles 1-3 by a Visual Analogue Scale at baseline, and body weight measured at baseline at the end of cycles 3 and 5. In addition, the bleeding time per cycle (days) was evaluated in all patients with an intact uterus. RESULTS: Continuous and cyclical transdermal ERT reduced, over three treatment cycles, the average climacteric symptom score by 1.77 and 1.70, respectively. The percentage remission and improvement rates for the ten climacteric symptoms ranged between 69.3 and 88.0% and did not differ between the two groups. In patients with a higher symptom score at baseline, the continuous treatment was slightly more effective. However, this effect was statistically not significant. After three treatment cycles body weight increased in both treatment groups by between 500 and 700 g. Further treatment during the follow-up study induced an additional average weight gain of 200-400 g. These results were not influenced by the addition of an oral progestogen. In patients with an intact uterus, the average bleeding time at the end of the first cycle (5.4 days in the continuous versus 5.3 days in the cyclical group) increased slightly during cycle 2 and returned to baseline values at the end of cycle 3. CONCLUSIONS: Continuous and cyclical transdermal ERT were equally effective in reducing climacteric symptoms. The short term use of five cycles transdermal ERT induced a slight increase in body weight which was independent of the treatment regimen. These results were not influenced by the type and mode of administration of a progestogen. Both ERT regimens were very well tolerated and are suitable alternatives for estrogen replacement therapy of postmenopausal women.

Administration, Cutaneous↗
PubMed1998

Can climacteric women self-adjust therapeutic estrogen doses using symptoms as markers?

OBJECTIVES: To investigate if disappearance of climacteric symptoms during hormone replacement therapy (HRT) also means good therapeutic level of serum estradiol. The study group comprised of 32 postmenopausal women who had frequent climacteric symptoms. METHODS: The women increased the daily treatment doses of percutaneous estradiol every 2 weeks until they felt comfortable with it. Each woman continued at that treatment dose for up to 3 months. Blood samples for estradiol assay were drawn at baseline, every time before the estradiol dosage was increased and at the end of the study. Climacteric symptoms were scored according to the Kupperman menopausal index. RESULTS: Despite the relief of climacteric symptoms, serum estradiol concentration was at a menopausal level (< 50 pg/ml) in 22% of the women. In all, 45% of the subjects showed serum estradiol remaining under 60 pg/ml, 29% of the women showed levels of 60-100 pg/ml and 26% showed serum estradiol concentration more than 100 pg/ml. CONCLUSIONS: The disappearance of climacteric symptoms during HRT does not guarantee that estrogen levels are sufficiently high for obtaining long term benefits of HRT.

Administration, Cutaneous↗
PubMed1998

Raloxifene effects on vasomotor and other climacteric symptoms in postmenopausal women.

Introduction and Objectives: Raloxifene, a novel selective estrogen receptor modulator (SERM), is under investigation for the prevention of osteoporosis in postmenopausal women. Like traditional estrogen replacement therapy, raloxifene has beneficial effects on bone and on serum lipids whereas, in contrast to estrogen's adverse effects in the breast and uterus, raloxifene is an estrogen antagonist in the breast and is nonstimulatory in the uterus. This study examines the effects of raloxifene 60 mg/day compared with placebo on: 1) the incidence of vasomotor symptoms: hot flashes (flushing) and sweating (including night sweats), 2) the severity and time course of hot flashes, and 3) the relation of hot flashes to baseline subject characteristics and study discontinuations. Additionally, the study explores the effects of raloxifene 60 mg/day compared with placebo on other climacteric symptoms that affect the quality of life of postmenopausal women, such as depression, insomnia, mood lability and genitourinary complaints.Methods: Integrated data from five randomized, placebo-controlled studies involving 1,165 healthy, postmenopausal women, with up to 30 months of study drug exposure, were analyzed. The incidence and severity of hot flashes and other climacteric symptoms were compared in patients treated with placebo or raloxifene (60 mg/day) via open-ended, non-directed subject self-assessment questionnaires. Data were analyzed for subgroup-by-therapy interactions using many baseline subject characteristics such as age, body mass index, smoking, alcohol, and years post-menopause, as well as preexisting conditions such as hot flashes, sweating, insomnia, depression, and history of hysterectomy. The overall incidence of other climacteric symptoms were reported as adverse events.Results: The increase in overall incidence of hot flashes in raloxifene-treated (24.6%) and placebo-treated (18.3%) subjects was modest, but statistically significant. However, this difference was significant only during the first 6 months of therapy, raloxifene (20.1%) compared with placebo (14.4%). After 6 months of treatment, there was no statistically significant difference in the incidence of hot flashes between the two treatment groups. The majority of hot flashes in raloxifene-treated subjects were subject-assessed as "mild-to-moderate" in severity (89%). The incidence of hot flashes reported as "severe" did not differ significantly in raloxifene- or placebo-treated subjects. Subgroup analyses revealed the overall incidence of hot flashes to be highest for both raloxifene and placebo-treated subjects, in younger (age < 55 years) women (P =.004), in women who had previously experienced hot flashes (P =.031), and in women having had hysterectomies (P <.001). Within each of these subgroups, there was no statistical difference in the incidence of hot flashes between the raloxifene and placebo groups. Between the two treatment groups, there was no difference in the overall incidence of subject discontinuations from study due to hot flashes. The occurrence of the other common vasomotor symptom, sweating (which includes night sweats), was not statistically different for the raloxifene- or placebo-treated subjects.Genitourinary complaints are often symptoms related to vaginal dryness, such as dyspareunia and decreased libido, as well as other symptoms of vaginitis and leukorrhea. No statistically significant differences occurred for raloxifene- or placebo-treated subjects in reports of these genitourinary symptoms. Similarly, for the other common climacteric symptoms; depression, insomnia, and mood lability, no significant differences in incidence between the raloxifene and placebo treatment groups were observed.Conclusions: Raloxifene (60 mg/day) treatment modestly increased the incidence of hot flashes compared with placebo, however, this difference was only statistically significant during the first 6 months of treatment. There were no differences in the severity of hot flashes between treatment groups, and this symptom did not adversely affect subjects' study participation. In both the raloxifene and placebo treatment groups, young postmenopausal women (age < 55), those with baseline hot flashes, and those with histories of hysterectomy were most likely to experience hot flashes. Raloxifene therapy did not affect the occurrence of other climacteric symptoms commonly affecting the quality of life of women after menopause.

Journal Article↗