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Biomedical subjects

Angelica Lindén Hirschberg

Publications and source records attributed to Angelica Lindén Hirschberg.

At least 19 recordsLinked to original sources

Menstrual disorders and associated factors among adolescent girls visiting a youth clinic.

BACKGROUND: Menstrual disturbances are common among teenagers and are often explained by immaturity of the hypothalamic-pituitary-gonadal axis. However, little is known about the underlying causes. The aim of this study was to evaluate endocrine mechanisms of menstrual disturbances and associated factors among adolescent girls visiting a Swedish youth clinic. METHODS. All adolescent girls visiting the youth clinic during a five-year period due to menstrual disturbances, except those with primary amenorrhea, were included in this retrospective study. These 203 girls were evaluated in a standardized manner by the same gynecologist. One third also met a psychologist and/or a dietician at the clinic. RESULTS: Secondary amenorrhea was diagnosed in 117 girls (58%) and oligomenorrhea in 86 girls (42%). Menarcheal age was 13 in both groups. Hypothalamic inhibition of the gonadal axis was more frequent in the girls with secondary amenorrhea, whereas a hyperandrogenic hormonal pattern as a feature of polycystic ovary syndrome was more common in the oligomenorrheic girls. Different types of eating disorders were diagnosed in 68% of the amenorrheic girls and in 38% of the oligomenorrheic girls. CONCLUSIONS: We found hypothalamic amenorrhea and hyperandrogenism to be frequent endocrine mechanisms of menstrual disorders in teenagers. Concomitant eating disorder was highly frequent and secondary amenorrhea was associated with anorectic behavior. It is important to evaluate endocrine patterns and eating behavior in adolescents with menstrual disturbances to ensure adequate medical care and treatment.

Adolescent↗

Effects of treatment with testosterone alone or in combination with estrogen on insulin sensitivity in postmenopausal women.

OBJECTIVE: Little is known about metabolic effects of testosterone treatment in postmenopausal women. The aim of the study was to compare the treatment effects of testosterone, estrogen, and testosterone plus estrogen on insulin sensitivities, body compositions, and lipid profiles in healthy postmenopausal women. DESIGN: An open, randomized clinical study with parallel group comparison. SETTING: Women's health clinical research unit at a university hospital. PATIENT(S): Sixty-three naturally postmenopausal women participated in the study. INTERVENTION(S): The participants were randomly assigned to 3 months of treatment with testosterone undecanoate (40 mg every second day), estradiol valerate (2 mg daily), or the combination of both. MAIN OUTCOME MEASURE(S): Insulin sensitivity assessed by euglycemic hyperinsulinemic clamp, body composition, and serum lipids. RESULT(S): Insulin-induced glucose disposal was reduced by approximately 20% after treatment with testosterone alone, and after the combined treatment, but not by estrogen alone. Body weight, but not total body fat, increased significantly by about 1 kg in all groups. Lean body mass was significantly increased in the group of combined treatment and tended to be increased by testosterone alone. High-density lipoprotein (HDL)-cholesterol decreased significantly by testosterone treatment. In contrast, HDL-cholesterol increased, whereas low-density lipoprotein (LDL)-cholesterol and lipoprotein-(a) [Lp(a)] decreased with estradiol treatment. CONCLUSION(S): We conclude that 3 months of treatment with testosterone undecanoate in postmenopausal women induces insulin resistance and an adverse serum lipid profile but may increase lean body mass.

Adult↗

Polycystic ovary syndrome in bulimic women--an evaluation based on the new diagnostic criteria.

An association between bulimia nervosa and polycystic ovary syndrome (PCOS) has been suggested but also questioned. Since there is still a controversy about this issue, we investigated clinical and biochemical symptoms of PCOS according to the new diagnostic criteria in a large group of bulimic women compared with controls. Seventy-seven women with bulimia and 59 matched healthy women were investigated with respect to menstrual status, polycystic ovaries, hirsutism, acne and sex hormone levels. We found increased occurrence of menstrual disturbances, hirsutism and PCOS in bulimic women, whereas ovarian variables and acne did not differ from controls. Hirsutism score and indices of biologically active testosterone were positively correlated in bulimics but not in controls, while there were no major differences in serum androgens. In conclusion, this study supports an increased frequency of PCOS in bulimic women and may also indicate increased androgen sensitivity in these women. PCOS may promote bulimic behavior since androgens have appetite-stimulating effects and could impair impulse control. Menstrual disturbances and clinical signs of hyperandrogenism should be evaluated in bulimics in order to provide adequate medical care and treatment.

Adult↗

Endothelial function in post-menopausal former elite athletes.

OBJECTIVE: To characterize endothelial function in postmenopausal former elite athletes in comparison to sedentary controls and to study the influence of hormone replacement therapy (HRT) on endothelial function in these groups of women. DESIGN: Cross-sectional study. SETTING: Research unit at a university hospital. PARTICIPANTS: Twenty postmenopausal former elite but still active endurance female athletes and 19 age-matched sedentary controls. The group of athletes and control subjects were each subdivided into two groups on the basis of utilization or non-utilization of HRT involving estrogen and gestagen. METHODS: Flow-mediated vasodilatation (FMD) was employed as an indicator of endothelial function. Fasting blood samples were analyzed for lipids and body composition determined by dual-energy x-ray absorptiometry. MAIN OUTCOME MEASURES: FMD, blood lipids and body composition. RESULTS: Former elite athletes not utilizing HRT demonstrated the highest FMD of all four subgroups, their values being significantly higher than those of control subjects not utilizing HRT (P < 0.05), whereas this difference was not seen between the subgroups of athletes and control subjects using HRT. Serum levels of cholesterol and low-density lipoprotein (LDL) and the percentage of fat mass were significantly lower in the former elite athletes than in the control group (P < 0.05 in all cases). However, these variables were not related to FMD. CONCLUSION: This investigation documents enhanced endothelial function in postmenopausal former elite endurance athletes not utilizing HRT, whereas the use of HRT equalizes FMD in former athletes and sedentary control subjects. Our findings suggest that long-term strenuous exercise has beneficial effects on endothelial function in postmenopausal women but that no further improvement can be obtained with HRT.

Case-Control Studies↗

Bone mineral density in bulimic women--influence of endocrine factors and previous anorexia.

OBJECTIVE: Data concerning bone mineral density (BMD) in bulimia nervosa are contradictory and include both low and normal values. The aim of the present study was to elucidate possible endocrine-and nutrition-related factors predicting BMD in bulimic women. DESIGN: Cross-sectional study. METHODS: Seventy-seven bulimic patients and 56 age- and body mass index (BMI)-matched healthy controls were examined with respect to BMD (dual energy X-ray absorptiometry) and to serum levels of hormones and metabolic factors. RESULTS: Bulimics had significantly lower spinal BMD and higher frequency of osteopenia in the total body than controls. Furthermore, bulimic women had significantly lower levels of estradiol-17beta and free thyroxine and significantly higher cortisol levels compared with controls. Among the bulimics, 31.2% had present menstrual disturbance, 51.9% had a history of amenorrhea and 23.4% had previous anorexia nervosa. Subgroups of bulimics with a history of amenorrhea and previous anorexia nervosa had significantly lower total and spinal BMD than controls, whereas those without such history did not differ from the controls. In univariate analysis, a history of amenorrhea, cortisol, testosterone, previous anorexia nervosa, and BMI showed significant associations with spinal BMD. Multiple regression analysis including all significant variables revealed previous anorexia nervosa to be the strongest determinant of spinal BMD, accounting for 34% of the variance, while associations between endocrine factors and BMI disappeared. CONCLUSIONS: Low bone mass in bulimics may be explained by previous anorexia nervosa, whereas endocrine variables related to BMD seem to be secondary determinants that are dependent on previous anorexia nervosa and BMI.

Absorptiometry, Photon↗

Altered postural control during the luteal phase in women with premenstrual symptoms.

The purpose of this study was to investigate postural control in women with and without premenstrual symptoms (PMS) in three hormonally verified phases of the menstrual cycle. Thirty-two women were recruited to participate in the study and 25 of these women were included in the results. Menstrual cycle phases were determined by sex hormone analyses in serum and LH detection in urine. A prospective rating of PMS was used to divide the subjects into two groups: one with PMS (cyclic) and one without (non-cyclic). For measurement of postural control, subjects stood on a force platform (AMTI) in two-legged stance (eyes open and closed) and one-legged stance (eyes open and closed). There were no significant differences in the two-legged stance between the phases of the menstrual cycle or between groups. In one-legged stance with eyes open, there was a significant increase in postural displacement in the mid-luteal phase in the cyclic group, but no differences were detected between phases in the non-cyclic group. These findings may be related to the previously reported increased injury rate and psychomotor slowing in the luteal phase in women with PMS.

Adult↗

Knee joint kinaesthesia and neuromuscular coordination during three phases of the menstrual cycle in moderately active women.

An increased incidence of sports related injuries in the premenstrual phase as well as in the menstrual phase of the menstrual cycle has been described. This may be explained by alterations in proprioception and neuromuscular coordination due to hormonal variations. Prospective, within women analysis of knee joint kinesthesia and neuromuscular coordination were performed by repeated measures analysis of variance in three hormonally verified phases of three consecutive menstrual cycles. Thirty-two healthy, moderately active female subjects volunteered to participate in the study. Twenty-five of the subjects performed at least one hormonally verified menstrual cycle. A specially designed device was used to investigate knee joint kinaesthesia and neuromuscular coordination was measured with the square hop test. These tests were carried out in the menstrual phase, ovulation phase and premenstrual phase determined by hormone analyses in three consecutive menstrual cycles. An impaired knee joint kinaesthesia was detected in the premenstrual phase and the performance of square hop test was significantly improved in the ovulation phase compared to the other two phases. The results of this study indicate that the variation of sex hormones in the menstrual cycle has an effect on performance of knee joint kinaesthesia and neuromuscular coordination.

Adult↗

Oral contraceptives improve endothelial function in amenorrheic athletes.

Athletic amenorrhea has been associated with endothelial dysfunction and unfavorable lipid profile. Estrogen substitution may reverse these metabolic consequences. The aim of this study was to evaluate the effects of oral contraceptives (OCs) on endothelial function measured as flow-mediated dilatation (FMD) of the brachial artery, the lipid profile, and blood markers of endothelial activation (inflammation) in amenorrheic athletes. Age- and body mass index-matched groups of young endurance athletes with amenorrhea (n = 11), regularly cycling athletes (n = 13), and sedentary controls (n = 12) were examined before and after 9 months of treatment with a low dose, monophasic, combined OC (30 mug ethinyl estradiol and 150 mug levonorgestrel). The amenorrheic athletes displayed the lowest FMD at baseline and the largest increase after OC treatment. FMD also increased in the control group, but not in the regularly menstruating athletes, who had the highest values of FMD before treatment. All three groups, particularly the controls, showed moderate unfavorable changes in the lipid profile in accordance with previous known effects of a second generation OC. Furthermore, there was an overall increase in some inflammatory markers (high sensitive C-reactive protein and TNF-alpha) and a decrease in one of the markers (vascular cell adhesion molecule-1). We conclude that amenorrheic athletes benefit from treatment with OC with respect to endothelial function. OC treatment is also associated with some modest alterations in the lipid profile and in markers of inflammation.

Adolescent↗

Luteal phase dosing with paroxetine controlled release (CR) in the treatment of premenstrual dysphoric disorder.

OBJECTIVE: This clinical trial evaluated luteal phase dosing with paroxetine controlled release (CR) (12.5 mg and 25 mg) in the treatment of premenstrual dysphoric disorder (PMDD). STUDY DESIGN: A multicenter, randomized, double-blind, placebo-controlled, 3-arm, fixed-dose study of luteal phase dosing with paroxetine CR in the treatment of PMDD. Three hundred seventy-three patients with PMDD were randomly assigned into the study. The primary measure of efficacy was the change from baseline in the mean luteal visual analogue scale (VAS)-Mood score. Secondary efficacy measures included disorder-specific evaluations, global assessments of disease severity, and assessments of functional impairment. Adverse events were recorded throughout the trial. RESULTS: Patients treated with either dose of paroxetine CR demonstrated significantly greater improvements on the primary efficacy measure (change from baseline in mean luteal phase VAS-Mood scores) and on the majority of secondary efficacy measures compared with patients randomly assigned to placebo. CONCLUSION: For the treatment of PMDD, luteal phase dosing with 12.5 mg and 25 mg of paroxetine CR is effective and generally well tolerated.

Adolescent↗

Pregnancy and neonatal outcomes in women with eating disorders.

OBJECTIVE: This study was initiated to examine pregnancy and neonatal outcomes in women with past or current eating disorders as compared with a control group. METHODS: Forty-nine nulliparous nonsmoking women previously diagnosed with eating disorders (24 anorexia nervosa, 20 bulimia nervosa, 5 eating disorders not otherwise specified) and 68 controls were recruited in early pregnancy. Data on antenatal complications, mode of delivery, and neonatal outcome variables were collected. For comparisons between groups 1-way analysis of variance or chi(2) test was used. RESULTS: Twenty-two percent of the patients had a verified relapse in eating disorders during pregnancy. Women with past or current eating disorders were at increased risk of hyperemesis (P < .01) and delivered infants with significantly lower birth weight (P < .01) and smaller head circumference (P < .001) as compared with controls. They were also at greater risk of delivering infants with microcephaly (P < .05) and small for gestational age infants (P < .05). CONCLUSION: Pregnant women with past or active eating disorders seem to be at greater risk for delivering infants with lower birth weight, smaller head circumference, microcephaly, and small for gestational age. LEVEL OF EVIDENCE: II-2.

Adult↗

Athlete's heart in postmenopausal former elite endurance female athletes.

OBJECTIVE: To investigate cardiac structure and function and exercise capacity in senior former elite athlete women. DESIGN: Cross-sectional study. PARTICIPANTS: Twenty postmenopausal former elite endurance athletes and 19 age-matched sedentary controls. METHODS: All subjects underwent transthoracic Doppler echocardiography and maximal exercise test on a bicycle ergometer. MAIN OUTCOME MEASURES: Cardiac chamber dimensions, wall thickness, cardiac function, and exercise capacity. RESULTS: The athletes had a greater exercise capacity (183 +/- 26 vs. 144 +/- 36 W; P < 0.01) compared with controls. Three of 20 (15%) athletes and 9 of 19 (47%) controls exhibited ST depressions during exercise test (P < 0.05). Echocardiographic measurements demonstrated larger left ventricular diameter (2.9 +/- 0.3 vs. 2.6 +/- 0.2 cm/m; P < 0.01), left ventricular volume (64 +/- 14 vs. 54 +/- 8 mL/m; P < 0.05), right ventricular diameter (1.6 +/- 0.2 vs. 1.4 +/- 0.2 cm/m; P < 0.01), left atrial volume (20.8 +/- 6 vs. 16.6 +/- 3.6 mL/m; P < 0.05), and stroke volume (45 +/- 10 vs. 36 +/- 5 mL/m; P < 0.01) in athletes than controls, whereas interventricular septum (9.3 +/- 1.7 vs. 10.1 +/- 1.8 mm; P > 0.05) and posterior wall thickness (9.0 +/- 1.6 vs. 9.2 +/- 1.0 mm; P > 0.05) did not differ between the groups. CONCLUSIONS: This study demonstrates cardiac enlargement without increased wall thickness in postmenopausal former elite endurance athlete women. Our results also indicate that long-term training maintains a high level of cardiovascular fitness in the aging female athletes.

Cardiac Output↗

Hyperprolactinaemia in 271 women: up to three decades of clinical follow-up.

OBJECTIVE: To characterize women with hyperprolactinaemia at diagnosis and to assess the effect of treatment after long duration of the disease. DESIGN: Retrospective chart review. PATIENTS AND MEASUREMENTS: Two hundred and seventy-one women with hyperprolactinaemia at the Karolinska University Hospital, Stockholm, Sweden between 1974 and 2002 were evaluated retrospectively. Criterion for inclusion was elevated S-PRL (> or = 20 microg/l) found on at least two occasions. Secondary hyperprolactinaemia was excluded. The patients were followed for a median time period of 111 (6-348) months. Two hundred and forty patients were treated with dopamine agonists, 17 underwent surgery, seven received radiotherapy and seven were followed without treatment. RESULTS: Mean age at diagnosis was 31 (+/- 9.5) years and median PRL level was 72 (25-3500) microg/l. Menstrual disturbances were present in 87% of the women of reproductive age and 47% had galactorrhoea. Microadenomas were found in 63%, macroadenomas in 8% and idiopathic hyperprolactinaemia in 29%. Patients with menstrual disturbances had higher PRL levels than women with normal menstrual function (P < 0.001). We found no differences in PRL levels between patients with or without galactorrhoea (P = 0.578). At the end of clinical follow-up, menstrual cycle was normalized in 94% and galactorrhoea disappeared in 94%. In the medically treated patients, median PRL levels decreased from 70 (25-3100) to 13 (0-89) microg/l, (P < 0.0001). Normalization of PRL level was achieved in 71% of the patients and 80% showed a total or partial degree of tumour shrinkage. In the surgically treated patients, 53% had normal PRL levels without medication at follow-up. CONCLUSION: Medical treatment was effective in correcting hypogonadism, normalizing PRL levels and reducing tumour size in the majority of the patients after short-term treatment and also in the long run. However, the possibility of transsphenoidal surgery in specific cases must be considered.

Adenoma↗

Amenorrhea in female athletes is associated with endothelial dysfunction and unfavorable lipid profile.

The aim of this study was to evaluate endothelial function measured as flow-mediated dilatation (FMD) of the brachial artery and blood markers of cardiovascular disease in young female endurance athletes with menstrual disturbance. Age- and body mass index-matched groups of young endurance athletes with amenorrhea (n = 14), oligomenorrhea (n = 9), and regular cycles (n = 12) and sedentary controls (n = 12) were compared with respect to endothelial function, lipid profile, markers of inflammation, and endocrine status. We found a significantly decreased FMD in the amenorrheic athletes, compared with all other groups. Amenorrheic athletes also had the most unfavorable lipid profile with significantly higher total cholesterol and low-density lipoprotein, compared with the other athlete groups. The oligomenorrheic athletes had the lowest levels of total cholesterol, low-density lipoprotein, and apolipoprotein B of all groups and significantly lower in comparison with the amenorrheic group. However, with respect to FMD, the oligomenorrheic group represented an intermediate between amenorrheic and regularly cycling subjects. There was a gradual impairment of FMD and the lipid profile to the degree of menstrual disturbance supporting an association with estrogen status. We conclude that amenorrhea in young endurance athletes is associated with endothelial dysfunction and unfavorable lipid profile. Additional studies are needed to elucidate the clinical implications of these results with regard to long-term risk for cardiovascular disease.

Adolescent↗

Effects of oral contraceptives on body composition and physical performance in female athletes.

Menstrual disturbances are common among female athletes, and oral contraceptives (OCs) are often recommended as estrogen substitution. However, there is little information about the effects of OC use in athletes, and there is great concern that OCs might impair physical performance. The aim of this study was to investigate the effects of OC use on body composition and physical performance in female athletes. Twenty-six endurance athletes (13 with oligo-/amenorrhea and 13 regularly menstruating athletes) and 12 sedentary controls were examined before and after 10 months of treatment with a low dose, monophasic, combined OC. Significant changes in body composition were recorded in the athletes, but not in the controls. There was an increase in weight and fat mass only in athletes with oligo-/amenorrhea. These changes were associated with a decrease in ovarian androgens. OC treatment also increased bone mineral density, with the largest increase in athletes with a low bone mineral density at baseline. Despite significant changes in body composition, little impact on physical performance was recorded. We have demonstrated that OC treatment in female athletes has predominantly beneficial effects on body composition without adverse effects on physical performance and could be used for the prevention of osteoporosis in athletic amenorrhea. However, it cannot be excluded that a marked increase in fat mass might have unfavorable effects for athletic performance in individual women.

Adolescent↗

Diurnal profiles of testosterone and pituitary hormones suggest different mechanisms for menstrual disturbances in endurance athletes.

The aim of this study was to evaluate the diurnal pattern of testosterone and pituitary hormones in endurance female athletes with different types of menstrual disorder. Age- and body mass index-matched groups of endurance athletes with amenorrhea (n = 10) and oligomenorrhea (n = 6), regularly cycling athletes (n = 8), and sedentary controls (n = 8) were compared with respect to 24-h hormonal profiles of testosterone, LH, prolactin (PRL), GH, insulin, IGF binding protein 1 (IGFBP-1), and cortisol. The 24-h hormone profiles in amenorrheic athletes were characterized by decreased LH pulsatility and peak amplitude of PRL and increased baseline levels of GH and cortisol. However, oligomenorrheic athletes displayed a significantly different pattern with higher diurnal testosterone secretion than all other groups. Furthermore, LH, PRL, GH, and cortisol secretions were comparable with regularly menstruating subjects. In the combined group of athletes with menstrual disturbances, diurnal secretions of testosterone, LH, and PRL were positively, whereas cortisol was negatively correlated with the number of menstruations the last year. Although this could be explained by a gradual inhibition of the hypothalamic-pituitary-gonadal axis, our results indicate that the symptoms of amenorrhea and oligomenorrhea may reflect two hormonally distinct conditions. Thus, amenorrheic athletes displayed a hormonal pattern in agreement with hypothalamic inhibition due to energy deficiency, whereas oligomenorrheic athletes demonstrated increased diurnal secretion of testosterone, suggesting a different mechanism, e.g. essential hyperandrogenism.

Adult↗

Hyperandrogenicity is an alternative mechanism underlying oligomenorrhea or amenorrhea in female athletes and may improve physical performance.

OBJECTIVE: To evaluate endocrine mechanisms underlying oligomenorrhea or amenorrhea in female athletes. DESIGN: Cross-sectional study. SETTING: Women's health clinical research unit at a university hospital. PATIENT(S): Age- and BMI-matched groups of athletes active in endurance sports with and without menstrual disturbances and regularly cycling sedentary controls. INTERVENTION(S): Groups were compared with respect to endocrine status, body composition, and physical performance. MAIN OUTCOME MEASURE(S): Identification of a subgroup of oligomenorrheic or amenorrheic athletes with increased androgen levels and anabolic body composition. RESULT(S): A subgroup of 8 of 25 athletes with menstrual disturbances had significantly higher serum levels of free and total testosterone, androstenedione, LH-FSH ratio, and lower SHBG levels than did all other groups. Other oligomenorrheic or amenorrheic athletes had normal values comparable to those in regularly menstruating athletes and controls. The hyperandrogenic subgroup showed a more anabolic body composition, with higher total bone mineral density and upper-lower fat mass ratio than did oligomenorrheic or amenorrheic athletes with normal androgen levels. The hyperandrogenic subgroup had the highest VO2 max and the highest performance values in general. CONCLUSION(S): Menstrual disturbances in female athletes are often explained as a consequence of hypothalamic inhibition and caloric deficiency. We suggest that essential hyperandrogenism is an alternative mechanism underlying oligomenorrhea or amenorrhea in some female athletes and may imply an advantage for physical performance.

Adult↗

Muscle strength and endurance do not significantly vary across 3 phases of the menstrual cycle in moderately active premenopausal women.

OBJECTIVE: To investigate muscle strength and muscle endurance in women during 3 well-determined phases of the menstrual cycle: early follicular phase, ovulation phase, and midluteal phase. DESIGN: Prospective, within-woman analysis was performed of muscle strength and muscle endurance by repeated measures analysis of variance in 3 hormonally verified phases of 2 consecutive menstrual cycles. PARTICIPANTS: Fifteen female subjects with moderate physical activity level and regular menstrual cycles volunteered to participate in the study. Analyses are based on 10 subjects who completed 2 consecutive menstrual cycles with hormonally verified phases. MAIN OUTCOME MEASUREMENTS: Handgrip strength, 1-leg hop test, isokinetic muscle strength, and muscle endurance were measured in 2 consecutive menstrual cycles in the early follicular phase, in the ovulation phase, and in the midluteal phase. Isokinetic muscle strength and endurance were tested with knee extension exercise on a standard instrument. Menstrual cycle phases were determined by analysis of sex hormone levels in serum, and ovulation was detected by luteinizing hormone surge in urine. RESULTS: No significant variation in muscle strength or muscle endurance could be detected during different well-determined phases of the menstrual cycle. CONCLUSIONS: This study detected no significant variation in muscle strength and muscle endurance during the menstrual cycle. In contrast to other studies showing variations in strength and endurance during the menstrual cycle, the present study was hormonally validated and was repeated in 2 consecutive menstrual cycles. However, it is unknown whether these data in moderately active university students would be relevant to the highly trained woman athlete.

Adult↗

An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women.

OBJECTIVE: The aim of this study was to determine the effects of the isopropanolic extract of black cohosh (Remifemin) on mammographic breast density and breast epithelial proliferation in healthy, naturally postmenopausal women with climacteric symptoms. DESIGN: This was a prospective, open, uncontrolled drug safety study in which baseline status was compared with status after 6 months of treatment by blinded observers. A total of 74 women were treated with 40 mg black cohosh daily, and 65 women completed the study. Mammograms were performed, and breast cells were collected by percutaneous fine needle aspiration biopsies at baseline and after 6 months. Mammographic density was quantified according to the Wolfe classification or a percentage scale. Breast cell proliferation was assessed using the Ki-67/MIB-1 monoclonal antibody. Safety was monitored by adverse event reporting, laboratory assessments, and measurement of the endometrium by vaginal ultrasound. RESULTS: None of the women showed any increase in mammographic breast density. Furthermore, there was no increase in breast cell proliferation. The mean change +/- SD in proportion of Ki-67-positive cells was -0.5% +/- 2.4% (median, 0.0; 95% CI = -1.32 to 0.34) for paired samples. The mean change in endometrial thickness +/- SD was 0.0 +/- 0.9 mm (median, 0.0). A modest number of adverse events were possibly related to treatment, but none of these were serious. Laboratory findings and vital signs were normal. CONCLUSIONS: The findings suggest that the isopropanolic extract of black cohosh does not cause adverse effects on breast tissue. Furthermore, our data do not indicate to any endometrial or general safety concerns during 6 months of treatment.

2-Propanol↗