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.
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.
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.
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.
Tumor size is crucial for clinical management and prognosis of breast malignancies.
The gold standard-size of 12 tumor phantoms was assessed at The Department of Production Engineering. Subsequently, ...with a conventional ruler, seven experienced mammographers measured the largest diameter of the 12 devices in two independent trials.
In the first trial, 30% (n=25) of the 84 values given by the seven mammographers failed to recreate the gold standard size by >1 mm and in the second, by 37% (31/84). Size was overestimated (>1 mm) in 9.5% (n=8) of 84 measurements in the first trial, and in 15.5% (14/84) in the second. Conversely, size was underestimated (>1 mm) in 20% (n=17) of 84 measurements in the first trial, and in 21% (18/84) in the second. Neither the age of the participants, nor their years of experience improved the obtained results.
The method used here raised doubts concerning the ability of discriminating size among subgroups of T1 breast tumors in mammograms. According to the TNM staging system, T1 tumors (≤2.0 cm in greatest dimension) are subdivided into T1mic: microinvasion (≤0.1 cm), T1a (>0.1 cm but not more than 0.5 cm), T1b (>0.5 cm but not more than 1.0 cm) and T1c (>1.0 cm but not more than 2.0 cm in their greatest dimension). Since the TNM staging system for breast tumors is important in therapeutic decision making, it is crucial to develop a more reliable method for tumor size assessment.
To study the effect on mammographic breast density of two different continuous combined regimens for hormone therapy.
Randomized clinical study.
University hospital.
Postmenopausal women without any ...previous history of breast disorder.
The women received either estradiol valerate/dienogest or estradiol/norethisterone acetate. Mammograms and venous blood samples were obtained at baseline and after 6 months.
Change in mammographic breast density. Correlations with levels of hormones, growth factors, and binding proteins.
An increase in mammographic density was recorded in approximately 50% of the women, and there were no differences between treatments. Increased density showed a positive correlation with estradiol, estrone, and sex hormone–binding globulin and showed a negative association to free T. Among hormonal factors, levels of free T were the most important for predicting increased density.
Continuous combined hormone therapy with different progestogens has a marked impact on the breast.
To perform a pilot study of the effects on the breast by low-dose intrauterine progestogen combined with estrogen.
A prospective pilot study.
University hospital.
Twenty postmenopausal women without ...any previous breast disorder.
Women were treated with a low-dose intrauterine system releasing 20 microg/24 hours of levonorgestrel in continuous combination with 2 mg of oral E2 valerate. The effects on mammographic breast density, breast cell proliferation, and hormonal levels were followed for 18 months.
Change in mammographic breast density and breast cell proliferation. Correlations with levels of hormones, growth factors, and binding proteins.
Three women showed an apparent increase in density. For the remaining 17 women the changes were only a few percent. Digitized assessment of density showed strong correlations with visual classification scales (rs = 0.96-0.97). There was no increase in proliferation as expressed by the percentage of MIB-1-positive breast cells in fine-needle aspiration biopsies. Increase in breast density displayed a positive correlation with patients age (rs = 0.52) and an inverse relationship with levels of E2 (rs = -0.50) and free T (rs = -0.50).
Low-dose intrauterine administration progestogen may develop into an attractive alternative for hormonal therapy in postmenopausal women as endometrial protection may be achieved at very low systemic levels.
Breast cancer outcomes in low‐ and middle‐income countries (LMCs) correlate with the degree to which 1) cancers are detected at early stages, 2) newly detected cancers can be diagnosed correctly, and ...3) appropriately selected multimodality treatment can be provided properly in a timely fashion. The Breast Health Global Initiative (BHGI) invited international experts to review and revise previously developed BHGI resource‐stratified guideline tables for early detection, diagnosis, treatment, and healthcare systems. Focus groups addressed specific issues in breast pathology, radiation therapy, and management of locally advanced disease. Process metrics were developed based on the priorities established in the guideline stratification. The groups indicated that cancer prevention through health behavior modification could influence breast cancer incidence in LMCs. Diagnosing breast cancer at earlier stages will reduce breast cancer mortality. Programs to promote breast self‐awareness and clinical breast examination and resource‐adapted mammographic screening are important early detection steps. Breast imaging, initially with ultrasound and, at higher resource levels with diagnostic mammography, improves preoperative diagnostic assessment and permits image‐guided needle sampling. Multimodality therapy includes surgery, radiation, and systemic therapies. Government intervention is needed to address drug‐delivery problems relating to high cost and poor access. Guideline dissemination and implementation research plays a crucial role in improving care. Adaptation of technology is needed in LMCs, especially for breast imaging, pathology, radiation therapy, and systemic treatment. Curricula for education and training in LMCs should be developed, applied, and studied in LMC‐based learning laboratories to aid information transfer of evidence‐based BHGI guidelines. Cancer 2008;113(8 suppl):2221–43. Published 2008 by the American Cancer Society.
Guideline dissemination and implementation research plays a crucial role in improving care, and adaptation of technology is needed in low‐ and middle‐income countries (LMCs), especially for breast imaging, pathology, radiation therapy, and systemic treatment. Curricula for education and training in LMCs should be developed, applied, and studied in LMC‐based learning laboratories to aid information transfer of evidence‐based Breast Health Global Initiative guidelines.
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