This regulatory post-marketing surveillance study aimed to evaluate the therapeutic efficacy and safety of drospirenone (DRSP) 2 mg/estradiol (E₂) 1 mg tablet in Korean postmenopausal women. A total of 4,149 patients were enrolled and the study was conducted at 207 clinical research centers. The patients' source data was collected between November 2006 and November 2012. More than 85% of patients experienced improvement of menopausal symptoms. The most frequently reported adverse events were vaginal bleeding and breast pain; most of the women suffering from these symptoms fully recovered. The incidence of adverse event was higher in patients of younger age (20 to 39 years), in patients with concomitant diseases, previous hormone replacement therapy in medical history, those treated with DRSP 2 mg/E₂ 1 mg for shorter duration (3 years or less) and in patients using concomitant medication. In conclusion, the results from this large post-marketing surveillance study confirm the efficacy and safety of DRSP 2 mg/E₂ 1 mg tablet in Korean postmenopausal women.
Female ; Hormone Replacement Therapy ; Humans ; Incidence ; Mastodynia ; Menopause ; Uterine Hemorrhage

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Embase, Cochrane library, JBI, CINAHL, PsycINFO, Clinical Trials Registry Platform portal, Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, Center Watch Registry from inception to May 15, 2022 to find randomized controlled trials, non-randomized controlled trials, case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage, with search terms of mastitis, acute mastitis, lactation mastitis, puerperal mastitis, breast problem, breast engorgement, milk stasis, blocked ducked, breast pain, breast massage, and acupoint massage. Outcomes and the measurement schemes (measurement methods, timing of assessing outcome, frequency of assessing outcome, measurers) were extracted from the included studies. We used the Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) to assess the quality of each study, then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials (OMERACT) Filter 2.1 framework.Results We identified 85 clinical trials, in which 54 different outcomes were reported. A total of 81.2% (69/85) of studies were assessed as medium quality with a mean score of 2.6, and 18.8% (16/85) as low quality with a mean score of 0.9. These outcomes were organized in three core areas. Lump size (89.4%, 76/85) was the most frequently reported outcome, followed by breast pain (69.4%, 59/85) and milk excretion (68.2%, 58/85). Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous. Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.
Child ; Female ; Humans ; Australia ; Massage ; Mastitis/therapy* ; Mastodynia ; Medicine, Chinese Traditional

PURPOSE: In this study the effects of breast massage on breast pain, breast-milk sodium, and newborn suckling in early postpartum mothers were investigated. METHODS: The design was a non-synchronized nonequivalent control group pretest-posttest design. Sixty postpartum mothers who were admitted to a postpartum care center and had problems with breastfeeding were recruited. Of these mothers, 44 were assigned to the intervention group and received two 30-minute breast massages within 10 days of postpartum period. The others were assigned control group and received only routine care. Breast pain was measured using a numeric pain scale and number of times newborns suckled was observed throughout breastfeeding. Breast milk was self-collected to evaluate breast-milk sodium. RESULTS: Mean age of postpartum mothers was 30 years old. Compared to the control group, women in the intervention group reported significant decreases in breast pain (p<.001), increases in number of times newborns suckled after the first and second massage (p<.001), and a decrease in breast-milk sodium after the first massage (p=.034). CONCLUSION: Breast massage may have effects on relieving breast pain, decreasing breast-milk sodium, and improving newborn suckling. Breast massage can be used to solve breast problems. Further research is needed to validate our findings.
Adult ; *Breast Feeding ; Female ; Humans ; Infant, Newborn ; Lactation ; Male ; *Massage ; Mastodynia/*therapy ; Milk, Human/*chemistry ; Postpartum Period ; Sodium/*analysis

OBJECTIVES: This study was performed to identify nurses' knowledge and attitudes on hormone replacement therapy (HRT) of menopausal women. METHODS: Data were collected from 221 nurses who were working at maternity hospitals in the whole country using questionnaires consisting of 9 questions related to menopause-related knowledge and HRT-related attitudes and knowledge. RESULTS: According to the nurses's responses, the diseases of concern in menopausal women were osteoporosis (78%), and depression (69%). Most nurses replied that the most effective treatment of menopausal symptoms is HRT, and nurses were very knowledgeable about its strengths (59%) and weaknesses (44%). Cancer was regarded as the major complication of HRT (71%), and its side effects were breast pain (77%) and vaginal bleeding (77%). Forty-six percent of nurses thought that the appropriate treatment duration of HRT is not necessary to limit the period. The most important considerations when conducting HRT were drug stability (59%) and improving the quality of life (36%). Ninety-fi ve percent of nurses responded that they personally would use HRT for menopausal treatment or would recommend their family. HRT for menopausal symptoms was being utilized before seeking medical treatment (40%) and after drug prescription (42%). CONCLUSION: Nurses have very positive attitudes about HRT but appeared to lack critical knowledge about HRT. Therefore, more educational programs for nurses about HRT should be required.
Depression ; Drug Prescriptions ; Drug Stability ; Female ; Hormone Replacement Therapy ; Hospitals, Maternity ; Humans ; Mastodynia ; Menopause ; Osteoporosis ; Quality of Life ; Uterine Hemorrhage ; Surveys and Questionnaires

BACKGROUND: Osteoporosis after menopause is known as a disease that needs preventive measures before medical treatment. Many patients, however, do not undergo hormone therapy to prevent it. This paper investigates some obstacles to hormone replacement therapy (HRT). METHOD: A total of 85 menopausal women who under went bone-mineralodensitometry (BMD) examination at Chuncheon Sungshim Hospital Health Care Clinic from May, 1995 to April, 1997 were the subjects of our study. We interviewed them by telephone, examined their medical records including their BMD results. We also examined what the obstacles were for them to receive HRT for osteoporosis. RESULTS: The average age of the subjects was 55.8years. Only 40 women (47%) replied that they knew beforehand the purpose of the BMD examination. The rest of the subjects replied that they simply went through the examination because it was inclusive to health items. Those who had heard of HRT for osteoporosis were only 43 people because(50.1%), and those who did not currently receive HRT amounted to 32 (74.4%). The reasons why they do not undergo the therapy were fear of cancer, no symptoms related to osteoporosis, financial difficulty, and weight gain. Among the 32 subjects, only 1 person replied that she would not receive the HRT even if the above obstacles were removed. Therefore, it seems that most of our subjects would receive HRT if such obstacles removed. Those who were currently receiving HRT were 11 people(12.9%). According to the open questionnaire, many of them replied that they do not feel any inconvenience while receiving the HRT, but some of them complained of epigastric pain, dysmenorrhea, or mastalgia. They replied that after the HRT they felt no arthralgia and felt far better in body and mind than before treatment. All the 11 people replied that they will continue to receive the HRT. CONCLUSION: The main reason why so few people received HRT for osteoporosis proved to be the lack of knowledge of the therapy. Even those who had heard of HRT complained about the negative aspects, which in fact can be overcome, and as a result a considerable number of them do not receive HRT. Therefore we conclude that in order to increase the number of patients who will undergo HRT for osteoporosis after menopause we need to strengthen education about the merits of this therapy rather than just performing BMD examination.
Arthralgia ; Delivery of Health Care ; Dysmenorrhea ; Education ; Female ; Gangwon-do ; Hormone Replacement Therapy* ; Humans ; Mastodynia ; Medical Records ; Menopause ; Osteoporosis ; Osteoporosis, Postmenopausal* ; Telephone ; Weight Gain ; Surveys and Questionnaires

BACKGROUND: Hormone replacement therapy in postmenopausal women is widely used for the relief of menopausal symptoms and the prevention of bone loss. But, it has been reported that many women discontinue hormone replacement therapy within early period, because the women suffer from breast pain, bleeding and weight gain. Also, further adverse influence of hormone replacement therapy on cardiovascular risk and breast cancer has been suggested. There are many controversies due to conflicting data of that. Recent studies suggest that low-dose estrogen provide bone benefits and micronized progesterone have favorable effects on lipid metabolism and breast density. This clinical trial evaluated the short-term effects of low-dose estrogen and micronized progesterone on bone turnover markers and serum lipid profiles in postmenopausal women. METHODS: This was a 12-week study in which 90 postmenopausal women received hormone replacement therapy. Participants were assigned in equal numbers to the following groups: (1) daily treatment with 0.625 mg conjugated equine estrogens (CEE) with medroxyprogesterone acetate MPA 2.5 mg to 5 mg, daily or cyclically; (2) daily treatment with 0.625 mg CEE with micronized progesterone (MP) 100 mg to 200 mg, daily or cyclically; (3) daily treatment with 0.3 mg CEE with MP 100 mg to 200 mg, daily or cyclically. Changes in bone turnover markers and serum lipid profiles were assessed. RESULTS: At 12-week, all treatment groups significantly improved bone turnover markers and serum lipid profiles, specifically serum alkaline phosphatase, serum osteocalcin, urine deoxypyridinoline and serum high density lipoprotein cholesterol level. CEE 0.625/MPA and CEE 0.625/MP significantly decreased serum low density lipoprotein cholesterol level. CEE 0.625/MPA significantly increased serum triglyceride level. CEE 0.625/MPA produced greater decreases in serum alkaline phosphatase level than CEE 0.625/MP and CEE 0.3/MP. CEE 0.625/MP produced greater increases in serum high density lipoprotein cholesterol level than CEE 0.625/MPA. CEE 0.625/MPA produced greater increase in serum triglyceride level than CEE 0.3/MP. CONCLUSION: Low-dose estrogen and MP generally improved bone turnover markers and serum lipid profiles. But, MP produced lesser favorable effects on a part of bone turnover markers. MP produced significantly greater increases in serum high density lipoprotein cholesterol than that of MPA. And Low-dose estrogen produced significantly lesser increases in triglyceride than that of conventional dose.
Alkaline Phosphatase ; Breast ; Breast Neoplasms ; Cholesterol, HDL ; Cholesterol, LDL ; Estrogens* ; Estrogens, Conjugated (USP) ; Female ; Hemorrhage ; Hormone Replacement Therapy ; Humans ; Lipid Metabolism ; Mastodynia ; Medroxyprogesterone Acetate ; Osteocalcin ; Progesterone* ; Triglycerides ; Weight Gain