"Hormone replacement therapy (HRT) with oral continuous combined 1 mg 17␤-oestradiol and 5 mg dydrogesterone has proved to be effective in relieving climacteric symptoms and increasing bone mineral density in postmenopausal women , whilst demonstrating good endometrial safety and bleeding patterns  . Nevertheless, current guidelines recommend the use of the lowest effective dose of oestrogen for the management of climacteric symptoms   . For this reason, an ultra low dose continuous combined regimen of 0.5 mg 17␤-oestradiol and 2.5 mg dydrogesterone has been developed. "
[Show abstract][Hide abstract] ABSTRACT: Objectives and study designThe aim of this open, multicentre study was to demonstrate the endometrial safety and assess the bleeding pattern of ultra low dose continuous combined hormone replacement therapy with 0.5 mg 17β-oestradiol and 2.5 mg dydrogesterone in 446 healthy, non-hysterectomised, postmenopausal women with symptoms of oestrogen deficiency.Main outcome measureAspiration endometrial biopsies were performed at baseline and after 1 year of treatment to assess the incidence of endometrial hyperplasia or a more serious endometrial outcome.ResultsThe only adverse endometrial outcome at the end of the study was one case of simple hyperplasia. This gives an overall incidence of 0.27% (95% CI: 0.01–1.48%) in the per protocol sample (n = 395). The overall rate of amenorrhoea in the full sample (n = 446) was 68% and 14% had only one or two bleeding/spotting episodes. The rate of amenorrhoea in months 10–12 (n = 413) was 88%. The number of bleeding/spotting days per cycle fell during the study. The mean number of bleeding/spotting days was 5.8 and the mean number of days without bleeding was 358.2. Spotting alone was the most prevalent bleeding intensity, whilst heavy bleeding was rare.ConclusionsIn conclusion, 2.5 mg dydrogesterone continuously combined with 0.5 mg 17β-oestradiol effectively protects the endometrium in postmenopausal women in accordance with the guidelines of the Committee for Medicinal Products for Human Use (CHMP). It has a favourable amenorrhoea rate and is well tolerated by the majority of women.
[Show abstract][Hide abstract] ABSTRACT: In a previous study, the special extract ERr 731 of Rheum rhaponticum significantly reduced vasomotor and other menopausal symptoms associated with perimenopause. This trial was conducted to confirm the efficacy of ERr 731.
A multicenter, randomized, placebo-controlled, clinical trial with 112 perimenopausal women with menopausal symptoms receiving either 1 enteric-coated tablet of ERr 731 (n = 56) or placebo (n = 56) daily for 12 weeks. Primary outcome criterion for efficacy of ERr 731 compared to placebo was the change of the Menopause Rating Scale (MRS) total score from day 0 to day 84. Other efficacy assessments analyzed included the number and severity of hot flushes, individual symptoms of the MRS, treatment outcome, and various safety parameters.
By 12 weeks, ERr 731 caused a highly significant reduction of the MRS total score from 27.0 +/- 4.7 points to 12.4 +/- 5.3 points when compared to the placebo-induced decrease from 27.0 +/- 5.3 points to 24.0 +/- 6.2 points (P < .0001). A significant reduction in each individual MRS item score, in hot flushes and the hot flush weekly weighted score, together with a marked improvement in treatment outcome were also observed (P < .0001). These results confirm the efficacy of ERr 731 in alleviating menopausal symptoms in perimenopausal women. Fourteen adverse events were reported in total: 11 by 5 women receiving ERr 731 and 3 by 3 women receiving placebo. ERr 731 was well tolerated by the majority of the women.
ERr 731 was confirmed to be effective for the treatment of menopausal symptoms in perimenopause.
Alternative therapies in health and medicine 15(1):24-34. · 1.24 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: is the founder and President of Gary Owens Associates. Owens has more than 20 years of experience in medical and pharmacy management. He man-aged multiple operations in a large regional health plan and was directly responsible for the implementation of multiple strategic initiatives, which included the 2006 launch of FutureScripts, a wholly-owned PBM of Independence Blue Cross. He managed phar-macy operations for more than 2.0 million members and was a leader in the evaluation and management of biotech drugs at the health plan. While at Independence Blue Cross from 1986 to 2006, Owens was vice president for Medical Management and Policy from 2003 to 2006. From 1996 to 2003, Owens was vice president for Patient Care Management and was responsible for medical management services for 3.2 million members. During his tenure at Independence Blue Cross, Owens had management responsi-bility for the Care Management and Coordination Department, the Pharmacy Services Department, and the Claims Payment Policy Department. He managed medical review services, including pre-certification of medical services, hospital care level reviews, high-tech radiology services pre-certification, discharge planning activities, and case management. Owens was responsible for the evaluation of new drugs and technologies as manager of the technology evaluation unit. In that capacity, he worked to develop the injectable medications management program, which included a program to assess and manage biotech and bio-oncology products. Owens is a graduate of the University of Pennsylvania and received his MD from Thomas Jefferson University. He is a senior scholar for the Department of Health Policy at Thomas Jefferson University. He is involved in medical teaching and previously served as vice chairman of the Department of Family Medicine at the Medical Center of Delaware. He has lectured and published extensively on managed care, pharmacy, and biotechnology-related subjects, including recent articles in the American Journal of Managed Care and Disease Management. Andrea Lukes, MD, MSHc, is the founder of the Carolina Women's Research and Wellness Center, a private research company that offers many clinical research oppor-tunities focused on women's health and wellness and conducts multiple ongoing FDA clinical trials. Lukes is also the founder and chairman of the ObGyn Alliance, which is an online peer-to-peer group of obstetricians and gynecologists dedicated to primary care, clinical research, best practices, and new tests and devices. She was previously a faculty member of Duke University, where she co-founded the Women's Hemostasis and Thrombosis Clinic and served as the Director of Gynecology for that clinic. Lukes' area of research interest is abnormal uterine bleeding and general women's wellness. Past research has included support from the CDC, NIH, and many industry-sponsored trials. Her area of clinical research is within abnormal uterine bleeding, hemostasis and thrombosis, contraception, alternatives to hysterectomy, hysteroscopy, and menopause. Philadelphia (USP). She served as director of the Doctor of Pharmacy Program from 2004 to 2007. During her time at USP, she developed practice and research interests in women's health and maintained an active practice site with the Department of Family and Community Medicine at Thomas Jefferson University Hospital where she also held an appointment as adjunct clinical assistant professor of Family Medicine in the Jefferson Medical College. She served as the chair of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy (ACCP), as well as leadership positions within the Mid-Atlantic Chapter of ACCP. She has given numerous local and national talks on women's health issues and has numerous publications focusing on these topics. During her tenure at USP, she was nominated for the Lindback Award for distinguished teaching and was awarded the Faculty Special Recognition Award in 2000. She was named the recipient of the Barbara H. Korberly endowed professorship in women's leadership and health in 2005. Umland has been a member of the American Association of Colleges of Pharmacy since 1996 and has assumed active participation in this organization during the past several years, serving, most recently, on the Institutional Research Advisory Committee and chairing a sub-task force to evaluate a standardized preceptor survey. Umland earned her BS and PharmD degrees from the Philadelphia College of Pharmacy and Science in 1993 and 1995, respectively. She completed a Primary Care Residency at the Veteran's Administration Medical Center in Iowa City, Iowa, in 1996.
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