Effect of raloxifene on quality of life: a prospective study using the Utian Quality of Life (UQOL) Scale

OBJECTIVE: The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women. DESIGN: This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint. RESULTS: A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score. CONCLUSION: Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.     

Implementation of an in vitro fertilization program

The establishment of an in vitro fertilization program is described. Organization of the physical laboratory, media formulation, and preliminary mouse embryo culture are discussed. Parameters of patient eligibility, ovarian stimulation, and laporoscopy are also defined. At the conclusion of Phase I, 17 patients were induced; 10 went to laparoscopy, and at least one four-cell embryo was returned to 7, resulting in one continuing pregnancy.     

Interruption of the aortic arch

Interruption of the aortic arch is an uncommon malformation in which there is no direct continuity between the aortic arch and the descending aorta, the latter arising through a patent ductus arteriosus. Three types are described, depending upon the site of interruption in relation to the arch vessels. A large ventricular septal defect is present in 94% of cases. It is to be distinguished from aortic arch atresia, which should be regarded as a severe form of preductal coarctation in which the luminal continuity of the arch and descending aorta is absent. Three cases are described: the first demonstrates the natural outcome of the uncorrected anomaly with progression to Eisenmenger's syndrome; the second illustrates the feasibility of surgical treatment in the neonate; the third is an example of total correction of aortic arch interruption with the common associated anomalies. Diagnosis in infancy is difficult in view of the paucity of definite clinical criteria. Surgery in the infant should consist of reconstruction of the aortic arch together with pulmonary artery banding. In older children total correction can usually be performed electively in a two-stage procedure.     

A methodology study to validate a structured diagnostic method used to diagnose female sexual dysfunction and its subtypes in postmenopausal women

The currently accepted gold standard for diagnosis of female sexual dysfunction (FSD) is a nonstandardized interview by a clinician whose field of expertise is FSD. However, the limited number of experts in the field has implications for running efficient large-scale clinical trials. Therefore, we developed a structured diagnostic method (SDM) to enable diagnosis of FSD in postmenopausal women by health care professionals who are not FSD experts. Our study objectives were to evaluate both convergent validity and intrarater reliability of the SDM. The results showed that the method had good convergent validity and excellent intrarater reliability. Thus, we conclude that the SDM can reliably diagnose FSD status and FSD subtypes in postmenopausal women.     

最新消息——有关绝经名词新与精确的国际标准定义

科学家、妇女、媒体以及所有的个体在研究或报告绝经有关的内容时,由于误用名词造成了概念混乱。当认识到需要一组国际公认与准确的有关绝经名词后,国际绝经学会(Interna-tionalMenopauseSociety,IMS)指令绝经学会下属委员会(CouncilAffiliatedMenopauseSo-cieties,CAMS)选择能代表国际委员会的成员,提供一组与绝经有关名词的标准定义,主要目的是保证在绝经范围内最大限度的统一与准确的字句,从而限制了在应用中仍可能出现的误解。委员会全面的设计了一组名词进行定义,尽可能保持已在医学范围内接受的定义,避免增加新的误解。尽管多数…     

Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder

CONTEXT: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD. DESIGN: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study). SETTING: The study was performed at private or institutional practices. PATIENTS: The subjects studied were women, aged 26-70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 microg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 mug/d testosterone group. INTERVENTION: Testosterone (300 microg/d) or placebo patches were applied twice weekly. MAIN OUTCOME MEASURE(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments. RESULTS: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups. CONCLUSION: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.     

Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial

OBJECTIVE: To investigate the efficacy of micro-dose transdermal estrogen in relieving menopausal vasomotor symptoms. METHODS: A randomized, double-blind, placebo-controlled, multi-center trial. Healthy postmenopausal women with at least seven moderate or severe hot flushes per day for at least 1 week, or at least 50 per week, applied transdermal patches with a nominal delivery of 0.023 mg/d 17beta-estradiol and 0.0075 mg/d levonorgestrel (low-dose E2/levonorgestrel; n=145), 0.014 mg/d E2 (micro-dose; n=147), or placebo (n=133) for 12 weeks. The coprimary efficacy variables were the mean changes from baseline in frequency and severity of moderate and severe hot flushes at the week 4 and 12 endpoints. RESULTS: At the week 12 endpoint, mean weekly frequencies of moderate and severe hot flushes were significantly reduced compared with placebo with low-dose E2/levonorgestrel (-51.80; P<.001) and micro-dose E2 (-38.46; P<.001). Severity scores were also significantly reduced with both treatments compared with placebo. At week 12 endpoint, 41.3% of women receiving micro-dose E2 were treatment responders (75% or more reduction from baseline in hot flush frequency; P=.003 compared with 24.2% placebo). In this group, the mean reduction in moderate and severe hot flushes from baseline was approximately 50% after 2, 70% after 4, 90% after 8, and 95% after 12 weeks. There were no differences between active treatments and placebo regarding adverse events. CONCLUSION: Micro-dose E2 (0.014 mg/d) was clinically and statistically significantly more effective than placebo in reducing the number of moderate and severe hot flushes, with a 41% responder rate, supporting the concept of the lowest effective dose. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00206622