Pulsed estrogen therapy improves postmenopausal quality of life: a 2-year placebo-controlled study.
Journal - Maturitas (Ireland )
OBJECTIVE: To investigate the effect of pulsed estrogen therapy S21400 (intranasal 17 beta-estradiol) on different quality of life (QoL) dimensions in early postmenopausal women treated with S21400 150 microg per day, S21400 300 microg per day, or placebo in a double blind, randomized, controlled 2-year study. STUDY DESIGN: QoL was assessed based on the validated Women's Health Questionnaire designed for peri- and post-menopausal women. Three hundred and thirty-five healthy, early postmenopausal Danish women, 53 years of age in average, who completed one questionnaire at baseline and one under study treatment were included in the analysis set. All analyses were performed on an intention-to-treat basis. RESULTS: QoL improved significantly in both S21400 groups compared to placebo in the dimensions 'memory/concentration', 'vasomotor symptoms', 'sleep problems' and 'sexual behavior' (difference in mean change scores being respectively +7.9, +28.3, +9.9 and +10.8%, p < 0.001, between the S21400 300 microg and placebo group). There were no significant differences between actively treated groups and placebo in the dimensions 'anxiety/depressed mood' and 'well-being'. CONCLUSION: Pulsed estradiol therapy had a pronounced effect not only on vasomotor symptoms but also a significant and clinically relevant improvement in several other QoL dimensions.
|ISSN : ||0378-5122|
|Mesh Heading : ||Administration, Intranasal Adult Aged Double-Blind Method Estradiol Estrogen Replacement Therapy Female Humans Middle Aged Postmenopause Pulsatile Flow Questionnaires administration & dosage drug effects|
|Mesh Heading Relevant : ||Quality of Life therapeutic use methods psychology|
Pulsed estrogen therapy in prevention of postmenopausal osteoporosis. A 2-year randomized, double blind, placebo-controlled study.
Journal - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (England )
The aim of this study was to evaluate the efficacy of pulsed estrogen therapy (intranasal 17beta-estradiol) in the prevention of postmenopausal bone loss. A total of 386 women (40-65 years old), less than 5 years past menopause, were randomized to intranasal placebo, 17beta-estradiol 150 micro g, or 300 micro g daily for 2 years. Women with an intact uterus received micronised progesterone 200 mg per day, 14 days of each 28-day cycle. Women randomised to placebo-treatment received placebo progesterone. The primary endpoints were changes in BMD at the spine (L2-L4) and femoral neck. Secondary endpoints were changes in bone turnover markers: serum osteocalcin (sOC) as a marker of bone formation and urinary C-terminal telopeptides (uCTX) as a marker of bone resorption. BMD increased at all measured sites in women receiving active treatment in a dose-related manner, the difference compared to placebo being 5.2% and 6.7% at the spine, and 3.2% and 4.7 % at the hip, respectively, with 150 microg and 300 microg ( P<0.001). On the other hand, a decrease versus baseline of -3.2% and -3.3% at the spine and hip, respectively, was observed in women receiving placebo ( P<0.001). In the patients with at least one risk factor for osteoporotic fracture, the difference between placebo and 150 microg or 300 micro g was even higher at the spine (5.4% and 7.4%, respectively), and at the femoral neck (4.0% and 5.2%, respectively). Correspondingly, uCTX decreased from baseline by 39% and 46 %, and sOC by 22% and 27%, in the 150 micro g group and 300 micro g group (all P<0.001 versus placebo). A strong correlation was found between variations of bone turnover markers after 1 year and BMD after 2 years, emphasizing that bone markers can predict BMD response during hormonal treatment. Acceptability and general tolerance were good. This study demonstrates that pulsed estrogen therapy at the dose of 150 microg and 300-microg per day prevents bone loss in a dose-dependant manner at each site studied, and normalizes bone turnover markers to premenopausal levels.
|ISSN : ||0937-941X|
|Mesh Heading : ||Administration, Intranasal Aged Biological Markers Bone Density Bone Remodeling Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Estradiol Estrogen Replacement Therapy Female Femur Neck Humans Lumbar Vertebrae Middle Aged Osteoporosis, Postmenopausal analysis drug effects drug effects administration & dosage physiopathology physiopathology physiopathology|
|Mesh Heading Relevant : ||methods prevention & control|