Efficacy and acceptability of intranasal 17 beta-oestradiol for menopausal symptoms: randomised dose-response study. Aerodiol Study Group

Studd, John; Pornel, Bruno; Marton, I; Bringer, J.; Varin, Claire; Tsouderos, Y; Christiansen, C

doi:10.3109/13697139909038078

Cited by 7 publications

(7 citation statements)

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“…The efficacy of estradiol on menopausal hot flashes was also evaluated by MBMA (Supply materials) . The results showed that the typical value of E max‐estradiol was estimated at 44.9%, which is about 1.8 times that of E max‐soy , and the time to achieve 50% of E max‐estradiol was only 3.09 weeks, much shorter than that of soy isoflavones (Table ).…”

Section: Resultsmentioning

confidence: 83%

Quantitative efficacy of soy isoflavones on menopausal hot flashes

et al. 2015

Brit J Clinical Pharma

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AIMThis study aimed to quantitate the efficacy of soy isoflavones in the treatment of menopausal hot flashes. METHODSModel based meta-analysis (MBMA) was used to quantitate the efficacy of soy isoflavones. We conducted a systemic literature search to build a time-effect model for placebo and soy isoflavones in treating menopausal hot flashes. Studies were identified, subjected to inclusion and exclusion criteria, and reviewed. RESULTSFrom 55 articles, 16 studies of soy isoflavones met the inclusion criteria, and contained 65 and 66 mean effect values in placebo and soy isoflavone groups, respectively, from about 1710 subjects. Interestingly, the developed model was found to describe adequately the time course of hot flashes reduction after administration of placebo and soy isoflavones. Using this model, we found that the maximal percentage change of hot flashes reduction by soy isoflavones was 25.2% after elimination of the placebo effect, accounting for 57% of the maximum effects of estradiol (E max-estradiol = 44.9%). However, a time interval of 13.4 weeks was needed for soy isoflavones to achieve half of its maximal effects, much longer than estradiol, which only required 3.09 weeks. These results suggest that treatment intervals of 12 weeks are too short for soy isoflavones, which require at least 48 weeks to achieve 80% of their maximum effects. CONCLUSIONSSoy isoflavones show slight and slow effects in attenuating menopausal hot flashes compared with estradiol. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Menopause hot flashes can be effectively treated with hormone replacement therapy (HRT). However, possible adverse effects of long term HRT have promoted the use of complementary therapies by menopausal women.• There has been debate on the benefits of soy isoflavones in the treatment of menopausal hot flashes. WHAT THIS STUDY ADDS• The effects of soy isoflavones on menopausal hot flashes was quantitated adequately by the model based meta-analysis. • The developed model provided the robust evidence that soy isoflavones have slight and slow effects in attenuating menopausal hot flashes compared with estradiol.

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Section: Resultsmentioning

confidence: 83%

Quantitative efficacy of soy isoflavones on menopausal hot flashes

et al. 2015

Brit J Clinical Pharma

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“…Fortunately, in the studies of E 2 and progesterone replacement in preterm infants, Trotter and coworkers found that changes in vaginal cytology and mammary and uterine growth were no greater than those that would have occurred in utero, and they ceased when replacement was discontinued (53). Furthermore, if necessary, systemic actions of estrogen can potentially be obviated by the use of E 2 in aerosolized form (54). Thus, after decades of consideration of estrogen treatment to prevent diseases in the postmenopausal period, the hormone now has the potential to ameliorate a devastating condition at the extreme opposite end of the age spectrum.…”

Section: Discussionmentioning

confidence: 99%

Postnatal Estradiol Up-regulates Lung Nitric Oxide Synthases and Improves Lung Function in Bronchopulmonary Dysplasia

McCurnin

Pierce

Willis³

et al. 2009

Am J Respir Crit Care Med

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Rationale: Nitric oxide (NO) plays an important role in lung development and perinatal lung function, and pulmonary NO synthases (NOS) are decreased in bronchopulmonary dysplasia (BPD) following preterm birth. Fetal estradiol levels increase during late gestation and estradiol up-regulates NOS, suggesting that after preterm birth estradiol deprivation causes attenuated lung NOS resulting in impaired pulmonary function. Objective: To test the effects of postnatal estradiol administration in a primate model of BPD over 14 days after delivery at 125 days of gestation (term 5 185 d). Methods: Cardiopulmonary function was assessed by echocardiography and whole body plethysmography. Lung morphometric and histopathologic analyses were performed, and NOS enzymatic activity and abundance were measured. Measurements and Main Results: Estradiol caused an increase in blood pressure and ductus arteriosus closure. Expiratory resistance and lung compliance were also improved, and this occurred before spontaneous ductal closure. Furthermore, both oxygenation and ventilation indices were improved with estradiol, and the changes in lung function and ventilatory support requirements persisted throughout the study period. Whereas estradiol had negligible effect on indicators of lung inflammation and on lung structure assessed after the initial 14 days of ventilatory support, it caused an increase in lung neuronal and endothelial NOS enzymatic activity. Conclusions: In a primate model of BPD, postnatal estradiol treatment had favorable cardiovascular impact, enhanced pulmonary function, and lowered requirements for ventilatory support in association with an up-regulation of lung NOS. Estradiol may be an efficacious postnatal therapy to improve lung function and outcome in preterm infants.The signaling molecule nitric oxide (NO), generated by nitric oxide synthase (NOS), plays a key role in multiple processes in the mature lung (1, 2). In the developing lung, NO participates in pulmonary vascularization, alveolarization, and airway branching, and also counteracts apoptosis in multiple lung cell types (3-6). In the perinatal period, epithelium-derived NO is critically involved in the regulation of lung liquid production and of peripheral contractile elements (7, 8), and it also mediates pulmonary vasomotor tone (9). In studies of lungs from fetal baboons, we showed that all three NOS isoforms, neuronal NOS (nNOS), endothelial NOS (eNOS), and inducible NOS (iNOS), are principally expressed in proximal respiratory epithelium, and that there are maturational increases in their abundance and in NO production during the early third trimester (10). Thus, pulmonary NOS expression is up-regulated during fetal development in the primate, and this process may be critical to lung structural development and airway, parenchymal, and pulmonary vascular function in the early postnatal period.Bronchopulmonary dysplasia (BPD) is a devastating primary complication of premature birth that develops in the preterm human lung following ventilatory and oxyg...

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“…Of these, 330 were excluded; 59 included fewer than 20 women per study arm and 54 were not an RCT; 126 did not clearly state a sample size calculation; 52 did not measure vasomotor symptoms as the primary outcome; 39 were secondary analysis. Following these exclusions, 214 RCT were included…”

Section: Resultsmentioning

confidence: 99%

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Iliodromiti

Wang

Lumsden

et al. 2019

BJOG

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Background There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis. Objectives To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments. Search strategy We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018. Selection criteria Randomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm. Data collection and analysis Data about study characteristics, primary vasomotor‐related outcomes and methods of measuring them. Main results The search identified 5591 studies, 214 of which were included. Forty‐nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined. Conclusions There is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms. Tweetable summary Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.

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Efficacy and acceptability of intranasal 17 beta-oestradiol for menopausal symptoms: randomised dose-response study. Aerodiol Study Group

Cited by 7 publications

References 0 publications

Quantitative efficacy of soy isoflavones on menopausal hot flashes

Quantitative efficacy of soy isoflavones on menopausal hot flashes

Postnatal Estradiol Up-regulates Lung Nitric Oxide Synthases and Improves Lung Function in Bronchopulmonary Dysplasia

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

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