Consumption of a soy drink has no effect on cognitive function but may alleviate vasomotor symptoms in post-menopausal women; a randomised trial

Purpose: Cognitive decline is commonly reported during the menopausal transition, with memory and attention being particularly affected. The aim of this study was to investigate the effects of a commercially available soy drink on cognitive function and menopausal symptoms in post-menopausal women. Methods: 101 post-menopausal women, aged 44–63 years, were randomly assigned to consume a volume of soy drink providing a low (10 mg/day; control group), medium (35 mg/day), or high (60 mg/day) dose of isoflavones for 12 weeks. Cognitive function (spatial working memory, spatial span, pattern recognition memory, 5-choice reaction time, and match to sample visual search) was assessed using CANTAB pre- and post-the 12 week intervention. Menopausal symptoms were assessed using Greene’s Climacteric Scale. Results: No significant differences were observed between the groups for any of the cognitive function outcomes measured. Soy drink consumption had no effect on menopausal symptoms overall; however, when women were stratified according to the severity of vasomotor symptoms (VMS) at baseline, women with more severe symptoms at baseline in the medium group had a significant reduction (P = 0.001) in VMS post-intervention (mean change from baseline score: − 2.15 ± 1.73) in comparison to those with less severe VMS (mean change from baseline score: 0.06 ± 1.21). Conclusions: Soy drink consumption had no effect on cognitive function in post-menopausal women. Consumption of ~ 350 ml/day (35 mg IFs) for 12 weeks significantly reduced VMS in those with more severe symptoms at baseline. This finding is clinically relevant as soy drinks may provide an alternative, natural, treatment for alleviating VMS, highly prevalent among western women

<it>In silico </it>toxicology models and databases as FDA Critical Path Initiative toolkits

<p>Abstract</p> <p><it>In silico </it>toxicology methods are practical, evidence-based and high throughput, with varying accuracy. <it>In silico </it>approaches are of keen interest, not only to scientists in the private sector and to academic researchers worldwide, but also to the public. They are being increasingly evaluated and applied by regulators. Although there are foreseeable beneficial aspects -- including maximising use of prior test data and the potential for minimising animal use for future toxicity testing -- the primary use of <it>in silico </it>toxicology methods in the pharmaceutical sciences are as decision support information. It is possible for <it>in silico </it>toxicology methods to complement and strengthen the evidence for certain regulatory review processes, and to enhance risk management by supporting a more informed decision regarding priority setting for additional toxicological testing in research and product development. There are also several challenges with these continually evolving methods which clearly must be considered. This mini-review describes <it>in silico </it>methods that have been researched as Critical Path Initiative toolkits for predicting toxicities early in drug development based on prior knowledge derived from preclinical and clinical data at the US Food and Drug Administration, Center for Drug Evaluation and Research.</p

Non-hormonal management of the menopause

The menopause can be associated with a number of symptoms, including hot flushes and night sweats (vasomotor symptoms), vaginal symptoms, depression, anxiety, irritability and mood swings (psychological effects), joint pains, migraines or headaches, sleeping problems and urinary incontinence. Vasomotor symptoms are the most commonly reported, and these are treated effectively with HRT, but there are a group of women for whom HRT is not suitable, and for these reasons, there is an interest in non-hormonal alternatives. Clonidine, SSRIs and gabapentin, and a number of over-the-counter remedies, as well as alternative therapies, are all used as alternatives to HRT, but not all are effective. This chapter addresses some of the most commonly used non-hormonal treatments for symptoms of the menopause