Efficacia clinica e sicurezza terapeutica dell’estratto di corteccia di Mimosa tenuiflora nelle ragadi mammarie

Le ragadi mammarie sono una patologia flogistica della mammella che durante il puerperio può condizionare il corretto allattamento. Non è disponibile a tutt’oggi un trattamento farmacologico specifico. È stato realizzato un preparato topico a base di estratto di corteccia di Mimosa tenuiflora, che possiede un’attività cicatrizzante e rigenerante cutanea, e di Calendula officinalis per la sua azione sinergica. È stato condotto uno studio clinico sull’efficacia e la sicurezza terapeutica di questa formulazione in crema nelle ragadi mammarie. In 65 donne in allattamento con età media di 30.6 anni che presentavano ragadi mammarie, la crema è stata applicata dopo ogni poppata, in media 6.3 volte al giorno, per 4 settimane. Le ragadi sanguinanti si sono risolte nel 95.4% dei casi entro 48-72 ore. Fissurazioni ed eritema si sono ridotti fino alla scomparsa totale e l’elasticità del capezzolo è migliorata nell’81,5% dei casi. Non è mai stato necessario interrompere l’allattamento, tranne 3 casi in cui non si sono ottenuti benefici. Il giudizio finale del medico e della mamma sull’efficacia è stato ottimo in più del 95% dei casi, e il giudizio sull’accettabilità è stato ottimo in tutti i lattanti. Nessuna reazione avversa è stata né lamentata né osservata nella mamma o nel bambino

Soy isoflavones, lactobacilli, vitamin D3 and calcium. Observational study in menopause

An observational study in clinical practice was carried out to draw an updated profile on the actual trend in menopause management and to detect the clinical activity of a new phytoestrogen. Each gynaecologist observed up to 10 consecutive menopause women, and collected the data concerning history, life style, past and actual treatments, HRT refusal/withdrawal, current therapy, symptoms, visits/exams in the previous 3 months, through the website www.estronet.net, by a confidential and protected individual access. The 181 gynaecologists collected a sample of 1398 menopause women of which 607 not treated, 327 on estrogens, and 464 on phytoestrogens. The most used phytoestrogen in the study (87.1%) contains genistin and daidzin (30+30 mg) + lactobacilli, Ca and vit. D3 (Estromineral, EM) and was administered to 392 women (aged 54.1 years, BMI 24.8) for 112.9 days (mean) up to 1 year. Menopause symptoms improved on EM independently from their baseline severity and the improvement increased with treatment duration: flushing improved up to 96.2% at 1 year; nocturnal sweating 100%, palpitations 63.6%, and vaginal dryness 56%. Tumour fear, absence of symptoms and fear of weight gain were the most frequent reasons for refusal/withdrawal of HRT. Women treated (HRT or phytoestrogens) were more controlled both before and during the treatment. In presence of concomitant clinical conditions, EM was preferred. Phytoestrogens plus lactobacilli and mineral supplement showed a satisfactory clinical activity and safety

A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol

Osteoporosis (OP) is a systemic disease of the skeleton characterized by increased risk of fracture. There is a general consensus on the efficacy of physical activity in the prevention of bone loss, falls and fractures, but there is no agreement on the best setting to exercise. The aim of the study is to evaluate the efficacy of a 12-months exercise protocol for women with post-menopausal OP when administered as individual home training (IHT) versus gym group training (GGT). The study is a randomized trial with two parallel groups. Sedentary patients with primary post-menopausal osteoporosis are recruited at the Istituto Ortopedico Rizzoli of Bologna. In the first group, the 12-month ACTLIFE program is performed as IHT, while in the second as GGT. The program is aimed at improving joint mobility, muscle force, balance, motor coordination and endurance. The study is single blinded. Patients are assessed at baseline and after 6 and 12 months. The primary outcome is the modification of quality of life measured with the Short Osteoporosis Quality of Life Questionnaire (ECOS-16). The findings of this study will highlight advantages and disadvantages of exercising in the two different settings and provide evidence on how to increase physical activity in osteoporotic women

Assessment of linear and nonlinear/complex heartbeat dynamics in subclinical depression (dysphoria)

Objective: Depression is one of the leading causes of disability worldwide. Most previous studies have focused on major depression, and studies on subclinical depression, such as those on so-called dysphoria, have been overlooked. Indeed, dysphoria is associated with a high prevalence of somatic disorders, and a reduction of quality of life and life expectancy. In current clinical practice, dysphoria is assessed using psychometric questionnaires and structured interviews only, without taking into account objective pathophysiological indices. To address this problem, in this study we investigated heartbeat linear and nonlinear dynamics to derive objective autonomic nervous system biomarkers of dysphoria. Approach: Sixty undergraduate students participated in the study: according to clinical evaluation, 24 of them were dysphoric. Extensive group-wise statistics was performed to characterize the pathological and control groups. Moreover, a recursive feature elimination algorithm based on a K-NN classifier was carried out for the automatic recognition of dysphoria at a single-subject level. Main results: The results showed that the most significant group-wise differences referred to increased heartbeat complexity (particularly for fractal dimension, sample entropy and recurrence plot analysis) with regards to the healthy controls, confirming dysfunctional nonlinear sympatho-vagal dynamics in mood disorders. Furthermore, a balanced accuracy of 79.17% was achieved in automatically distinguishing dysphoric patients from controls, with the most informative power attributed to nonlinear, spectral and polyspectral quantifiers of cardiovascular variability. Significance: This study experimentally supports the assessment of dysphoria as a defined clinical condition with specific characteristics which are different both from healthy, fully euthymic controls and from full-blown major depression

The moderating role of depressive symptoms in the association between heart rate variability and cognitive performance in cardiac patients

Introduction: Coronary heart disease (CHD) is strongly associated with cognitive impairment, which is a core feature of depression, highly prevalent in patients with CHD. Interestingly, patients with CHD and individuals with depression display reduced heart rate variability (HRV), which proxies a complex network integrating autonomic and attentional systems. This study investigated the moderating role of depressive symptoms in the relation between reduced HRV and cognitive performance in patients with CHD. Method: The sample included 274 patients with CHD (mean [standard deviation] age = 62 [9.5] years; 13 % women) admitted to cardiac rehabilitation units. Visual attention and task switching were assessed through the Trail Making Test (TMT). Depressive symptoms were assessed with the Beck Depression Inventory-II (BDI-II). Resting electrocardiographic recordings were collected to compute HRV indices. Results: Patients with more severe depressive symptoms displayed an inverse association between HRV and cognitive performance (TMT-A: b = -0.08, p = .022; TMTB: b = -0.07, p = .042), whereas patients with milder depressive symptoms showed no significant association (TMT-A: b = -0.00, p = .90; TMTB: b = -0.02, p = .44). Conclusions: Depressive symptoms may strengthen the relation between reduced HRV and poorer cognitive performance in cardiac patients. The presence of depressive symptoms may signal the dysfunction of a network subserving autonomic and cognitive function