The effect of a new geometric bicycle saddle on the genital-perineal vascular perfusion of female cyclists

Purpose. — Female cyclists undergo a perineal compression of the pudendal nerve and genitalperineal area, with underexplored effects on genital injuries and sexual dysfunctions. This study tests the effects of a new geometric bicycle saddle (SMP) on perineal compression, blood perfusion, genital sensation and sexual function. Methods. — Thirty-three professional female athletes were monitored when using both the new saddle and a traditional professional saddle, in a randomized order. Short-term effects are estimated by measuring the partial pressure of vagina transcutaneous oxygen (PtcO2) before using the saddle, after 10 minutes of static sitting, after riding 20 minutes. Long-term effects are estimated by measuring athletes Female Sexual Distress Scale (FSDS) before using the new saddle and after 6 months using it. Results. — From an initial average of 70 mmHg, PtcO2 decreases by 30 mmHg after riding on a traditional saddle, 10 mmHg on the new saddle (respectively 20 and 7 after just sitting). When using the traditional saddle all FSDS scores are well over the 12 ‘‘normality’’ threshold, with an average of 41, while after using the new saddle the average falls to 12. All differences between the saddles are strongly significant: paired t-tests > 6; P < 0.001; 95% confidence intervals respectively 13 ± 3 mmHg after sitting, 20 ± 3 mmHg after riding, 29 ± 2 FSDS scores. Conclusion. — Traditional saddles have strong negative effects on the vascular perfusion of the vulva, with possible consequences on female sexual functions. The SMP saddle reduces the compression on the pelvic floor and can help reducing the incidence of urogenital pathologies for female cyclists

Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations

The FORWARD study is a randomised, double-blind trial that compares the efficacy and safety of 48 weeks treatment with extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI, 2 inhalations BID, vs. FOR 12 μg pMDI, 1 inhalation BID, in severe COPD patients with a history of exacerbations. Co-primary endpoints were exacerbation rate over 48 weeks and pre-dose morning FEV1 at 12 weeks. The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV1 42% predicted). Salbutamol as rescue therapy, theophylline and tiotropium (if stable regimen prior to screening) were allowed. Compared to FOR, BDP/FOR: (1) reduced the exacerbation rate (rate ratio: 0.72 [95% confidence interval 0.62–0.84], p < 0.001); (2) improved pre-dose morning FEV1 (mean difference: 0.069 L [0.043–0.095] p < 0.001); (3) prolonged the time to first exacerbation; (4) improved the SGRQ total score. The percentage of patients with adverse events was similar (52.1% with BDP/FOR and 49.2% with FOR). Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs. Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma

n/

Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.

Asthma guidelines suggest that therapy can be reduced once asthma is controlled. Despite these recommendations, asthmatic patients are seldom stepped down in clinical practice, and questions remain about when and how to reduce asthma therapy. The purpose of the present study was to evaluate lung function and asthma control in patients who were stepped down from the highest recommended dose of inhaled corticosteroid/long acting \u3b22 agonist combination therapy. METHODS: This was a prospective, randomised, controlled, two-arm parallel group study. Asthmatic patients who were fully controlled with a high daily dose (1000/100\u2009\u3bcg) of fluticasone/salmeterol were randomly assigned to 6\u2009months of open-label treatment with either 500/100\u2009\u3bcg fluticasone/salmeterol Diskus daily or 400/24\u2009\u3bcg extrafine beclomethasone/formoterol pMDI daily. The primary outcome was the change in morning peak expiratory flow (PEF) values between baseline and the end of treatment. The secondary outcomes included asthma control and exacerbation frequency. RESULTS: Four hundred twenty-two patients were included in the analysis. The PEF values remained above 95% of the predicted values throughout the study. The end-study morning PEF rates showed equivalence between the groups (difference between means, 2.49\u2009L/min; 95% CI, -13.43 to 18.42). No changes from baseline were detected in PEF and forced expiratory volume in 1 second measured at the clinics, in the symptom scores or in the use of rescue medication. Asthma control was maintained in 95.2% of the patients at 6\u2009months. No significant differences between the groups were detected in any other parameter, including exacerbation frequency and adverse events. CONCLUSIONS: Stepping down patients whose asthma is controlled with the highest recommended dose of fluticasone/salmeterol to either 500/100\u2009\u3bcg fluticasone/salmeterol daily or 400/24\u2009\u3bcg extra-fine beclomethasone/formoterol daily provides comparable maintenance of lung function and asthma control. TRIAL REGISTRATION: clinicaltrials.gov NCT00497237

the use of administrative data to evaluate the impact of active labor market policies the case of the italian liste di mobilita

Administrative data are a valuable source of information in several ways for the design of an impact evaluation. Conditional on providing the information required for the evaluation, they feature major advantages: they cover the whole (sub)population of reference for their administrative purposes, and not just a sample of individuals; very often they extend over long time periods; they are not susceptible to the typical measurement errors of survey data; and, finally, they are free of charge. The case of the Italian Liste di Mobilita, an Active Labor Market Policy (ALPM) to handle collective redundancies, illustrates how much empirical labor economics can benefit from having access to this kind of data. The accessibility of administrative archives for scientific purposes is a critical issue, as the history of this scheme demonstrates

Early administration of oral oseltamivir increases the benefits of influenza treatment

Our objective was to evaluate the benefit of early treatment of influenza illness using oral oseltamivir. This open-label, multicentre international study investigated the relationship between the interval from illness onset to first dose (time-to-treatment) and illness duration in the intent-to-treat infected population using accelerated failure time (AFT) modelling. A total of 1426 patients (12-70 years) presenting within 48 h of the onset of influenza symptoms were treated with oseltamivir 75 mg twice a day for 5 days during the 1999-2000 influenza season; 958 (67%) had laboratory-confirmed influenza virus infection. Earlier intervention was associated with shorter illness duration (P < 0.0001). Initiation of therapy within the first 12 h after fever onset reduced the total median illness duration by 74.6 h (3.1 days; 41%) more than intervention at 48 h. Intermediate interventions reduced the illness proportionately compared with 48 h. In addition, the earlier administration of oseltamivir further reduced the duration of fever, severity of symptoms and the times to return to baseline activity and health scores. Oseltamivir was well tolerated. The most common adverse events were nausea and vomiting, which were transient and generally occurred only with first dosing. When oseltamivir was taken with food, the tolerability was enhanced. The overall discontinuation rate was low (1.8%). In conclusion, the IMPACT study demonstrated that earlier initiation of oral oseltamivir therapy increased its therapeutic effects, which were seen at every time point of intervention and were progressive. Thus, early presentation, diagnosis and treatment of patients with influenza maximized the benefits of oseltamivir therap

Comparison of anti-inflammatory and clinical effects of beclomethasone dipropionate and salmeterol in moderate asthma

n/

Distinct profile of inflammatory and remodelling biomarkers in sputum of severe asthmatic patients with or without persistent airway obstruction

Background: Both inflammatory and remodelling processes are associated with irreversible airway obstruction observed in severe asthma. Our aim was to characterize a group of severe asthmatic patients with or without persistent airway obstruction in relation to specific sputum inflammatory and remodelling biomarkers. Methods: Forty-five patients under regular high-dose inhaled corticosteroid/ß-2agonist treatment were studied, after a follow-up period of at least 2 years, with a minimum of 4 visits. Periostin, TGF-ß, RANTES, IL-8, GM-CSF, FGF-2, and cell counts were measured in induced sputum. Serum periostin was also measured. Results: Sputum induction was successfully performed in all but 5 patients. There were no significant differences in demographic and clinical data between patients with non-persistent obstruction (NO: FEV1/VC&gt;88%pred.) and those with persistent obstruction (O: a not completely reversible obstruction with FEV1/VC&lt;88%pred. at each visit before the study visit). Patients with persistent obstruction had significantly higher sputum periostin and TGF-ß concentrations than NO patients and a trend of higher serum periostin levels. GM-CSF and FGF-2 were significantly increased in NO compared to O patients. No differences between groups were found for RANTES, IL-8 and differential cell counts. Sputum periostin inversely correlated with functional parameters (prebronch. FEV1: rho = −0.36, p &lt; 0.05; postbronch. FEV1: rho = −0.33, p = 0.05). Patients with high sputum periostin concentration (&gt;103.3 pg/ml: median value) showed an absolute number of sputum eosinophils significantly higher than patients with low sputum periostin; this behavior was unobserved when serum periostin was considered. Conclusions: Only periostin and TGF-ß identified a subgroup of severe asthmatic patients with persistent airway obstruction. Sputum periostin was also inversely associated with FEV1 and proved to be a more sensitive biomarker than serum periostin to identify severe asthmatics with higher sputum eosinophilia

Comparison between Airway Responses to High versus Low Molecular Weight Compounds in Occupational Asthma

Occupational asthma (OA) is a heterogeneous disease, and the characteristics of the sensitizer responsible for OA may induce different clinical, functional, and biological manifestations. We examined the characteristics of 74 patients with OA induced by low molecular weight compounds (LMWC) or by high molecular weight compounds (HMWC) and diagnosed by specific inhalation challenge (SIC). Patients with OA induced by LMWC had a longer occupational exposure before the beginning of symptoms, a lower sputum eosinophilia, and a higher prevalence of late airway response (LAR), in comparison with patients with OA induced by HMWC. Pulmonary function tended to be poorer and atopy tended to be less frequent in LMWC-induced OA than in HMWC-induced OA. These data confirm and extend previous observations showing that the characteristics of the specific sensitizer inducing OA may determine different clinical, functional, and biological features, probably related to the difference pathogenetic mechanisms underlying these different types of OA