Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.

Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of Bifidobacterium breve CECT7263 and a combination of this and Lactobacillus fermentum CECT5716 versus simethicone in reducing the daily time spent crying in colicky infants. A multicentre randomised, open-label, parallel, controlled trial of 28 days was performed in 150 infants who were diagnosed with colic according to the Rome III criteria and who randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×108 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×108 cfu/day per strain, Bb+Lf group). The main outcomes were minutes of crying per day and the percentage of reduction in daily crying from baseline. Data were analysed per intention to treat. All treatments significantly decreased the daily crying time at the end of the intervention (P-time <0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<0.05). The percentage of reduction in the minutes of crying from baseline in the Bb group was significantly higher than that in the Simethicone group every week of the intervention (-40.3 vs -27.6% at 1-week; -59.2 vs -43.2% at 2-weeks; -64.5 vs -53.5% at 3-week and -68.5 vs -59.5% at 4-weeks, P<0.05). Additionally, in the Bb group, infants had better night sleep, and parents reported a more positive mood at the end of the intervention. All the products used in the study were safe and well tolerated. In conclusion, the breastmilk-isolated probiotic strain B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.

Alcohol-induced risk behaviors among Brazilian nightclub patrons: a latent class analysis.

OBJECTIVE: The aim of this study is to identify risk behavior profiles associated with alcohol consumption among patrons during or just after departure from nightclubs in São Paulo, Brazil. STUDY DESIGN: Cross-sectional survey. METHODS: The study used a two-stage cluster sampling survey design. Data were collected on a probabilistic sample of nightclub patrons. Overall, 2422 patrons were interviewed at the entrance of 31 nightclubs. Latent class analysis (LCA) was used to identify risk behavior profiles with an emphasis on risky driving, fights, alcoholic blackouts, and harm and unsafe sex. RESULTS: A 3-class LCA model was selected, with classes consisting of low (43%), medium (33%), and high (24%) risk patrons. Compared to patrons in the low-risk class, patrons in the medium- and high-risk classes were more likely to be men (odds ratio [OR] = 2.2, 95% confidence interval {CI} [1.2-4.0] and OR = 3.2, 95% CI [1.8-5.8], respectively), to have engaged in binge drinking during the last year (OR = 15.0, 95% CI [7.2-31.3] and OR = 14.3, 95% CI [9.4-21.8]), to be in the highest socioeconomic stratum (OR = 2.6, 95% CI [1.3-5.1] and OR = 2.0, 95% CI [1.2-3.5]) and to have been interviewed at a hip-hop music nightclub (OR = 2.8, 95% CI [1.1-6.8] and OR = 3.7, 95% CI [1.5-9.1]). CONCLUSIONS: Risk behaviors were not equally distributed among nightclubs. Individual- and environmental-level characteristics are associated with higher risk. Alcohol harm reduction, such as the implementation of a responsible drinking service, should be implemented in São Paulo nightclubs.

Forearm skin aging: characterization by instrumental measurements.

BACKGROUND: The intrinsic ageing and photoaged skin present biomechanical and morphological differences, which are reflected in the appearance of roughness, superficial and deep wrinkles, atrophy, reduced elasticity, hypo- and hyperpigmentation and actinic keratosis. OBJECTIVE: To evaluate and compare the characteristics of the flexor (with a predominance of intrinsic ageing) and extensor (chronically exposed to sunlight and other environmental factors, with a predominance of photoageing) skin surfaces of the forearms. METHODS: Interventional, prospective, diagnostic study, including 23 females, aged over 60 years. The extensor and flexor faces of forearms were compared in relation to clinical parameters and non-invasive instrumental measurements, such as skin surface, elasticity, hydration as well as dermal thickness and echogenicity. RESULTS: Regarding the water content of the stratum corneum, the flexor face presented an average value higher than the extensor face. The average of measures obtained through images of high-frequency ultrasound demonstrated greater echogenicity of flexor face compared to the extensor face. The measurements of the skin surface showed significant differences between the faces. The roughness and scaliness were lower in the flexor face. Regarding the depth of wrinkles, there was no significant difference between the faces. The average of the measurements was slightly higher in the flexor face, which demonstrated that wrinkles are present in the intrinsic ageing and photoageing. The presence of elastosis and the reduction in elasticity in the clinical aspect of the photoaged face of forearms were according to the results of the non-invasive measurements. CONCLUSION: Meaningful differences in the biophysical characteristics of the extensor and flexor faces of the forearms were detected. Because the non-invasive instrumental measurements correlated with clinical findings, they may represent useful tools to assess efficacy and safety of skin ageing treatments in clinical research.

Cellulite: poor correlation between instrumental methods and photograph evaluation for severity classification.

BACKGROUND: Cellulite refers to skin relief alterations in women's thighs and buttocks, causing dissatisfaction and search for treatment. Its physiopathology is complex and not completely understood. Many therapeutic options have been reported with no scientific evidence about benefits. The majority of the studies are not controlled nor randomized; most efficacy endpoints are subjective, like not well-standardized photographs and investigator opinion. Objective measures could improve severity assessment. Our purpose was to correlate non-invasive instrumental measures and standardized clinical evaluation. METHODS: Twenty six women presenting cellulite on buttocks, aged from 25 to 41, were evaluated by: body mass index; standardized photography analysis (10-point severity and 5-point photonumeric scales) by five dermatologists; cutometry and high-frequency ultrasonography (dermal density and dermis/hypodermis interface length). Quality of life impact was assessed. Correlations between clinical and instrumental parameters were performed. RESULTS: Good agreement among dermatologists and main investigator perceptions was detected. Positive correlations: body mass index and clinical scores; ultrasonographic measures. Negative correlation: cutometry and clinical scores. Quality of life score was correlated to dermal collagen density. CONCLUSION: Cellulite caused impact in quality of life. Poor correlation between objective measures and clinical evaluation was detected. Cellulite severity assessment is a challenge, and objective parameters should be optimized for clinical trials.

Long-wave infrared radiation reflected by compression stockings in the treatment of cellulite: a clinical double-blind, randomized and controlled study.

BACKGROUND: Cellulite refers to changes in skin relief on the thighs and buttocks of women, with a prevalence of 80-90%, causing dissatisfaction and search for treatment. Etiopathogenesis is multifactorial, as follows: herniation of the hypodermis towards the dermis, facilitated by perpendicular fibrous septa, changes in the dermal extracellular matrix, decreased adiponectin, genetic polymorphism, microcirculation alterations and inflammatory process. There are numerous therapeutic approaches, with little evidence of effectiveness. The long-wave infrared (LWIR) radiation interacts with water, improves microcirculation and stimulates metabolic processes. To date, the use of tissues with potential reflection of LWIR radiation has not been systematically investigated as adjuvant treatment for cellulite. OBJECTIVE: To investigate the efficacy and safety of the treatment of cellulite through the use of compression stockings made with thread reflecting LWIR radiation. PATIENTS AND METHODS: Clinical study of therapeutic intervention, controlled and double-blind, including 30 women, aging from 25 to 40 years, with cellulite of grades II and III on the thighs and buttocks who used compression stockings, "pantyhose" model, made with reflector thread of LWIR radiation, on only one randomized side. Women under other treatments for cellulite and with venous and/or blood insufficiencies were excluded. Evaluation of efficacy by clinical parameters, photographs, Dermatology Life Quality Index (DLQI), cutometry and high frequency ultrasonography and security by observation of adverse events and venous EcoDoppler recordings. RESULTS: DLQI scores showed significant reduction; the two-dimensional high-frequency ultrasonography showed an insignificant increase in dermal echogenicity as well as other efficacy parameters demonstrated no or slight improvement, with no differences between the sides exposed or not to LWIR; and there were no severe adverse events. CONCLUSION: Compression stockings, with or without thread reflector of LWIR, showed slight effects in the appearance of cellulite, but the treatment determined a positive impact on women quality of life.

Analysis of criteria for metabolic syndrome in a population-based study of Japanese-Brazilians.

OBJECTIVE: Criteria for metabolic syndrome (MS) differ particularly regarding the definition of central obesity and consequently, there could be differences in the assessment of cardiovascular risk. We estimated the prevalence of metabolic syndrome, compared the agreement of the World Health Organization (WHO) criteria with the standard and a modified National Cholesterol Education Program (NCEP) criterion and investigated whether additional factors were associated with the diagnosis of the syndrome in a Japanese descendant population. METHODS: In this cross-sectional, population-based survey, 1166 Japanese-Brazilians (533 men, 633 women) aged 57.4 +/- 12.4 years with mean body mass index (BMI) and waist of 25.2 +/- 4.0 kg/m(2) and 84.5 +/- 10.6 cm, respectively, were included. McNemar and kappa statistics were used to assess the concordance between WHO criteria with the standard and a modified NCEP criteria (waist of 90 and 80 cm, for men and women, respectively). In logistic regression analysis, a number of metabolic variables and albumin-to-creatinine ratio were included to test independent associations with metabolic syndrome defined by the modified NCEP criteria. RESULTS: According to WHO, 55.4% (95% CI 52.5-58.2%) of the subjects had MS and to NCEP 47.4% (95% CI 44.6-50.0%). WHO criterion detected 48.3% of central obese subjects while NCEP only 14.0%. Kappa statistics showed a good strength of agreement (k = 0.67, p < 0.01) between WHO and NCEP standard definitions of MS. Using the modified NCEP criterion for Asians, more subjects with metabolic syndrome were identified (58%) and agreement with WHO was improved (k = 0.72, p < 0.001). However, similar Framingham risk scores were attributed to the subsets of subjects classified by any of the three criteria. Areas under the receiver operating characteristic curves, obtained for the modified waist values to diagnose metabolic syndrome according to WHO, were > 0.80 and corresponded, respectively, to sensitivity and specificity of 63 and 83% for men and 77 and 72% for women. In final logistic regression model, age, male sex, BMI and homeostasis model assessment-insulin resistance but not with albumin-to-creatinine ratio (ACR) were independently associated with the syndrome. CONCLUSIONS: High prevalence of MS, independent of the criterion considered, was found in this Japanese-Brazilian population. The replacement of waist cutoff by those proposed by WHO for Asians lead to this diagnosis in a higher number of subjects with elevated cardiovascular risk. Our data did not support that ACR should be included in the classical definition of MS in Japanese descendants as previously suggested by WHO.

The relationship between symptoms and electrophysiological detected compression of the median nerve at the wrist.

OBJECTIVE: The aim of this study was to evaluate the relationship between carpal tunnel syndrome symptoms and compression of the median nerve at the wrist in symptomatic patients. METHODS: A total of 250 patients were selected among those referred for electrodiagnostic evaluation with complaints involving hand or wrist. Primary and secondary symptoms were extracted from the answers to the instrument proposed by Levine et al. [J Bone Joint Surg Am 1993;75:1585]. The association of symptoms and the presence of compression of the median nerve at the wrist were ascertained through a multiple logistic regression test. RESULTS: Secondary symptoms (pain and weakness) were inversely associated with the presence of median nerve compression. Furthermore, primary symptoms (paresthesia, disability and nocturnal symptom) occurred similarly in patients with and without electrophysiologic findings of median nerve compression at the wrist.

Independent impact of glycemia and blood pressure in albuminuria on high-risk subjects for metabolic syndrome.

BACKGROUND: Microalbuminuria may reflect diffuse endothelial damage. Considering that diabetes and hypertension cause vasculopathy, we investigated associations of albumin-to-creatinine ratio (ACR) with plasma glucose and blood pressure levels in high-risk subjects for metabolic syndrome. METHODS: A sample of 519 (246 men) Japanese-Brazilians (aged 60 +/- 11 years), who participated in a population-based study, had their ACR determined in a morning urine specimen. Backward models of multiple linear regression were created for each gender including log-transformed values of ACR as dependent variable; an interaction term between diabetes and hypertension was included. RESULTS: Macroalbuminuria was found in 18 subjects. ACR mean values for subjects with normal glucose tolerance, impaired fasting glycemia, impaired glucose tolerance and diabetes were 9.9 +/- 6.0, 19.0 +/- 35.4, 20.7 +/- 35.4, and 33.9 +/- 55.0 mg/g, respectively. Diabetic subjects showed higher ACR than the others (p < 0.05). An increase in the proportion of albuminuric subjects was observed as glucose metabolism deteriorated (4.9, 17.0, 23.0 and 36.0%). Stratifying into 4 groups according to postchallenge glycemia (< 7.8 mmol/l, n = 91; > or = 7.8 mmol/l, n = 410) and hypertension, hypertensive and glucose-intolerant subgroups showed higher ACR values. ACR was associated with gender, waist circumference, blood pressure, plasma glucose and triglyceride (p < 0.05); albuminuric subjects had significantly higher levels of such variables than the normoalbuminuric ones. In the final models of linear regression, systolic blood pressure and 2-hour glycemia were shown to be independent predictors of ACR for both genders (p < 0.05). In men, also waist was independently associated with ACR. No interaction was detected between "diabetes and hypertension". CONCLUSIONS: These findings suggest that both glucose intolerance and hypertension could have independent but not synergistic effects on endothelial function--reflected by albumin loss in urine. Such hypothesis needs to be confirmed in prospective studies.

Stunning and myocardial contractile autoregulation studied on the isolated isovolumic blood-perfused dog heart.

AIM: To study, for the first time, the effects of stunning on homeometric and heterometric autoregulation. METHODS AND RESULTS: Ischaemia (15 min)/reperfusion (30 min) was induced in the isovolumic blood-perfused dog heart preparation. Heart rate elevations (n = 9) from 60 to 200 beats min-1, in steps of 20 beats min-1, promoted the same inotropic stimulation in control (C) and stunning (S), indicating that ischaemia/reperfusion does not affect the changes in calcium kinetics elicited by the Bowditch effect. Sudden ventricular dilation (VD) (n = 10) evoked an instantaneous increase in developed pressure (Delta1DP) followed by a continuous slow performance increase (Delta2DP) in C and S. Delta1DP (C: 35 +/- 2.2 mmHg; S: 27 +/- 2.1 mmHg; P = 0.002) and Delta2DP (C: 20 +/- 1.6 mmHg; S: 14 +/- 1.3 mmHg; P = 0.002) decreased proportionally, while Delta2/Delta1DP (C: 0.57 +/- 0.13; S: 0.58 +/- 0.14) and slow response time course (T/2) were unchanged (C: 55 +/- 6.6 s; S: 57 +/- 7.7 s) after ischaemia/reperfusion. The reduction of Delta1DP can be understood as a decline of the myofilaments calcium responsiveness, the main pathophysiological effect of stunning. The reason for the weakening of Delta2DP, due to intracellular calcium gain, was not determined but it was supposed that its complete manifestation could be restricted by cyclic adenosine monophosphate (cAMP) myocardial content reduction. As reported by others, Delta2DP depends on myocardial cAMP, and it has been shown that myocardial cAMP is decreased after ischaemia/reperfusion. CONCLUSIONS: Contractile depression due to stunning has no effect on the inotropic stimulation generated by the Bowditch phenomenon. Immediate and time-dependent enhancements of contraction evoked by sudden VD are proportionally reduced and the slow response time course is unaffected in the stunned myocardium.