Sugar-and artificially sweetened beverages and intrahepatic fat : a randomized controlled trial.

OBJECTIVE: To test the hypothesis that substituting artificially sweetened beverages (ASB) for sugar-sweetened beverages (SSB) decreases intrahepatocellular lipid concentrations (IHCL) in overweight subjects with high SSB consumption. METHODS: About 31 healthy subjects with BMI greater than 25 kg/m(2) and a daily consumption of at least 660 ml SSB were randomized to a 12-week intervention in which they replaced SSBs with ASBs. Their IHCL (magnetic resonance spectroscopy), visceral adipose tissue volume (VAT; magnetic resonance imaging), food intake (2-day food records), and fasting blood concentrations of metabolic markers were measured after a 4-week run-in period and after a 12-week period with ASB or control (CTRL). RESULTS: About 27 subjects completed the study. IHCL was reduced to 74% of the initial values with ASB (N = 14; P < 0.05) but did not change with CTRL. The decrease in IHCL attained with ASB was more important in subjects with IHCL greater than 60 mmol/l than in subjects with low IHCL. ALT decreased significantly with SSB only in subjects with IHCL greater than 60 mmol/l. There was otherwise no significant effect of ASB on body weight, VAT, or metabolic markers. CONCLUSIONS: In subjects with overweight or obesity and a high SSB intake, replacing SSB with ASB decreased intrahepatic fat over a 12-week period.

Effects of oral supplementation of iron on hepcidin blood concentrations among non-anaemic female blood donors: a randomized controlled trial.

BACKGROUND AND OBJECTIVES: Hepcidin is the main hormone that regulates iron balance. Its lowering favours digestive iron absorption in cases of iron deficiency or enhanced erythropoiesis. The careful dosage of this small peptide promises new diagnostic and therapeutic strategies. Its measurement is progressively being validated and now its clinical value must be explored in different physiological situations. Here, we evaluate hepcidin levels among premenopausal female donors with iron deficiency without anaemia. MATERIALS AND METHODS: In a preceding study, a 4-week oral iron treatment (80 mg/day) was administered in a randomized controlled trial (n = 145), in cases of iron deficiency without anaemia after a blood donation. We subsequently measured hepcidin at baseline and after 4 weeks of treatment, using mass spectrometry. RESULTS: Iron supplementation had a significant effect on plasma hepcidin compared to the placebo arm at 4 weeks [+0·29 nm [95% CI: 0·18 to 0·40]). There was a significant correlation between hepcidin and ferritin at baseline (R(2) = 0·121, P < 0·001) and after treatment (R(2) = 0·436, P < 0·001). Hepcidin levels at baseline were not predictive of concentration changes for ferritin or haemoglobin. However, hepcidin levels at 4 weeks were significantly higher (0·79 nm [95% CI: 0·53 to 1·05]) among ferritin responders. CONCLUSIONS: This study shows that a 4-week oral treatment of iron increased hepcidin blood concentrations in female blood donors with an initial ferritin concentration of less than 30 ng/ml. Apparently, hepcidin cannot serve as a predictor of response to iron treatment but might serve as a marker of the iron repletion needed for erythropoiesis.

Internet-Based Brief Intervention to Prevent Unhealthy Alcohol Use among Young Men: A Randomized Controlled Trial.

INTRODUCTION: Alcohol use is one of the leading modifiable morbidity and mortality risk factors among young adults. STUDY DESIGN: 2 parallel-group randomized controlled trial with follow-up at 1 and 6 months. SETTING/PARTICIPANTS: Internet based study in a general population sample of young men with low-risk drinking, recruited between June 2012 and February 2013. INTERVENTION: Internet-based brief alcohol primary prevention intervention (IBI). The IBI aims at preventing an increase in alcohol use: it consists of normative feedback, feedback on consequences, calorific value alcohol, computed blood alcohol concentration, indication that the reported alcohol use is associated with no or limited risks for health. INTERVENTION group participants received the IBI. Control group (CG) participants completed only an assessment. MAIN OUTCOME MEASURES: Alcohol use (number of drinks per week), binge drinking prevalence. Analyses were conducted in 2014-2015. RESULTS: Of 4365 men invited to participate, 1633 did so; 896 reported low-risk drinking and were randomized (IBI: n = 451; CG: n = 445). At baseline, 1 and 6 months, the mean (SD) number of drinks/week was 2.4(2.2), 2.3(2.6), 2.5(3.0) for IBI, and 2.4(2.3), 2.8(3.7), 2.7(3.9) for CG. Binge drinking, absent at baseline, was reported by 14.4% (IBI) and 19.0% (CG) at 1 month and by 13.3% (IBI) and 13.0% (CG) at 6 months. At 1 month, beneficial intervention effects were observed on the number of drinks/week (p = 0.05). No significant differences were observed at 6 months. CONCLUSION: We found protective short term effects of a primary prevention IBI. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN55991918.

Randomized, crossover, double-blind, placebo-controlled trial to assess the lipid lowering effect of co-formulated TDF/FTC

Abstract INTRODUCTION: Previous studies have described improvements on lipid parameters when switching from other antiretroviral drugs to tenofovir (TDF) and impairments in lipid profile when discontinuing TDF. [1-3] It is unknown, however, if TDF has an intrinsic lipid-lowering effect or such findings are due to the addition or removal of other offending agents or other reasons. MATERIALS AND METHODS: RESULTS: 46 subjects with a median age of 43 (40-48) years were enrolled in the study: 70% were male, 56% received DRV/r and 44% LPV/r. One subject withdrew the study voluntarily at week 4 and another one interrupted due to diarrhoea at week 24. Treatment with TDF/FTC decreased total, LDL and HDL-cholesterol from 235.9 to 204.9 (p<0.001), 154.7 to 127.6 (p<0.001) and 50.3 to 44.5 mg/dL (p<0.001), respectively. In comparison, total, LDL and HDL-cholesterol levels remained stable during placebo exposure. Week 12 total cholesterol (p<0.001), LDL-cholesterol (p<0.001) and HDL-cholesterol (p=0.011) levels were significantly lower in TDF/FTC versus placebo. Treatment with TDF/FTC reduced the fraction of subjects with abnormal fasting total-cholesterol (≥200 mg/dL) from 86.7% to 56.8% (p=0.001) and LDL-cholesterol (≥130 mg/dL) from 87.8% to 43.9% (p<0.001), which was not observed with placebo. There were no virological failures, and CD4 and triglyceride levels remained stable regardless of exposure. CONCLUSION: Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF.

IV paracetamol versus IV ibuprofen for the treatment of PDA in LBW infants: a randomized controlled trial

Patent ductus arteriosus is a prevalent problem in low birth weight infants and it has an important morbidity and mortality in this group of patients. Classical treatment options include drugs (intravenous cyclooxygenase inhibitors: indomethacin and ibuprofen) and surgical ligation, but these treatments are associated with significant adverse effects. An alternative treatment with fewer side effects is needed. The role of oral paracetamol has gained importance in recent years, this new therapeutic option is being widely studied, and there are already many studies which support oral paracetamol as first line treatment for PDA, due to its better safety profile than classical drugs. In LBW infants is difficult to administer enteral treatment, since they are often multi pathological patients with several complications that preclude oral administration and they usually receive intravenous treatments. This multicenter, prospective, single blinded, randomized, controlled, parallel-group and noninferiority trial is designed to evaluate the efficacy and safety of intravenous paracetamol versus intravenous ibuprofen in the treatment of PDA in LBW infants. Sixty eight infants with echocardiography confirmed PDA will be randomly assigned to receive either intravenous paracetamol or intravenous ibuprofen. The main endpoints will be the rate of ductal closure of each drug and adverse events in each group of treatment

Percutaneous access versus standard femoral exposure for endovascular abdominal aortic aneurysm repair: a randomized, controlled trial

The treatment of abdominal aortic aneurysm (AAA) has shifted from the exposure of the aorta artery in an open repair technique to a small groin cut in an endovascular repair. Recently, a percutaneous access for endovascular repair has appeared. This new technique aims to minimize the complications of the common femoral artery exposure, the patient discomfort and the length of hospitalizationObjectives: To compare the proportion of discharged patients within the first 48 postoperative hours of two common femoral artery accesses for endovascular repair of AAA: the open exposure technique and the percutaneous technique. Secondary objectives include to evaluate the total procedure time, the femoral access complications, the need for extra analgesia and the patient satisfaction and groin discomfort of the two techniquesDesign: Randomized controlled trial conducted between 2014 and 2017Participants: Patients diagnosed with abdominal aortic aneurysm with elective endovascular repair indication

Induction of labor with titrated oral misoprostol solution versus oxytocin in term pregnancy: randomized controlled trial

PURPOSE: To evaluate the effectiveness and the safety of orally administered misoprostol in comparison to intravenously infused oxytocin for labor induction in term pregnant women. METHODS: Between 2008 and 2010, a total of 285 term pregnant women whom were candidate for vaginal delivery were assessed for eligibility to enter the study. Twenty five patients were excluded for different reasons; and 260 included women were randomly assigned to one of the two groups according to the method of treatment, misoprostol or oxytocin. The misoprostol group received 25 µg every 2 hours for up to 24 hours for induction. The oxytocin group received an infusion of 10 IU which was gradually increased. The time from induction to delivery and induction to the beginning of the active phase and successful inductions within 12, 18, and 24 hours were recorded. The trial is registered at irct.ir, number IRCT2012061910068N1. RESULTS: Failure of induction, leading to caesarean section was around 38.3% in the oxytocin group and significantly higher than that of the misoprostol group (20.3%) (p<0.001). Despite the more prevalent failure in the oxytocin group, the mean time intervals from induction to active phase and labor of this group were both significantly less than the misoprostol group (10.1±6.1 and 13.2±7.7 versus 12.9±5.4 and 15.6±5.1 hours respectively, both p-values were <0.05). Maternal and fetal complications were comparable between groups except gastrointestinal symptoms which were encountered more frequently in the misoprostol (10.9 versus 3.9%, p=0.03). CONCLUSIONS: Misoprostol is a safe and effective drug with low complications for the induction of labor. Failure is seen less with misoprostol and caesarean sections are less frequently indicated as compared to oxytocin.

The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial

PURPOSE: To assess the effects of a soy dietary supplement on the main biomarkers of cardiovascular health in postmenopausal women compared with the effects of low-dose hormone therapy (HT) and placebo.METHODS: Double-blind, randomized and controlled intention-to-treat trial. Sixty healthy postmenopausal women, aged 40-60 years, 4.1 years mean time since menopause were recruited and randomly assigned to 3 groups: a soy dietary supplement group (isoflavone 90mg), a low-dose HT group (estradiol 1 mg plus noretisterone 0.5 mg) and a placebo group. Lipid profile, glucose level, body mass index, blood pressure and abdominal/hip ratio were evaluated in all the participants at baseline and after 16 weeks. Statistical analyses were performed using the χ2 test, Fisher's exact test, Kruskal-Wallis non-parametric test, analysis of variance (ANOVA), paired Student's t-test and Wilcoxon test.RESULTS: After a 16-week intervention period, total cholesterol decreased 11.3% and LDL-cholesterol decreased 18.6% in the HT group, but both did not change in the soy dietary supplement and placebo groups. Values for triglycerides, HDL-cholesterol, glucose level, body mass index, blood pressure and abdominal/hip ratio did not change over time in any of the three groups.CONCLUSION: The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT. Clinical Trial Registry: The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75.

Preventive effect of reduced glutathione on contrast-induced nephropathy in elderly patients undergoing coronary angiography or intervention: a randomized, controlled trial

Coronary angiography can be a high-risk condition for the incidence of contrast-induced nephropathy (CIN) in elderly patients. Reduced glutathione, under a variety of mechanisms, may prevent CIN in this procedure. We prospectively examined whether hydration with reduced glutathione is superior to hydration alone for prevention of CIN in an elderly Han Chinese population. A total of 505 patients (271 males and 234 females) aged 75 years or older who underwent non-emergency coronary angiography or an intervention were randomly divided into two groups. The treatment group received hydration with reduced glutathione (n=262) and the control group received hydration alone (n=243). Serum creatinine and blood urea nitrogen levels were measured prior to coronary angiography and 48 h after this procedure. The primary endpoint was occurrence of CIN, which was defined as 25% or 44.2 µmol/L above baseline serum creatinine levels 48 h after the procedure. The overall incidence of CIN was 6.49% in the treatment group and 7.41% in the control group, with no significant difference between the groups (P=0.68). In subgroup analysis by percutaneous coronary intervention, no significant differences were found between the two groups. In summary, reduced glutathione added to optimal hydration does not further decrease the risk of CIN in elderly patients undergoing coronary angiography or an intervention.

Evaluating three self-help smoking cessation interventions for post-secondary smokers : a randomized controlled trial on six Ontario campuses

Objective. Smoking prevalence is highest among the young adult cohort. Postsecondary students are no exception. Although many students intend to quit smoking, no research has established what methods best promote reductions in, or complete abstinence from smoking. This randomized controlled trial examined the effectiveness of three self-help smoking cessation interventions. Method. On six post-secondary campuses, 483 smokers who voluntarily accessed Leave The Pack Behind (a tobacco control initiative) were randomly assigned to one of three smoking cessation interventions: One Step At A Time (a 2-booklet, *gold standard' program for adults); Smoke|Quit (a newly-developed 2-booklet program for young adult students); and usual care (a 'Quit Kit' containing a booklet on stress management, information about pharmacological quitting aides and novelty items). All participants also received one proactive telephone support call from a peer counsellor. During the study, 85 participants withdrew. The final sample of 216 students who completed baseline questionnaires and 12-week follow-up telephone interviews was representative of the initial sample in terms of demographic characteristics, and smokingquitting- related variables. Results. Whether participants quit smoking depended upon treatment condition, ^(2, N=2\6) = 6.34, p = .04, with Smoke|Quit producing more successfijl quitters (18.4%) than One Step At A Time (4.5%) or the Quit Kit (1 1.4%). On average, participants had quit 53.46 days, with no significant difference across treatments. Selfefficacy also increased. Use of the intervention or other quitting aides was not associated with treatment condition. Among the 191 participants who did not quit smoking, treatment condition did not influence outcomes. Overall, 46.2% had made a quit attempt. Significant decreases in weekly tobacco consumption and increases in self-efficacy to resist smoking were observed from baseline to follow-up. Conclusion. Post-secondary institutions represent a potentially final opportunity for age-targeted interventions. Self-help resources tailored to students' social and contextual characteristics will have considerable more impact than stage-only tailored interventions. Both reduction and abstinence outcomes should be emphasized to positively support students to stop smoking.

A randomized controlled trial evaluating the quality of life and the sense of coherence in seniors wearing complete conventional dentures or mandibular two-implant overdentures

La supériorité des prothèses mandibulaires retenues par deux implants (IODs) sur les prothèses conventionnelles (CDs) nécessitent d’être éclaircies notamment en rapport à leur influence sur la qualité de vie reliée à la santé bucco-dentaire (OHRQoL) ainsi que sur la stabilité de cet effet de traitement. De plus, l’influence des facteurs psychologiques, tel que le sens de cohérence (SOC), sur l’effet de traitement reste encore inconnue. Le but de cette étude est de déterminer l’amplitude de l’influence du port des IODs et des CDs sur l’OHRQoL et d’évaluer la stabilité de l’effet de traitement dans le temps, tout en prenant en considération le niveau du SOC. MÉTHODOLOGIE: Des participants édentés (n=172, âge moyen 71, SD = 4.5) ayant reçu des CDs ou des IODs ont été suivis sur une période de deux ans. L’OHRQoL a été évaluée à l’aide du questionnaire « Oral Health Impact Profile (OHIP -20) » et ce avant le traitement et à chacun des deux suivis. Le SOC a été évalué à l’aide du questionnaire « The Orientation to Life (SOC -13) » à chacun des deux suivis. Des analyses statistiques ont été effectuées pour évaluer les différences intra et entre groupes (analyses statistiques descriptives, bivariées et multivariées). RÉSULTATS: Une amélioration statistiquement significative de l’OHRQoL entre les statuts avant et après traitement a été notée dans les deux groupes (Wilks’s Lambda = 0.473, F (1,151) = 157.31, p < 0.0001). L’amplitude de l’effet du traitement IOD est 1.5 fois plus grande que celle du traitement CD. Ces résultats ont été stables pendant les deux années d’étude et ils n’ont pas été influencés par le SOC. CONCLUSION: Le traitement IOD amène une meilleure OHRQoL à long terme en comparaison avec le traitement CD et ce sans influence du niveau du SOC. Ces résultats sont cliniquement significatifs et confirment la supériorité des IODs sur les CDs.

The Role of Kinaesthetic Motor Imagery in Promoting Activation of the Lumbrical Muscles in the Hemiparetic Hand: a Randomised Controlled Study

The objective of the investigation who gave as result this work was to investigate the effectiveness of kinaesthetic motor imagery in the activation of the hemiplegic hand muscles following stroke. The experiment consisted of two random groups. Movements were measured after treatment. The participants were ten patients with hemiplegic hands (men who mean age was 74.4 years; mean time since stroke 3.05 months). All patients received three sessions of physical treatment based on an identical treatment protocol. Five patients were randomly assigned to an experimental group practising kinaesthetic motor imagery of a grasp using the 'lumbrical action' (experimental group). The others five (control group) followed a relaxation script. All the patients were then asked to grasp an object using the 'lumbrical action'. The grasps were recorded using an optoelectronic motion capture system. The magnitude of the extension of the index finger and the correlation of the angular displacement of the proximal phalangeal joints and the metacarpophalangeal joints were calculated. The movement time for the whole grip was calculated. The experimental group demonstrated higher extension in the index finger (p = < 0.01) and they had a higher correlation coefficient (0.99) than the control group (0.77) for the displacement of the proximal interphalangeal joint and the metacarpophalangeal joints. The movement time for the experimental group was faster, although the difference was not significant.

El costo de la atención ambulatoria del lupus eritematoso sistémico en Colombia. Contrastes y comparaciones con otras poblaciones.

Introducción: el lupus eritematoso sistémico (LES) es considerado una enfermedad de alto costo. La expresión clínica de la enfermedad depende de la ubicación geografía y la etnicidad. El objetivo de este estudio fue el calcular los costos ambulatorios relacionado al LES en una cohorte colombiana, identificar los predictores de costos y comparar nuestro resultados con otras poblaciones. Métodos: Se realizó una aproximación de tipo prevalencia en 100 pacientes LES en quienes se evaluaron los costos directos médicos, directos no médicos, indirectos e intangibles. Todos los costos médicos fueron evaluados usando una metodología abajo hacia arriba. Los costos directos fueron valorados desde una perspectiva social usando una metodología de micro-costeo. Los costos indirectos se evaluaron mediante una aproximación de capital humano, y los costos intangibles calculados a partir de los años de vida ajustados por calidad (AVAC). Se analizaron los datos por medio de un análisis multivariado. Para comparaciones con otras poblaciones todos los costos fueron expresados como la razón entre los costos y producto interno bruto nacional per cápita. Resultados: La media de costos totales fue 13.031±9.215 USD (ajustados por el factor de conversión de paridad del poder adquisitivo), lo cual representa el 1,66 del PIB per capita de Colombia. Los costos directos son el 64% de los costos totales. Los costos médicos representan el 80% de los costos directos,. Los costos indirectos fueron el 10% y los costos intangibles el 25% de los costos totales. Los medicamentos representaron el 45% de los costos directos. Mayores costos se relacionaron con el estrato socioeconómico, seguro médico privado, AVAC, alopecia, micofenolato mofetilo, y terapia anticoagulante. Los costos directos ajustados de los pacientes con LES en Colombia fueron mayores que en Norte América y en Europa. Conclusiones: el LES impone una carga económica importante para la sociedad. Los costos relacionados con la atención médica y AVAC fueron los principales contribuyentes al alto costo de la enfermedad. Estos resultados pueden ser referencia para determinar políticas en salud pública así como comparar el gasto en salud de forma internacional.