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A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis.
Alexopoulos, A, Dakoutrou, M, Nasi, L, Thanopoulou, I, Kakourou, T, Kontara, L, Douladiris, N, Galani, M, Xepapadaki, P, Doxani, C, et al
Pediatric dermatology. 2023;(1):78-83
Abstract
BACKGROUND Ectoine is a widespread osmolyte enabling halophilic bacteria to withstand high osmotic stress that has many potential applications ranging from cosmetics to its use as a therapeutic agent. OBJECTIVE The aim of this study was to compare the efficacy and tolerability of ectoine 1% and hyaluronic acid 0.1% containing (EHA) cream with a vehicle cream in children with mild-to-moderate atopic dermatitis (AD). METHODS A randomized, controlled, observer-blind, multicenter clinical trial was conducted in children aged 2-18 years, diagnosed with mild-to-moderate AD (SCORAD ≤20). Patients were randomized to either receiving EHA cream or vehicle cream twice daily for 4 weeks. The primary outcome measure was the mean change in objective SCORAD from baseline to the final visit. The secondary outcome measures included the mean change in Investigator's Global Assessment score, patient's judgment of efficacy and patient's assessment of pruritus. Safety of EHA cream was also assessed. RESULTS A total of 70 patients (35 in each group) were randomized and 57 were included in the final analysis set. Based on SCORAD measurements, patients using EHA cream achieved superior clinical improvement compared to the control group at 28 days (p < .001). EHA cream was also superior to the vehicle cream regarding all secondary outcome measures. Eight (23.5%) patients receiving EHA cream and two (5.7%) patients receiving vehicle cream experienced mild cutaneous adverse events (AEs). CONCLUSIONS In children 2-18 years old with mild-to-moderate AD, EHA cream was superior to vehicle cream, with minor AEs.
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Electronic registry for the management of childhood obesity in Greece.
Kassari, P, Papaioannou, P, Billiris, A, Karanikas, H, Eleftheriou, S, Thireos, E, Manios, Y, Chrousos, GP, Charmandari, E
European journal of clinical investigation. 2018;(3)
Abstract
BACKGROUND Obesity in childhood and adolescence represents a major health problem in our century. In Greece, more than 30%-35% of children and adolescents are either overweight or obese. MATERIALS AND METHODS Using information and communication technologies, we developed a "National Registry for the Prevention and Management of Overweight and Obesity in Childhood and Adolescence" for guidance and training of Pediatricians and General Practitioners. The application supports interoperability with other national infrastructures and multi-layered security spanning preventive, detective and administrative controls. The Patient Summary Dataset includes information on medical history, family history, medications, immunizations, clinical examination and laboratory findings and appointment booking service. RESULTS The application was launched in September 2015 and is accessible by: http://app.childhood-obesity.gr/. Based on the data that the doctor registers, the system calculates a personalized therapeutic algorithm that provides information on diet, physical exercise and sleep, as well as guidance on laboratory investigations and referral to specialized centres. A pilot study performed in 1270 children and adolescents indicated that using this system resulted in a reduction in obesity rates by 30% and overweight rates by 35% within 1 year. CONCLUSIONS This National e-Health System appears to be effective in the management of overweight and obesity in childhood and adolescence.
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A HEALth Promotion and STRESS Management Program (HEAL-STRESS study) for prehypertensive and hypertensive patients: a quasi-experimental study in Greece.
Darviri, C, Artemiadis, AK, Protogerou, A, Soldatos, P, Kranioutou, C, Vasdekis, S, Varvogli, L, Nasothimiou, E, Vasilopoulou, E, Karantzi, E, et al
Journal of human hypertension. 2016;(6):397-403
Abstract
Current hypertension guidelines advocate strategies encouraging healthy lifestyle behaviours. So far, there is a paucity of studies for the efficacy of such multifaceted programmes. The aim of this study is to investigate the efficacy of an 8-week health-promotion programme for lowering blood pressure (BP) in prehypertensive and hypertensive patients in the community. This was a quasi-experimental study using wait-list controls of 548 patients. The intervention group was administered with an 8-week health-promotion intervention. Measurements included home BP, smoking, body mass index (BMI), perceived stress, depression, anxiety and Health Locus of Control. After adjusting for confounders, the intervention group had a significant reduction in both systolic BP (SBP; mean -2.62 mm Hg, 95% confidence interval (CI): -1.29 to -3.96) and diastolic BP (DBP; mean -1.0, 95% CI: -0.93 to -1.9) compared with controls. In all, 14.9% of patients in the intervention group had >10 mm Hg reduction in SBP vs 4.4% in the control group (P<0.001, numbers needed to treat (NNT)=10). With regards to DBP, 21.7% of patients in the intervention group had >5 mm Hg reduction vs 12.5% in the control group (P=0.01, NNT=11). In terms of effect size, moderate-to-large improvements of BMI, perceived stress, anxiety, depression, external and chance Health Locus of Control were recorded. Changes in SBP and DBP were attributed to BMI and depressive symptom reductions, respectively. Comprehensive non-pharmaceutical programmes for BP management are strongly encouraged. Their long-term benefits on cardiovascular morbidity and mortality remain to be established by future research.
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Vitamin D supplementation in patients with diabetes mellitus type 2 on different therapeutic regimens: a one-year prospective study.
Alkharfy, KM, Al-Daghri, NM, Sabico, SB, Al-Othman, A, Moharram, O, Alokail, MS, Al-Saleh, Y, Kumar, S, Chrousos, GP
Cardiovascular diabetology. 2013;:113
Abstract
BACKGROUND Little or no research has determined the effect of vitamin D3 supplementation in conjunction with pharmacological and non-pharmacological approaches in the diabetes mellitus type 2 (DMT2) patients. The objective of this study was to determine the effect of vitamin D3 supplementation in a cohort of Saudi DMT2 population on diet, insulin and/or different oral hypoglycemic agents and compare them with a non-DMT2 control cohort. METHODS A total of 499 randomly selected Saudi subjects divided into 8 groups [Non-DMT2 Control = 151; Rosiglitazone alone = 49; Diet = 15; Insulin alone = 55; Insulin + Orals = 12; Metformin alone = 121; Oral agents combination = 37; Sulphonylurea alone = 59] were included in this 12-month interventional study. All DMT2 patients were given 2000 IU vitamin D3 daily, while the control group received none but were advised to increase sun exposure. Anthropometrics, glucose, lipid profile and 25-hydroxyvitamin D (25-OHVitD) were measured at baseline, 6 and 12 months. RESULTS Circulating 25-OHVitD concentrations improved in all patient groups. The metformin group showed the highest change in circulating vitamin D levels both at 6 months (62.6%) and 12 months (50.6%) as compared to baseline (p < 0.001). No significant changes were observed in the BMI and glucose in any of the DMT2 groups. In contrast, the insulin + oral agents group showed more significant improvements in the metabolic profile, which included triglycerides and total cholesterol, as well as systolic blood pressure and HDL-cholesterol in males. Also, significant decreases in triglycerides were observed in the rosiglitazone and insulin + oral hypoglycemic agent groups both at 6 and 12 months of supplementation (both p-values <0.001). CONCLUSION While in all DMT2 groups circulating levels of 25-OHVitD increased after supplementation, in DMT2 patients on insulin in combination with other drugs benefitted the most in improving cardiovascular risk. Metformin improves 25-hydroxyvitamin D levels but did not seem to confer other added cardiometabolic benefits.