Objective: In this study we aim to characterize a sample of 85 pregnant crack addicts admitted for detoxification in a psychiatric inpatient unit. Method: Cross-sectional study. Sociodemographic, clinical, obstetric and lifestyle information were evaluated. Results: Age of onset for crack use varied from 11 to 35 years (median = 21). Approximately 25% of the patients smoked more than 20 crack rocks in a typical day of use (median = 10; min-max = 1-100). Tobacco (89.4%), alcohol (63.5%) and marijuana (51.8%) were the drugs other than crack most currently used. Robbery was reported by 32 patients (41.2%), imprisonment experience by 21 (24.7%), trade of sex for money/drugs by 38 (44.7%), home desertion by 33 (38.8%); 15.3% were positive for HIV, 5.9% for HCV, 1.2% for HBV and 8.2% for syphilis. After discharge from the psychiatric unit, only 25% of the sample followed the proposed treatment in the chemical dependency outpatient service. Conclusion: Greater risky behaviors for STD, as well as high rates of maternal HIV and Syphilis were found. Moreover, the high rates of concurrent use of other drugs and involvement in illegal activities contribute to show their chaotic lifestyles. Prevention and intervention programs need to be developed to address the multifactorial nature of this problem. RESUMOObjetivo: Caracterizar uma amostra de 85 gestantes dependentes de crack admitidas para desintoxicação numa unidade de internação psiquiátrica. Método: Foram avaliadas, de forma transversal, variáveis sociodemográficas, clínico-obstétricas e informações sobre o seu estilo de vida. Resultados: A idade de início de uso do crack variou dos 11 aos 35 anos (mediana = 21). Aproximadamente, 25% das pacientes fumavam mais de 20 pedras de crack em um dia típico de uso (mediana = 10; mín-máx = 1-100). Além do crack, as drogas mais utilizadas eram: tabaco (76; 89,4%), álcool (54; 63,5%) e maconha (44; 51,8%). Roubo foi relatado por 41,2% (32 pacientes), prisão por 24,7% (21), troca de sexo por dinheiro/drogas por 44,7% (38) e abandono do lar por 38,8% (33); 15,3% (13) tinham soropositividade para HIV, Recebido em 25/7/2011 Aprovado em
Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.
Introduction: The aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals. Methods: In a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (Body Mass Index (BMI) 25 to < 35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual’s daily energy requirements) for 12 weeks. At week 0 (baseline), week 4, 8 and 12 of the intervention periods, the participants’ body weight, BMI, body fat composition and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening. Results: At the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo) respectively experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104. Conclusion: Results demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.
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