New therapeutic approach to Tourette Syndrome in children based on a randomized placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6.

BACKGROUND: Tourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity. Considered an uncommon illness, it first becomes apparent during childhood. Current standard treatment only achieves partial control of the condition, and provokes frequent, and sometimes severe, side effects. METHODS AND DESIGN: Main aim: To show that, with respect to placebo treatment, the combination of 0.5 mEq/Kg magnesium and 2 mg/Kg vitamin B6 reduces motor and phonic tics and incapacity in cases of exacerbated TS among children aged 7-14 years, as measured on the Yale Global Tic Severity Scale (YGTSS). Secondary aims: Assess the safety of the treatment. Describe metabolic changes revealed by PET. Measure the impact of the experimental treatment on family life. METHODOLOGY: Randomized, blinded clinical trials. Phase IV study (new proposal for treatment with magnesium and vitamin B6). SCOPE: children in the geographic area of the study group. Recruitment of subjects: to include patients diagnosed with TS, in accordance with DSM-IV criteria (307.23), during a period of exacerbation, and provided none of the exclusion criteria are met. INSTRUMENTATION: clinical data and the YGTSS score will be obtained at the outset of a period of exacerbation (t0). The examinations will be made after 15 (t1), 30 (t2), 60 (t3) and 90 days (t4). PET will be performed at the t0 and t4. We evaluated decrease in the overall score (t0, t1, t2, t3, t4), PET variations, and impact made by the treatment on the patient's life (Psychological General Well-Being Index). DISCUSSION: Few clinical trials have been carried out on children with TS, but they are necessary, as current treatment possibilities are insufficient and often provoke side effects. The difficulty of dealing with an uncommon illness makes designing such a study all the more complicated. The present study seeks to overcome possible methodological problems by implementing a prior, phase II study, in order to calculate the relevant statistical parameters and to determine the safety of the proposed treatment. Providing a collateral treatment with magnesium and vitamin B6 could improve control of the illness and help reduce side effects. This protocol was approved by the Andalusian Government Committee for Clinical Trials (Spain). This study was funded by the Health Department of the Andalusian Regional Government and by the Healthcare Research Fund of the Carlos III Healthcare Institute (Spanish Ministry of Health). TRIAL REGISTRATION: Current Controlled Trials ISRCTN41082378.

[An open study evaluating the efficacy and security of magnesium and vitamin B(6) as a treatment of Tourette syndrome in children]. / Estudio piloto sin grupo control del tratamiento con magnesio y vitamina B(6) del síndrome de Gilles de la Tourette en niños.

BACKGROUND AND OBJECTIVE: We intended to ascertain the effectiveness and safety of oral solutions of magnesium and vitamin B(6) in alleviating the symptoms emerged during clinical exacerbations in children aged 7-14 years suffering from Tourette syndrome (TS). We also aimed to determine the mean and the standard deviation of such an improvement in order to estimate sample sizes in future assays with a control group. PATIENTS AND METHOD: The treatment under investigation was administered to children diagnosed with TS, in accordance with Diagnostic and Statistical Manual of Mental Disorders, fourth edition -IV, under conditions of clinical exacerbation. The effects were scored on the Yale Global Tics Severity Scale (YGTSS) at 0, 15, 30, 60 and 90 days. RESULTS: The total tics score decreased from 26.7 (t0) to 12.9 (t4) and the total effect on the YGTSS was a reduction from 58.1 to 18.8. Both results were statistically significant. With respect to the application of conventional treatment or otherwise, no significant differences were observed. No side effects were seen. CONCLUSIONS: The treatment assayed is safe and effective in reducing the harmful effects of TS in children. Further studies are needed, with a control group, and evaluation of different doses of the drugs.

Estudio piloto sin grupo control del tratamiento con magnesio y vitamina B6 del síndrome de Gilles de la Tourette en niños / An open study evaluating the efficacy and security of magnesium and vitamin B6 as a treatment of Tourette syndrome in children

FUNDAMENTO Y OBJETIVO: Estudiar la efectividad y seguridadde soluciones orales de magnesio y vitaminaB6 para disminuir los síntomas durante las exacerbacionesclínicas en niños de entre 7 y 14 añoscon síndrome de Gilles de la Tourette (SGT). Determinarla mejoría en la puntuación y su desviaciónestándar para estimar el tamaño muestral de futurosensayos con grupo control.PACIENTES Y MÉTODO: El tratamiento estudiado se administróa niños diagnosticados de SGT de acuerdocon el Manual Diagnóstico y Estadística de losTrastornos Mentales, cuarta edición, durante unaexacerbación clínica. La clínica se cuantificó mediantela Yale Global Tics Severity Scale (YGTSS) alos 0, 15, 30, 60 y 90 días de tratamiento.RESULTADOS: La puntuación de los tics pasó de 26,7(inicio) a 12,9 (a los 90 días de tratamiento) y lapuntuación total de la YGTSS pasó de 58,1 a18,8. Estos resultados fueron estadísticamente significativos.Con respecto a la aplicación o no detratamiento convencional, no observamos diferenciassignificativas en los resultados obtenidos. Nose registraron efectos secundarios.CONCLUSIONES: El tratamiento analizado es seguro yefectivo para reducir los síntomas del SGT en niños.Es necesario realizar estudios con un grupocontrol y diferentes dosis de fármacos para confirmarestos resultados

BACKGROUND AND OBJECTIVE: We intended to ascertainthe effectiveness and safety of oral solutions ofmagnesium and vitamin B6 in alleviating the symptomsemerged during clinical exacerbations in childrenaged 7-14 years suffering from Tourette syndrome(TS). We also aimed to determine the meanand the standard deviation of such an improvementin order to estimate sample sizes in future assayswith a control group.PATIENTS AND METHOD: The treatment under investigationwas administered to children diagnosed withTS, in accordance with Diagnostic and StatisticalManual of Mental Disorders, fourth edition -IV, underconditions of clinical exacerbation. The effectswere scored on the Yale Global Tics Severity Scale(YGTSS) at 0, 15, 30, 60 and 90 days.RESULTS: The total tics score decreased from 26.7(t0) to 12.9 (t4) and the total effect on the YGTSSwas a reduction from 58.1 to 18.8. Both resultswere statistically significant. With respect to theapplication of conventional treatment or otherwise,no significant differences were observed. No sideeffects were seen.CONCLUSIONS: The treatment assayed is safe and effectivein reducing the harmful effects of TS inchildren. Further studies are needed, with a controlgroup, and evaluation of different doses of thedrugs

[Prevalence of tuberculosis infection in BCG-vaccinated and unvaccinated Mediterranean schoolchildren]. / Prevalencia de infección por tuberculosis en una población escolar mediterránea (con y sin vacunación antituberculosa).

OBJECTIVE: To determine the prevalence of tuberculous infection in schoolchildren in the province of Malaga, Spain, and to evaluate its relation to sociodemographic variables. POPULATION AND METHODS: Tuberculin skin tests were used to screen 6-year-olds in their first year of primary school in this cross-sectional study of the prevalence of infection, with calculation of 95% confidence interval (CI). Children who had not been vaccinated against tuberculosis at birth were considered to have a positive test result if they had an induration of >or=5 mm. Those who had received bacillus Calmette-Guerin (BCG) vaccination at birth were considered to have a positive test result if they had an induration size of >10 mm or >15 mm, depending on whether they came from a country with a high or low prevalence of tuberculosis, respectively. RESULTS: The prevalence of infection in the group of unvaccinated children was 1.16% (95% CI, 0.69%-1.63%). No statistically significant differences were found for any of the sociodemographic variables analyzed. The prevalence of infection in the BCG-vaccinated children was 6.66% (95% CI, 5.55%-7.77%). CONCLUSIONS: The prevalence of tuberculosis infection in our area is slightly higher than that reported after other studies conducted in Spain. This could indicate that tuberculosis continues to be a public health problem in the province of Malaga. Infection in the subgroup of BCG-vaccinated children, however, was lower than that observed in studies of immigrants in Spain who had been immunized at birth. This is probably because the majority of immigrants in our area come from countries with a low incidence of tuberculosis.

Prevalencia de infección por tuberculosis en una población escolar mediterránea (con y sin vacunación antituberculosa) / Prevalence of tuberculosis infection in BCG-vaccinated and unvaccinated mediterranean schoolchildren

Objetivo: Conocer la prevalencia de infección por tuberculosis en la población escolar de la Costa del Sol y valorar la relación de variables sociodemográficas con la prevalencia de infección tuberculosa. Población y métodos: Se trata de un estudio de corte transversal, en el que se realizó cribado tuberculínico a los niños de primer curso de primaria (6 años). El índice epidemiológico analizado fue la prevalencia de infección, con su intervalo de confianza (IC) del 95%. Se consideró positivo a la prueba de la tuberculina a todo niño que no había recibido la vacuna antituberculosa al nacer y que presentaba una induración igual o superior a 5 mm. En el subgrupo vacunado contra la tuberculosis al nacer se consideró positivos a los niños con induración superior a 10 mm o a 15 mm, según procediesen de países con elevada o baja prevalencia de tuberculosis, respectivamente. Resultados: La prevalencia de infección obtenida en el grupo de no vacunados fue del 1,16% (IC del 95%, 0,69-1,63%). No se encontraron diferencias estadísticamente significativas entre las variables analizadas. La prevalencia de infección en el subgrupo de vacunados fue del 6,66% (IC del 95%, 5,55-7,77%). Conclusiones: La prevalencia de infección tuberculosa en nuestra zona es ligeramente elevada en comparación con la observada en otros estudios realizados en nuestro país, lo que podría indicar que la tuberculosis sigue siendo un problema de salud pública en nuestra provincia. No ocurre así con el subgrupo de vacunados contra la tuberculosis, en el que, comparado con los de otros estudios realizados en nuestro país entre la población inmigrante vacunada al nacer, la prevalencia es baja, probablemente debido a que la mayoría de inmigrantes de la Costa del Sol proviene de países con baja incidencia de la enfermedad

Objective: To determine the prevalence of tuberculous infection in schoolchildren in the province of Malaga, Spain, and to evaluate its relation to sociodemographic variables. Population and methods: Tuberculin skin tests were used to screen 6-year-olds in their first year of primary school in this cross-sectional study of the prevalence of infection, with calculation of 95% confidence interval (CI). Children who had not been vaccinated against tuberculosis at birth were considered to have a positive test result if they had an induration of é5 mm. Those who had received bacillus Calmette­Guerin (BCG) vaccination at birth were considered to have a positive test result if they had an induration size of >10 mm or >15 mm, depending on whether they came from a country with a high or low prevalence of tuberculosis, respectively. Results: The prevalence of infection in the group of unvaccinated children was 1.16% (95% CI, 0.69%-1.63%). No statistically significant differences were found for any of the sociodemographic variables analyzed. The prevalence of infection in the BCG-vaccinated children was 6.66% (95% CI, 5.55%-7.77%). Conclusions: The prevalence of tuberculosis infection in our area is slightly higher than that reported after other studies conducted in Spain. This could indicate that tuberculosis continues to be a public health problem in the province of Malaga. Infection in the subgroup of BCG-vaccinated children, however, was lower than that observed in studies of immigrants in Spain who had been immunized at birth. This is probably because the majority of immigrants in our area come from countries with a low incidence of tuberculosis

Renal failure and acquired hypothyroidism.

The effects of thyroid metabolism on renal function in children are barely referred to in the literature. Primary hypothyroidism is known to be associated with a consistent elevation in serum creatinine levels. This is essentially because of the hypodynamic state that occurs in hypothyroidism, leading to a reduced glomerular filtration rate and hypercreatinemia. A teenager who developed renal failure due to primary hypothyroidism is reported. He displayed diverse serum biochemistry anomalies with an unremarkable physical examination. Thyroxine replacement therapy completely restored the euthyroid state and renal function. We propose, in accordance with other authors, measurement of thyrotropin levels in patients with hypercreatinemia.