Revisión sistemática sobre la eficacia de racecadotrilo en el tratamiento de la diarrea aguda / Systematic review of the efficacy of racecadotril in the treatment of acute diarrhoea

Objetivo: Obtener un estimador de la eficacia del racecadotrilo en el tratamiento de la diarrea aguda mediante revisión sistemática y metaanálisis. Material y métodos: Se seleccionaron ensayos clínicos de calidad realizados en niños en los que se compara la eficacia del racecadotrilo frente a placebo en cuanto a duración de los síntomas, cantidad de deposiciones y efectos secundarios. La búsqueda se ha realizado en bases electrónicas (Med-line, EMBASE, CENTRAL, CINAHL, mRCT, Pascal), en las referencias de los artículos recuperados y mediante contacto con el fabricante, hasta diciembre de 2007. Dos evaluadores independientes han evaluado la calidad. Resultados: Se seleccionaron dos ensayos de muestra pequeña (135 y 172 niños, todos hospitalizados) y de calidad media. Éstos incluyen a niños de edades comprendidas entre 3 meses y 4 años con diarrea aguda de menos de 5 días de evolución a quienes al tratamiento habitual se añade racecadotrilo o placebo. No existen diferencias en la proporción de niños enfermos al quinto día (riesgo relativo [RR] = 0,73; intervalo de confianza [IC] del 95 %, 0,29-1,81). Se demuestra una eficacia leve en el volumen de las deposiciones en las primeras 48 h (diferencia estandarizada de medias [DEM] = -0,65; IC 95 %, -0,88 a -0,42). No se observan diferencias en los efectos secundarios (vómitos, RR = 1,16; IC 95 %, 0,64-2,12). Conclusión: La proporción de curados al quinto día no mejora añadiendo racecadotrilo al tratamiento habitual, si bien disminuye el volumen de deposiciones en las primeras 48 h. Sería interesante estudiar la eficacia en atención primaria valorando el número y volumen de las deposiciones y la duración y número de ingresos (AU)

Objective: To estimate, through a systematic review of the literature, the efficacy of racecadotril in the treatment of acute diarrhoea. Material and methods: Randomised trials carried out in children comparing racecadotril with placebo in terms of diarrhoea recovery, stools output and adverse effects were selected. Electronic databases (Medline, EMBASE, CENTRAL, CINAHL, mRCT, Pascal) and bibliographies of retrieved articles were searched, and the drug developer was contacted. Two authors independently assessed the quality of the retrieved articles and extracted the data. Results: Two small sample size randomised trials (135 and 172 children) of moderate quality were selected. They included children with less than five days diarrhoea and aged between 3 months and 4 years. There was no difference in the proportion of children who recovered by day 5 (RR = 0.73, CI95 % 0.29 to 1.81), although the stools volume during the first 48 hours was less in the racecadotril group (SMD = -0.65, CI95 % -0.88 to -0.52). There is no difference in the risk of vomiting (RR = 1.16, CI95 % 0.64 to 2.12). Conclusion: The proportion of recoveries by the 5th day is the same, although the stool volumes during the first 48 hours are less in the racecadotril treated children. It would be interesting to study the efficacy in a primary care setting assessing the cure rate, the stool volumes and the admission rate to elucidate if there is room for this drug (AU)

[Systematic review of the efficacy of racecadotril in the treatment of acute diarrhoea]. / Revisión sistemática sobre la eficacia de racecadotrilo en el tratamiento de la diarrea aguda.

OBJECTIVE: To estimate, through a systematic review of the literature, the efficacy of racecadotril in the treatment of acute diarrhoea. MATERIAL AND METHODS: Randomised trials carried out in children comparing racecadotril with placebo in terms of diarrhoea recovery, stools output and adverse effects were selected. Electronic databases (Medline, EMBASE, CENTRAL, CINAHL, mRCT, Pascal) and bibliographies of retrieved articles were searched, and the drug developer was contacted. Two authors independently assessed the quality of the retrieved articles and extracted the data. RESULTS: Two small sample size randomised trials (135 and 172 children) of moderate quality were selected. They included children with less than five days diarrhoea and aged between 3 months and 4 years. There was no difference in the proportion of children who recovered by day 5 (RR=0.73, CI 95% 0.29 to 1.81), although the stools volume during the first 48 hours was less in the racecadotril group (SMD=-0.65, CI 95% -0.88 to -0.52). There is no difference in the risk of vomiting (RR=1.16, CI 95% 0.64 to 2.12). CONCLUSION: The proportion of recoveries by the 5th day is the same, although the stool volumes during the first 48 hours are less in the racecadotril treated children. It would be interesting to study the efficacy in a primary care setting assessing the cure rate, the stool volumes and the admission rate to elucidate if there is room for this drug.

Glucocorticoides inhalados y sibilancias posbronquiolitis / Inhaled corticosteroids and wheezing post-bronchiolitis

OBJETIVO: Determinar si el tratamiento con glucocorticoides inhalados durante 3 meses, después de una bronquiolitis leve, disminuye la incidencia y/o la gravedad de los episodios de sibilancias durante los siguientes 12 meses. DISEÑO: Estudio de intervención, multicéntrico, controlado, en grupos paralelos, con asignación aleatoria por bloques. ÁMBITO DE ESTUDIO: Centros de atención primaria de Lezo, Beraun, Andoain e Irún (Gipuzkoa). SUJETOS DEL ESTUDIO: Niños menores de 12 meses (n = 94) diagnosticados de bronquiolitis leve. INSTRUMENTALIZACIÓN: Se establecieron dos grupos de sujetos: grupo 1 (n = 47), tratados con beclometasona inhalada (250 mg/12 h) con cámara espaciadora Babyhaler(r), 8 días después del diagnóstico de bronquiolitis durante 3 meses; grupo 2 (n = 47), sin tratamiento. Se han comparado el número y gravedad de los episodios de sibilancias durante el período de intervención (3 meses) y durante el período de seguimiento (12 meses), mediante las pruebas de la t de Student y la ?2. RESULTADOS: Se han estudiado 89 niños (grupo 1, n = 42; grupo 2, n = 47). El 67 por ciento presentaron episodios de sibilancias durante el período del estudio (15 meses). No hubo diferencias significativas entre ambos grupos en los dos períodos estudiados. CONCLUSIÓN: El tratamiento con beclometasona durante 3 meses no modifica los episodios de sibilancias durante el tratamiento ni en los 12 meses siguientes (AU)

[Inhaled corticosteroids and wheezing post-bronchiolitis]. / Glucocorticoides inhalados y sibilancias posbronquiolitis.

OBJECTIVE: To determine whether inhaled corticosteroid therapy given for 3 months after mild bronchiolitis decreases the incidence and/or severity of wheezing in the following 12 months. DESIGN: Multicentric, single-blind, controlled, randomised intervention study. SETTING: Primary Health Care Centers in Lezo, Beraun, Andoain and Irún (Gipuzkoa, Spain). PATIENTS: Infants less than 12 months old (n = 94) diagnosed with mild bronchiolitis. INTERVENTION: We established two groups of patients: group 1 (n = 47) was treated with inhaled beclomethasone (250 pg/12 hours) using a valved holding chamber (Babyhaler); the treatment started eight days after diagnosis of bronchiolitis and lasted 3 months. Group 2 (n = 47) received no treatment. We compared the number of wheezing episodes and their severity during the intervention period (3 months) and the follow-up period (12 months) with the Students t-test and the Chi-squared test. RESULTS: We studied 89 infants (group 1, n = 42; group 2, n = 47), 67% of whom wheezed during the study period (15 months). There were no significant differences between the treatment and the control group in the study periods. CONCLUSIONS: Inhaled beclomethasone given for 3 months does not significantly modify the occurrence of wheezing episodes during the treatment period or during the following 12 months.