Probiotics for induction of remission in ulcerative colitis

Background Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first‐ or second‐line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response. Objectives To assess the efficacy of probiotics compared with placebo or standard medical treatment (5‐aminosalicylates, sulphasalazine or corticosteroids) for the induction of remission in people with active ulcerative colitis. Search methods We searched CENTRAL, MEDLINE, Embase, and two other databases on 31 October 2019. We contacted authors of relevant studies and manufacturers of probiotics regarding ongoing or unpublished trials that may be relevant to the review, and we searched ClinicalTrials.gov. We also searched references of trials for any additional trials. Selection criteria Randomised controlled trials (RCTs) investigating the effectiveness of probiotics compared to standard treatments or placebo in the induction of remission of active ulcerative colitis. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors Data collection and analysis Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE methodology. Main results In this review, we included 14 studies (865 randomised participants) that met the inclusion criteria. Twelve of the studies looked at adult participants and two studies looked at paediatric participants with mild to moderate ulcerative colitis, the average age was between 12.5 and 47.7 years. The studies compared probiotics to placebo, probiotics to 5‐ASA and a combination of probiotics plus 5‐ASA compared to 5‐ASA alone. Seven studies used a single probiotic strain and seven used a mixture of strains. The studies ranged from two weeks to 52 weeks. The risk of bias was high for all except two studies due to allocation concealment, blinding of participants, incomplete reports of outcome data and selective reporting. This led to GRADE ratings of the evidence ranging from moderate to very low. Probiotics versus placebo Probiotics may induce clinical remission when compared to placebo (RR 1.73, 95% CI 1.19 to 2.54; 9 studies, 594 participants; low‐certainty evidence; downgraded due to imprecision and risk of bias, number needed to treat for an additional beneficial outcome (NNTB) 5). Probiotics may lead to an improvement in clinical disease scores (RR 2.29, 95% CI 1.13 to 4.63; 2 studies, 54 participants; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.04, 95% CI 0.42 to 2.59; 7 studies, 520 participants). Reported adverse events included abdominal bloating and discomfort. Probiotics did not lead to any serious adverse events in any of the seven studies that reported on it, however five adverse events were reported in the placebo arm of one study (RR 0.09, CI 0.01 to 1.66; 1 study, 526 participants; very low‐certainty evidence; downgraded due to high risk of bias and imprecision). Probiotics may make little or no difference to withdrawals due to adverse events (RR 0.85, 95% CI 0.42 to 1.72; 4 studies, 401 participants; low‐certainty evidence). Probiotics versus 5‐ASA There may be little or no difference in the induction of remission with probiotics when compared to 5‐ASA (RR 0.92, 95% CI 0.73 to 1.16; 1 study, 116 participants; low‐certainty evidence; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.33, 95% CI 0.53 to 3.33; 1 study, 116 participants). Reported adverse events included abdominal pain, nausea, headache and mouth ulcers. There were no serious adverse events with probiotics, however perforated sigmoid diverticulum and respiratory failure in a patient with severe emphysema were reported in the 5‐ASA arm (RR 0.21, 95% CI 0.01 to 4.22; 1 study, 116 participants; very low‐certainty evidence). Probiotics combined with 5‐ASA versus 5‐ASA alone Low‐certainty evidence from a single study shows that when combined with 5‐ASA, probiotics may slightly improve the induction of remission (based on the Sunderland disease activity index) compared to 5‐ASA alone (RR 1.22 CI 1.01 to 1.47; 1 study, 84 participants; low‐certainty evidence; downgraded due to unclear risk of bias and imprecision). No information about adverse events was reported. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes (progression to surgery, need for additional therapy, quality of life scores, or steroid withdrawal) were reported in any of the studies. Authors' conclusions Low‐certainty evidence suggests that probiotics may induce clinical remission in active ulcerative colitis when compared to placebo. There may be little or no difference in clinical remission with probiotics alone compared to 5‐ASA. There is limited evidence from a single study which failed to provide a definition of remission, that probiotics may slightly improve the induction of remission when used in combination with 5‐ASA. There was no evidence to assess whether probiotics are effective in people with severe and more extensive disease, or if specific preparations are superior to others. Further targeted and appropriately designed RCTs are needed to address the gaps in the evidence base. In particular, appropriate powering of studies and the use of standardised participant groups and outcome measures in line with the wider field are needed, as well as reporting to minimise risk of bias

Sobre el estado de las Revistas Iberolatinoamericanas dedicadas a las Ciencias de la Alimentación y la Nutrición

Rationale: Publishing of the results of a concluded research is the final step of the scientific activity. Choice of the literary container is determinant for the visibility and the impact of the scientific communication. Objective: To describe the state of the ibero-latin-american (ILA) journals devoted to publishing contents of the Food and Nutrition sciences. Study design: Descriptive. Methods: ILA journals specialized in publishing of contents of the Food and Nutrition sciences that where identified in selected literary repositories were described regarding the host country, the Publisher, the number of items comprising each volume, the adherence to the “Open Access” declaration, and the “Article Processing Charges” (APC) canon. Performance of the ILA journals was described by means of several metrics. Results: Twenty-seven journals were identified among 8 different countries. Journals differed regarding the publisher, number of items per volume, and adherence to the “Open Access” declaration. All (but one of) the examined journals accept original contributions without charging the APC canon. Visibility of ILA journals dedicated to Food and Nutrition sciences is poor when examined by means of different performance metrics. Conclusions: Visibility of ILA journals specialized in publishing contents of the Food and Nutrition sciences is poor, and that might explain (at least in part) their insufficient impact. A change of mentality and attitude towards the scientific publication is needed in order to increase the visibility, and consequently the impact of the journals dedicated in the ILA area to Food and Nutrition sciences.Introducción: La publicación de los resultados de una investigación terminada es el último paso de la actividad científica. La elección del contenedor literario es determinante para la visibilidad y el impacto de la comunicación científica. Objetivo: Describir el estado de las revistas Iberolatinoamericanas (ILA) dedicadas a la publicación de contenidos de las ciencias de la Alimentación y Nutrición. Diseño del estudio: Descriptivo. Métodos: Las revistas ILA verticalizadas en la publicación de contenidos de las ciencias de la Alimentación y la Nutrición que se identificaron en repositorios literarios seleccionados fueron descritas respecto del país sede, el auspiciador, el número de ítems que componen cada volumen, la adherencia a la declaración de “Acceso Abierto”, y el cobro de aranceles por publicación. El desempeño de las revistas ILA se describió mediante diferentes métricas. Resultados: Se identificaron 27 revistas en 8 países. Las revistas difirieron en cuanto al auspiciador, el número de ítems per volumen, y la adherencia a la declaración “Acceso Abierto”. Todas (menos una de) las revistas reseñadas aceptan las contribuciones originales sin cobrar aranceles por las tareas de edición/publicación. La visibilidad de las revistas ILA dedicadas a las ciencias de la Alimentación y la Nutrición es pobre cuando se examinan las métricas de desempeño. Conclusiones: La visibilidad de las revistas ILA verticalizadas en la publicación de contenidos de las ciencias de la Alimentación y la Nutrición es pobre, y ello podría explicar (en parte) el insuficiente impacto de las mismas. Se requiere un cambio de mentalidad y de actitud hacia la publicación científica para incrementar la visibilidad, y con ello, mejorar el impacto de las revistas del área dedicadas a las ciencias de la Alimentación y la Nutrición

Intervalos de referencia locales para la excreción urinaria de creatinina en una población adulta Local reference intervals for the excretion of creatinine in urine for an adult population

Objetivo: Presentar los intervalos de referencia, específicos para la talla y el sexo, de la excreción urinaria de creatinina para sujetos cubanos con edades entre 19-58 años. Trasfondo teórico: Los estándares propuestos por Bistrian (1985) para sujetos anglosajones sanos se han usado tradicionalmente para la construcción del índice de excreción de creatinina (IEC). Esta práctica puede conducir a errores diagnósticos en el caso del cálculo del IEC en otras poblaciones con diferentes composición corporal y hábitos dietéticos. Métodos: Se obtuvieron los valores de excreción urinaria de creatinina de 103 hombres y 112 mujeres con edades entre 19 y 58 años, y estado nutricional (peso dentro del rango intercuartil para la talla; 18,5 ≤ índice de masa corporal ≤ 30,0 kg/m²) y función renal (creatinina sérica ≤ 132 µmol/l) conservados, después del análisis retrospectivo de las bases de datos de la Sección de Orina del Servicio de Laboratorio Clínico del Hospital Clínico-Quirúrgico "Hermanos Ameijeiras" (La Habana, Cuba). En cada sexo, se construyeron las rectas de regresión excreción urinaria de creatinina = c + d · talla, con c, d: parámetros dependientes de la talla del sujeto. Los valores predichos de excreción urinaria de creatinina para los sujetos cubanos, específicos para el sexo, se derivaron de los intervalos de predicción (IP) al 100 (1-α) asociados a la recta de regresión. Resultados: La excreción urinaria de creatinina en un hombre cubano con una edad entre 19 y 58 años, talla de 170 cm y peso de 66,5 kg fue de 1.216,19 mg/24 horas (IP 95%: 821,02-1.611,36 mg/24 horas). La excreción urinaria de creatinina en una mujer cubana con una edad entre 19 y 58 años, talla de 160 cm y peso de 59,7 kg fue de 852,00 mg/24 horas (IP 95%: 420,15-1.283,84 mg/24 horas). Cuando se corrigió para el peso del sujeto, la excreción urinaria de creatinina de los sujetos cubanos fue menor que la observada en sujetos anglosajones que compartían las mismas propiedades biológicas. No se comprobó correlación entre la edad del sujeto y la excreción urinaria de creatinina. Conclusiones: Se recomienda emplear los valores de la excreción urinaria de creatinina obtenidos localmente y tabulados en este artículo para la realización de estudios de composición corporal y evaluación nutricional.Objetive: To present the height- and sex-specific reference intervals for the urinary excretion of creatinine in cuban subjects with ages between 19-58 years. Background: The standards advanced by Bistrian (1985) for anglosaxon subjects have been traditionally used for the construction of the Index of Creatinine Excretion (ICE). This practice could lead to diagnostic errors in the case of ICE calculation for non-anglosaxon populations differing in dietetic behaviour and body composition. Methods: Values of urinary excretion of Creatinine measured in 103 men and 112 women with ages between 19 and 58 years, and preserved nutritional wellbeing (weight within the interquartile range for height; 18.5 ≤ body mass index ≤ 30.0 kg/m²) and renal function (serum Creatinine ≤ 132 µmol/l) were drawn retrospectively from the databases of the Section of Urinalysis, Service of Clinical Laboratory, "Hermanos Ameijeiras" Hospital (La Habana, Cuba). For each sex, the regression line urinary- Excrecion-of-Creatinine = c + d · height, where c, d: parameters dependent on the subject’s height, were constructed. The predicted values of the urinary excretion of Creatinine for the cuban subjects were derived from the 100 (1-α)% prediction intervals (Pl) of the regression line. Results: The urinary excretion of Creatinine for a 170 cm-height, 66.5 kg-weight, cuban male with age between 19-58 years, was 1216.19 mg/24 hours (95% Pl: 821.02-1611.36 mg/24 hours). The urinary excretion of Creatinine for a 160 cm-height, 59.7kKg-weight, cuban female with age between 19-58 years, was 852.00 mg/24 hours (95% Pl: 420.15-1283.84 mg/24 hours). After taking into account the subject’s weight, the urinary excretion of Creatinine for the cuban subjects was lower than that of their anglosaxon counterparts. There was not correlation between the age of the subject and the urinary excretion of Creatinine. Conclusions: We recommend the use of the values of the urinary excretion of Creatinine tabulated in this article in the conduction of studies of body composition and nutritional assessment

Sobre la capacidad discriminativa de diferentes autoanticuerpos en el diagnóstico del Lupus Eritematoso Sistémico

Rationale. Several autoantibodies have been proposed for the differential diagnosis of Systemic Lupus Erythematosus (SLE). Use of these autoantibodies might result in different operational characteristics. Objective. To assess the operational characteristics of selected autoantibodies in the differential diagnosis of SLE. Study design. Retrospective, analytical. Study serie. One-hundred and sixty-nine subjects (SLE: 35.5 %; Non-SLE diseases of connective tissue: 38.5  %; Apparently healthy subjects: 26.0 %; Women: 84.6 %; Average age: 30.9 ± 17.9 years; Average evolution  time of lupic disease: 3.9 ± 4.7 years). Methods. Anti-double stranded DNA (anti-dsDNAdc), anti-nucleosomes (anti-Nuc), anti-Smith protein (anti- Sm) and anti-ribosomes (anti-Rib) autoantibodies were determined by immunoenzymatic techniques (Orgentec Diagnostika, Mainz, Alemania). Anti-nuclear antibodies (ANA) were indistinctely determined either by immunoenzimatic techniques (ANA-EIA) or immunofluorescent methods with Hep2 cells (ANAHep2). Operational characteristics of the autoantibodies in the differential diagnosis of SLE were calculated. In  addition, corresponding ROC curves for each instance of analysis were obtained, and diagnostic accuracy was estimated from the area under the ROC curve (AROC). Results. Accuracy of the autoantibodies used in the differential diagnosis of SLE was as follows (in descending order): anti-dsDNA: 0.9528 ± 0.0288; anti-Nuc: 0.7851 ± 0.0675; ANA-EIA: 0.7755 ± 0.2633; anti-Sm: 0.5926 ± 0.0790; anti-Rib: 0.5770 ± 0.2641; and ANA-Hep2: 0.5341 ± 0.2635; respectively. With the exception of  anti-dcDNA, operational characteristics of the remaining antibodies were dependent upon cut-off value,  sampled subpopulation, and analytical method. Conclusions. anti-dsDNA antibodies were the most accurate in the differential diagnosis of SLE.  Introducción. Se han propuesto varios autoanticuerpos en el diagnóstico diferencial del Lupus Eritematoso  Sistémico (LES). El uso de estos autoanticuerpos puede resultar en diferentes características operacionales. Objetivo. Evaluar las características operacionales de autoanticuerpos selectos en el diagnóstico diferencial  del LES. Diseño del estudio. Retrospectivo, analítico. Serie de estudio. Ciento sesenta y nueve sujetos (LES: 35.5 %; Enfermedades del tejido conectivo diferentes  del LES: 38.5 %; Sujetos aparentemente sanos: 26.0 %; Mujeres: 84.6 %; Edad promedio: 30.9 ± 17.9 años;  Tiempo promedio de evolución de la enfermedad lúpica: 3.9 ± 4.7 años). Métodos. Los anticuerpos anti-ADN de doble cadena (anti-ADNdc), anti-nucleosomas (anti-Nuc), antiproteína Smith (anti-Sm) y anti-ribosomas P (anti-Rib P) se determinaron mediante técnicas inmunoenzimáticas  (Orgentec Diagnostika, Mainz, Alemania). Los anticuerpos antinucleares (ANA) se determinaron  indistintamente mediante técnicas inmunoenzimáticas (ANA-EIA) e inmunofluorescentes con células Hep2 (ANA-Hep2). Se calcularon las características operacionales de los autoanticuerpos en el diagnóstico  diferencial del LES. Asimismo, se obtuvieron las correspondientes curvas ROC en cada instancia de análisis, y  se estimó la exactitud diagnóstica del anticuerpo del área bajo la curva ROC (AROC). Resultados. La exactitud de los anticuerpos empleados en el diagnóstico diferencial del LES fue como sigue  (en orden descendente): anti-ADNdc: 0.9528 ± 0.0288; anti-Nuc: 0.7851 ± 0.0675; ANA-EIA: 0.7755 ± 0.2633;  anti-Sm: 0.5926 ± 0.0790; anti-Rib P: 0.5770 ± 0.2641; y ANA-Hep2: 0.5341 ± 0.2635; respectivamente.  Excepción hecha de los anti-ADNdc, las características operacionales de los otros anticuerpos fueron  dependientes del punto de corte, la subpoblación muestreada, y el método analítico. Conclusiones. Los anticuerpos anti-ADNdc son los más exactos en el diagnóstico diferencial del LES.