A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care.

INTRODUCTION: The clinical effect of domperidone against COVID-19 has been investigated in a double-blind phase III clinical trial (EudraCT number 2021-001228-17). Domperidone has shown in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential immudolatory properties through the stimulation of prolactin secretion. PATIENTS AND METHODS: The efficacy of oral domperidone plus standard of care (SOC; n = 87) versus placebo plus SOC (n = 86) was evaluated in a 28-day randomized double-blind multicentre study in primary health care centres. A total of 173 outpatients with mild-to-moderate COVID-19 were included. Three daily doses of 10 mg (30 mg/day) of domperidone or placebo were administered for 7 days. Reduction of viral load on day 4 was the primary efficay endpoint. It was estimated in saliva samples by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), as the cycle thresholds detected ORF1ab, N Protein and S Protein genes. RESULTS: A significant reduction in the viral load was observed (p < 0.001) from baseline to days 4, 7 and 14 of the three genes studied with non-significant differences between domperidone and placebo groups. Twenty-three patients (13.3%) experienced adverse events, 14 patients in the domperidone group (16.1%) and 9 patients in the placebo group (10.5%). No patients needed to be hospitalized. CONCLUSION: Results do not prove the use of domperidone as antiviral in patients with COVID-19.

A 28-day double-blind clinical trial was performed to investigate the antiviral effect of domperidone, 30 mg/day for 7 days (n = 87) versus placebo (n = 86) in outpatients with mild-to-moderate COVID-19.The primary efficacy endpoint was the reduction of viral load on day 4 as compared with baseline, estimated as the cycle thresholds to detect ORF1ab, N Protein and S Protein genes by RT-qPCR in saliva samples.The study findings do not prove the use of domperidone as antiviral in patients with COVID-19.

Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study.

BACKGROUND: The World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding. Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions. METHODS: This study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate. The main response variable is mother-infant pairs using exclusive breast-feeding at six months. Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models. DISCUSSION: We must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).

Adecuación de la solicitud de la microalbuminuria en pacientes con diabetes mellitus en atención primaria / Adaptation of the request for microalbuminuria in patients with diabetes mellitus in primary care

Objetivo. Evaluar el grado de cumplimiento en la determinación anual de MAU en los pacientes diabéticos. Metodología. Estudio observacional descriptivo transversal, donde se seleccionaron 381 historias clínicas de pacientes con DM2 en 3 equipos de atención primaria de Madrid. Se recogieron datos sociodemográficos y de enfermedades concomitantes, se determinó la fecha de solicitud anual de MAU, así como la existencia de MAU patológica y se evaluó el cumplimiento en la solicitud de la HbA1c y del perfil lipídico en el último año. Resultados. Fueron evaluados 298 pacientes (edad media: 55,7 años; desviación estándar 7,51 y el 57,7% varones). Se ha solicitado la MAU en el 42,3% (IC 95%: 36,5–48,05) de los casos, pero en los pacientes con antecedentes de ECV, desciende al 25,6% (p: 0,017). El 59% presentaba HTA, el 43,3% tenía dislipemia, el 63,7% obesidad (IMC>30) y el 14,4% padecía alguna ECV asociada. En los 30 pacientes donde existen registros el 24,3%(IC 95%: 16,3–32,3) tenían la MAU alterada. El valor medio de la Hba1c fue de 6,87 (±1,57). Conclusiones. La petición de MAU en nuestro ámbito es deficiente. Los médicos y enfermeros deben concienciarse de la importancia de solicitar la MAU de forma sistemática (AU)

Objective. To evaluate the degree of compliance in the annual measurement of microalbuminuria in diabetic patients. Methods. A descriptive, cross-sectional observational study in which 381 clinical histories of patients with DM2 were selected in three teams of primary care centers of Madrid. Sociodemiographic and concomitant disease information were gathered, the date of the annual request for the microalbuminuria as well as the existence of pathological microalbuminuria were determined and compliance in the request for HbA1c and lipid profile in the last year was evaluated. Results. Two hundred ninety eight patients were evaluated (mean age: 55.7 years; SD 7.51 and 55.7% were males). Microalbuminuria was requested in 42.3% (95% CI: 36.5–48.05) of the cases, however, this decreased to 25.6% (p: 0.017) in patients with a background of cardiovascular disease (CVD). A total of 59% had arterial hypertension, 43.3% dyslipidemia, 63.7% obesity (BMI>30) and 10% had some associated cardiovascular disease. In the 30 patients for whom there were records, 24% (95% CI: 16.3–32.3) had altered microalbuminuria. The mean value of HbA1c was 6.87 (±1.57). Conclusions. Request for Microalbuminuria in our setting is deficient. Both physicians and nurses must become aware of the importance of the routine request for microalbuminuria (AU)