Ensayo clínico aleatorizado, multicéntrico, controlado, de grupos paralelos, para evaluar la no inferioridad terapéutica de una dieta libre frente a una dieta progresiva, en el tratamiento de la diverticulitis aguda no complicada

Abstract

INTRODUCCIÓN En los pacientes con diverticulitis aguda no complicada (DANC) no es necesaria la restricción oral. Numerosos autores y guías clínicas aconsejan una dieta progresiva a base de líquidos durante 2-3 días y dieta blanda baja en fibra después. No existen estudios de evidencia nivel I que valoren los efectos de esta dieta, su tolerancia o su duración. Presentamos un ensayo clínico que evalúa la dieta en pacientes con DANC. HIPÓTESIS El efecto de la dieta libre (DL) no será inferior al de la dieta progresiva (DP) en los pacientes diagnosticados de DANC. Otros factores como la seguridad, el dolor, la tolerancia y parámetros relacionados con indicadores analíticos de inflamación permitirán afianzar su uso como alternativa a la DP. OBJETIVOS Demostrar la no inferioridad en términos de eficacia terapéutica, de una DL frente a una DP en el tratamiento de la DANC. Demostrar la no inferioridad en términos de seguridad terapéutica, de una DL frente a una DP en el tratamiento de la DANC. Comparar la tolerancia oral, el dolor y las variaciones de temperatura y de parámetros analíticos en ambos grupos de tratamiento.

MATERIAL Y MÉTODO Se realizó un ensayo clínico randomizado, multicéntrico, en pacientes con DANC entre abril de 2.018 y mayo de 2.019. Los sujetos se aleatorizaron para comparar una DL frente a una DP. Para valorar la eficacia terapéutica, se realizó un análisis de no inferioridad teniendo en cuenta el fracaso del tratamiento considerado como el número de pacientes que presentaron: empeoramiento en la escala Hinchey modificada y/o cirugía, precisaron ingreso o fallecieron en cada grupo. Respecto a la seguridad terapéutica se tuvo en cuenta la proporción de complicaciones y acontecimientos adversos ocurridos en el primer mes. Para evaluar el cumplimiento de los objetivos secundarios se tuvieron en cuenta, la tolerancia a la dieta, la intensidad del dolor, la temperatura, los niveles de PCR, leucocitos y la relación neutrófilos/linfocitos, con controles el día 0, 3º, 7º y 30º. En relación con la calidad de vida relacionada con la salud (CVRS) se entregó el cuestionario SF-12 en ambos grupos. RESULTADOS Se incluyeron un total de 132 pacientes (66 en cada grupo). La edad media fue de 55.7 (DT13.8) años y el 52.3% eran varones. Ambos grupos del estudio eran homogéneos en características demográficas y antropométricas.

INTRODUCTION A restrictive diet is not necessary in patients with acute uncomplicated diverticulitis (AUD). Many authors and clinical guides advise a progressive, liquid-based diet over a period of 2-3 days, and a low-fibre, bland diet afterwards. There are no Level I studies that assess the effects of this diet regarding tolerance or duration. This clinical trial assesses diet in patients with AUD. HYPOTHESIS The effects of a free diet (FD) will not be lower than those of a progressive diet (PD) in patients diagnosed with AUD. Other factors such as safety, pain, tolerance and parameters related to the inflammation analytics indicators will permit consolidating the use of a free diet as an alternative to PD. OBJECTIVES To prove non-inferiority of an FD compared to a PD in terms of AUD treatment efficacy. To prove non-inferiority of an FD compared to a PD in terms of AUD treatment safety. To compare diet tolerance, pain and temperature variations and analytics parameters in both treatment groups.

MATERIAL AND METHOD A randomised, multi-site clinical trial was conducted on AUD patients between April 2018 and May 2019. The subjects were randomised to compare an FD with a PD. In order to assess the treatment efficacy, a non-inferiority analysis was conducted considering treatment failure, considering such to be the number of patients who reported: a worsening on the modified Hinchey classification and/or surgery, who required hospitalisation or who deceased in each group. In regard to treatment safety, the proportion of complications and adverse events in the first month were taken into account. To assess fulfilment of the secondary objectives, diet tolerance, pain intensity, temperature, PCR levels, leukocytes and the neutrophil/lymphocyte ratio were taken into account, with controls performed on days 0, 3, 7 and 30. The questionnaire SF-12 was given to both groups to assess their quality of life in regard to health (QOLQ). RESULTS A total of 132 patients were included in the trial (66 in each group). The mean age was 55.7 years (SD 13.8) of whom 52.3% were males. Both groups had uniform demographic and anthropometric characteristics.

Treatment failure was reported in 7 patients, 4 in FD and 3 in PD, without any significant differences between the groups being reported (P=1.000). The FD has been proved to be non-inferior to the PD. After analysing the results, we did not find any statistically significant differences in regard to complications, thus demonstrating that an FD is not inferior to a PD in this sense. Neither did we observe any statistically significant differences in regard to diet tolerance, pain, temperature or analytics parameters between the two groups. CONCLUSIONS It has been proved that a free diet is not inferior to a progressive diet in terms of treatment failure in patients with acute uncomplicated diverticulitis. It has been proved that a free diet is not inferior to a progressive diet in terms of complications appearing in patients with acute uncomplicated diverticulitis. A free diet is similar in terms of pain intensity, temperature curve, diet tolerance and variations in inflammation biochemical parameters compared to a progressive diet. A free diet accounts for comparable treatment to a progressive diet in terms of efficacy and safety, and we should therefore consider that it can be recommended in the treatment of acute uncomplicated diverticulitis, thus contributing to a more normal lifestyle for patients.