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

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.