Eficacia de la dieta alta en fibra en la mejora del estreñimiento en pacientes con disinergia defecatoria en tratamiento con biofeedback anorrectal. Ensayo clínico exploratorio, aleatorizado / Effectiveness of a high fiber diet in improving constipation in patients with defecatory dyssynergy under treatment with anorrectal biofeedback. Exploratory, randomized clinical trial

Introducción: La fibra es el tratamiento inicial en el estreñimiento crónico funcional. Sin embargo, su papel en el grupo de pacientes con disinergia defecatoria no está bien establecido. El objetivo del estudio es evaluar la eficacia y la seguridad de la dieta alta en fibra en pacientes con disinergia defecatoria en el tratamiento con biofeedback anorrectal. Pacientes y métodos: Se realizó un ensayo clínico exploratorio, aleatorizado (1:1), doble ciego, controlado add-on, en un centro de referencia en España en pacientes con estreñimiento funcional y disinergia defecatoria de acuerdo con criterios de ROMAIV. Grupo control: tratamiento con biofeedback y dieta baja en fibra (15-20g/día). Grupo experimental: tratamiento con biofeedback y dieta alta en fibra (25-30g/día). Se analizó: respondedor (variable principal), paciente en quien la disinergia defecatoria se había corregido (>20% de reducción de la presión anal durante la maniobra defecatoria y prueba de expulsión del balón normal); parámetros anorrectales (relajación anal, reducción del esfuerzo); seguridad (síntomas abdominales: flatulencia, dolor, borborigmo, distensión). Resultados: Un total de 44 pacientes fueron aleatorizados: 22 por grupo. El porcentaje de respondedores fue del 75% (15/20; IC95%: 53-89%) grupo control y 70% (14/20; IC95%: 48-85%) grupo experimental, p=0,225. Solo se observaron diferencias a favor del grupo control en síntomas abdominales: flatulencias (p=0,028), distensión abdominal (p=0,041) y bienestar digestivo (p=0,043). Conclusión: En pacientes con disinergia defecatoria la dieta alta en fibra no solo no mejora la eficacia del biofeedback anorrectal, sino que se asocia a una pérdida de la mejoría de los síntomas abdominales. (AU)

Introduction: Fiber is the initial treatment in chronic functional constipation. However, its role in the group of patients with defecatory dyssynergy is not well established. The objective of the study is to evaluate the efficacy and safety of a high fiber diet in patients with defecatory dyssynergy in the treatment with anorectal biofeedback. Patients and methods: An exploratory, randomized (1:1), double-blind, controlled «add-on» clinical trial was carried out in a reference center in Spain in patients with functional constipation and defecatory dyssynergy according to the ROMEIV criteria. Control group: treatment with biofeedback and low-fiber diet (15-20g/day). Experimental group: treatment with biofeedback and high fiber diet (25-30g/day). Analyzed: responder (primary endpoint), patient whose defecatory dyssynergy had been corrected (>20% reduction in anal pressure during the defecation maneuver and normal balloon expulsion test); anorectal parameters (anal relaxation, reduced straining); safety (abdominal symptoms: flatulence, pain, borborygmus, bloating). Results: A total of 44 patients were randomized: 22 per group. The percentage of responders was 75% (15/20; 95%CI: 53 89%) control group and 70% (14/20; 95%CI: 48-85%) experimental group, P=.225. Differences in favor of the control group were only observed in abdominal symptoms: flatulence (P=.028), abdominal distension (P=.041) and digestive comfort (P=.043). Conclusions: In patients with defecatory dyssynergy, a high-fiber diet not only does not improve the efficacy of anorectal biofeedback but is associated with a loss of improvement in abdominal symptoms. (AU)

Effectiveness of a high fiber diet in improving constipation in patients with defecatory dyssynergy under treatment with anorrectal biofeedback. Exploratory, randomized clinical trial. / Eficacia de la dieta alta en fibra en la mejora del estreñimiento en pacientes con disinergia defecatoria en tratamiento con biofeedback anorrectal. Ensayo clínico exploratorio, aleatorizado.

INTRODUCTION: Fiber is the initial treatment in chronic functional constipation. However, its role in the group of patients with defecatory dyssynergy is not well established. The objective of the study is to evaluate the efficacy and safety of a high fiber diet in patients with defecatory dyssynergy in the treatment with anorectal biofeedback. PATIENTS AND METHODS: An exploratory, randomized (1:1), double-blind, controlled «add-on¼ clinical trial was carried out in a reference center in Spain in patients with functional constipation and defecatory dyssynergy according to the ROMEIV criteria. CONTROL GROUP: treatment with biofeedback and low-fiber diet (15-20g/day). Experimental group: treatment with biofeedback and high fiber diet (25-30g/day). Analyzed: responder (primary endpoint), patient whose defecatory dyssynergy had been corrected (>20% reduction in anal pressure during the defecation maneuver and normal balloon expulsion test); anorectal parameters (anal relaxation, reduced straining); safety (abdominal symptoms: flatulence, pain, borborygmus, bloating). RESULTS: A total of 44 patients were randomized: 22 per group. The percentage of responders was 75% (15/20; 95%CI: 53 89%) control group and 70% (14/20; 95%CI: 48-85%) experimental group, P=.225. Differences in favor of the control group were only observed in abdominal symptoms: flatulence (P=.028), abdominal distension (P=.041) and digestive comfort (P=.043). CONCLUSIONS: In patients with defecatory dyssynergy, a high-fiber diet not only does not improve the efficacy of anorectal biofeedback but is associated with a loss of improvement in abdominal symptoms.