ABSTRACT
The advancement of knowledge in pathophysiology and underlying etiologies of gastroesophageal reflux disease (GERD) has allowed the development of the concept of disease beyond the acidity of reflux. The variability in the symptom presentation and the response to treatment cannot be attributed only to reflux composition, since esophageal factors, such as structural, mechanical, biochemical, and physiological aspects, play an important role. The proposed personalized approach to GERD uses a stepwise approach that optimizes performance and phenotypic outcome while minimizing invasiveness, risk, and cost. Throughout the staggered approach to determine the GERD phenotype, clinicians may choose to stop further testing and continue treatment if available information identifies a different GERD phenotype. Since not all phenotypes GERD are the same and not all treatments are appropriate for all patients, therapeutic strategies must be personalized according to their phenotype.
El avance del conocimiento sobre la fisiopatología y la etiología subyacentes a la enfermedad por reflujo gastroesofágico (ERGE) ha permitido que el desarrollo de esta se extienda más allá de la acidez del reflujo. La variabilidad en la presentación de los síntomas y la respuesta al tratamiento no se puede atribuir solo a la composición del reflujo, ya que factores esofágicos, como aspectos estructurales, mecánicos, bioquímicos y fisiológicos, desempeñan un papel importante. El enfoque personalizado propuesto para la ERGE utiliza un método gradual que optimiza el rendimiento y el resultado fenotípico, y minimiza la invasividad, el riesgo y el costo. A lo largo del método escalonado para determinar el fenotipo de la ERGE, los médicos pueden optar por detener las pruebas adicionales y continuar con el tratamiento si la información disponible identifica un fenotipo de ERGE distinto. Dado que la ERGE no es la misma y no todos los tratamientos disponibles para controlarla son apropiados para todos los pacientes, las estrategias terapéuticas deben personalizarse de acuerdo con su fenotipo.
Subject(s)
Gastroesophageal Reflux , Humans , Gastroesophageal Reflux/etiology , Gastroesophageal Reflux/diagnosis , Retrospective StudiesABSTRACT
GOALS: We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS). BACKGROUND: IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials. MATERIALS AND METHODS: IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores. RESULTS: A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events. CONCLUSIONS: PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.
