Efficacy of low-dose lansoprazole in the treatment of non-erosive gastrooesophageal reflux disease. Influence of infection by Helicobacter pylori.

INTRODUCTION: Proton pump inhibitors (PPIs) are the most effective drugs to cure peptic esophagitis and control the symptoms of gastroesophageal reflux disease (GERD). In most patients with GERD esophagitis is not detected by endoscopy, which represents GERD with a negative endoscopy or non-erosive reflux disease (NERD). The influence of infection by H. pylori in the evolution of GERD is controversial since a protective action is identified by some studies, but not all. We conducted a clinical trial to assess the efficacy of lansoprazole 15 mg/day in the initial control of NERD symptoms, and as a secondary endpoint the impact of H. pylori infection on response to treatment. PATIENTS AND METHODS: A pilot, single-center clinical trial was conducted--single-blind regarding the experimental medication (unknown to patients), and double-blind regarding the information concerning H. pylori infection. Sixty (60) patients with NERD were initially included, who had suffered from daytime or nocturnal heartburn for 1-2 days in each of the last two weeks. Nine patients were excluded for failing to comply with the study protocol. The 51 remaining patients, 35 women and 16 men, with a mean age of 49 years, comprised the per protocol analysis population. Patients received treatment for two weeks with a capsule of the study medication (15 mg/day of lansoprazole), with daily controls on the presence and severity of daytime and nocturnal heartburn. Treatment was considered effective when, upon completion, patients referred a maximum of one episode of mild heartburn as defined in the protocol, or answered the following question in the affirmative: "Does the medication you are receiving satisfactorily control the symptoms of your disease?". During diagnostic endoscopy we obtained biopsies of the gastric body and antrum to investigate infection by H. pylori by means of a urease test. Treatment efficacy was assessed with no patients or doctors responsible for the study being aware of urease test results. RESULTS: 41 patients (80.3%) reported that treatment had satisfactorily controlled their symptoms, and 34 patients (66.6%) had a maximum of one episode of mild heartburn in the last week. Forty-two (42) patients (82.3%) had infection by H. pylori. No significant differences were observed in the response to treatment between patients with or without H. pylori infection. CONCLUSIONS: With the limitations of a pilot study, these results suggest that lansoprazole 15 mg/day is an effective treatment in the control of NERD symptoms, that it may be a good initial therapeutic strategy, and that, according to data available, H. pylori infection has no significant effect on the response to treatment.

Eficacia de lansoprazol a dosis bajas en el tratamiento de la enfermedad por reflujo gastroesofágico no erosiva. Influencia de la infección por Helicobacter pylori / Efficacy of low-dose lansoprazole in the treatment of non-erosive gastrooesophageal reflux disease. Influence of infection by Helicobacter pylori

Introducción: los inhibidores de la bomba de protones (IBP) son los fármacos más eficaces en la curación de la esofagítis péptica y en el control de los síntomas de la enfermedad por reflujo gastroesofágico (ERGE). En la mayoría de los pacientes con ERGE no se detecta esofagitis al practicarse endoscopia presentando una ERGE con endoscopia negativa o no erosiva (ERNE). La influencia de la infección H. pylori en la evolución de la ERGE es controvertida, ya que mientras que unos estudios le asignan una acción protectora, otros se la niegan. Hemos realizado un ensayo clínico para valorar la eficacia de lansoprazol 15 mg/día en el control inicial de los síntomas de la ERNE y, como objetivo secundario, la influencia de la infección H. pylori en la respuesta al tratamiento. Pacientes y métodos: se realiza un ensayo clínico piloto, unicéntrico, simple ciego en cuanto a la medicación experimental, no conocida por los pacientes, y doble ciego en cuanto a la información de la infección por H. pylori. Se incluyeron inicialmente 60 pacientes con ERNE que presentaban al menos dos días con pirosis diurna o nocturna en cada una de las dos últimas semanas. Se excluyeron 9 pacientes por incumplimiento del protocolo del estudio. Los 51 pacientes restantes, 35 mujeres y 16 hombres, con edad media de 49 años, constituyeron la población de análisis por protocolo. Los pacientes recibieron tratamiento durante dos semanas con una cápsula de la medicación de estudio (15 mg/día de lansoprazol), realizándose en este tiempo un seguimiento diario de la presencia e intensidad de la pirosis diurna y nocturna. Se consideró que el tratamiento era eficaz cuando a su finalización los pacientes referían haber presentado como máximo un episodio de pirosis de intensidad leve, según definición del protocolo, o bien respondían afirmativamente a la siguiente pregunta: “¿la medicación que recibe le controla de forma satisfactoria los síntomas de su enfermedad?”. Durante la endoscopia diagnóstica se obtuvieron biopsias de cuerpo y antro gástrico para investigar, mediante test de la ureasa, la infección por H. pylori. Se valoró la eficacia del tratamiento sin conocerse por los pacientes y médicos responsables del estudio los resultados de los test de ureasa. Resultados: cuarenta y un pacientes (80,3%) referían que el tratamiento les controlaba de forma satisfactoria la sintomatología y 34 pacientes (66,6%) habían presentado como máximo un episodio de pirosis de intensidad leve en la última semana. Cuarenta y dos pacientes (82,3%) presentaban infección por H. pylori. No se observaron diferencias significativas en la respuesta al tratamiento en los pacientes con o sin infección por H. pylori. Conclusiones: con las limitaciones propias de un estudio piloto, estos resultados, orientan a que lansoprazol 15 mg/día es un tratamiento eficaz en el control de la sintomatología de la ERNE, pudiendo ser una buena estrategia terapéutica inicial y que, con los datos disponibles, la infección por H. pylori no influye de forma significativa en la respuesta al tratamiento

Introduction: proton pump inhibitors (PPIs) are the most effective drugs to cure peptic esophagitis and control the symptoms of gastroesophageal reflux disease (GERD). In most patients with GERD esophagitis is not detected by endoscopy, which represents GERD with a negative endoscopy or non-erosive reflux disease (NERD). The influence of infection by H. pylori in the evolution of GERD is controversial since a protective action is identified by some studies, but not all. We conducted a clinical trial to assess the efficacy of lansoprazole 15 mg/day in the initial control of NERD symptoms, and as a secondary endpoint the impact of H. pylori infection on response to treatment. Patients and methods: a pilot, single-center clinical trial was conducted –single-blind regarding the experimental medication (unknown to patients), and double-blind regarding the information concerning H. pylori infection. Sixty (60) patients with NERD were initially included, who had suffered from daytime or nocturnal heartburn for 1-2 days in each of the last two weeks. Nine patients were excluded for failing to comply with the study protocol. The 51 remaining patients, 35 women and 16 men, with a mean age of 49 years, comprised the per protocol analysis population. Patients received treatment for two weeks with a capsule of the study medication (15 mg/day of lansoprazole), with daily controls on the presence and severity of daytime and nocturnal heartburn. Treatment was considered effective when, upon completion, patients referred a maximum of one episode of mild heartburn as defined in the protocol, or answered the following question in the affirmative: “Does the medication you are receiving satisfactorily control the symptoms of your disease?”. During diagnostic endoscopy we obtained biopsies of the gastric body and antrum to investigate infection by H. pylori by means of a urease test. Treatment efficacy was assessed with no patients or doctors responsible for the study being aware of urease test results. Results: 41 patients (80.3%) reported that treatment had satisfactorily controlled their symptoms, and 34 patients (66.6%) had a maximum of one episode of mild heartburn in the last week. Forty-two (42) patients (82.3%) had infection by H. pylori. No significant differences were observed in the response to treatment between patients with or without H. pylori infection. Conclusions: with the limitations of a pilot study, these results suggest that lansoprazole 15 mg/day is an effective treatment in the control of NERD symptoms, that it may be a good initial therapeutic strategy, and that, according to data available, H. pylori infection has no significant effect on the response to treatment