RESUMEN
BACKGROUND: Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking. AIM: To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD. METHODS: A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours. RESULTS: Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003). CONCLUSION: Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).
Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Divertículo del Colon/tratamiento farmacológico , Mesalamina/uso terapéutico , Probióticos/uso terapéutico , Dolor Abdominal/etiología , Anciano , Antiinflamatorios no Esteroideos/administración & dosificación , Divertículo del Colon/patología , Método Doble Ciego , Femenino , Estudios de Seguimiento , Humanos , Lactobacillus , Masculino , Mesalamina/administración & dosificación , Persona de Mediana Edad , Prevención Secundaria , Resultado del TratamientoRESUMEN
BACKGROUND AND AIM: One-week triple therapy for Helicobacter pylori revealed, during these last few years, a decrease in the eradication rate, so that the prolongation of its duration has been proposed. A sequential scheme recently showed very satisfactory results. We performed a prospective randomised study with the aim of either evaluating whether the triple therapy prolongation may improve its effectiveness and comparing its outcome with that of sequential regimen. PATIENTS AND METHODS: Three hundred and forty-two H. pylori positive patients completed the study. They were randomised to receive one of the following treatments: (i) a 7-day triple therapy comprising of rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and amoxycillin (1 g, b.i.d.); (ii) a 10-day triple therapy comprising the same scheme; (iii) a 10-day sequential regimen comprising of rabeprazole (20 mg, b.i.d.) plus amoxycillin (1 g, b.i.d.) for 5 days followed by rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and tinidazole (500 mg, b.i.d.) for the next 5 days. Therapeutic results were expressed using both intention-to-treat and per protocol analyses with 95% confidence intervals. A model of multivariate logistic regression analysis was performed using therapeutic outcome as a dependent variable and including endoscopic finding, smoking habit, age and sex as candidates for the model. RESULTS: Sequential regimen showed a significant gain in the eradication rate as compared to the 7-day (P < 0.0001) and the 10-day (P < 0.01) triple therapies, respectively. Overall eradication was lower in smokers than in non-smokers, but the difference remained significant only in the 7-day triple therapy (P < 0.01). Additionally, the overall eradication was higher in peptic ulcer than dyspepsia (P < 0.01), even if this difference was significant only for both triple therapies. CONCLUSIONS: Seven-day triple therapy achieves disappointing eradication rates in dyspeptics and smokers. Prolonging triple therapy to 10 days does not significantly improve the eradication rate. The novel 10-day sequential regimen is more effective and equally tolerated than the 10-day triple therapy.
Asunto(s)
Infecciones por Helicobacter/tratamiento farmacológico , 2-Piridinilmetilsulfinilbencimidazoles , Amoxicilina/administración & dosificación , Amoxicilina/efectos adversos , Amoxicilina/economía , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Antibacterianos/economía , Antiulcerosos/administración & dosificación , Antiulcerosos/efectos adversos , Antiulcerosos/economía , Antitricomonas/administración & dosificación , Antitricomonas/efectos adversos , Antitricomonas/economía , Bencimidazoles/administración & dosificación , Bencimidazoles/efectos adversos , Bencimidazoles/economía , Claritromicina/administración & dosificación , Claritromicina/efectos adversos , Claritromicina/economía , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Quimioterapia Combinada , Dispepsia/tratamiento farmacológico , Dispepsia/microbiología , Femenino , Infecciones por Helicobacter/complicaciones , Helicobacter pylori , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Omeprazol/análogos & derivados , Cooperación del Paciente , Úlcera Péptica/tratamiento farmacológico , Úlcera Péptica/microbiología , Estudios Prospectivos , Rabeprazol , Fumar/epidemiología , Tinidazol/administración & dosificación , Tinidazol/efectos adversos , Tinidazol/economía , Resultado del TratamientoRESUMEN
BACKGROUND: A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate than standard 7-day therapy in both peptic ulcer disease and non-ulcer dyspepsia. Its higher performance has recently been confirmed using a halved clarithromycin dose in peptic ulcer disease. AIMS: To evaluate whether an acceptable eradication rate could also be obtained by halving the clarithromycin dose in dyspeptic patients and to assess the role of possible factors affecting the outcome of therapy. METHODS: In a prospective, open-label study, 162 patients with non-ulcer dyspepsia and Helicobacter pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either 10-day sequential therapy, comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (low-dose therapy), or a similar schedule with clarithromycin 500 mg b.d. (high-dose therapy). Four to six weeks after therapy, H. pylori eradication was assessed by endoscopy/histology. RESULTS: A similar H. pylori eradication rate was observed following low- and high-dose regimens for both per protocol (94% vs. 95%; P = N.S.) and intention-to-treat (93% vs. 94%; P = N.S.) analyses. No major side-effects were reported. Halving the clarithromycin dose leads to a per patient saving in pharmaceutical costs of 24.6 euros. None of the variables examined affected the effectiveness of eradication of the sequential regimen. CONCLUSION: A reduction of the clarithromycin dose does not affect H. pylori eradication with the sequential regimen in non-ulcer dyspepsia and affords lower costs.
Asunto(s)
Antiinfecciosos/administración & dosificación , Antiulcerosos/administración & dosificación , Bencimidazoles/administración & dosificación , Dispepsia/tratamiento farmacológico , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori , 2-Piridinilmetilsulfinilbencimidazoles , Amoxicilina/administración & dosificación , Antiinfecciosos/economía , Claritromicina/administración & dosificación , Costos de los Medicamentos , Quimioterapia Combinada/administración & dosificación , Dispepsia/economía , Femenino , Infecciones por Helicobacter/economía , Humanos , Masculino , Persona de Mediana Edad , Omeprazol/análogos & derivados , Estudios Prospectivos , Rabeprazol , Tinidazol/administración & dosificación , Resultado del TratamientoRESUMEN
BACKGROUND: Predicting factors for the outcome of conventional Helicobacter pylori triple therapy have been identified. Of these, the presence of the CagA gene is a strong predictor of successful treatment. Our preliminary data show that this factor becomes irrelevant when sequential therapy is used. AIM: To identify predicting factors for the outcome of H. pylori eradication using two therapeutic schemes (triple and sequential) of equal duration (10 days). METHODS: Ninety-six patients with H. pylori infection were randomly assigned to receive one of the following therapeutic schemes: group A: rabeprazole (20 mg b.d.) plus amoxicillin (1 g b.d.) for 5 days, followed by rabeprazole (20 mg b.d.) plus tinidazole (500 mg b.d.) and clarithromycin (500 mg b.d.) for a further 5 days; group B: rabeprazole (20 mg b.d.) plus amoxicillin (1 g b.d.) and clarithromycin (500 mg b.d.) for 10 days. Age, sex, smoking, endoscopic and histological findings, and CagA and VacA status were considered as candidates for a model of multivariate analysis which used therapeutic outcome as the dependent variable. CagA and VacA status were assessed by polymerase chain reaction on DNA isolated from gastric antral specimens. RESULTS: The sequential scheme was significantly more effective than prolonged triple therapy (P < 0.05). Smoking (P < 0.001) and the absence of the CagA gene (P < 0.05) were significantly associated with the failure of triple therapy, but the effectiveness of sequential treatment was not predicted by these factors. CONCLUSION: Our data suggest that sequential therapy is not affected by bacterial and host factors which have, until now, predicted the outcome of conventional eradication treatments.
Asunto(s)
Antibacterianos/administración & dosificación , Antiulcerosos/administración & dosificación , Dispepsia/tratamiento farmacológico , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/genética , Úlcera Péptica/tratamiento farmacológico , 2-Piridinilmetilsulfinilbencimidazoles , Adulto , Amoxicilina/administración & dosificación , Antígenos Bacterianos/genética , Proteínas Bacterianas/genética , Bencimidazoles/administración & dosificación , Claritromicina/administración & dosificación , ADN/análisis , Evaluación de Medicamentos , Quimioterapia Combinada , Dispepsia/genética , Dispepsia/microbiología , Femenino , Infecciones por Helicobacter/genética , Humanos , Masculino , Persona de Mediana Edad , Omeprazol/análogos & derivados , Úlcera Péptica/genética , Úlcera Péptica/microbiología , Reacción en Cadena de la Polimerasa/métodos , Rabeprazol , Factores de Riesgo , Fumar , Tinidazol/administración & dosificación , Resultado del TratamientoRESUMEN
A 17-year-old female patient with features of epilepsy was treated with valproic acid. Two years later, hypoglycemia and hyperinsulinemia appeared. Transabdominal ultrasonography, spiral computed tomography, and indium-111 Octreoscan were performed without positive results. Endoscopic ultrasonography identified an oval tumor in the pancreatic tail with a color Doppler hypervascular pattern. Surgical enucleation decreased levels of insulin and C-peptide within 20 min, and the patient became free of symptoms and medications.
Asunto(s)
Endosonografía , Epilepsia/diagnóstico , Insulinoma/diagnóstico por imagen , Neoplasias Pancreáticas/diagnóstico por imagen , Adolescente , Anticonvulsivantes/uso terapéutico , Péptido C/sangre , Errores Diagnósticos , Epilepsia/tratamiento farmacológico , Femenino , Humanos , Insulina/sangre , Insulinoma/cirugía , Neoplasias Pancreáticas/cirugía , Ácido Valproico/uso terapéuticoAsunto(s)
Amoxicilina/uso terapéutico , Antibacterianos/uso terapéutico , Defensinas/uso terapéutico , Fármacos Gastrointestinales/uso terapéutico , Enfermedades Gastrointestinales/microbiología , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori , Lactobacillus acidophilus , Omeprazol/uso terapéutico , Quimioterapia Combinada , Enfermedades Gastrointestinales/tratamiento farmacológico , Humanos , Penicilinas/uso terapéuticoAsunto(s)
Úlcera Duodenal/diagnóstico , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/efectos de los fármacos , Obstrucción Intestinal/diagnóstico , Omeprazol/administración & dosificación , Adulto , Antiulcerosos/administración & dosificación , Enfermedades Duodenales/diagnóstico , Enfermedades Duodenales/etiología , Enfermedades Duodenales/fisiopatología , Úlcera Duodenal/tratamiento farmacológico , Úlcera Duodenal/microbiología , Duodenoscopía , Femenino , Estudios de Seguimiento , Infecciones por Helicobacter/complicaciones , Helicobacter pylori/aislamiento & purificación , Humanos , Obstrucción Intestinal/etiología , Obstrucción Intestinal/fisiopatología , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: It has been suggested that short-term triple therapy comprising a proton pump inhibitor, plus clarithromycin and amoxycillin be used as first choice in treating H. pylori infection, while eradication failure patients should be further treated with a quadruple therapy. Nevertheless, conflicting results have been reported using these treatment regimens in different countries. METHODS: A total of 278 patients with H. pylori infection were randomised to receive one-week triple therapy, comprising clarithromycin 500 mg b.d., amoxycillin 1 g b.d., and either omeprazole 20 mg b.d. (OAC; 90 patients), or pantoprazole 40 mg b.d. (PAC; 95 patients), or lansoprazole 30 mg b.d. (LAC; 93 patients). H. pylori infection at entry, and eradication 4-6 weeks after therapy had ended, were assessed by rapid urease test and histology on biopsies from the antrum and the corpus. When eradication did not occur, patients were given a 2-week treatment comprising ranitidine bismuth citrate 400 mg b.d., tetracycline 500 mg t.d.s. and tinidazole 500 mg b.d. (RBTT). Eradication in these patients was assessed 4-6 weeks after conclusion of treatment by a further endoscopy. RESULTS: Six patients were lost to the follow-up. At the end of the first course of treatment, the overall H. pylori eradication rate was 78% (95% CI: 73-83) and 79% (95% CI: 75-84) at 'intention-to-treat' (ITT) and 'per protocol' (PP) analysis, respectively, without any statistically significant difference between treatment regimens, although a trend for better results with the omeprazole combination was observed. Moreover, H. pylori eradication was achieved in 82% (95% CI: 75-97) (ITT) and 86% (95% CI: 69-94) (PP) of 38 patients re-treated with RBTT regimen. CONCLUSIONS: Our data found that this short-term triple therapy is not a satisfactory treatment (< 80% eradication rate) for H. pylori infection. The 2-week triple therapy used as re-treatment in eradication failure patients yielded more promising results.