IBD-PODCAST Spain: A Close Look at Current Daily Clinical Practice in IBD Management.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBD) that contributes in part to irreversible bowel damage and long-term complications, reduced quality of life, invalidity, and economic burden. Suboptimal control of IBD is associated with higher healthcare resource utilization (HCRU), impaired quality of life (QoL), and reduced work productivity. AIMS: The IBD-PODCAST study aimed to assess the proportion of IBD patients with suboptimal control and its associated impact. METHODS: IBD-PODCAST is a cross-sectional, multicenter study that aimed to characterize the CD and UC population with optimal or suboptimal control according to the STRIDE-II criteria and patient- and physician-reported measures. Here we present the results of the Spanish cohort (n = 396). RESULTS: A total of 104/196 (53.1%) CD and 83/200 (41.5%) UC patients were found to have suboptimal disease control. Long-term treatment targets according to STRIDE-II were applied in 172 (87.8%) CD and 181 (90.5%) UC patients. 125 of 172 (72.7%) CD and 74 of 181 (40.9%) UC patients were currently treated with targeted immunomodulators. Patients with CD and UC and suboptimal disease control showed impaired QoL, higher HCRU and direct costs, and also loss of work productivity compared to those with optimal control. CONCLUSION: Despite a high rate of targeted immunomodulator therapy, a substantial proportion of IBD patients show suboptimal disease control according to the STRIDE II criteria. Those patients with suboptimal disease control exhibit impaired QoL, less work productivity, and higher HCRU, suggesting that there is considerable need for better treatment approaches in IBD.

Safety and effectiveness of direct-acting antiviral drugs in the treatment of hepatitis C in patients with inflammatory bowel disease.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) management in Inflammatory Bowel Disease (IBD) is uncertain. The ECCO guidelines 2021 recommended HCV treatment but warn about the risk of IBD reactivation. We aimed to evaluate 1) the effectiveness and safety of direct-acting antivirals (DAAs) in IBD; 2) the interaction of DAAs with IBD drugs. METHODS: Multicentre study of IBD patients and HCV treated with DAAs. Variables related to liver diseases and IBD, as well as adverse events (AEs) and drug interactions, were recorded. McNemar's test was used to assess differences in the proportion of active IBD during the study period. RESULTS: We included 79 patients with IBD and HCV treated with DAAs from 25,998 IBD patients of the ENEIDA registry. Thirty-one (39.2 %) received immunomodulators/biologics. There were no significant differences in the percentage of active IBD at the beginning (n = 11, 13.9 %) or at the 12-week follow-up after DAAs (n = 15, 19 %) (p = 0.424). Sustained viral response occurred in 96.2 % (n = 76). A total of 8 (10.1 %) AEs occurred and these were unrelated to activity, type of IBD, liver fibrosis, immunosuppressants/biologics, and DAAs. CONCLUSIONS: We demonstrate a high efficacy and safety of DAAs in patients with IBD and HCV irrespective of activity and treatment of IBD.

Treatment patterns and intensification within 5 year of follow-up of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study.

BACKGROUND: Anti-TNFα represent one of the main treatment approaches for the management of inflammatory bowel diseases (IBD). Therefore,the evaluation of their treatment patterns over time provides valuable insights about the clinical value of therapies and associated costs. AIMS: To assess the treatment patterns with the first anti-TNFα in IBD. METHODS: Retrospective, observational study. RESULTS: 310 IBD patients were analyzed along a 5-year follow-up period. 56.2% of Crohn's disease (CD) patients started with adalimumab (ADA), while 43.8% started with infliximab (IFX). 12.9% of ulcerative colitis (UC) patients initiated with ADA, while 87.1% initiated with IFX. Treatment intensification was required in 28.9% of CD and 37.1% of UC patients. Median time to treatment intensification was shorter in UC than in CD (5.3 vs. 14.3 months; p = 0.028). Treatment discontinuation due to reasons other than remission were observed in 40.7% of CD and 40.5% of UC patients, although, in UC patients there was a trend to lower discontinuation rates with IFX (36.6%) than with ADA (66.7%). Loss of response accounted for approximately one-third of discontinuations, in both CD and UC. CONCLUSIONS: Around one-third of IBD biologic-naive patients treated with an anti-TNFα required treatment intensification (earlier in UC) and around 40% discontinued the anti-TNFα due to inappropriate disease control.

Immunomodulatory Therapy Does Not Increase the Risk of Cancer in Persons With Inflammatory Bowel Disease and a History of Extracolonic Cancers.

OBJECTIVES: Immunosuppressant therapies (IMTs; thiopurines, anti-tumor necrosis factor agents) may influence the immunologic control of cancer and might facilitate the spread and recurrence of cancer. This study assesses the impact of the use of IMTs on the development of incident cancers (recurrent or new) in patients with inflammatory bowel disease (IBD) and a history of malignancy. METHODS: Patients with IBD included in the ENEIDA registry with a history of cancer without being exposed to IMTs were identified and retrospectively reviewed and compared regarding further treatment with IMTs or not by means of a log-rank test. RESULTS: Overall, 520 patients with previous extracolonic cancer naive to IMTs before the diagnosis of cancer were identified. Of these, 146 were subsequently treated with IMTs (exposed), whereas 374 were not (nonexposed). The proportion of patients with incident cancers was similar in both exposed (16%) and nonexposed (18%) patients (P = 0.53); however, there was more than a 10-year difference in the age at index cancer between these 2 groups. Cancer-free survival was 99%, 98%, and 97% at 1, 2, and 5 years in exposed patients, and 97%, 96%, and 92% at 1, 2, and 5 years in non-exposed patients, respectively (P = 0.03). No differences in incident cancer rates were observed between exposed and nonexposed patients when including only those who were exposed within the first 5 years after cancer diagnosis. DISCUSSION: In patients with IBD and a history of cancer not related to immunosuppression, the use of IMTs is not associated with an increased risk of new or recurrent cancers even when IMTs are started early after cancer diagnosis.

Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study.

OBJECTIVES: The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS: This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS: A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS: The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.

Therapeutic guidelines on ulcerative colitis: a GRADE methodology based effort of GETECCU / Guía clínica GETECCU del tratamiento de la colitis ulcerosa elaborada con la metodología GRADE

Los objetivos de la Guía son: 1. Establecer recomendaciones basadas en las pruebas disponibles, para el tratamiento de inducción en el brote grave de colitis ulcerativa 2. Establecer recomendaciones para el tratamiento de inducción en el brote leve- moderado de colitis ulcerativa 3. Establecer recomendaciones para el tratamiento de mantenimiento de la colitis ulcerativa en remisión

Risk factors for ulcerative colitis: A population-based, case-control study in Spain.

BACKGROUND: Environmental factors seem to be very important in the aetiology of Ulcerative Colitis (UC), with smoking, contraceptive use, and hygiene being the factors most commonly linked to disease. AIM: To analyse the association between different risk factors and development of UC in our community. PATIENTS AND METHODS: This is a case-control, population-based study. The UC population consists of an inception-case population of all cases diagnosed, using Lennard-Jones criteria, in our community from 1st February 1992 to 31st January 1995 that were prospectively included. Controls were selected from healthy population and matched with patients for age, sex and rural/urban habitat. We used the SPSS/PC+ software, EpiInfo and Statistix for statistical analysis, giving the rates as point estimates and 95% confidence intervals (95%CI) or as mean±standard deviation in quantitative variables. For multivariate analysis we used conditional logistic regression. RESULTS: 205 patients were diagnosed of UC. 38 patients (18.5%) with UC were smokers, compared with 84 (40.8%) controls (p<0.001). Smoking behaved as a protector factor for UC (OR=0.55 (CI 95% 0.33-0.92) and ex-smoker acted as a risk factor (OR=1.94 (CI 95% 1.14-3.34). After the multivariate analysis, both associations were maintained. We did not detect statistical differences in the analysis of previous appendectomy, childhood hygiene or oral contraceptive use. Five of the 12 cases with family aggregation had first-degree relatives and 7 of them second-degree relatives. None of the controls had previous IBD history (p=0.0002). CONCLUSION: Ex-smoking and previous family history of inflammatory bowel disease appeared as risk factors for developing ulcerative colitis while current smoking behaved as a protective factor in this population.

[Surgery at follow-up in an incidence cohort of patients with Crohn's disease in Aragon (Spain): etiology, type of surgery and associated epidemiological factors]. / Cirugía de una cohorte incidente de pacientes con enfermedad de Crohn en Aragón: indicaciones, tipo de cirugía y factores de riesgo asociados.

INTRODUCTION: Few population-based studies have been published on predictive factors in the clinical course of Crohn's disease (CD). The only constant risk factor for postsurgical recurrence is smoking. The aim of this study is to describe surgical need, etiology and characteristics, and the distinct clinical variables that act as risk or protective factors for the indication of surgery in an incidence cohort of patients with a diagnosis of CD in Aragon. MATERIAL AND METHODS: Based on the results of a population-based, prospective study reporting the incidence of inflammatory bowel disease in Aragon, 88 patients with a diagnosis of CD were included in the present study. The patients medical records were reviewed and data on the following clinical variables from diagnosis (1992-1995) to February 2001 were gathered: surgery, type of surgery and etiology, anatomic distribution, number of relapses, remission, clinical course, death, smoking, oral contraceptive intake, and hospitalization. Descriptive and bivariate analyses were performed to investigate the association between these variables and surgery during follow-up. RESULTS: Eighty-eight patients with at least 6 months of follow-up were included (88/103; 85%), with a mean follow-up of 77 months (range, 6-110 months). Some kind of surgery during follow-up was required by 20.5% of our patients; in nearly 50% of these, surgery was indicated for intestinal obstruction. A second surgical intervention was required in 10.2% due to fistula and/or abscess or ileostomy for subsequent reconstruction of intestinal transit. Although ileal localization was more frequently associated with surgery, this association was not statistically significant. No association was found between surgery during follow-up and sex, age at diagnosis or oral contraceptive intake. Factors positively associated with surgery were a chronic clinical course and a greater number of hospitalizations. We found no positive or negative association with smoking, non-smoking or time free of smoking, but the total time of smoking was positively associated with surgery. CONCLUSIONS: Risk factors for surgery in patients with CD were a chronic clinical course, the number of hospitalizations and total time of smoking. Ileal localization was more frequently associated with surgery but this association was not statistically significant.

Cirugía de una cohorte incidente de pacientes con enfermedad de Crohn en Aragón: indicaciones, tipo de cirugía y factores de riesgo asociados / Surgery at follow-up in an incidence cohort of patients with crohn’s disease in Aragon (Spain): etiology, type of surgery and associated epidemiological factors

INTRODUCCIÓN: Con los estudios poblacionales disponibles conocemos poco sobre factores predictivos en el curso clínico de la enfermedad de Crohn (EC). El único factor consistente es el mayor índice de recurrencia quirúrgica de los pacientes fumadores. El objetivo de este estudio fue valorar la necesidad de cirugía, así como las distintas variables clínicas que actúan como factores de riesgo y/o protectores respecto a la indicación quirúrgica de una cohorte incidente de pacientes con diagnóstico de EC en Aragón. MATERIAL Y MÉTODOS: Basándonos en los resultados de un estudio poblacional y prospectivo incidente en Aragón, incluimos en el estudio a 88 pacientes diagnosticados de EC. Se analizaron las siguientes variables: cirugía, tipos de intervención quirúrgica y etiología, localización anatómica, número de brotes e ingresos, remisión, curso crónico, fallecimientos, exposición al tabaco y toma de anticonceptivos orales en el momento del ingreso. Se aplicaron análisis descriptivo y bivariante para investigar la asociación de dichas variables con la cirugía durante el seguimiento. RESULTADOS: De los 103 pacientes diagnosticados de EC, se obtuvo información con al menos 6 meses de seguimiento de 88, esto es, un 85%, con una media de 77 meses de seguimiento(mediana, 81; rango, 6-110). El 20,5% de los pacientes precisaron durante el seguimiento algún tipo de intervención quirúrgica, motivada en cerca del 50% por obstrucción intestinal; el 10,2% precisó una segunda cirugía por fístula y/o absceso, o la presencia de una ileostomía para posterior reconstrucción del tránsito intestinal. Aunque la afectación ileal se asoció más frecuentemente a la cirugía, esta diferencia no alcanzó significación estadística. Ni el sexo, ni la edad en el momento del diagnóstico, ni la toma de anticonceptivos se asociaron a la presencia de cirugía durante el seguimiento. Los pacientes que la precisaron habían presentado un curso clínico de más de un brote y un mayor número de ingresos. No observamos asociación positiva ni negativa con las variables «expuesto» al tabaco, no fumador ni tiempo libre de exposición, pero sí con el tiempo total de exposición al tabaco. CONCLUSIONES: La presencia de un curso crónico, el número de ingresos y el tiempo global de exposición al tabaco son factores de riesgo para la cirugía en los pacientes con EC

INTRODUCTION: Few population-based studies have been publishedon predictive factors in the clinical course of Crohn’s disease (CD). The only constant risk factor for postsurgical recurrence is smoking. The aim of this study is to describe surgical need, etiology and characteristics, and the distinct clinical variables that act as risk or protective factors for the indication of surgery in an incidence cohort of patients with a diagnosis of CD in Aragon. MATERIAL AND METHODS: Based on the results of a population-based, prospective study reporting the incidence of inflammatory bowel disease in Aragon, 88 patients with a diagnosis of CD were included in the present study. The patients’ medical records were reviewed and data on the following clinical variables from diagnosis (1992-1995) to February2001 were gathered: surgery, type of surgery and etiology, anatomic distribution, number of relapses, remission, clinical course, death, smoking, oral contraceptive intake, and hospitalization. Descriptive and bivariate analyses were performed to investigate the association between these variables and surgery during follow-up. RESULTS: Eighty-eight patients with at least 6 months of follow-up were included (88/103; 85%), with a mean follow-up of 77 months (range, 6-110 months). Some kind of surgery during follow-up was required by 20.5% of our patients; in nearly 50% of these, surgery was indicated for intestinal obstruction. A second surgical intervention was required in 10.2% due to fistula and/or abscess or ileostomy for subsequent reconstruction of intestinal transit. Although ileal localization was more frequently associated with surgery, this association was not statistically significant. No association was found between surgery during follow-up and sex, age at diagnosis or oral contraceptive intake. Factors positively associated with surgery were a chronic clinical course and a greater number of hospitalizations. We found no positive or negative association with smoking, non-smoking or time free of smoking, but the total time of smoking was positively associated with surgery. CONCLUSIONS: Risk factors for surgery in patients with CD were a chronic clinical course, the number of hospitalizations and total time of smoking. Ileal localization was more frequently associated with surgery but this association was not statistically significant

[Ulcerative pancolitis predicts the need for colectomy: study of an incident cohort of patients with ulcerative colitis in Aragón (Spain)]. / La afectación pancolónica inicial en la colitis ulcerosa predice la necesidad de colectomía: estudio poblacional basado en una cohorte incidente de pacientes en Aragón.

INTRODUCTION: Population-based studies show pancolitis as the only risk factor for colectomy in patients with ulcerative colitis (UC). AIM: To evaluate surgical need, its etiology and characteristics, and the distinct clinical variables that act as risk and/or protective factors for the indication for surgery in an incident cohort of patients with UC in Aragón. PATIENTS AND METHOD: Based on the results of a population-based, prospective study reporting the incidence of inflammatory bowel disease in Aragón, 168 patients with a diagnosis of UC were included in the present study. The patients' medical records were reviewed and the following clinical variables were collected from the time of diagnosis (1992-1995) to February 2001: surgery, type of surgical intervention and etiology, anatomic distribution, number of relapses, remissions, clinical course, death, smoking, oral contraceptives and hospitalizations. To investigate the association between these variables and surgery during follow-up, descriptive and bivariate analyses were performed. RESULTS: Of 204 patients diagnosed with UC, 168 (82.3%) with a follow-up of at least 6 months were included. The mean follow-up was 77 months (range: 6-110 months). Some type of surgery was required by 6.5% of our patients during follow-up and 3.6% needed a second surgical intervention. Surgery was indicated for various etiologies. Most patients underwent colectomy and ileostomy with subsequent surgical reconstruction of the intestinal tract. Pancolitis was a clear independent risk factor for colectomy in our patient cohort. No association was found between sex, age at diagnosis, and oral contraceptive intake with surgery during follow-up. Patients who underwent surgery had previously shown more than one relapse and several hospitalizations but did not necessarily show a chronic clinical course. We found no positive or negative association with any smoking-related variables: smoker, non-smoker, years of smoking or years free of smoking. CONCLUSION: Ulcerative pancolitis at diagnosis is a predictive factor for surgery in the short term in patients with a diagnosis of UC in Aragón. We found no other significant associations with the remaining epidemiological factors studied.

La afectación pancolónica inicial en la colitis ulcerosa predice la necesidad de colectomía: estudio poblacional basado en una cohorte incidente de pacientes en Aragón / Ulcerative pancolitis predicts the need for colectomy: study of an incident cohort of patients with ulcerative colitis in Aragón (Spain)

INTRODUCCIÓN: Sobre la base de estudios poblacionales, la única variable clínica consistente y predictiva de un determinado curso clínico que se ha descrito es el mayor riesgo decolectomía en los pacientes con pancolitis ulcerosa. OBJETIVO: Valorar la necesidad de cirugía, su etiología y sus características, así como las distintas variables clínicas que actúan como factores de riesgo o protectores respecto de la indicación quirúrgica de una cohorte incidente de pacientes con diagnóstico de colitis ulcerosa (CU) en Aragón. PACIENTES Y MÉTODO: Basados en los resultados de un estudio poblacional y prospectivo incidente en Aragón, incluimos en el estudio a 168 pacientes diagnosticados de CU; se revisaron sus historias clínicas y se recogieron las distintas variables clínicas desde su diagnóstico (1992-1995) hasta febrero de 2001: cirugía, tipos de intervención quirúrgica y etiología, localización anatómica, número de brotes e ingresos, remisión, curso crónico, fallecimiento, exposición al tabaco, anticonceptivos orales e ingresos. Se realizó un análisis descriptivo y un análisis bivariante para investigar la asociación de estas variables con la cirugía durante el seguimiento. RESULTADOS: Hemos obtenido información durante 6 meses de seguimiento de 168 pacientes (168/204) (82,3%), con un seguimiento medio de 77 meses (rango, 6-110 meses). Durante el seguimiento, el 6,5% de los pacientes precisó algún tipo de intervención quirúrgica y el 3,6%, una segunda cirugía. La indicación quirúrgica es variable; en la mayoría de los casos se realizó colectomía e ileostomía, y fue necesaria una segunda cirugía para la reconstrucción del tránsito intestinal. La pancolitis ulcerosa se comporta como un factor de riesgo independiente para la necesidad de cirugía. En nuestros pacientes, el sexo, la edad al diagnóstico y la toma de anticonceptivos no se asociaron a la presencia de cirugía. Los pacientes que precisaron cirugía durante el seguimiento habían presentado previamente un curso clínico de más de un brote y un mayor número de ingresos, pero no necesariamente un curso crónico. No objetivamos una asociación positiva ni negativa con las variables: expuesto, no fumador, tiempo libre de exposición al tabaco ni tiempo global de exposición. CONCLUSIÓN: La pancolitis ulcerosa al diagnóstico es un factor que se relaciona con la necesidad a corto plazo de la cirugía en los pacientes con diagnóstico inicial de CU en Aragón; no se objetivó ninguna otra asociación entre otros factores epidemiológicos estudiados

INTRODUCTION: Population-based studies show pancolitis as the only risk factor for colectomy in patients with ulcerative colitis (UC).AIM: To evaluate surgical need, its etiology and characteristics, and the distinct clinical variables that act as risk and/or protective factors for the indication for surgery in an incident cohort of patients with UC in Aragón. PATIENTS AND METHOD: Based on the results of a population based, prospective study reporting the incidence of inflammatory bowel disease in Aragón, 168 patients with a diagnosis of UC were included in the present study. The patients’ medical records were reviewed and the following clinical variables were collected from the time of diagnosis (1992-1995)to February 2001: surgery, type of surgical intervention andetiology, anatomic distribution, number of relapses, remissions, clinical course, death, smoking, oral contraceptives and hospitalizations. To investigate the association between these variables and surgery during follow-up, descriptive and bivariate analyses were performed. RESULTS: Of 204 patients diagnosed with UC, 168 (82.3%)with a follow-up of at least 6 months were included. Theme an follow-up was 77 months (range: 6-110 months). Some type of surgery was required by 6.5% of our patients during follow-up and 3.6% needed a second surgical intervention. Surgery was indicated for various etiologies. Most patients underwent colectomy and ileostomy with subsequent surgical re- construction of the intestinal tract. Pancolitis was a clear independent risk factor for colectomy in our patient cohort. No association was found between sex, age at diagnosis, and oral contraceptive intake with surgery during follow-up. Patients who underwent surgery had previously shown more than one relapse and several hospitalizations but did not necessarily show a chronic clinical course. We found no positive or negative association with any smoking related variables: smoker, non-smoker, years of smoking or years free of smoking. CONCLUSION: Ulcerative pancolitis at diagnosis is a predictive factor for surgery in the short

[Is the breath test reliable in primary care diagnosis of Helicobacter pylori infection?]. / ¿Es fiable el test del aliento para el diagnóstico de infección por Helicobacter pylori en atención primaria?

OBJECTIVE: To evaluate the reliability of the breath test urea 13C in the primary care for the diagnosis of Helicobacter pylori (Hp) infection. DESIGN: Descriptive, prospective and multicentric.Location. Urban area belonging to the Health Center Actur Sur of Zaragoza with participation of Miguel Servet Hospital. PARTICIPANTS: 87 patients with clinical diagnosis of functional dispepsia. In all of them was made a breath test with 13C urea as well as a gastroscopy with taking of samples for histology and ureasa fast test. MAIN MEASUREMENTS: Age, sex and the presence of positivity or negativity of infection by Hp were valued in the histology, ureasa test and in the breath test, considering the histology and the ureasa test like gold tests for this measurement, reason why it was demanded that the positive or outside negative result in both considering it nonambiguous. RESULTS: Two cases were excluded by ambiguous results. The 77.6% (66/85) were positive by histology and ureasa test, and these, 92.4% (61/66) were positives to the breath test. The sensitivity of this test was 92% and the specificity 100%. CONCLUSIONS: The breath test in primary care has a high value diagnosis of Hp infection, being able to avoid, in some cases, another invasives techniques like gastroscopy.

¿Es fiable el test del aliento para el diagnóstico de infección por Helicobacter pylori en atención primaria? / Is the breath test reliable in primary care diagnosis of Helicobacter pylori infection?

Objetivo. Evaluar la fiabilidad del test del aliento con urea 13C en atención primaria para el diagnóstico de infección por Helicobacter pylori (Hp).Diseño. Estudio descriptivo, prospectivo y multicéntrico. Emplazamiento. Área urbana perteneciente al Centro de Salud Actur Sur de Zaragoza, con participación del Hospital Miguel Servet. Participantes. Se incluyó a 87 pacientes con diagnóstico clínico de dispepsia funcional. A todos ellos se les realizó un test de aliento con urea 13C, así como una gastroscopia con toma de muestras para histología y test de ureasa rápida. Mediciones principales. Se valoraron edad, sexo y la presencia de positividad o negatividad de infección por Hp en la histología, el test de ureasa y el test del aliento, considerando la histología y el test de ureasa pruebas gold standard para esta medición, por lo que se exigía que el resultado en ambas fuera positivo o negativo para considerarlo no equívoco. Resultados. Se excluyeron 2 casos por resultados equívocos. El 77,6 per cent (66/85) fue positivo por histología y test de ureasa, de los que un 92,4 per cent (61/66) resultó positivo al test del aliento. La sensibilidad de esta prueba fue del 92 per cent y la especificidad del 100 per cent. Conclusiones. El test del aliento en atención primaria tiene un alto valor diagnóstico de infección por Hp, pudiendo evitar así en algunos casos la realización de técnicas más invasivas como la gastroscopia (AU)

[Helicobacter pylori eradication in patients with peptic ulcer after two treatment failures: a prospective culture-guided study]. / Erradicación de Helicobacter pylori en pacientes con úlcera péptica tras fracaso de dos tratamientos previos: estudio prospectivo guiado por cultivo.

AIM: To determine the effectiveness of a third, culture-guided, treatment of H. pylori infection after two unsuccessful attempts. PATIENTS AND METHODS: Forty-two consecutive patients with a diagnosis of peptic ulcer were included in an open prospective and multicenter study. After two unsuccessful attempts at eradication (demonstrated by positive urea breath test), all patients underwent endoscopy and H. pylori infection was confirmed by urease test, histology and culture (Pylori-Agar, Bio Merieux, France). Antibiotic susceptibility to metronidazole, amoxicillin, tetracycline and clarithromycin was defined by E-test. Thirty-nine patients received a two-week quadruple culture-guided therapy defined by the protocol, which considered sensitivity data and previous allergies to antibiotics (one culture was contaminated, one patient refused treatment and one was allergic to tetracycline and amoxicillin and was resistant to metronidazole and clarithromycin). Compliance was monitored by pill counting and eradication was defined as a negative urea breath test six weeks after the end of treatment. RESULTS: Sensitivity data were obtained in 41 patients. Intention-to-treat analysis revealed that overall eradication was achieved in 60% (24/40). Eighteen strains (43.9%) were resistant to metronidazole, 21 (51.2%) were resistant to clarithromycin and 8 (19.5%) were resistant to both drugs. None of the strains were resistant to amoxicillin or tetracycline. We used mainly two kinds of quadruple therapy in the 39 patients. Despite good compliance with treatment based on omeprazole (20 mg/12 h), bismuth subcitrate (120 mg/6 h), tetracycline (500 mg/4 h) and clarithromycin (500 mg/ 12 h) (OBTC) eradication was achieved in only 9 of 19 patients (47.4%; CI: 24.4-71.1) (one patient failed to attend the urea breath test). Nineteen clarithromycin-resistant patients received amoxicillin (1,000 mg/12 h) instead of clarithromycin (OBTA) and this treatment was effective in 14 (73.7%; CI: 48.8-90.9). Eradication was achieved in one patient who was allergic to amoxicillin and resistant to clarithromycin and metronidazole and who received ciprofloxacin (500 mg/8 h) instead of clarithromycin (OBTCipro). No clinical factors associated with eradication failure were found. CONCLUSIONS: Despite the use of two-week, high-dose, quadruple and culture-guided combinations of drugs, a third treatment was frequently unsuccessful. The lowest eradication rate was obtained in patients with H. pylori strains sensitive to all antibiotics; therefore, we believe that other factors could influence eradication rates. New prospective and randomized studies are needed in this subgroup of patients to find effective treatments.

Environmental risk factors and Crohn's disease: a population-based, case-control study in Spain.

BACKGROUND: The pathogenesis of inflammatory bowel disease probably involves an interaction between genetic and environmental factors: cigarette smoking, appendectomy and oral contraceptives have been the factors most frequently linked to its aetiology AIM: To analyse the association between known environmental risk factors and development of Crohn's disease in the community of Aragón, Spain. PATIENTS AND METHODS: A case-control, population-based study has been carried out. All patients diagnosed with Crohn's disease in the community of Aragón from 1st February 1992 to 31st January 1995 were prospectively included. The Lennard Jones criteria were used to define the cases and selected controls among the healthy population matched with patients for age, sex and rural/urban habitat. Statistical analysis included multivariate analysis using conditional logistic regression, testing 38 different models. RESULTS: A total of 103 patients were diagnosed with Crohn's disease in Aragón from 1st February, 1992 to 31st January, 1995. Of these 62 patients (60.2%) with Crohn's disease were smokers, compared with 42 (40.8%) controls (p<0.001). Cigarette smoking is considered a risk factor for Crohn's disease with an odds ratio of 3.09 (95% confidence interval, 1.58-6.05). After multivariate analysis, the positive association is maintained. A dose-dependent relation could not be demonstrated. No statistical differences (p=0.50) were detected in the analysis of previous appendectomy. Use of oral contraceptive acts as a risk factor with a p=0.048; odds ratio 2, 8, 95% confidence interval: 1.009-7.774; but this association disappears in the multivariate analysis. Eight patients had a family history (3 first degree and 5 second degree relatives) versus none of the controls (p=0.002). Of the variables studied for childhood hygiene none appeared significant. CONCLUSION: Smoking, family history, and oral contraceptive use, appear as risk factors for developing Crohn's disease in univariate analysis, but only smoking remains significant in all models of multivariate analysis.

Helicobacter pylori: strategies for treatment.

Helicobacter pylori (Hp) is a Gram-negative bacteria able to live in the human stomach, a very surprising fact considering the acid environment of gastric mucosa. Identified by Marshall and Warren in 1982 [1,2], this bacterium seems aetiologically related to many gastric diseases, previously known as 'acid related diseases'. Compelling evidence demonstrates that Hp is the most important aetiological agent of gastritis [3], the principal causal factor in peptic ulcer [4], contributes to the genesis of gastric cancer [5] and has a critical role in the development of many mucosa-associated lymphoid tissue (MALT) lymphomas [6]. Although experimental data have recently provided hard evidence to support the role of Hp in the genesis of gastritis, ulcer and carcinoma [7], a critical argument for Hp generating peptic ulcer disease has been, in fact, the change in the natural history of peptic ulcer that follows the cure of the infection.

Factors affecting the variation in antibiotic resistance of Helicobacter pylori over a 3-year period.

Strains of Helicobacter pylori, isolated from 300 patients between 1996 and 2000 were tested for their sensitivity to clarithromycin, metronidazole and amoxycillin. Primary resistances (95% CI) were 9. 7% for clarithromycin and 21.7% for metronidazole. No strains were resistant to amoxycillin. There was no significant difference between the number of resistant strains in the male and female groups. Clarithromycin resistance was more common in older patients (P<0.01) and metronidazole resistance was more common in patients with peptic ulcer compared with patients with chronic gastritis (P<0. 05). Logistic regression analysis confirmed these results.

Third line treatment for Helicobacter pylori: a prospective, culture-guided study in peptic ulcer patients.

BACKGROUND: A third line treatment is needed in roughly 5% of patients infected with Helicobacter pylori. Few data have been reported on efficacy of treatment regimens in these patients. METHODS: A prospective trial was designed to study the effectiveness of third line treatment of H. pylori infection in ulcer patients. Two-week quadruple, culture-guided, combinations were used in 31 consecutive patients. Susceptibility to metronidazole and clarithromycin were studied by E-test, and thereafter a predetermined treatment regimen was used. Compliance was evaluated by pill count, and eradication defined by negative urea breath test at 6 weeks. RESULTS: Two main quadruple regimens were used in 29 patients. In spite of good compliance, the combination of omeprazole, tetracycline, bismuth and clarithromycin (OTBC) showed an eradication rate (per protocol analysis) of 36% (five out of 14; CI: 12.8-64.9), and if amoxycillin was used (OTBA) the rate was 67% (eight out of 12; CI: 34.9-90.1). The difference was not significant. No clinical factor was found to be associated with failure to eradicate. CONCLUSIONS: Third line treatment often fails to eradicate H. pylori infection. New strategies need to be developed and tested for this common clinical situation.

[High eradication rates in Helicobacter pylori infection in patients with duodenal ulcer who failed previous eradication therapy]. / Alto índice de erradicación de Helicobacter pylori en pacientes con úlcera duodenal tras fracaso de un tratamiento previo.

BACKGROUND: To analyze the effectiveness of a second-line treatment of Helicobacter pylori infection in patients with duodenal ulcer based on previous antibiotic regimen. PATIENTS AND METHODS: Open, prospective, uncontrolled study, but guided by protocol including 30 consecutive patients with endoscopic diagnosis of active duodenal ulcer and failure of a first-line H. pylori eradication treatment diagnosed by urea breath test or a new endoscopy with histology and positive urease test. Treatment consisted in 10 days with omeprazole (20 mg/12 h), bismuth subcitrate (120 mg/6 h), tetracycline (500 mg/6 h) and metronidazole (500 mg/8 h) (OBTM) if previous regimen was with clarithromycin; or 10 days with omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and amoxycillin (1g/12 h) (OCA) if previous regimen did not include clarithromycin; using metronidazole (500 mg/8 h) instead of amoxycillin (OCM) in case of allergy. Eradication was defined as a negative 13C-urea breath test 2 months after the end of therapy. RESULTS: One patient had to stop treatment due to the side effects and in 2 patients urea breath test was not performed (3 patients due to the OBTM group). Per protocol eradication was achieved in 25 out of 27 patients (92.6%) and by intention-to-treat eradication was attained in 25 out of 30 cases (83.3%). When both groups analyzed separately, the OCA combination was successful in 5 from 6 patients (83.3%; 95% CI 35.9-99.6); while the OBTM combination was successful in 20 from 21 valuable patients (95. 2%; 95% CI 76.2-99.9). In this second case we make an intention to treat analysis and eradication was achieved in 20 from 24 (83.3%; 95% CI 62.6-95.3). CONCLUSION: The eradicative treatment for H. pylori based in different antibiotics used in subsequent attempts get high eradication rates in patients with duodenal ulcer.

[Incidence of inflammatory bowel disease in Aragon: outcome of a prospective population-based study]. / Incidencia de la enfermedad inflamatoria intestinal en Aragon: resultados de un estudio prospectivo y poblacional.

OBJECTIVE: To identify every new case of ulcerative colitis (UC) (including ulcerative proctitis), Crohn's disease (CD) and indeterminate colitis (IC) in Aragon, in Spain (population: 1,189,000, area: 47,719 km2) and to compare the incidence in this region with that in the rest of Spain and Europe. PATIENTS AND METHODS: We designed a prospective, population-based study based on inception cohorts. During a 3-year predetermined period (1st February 1992-31st January 1995) we identified every new case of inflammatory bowel disease in Aragon by checking the records in all the hospitals, outpatient clinics and private practices in this region. RESULTS: The overall adjusted incidence rate per 100,000 inhabitants/year was 7.2 for UC (a figure lower than the average for Europe) and 3.9 for Crohn's disease (a rate similar to that of Southern Europe). These rates are much higher than those previously described in Spanish studies, probably due to the design and methods used as well as to a real increase in the incidence of CD in Spain. The age and sex pattern was similar to those other studies. CONCLUSIONS: The incidence rates for inflammatory bowel disease in Aragon are higher than those previously described, the incidence of UC being inferior to that of Europe. Nevertheless, the incidence of CD is similar the average for southern Europe, which suggests that there has been a recent increase in the incidence of this disease in Aragon.