Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management.

BACKGROUND: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. OBJECTIVE: To determine which factors influence compliance with treatment. METHODS: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. RESULTS: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001). CONCLUSIONS: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.

IV Spanish Consensus Conference on Helicobacter pylori infection treatment / IV Conferencia Española de Consenso sobre el tratamiento de la infección por Helicobacter pylori

Helicobacter pylori approximately infect 50% of Spanish population and causes chronic gastritis, peptic ulcer and gastric cancer. Until now, three consensus meetings on H.pylori infection had been performed in Spain (the last in 2012). The changes in the treatment schemes, and the increasing available evidence, have justified organizing the IVSpanish Consensus Conference (March 2016), focused on the treatment of this infection. Nineteen experts participated, who performed a systematic review of the scientific evidence and developed a series of recommendation that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. As starting point, this consensus increased the minimum acceptable efficacy of recommended treatments that should reach, or preferably surpass, the 90% cure rate when prescribed empirically. Therefore, only quadruple therapies (with or without bismuth), and generally lasting 14 days, are recommended both for first and second line treatments. Non-bismuth quadruple concomitant regimen, including a proton pump inhibitor, clarithromycin, amoxicillin and metronidazole, is recommended as first line. In the present consensus, other first line alternatives and rescue treatments are also reviewed and recommended

La infección por Helicobacter pylori afecta aproximadamente al 50% de la población española y es causante de la gastritis crónica, la úlcera péptica y el cáncer gástrico. Se han llevado a cabo hasta el momento, en nuestro país, 3 reuniones de Consenso sobre el manejo de la infección por H. pylori (la última de ellas en 2012). Los cambios en los esquemas de tratamiento y la creciente evidencia disponible al respecto han justificado la organización de esta IV Conferencia Española de Consenso en marzo de 2016, centrada en el tratamiento de esta infección. Participaron 19 expertos sobre el tema, que realizaron una búsqueda sistemática de la evidencia científica y elaboraron una serie de recomendaciones que fueron sometidas a un proceso de interacción de votaciones anónimas seriadas mediante metodología Delphi. Para clasificar la evidencia científica y la fuerza de las recomendaciones se utilizó el sistema GRADE. Este consenso establece, como punto de partida, un aumento de la exigencia en la eficacia de los tratamientos recomendados, que deben alcanzar, o preferiblemente superar, el 90% de curación al ser administrados de forma empírica. De este modo, tanto en primera como en segunda línea se recomiendan tratamientos cuádruples con o sin bismuto, generalmente prescritos durante 14 días. El tratamiento cuádruple sin bismuto concomitante, que incluye un inhibidor de la bomba de protones, claritromicina, amoxicilina y metronidazol, se recomienda como primera línea. En el presente consenso se revisan también con detalle otras alternativas de tratamiento tanto de primera línea como de rescate.

Helicobacter pylori second-line rescue therapy with levofloxacin- and bismuth-containing quadruple therapy, after failure of standard triple or non-bismuth quadruple treatments.

BACKGROUND: The most commonly used second-line Helicobacter pylori eradication regimens are bismuth-containing quadruple therapy and levofloxacin-containing triple therapy, both offering suboptimal results. Combining bismuth and levofloxacin may enhance the efficacy of rescue eradication regimens. AIMS: To evaluate the efficacy and tolerability of a second-line quadruple regimen containing levofloxacin and bismuth in patients whose previous H. pylori eradication treatment failed. METHODS: This was a prospective multicenter study including patients in whom a standard triple therapy (PPI-clarithromycin-amoxicillin) or a non-bismuth quadruple therapy (PPI-clarithromycin-amoxicillin-metronidazole, either sequential or concomitant) had failed. Esomeprazole (40 mg b.d.), amoxicillin (1 g b.d.), levofloxacin (500 mg o.d.) and bismuth (240 mg b.d.) was prescribed for 14 days. Eradication was confirmed by (13) C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Incidence of adverse effects was evaluated by questionnaires. RESULTS: 200 patients were included consecutively (mean age 47 years, 67% women, 13% ulcer). Previous failed therapy included: standard clarithromycin triple therapy (131 patients), sequential (32) and concomitant (37). A total of 96% took all medications correctly. Per-protocol and intention-to-treat eradication rates were 91.1% (95%CI = 87-95%) and 90% (95%CI = 86-94%). Cure rates were similar regardless of previous (failed) treatment or country of origin. Adverse effects were reported in 46% of patients, most commonly nausea (17%) and diarrhoea (16%); 3% were intense but none was serious. CONCLUSIONS: Fourteen-day bismuth- and levofloxacin-containing quadruple therapy is an effective (≥90% cure rate), simple and safe second-line strategy in patients whose previous standard triple or non-bismuth quadruple (sequential or concomitant) therapies have failed.

Third-line rescue therapy with bismuth-containing quadruple regimen after failure of two treatments (with clarithromycin and levofloxacin) for H. pylori infection.

BACKGROUND: Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20 % of patients. AIM: To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures. METHODS: Prospective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire. RESULTS: Two hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60-74 %) and 65 % (58-72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe. CONCLUSION: A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.

High-dose, ten-day esomeprazole, amoxicillin and metronidazole triple therapy achieves high Helicobacter pylori eradication rates.

BACKGROUND: Strong acid inhibition using esomeprazole increases cure rates with triple therapy and 10-day treatments are more effective than 7-day ones. The combination of amoxicillin plus metronidazole at full doses, and using a physiologically-correct schedule three times a day, and has been shown to overcome metronidazole resistance and to achieve good eradication rates. AIMS: To assess the eradication rate of a new first-line treatment regimen associating strong acid inhibition, amoxicillin and metronidazole and to evaluate tolerance. METHODS: Patients from eight hospitals were included. Helicobacter pylori status was assessed by at least one of the following: histology, culture, rapid urease test or urea breath test (UBT). Ten-day treatment was prescribed comprising esomeprazole 40 mg twice a day plus amoxicillin 1 g and metronidazol 500 mg both three times a day. Helicobacter pylori cure was assessed by UBT. RESULTS: A hundred and thirty-six patients were enrolled. Mean age was 52.6 ± 16 years and 59.6% of patients were men. Main indications for treatment were: uninvestigated dyspepsia (13.6%); functional dyspepsia (18.2%); gastric ulcer (21.8%); and duodenal ulcer (39.8%). Helicobacter pylori eradication was achieved in 112 of the 127 patients who returned for follow-up. Eradication rates were 82.4% (95% CI: 74.7-88.1) by intention-to-treat analysis and 88.2% (95% CI: 81.2-92.8) by per protocol. Treatment was well tolerated and no major side effects were reported. Nine patients complained of mild side effects. CONCLUSIONS: Cure rates of the combination of esomeprazole, amoxicillin and metronidazole are high and the treatment was well tolerated. This pilot study warrants the comparison of this schedule with current standards.

Fourth-line rescue therapy with rifabutin in patients with three Helicobacter pylori eradication failures.

BACKGROUND: In some cases, Helicobacter pylori infection persists even after three eradication treatments. AIM: To evaluate the efficacy of an empirical fourth-line rescue regimen with rifabutin in patients with three eradication failures. DESIGN: Multicentre, prospective study. PATIENTS: In whom the following three treatments had consecutively failed: first (PPI + clarithromycin + amoxicillin); second (PPI + bismuth + tetracycline + metronidazole); third (PPI + amoxicillin + levofloxacin). INTERVENTION: A fourth regimen with rifabutin (150 mg b.d.), amoxicillin (1 g b.d.) and a PPI (standard dose b.d.) was prescribed for 10 days. OUTCOME: Eradication was confirmed by (13) C-urea breath test 4-8 weeks after therapy. Compliance and tolerance: Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated using a questionnaire. RESULTS: One-hundred patients (mean age 50 years, 39% men, 31% peptic ulcer/69% functional dyspepsia) were included. Eight patients did not take the medication correctly (in six cases due to adverse effects). Per-protocol and intention-to-treat eradication rates were 52% (95% CI = 41-63%) and 50% (40-60%). Adverse effects were reported in 30 (30%) patients: nausea/vomiting (13 patients), asthenia/anorexia (8), abdominal pain (7), diarrhoea (5), fever (4), metallic taste (4), myalgia (4), hypertransaminasemia (2), leucopenia (<1,500 neutrophils) (2), thrombopenia (<150,000 platelets) (2), headache (1) and aphthous stomatitis (1). Myelotoxicity resolved spontaneously in all cases. CONCLUSIONS: Even after three previous H. pylori eradication failures, an empirical fourth-line rescue treatment with rifabutin may be effective in approximately 50% of the cases. Therefore, rifabutin-based rescue therapy constitutes a valid strategy after multiple previous eradication failures with key antibiotics, such as clarithromycin, metronidazole, tetracycline and levofloxacin.

Helicobacter pylori first-line treatment and rescue option containing levofloxacin in patients allergic to penicillin.

AIM: To assess the efficacy and tolerability of Helicobacter pylori first-line treatment (omeprazole-clarithromycin-metronidazole) and second-line rescue option (omeprazole-clarithromycin-levofloxacin) in patients allergic to penicillin. PATIENTS: Prospective multicenter study including consecutive patients allergic to penicillin. Therapy regimens: First-line treatment (50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and metronidazole (500 mg b.i.d.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and levofloxacin (500 mg b.i.d.) for 10 days. OUTCOME VARIABLE: Negative (13)C-urea breath test 8 weeks after completion of treatment. RESULTS: (1) First-line treatment (omeprazole-clarithromycin-metronidazole): Per-protocol and intention-to-treat eradication rates were 55% (27/49; 95%CI=40-70%) and 54% (27/50; 95%CI=39-69%). Compliance with treatment and follow-up was complete in 98% of cases (one patient was not compliant due to nausea). Adverse events were reported in 5 patients (10%): 4 nausea, 1 diarrhoea. (2) Second-line treatment (omeprazole-clarithromycin-levofloxacin): Per-protocol and intention-to-treat eradication rates were both 73% (11/15; 95%CI=45-92%). Compliance with treatment and follow-up was complete in all the cases. Adverse events were reported in 4 patients (20%), which did not prevent the completion of treatment: Mild nausea (2 patients), and vomiting and myalgias/arthralgias (1 patient). CONCLUSION: In H. pylori infected patients allergic to penicillin, the generally recommended first-line treatment with omeprazole, clarithromycin and metronidazole has low efficacy for curing the infection. On the other hand, a levofloxacin-containing regimen (together with omeprazole and clarithromycin) represents an encouraging second-line alternative in the presence of penicillin allergy.

Efficacy of triple therapy with a proton pump inhibitor, levofloxacin, and amoxicillin as first-line treatment to eradicate Helicobacter pylori.

BACKGROUND: Triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late, and alternative therapies are currently under evaluation. OBJECTIVES: To evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA)--replacing clarithromycin--for the eradication of H. pylori. METHODS: The study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive urease rapid test, histological analysis, or C13-urea breath test. DIAGNOSIS: non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and its effects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days. RESULTS: 130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135) and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group. CONCLUSIONS: Triple therapy with a PPI, amoxicillin and levofloxacin for 10 days is a well-tolerated treatment that is easy to comply with; however it has low efficiency - less than 80% - and is not recommended as a first-choice treatment for H. pylori eradication. Similar results were obtained with the classic triple therapy using a PPI, clarithromycin and amoxicillin.

Eficacia de una triple terapia con un inhibidor de la bomba de protones, levofloxacino y amoxicilina, como primer tratamiento, en la erradicación de Helicobacter pylori / Efficacy of triple therapy with a proton pump inhibitor, levofloxacin, and amoxicillin as first-line treatment to eradicate Helicobacter pylori

Introducción: la triple terapia con un inhibidor de la bomba de protones, claritromicina y amoxicilina (IBP-CA) es el tratamiento de primera elección más utilizado en la erradicación de H. pylori. La eficacia de este tratamiento está disminuyendo en los últimos años y se están valorando otras alternativas terapéuticas. Objetivos:valorar la eficacia, cumplimiento y seguridad de una triple terapia con un IBP, amoxicilina y levofloxacino, sustituyendo a la claritromicina, en la erradicación de H. pylori. Métodos: periodo de estudio: 2007-2008. Se incluyen 135 pacientes (65% mujeres), edad media de 53 años, con síntomas dispépticos e infección por H. pylori, constatada por positividad del test rápido de la ureasa, histología o prueba del aliento con urea-C13. Diagnósticos: dispepsia no investigada: 48,9%, dispepsia funcional: 36,3% y dispepsia ulcerosa: 14,8%. Se indica tratamiento con un inhibidor de la bomba de protones, a dosis habitual, amoxicilina 1 g y levofloxacino 500 mg (IBP-LA), administrados de forma conjunta en desayuno y cena, durante 10 días. Se valora el cumplimiento de la triple terapia y sus efectos adversos mediante interrogatorio y su eficacia mediante la negatividad de la prueba del aliento con urea-C13 practicada a las 6-8 semanas del término del tratamiento. Se compara la eficacia, por protocolo, del tratamiento con IBP-LA con la observada en un grupo control de 270 pacientes tratados con IBP-CA durante 10 días en los años 2006-2007. Resultados: 130/135 pacientes (96,2) del grupo de estudio completaron el tratamiento y el protocolo del seguimiento. La eficacia por intención de tratar fue del 71,8% (97/135) y por protocolo del 74,6% (97/130). Dieciséis pacientes (11,8%) presentaron efectos adversos bien tolerados, excepto en 5 pacientes (3.7%) que motivan el abandono del tratamiento. El tratamiento con IBP-CA resultó eficaz, por protocolo, en 204/270 (75,5%) pacientes del grupo control...(AU)

Background: triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late, and alternative therapies are currently under evaluation. Objectives: to evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA) - replacing clarithromycin - for the eradication of H. pylori. Methods: the study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive urease rapid test, histological analysis, or C13-urea breath test. Diagnosis: non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and its effects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days. Results: 130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135) and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group...(AU)

Colitis ulcerosa grave, con megacolon tóxico, resuelta con infliximab / Severe ulcerative colitis and toxic megacolon resolved with infliximab therapy

No disponible

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.

Recurrence of Helicobacter pylori infection after several eradication therapies: long-term follow-up of 1000 patients.

AIM: To study the incidence of Helicobacter pylori recurrence, its chronological aspects, and the variables that might influence it. METHODS: A total of 1000 patients in whom H. pylori had been eradicated were prospectively studied. Therapies were classified as low and high efficacy regimens. Four to eight weeks after completion of therapy, 13C-urea-breath-test was performed, and it was repeated yearly up to 5 years. In some patients, endoscopy with biopsies was also performed to confirm H. pylori eradication. RESULTS: A total of 1000 patients were included, giving 2744 patient-years of follow-up. Seventy-one H. pylori recurrences were observed (2.6% per patient-year). Probability of being H. pylori-negative at 1 year was 94.7%, and at 5 years 90.7%. In the multivariate analysis, low age (OR: 1.84; 95% CI: 1.04-3.26) and low efficacy therapies (OR: 2.5; 1.23-5.04) correlated with 1-year H. pylori recurrence. Differences were observed when Kaplan-Meier curves were compared depending on age and therapy regimen. CONCLUSION: Risk of posteradication H. pylori recurrence is higher during the first year, which suggests that most recurrences during this period are recrudescence and not true reinfections. H. pylori recurrence is more frequent in younger patients and in those treated with low efficacy therapies, but is exceptional if high efficacy therapies are used, in which case post-therapy eradication can be safely confirmed at 4 weeks with 13C-urea-breath-test.

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

[Influence of nonsteroidal antiinflammatory drugs in gastrointestinal bleeding due to gastroduodenal ulcers or erosions in patients with liver cirrhosis]. / Influencia de los antiinflamatorios no esteroideos en la hemorragia digestiva por úlceras o erosiones gastroduodenales en pacientes con cirrosis hepática.

INTRODUCTION: Peptic ulcer disease, with or without complications, is more common in patients with liver cirrhosis than in the general population. Factors associated with portal hypertension are involved in its pathogenesis. The prevalence of Helicobacter pylori infection in patients with liver cirrhosis and the general population is similar. The aim of the present study was to determine the influence of nonsteroidal antiinflammatory drugs (NSAIDs) in the etiology of bleeding peptic ulcer disease in patients with liver cirrhosis. PATIENTS AND METHODS: We studied 35 patients with liver cirrhosis and gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group A), 125 noncirrhotic patients with gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group B), and 70 patients with liver cirrhosis who were admitted to hospital without gastrointestinal bleeding (group C). All patients were questioned about NSAID consumption, including aspirin, during the week prior to hospital admission. RESULTS: NSAID consumption was reported by 15 patients (42.8%) in group A, 102 patients (58.2%) in group B, and 6 patients (8.5%) in group C. Statistically significant differences were obtained when the results for group A were compared with those for group C. CONCLUSIONS: NSAID consumption in patients with liver cirrhosis without gastrointestinal bleeding was low (8.5%) and was much lower than that observed in patients with cirrhosis admitted to hospital for bleeding due to gastroduodenal ulcers or erosions (42.8%). As occurs in the general population, NSAIDs play a significant role in the pathogenesis of bleeding due to peptic ulcer disease in patients with liver cirrhosis and portal hypertension.