Long-term follow-up of 1,000 patients cured of Helicobacter pylori infection following an episode of peptic ulcer bleeding.

OBJECTIVES: To evaluate the effect of Helicobacter pylori (H. pylori) eradication on ulcer bleeding recurrence in a prospective, long-term study including 1,000 patients. METHODS: Patients with peptic ulcer bleeding were prospectively included. Prior non-steroidal anti-inflammatory drug (NSAID) use was not considered exclusion criteria. H. pylori infection was confirmed by rapid urease test, histology, or (13)C-urea breath test. Several eradication therapies were used. Subsequently, ranitidine 150 mg o.d. was administered until eradication was confirmed by (13)C-urea breath test 8 weeks after completing therapy. Patients with therapy failure received a second, third, or fourth course of eradication therapy. Patients with eradication success did not receive maintenance anti-ulcer therapy and were controlled yearly with a repeat breath test. NSAID use was not permitted during follow-up. RESULTS: Thousand patients were followed up for at least 12 months, with a total of 3,253 patient-years of follow-up. Mean age 56 years, 75% males, 41% previous NSAID users. In all, 69% had duodenal ulcer, 27% gastric ulcer, and 4% pyloric ulcer. Recurrence of bleeding was demonstrated in three patients at 1 year (which occurred after NSAID use in two cases, and after H. pylori reinfection in another one), and in two more patients at 2 years (one after NSAID use and another after H. pylori reinfection). The cumulative incidence of rebleeding was 0.5% (95% confidence interval, 0.16-1.16%), and the incidence rate of rebleeding was 0.15% (0.05-0.36%) per patient-year of follow up. CONCLUSION: Peptic ulcer rebleeding virtually does not occur in patients with complicated ulcers after H. pylori eradication. Maintenance anti-ulcer (antisecretory) therapy is not necessary if eradication is achieved. However, NSAID intake or H. pylori reinfection may exceptionally cause rebleeding in H. pylori-eradicated patients.

A two-phase case-control study for colorectal cancer genetic susceptibility: candidate genes from chromosomal regions 9q22 and 3q22.

BACKGROUND: Colorectal cancer (CRC) is the second cause of cancer-related death in the Western world. Much of the CRC genetic risk remains unidentified and may be attributable to a large number of common, low-penetrance genetic variants. Genetic linkage studies in CRC families have reported additional association with regions 9q22-31, 3q21-24, 7q31, 11q, 14q and 22q. There are several plausible candidate genes for CRC susceptibility within the aforementioned linkage regions including PTCH1, XPA and TGFBR1 in 9q22-31, and EPHB1 and MRAS in 3q21-q24. METHODS: CRC cases and matched controls were from EPICOLON, a prospective, multicentre, nationwide Spanish initiative, composed of two independent phases. Phase 1 corresponded to 515 CRC cases and 515 controls, whereas phase 2 consisted of 901 CRC cases and 909 controls. Genotyping was performed for 172 single-nucleotide polymorphisms (SNPs) in 84 genes located within regions 9q22-31 and 3q21-q24. RESULTS: None of the 172 SNPs analysed in our study could be formally associated with CRC risk. However, rs1444601 (TOPBP1) and rs13088006 (CDV3) in region 3q22 showed interesting results and may have an effect on CRC risk. CONCLUSIONS: TOPBP1 and CDV3 genetic variants on region 3q22 may modulate CRC risk. Further validation and meta-analysis should be undertaken in larger CRC cohorts.

Long-term results of biofeedback treatment for faecal incontinence: a comparative study with untreated controls.

AIM: Long-term results of biofeedback for faecal incontinence are controversial. Moreover, its value compared with standard care has been recently questioned. The study aimed to analyse the long-term efficacy of biofeedback therapy for faecal incontinence to formed stool and to compare it with no treatment. METHOD: Seventy-nine patients with faecal incontinence to solid stool were evaluated at baseline and 1, 6, 36 and 60 months after treatment. To compare the long-term results with no treatment, 40 patients initially evaluated but not referred for therapy were used as controls. RESULTS: More than 80% of patients recovered continence or had a reduction in the number of episodes of incontinence greater than 75% at 1, 6, 36 and 60 months, indicating that the success rate of biofeedback was maintained over time. At 60 months, 86% of patients treated with biofeedback were fully continent or had a > 75% reduction in the number of incontinent episodes compared to 26% of the untreated patients (P < 0.001). CONCLUSION: Biofeedback therapy is effective in patients with faecal incontinence to formed stool compared with no treatment. Overall, clinical improvement is maintained in the long term.

Late Crohn's disease patients present an increase in peripheral Th17 cells and cytokine production compared with early patients.

BACKGROUND: Th1 and Th17 cells have been implicated in Crohn's disease (CD) pathophysiology and may play a role in disease persistence. Aim To determine Th1 and Th17 responses in intestine and peripheral blood of early (<32 weeks since initial symptoms) and late (>2 years) CD patients. METHODS: Cytokine mRNA in intestinal biopsies was determined by RT-PCR. Cytokine concentration in culture was measured by ELISA and cytokine-producing cells were identified by intracellular staining. RESULTS: The inflamed mucosa showed significantly increased IL-17 mRNA levels compared with non-inflamed areas, both in early and late CD patients. However, only patients with late (n = 12), but not early (n = 9), active disease showed increased IL-17 production, as well as a significantly higher percentage of IL-17(+)CD4(+) cells in blood, compared with controls (n = 12) or patients in remission (n = 13). Moreover, cultured peripheral CD4(+) cells from late active CD patients presented significantly higher percentages of IL-17(+), IL-22(+) and IFN-gamma(+) and a significantly increased production of IL-17 and IL-22, but not IFN-gamma(+). CONCLUSIONS: Increased IL-17 gene transcription is common to early and late CD mucosa. However, exacerbated Th17 responses in the peripheral blood appear only in late disease. We propose that this population may constitute a mechanism of perpetuating the disease.

Effects of long-term cyclo-oxygenase 2 selective and acid inhibition on Barrett's oesophagus.

BACKGROUND: There is an overexpression of cyclo-oxygenase 2 (COX-2) in Barrett's oesophagus (BO). AIM: To determine the long-term effect of a COX-2 inhibitor on cellular mechanisms involved in BO. METHODS: A randomized controlled trial was conducted in BO patients allocated to continue the usual proton pump inhibitor (PPI) alone treatment, or PPI combined with rofecoxib (25 mg/day) for 6 months. Cell proliferation index and COX-2 expression in BO glands was determined in biopsy specimens at baseline and after treatment. Cell apoptosis, cyclin D1, p53 and vascular endothelial growth factor (VEGF) expression was also explored in a subset of patients. Student-t test and the U-Mann-Whitney test were used for quantitative and ordinal variables. RESULTS: Of 62 patients, 58 completed the study. A higher proportion of patients on rofecoxib + PPI exhibited a decrease in COX-2 expression compared to those treated with PPI alone, but cell proliferation index was not affected. Unlike PPI alone, rofecoxib + PPI was associated with an increase in the apoptotic cell index, a decrease in p53 cell staining and VEGF expression in mucosal vessels. No effect on low-grade dysplasia or cyclin D1 was observed. CONCLUSIONS: The addition of rofecoxib to PPI therapy does not affect cell proliferation index in BO cells after 6 months of therapy, but does reduce COX-2 and VEGF expression and increases cell apoptosis.

Combined type-1 plasminogen activator inhibitor and NOD2/CARD15 genotyping predicts complicated Crohn's disease behaviour.

BACKGROUND: NOD2/CARD15 gene variants have not been universally associated with stricturing behaviour in Crohn's disease. Other behaviour modifying genes could explain these results. AIM: To study the combined influence of NOD2/CARD15 variants and 4G/4G genotype of type-1 plasminogen activator inhibitor (PAI-1) gene on Crohn's disease behaviour. METHODS: One hundred and seventy Crohn's disease patients were studied prospectively, with a mean follow-up of 7+/- 6 years. Disease behaviour was registered by using two criteria: the Vienna classification and a non-hierarchical classification based on the behavioural Vienna categories. RESULTS: In the multivariate analysis for stricturing behaviour according to the Vienna categories, only absence of colonic disease (OR, 4.0; 95% CI: 1.49-11.1; P = 0.006) was an independent predictive factor. However, in the multivariate analysis for stricturing disease applying a non-hierarchical criteria, ileal disease (OR, 4.19; 95% CI: 1.30-13.5; P = 0.01), and carrying both NOD2/CARD15 variants and the 4G/4G PAI-1 genotype (OR, 5.02; 95% CI: 1.44-17.48; P = 0.01) were independent predictive factors. In the multivariate analysis for penetrating behaviour, the 4G/4G PAI-1 (OR, 3.10; 95% CI: 1.54-6.23; P = 0.001) and male sex (OR, 2.44; 95% CI: 1.30-4.60; P = 0.005) were independent predictive factors irrespective of criteria applied. CONCLUSIONS: Combined PAI-1 and NOD2/CARD15 genotyping predict complicated Crohn's disease. Patients with these variants could benefit from early interventions.

Prospective assessment of the role of antibiotic prophylaxis in ERCP.

BACKGROUND/AIMS: Despite the existence of published recommendations, various studies of antibiotic prophylaxis have reached conflicting conclusions, and controversy exists regarding the role of antibiotic prophylaxis in ERCP. The aim of this study was to analyze the efficacy of the intramuscular administration of clindamicine and gentamicine before ERCP. METHODOLOGY: Sixty-one consecutive patients referred for ERCP were prospectively randomized to receive either clindamicine 600mg and gentamicine 80mg, both intramuscularly one hour before the ERCP (group I; 31 patients) or not (group II; 30 patients). Two blood samples were obtained from every patient (just before endoscopy and within 5 minutes of withdrawal of the endoscope) and were incubated for 7 days and examined daily for growth of bacteria. Patients were closely monitored for 7 days after endoscopy to detect the development of infectious complications. RESULTS: Only 7 cultures from 7 patients were positive. Four were obtained post-ERCP (two patients in group I and two in group II) and the remaining three before endoscopy. The post-ERCP isolated bacteria were: Streptococcus mitis, Peptoestreptococcus anaerobious, Moraxella spp and Escherichia coli. Two patients, one from each group, developed post-ERCP cholangitis that were solved with medical treatment. CONCLUSIONS: Our findings indicate that ERCP induce bacteremia in a small group of patients and suggest that prophylactic administration of clindamicine plus gentamicine does not reduce the incidence of bacteremia and cholangitis, and do not support the routine use of prophylactic antibiotics prior to ERCP.

Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-steroidal anti-inflammatory drugs, aspirin and combinations.

BACKGROUND: The risks and benefits of coxibs, non-steroidal anti-inflammatory drugs (NSAIDs), and aspirin treatment are under intense debate. OBJECTIVE: To determine the risk of peptic ulcer upper gastrointestinal bleeding (UGIB) associated with the use of coxibs, traditional NSAIDs, aspirin or combinations of these drugs in clinical practice. METHODS: A hospital-based, case-control study in the general community of patients from the National Health System in Spain. The study included 2777 consecutive patients with endoscopy-proved major UGIB because of the peptic lesions and 5532 controls matched by age, hospital and month of admission. Adjusted relative risk (adj RR) of UGIB determined by conditional logistic regression analysis is provided. RESULTS: Use of non-aspirin-NSAIDs increased the risk of UGIB (adj RR 5.3; 95% confidence interval (CI) 4.5 to 6.2). Among non-aspirin-NSAIDs, aceclofenac (adj RR 3.1; 95% CI 2.3 to 4.2) had the lowest RR, whereas ketorolac (adj RR 14.4; 95% CI 5.2 to 39.9) had the highest. Rofecoxib treatment increased the risk of UGIB (adj RR 2.1; 95% CI 1.1 to 4.0), whereas celecoxib, paracetamol or concomitant use of a proton pump inhibitor with an NSAID presented no increased risk. Non-aspirin antiplatelet treatment (clopidogrel/ticlopidine) had a similar risk of UGIB (adj RR 2.8; 95% CI 1.9 to 4.2) to cardioprotective aspirin at a dose of 100 mg/day (adj RR 2.7; 95% CI 2.0 to 3.6) or anticoagulants (adj RR 2.8; 95% CI 2.1 to 3.7). An apparent interaction was found between low-dose aspirin and use of non-aspirin-NSAIDs, coxibs or thienopyridines, which increased further the risk of UGIB in a similar way. CONCLUSIONS: Coxib use presents a lower RR of UGIB than non-selective NSAIDs. However, when combined with low-dose aspirin, the differences between non-selective NSAIDs and coxibs tend to disappear. Treatment with either non-aspirin antiplatelet or cardioprotective aspirin has a similar risk of UGIB.

Predictive factors of irritable bowel syndrome improvement: 1-year prospective evaluation in 400 patients.

BACKGROUND: The natural history of the irritable bowel syndrome is poorly understood. AIM: To assess the clinical course of the irritable bowel syndrome and the factors that might predict it. METHODS: An observational prospective study, involving 400 irritable bowel syndrome patients meeting Rome II criteria. Symptoms were recorded in a diary over four non-consecutive months (1, 4, 7 and 10). Demographic data, associated disorders, psychological status and health-related quality of life were obtained. RESULTS: At 1-year follow-up, half of the patients and half of their physicians considered irritable bowel syndrome to have improved, but improvement was minor. Diary data showed that, according to the type of symptom, improvement was small and quite different: diarrhoea in 19% of patients, abdominal pain frequency in 26%, constipation in 33% and abdominal pain intensity in 60%. Factors related to improvement at one year were: severe symptoms and poor health-related quality of life at first visit, irritable bowel syndrome-constipation, good improvement at 3 months, anxiety/depression, stress, symptoms related to meals and absence of comorbidity. By multivariate logistic regression, predictors were: severe basal symptoms and good improvement at 3 months (OR:CI 95%, 1.32:1.09-1.59 and 4.44:2.81-7.05). CONCLUSIONS: At 1-year follow-up, half the patients and their physicians considered the irritable bowel syndrome to have had some improvement but, symptom diaries demonstrated that improvement was small and heterogeneous. Severe basal symptoms and improvement at 3 months were related to better prognosis.

Prevalence of gastro-oesophageal reflux disease in Spain and associated factors.

BACKGROUND: The prevalence of gastro-oesophageal reflux disease (GERD), has not been characterized in Spain. Aim To measure the prevalence of GERD in Spain, and the factors associated with it, by means of a primary care-based study. METHODS: An epidemiological, multicentre, cross-sectional, population-based study. A self-administered questionnaire was sent out to randomly selected patients. Data were statistically analysed to provide the prevalence of GERD and to compare it with that of gastro-oesophageal reflux symptoms. Factors associated with GERD were studied using logistic regression models. RESULTS: The response rate was 45%. The prevalence of GERD was 15% (95% CI: 13.2-16.2). When compared with gastro-oesophageal reflux symptoms patients, those with GERD experienced more intense symptoms (moderate-severe: 35% vs. 8%, P < 0.001) and suffered heartburn more frequently both at day and night (48% vs. 25%, P < 0.001) and for longer period of times (69% vs. 62%, P = 0.057). A body mass index of >25% (odds ratio: 1.07; 95% CI: 1.03-1.11) was the only independent variable associated with GERD. The risk of suffering GERD increases by 7% for each kg/m(2) that the body mass index increases. CONCLUSIONS: The prevalence of GERD among the Spanish population is 15%. Body mass index is the only risk factor significantly associated with GERD.

Anti-inflammatory effects of pancreatitis associated protein in inflammatory bowel disease.

BACKGROUND AND AIMS: Increased pancreatitis associated protein (PAP) mRNA has been reported in active inflammatory bowel disease (IBD). The aims of the current study were to characterise PAP production in IBD and the effects of PAP on inflammation. PATIENTS AND METHODS: Serum PAP levels were determined in healthy controls (n = 29), inflammatory controls (n = 14), and IBD patients (n = 171). Ex vivo PAP secretion in intestinal tissue was measured in 56 IBD patients and 13 healthy controls. Cellular origin of PAP was determined by immunohistochemistry. The effects of exogenous PAP on nuclear factor kappaB (NFkappaB) activation, proinflammatory cytokine production, and endothelial adhesion molecule expression were also analysed ex vivo. RESULTS: Patients with active IBD had increased serum PAP levels compared with controls, and these levels correlated with clinical and endoscopic disease severity. Ex vivo intestinal PAP synthesis was increased in active IBD and correlated with endoscopic and histological severity of inflammatory lesions. PAP localised to colonic Paneth cells. Incubation of mucosa from active Crohn's disease with PAP dose dependently reduced proinflammatory cytokines secretion. PAP prevented TNF-alpha induced NFkappaB activation in monocytic, epithelial, and endothelial cells and reduced proinflammatory cytokine mRNA levels and adhesion molecule expression. CONCLUSIONS: PAP is synthesised by Paneth cells and is overexpressed in colonic tissue of active IBD. PAP inhibits NFkappaB activation and downregulates cytokine production and adhesion molecule expression in inflamed tissue. It may represent an anti-inflammatory mechanism and new therapeutic strategy in IBD.

The European panel on the appropriateness of gastrointestinal endoscopy guidelines colonoscopy in an open-access endoscopy unit: a prospective study.

BACKGROUND: The demand for gastrointestinal endoscopy is increasing in most developed countries, resulting in an important rise in overall costs and waiting lists for endoscopic procedures. Therefore, adherence to appropriate indications for these procedures is essential for the rational use of finite resources in an open-access system. AIM: To assess indications and appropriateness of colonoscopy according to the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE) criteria. METHODS: From May to June 2004, all consecutive patients referred to our Unit for open-access colonoscopy were considered for inclusion in this prospective study. Appropriateness of each colonoscopy was established according to the EPAGE criteria. In order to evaluate whether appropriateness of use correlated with the diagnostic yield of colonoscopy, relevant endoscopic findings were also recorded. RESULTS: A total of 350 consecutive patients were included in the study. In 38 of them, the colonoscopy indication was not listed in the EPAGE guidelines and, consequently, they were not evaluated. In the remaining 312 patients, the indication for the procedure was considered inappropriate in 73 (23%) patients. Both referring doctor characteristics (specialty and health care setting) and patient data (age) correlated with appropriateness of endoscopy. The diagnostic yield was significantly higher for appropriate colonoscopies (42%) than in those judged inappropriate (21%) (P = 0.001). CONCLUSIONS: A noteworthy proportion of patients referred for colonoscopy to an open-access endoscopy unit are considered inappropriate because of their indication, with significant differences among specialties. These results suggest that implementation of validated guidelines for its appropriate use could improve this situation and, considering the correlation between appropriateness and diagnostic yield, even contribute to improve the prognosis of patients with colorectal diseases.

[Psychometric validation of translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) in patients with gastroesophageal reflux disease]. / Validación psicométrica de la traducción al español de la escala de evaluación de síntomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD) en los pacientes con enfermedad por reflujo gastroesofágico.

INTRODUCTION: Pyrosis symptoms and their impact on the quality of life related with health (QLRH) are frequently evaluated in clinical trials. When a questionnaire is translated into a language other than the original, it is necessary to have a linguistic validation, although this is not sufficient unless the psychometric characteristics have been verified. This study aims to document the psychometric characteristics of the translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD). MATERIAL AND METHOD: One hundred fifty eight patients with pyrosis symptoms (age: 51.0; SD: 16.3 years; men: 42.4%) completed the translation to Spanish of the GSRS, the pyrosis version of the QOLRAD, the Short-Form-36 (SF-36) and the hospital of anxiety and depression (HAD) scale. Seventy six patients were given an appointment for a second visit after one week, to fill out the GSRS and QOLRAD again. RESULTS: The reliability of the internal consistence of the GSRS was 0.59-0.83 and that of the QOLRAD: 0.87-0.95, and test-retest reliability of the GSRS was 0.44-0.63 and QOLRAD: 0.77-0.85. Score of the important domains of the GSRS "reflux", "abdominal pain" and "indigestion" and above all those of the QOLRAD correlated significantly. The domain "abdominal pain" of the GSRS had a strong correlation (negative) with the relevant domains of the SF-36. The QOLRAD domains significantly correlated with all the related domains of the SF-36. CONCLUSIONS: The psychometric characteristics of the translation to Spanish of the GSRS and QOLRAD were good, with satisfactory reliability and validity. However, the test-retest reliability of the "reflux" domain of the GSRS was not optimum.

Wireless capsule endoscopy in patients with obscure gastrointestinal bleeding: a comparative study with push enteroscopy.

BACKGROUND: The identification and treatment of lesions located in the small intestine in obscure gastrointestinal bleeding is always a clinical challenge. AIM: To examine prospectively the diagnostic precision and the clinical efficacy of capsule endoscopy compared with push enteroscopy in obscure gastrointestinal bleeding. METHODS: Forty-two patients (22 men and 20 women) with obscure gastrointestinal bleeding (overt bleeding in 26 cases and occult blood loss with chronic anaemia in 16) and normal oesophagogastroduodenoscopy and colonoscopy were analysed. All patients were instructed to receive the capsule endoscopy and push enteroscopy was performed within the next 7 days. Both techniques were blindly performed by separate examiners. The diagnostic yield for each technique was defined as the frequency of detection of clinically relevant intestinal lesions carrying potential for bleeding. RESULTS: A bleeding site potentially related to gastrointestinal bleeding or evidence of active bleeding was identified in a greater proportion of patients using capsule endoscopy (74%; 31 of 42) than enteroscopy (19%; eight of 42) (P = 0.05). The most frequent capsule endoscopy findings were: angiodysplasia (45%), fresh blood (23%), jejunal ulcers (10%), ileal inflammatory mucosa (6%) and ileal tumour (6%). No additional intestinal diagnoses were made by enteroscopy. In seven patients (22%), the results obtained with capsule endoscopy led to a successful change in the therapeutic approach. CONCLUSIONS: Compared with push enteroscopy, capsule endoscopy increases the diagnosis yield in patients with obscure gastrointestinal bleeding, and allows modification on therapy strategy in a remarkable proportion of patients.

Laparoscopic-assisted colectomy in patients with liver cirrhosis.

BACKGROUND: Nonhepatic abdominal surgery, and especially colorectal surgery, is associated with high rates of morbidity and mortality among cirrhotic patients. With proper patient selection and preoperative optimization of the patient's condition, laparoscopic-assisted colectomy could become effective and safe for patients with compensated liver cirrhosis. The aim of this study was to evaluate the safety and feasibility of minimal-access surgery in these patients. METHODS: Between September 1993 and March 2003, 820 patients underwent laparoscopic-assisted colectomy at our hospital. We studied all patients with liver cirrhosis who underwent this operation. RESULTS: Seventeen patients with cirrhosis were included in the study. Twelve were Child's A and five were Child's B. The mean operative time was 150 min (ranges 75-280), mean estimated blood loss was 245 ml (ranges 100-250). The conversion rate to open surgery was 29% (five patients). Median length of hospital stay was 5 days. The morbidity rate was 29% (five patients). There were no anastomotic leaks or operative-related deaths. The median follow-up was 21 months. CONCLUSIONS: Laparoscopic-assisted colorectal surgery can be performed in compensated cirrhotic patients with low morbidity and mortality. Adequate patient selection and expertise in advanced minimal-access surgery are essential to obtain such good results.

[Burden of gastroesophageal reflux disease. Evidence from a recent methodological study in Spain]. / Repercusión de la enfermedad en pacientes con reflujo gastroesofágico. Evidencia de un estudio metodológico reciente en España.

INTRODUCTION: The clinical and socioeconomic burden of gastroesophageal reflux disease (GERD) is considerable. AIM: The aim of this study was to describe the impact of heartburn on patients' health-related quality of life (HRQL) in Spain, using validated generic and disease-specific instruments to measure patient-reported outcomes. PATIENTS AND METHODS: Patients with symptoms of heartburn completed the Spanish versions of the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), the Short Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. The frequency and severity of heartburn in the previous 7 days were also recorded. RESULTS: One hundred fifty-eight patients completed the assessments (mean age: 51 years, SD = 16; 58% female). Sixty-one percent of the patients had moderate symptoms and 73% had symptoms on three or more days in the previous week. Patients were most bothered by symptoms of reflux (mean GSRS score of 3.8 on a scale of 1 [not bothered] to 7 [very bothered]), abdominal pain (3.1) and indigestion (3.1). As a result of their symptoms, patients experienced problems with food and drink (mean QOLRAD score of 4.5 on a scale of 1 to 7, where 1 represents the most severe impact on daily functioning), impaired vitality (4.7) and emotional distress (4.8). This led to impaired overall HRQL across all domains (mean SF-36 score of this heartburn population compared with a general population in Spain). The HAD scale showed that 28% of patients were anxious and 13% were depressed. CONCLUSION: There is consistent evidence that GERD substantially impairs all aspects of HRQL.