Belen Herreros

Unstimulated salivary flow rate, pH and buffer capacity of saliva in healthy volunteers

OBJECTIVES To assess the salivary flow rate, pH, and buffer capacity of healthy volunteers, and their relationships with age, gender, obesity, smoking, and alcohol consumption, and to establish the lower-end value of normal salivary flow (oligosialia). METHODS A prospective study was conducted in 159 healthy volunteers (age > 18 years, absence of medical conditions that could decrease salivary flow). Unstimulated whole saliva was collected during ten minutes, and salivary flow rate (ml/min), pH, and bicarbonate concentration (mmol/l) were measured using a Radiometer ABL 520. The 5 percentile of salivary flow rate and bicarbonate concentration was considered the lower limit of normality. RESULTS Median salivary flow rate was 0.48 ml/min (range: 0.1-2 ml/min). Age younger than 44 years was associated with higher flow rates (OR 2.10). Compared with women, men presented a higher flow rate (OR 3.19) and buffer capacity (OR 2.81). Bicarbonate concentration correlated with salivary flow rate. The lower-end values of normal flow rate and bicarbonate concentration were 0.15 ml/min and 1.800 mmol/l, respectively. The presence of obesity, smoking, and alcohol consumption did not influence salivary parameters. CONCLUSIONS In healthy volunteers, salivary flow rate depends on age and gender, and correlates with buffer capacity. Obesity, smoking, and alcohol use do not influence salivary secretion.

Dental and periodontal lesions in patients with gastro-oesophageal reflux disease

OBJECTIVE Dental erosion has been considered an extraesophageal manifestation of gastro-oesophageal reflux disease, but few reports have studied the relationship between this disease and other periodontal or dental lesions. The aim of this study was to investigate the prevalence of dental and periodontal lesions in patients with gastro-oesophageal reflux disease. PATIENTS AND METHODS A total of 253 subjects were prospectively studied between April 1998 and May 2000. Two study groups were established: 181 patients with gastro-oesophageal reflux disease and 72 healthy volunteers. Clinical assessment, including body mass index and consumption of tobacco and alcohol, was performed in all subjects, as well as a dental and periodontal examination performed by a dentist physician, blind as to the diagnosis of subjects. Parameters evaluated were: (a) presence and number of dental erosion, location and severity, according to the Eccles and Jenkins index [Prosthet Dent 1979;42:649-53], modified by Hattab [Int J Prosthes 2000;13:101-71; (b) assessment of dental condition by means of the CAO index; and (c) periodontal status analysed by the plaque index, the haemorrhage index, and gingival recessions. RESULTS Clinical parameters were similar in both groups (p > 0.05). Age was statistically associated with the CAO index, presence of dental erosion, and gingival recession (p < 0.001, Students t-test). Compared with the control group, the percentage of dental erosion was significantly higher in the gastro-oesophageal reflux disease group (12.5 vs. 47.5%, p < 0.001, chi2-test), as was the number and severity of dental erosions (p < 0.001, Students t-test). Location of dental erosion was significantly different between groups. Age was not statistically related to either the amount or severity of dental erosion. CAO and periodontal indices were similarly distributed between groups. CONCLUSIONS Dental erosion may even be considered as an extraesophageal manifestation of gastro-oesophageal reflux disease. The fact that the prevalence of caries and periodontal lesions is similar in patients with gastro-oesophageal reflux disease and in healthy volunteers suggests a lack of relationship with gastro-oesophageal reflux disease.

Recurrence of acute gallstone pancreatitis and relationship with cholecystectomy or endoscopic sphincterotomy.

OBJECTIVES:To determine the prevalence of recurrence of gallstone pancreatitis, its clinical features, and the presence of prognostic factors of recurrence.METHODS:From January 1, 2000 to August 31, 2003, 233 patients admitted with acute gallstone pancreatitis (AGP) were prospectively studied. Patients were divided into two groups: recurrent and nonrecurrent group. Clinical, analytical, radiological, prognostic parameters, and severity (Atlanta criteria) were assessed, along with the performance of cholecystectomy or endoscopic sphincterotomy (ES). Clinical features of recurrence were analyzed. Univariate (χ2, Students t-test) and multivariate tests were performed. Statistical significance was assumed if p < 0.05.RESULTS:Two hundred and eighty-six attacks were identified. Forty-two patients (18.2%) recurred, suffering 53 recurrent attacks, which took place within 30 days in 23.3%. Patients who did not undergo surgery after the first attack had 31-fold risk of recurrence (OR = 31.5%, CI = 95%[7.22–137.84], p < 0.001). In patients not operated, recurrence was more frequent if ES was not performed (37.04%vs 0%, p= 0.019). Among patients with surgical risk, none who recurred underwent ES, compared with 27.9% of those who did not recur. Patients in the nonrecurrent group underwent cholecystectomy within the first 30 days or ES more frequently (31.2%vs 7.3%, p= 0.001).CONCLUSIONS:Recurrence of gallstone pancreatitis is a frequent event. Delay of cholecystectomy implies an increased risk of recurrence. ES could be an acceptable option to prevent recurrence in patients who are not candidates for surgery or who do not desire to undergo cholecystectomy.

Oesophageal motility disorders in type 1 diabetes mellitus and their relation to cardiovascular autonomic neuropathy

Abstract  The relationship between cardiovascular autonomic neuropathy (CVAN) and oesophageal dysfunction in diabetes mellitus has not been well established because reports are contradictory. The aim of this study was to assess oesophageal function and its correlation with CVAN in type 1 diabetic patients without oesophageal symptoms. Forty‐six type 1 diabetic patients without oesophageal symptoms (DG) and 34 healthy volunteers (CG) were studied. Both groups underwent CVAN tests and oesophageal manometry and pH‐metry. Differences between groups regarding results of cardiovascular autonomic tests and oesophageal studies were statistically analysed. Compared with the CG, the DG group showed insufficient lower oesophageal sphincter (LOS) relaxation and a higher percentage of simultaneous waves (P < 0.01). Patients with CVAN (n = 22) showed a higher prevalence of pathological simultaneous contractions (>10%), and the prevalence of simultaneous waves related to the degree of autonomic neuropathy was: 9% of patients without CVAN, 7% of those suspected to have it and 50% of patients with CVAN (P < 0.001). Factors associated with the presence of pathological simultaneous waves (>10%) were the presence of CVAN and duration of diabetes (P < 0.05, logistic regression analysis). Increase in simultaneous waves and impaired relaxation of LOS are more frequent in diabetic patients with CVAN.

Prevalence of silent fecal and urinary incontinence in women from the town of Teruel

OBJECTIVES To study the prevalence of fecal (FI) and urinary incontinence (UI) in women from Teruel (Spain), as well as the clinical conditions associated with these disorders. METHODS We studied prospectively women with an age range of 20-64 years who were randomly selected from the population seen in a primary care center because of medical disorders not related to incontinence. Patients with functional or cognitive impairment were excluded. Medical and obstetric antecedents, as well as the type and frequency of incontinence symptoms were collected in a questionnaire. RESULTS Out of 115 women, 103 completed the study (mean age: 41+/-12 years range 20-64). UI was present in 34.9% (stress 33%, urge 14%, mixed 47%), FI in 14 (13.6%) (flatus 57%, liquid stools 43%), and 10 (9.7%) displayed both disorders. Age > 42 years and body mass index more or equal of 25 were associated with FI and UI; pregnancy was only associated with UI, but the group of women with more or equal of 2 vaginal deliveries showed a higher frequency of FI (p < 0.05, Chi squared test). In the multivariate analysis, only the presence of UI was associated with FI (OR 6.0; CI 95% 1.7-21). Association of FI and UI was more frequent in women older than 42 years (OR 16.7, CI 95% 1.9-141). No statistical differences were found when smoking, exercise, and type of childbirth were compared between the presence/absence of FI or UI. CONCLUSIONS Urinary and fecal incontinence are frequent in women, and the coexistence of both disorders is not uncommon. Age, overweight and parity are associated with the presence of fecal and/or urinary incontinence.

Tu1325 Therapeutic Cut-Off of Infliximab in Patients With Inflammatory Bowel Diseases

Introduction Anti-TNF antibody, infliximab (IFX), is highly effective in inducing and maintaining remission of patients with Inflammatory Bowel Diseases (IBD). However, a large portion of patients develop secondary loss of response mainly due to the formation of antibodies to infliximab (ATI). The strong correlation between IFX levels, ATI and loss of clinical response is widely acknowledged. In order to improve existing algorithms for the management of patients with therapeutic drug monitoring data, drug cut-offs must be implemented. The aim of the present study was to determine therapeutic cut-off level of IFX in patients with IBD categorised as in remission or with active disease. Method A total of 50 patients were retrospectively included (33 patients with Crohn´s disease and 17 with ulcerative colitis). Patients were routinely assessed by endoscopic evaluation. Serum was collected immediately before the infusion (trough levels) and stored until the analysis. IFX and ATI trough levels were measured with Promonitor-IFX and Promonitor-ANTI-IFX ELISA kits (Progenika, Spain). Measurement range allowed quantification across the clinically relevant range of 0.035 to 14.4 µg/mL for IFX and 5 to 1440 AU/mL for ATI. Forty three (86%) and seven (14%) patients were categorised as in remission and active disease, respectively. Results IFX trough levels were significantly higher in patients classified as in remission (median 3.1 µg/mL, IQR 1.5–5.1, n = 43) compared to those who had active disease (median 0 µg/mL, IQR 0–0.5, n = 7; p .001). Using receiver operating characteristics (ROC) analysis an optimal IFX cut-off value of p = 0 .002). Four patients (57%) with active disease showed ATI as compared to only 7% of patients classified as in remission ( p .001). All patients with ATI showed no IFX levels. One patient with active disease showed an infusion-related reaction (459 AU/mL of ATI). Results are in agreement with previously published studies confirming the IFX cut-off. Conclusion ELISA is a simple and powerful technology that provides an accurate quantitation of IFX levels and excellent correlation with clinical outcome. The measurement of IFX and ATI trough levels can help to make a more rational management of patients with IBD. The cut-off level of IFX described in this study can be easily used to discriminate between different clinical responses and guide IFX therapy. Disclosure of interest D. Nagore Employee of: Progenika, A. Ruiz del Agua Employee of: Progenika, J. Pascual Employee of: Progenika, F. Llinares-Tello: None Declared, B. Herreros: None Declared, A. Martinez Employee of: Progenika, S. Martin Grant/ Research Support from: Progenika, R. Navarro: None Declared.

Absence of cardiovascular autonomic dysfunction and vagal pancreatic impairment in idiopathic achalasia of the oesophagus

Abstract  Extra‐oesophageal autonomic dysfunction in idiopathic achalasia is not well documented, due to contradictory results reported. We aimed to study the cardiovascular and pancreatic autonomic function in patients with idiopathic achalasia. Thirty patients with idiopathic achalasia (16M/14F; 34.5 ± 10.8 years) and 30 healthy volunteers (13M/17F; 34.8 ± 10.7 years) were prospectively studied. Age >60 years and conditions affecting results of autonomic evaluation were excluded. Both groups underwent the sham feeding test and plasmatic levels of pancreatic polypeptide (PP) were determined by radioimmunoassay (basal, at 5, 10, 20 and 30 min). Cardiovascular parasympathetic (deep breathing, standing, Valsalva) and sympathetic function (postural decrease of systolic blood pressure, Handgrip test) were assessed. Statistical comparison of basal and increase levels of PP and parasympathetic/sympathetic cardiovascular parameters was performed between groups. Basal levels of PP were similar in controls and patients and maximum increase of PP during sham feeding test. A similar rate of abnormal cardiovascular tests was found between groups (P > 0.05). E/I ratio was the mostly impaired parameter (patients: 36.7%vs controls: 20%, P = 0.15, chi‐squared test). Autonomic cardiovascular tests and pancreatic response to vagal stimulus are not impaired in patients with primary achalasia of the oesophagus.

PTU-088 Method comparison study of assays for the determination of infliximab, adalimumab, and anti-drug antibody levels in patients with inflammatory bowel diseases

Introduction Several methods are used to measure infliximab (IFX), adalimumab (ADL), antibodies to IFX (ATI) and antibodies to ADL (ATA). These agents elicit an unwanted immune response leading to loss of response. Measurement of drug levels (DL) and anti-drug antibodies (ADA) are often required for routine patient monitoring. The aim of this study was to compare different commercially available ELISA tests for the measurement of DL and ADA for IFX and ADL. Method A total of 109 samples (69 IFX and 40 ADL) from 71 patients with IBD were included in the study. DL and ADA trough levels were measured with Promonitor kits (Progenika, Spain) and LISA-TRACKER (LT) Duo IFX and ADL kits (Theradiag, France). In addition, drug-spiked samples were analysed to ascertain trueness. Pearson and Bland-Altman analysis was used to study the association and agreement between DL methods. Cohen´s kappa was used to study agreement of ADA assays. Results Correlation coefficients between each Promonitor test and the corresponding LT assay were 0.99 and 0.83 (p < 0.0001), for IFX and ADL, respectively. Results provided by each DL test were significantly different (p < 0.05): IFX mean±SEM 2.2 ± 0.24 vs 3.4 ± 0.36 mg/L; and ADL 6.0 ± 0.55 vs 4.9 ± 0.39 mg/L for Promonitor and LT, respectively. Analysis of spiked samples indicated that LT make an overestimation and underestimation of IFX and ADL levels, respectively. 23% and 10% of LT measurements were outside the upper limit of quantification (8 mg/L) of each IFX and ADL tests, respectively, and required retesting with higher sample dilutions. All results of Promonitor assays were within the measurement range of the assays (0.035–14.4 mg/L and 0.024–12 mg/L for IFX and ADL, respectively). Analytical sensitivity was similar. In regards to ADA analysis, regardless of the different outputs (assays provide results as arbitrary units and nanograms per millilitre for Promonitor and LT tests, respectively), each pair of tests provided similar qualitative results. Dichotomous analysis with Cohen´s kappa provided values of 0.8 and 1.0 for ATI and ATA, respectively. However, quantification of ATI by LT Duo IFX test was impaired by the limited measurement range of the kit (10–200 ng/mL), with 75% of measurements outside the upper measurement range, which required retesting. Conclusion Performances of both assays were comparable for all measurements. However, the systematic differences in the magnitude of DL and limited measurement ranges observed for LT tests should be taken with caution since this could impact patient management. Disclosure of interest D. Nagore Employee of: Progenika, A. Ruiz del Agua Employee of: Progenika, J. Pascual Employee of: Progenika, F. Llinares-Tello: None Declared, B. Herreros: None Declared, A. Martínez Employee of: Progenika, S. Martín Grant/ Research Support from: Progenika, R. Navarro: None Declared, L. del Rio Employee of: Progenika.

Cost analysis of outpatient management versus hospitalization in patients diagnosed of upper gastrointestinal hemorrhage not associated with portal hypertension

Antecedents: In accord with objective criteria, outpatient management of upper gastrointestinal hemorrhage (UG1H) is a safe alternative to hospitalization, so it may save in terms of hospital costs. Aim: To compare the costs between outpatient management vs. hospitalization in patients with UGIH with similar clinical and endoscopic features. Patients and Methods: Two groups of patients with UG1H not associated with portal hypertension, who were prospectively evaluated at Emergency, were included: 150 admitted at hospital (HG) and 150 that were early discharge (OG). At Emergency, all patients were examined by a gastroenterologist: hemodynamic status, clinical history, laboratory tests and shortly endoscopy (before 8 hours in OG). In accord with specific guidelines, patients with any criterion for hospitalization were not included (severe heart failure; recent myocardial or cerebrovascular accident; severe coagulopathy; unsuitable family conditions; severe hemodynamic repercussion; endoscopy stigmata of recent bleeding; impossibility of performing endoscopy), as well as recurrent hemorrhage, surgery or death. Features of both groups were compared: clinical (comorbidy, alcohol/NSAlDs/anticoagulants use, symptoms, hemodypamic status); biological ; endoscopic findings (cause and severity of UGIH), need of blood transfusion and eradication therapy. Cost analysis were obtained by comparison between groups of cost data of Emergency stay, hospital stay, diagnostic procedures, hospital and outpatient therapy and clinic visit on four weeks after discharge. Results: No statistical differences between groups when clinical, hemodynamic, biological variables and transfusion were compared (p>0.05, ChiSquare test). Endoscopy was not performed in 9 patients of HG because negative and no endoscopic findings were detected in 16 of OG. The remaining (141 HG and 134 OG) presented blackish rests or lesion without stigmata. Mean of hospital stay was of 3.05 + 2.13 days in HG, whereas all patients of the OG were discharge at Emergency in <24 hours. Mean costs were of

Predictive value of the balloon expulsion test for excluding the diagnosis of pelvic floor dyssynergia in constipation

970 + 428 for HG and