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P.20.12 EFFECT OF CLEBOPRIDE ON ESOPHAGEAL MOTOR FUNCTION IN PATIENTS WITH SCLERODERMA: EVALUATION USING HIGH RESOLUTION MANOMETRY
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Abstracts of the 18th National Congress of Digestive Diseases / Digestive and Liver Disease 44S (2012) S55–S220
P.20.12 EFFECT OF CLEBOPRIDE ON ESOPHAGEAL MOTOR FUNCTION IN PATIENTS WITH SCLERODERMA: EVALUATION USING HIGH RESOLUTION MANOMETRY L. Grossi ∗ , A.M. Di Tullio, M. Pagliaro, R. Tavani, S. Cocciolillo, A.F. Ciccaglione, L. Marzio G. D’Annunzio University of Chieti-Pescara, School of Gastroenterology, Digestive Physiopathology Ospedale Spirito Santo, Pescara, Italy Background and aim: Patients with scleroderma usually show low-amplitude esophageal body waves and low basal LES tone, alterations limiting the clearing ability of the esophagus. The only benefit for these patients are antisecretory drugs, effective prokinetics agents lacking after withdrawal of cisapride. Clebopride is able to improve the esophageal motility in patients with Ineffective Esophageal Motility, IEM (DDW, Chicago 7-10 May 2011: Mo1209). Aim of this study was to analyse whether such an effect also occurs in patients with scleroderma. Material and methods: 7 patients (6F, 1M) with scleroderma complaining of heartburn, regurgitation, dysphagia underwent High Resolution Manometry (HRM, Manoscan 360, Sierra Instruments, CA, USA distributed in Italy by Menfis Biomedica Bologna, Italy). Once confirmed the IEM, patients were asked to assume before meals placebo for the next four weeks and clebopride 0.5 mg for the following month. Esophageal HRM was re-scheduled at week 4 and 8. Symptoms such as dysphagia, heartburn and regurgitation were also evaluated. Results: The basal manometry revealed in all patients a low basal LES tone (8.1±2.7 mmHg) and low amplitude esophageal body waves (18±4.7 mmHg). Placebo did not modify the motor pattern during the first month. Clebopride elicited an increase of the basal LES tone (15.1±2.9 mmHg, p=0.032 vs basal) whilst the amplitude of esophageal body waves resulted unaltered (22±3.8 mmHg, n.s. vs basal). Dysphagia was not affected throughout the study period; patients experienced a significant improvement in heartburn and regurgitation after clebopride administration (p=0.04). No side effects were reported. Conclusions: The administration of clebopride determines an increase in the basal LES tone with no improvement in the esophageal body motility of scleroderma patients. This action could be in part useful to reinforce the barrier mechanism at the esophago-gastric junction. The structural alterations of the esophageal smooth muscle induced by the collagen disease may represent the major factor limiting the effect of the drug on esophageal peristalsis. Whether clebopride could have a better role on the esophageal motility in the earlier stage of the disease needs to be elucidated.
P.20.13 ASSESSMENT OF THE ANTI-REFLUX PROPERTIES AND THERAPEUTIC EFFICACY OF FARINGEL IN PATIENTS WITH MILD TO MODERATE GERD E. Savarino ∗ ,1 , N. De Bortoli 2 , P. Zentilin 3 , M. Furnari 3 , I. Martinucci 3 , L. Bruzzone 3 , E. Giambruno 3 , S. Marchi 2 , G.C. Sturniolo 1 , V. Savarino 3 1 Division of Gastroenterology, Department of Surgery and Gastroenterology, University of Padua, Padua, Italy; 2 Division of Gastroenterology, Department of Internal Medicine, University of Pisa, Pisa, Italy; 3 Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy
Background and aim: Antacids are frequently used as add-on therapy in GERD patients in order to help in controlling heartburn. However, there is limited data regarding the mechanisms by which they modify the perception of symptoms. Recently, a novel compound containing sodium bicarbonate and alginate with the addition of herbal components has been introduced on market. The aim of the study is to evaluate the effect of Faringel in modifying reflux characteristics and controlling reflux symptoms. Material and methods: In this prospective study, 38 patients reporting heartburn and regurgitation with proven reflux disease (i.e. positive impedance-pH test/presence of erosive esophagitis) underwent 2-h impedance-pH testing after eating a refluxogenic meal (one cappuccino, two brioches containing chocolate cream and an orange juice). They were studied 1 h in basal condi-
tions and 1 h after taking 10 mL of Faringel. In both sessions, measurements were obtained in right lateral and supine decubitus. Patients completed a validated symptoms questionnaire (range 0-4) and a 10-cm visual analogue scale (VAS) to evaluate the therapeutic efficacy of Faringel. Results: Faringel decreased significantly (P<0.05), in both right lateral and supine decubitus, esophageal acid exposure time (median 10 [25th-75th perc. 6-16] vs. 6 [4-11] and 16 [12-20] vs. 8 [6-11], respectively), number of acid reflux episodes (5 [3-7] vs. 1 [1-2] and 6 [4-8] vs. 1 [1-2], respectively) and percentage of proximal reflux episodes (60% vs. 33% and 65% vs. 35%) compared with baseline. In contrast, Faringel increased the number of non-acid reflux events compared with baseline (2 [1-3] vs. 3 [2-5] and 3 [2-4] vs. 6 [3-8]). Faringel was also significantly effective (P <0.05) in controlling the symptom heartburn (Likert scale 3.1 [range 1-4] vs. 0.9 [0-2] and VAS score 7.1 [3-9.8] vs. 2 [0.1-4.8]), while was less effective with the symptom regurgitation (2.6 [1-4] vs. 2.2 [1-4] and VAS score 5.6 [2-9.6] vs. 3.9 [1-8.8]). Conclusions: Our findings demonstrate that Faringel is highly tolerated and effective in controlling, or at least reducing, heartburn in GERD patients modifying the number of acid reflux episodes and reducing the proximal migration of the refluxate. As expected, it was less effective in controlling non-acid reflux and regurgitation.
P.20.14 IMPEDANCE PH MONITORING IS SUPERIOR TO THE CONVENTIONAL 24-H PH METER IN THE EVALUATION OF PATIENTS WITH LARYNGOPHARYNGEAL REFLUX: ANALYSIS OF 72 PATIENTS M. Bruno 1 , R. D’Onofrio 2 , G. Iaquinto 1 , V. D’Onofrio ∗ ,1 1 Aorn
“San G. Moscati” Uoc Gastroenterologia Ed Endoscopia Digestiva, Avellino, Italy; 2 Campus Biomedico, Roma, Italy Background and aim: Laryngopharyngeal reflux (LPR) is associated with symptoms of laryngeal irritation such as throat pain, cough, and voice change. Currently, the two main diagnostic tools are laryngoscopy and reflux monitoring. On laryngoscopy, the signs most commonly used to diagnose LPR are erythema and edema of the larynx; but, these signs are not specific fbecause may be associated with other causes, or even be found in healthy individuals. In addition, pH testing has low sensitivity in diagnosing gastroesophageal reflux. Therefore, the diagnosis of LPR is not easily made. The aims of the study were to determine the prevalence of high esophageal acid exposure time (AET) in patients presenting with cough or other laryngopharyngeal symptoms (LPS) and determine the incremental yield of multichannel intraluminal impedance-pH (MII-pH) monitoring. Material and methods: We retrospectively analyzed the usefulness of combined ambulatory 24h pHimpedance monitoring as compared to 24h pH monitoring alone in 72 patients with suspected LPR. Results of the diagnostic workup (laryngoscopy, upper gastrointestinal endoscopy, water-perfusion manometry, 24h pH with or without impedance monitoring) and treatment success were determined based on the medical records. Results: Of the 72 patients with suspected LPR, 20 (28%) underwent 24h pH monitoring without impedance and 52 (72%) underwent combined 24h pH-impedance monitoring. There were no differences in male/female ratio and mean age (48±3 vs. 47±2 years) between both groups. The diagnosis of LPR was confirmed with pH monitoring alone in 3/23 (13%) patients whereas combined pHimpedancemonitoring confirmed LPR in 38/52 (73%) patients (Chi-square p<0.05). Symptomatic improvement to medical therapy was obtained in only 29% of LPR patients diagnosed with pH monitoring alone as compared to 74% (Chi-square p<0.05) of LPR patients diagnosed with combined pH-impedance monitoring. Conclusions: Combined ambulatory 24h pH-impedance monitoring increase significantly the diagnostic success rate of suspected LPR. Moreover, it results in a significantly higher medical treatment success since it enables differentiation between acid, weakly acid and non-acid reflux.
Abstracts of the 18th National Congress of Digestive Diseases / Digestive and Liver Disease 44S (2012) S55–S220
P.20.12 EFFECT OF CLEBOPRIDE ON ESOPHAGEAL MOTOR FUNCTION IN PATIENTS WITH SCLERODERMA: EVALUATION USING HIGH RESOLUTION MANOMETRY L. Grossi ∗ , A.M. Di Tullio, M. Pagliaro, R. Tavani, S. Cocciolillo, A.F. Ciccaglione, L. Marzio G. D’Annunzio University of Chieti-Pescara, School of Gastroenterology, Digestive Physiopathology Ospedale Spirito Santo, Pescara, Italy Background and aim: Patients with scleroderma usually show low-amplitude esophageal body waves and low basal LES tone, alterations limiting the clearing ability of the esophagus. The only benefit for these patients are antisecretory drugs, effective prokinetics agents lacking after withdrawal of cisapride. Clebopride is able to improve the esophageal motility in patients with Ineffective Esophageal Motility, IEM (DDW, Chicago 7-10 May 2011: Mo1209). Aim of this study was to analyse whether such an effect also occurs in patients with scleroderma. Material and methods: 7 patients (6F, 1M) with scleroderma complaining of heartburn, regurgitation, dysphagia underwent High Resolution Manometry (HRM, Manoscan 360, Sierra Instruments, CA, USA distributed in Italy by Menfis Biomedica Bologna, Italy). Once confirmed the IEM, patients were asked to assume before meals placebo for the next four weeks and clebopride 0.5 mg for the following month. Esophageal HRM was re-scheduled at week 4 and 8. Symptoms such as dysphagia, heartburn and regurgitation were also evaluated. Results: The basal manometry revealed in all patients a low basal LES tone (8.1±2.7 mmHg) and low amplitude esophageal body waves (18±4.7 mmHg). Placebo did not modify the motor pattern during the first month. Clebopride elicited an increase of the basal LES tone (15.1±2.9 mmHg, p=0.032 vs basal) whilst the amplitude of esophageal body waves resulted unaltered (22±3.8 mmHg, n.s. vs basal). Dysphagia was not affected throughout the study period; patients experienced a significant improvement in heartburn and regurgitation after clebopride administration (p=0.04). No side effects were reported. Conclusions: The administration of clebopride determines an increase in the basal LES tone with no improvement in the esophageal body motility of scleroderma patients. This action could be in part useful to reinforce the barrier mechanism at the esophago-gastric junction. The structural alterations of the esophageal smooth muscle induced by the collagen disease may represent the major factor limiting the effect of the drug on esophageal peristalsis. Whether clebopride could have a better role on the esophageal motility in the earlier stage of the disease needs to be elucidated.
P.20.13 ASSESSMENT OF THE ANTI-REFLUX PROPERTIES AND THERAPEUTIC EFFICACY OF FARINGEL IN PATIENTS WITH MILD TO MODERATE GERD E. Savarino ∗ ,1 , N. De Bortoli 2 , P. Zentilin 3 , M. Furnari 3 , I. Martinucci 3 , L. Bruzzone 3 , E. Giambruno 3 , S. Marchi 2 , G.C. Sturniolo 1 , V. Savarino 3 1 Division of Gastroenterology, Department of Surgery and Gastroenterology, University of Padua, Padua, Italy; 2 Division of Gastroenterology, Department of Internal Medicine, University of Pisa, Pisa, Italy; 3 Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy
Background and aim: Antacids are frequently used as add-on therapy in GERD patients in order to help in controlling heartburn. However, there is limited data regarding the mechanisms by which they modify the perception of symptoms. Recently, a novel compound containing sodium bicarbonate and alginate with the addition of herbal components has been introduced on market. The aim of the study is to evaluate the effect of Faringel in modifying reflux characteristics and controlling reflux symptoms. Material and methods: In this prospective study, 38 patients reporting heartburn and regurgitation with proven reflux disease (i.e. positive impedance-pH test/presence of erosive esophagitis) underwent 2-h impedance-pH testing after eating a refluxogenic meal (one cappuccino, two brioches containing chocolate cream and an orange juice). They were studied 1 h in basal condi-
tions and 1 h after taking 10 mL of Faringel. In both sessions, measurements were obtained in right lateral and supine decubitus. Patients completed a validated symptoms questionnaire (range 0-4) and a 10-cm visual analogue scale (VAS) to evaluate the therapeutic efficacy of Faringel. Results: Faringel decreased significantly (P<0.05), in both right lateral and supine decubitus, esophageal acid exposure time (median 10 [25th-75th perc. 6-16] vs. 6 [4-11] and 16 [12-20] vs. 8 [6-11], respectively), number of acid reflux episodes (5 [3-7] vs. 1 [1-2] and 6 [4-8] vs. 1 [1-2], respectively) and percentage of proximal reflux episodes (60% vs. 33% and 65% vs. 35%) compared with baseline. In contrast, Faringel increased the number of non-acid reflux events compared with baseline (2 [1-3] vs. 3 [2-5] and 3 [2-4] vs. 6 [3-8]). Faringel was also significantly effective (P <0.05) in controlling the symptom heartburn (Likert scale 3.1 [range 1-4] vs. 0.9 [0-2] and VAS score 7.1 [3-9.8] vs. 2 [0.1-4.8]), while was less effective with the symptom regurgitation (2.6 [1-4] vs. 2.2 [1-4] and VAS score 5.6 [2-9.6] vs. 3.9 [1-8.8]). Conclusions: Our findings demonstrate that Faringel is highly tolerated and effective in controlling, or at least reducing, heartburn in GERD patients modifying the number of acid reflux episodes and reducing the proximal migration of the refluxate. As expected, it was less effective in controlling non-acid reflux and regurgitation.
P.20.14 IMPEDANCE PH MONITORING IS SUPERIOR TO THE CONVENTIONAL 24-H PH METER IN THE EVALUATION OF PATIENTS WITH LARYNGOPHARYNGEAL REFLUX: ANALYSIS OF 72 PATIENTS M. Bruno 1 , R. D’Onofrio 2 , G. Iaquinto 1 , V. D’Onofrio ∗ ,1 1 Aorn
“San G. Moscati” Uoc Gastroenterologia Ed Endoscopia Digestiva, Avellino, Italy; 2 Campus Biomedico, Roma, Italy Background and aim: Laryngopharyngeal reflux (LPR) is associated with symptoms of laryngeal irritation such as throat pain, cough, and voice change. Currently, the two main diagnostic tools are laryngoscopy and reflux monitoring. On laryngoscopy, the signs most commonly used to diagnose LPR are erythema and edema of the larynx; but, these signs are not specific fbecause may be associated with other causes, or even be found in healthy individuals. In addition, pH testing has low sensitivity in diagnosing gastroesophageal reflux. Therefore, the diagnosis of LPR is not easily made. The aims of the study were to determine the prevalence of high esophageal acid exposure time (AET) in patients presenting with cough or other laryngopharyngeal symptoms (LPS) and determine the incremental yield of multichannel intraluminal impedance-pH (MII-pH) monitoring. Material and methods: We retrospectively analyzed the usefulness of combined ambulatory 24h pHimpedance monitoring as compared to 24h pH monitoring alone in 72 patients with suspected LPR. Results of the diagnostic workup (laryngoscopy, upper gastrointestinal endoscopy, water-perfusion manometry, 24h pH with or without impedance monitoring) and treatment success were determined based on the medical records. Results: Of the 72 patients with suspected LPR, 20 (28%) underwent 24h pH monitoring without impedance and 52 (72%) underwent combined 24h pH-impedance monitoring. There were no differences in male/female ratio and mean age (48±3 vs. 47±2 years) between both groups. The diagnosis of LPR was confirmed with pH monitoring alone in 3/23 (13%) patients whereas combined pHimpedancemonitoring confirmed LPR in 38/52 (73%) patients (Chi-square p<0.05). Symptomatic improvement to medical therapy was obtained in only 29% of LPR patients diagnosed with pH monitoring alone as compared to 74% (Chi-square p<0.05) of LPR patients diagnosed with combined pH-impedance monitoring. Conclusions: Combined ambulatory 24h pH-impedance monitoring increase significantly the diagnostic success rate of suspected LPR. Moreover, it results in a significantly higher medical treatment success since it enables differentiation between acid, weakly acid and non-acid reflux.