Brief Article
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World J Gastroenterol. Aug 28, 2012; 18(32): 4371-4378
Published online Aug 28, 2012. doi: 10.3748/wjg.v18.i32.4371
Alginate controls heartburn in patients with erosive and nonerosive reflux disease
Edoardo Savarino, Nicola de Bortoli, Patrizia Zentilin, Irene Martinucci, Luca Bruzzone, Manuele Furnari, Santino Marchi, Vincenzo Savarino
Edoardo Savarino, Patrizia Zentilin, Luca Bruzzone, Manuele Furnari, Vincenzo Savarino, Division of Gastroenterology, Department of Internal Medicine, University of Genoa, 16126 Genoa, Italy
Edoardo Savarino, Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, 35128 Padua, Italy
Nicola de Bortoli, Irene Martinucci, Santino Marchi, Division of Gastroenterology, Department of Internal Medicine, University of Pisa, 56100 Pisa, Italy
Author contributions: Savarino E and de Bortoli N designed the study, collected and analyzed the data, wrote the manuscript, approved final version; Zentilin P, Martinucci I, Bruzzone L and Furnari M collected data and approved the final version; Marchi S wrote the manuscript and approved the final version; Savarino V designed the study, wrote the manuscript and approved the final version.
Correspondence to: Edoardo Savarino, MD, PhD, Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Viale Giustiniani 2, 35128 Padua, Italy. edoardo.savarino@gmail.com
Telephone: +39-349-8728491 Fax: +39-049-8760820
Received: June 5, 2012
Revised: July 27, 2012
Accepted: August 15, 2012
Published online: August 28, 2012
Abstract

AIM: To evaluate the effect of a novel alginate-based compound, Faringel, in modifying reflux characteristics and controlling symptoms.

METHODS: In this prospective, open-label study, 40 patients reporting heartburn and regurgitation with proven reflux disease (i.e., positive impedance-pH test/evidence of erosive esophagitis at upper endoscopy) underwent 2 h impedance-pH testing after eating a refluxogenic meal. They were studied for 1 h under basal conditions and 1 h after taking 10 mL Faringel. In both sessions, measurements were obtained in right lateral and supine decubitus positions. Patients also completed a validated questionnaire consisting of a 2-item 5-point (0-4) Likert scale and a 10-cm visual analogue scale (VAS) in order to evaluate the efficacy of Faringel in symptom relief. Tolerability of the treatment was assessed using a 6-point Likert scale ranging from very good (1) to very poor (6).

RESULTS: Faringel decreased significantly (P < 0.001), in both the right lateral and supine decubitus positions, esophageal acid exposure time [median 10 (25th-75th percentil 6-16) vs 5.8 (4-10) and 16 (11-19) vs 7.5 (5-11), respectively] and acid refluxes [5 (3-8) vs 1 (1-1) and 6 (4-8) vs 2 (1-2), respectively], but increased significantly (P < 0.01) the number of nonacid reflux events compared with baseline [2 (1-3) vs 3 (2-5) and 3 (2-4) vs 6 (3-8), respectively]. Percentage of proximal migration decreased in both decubitus positions (60% vs 32% and 64% vs 35%, respectively; P < 0.001). Faringel was significantly effective in controlling heartburn, based on both the Likert scale [3.1 (range 1-4) vs 0.9 (0-2); P < 0.001] and VAS score [7.1 (3-9.8) vs 2 (0.1-4.8); P < 0.001], but it had less success against regurgitation, based on both the Likert scale [2.6 (1-4) vs 2.2 (1-4); P = not significant (NS)] and VAS score [5.6 (2-9.6) vs 3.9 (1-8.8); P = NS]. Overall, the tolerability of Faringel was very good 5 (2-6), with only two patients reporting modest adverse events (i.e., nausea and bloating).

CONCLUSION: Our findings demonstrate that Faringel is well-tolerated and effective in reducing heartburn by modifying esophageal acid exposure time, number of acid refluxes and their proximal migration.

Keywords: Impedance pH-metry; Nonerosive reflux disease; Erosive esophagitis; Nonacid reflux; Proximal reflux