Efficacy of Adding Baclofen to Treat Patients with Non-Erosive Reflux Disease Resistant to Treatment

Document Type : Original Article (s)

Authors

1 Student of Medicine, Department of Medicine, Islamic Azad University, Najafabad Branch, Isfahan, Iran

2 Assistant Professor, Department of Internal Medicine, Islamic Azad University, Najafabad Branch, Isfahan, Iran

3 Assistant Professor, Department of Medicine, Islamic Azad University, Najafabad Branch, Isfahan, Iran

Abstract

Background: Non-erosive reflux disease (NERD) is one of the categories of gastro-esophageal reflux disease defined as the presence of classic reflux symptoms in the absence of esophageal mucosal injury during upper endoscopy. The efficacy of proton pump inhibitor (PPI) is observed in these patients and it is demonstrated that the proportion of them respond to a standard dose of proton pump inhibitors lower than patients with erosive esophagitis. Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has been shown to reduce transient lower esophageal sphincter relaxations (TLESRs), a major cause of gastro-esophageal reflux disease. This study aimed to investigate the efficacy of adding baclofen to treat patients with non-erosive reflux disease resistant to proton-pump-inhibitor treatment.Methods: Ninety patients with non-erosive reflux disease resistant to treatment with proton pump inhibitor were randomly divided into two groups. The first group received baclofen (20 mg per day) plus omeprazole (20 mg per day) and the second group received only omeprazole (20 mg per day). After 2 months, the findings were compared.Findings: Differences in age, sex, weight, previous treatment with proton pump inhibitor, existence of hiatal hernia and previous treatment of Helicobacter pylori were not significant between the groups. Patients receiving baclofen plus omeprazole had significantly less heart burn (P = 0.014), regurgitation (P = 0.012), sour taste (P = 0.029) and belching (P = 0.001).Conclusion: The data suggest that baclofen plus omeprazole have additive effects in treatment of patients with non-erosive reflux disease.

Keywords


  1. Cange L, Johnsson E, Rydholm H, Lehmann A, Finizia C, Lundell L, et al. Baclofen-mediated gastro-oesophageal acid reflux control in patients with established reflux disease. Aliment Pharmacol Ther 2002; 16(5): 869-73.
  2. Fass R, Sifrim D. Management of heartburn not responding to proton pump inhibitors. Gut 2009; 58(2): 295-309.
  3. Fass R. Proton PUMP inhibitor failure--what are the therapeutic options? Am J Gastroenterol 2009; 104(Suppl 2): S33-S38.
  4. Vaezi MF. "Refractory GERD": acid, nonacid, or not GERD? Am J Gastroenterol 2004; 99(6): 989-90.
  5. Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease--where next? Aliment Pharmacol Ther 2005; 22(2): 79-94.
  6. Fass R, Murthy U, Hayden CW, Malagon IB, Pulliam G, Wendel C, et al. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventional-dose lansoprazole therapy-a prospective, randomized, multi-centre study. Aliment Pharmacol Ther 2000; 14(12): 1595-603.
  7. Cossentino MJ, Mann K, Armbruster SP, Lake JM, Maydonovitch C, Wong RK. Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux--a randomised prospective study. Aliment Pharmacol Ther 2012; 35(9): 1036-44.
  8. McDermott CM, Abrahams TP, Partosoedarso E, Hyland N, Ekstrand J, Monroe M, et al. Site of action of GABA(B) receptor for vagal motor control of the lower esophageal sphincter in ferrets and rats. Gastroenterology 2001; 120(7): 1749-62.
  9. Lidums I, Lehmann A, Checklin H, Dent J, Holloway RH. Control of transient lower esophageal sphincter relaxations and reflux by the GABA(B) agonist baclofen in normal subjects. Gastroenterology 2000; 118(1): 7-13.
  10. Ciccaglione AF, Marzio L. Effect of acute and chronic administration of the GABA B agonist baclofen on 24 hour pH metry and symptoms in control subjects and in patients with gastro-oesophageal reflux disease. Gut 2003; 52(4): 464-70.
  11. Gerson LB, Huff FJ, Hila A, Hirota WK, Reilley S, Agrawal A, et al. Arbaclofen placarbil decreases postprandial reflux in patients with gastroesophageal reflux disease. Am J Gastroenterol 2010; 105(6): 1266-75.
  12. Dean BB, Gano AD, Jr., Knight K, Ofman JJ, Fass R. Effectiveness of proton pump inhibitors in nonerosive reflux disease. Clin Gastroenterol Hepatol 2004; 2(8): 656-64.
  13. Vela MF, Tutuian R, Katz PO, Castell DO. Baclofen decreases acid and non-acid post-prandial gastro-oesophageal reflux measured by combined multichannel intraluminal impedance and pH. Aliment Pharmacol Ther 2003; 17(2): 243-51.