Document Type : original article
Authors
- Ramin Madani 1
- Mohammad Mahdi Heidari 1, 2, 3
- Mohammad Ali Sabahi 1
- Mahdi Salehi 3
- Davood Kheirkhah 1, 2
- Abbas Taghavi-Ardakani 1, 2
- Somayeh Jamei 4
- Amir Mahdi Shafiei 3
- Hamid Reza Gilasi 5
1 Department of Pediatrics, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.
2 Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.
3 Student Research Committee, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.
4 Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
5 Department of Biostatistics and Public Health, Kashan University of Medical Sciences, Kashan, Iran.
Abstract
Background: Gastroesophageal Reflux Disease (GERD) is common in infants and its treatment remains extremely challenging in this age group. Therefore this study aimed to compare the efficacy and safety of omeprazole and esomeprazole in infants, aged 1-11 months old, presented with GERD.
Methods: This double-blind randomized controlled trial was conducted on 80 infants. All patients were randomly divided into omeprazole and esomeprazole treatment groups for four weeks. The signs, symptoms, and disease severity based on the Visual Analog Scale (VAS) of GERD were evaluated after treatment in both groups. The data were then analyzed using the SPSS Statistics software (version 21).
Results: The results of this study did not show significant differences between the mean disease severity based on VAS of both omeprazole- (81.1±55.7) and esomeprazole-receiving (79.1±77.6) groups (p=0.091). However, in each group, the mean disease severity after one month of treatment was significantly lower as compared to baseline (p<0.01). The recovery rates were similar in both groups (75% and 70% for omeprazole and esomeprazole groups, respectively) (p=0.799).
Conclusion: Omeprazole and esomeprazole did not have significant differences in signs, symptoms, and disease severity of GERD, however, we observed a significant reduction in disease severity in both groups indicating that these two drugs could be used interchangeably for the treatment of GERD disorder.
Keywords
- Vandenplas Y, Sacre-Smits L. Continuous 24-hour esophageal pH monitoring in 285 asymptomatic infants 0-15 months old. J Pediatr Nutr 1987; 6:220–4.
- Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 1997; 151:569–72.
- Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000; 154:150–4.
- Rudolph CD, Mazur LJ, Liptak GS, Baker RD, Boyle JT, Colletti RB, Gerson WT, Werlin SL; North American Society for Pediatric Gastroenterology and Nutrition. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: recommendations of the North American Society for Pediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 2001; 32:S1–31.
- Gold BD. Gastroesophageal reflux disease: could intervention in childhood reduce the risk of later complications? Am J Med 2004; 117:23S–9S.
- Sherman PM, Hassal E, Fagundes-Neto U, Gold BD, Kato S, Koletzko S, Orenstein S, Rudolph C, Vakil N, Vandenplas Y. A global, evidence based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Am J Gastroenterol 2009; 104:1278-95.
- Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr 2009; 49:498–547.
- Orenstein SR, Shalaby TM, Kelsey SF, Frankel E. Natural history of infant reflux esophagitis: symptoms and morphometric histology during one year without pharmacotherapy. Am J Gastroenterol 2006; 101:628–40.
- Lindberg P, Keeling D, Fryklund J, Andersson T, Lundborg P, Carlsson E. Review article: Esomeprazole--enhanced bioavailability, specificity for the proton pump and inhibition of acid secretion. Aliment Pharmacol Ther. 2003; 17:481–488.
- Sjövall H, Björnsson E, Holmberg J, Hasselgren G, Röhss K, Hassan-Alin M. Pharmacokinetic study of esomeprazole in patients with hepatic impairment. Eur J Gastroenterol Hepatol. 2002; 14:491–496.
- Lind T, Rydberg L, Kylebäck A, Jonsson A, Andersson T, Hasselgren G, Holmberg J, Röhss K. Esomeprazole provides improved acid control vs. omeprazole In patients with symptoms of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2000; 14:861–867.
- Andersson T, Hassan-Alin M, Hasselgren G, Röhss K, Weidolf L. Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole. Clin Pharmacokinet. 2001; 40:411–426.
- Kahrilas PJ, Falk GW, Johnson DA, Schmitt C, Collins DW, Whipple J, D'Amico D, Hamelin B, Joelsson B. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. The Esomeprazole Study Investigators. Aliment Pharmacol Ther. 2000; 14:1249–1258.
- Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged < 1 year. Paediatr Drugs 2008; 10:255–63.
- Khoshoo V, Dhume P. Clinical response to 2 dosing regimens of lansoprazole in infants with gastroesophageal reflux. J Pediatr Gastroenterol Nutr 2008; 46:352–4.
- Omari T, Davidson G, Bondarov P, Nauclér E, Nilsson C, Lundborg P. Pharmacokinetics and acid suppressive effects of esomeprazole in infants 1-24 months old with symptoms of gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2007; 45:530–7.
- Omari TI, Haslam RR, Lundborg P, Davidson GP. Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux. J Pediatr Gastroenterol Nutr 2007; 44:41–4.
- Bishop J, Furman M, Thomson M. Omeprazole for gastroesophageal reflux disease in the first 2 years of life: a dose-finding study with dual channel pH monitoring. J Pediatr Gastroenterol Nutr 2007; 45:50–5.
- Orenstein SR, Hassal E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr 2009; 154:514–20.
- Winter H, Kum-Nji P, Mahomedy SH, Kierkus J, Hinz M, Li H, Maguire MK, Comer GM. Efficacy and safety of pantoprazole delayed-release granules for oral suspension in a placebo controlled treatment-withdrawal study in infants 1–11 months old with symptomatic GERD. J Pediatr Gastroenterol Nutr 2010; 50:609–18.
- Srikanth G, Jagadishbabu D, Junied S, Sriharsha M. Comparative study of pantoprazole and esomeprazole for erosive gastroesophageal reflux disease: a prospective study.International Journal of Basic & Clinical Pharmacology. 2014; 3 (3): 460-464.
- Candela NM, Lightdale JR. Therapies for Gastroesophageal Reflux in Infants. InInfectious Disease and Pharmacology 2019 Jan 1 (pp. 261-277). Content Repository Only.
- Mousa H, Hassan M. Gastroesophageal reflux disease. Pediatric Clinics. 2017 Jun 1; 64(3):487-505.
- El-Mahdy MA, Mansoor FA, Jadcherla SR. Pharmacological management of gastroesophageal reflux disease in infants: current opinions. Current opinion in pharmacology. 2017 Dec 1; 37:112-7.
- Abbasi R, Abbasi F, Mosavizadeh A, Sadeghi H, Keshtekari A. comparison of the effect of omeprazole, esomeprazole and lanzoprazole on treatment of gastroesophageal reflux disease referred children aged 2 to 24 months to shahid- mofatteh clinic of yasuj-2015. JCCS. 2020; 1 (3).
- Armstrong D, Talley NJ, Lauritsen K, Moum B, Lind T, Tunturi‐Hihnala H, Venables T, Green J, Bigard MA, Mössner J, Junghard O. The role of acid suppression in patients with endoscopy‐negative reflux disease: the effect of treatment with esomeprazole or omeprazole. Alimentary pharmacology & therapeutics. 2004 Aug; 20(4):413-21.
- Röhss, K., Hasselgren, G. & Hedenström, H. Effect of Esomeprazole 40 mg vs Omeprazole 40 mg on 24-Hour Intragastric pH in Patients with Symptoms of Gastroesophageal Reflux Disease. Dig Dis Sci 47, 954–958 (2002). https://doi.org/10.1023/A:1015009300955
- Olbe, L., Carlsson, E. & Lindberg, P. A proton-pump inhibitor expedition: the case histories of omeprazole and esomeprazole. Nat Rev Drug Discov 2, 132–139 (2003). https://doi.org/10.1038/nrd1010.
- Lind T, Rydberg L, Kylebäck A, Jonsson A, Andersson T, Hasselgren G, Holmberg J, Röhss K. Esomeprazole provides improved acid control vs. omeprazole In patients with symptoms of gastro-oesophageal reflux disease. Alimentary pharmacology & therapeutics. 2000 Jul; 14(7):861-7.
- Shreef K. Chronic Gastric Volvulus: Is it a Missed Cause of Gastro-Esophageal Reflux in Children? A Single Institution Study. EC Gastroenterology and Digestive System. 2019; 6:280-6.
- Duncan DR, Larson K, Rosen RL. Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia. Current gastroenterology reports. 2019 Jul 1; 21(7):30.
)