GASTROINTESTINAL EFFICACY OF OMEPRAZOLE IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

Main Article Content

Dr Mian Shah Yousaf
Dr Noman Khan
Dr Wajid Iqbal
Dr. Arbab Muhammad Kashif Khan
Dr Masood Muhammad Karim
Dr Muhammad Abbas

Keywords

Gastroesophageal reflux disease (GERD), omeprazole, proton pump inhibitors, gastrointestinal efficacy

Abstract

Introduction: Gastroesophageal Reflux Disease (GERD) poses a significant global health burden, necessitating effective treatment strategies. Proton pump inhibitors, particularly omeprazole, are commonly prescribed for GERD management. However, comprehensive investigations into the gastrointestinal efficacy of omeprazole, considering symptom duration, frequency, severity, and quality of life improvements, are warranted.


Methodology: This randomized controlled trial aimed to systematically investigate the gastrointestinal efficacy of omeprazole in individuals diagnosed with GERD. Following CONSORT guidelines, the study enrolled 180 adult participants to evaluate how omeprazole influenced the duration, frequency, and severity of symptoms, along with its impact on health-related quality of life. Adults aged 25 to 65 with GERD were randomly assigned to either the omeprazole intervention or control group. The intervention group received a standardized daily dose of 20 mg oral omeprazole over a four-week period. Baseline characteristics, including age, gender, BMI, smoking status, comorbidities, and dietary habits, were thoroughly examined. Continuous monitoring of daily vital signs and adverse events was implemented to ensure safety and tolerability.


Results: The study revealed a significantly shorter mean duration of GERD symptoms in the omeprazole group (5.2 ± 1.3 days) compared to the control group (7.8 ± 1.5 days), emphasizing the rapid relief provided by omeprazole (p < 0.001). Efficacy analysis demonstrated a remarkable reduction in symptom frequency (92% vs. 65%, p < 0.001) and severity (p < 0.001) in the omeprazole group. Health-related quality of life significantly improved in the omeprazole group, as reflected in the GERD-QOL scores (p < 0.001).


Conclusion: This trial provides robust evidence supporting the gastrointestinal efficacy of omeprazole in managing GERD symptoms. The rapid relief, significant reductions in symptom frequency and severity, and improvement in health-related quality of life underscore the clinical relevance of omeprazole. The study contributes valuable insights to GERD management and informs future research directions.

Abstract 357 | pdf Downloads 125

References

[1] Aslam N, Telese A, Sehgal V, Sweis R, Lovat LB, Haidry R. Minimally invasive endoscopic therapies for gastro-oesophageal reflux disease. Frontline Gastroenterol 2023;14:249–57. https://doi.org/10.1136/flgastro-2022-102343.
[2] Vakil N, van Zanten S V., Kahrilas P, Dent J, Jones R. The Montreal Definition and Classification of Gastroesophageal Reflux Disease: A Global Evidence-Based Consensus. Am J Gastroenterol 2006;101:1900–20. https://doi.org/10.1111/j.1572-0241.2006.00630.x.
[3] Kinoshita Y, Adachi K, Hongo M, Haruma K. Systematic review of the epidemiology of gastroesophageal reflux disease in Japan. J Gastroenterol 2011;46:1092–103. https://doi.org/10.1007/s00535-011-0429-3.
[4] Matsuki N, Fujita T, Watanabe N, Sugahara A, Watanabe A, Ishida T, et al. Lifestyle factors associated with gastroesophageal reflux disease in the Japanese population. J Gastroenterol 2013;48:340–9. https://doi.org/10.1007/s00535-012-0649-1.
[5] RONKAINEN J, ARO P, STORSKRUBB T, LIND T, BOLLING‐STERNEVALD E, JUNGHARD O, et al. Gastro‐oesophageal reflux symptoms and health‐related quality of life in the adult general population – the Kalixanda study. Aliment Pharmacol Ther 2006;23:1725–33. https://doi.org/10.1111/j.1365-2036.2006.02952.x.
[6] WAHLQVIST P, REILLY MC, BARKUN A. Systematic review: the impact of gastro‐oesophageal reflux disease on work productivity. Aliment Pharmacol Ther 2006;24:259–72. https://doi.org/10.1111/j.1365-2036.2006.02996.x.
[7] Wiklund I. Review of the Quality of Life and Burden of Illness in Gastroesophageal Reflux Disease. Digestive Diseases 2004;22:108–14. https://doi.org/10.1159/000080308.
[8] van Pinxteren B, Numans ME. Short-term treatment with proton pump inhibi-tors, H2-receptor antagonists and prokinetics in gastroesophageal reflux disease: A systematic review. Gastroenterology 2000;118:A219. https://doi.org/10.1016/S0016-5085(00)82950-9.
[9] Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, et al. Quality of life in relation to symptoms in patients with gastro‐oesophageal reflux disease — an analysis based on the ProGERD initiative. Aliment Pharmacol Ther 2003;18:767–76. https://doi.org/10.1046/j.1365-2036.2003.01770.x.
[10] PACE F, NEGRINI C, WIKLUND I, ROSSI C, SAVARINO V. Quality of life in acute and maintenance treatment of non‐erosive and mild erosive gastro‐oesophageal reflux disease. Aliment Pharmacol Ther 2005;22:349–56. https://doi.org/10.1111/j.1365-2036.2005.02558.x.
[11] DE VAULT KR, CASTELL DO. Current Diagnosis and Treatment of Gastroesophageal Reflux Disease. Mayo Clin Proc 1994;69:867–76. https://doi.org/10.1016/S0025-6196(12)61790-X.
[12] Chiba N. Proton pump inhibitors in acute healing and maintenance of erosive or worse esophagitis: a systematic overview. Can J Gastroenterol 1997;11 Suppl B:66B-73B.
[13] Holloway RH, Dent J, Narielvala F, Mackinnon AM. Relation between oesophageal acid exposure and healing of oesophagitis with omeprazole in patients with severe reflux oesophagitis. Gut 1996;38:649–54. https://doi.org/10.1136/gut.38.5.649.
[14] Watson RG, Tham TC, Johnston BT, McDougall NI. Double blind cross-over placebo controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux--the “sensitive oesophagus”. Gut 1997;40:587–90. https://doi.org/10.1136/gut.40.5.587.
[15] Spechler SJ. Epidemiology and Natural History of Gastro-Oesophageal Reflux Disease. Digestion 1992;51:24–9. https://doi.org/10.1159/000200911.
[16] Bell NJ, Hunt RH. Progress with proton pump inhibition. Yale J Biol Med 1992;65:649-57;discussion 689-92.
[17] Fennerty MB. Medical treatment of gastroesophageal reflux disease in the managed care environment. Semin Gastrointest Dis 1997;8:90–9.
[18] BATE CM, GRIFFIN SM, KEELING PWN, AXON ATR, DRONFIELD MW, CHAPMAN RWG, et al. Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis. Aliment Pharmacol Ther 1996;10:547–55. https://doi.org/10.1046/j.1365-2036.1996.44186000.x.
[19] Carlsson R, Dent J, Watts R, Riley S, Sheikh R, Hatlebakk J, et al. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998;10:119–24.
[20] Katz PO, Gerson LB, Vela MF. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. American Journal of Gastroenterology 2013;108:308–28. https://doi.org/10.1038/ajg.2012.444.
[21] Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, et al. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa. Gastroenterology 2000;118:661–9. https://doi.org/10.1016/S0016-5085(00)70135-1.
[22] Bolzern JE, Mitchell A, Torgerson DJ. Baseline testing in cluster randomised controlled trials: should this be done? BMC Med Res Methodol 2019;19:106. https://doi.org/10.1186/s12874-019-0750-8.
[23] Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized Controlled Trials. Dtsch Arztebl Int 2011. https://doi.org/10.3238/arztebl.2011.0663.
[24] Zheng R-N. Comparative study of omeprazole, lansoprazole, pantoprazole and esomeprazole for symptom relief in patients with reflux esophagitis. World J Gastroenterol 2009;15:990. https://doi.org/10.3748/wjg.15.990.
[25] Pouchain D, Bigard M-A, Liard F, Childs M, Decaudin A, McVey D. Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial. BMC Gastroenterol 2012;12:18. https://doi.org/10.1186/1471-230X-12-18.
[26] Nagahara A, Suzuki T, Nagata N, Sugai N, Takeuchi Y, Sakurai K, et al. A multicentre randomised trial to compare the efficacy of omeprazole versus rabeprazole in early symptom relief in patients with reflux esophagitis. J Gastroenterol 2014;49:1536–47. https://doi.org/10.1007/s00535-013-0925-8.
[27] Skoutakis VA, Joe RH, Hara DS. Comparative Role of Omeprazole in The Treatment of Gastroesophageal Reflux Disease. Annals of Pharmacotherapy 1995;29:1252–62. https://doi.org/10.1177/106002809502901212.
[28] Funaki Y, Tokudome K, Izawa S, Tamura Y, Kondo Y, Iida A, et al. Comparison of the effect of a single dose of omeprazole or lansoprazole on intragastric pH in Japanese participants: A two-way crossover study. Journal of the Chinese Medical Association 2013;76:131–4. https://doi.org/10.1016/j.jcma.2012.11.006.
[29] Havelund T, Lind T, Wiklund I, Glise H, Hernqvist H, Lauritsen K, et al. Quality of Life in Patients With Heartburn But Without Esophagitis: Effects of Treatment With Omeprazole. American Journal of Gastroenterology 1999;94:1782–9. https://doi.org/10.1111/j.1572-0241.1999.01206.x.
[30] Budzyński J, Pulkowski G, Suppan K, Fabisiak J, Majer M, Kłopocka M, et al. Improvement in health-related quality of life after therapy with omeprazole in patients with coronary artery disease and recurrent angina-like chest pain. A double-blind, placebo-controlled trial of the SF-36 survey. Health Qual Life Outcomes 2011;9:77. https://doi.org/10.1186/1477-7525-9-77.
[31] Revicki D, Sorensen S, Maton P, Orlando R. Health-Related Quality of Life Outcomes of Omeprazole versus Ranitidine in Poorly Responsive Symptomatic Gastroesophageal Reflux Disease. Digestive Diseases 1998;16:284–91. https://doi.org/10.1159/000016878.
[32] Forgerini M, Mieli S, Mastroianni P de C. Safety assessment of omeprazole use: a review. Sao Paulo Medical Journal 2018;136:557–70. https://doi.org/10.1590/1516-3180.2018.0019220318.
[33] Jeridi D, Pellat A, Ginestet C, Assaf A, Hallit R, Corre F, et al. The Safety of Long-Term Proton Pump Inhibitor Use on Cardiovascular Health: A Meta-Analysis. J Clin Med 2022;11:4096. https://doi.org/10.3390/jcm11144096.
[34] Batchelor R, Kumar R, Gilmartin‐Thomas JFM, Hopper I, Kemp W, Liew D. Systematic review with meta‐analysis: risk of adverse cardiovascular events with proton pump inhibitors independent of clopidogrel. Aliment Pharmacol Ther 2018;48:780–96. https://doi.org/10.1111/apt.14955.
[35] Chen L, Chen Y, Li B. The efficacy and safety of proton-pump inhibitors in treating patients with non-erosive reflux disease: a network meta-analysis. Sci Rep 2016;6:32126. https://doi.org/10.1038/srep32126.
[36] Wang Y-K, Hsu W-H, Wang SSW, Lu C-Y, Kuo F-C, Su Y-C, et al. Current Pharmacological Management of Gastroesophageal Reflux Disease. Gastroenterol Res Pract 2013;2013:1–12. https://doi.org/10.1155/2013/983653.
[37] Kee PS, Maggo SDS, Kennedy MA, Barclay ML, Miller AL, Lehnert K, et al. Omeprazole Treatment Failure in Gastroesophageal Reflux Disease and Genetic Variation at the CYP2C Locus. Front Genet 2022;13. https://doi.org/10.3389/fgene.2022.869160.
[38] Javed M, Ali MH, Tanveer MS, Tanveer MH. Omeprazole vs Lansoprazole in the Management of Gastroesophageal Reflux Disease: A Systematic Literature Review. J Med Res Innov 2020;4:e000204. https://doi.org/10.32892/jmri.204.

Most read articles by the same author(s)