Efficacy of combined therapy in patients with erosive gastroesophageal reflux disease
DOI: 10.32364/2587-6821-2021-5-6-366-372
I.V. Matoshina1, M.A. Livzan1, M.M. Fedorin1, I.V. Lapteva2
1Omsk State Medical University, Omsk, Russian Federation
2City Hospital No. 3, Omsk, Russian Federation
Aim: to evaluate the efficacy and safety of combined therapy with a proton pump inhibitor (PPI) and an esophagoprotector to relieve the symptoms of reflux esophagitis, improve the life quality of patients and achieve faster and complete disease remission.
Patients and Methods: a randomized study included 60 patients, including 33 men (mean age 40.96±13.44 years) and 27 women (mean age 48.29±12.69 years) with a duration of gastroesophageal reflux disease (GERD) of 21.85±15.48 months and C/D stage of reflux esophagitis. Depending on the prescribed treatment, the patients were divided into 2 groups of 30 subjects. Patients of the main group received complex therapy: PPI pantoprazole 40 mg once per day and esophagoprotector based on hyaluronic acid, chondroitin sulfate and poloxamer 407. In the comparison group, only pantoprazole was prescribed at the same dosage. The duration of the treatment course in both groups was 4 weeks. Before and after treatment, the pr esence and severity of complaints were assessed on the Likert scale, life quality according to the SF-36 questionnaire and endoscopic examination data.
Results: after the end of the therapy course, a statistically significant decrease in the severity of epigastric burning, regurgitation, substernal pain, gaseous eructation, odynophagia and dysphagia was found both in the main group (in all cases p<0.05, Wilcoxon Matched Pairs Test) and the comparison group (in all cases p<0,05, Wilcoxon Matched Pairs Test). The use of combination therapy made it possible to achieve a more significant improvement in the life quality of patients in all indicators versus PPI monotherapy. In addition, 3 (10%) patients of the main group achieved endoscopic remission, while there were no such patients in the comparison group. The use of esophagoprotector in addition to PPI made it possible to reach the primary and secondary endpoints significantly more commonly versus during monotherapy.
Conclusion: the obtained data indicate the high efficiency and safety of PPI therapy in combination with esophagoprotector for relieving the disease symptoms and improving the life quality of patients, faster and complete remission of reflux esophagitis by additional restoration of the esophageal mucosa resistance. Esophagoprotector as a component of complex therapy together with PPI allows achieving clinical and endoscopic disease remission in patients with erosive esophagitis in shorter terms.
Keywords: gastroesophageal reflux disease, esophageal mucosa resistance, esophagoprotection, proton pump inhibitor, quality of life.
For citation: Matoshina I.V., Livzan M.A., Fedorin M.M., Lapteva I.V. Efficacy of combined therapy in patients with erosive gastroesophageal reflux disease. Russian Medical Inquiry. 2021;5(6):366–372 (in Russ.). DOI: 10.32364/2587-6821-2021-5-6-366-372.
About the authors:
Irina V. Matoshina — Assistant Professor of the Department of Faculty Therapy and Gastroenterology, Omsk State Medical University; 12, Lenin str., Omsk, 644099, Russian Federation; ORCID iD 0000-0001-6282-8979.
Maria A. Livzan — Dr. Sc. (Med.), Professor, Head of the Department of Faculty Therapy and Gastroenterology, Omsk State Medical University; 12, Lenin str., Omsk, 644099, Russian Federation; ORCID iD 0000-0002-6581-7017.
Maxim M. Fedorin — Resident of the Department of Faculty Therapy and Gastroenterology, Omsk State Medical University; 12, Lenin str., Omsk, 644099, Russian Federation; ORCID iD 0000-0002-0238-4664.
Irina V. Lapteva — Head of the Department of Internal Medicine No. 1, Head of the Center of Gastroenterology, City Hospital No. 3; 19, Energetiki str., Omsk, 644029, Russian Federation.
Contact information: Maxim M. Fedorin, e-mail: maxim.f@gmail.com.
Financial Disclosure: grant of the President of the Russian Federation for state support of leading scientific schools (NSH-2558.2020.7) (Agreement No. 075-15-2020-036 of March 17, 2020) "Development of health-preserving technology for patient with comorbid gastroenterological profile based on adherence control".
There is no conflict of interests.
Received 25.06.2021.
Revised 20.07.2021.
Accepted 12.08.2021.
2. Hopwood D., Bateson M.C., Milne G., Bouchier I.A. Effects of bile acids and hydrogen ion on the fine structure of oesophageal epithelium. Gut. 1981;22(4):306–311. DOI: 10.1136/gut.22.4.306.
3. Dixon M.F., Neville P.M., Mapstone N.P. et al. Bile reflux gastritis and Barrett’s oesophagus: further evidence of a role for duodenogastro-oesophageal reflux? Gut. 2001;49(3):359–363. DOI: 10.1136/gut.49.3.359.
4. Simanenkov V.I., Maev I.V., Tkacheva O.N. et al. Syndrome of increased epithelial permeability in clinical practice. Multidisciplinary national Consensus. Cardiovascular Therapy and Prevention. 2021;20(1):2758 (in Russ.). DOI: 10.15829/1728-8800-2021-2758.
5. Matoshina I.V., Fedorin M.M., Livzan M.A., Mozgovoy S.I. Resistance of the esophageal mucosa in patients with GERD: the dialogue between clinician and pathologist. Effective pharmacotherapy. 2021;17(4):34–39 (in Russ.). DOI: 10.33978/2307-3586-2021-17-4-34-39.
6. Hunt R., Armstrong D., Katelaris P. et al. Review Team. World Gastroenterology Organisation Global Guidelines: GERD Global Perspective on Gastroesophageal Reflux Disease. J Clin Gastroenterol. 2017;51(6):467–478. DOI: 10.1097/MCG.0000000000000854.
7. Alekseyenko S.A., Bagdasaryan A.A., Bakulin I.G. et al. Brief algorithms for managing patients at the stage of primary health care. M.: Vidoks; 2019 (in Russ.).
8. Akiyama J., Kuribayashi S., Baeg M.K. et al. Current and future perspectives in the management of gastroesophageal reflux disease. Ann N Y Acad Sci. 2018;1434(1):70–83. DOI: 10.1111/nyas.13850.
9. Moayyedi P., Santana J., Khan M. et al. WITHDRAWN: Medical treatments in the short term management of reflux oesophagitis. Cochrane Database Syst Rev. 2011;(2):CD003244. DOI: 10.1002/14651858.CD003244.pub3.
10. Wolfe M.M., Sachs G. Acid suppression: optimizing therapy for gastroduodenal ulcer healing, gastroesophageal reflux disease, and stress-related erosive syndrome. Gastroenterology. 2000;118(2 Suppl 1):S9–31. DOI: 10.1016/s0016-5085(00)70004-7.
11. Maev I.V., Andreev D.N., Kucheryavyy Yu.A. et al. Current advances in the treatment of gastroesophageal reflux disease: a focus on esophageal protection. Therapeutic Archive. 2019;91(8):4–11 (in Russ.). DOI: 10.26442/00403660.2019.08.000387.
12. Livzan M.A., Kononov A.V. Clinical and pharmacoeconomic aspects of the antisecretory therapy of gastroesophageal refluxed disease. Experimental and clinical gastroenterology journal. 2004;(4):55–60 (in Russ.).
13. Tack J. Review article: role of pepsin and bile in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005;22 Suppl 1:48–54. DOI: 10.1111/j.1365-2036.2005.02609.x.
14. Zhang J.X., Ji M.Y., Song J. et al. Proton pump inhibitor for non-erosive reflux disease: a meta-analysis. World J Gastroenterol. 2013;19(45):8408–8419. DOI: 10.3748/wjg.v19.i45.8408.
15. El-Serag H., Becher A., Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther. 2010;32(6):720–737. DOI: 10.1111/j.1365-2036.2010.04406.x.
16. Nikolaev N.A., Martynov A.I., Skirdenko Yu.P. et al. Treatment management based on adherence: patient recommendation algoritms. Cross-disciplinary guidelines. Medical News of North Caucasus. 2020;15(4):461–468 (in Russ.). DOI: 10.14300/mnnc.2020.15109.
17. Embutnieks Yu.V., Valitova E.R., Bordin D.S. The New Approach to the Treatment of Gastroesophageal Refl ux Disease: the Protection of the Esophageal Mucosa. Effektivnaya farmakoterapiya. 2019;15(18):16–22 (in Russ.). DOI: 10.33978/2307-3586-2019-15-18-16-22.
18. Savarino E., Zentilin P., Marabotto E. et al. Drugs for improving esophageal mucosa defense: where are we now and where are we going? Ann Gastroenterol. 2017;30(6):585–591. DOI: 10.20524/aog.2017.0187.
19. Vakil N., van Zanten S.V., Kahrilas P. et al. Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900–1920; quiz 1943. DOI: 10.1111/j.1572-0241.2006.00630.x.
20. Savarino V., Pace F., Scarpignato C. Esoxx Study Group. Randomised clinical trial: mucosal protection combined with acid suppression in the treatment of non-erosive reflux disease — efficacy of Esoxx, a hyaluronic acid-chondroitin sulphate based bioadhesive formulation. Aliment Pharmacol Ther. 2017;45(5):631–642. DOI: 10.1111/apt.13914.
21. Palmieri B., Merighi A., Corbascio D. et al. Fixed combination of hyaluronic acid and chondroitin-sulphate oral formulation in a randomized double blind, placebo controlled study for the treatment of symptoms in patients with non-erosive gastroesophageal reflux. Eur Rev Med Pharmacol Sci. 2013;17(24):3272–3278.
This work is licensed under a Creative Commons «Attribution» 4.0 License.
Распечатать