Effectiveness of Rebamipide as a part of the Helicobacter pylori eradication therapy in Russia: a meta-analysis of controlled trials
- Authors: Andreev D.N.1, Maev I.V.1, Bordin D.S.1,2,3, Lyamina S.V.1, Dicheva D.T.1, Fomenko A.K.1, Bagdasarian A.S.1
-
Affiliations:
- Yevdokimov Moscow State University of Medicine and Dentistry
- Loginov Moscow Clinical Scientific Center
- Tver State Medical University
- Issue: Vol 24, No 5 (2022)
- Pages: 333-338
- Section: Gastroenterology
- URL: https://journals.rcsi.science/2075-1753/article/view/112445
- DOI: https://doi.org/10.26442/20751753.2022.5.201863
- ID: 112445
Cite item
Full Text
Abstract
Aim. To perform a meta-analysis of the data on Rebamipide efficacy and safety as a part of Helicobacter pylori eradication therapy in Russian patients.
Materials and methods. A search for original studies was conducted in the electronic database of the Russian Science Citation Index (RSCI) on the Scientific Electronic Library (SEL — Elibrary.ru). Google (Google.com) was used for the "grey" search. All Russian controlled studies comparing the efficacy and/or safety of Rebamipide as a part of the regimen of H. pylori eradication therapy were included in the final analysis.
Results. In 6 included controlled trials with a cumulative population (considering double comparisons between multiple groups) of 531 patients (273 in Rebamipide groups and 258 in groups without Rebamipide), the pooled eradication effectiveness was 90.376% (95% confidence interval – CI 86.311–93.560) in patients receiving Rebamipide and 81.681% (95% CI 76.499–86.141) in patients receiving eradication regimens without Rebamipide. The meta-analysis showed that the Rebamipide addition to eradication regimens significantly improved efficacy (odds ratio 2.162, 95% CI 1.268–3.685; p=0.005). No significant heterogeneity was found between study results (p=0.863; I2=0.00%); therefore, a fixed effects model was used in the resulting analysis. In addition, the meta-analysis of included studies showed a reduction of adverse events (odds ratio 0.569, 95% CI 0.333–0.970) in the groups receiving Rebamipide; p=0.038). This effect of Rebamipide deserves special attention and requires additional study, as the result was at the border of statistical significance in the subanalysis of three studies with a large margin of risk reduction in one of them (with the largest sample of patients).
Conclusion. The present meta-analysis demonstrated that the Rebamipide addition to H. pylori eradication regimens significantly improves the treatment effectiveness in the Russian patient population.
Full Text
##article.viewOnOriginalSite##About the authors
Dmitry N. Andreev
Yevdokimov Moscow State University of Medicine and Dentistry
Author for correspondence.
Email: dna-mit8@mail.ru
ORCID iD: 0000-0002-4007-7112
Cand. Sci. (Med.), Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowIgor V. Maev
Yevdokimov Moscow State University of Medicine and Dentistry
Email: dna-mit8@mail.ru
ORCID iD: 0000-0001-6114-564X
D. Sci. (Med.), Prof., Acad. RAS, Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowDmitry S. Bordin
Yevdokimov Moscow State University of Medicine and Dentistry; Loginov Moscow Clinical Scientific Center; Tver State Medical University
Email: dna-mit8@mail.ru
ORCID iD: 0000-0003-2815-3992
D. Sci. (Med.), Yevdokimov Moscow State University of Medicine and Dentistry, Loginov Moscow Clinical Scientific Center, Tver State Medical University
Russian Federation, Moscow; Moscow; TverSvetlana V. Lyamina
Yevdokimov Moscow State University of Medicine and Dentistry
Email: dna-mit8@mail.ru
ORCID iD: 0000-0001-8300-8988
D. Sci. (Med.), Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowDiana T. Dicheva
Yevdokimov Moscow State University of Medicine and Dentistry
Email: dna-mit8@mail.ru
ORCID iD: 0000-0001-9224-7382
Cand. Sci. (Med.), Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowAleksei K. Fomenko
Yevdokimov Moscow State University of Medicine and Dentistry
Email: dna-mit8@mail.ru
ORCID iD: 0000-0002-1794-7263
Lecturer, Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowArmine S. Bagdasarian
Yevdokimov Moscow State University of Medicine and Dentistry
Email: dna-mit8@mail.ru
ORCID iD: 0000-0002-0528-2903
Graduate Student, Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation, MoscowReferences
- Feldman M, Friedman LS, Brandt LJ (eds.) Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 11th ed. 2020.
- Bordin DS, Voynovan IN, Andreev DN, Maev IV. Current Helicobacter pylori Diagnostics. Diagnostics (Basel). 2021;11(8):1458. doi: 10.3390/diagnostics11081458
- Zamani M, Ebrahimtabar F, Zamani V, et al. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther. 2018;47(7):868-76.
- Bordin D, Plavnik R, Tivanova E, et al. Trends in the prevalence of Helicobacter pylori in Russia. Helicobacter. 2020;25(Suppl. 1):e12745:64-65.
- Lee YC, Chen THH, Chiu HM, et al. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut. 2013;62:676-82.
- Маев И.В., Самсонов А.А., Андреев Д.Н., и др. Современные аспекты диагностики и лечения инфекции Helicobacter pylori. Медицинский Совет. 2012;8:10-9 [Maev IV, Samsonov AA, Andreev DN, et al. Sovremennye aspekty diagnostiki i lecheniia infektsii Helicobacter pylori. Meditsinskii Sovet. 2012;8:10-9 (in Russian)].
- Маев И.В., Андреев Д.Н., Самсонов А.А., и др. Эволюция представлений о дефиниции, классификации, диагностике и лечении гастрита, ассоциированного с инфекцией Helicobacter pylori (по материалам Киотского консенсуса, 2015). Фарматека. 2016;6:24-33 [Maev IV, Andreev DN, Samsonov AA, et al. Evoliutsiia predstavlenii o definitsii, klassifikatsii, diagnostike i lechenii gastrita, assotsiirovannogo s infektsiei Helicobacter pylori (po materialam Kiotskogo konsensusa, 2015). Farmateka. 2016;6:24-33 (in Russian)].
- Ивашкин В.Т., Маев И.В., Лапина Т.Л., и др. Клинические рекомендации Российской гастроэнтерологической ассоциации и ассоциации «Эндоскопическое общество РЭНДО» по диагностике и лечению гастрита, дуоденита. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2021;31(4):70-99 [Ivashkin VT, Maev IV, Lapina TL, et al. Clinical Recommendations of Russian Gastroenterological Association and RENDO Endoscopic Society on Diagnosis and Treatment of Gastritis and Duodenitis. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021;31(4):70-99 (in Russian)]. doi: 10.22416/1382-4376-2021-31-4-70-99
- Ивашкин В.Т., Маев И.В., Каприн А.Д., и др. Раннее выявление онкологических заболеваний органов пищеварения (методическое руководство Российской гастроэнтерологической ассоциации и Ассоциации онкологов России для врачей первичного звена здравоохранения). Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2019;29(5):53-74 [Ivashkin VT, Mayev IV, Kaprin AD, et al. Early Detection of Oncological Diseases of the Digestive System (Guidelines of the Russian Gastroenterological Association and the Russian Association of Oncologists for Primary Care Physicians). Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2019;29(5):53-74 (in Russian). doi: 10.22416/1382-4376-2019-29-5-53-74
- Feng L, Wen MY, Zhu YJ, et al. Sequential Therapy or Standard Triple Therapy for Helicobacter pylori Infection: An Updated Systematic Review. Am J Ther. 2016;23(3):e880-93.
- Puig I, Baylina M, Sánchez-Delgado J, et al. Systematic review and meta-analysis: triple therapy combining a proton-pump inhibitor, amoxicillin and metronidazole for Helicobacter pylori first-line treatment. J Antimicrob Chemother. 2016;71(10):2740-53.
- Nyssen OP, Bordin D, Tepes B, et al; Hp-EuReg Investigators. European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients. Gut. 2020;70(1):40-54. doi: 10.1136/gutjnl-2020-321372
- Бордин Д.С., Эмбутниекс Ю.В., Вологжанина Л.Г., и др. Европейский регистр Helicobacter pylori (Hp-EuReg): как изменилась клиническая практика в России с 2013 по 2018 г. Терапевтический архив. 2019;91(2):16-24 [Bordin DS, Embutnieks YuV, Vologzhanina LG, et al. European registry Helicobacter pylori (Hp-EuReg): how has clinical practice changed in Russia from 2013 to 2018 years. Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(2):16-24 (in Russian)]. doi: 10.26442/00403660.2019.02.000156
- Андреев Д.Н., Дичева Д.Т., Маев И.В. Возможности оптимизации эрадикационной терапии инфекции Helicobacter pylori в современной клинической практике. Терапевтический архив. 2017;2:76-83 [Andreev DN, Dicheva DT, Maev IV. Vozmozhnosti optimizatsii eradikatsionnoi terapii infektsii Helicobacter pylori v sovremennoi klinicheskoi praktike. Terapevticheskii Arkhiv (Ter. Arkh.). 2017;2:76-83 (in Russian)].
- Бордин Д.С., Кролевец Т.С., Ливзан М.А. Готовы ли врачи первичного звена соблюдать протоколы диагностики и лечения заболеваний, ассоциированных с Helicobacter pylori: результаты опроса 2020–2021 годов. Альманах клинической медицины. 2021;49(7):455-68 [Bordin DS, Krolevets TS, Livzan MA. Gotovy li vrachi pervichnogo zvena sobliudat' protokoly diagnostiki i lecheniia zabolevanii, assotsiirovannykh s Helicobacter pylori: rezul'taty oprosa 2020–2021 godov. Al'manakh klinicheskoi meditsiny. 2021;49(7):455-68 (in Russian)].
- Gisbert JP, McNicholl AG. Optimization strategies aimed to increase the efficacy of H. pylori eradication therapies. Helicobacter. 2017;22(4). doi: 10.1111/hel.12392
- Dore MP, Lu H, Graham DY. Role of bismuth in improving Helicobacter pylori eradication with triple therapy. Gut. 2016;65(5):870-8. doi: 10.1136/gutjnl-2015-311019
- Alkim H, Koksal AR, Boga S, et al. Role of Bismuth in the Eradication of Helicobacter pylori. Am J Ther. 2017;24(6):e751-7. doi: 10.1097/MJT.0000000000000389
- Wang F, Feng J, Chen P, et al. Probiotics in Helicobacter pylori eradication therapy: Systematic review and network meta-analysis. Clin Res Hepatol Gastroenterol. 2017;41(4):466-75. doi: 10.1016/j.clinre.2017.04.004
- Zhu XY, Liu F. Probiotics as an adjuvant treatment in Helicobacter pylori eradication therapy. J Dig Dis. 2017;18(4):195-202. doi: 10.1111/1751-2980.12466
- Андреев Д.Н., Кучерявый Ю.А., Маев И.В. Эффективность включения масляной кислоты в схемы эрадикационной терапии инфекции Helicobacter pylori: метаанализ контролируемых исследований. Терапевтический архив. 2021;93(2):158-63 [Andreev DN, Kucheryavyy YuA, Maev IV. Efficacy of butyric acid inclusion in eradication regimens for Helicobacter pylori infection: a meta-analysis of controlled trials. Terapevticheskii Arkhiv (Ter. Arkh.). 2021;93(2):158-63 (in Russian)]. doi: 10.26442/00403660.2021.02.200608
- Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert Rev Gastroenterol Hepatol. 2010;4(3):261-70. doi: 10.1586/egh.10.25
- Андреев Д.Н., Маев И.В. Ребамипид: доказательная база применения в гастроэнтерологии. Терапевтический архив. 2020;92(12):97-104 [Andreev DN, Maev IV. Rebamipide: evidence base for use in gastroenterology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(12):97-104 (in Russian)]. doi: 10.26442/00403660.2020.12.200455
- Hayashi S, Sugiyama T, Amano K, et al. Effect of rebamipide, a novel antiulcer agent, on Helicobacter pylori adhesion to gastric epithelial cells. Antimicrob Agents Chemother. 1998;42(8):1895-9.
- Lee KH, Kim JY, Kim WK, et al. Protective effect of rebamipide against Helicobacter pylori-CagA-induced effects on gastric epithelial cells. Dig Dis Sci. 2011;56(2):441-8.
- Nishizawa T, Nishizawa Y, Yahagi N, et al. Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2014;29 Suppl. 4:20-4. doi: 10.1111/jgh.12769
- Andreev DN, Maev IV, Dicheva DT. Efficiency of the Inclusion of Rebamipide in the Eradication Therapy for Helicobacter pylori Infection: Meta-Analysis of Randomized Controlled Studies. J Clin Med. 2019;8(9):1498. doi: 10.3390/jcm8091498
- Андреев Д.Н., Кучерявый Ю.А. Факторы микро- и макроорганизма, влияющие на эффективность антихеликобактерной терапии. Consilium Medicum. 2013;15(8):5-9 [Andreev DN, Kucheriavyi IuA. Faktory mikro- i makroorganizma, vliiaiushchie na effektivnost' antikhelikobakternoi terapii. Consilium Medicum. 2013;15(8):5-9 (in Russian)].
- Маев И.В., Андреев Д.Н. Молекулярно-генетические предикторы резистентности к антихеликобактерной терапии. Терапевтический архив. 2017;89(8):5-12 [Maev IV, Andreev DN. Molecular genetic predictors of resistance to anti-Helicobacter pylori therapy. Terapevticheskii Arkhiv (Ter. Arkh.). 2017;89(8):5-12 (in Russian)]. doi: 10.17116/terarkh20178985-12
- Симаненков В.И., Бакулина Н.В., Филь Т.С., Хубиева А.Х. Оценка эффективности эрадикации H. pylori при добавлении к схеме лечения цитопротективного препарата ребамипид: результаты исследования БАСТИОН. Фарматека. 2017;5(17):65-71 [Simanenkov VI, Bakulina NV, Fil' TS, Khubieva AKh. Otsenka effektivnosti eradikatsii H. pylori pri dobavlenii k skheme lecheniia tsitoprotektivnogo preparata rebamipid: rezul'taty issledovaniia BASTION. Farmateka. 2017;5(17):65-71 (in Russian)].
- Vyalov SS. Efficacy and tolerability of rebamipide in triple therapy for eradication of Helicobacter pylori: a randomized clinical trial. United European Gastroenterology Journal. 2017;5(Suppl. 1). Available at: https://ueg.eu/library/efficacy-and-tolerability-of-rebamipide-in-triple-therapy-for-eradication-of-helicobacter-pylori-a-randomized-clinical-trial/153228. Accessed: 20.07.2022.
- Дичева Д.Т., Андреев Д.Н., Парцваниа-Виноградова Е.В., Маев И.В. Оценка эффективности и безопасности применения ребамипида в схеме тройной эрадикационной терапии инфекции Helicobacter pylori пилотное исследование. Медицинский Совет. 2018;(3):86-89 [Dicheva DT, Andreev N, Partsvania-Vinogradova IV, Maev IV. Evaluation of efficacy and safety of rebamipide use in the triple therapy for Helicobacter pylori eradication: a pilot study. Medical Council. 2018;(3):86-89 (in Russian)]. doi: 10.21518/2079-701X-2018-3-86-89
- Андреев Д.Н., Маев И.В., Дичева Д.Т., и др. Эффективность и безопасность применения ребамипида в схеме тройной эрадикационной терапии инфекции Helicobacter pylori: проспективное рандомизированное сравнительное исследование. Терапевтический архив. 2018;90(8):27-32 [Andreev DN, Maev IV, Dicheva DT, et al. Efficacy and safety of the use of rebamipide in the scheme of triple eradication therapy of Helicobacter pylori infection: a prospective randomized comparative study. Terapevticheskii Arkhiv (Ter. Arkh.). 2018;90(8):27-32 (in Russian)]. doi: 10.26442/terarkh201890827-32
- Коробейникова Е.Р., Шкатова Е.Ю. Комплексная терапия helicobacter pylori-ассоциированных эрозивных поражений гастродуоденальной зоны с применением ребамипида и интерактивных обучающих технологий у юношей. Экспериментальная и клиническая гастроэнтерология. 2019;169(9):27-31 [Korobeynikova ER, Shkatova EYu. The treatment of helicobacter pylori-associated erosive lesions of gastroduodenal zone with the use of interactive learning technologies and rebamipide in young men. Experimental and Clinical Gastroenterology. 2019;169(9):27-31 (in Russian)]. doi: 10.31146/1682-8658-ecg-169-9-27-31
- Гарбузова О.Г., Каюмова Е.Р. Эффективность добавления ребамипида к эрадикационной терапии 1-й линии у пациентов с H. pylori-ассоциированными эрозивно-язвенными поражениями гастродуоденальной зоны. Вестник научных конференций. 2020;11-1(63):42-5 [Garbuzova OG, Kaiumova ER. Effektivnost' dobavleniia rebamipida k eradikatsionnoi terapii 1-i linii u patsientov s H. pylori-assotsiirovannymi erozivno-iazvennymi porazheniiami gastroduodenal'noi zony. Vestnik nauchnykh konferentsii. 2020;11-1(63):42-5 (in Russian)].
- Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017;66(1): 6-30. doi: 10.1136/gutjnl-2016-312288
- Кучерявый Ю.А., Андреев Д.Н., Баркалова Е.В. Клинико-молекулярные аспекты резистентности Helicobacter pylori к антибактериальным препаратам. Медицинский Совет. 2013;10:11-5 [Kucheriavyi IuA, Andreev DN, Barkalova EV. Kliniko-molekuliarnye aspekty rezistentnosti Helicobacter pylori k antibakterial'nym preparatam. Meditsinskii Sovet. 2013;10:11-5 (in Russian)].
- Маев И.В., Кучерявый Ю.А., Андреев Д.Н. Антибиотикорезистентность Helicobacter pylori: от клинического значения до молекулярных механизмов. Лечащий врач. 2014;2:34-9 [Maev IV, Kucheriavyi IuA, Andreev DN. Antibiotikorezistentnost' Helicobacter pylori: ot klinicheskogo znacheniia do molekuliarnykh mekhanizmov. Lechashchii vrach. 2014;2:34-9 (in Russian)].
- Jaafar MH, Safi SZ, Tan MP, et al. Efficacy of Rebamipide in Organic and Functional Dyspepsia: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2018;63(5):1250-60.
- Li M, Yin T, Lin B. Rebamipide for chronic gastritis: a meta-analysis. Chinese J Gastroenterol Hepatol. 2015;24:667-73.
- Park S, Park SY, Kim YJ, et al. Effects of Rebamipide on Gastrointestinal Symptoms in Patients with Type 2 Diabetes Mellitus. Diabetes Metab J. 2016;40(3):240-7. doi: 10.4093/dmj.2016.40.3.240
- Парфенов А.И., Белостоцкий Н.И., Хомерики С.Г., и др. Ребамипид повышает активность дисахаридаз у больных энтеропатией с нарушением мембранного пищеварения. Пилотное исследование. Терапевтический архив. 2019;91(2):25-31 [Parfenov AI, Belostotsky NI, Khomeriki SG, et al. Rebamipide increases the disaccharidases activity in patients with enteropathy with impaired membrane digestion. Pilot study. Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(2):25-31 (in Russian)]. doi: 10.26442/00403660.2019.02.000123