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Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease

Received: 3 June 2022    Accepted: 8 July 2022    Published: 20 July 2022
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Abstract

Gastro Esophageal Reflux Disease (GERD) is a common and chronic disease in children, especially in children under 2 years old. Proton pump inhibitors (PPIs) have been recommended as the effective therapy in GERD. Esomeprazole is a safe and tolerable PPI in pediatrics. Studies have also shown that Baclofen effectively reduces symptoms of GERD in adult, but there are limited studies in pediatric patients. Purpose: This study aimed to compare the effect of Esomeprazole and the combination of Esomeprazole and Baclofen in the treatment of infantile GERD and its related manifestations. Methods: In a randomized clinical trial study, 50 infants with GERD were selected and randomly assigned into two groups receiving Esomeprazole (1mg/kg, once daily for two weeks) or a combination of Esomeprazole (1mg/kg, once daily for two weeks) and baclofen (0.2 mg/kg, once daily for two weeks). Patients were evaluated for reflux symptoms before treatment as well as at one week, two weeks, four weeks, two months and three months after initiation of treatment. The rate of remission of reflux was also determined in two groups. Results: During three months of treatment, improvement of symptoms associated with reflux including sleep disturbance, refusal to eat, restlessness, impaired quality of life, frequency of waking, nausea and regurgitation in the group treated with Esomeprazole plus baclofen were more favorable than those treated with Esomeprazole alone. Conclusion: Addition of baclofen to Esomeprazole can improve reflux disease more rapidly and favorably in infants with GERD.

Published in American Journal of Biomedical and Life Sciences (Volume 10, Issue 4)
DOI 10.11648/j.ajbls.20221004.11
Page(s) 102-109
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Gastro Esophageal Reflux Disease, Esomeprazole, Baclofen, Infant

References
[1] Rachel, R. (2018). Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology. J Pediatr Gastroenterol Nutr, 49, 491-547.
[2] Orenstein, SR. (1991). Gastroesophageal reflux. Current Problem in Pediatrics, 21 (5), 193-241.
[3] Sretenovic, A., Perisic, V., Simic, A., Zivanovic, D., et al. (2008). Gastroesophageal reflux in infants and children. Acta Chir Iugosl 55 (1), 47-53.
[4] Yalçin, S., Ciftci, AO., Senocak, ME., Tanyel, FC. (2008). Clinical presentation and management of gastroesophageal reflux disease in a referral center in Turkey. Eur J Pediatr Surg, 18 (3), 180-4.
[5] Huber, R., Hartmann, M., Bliesath, H., et al. (2016) Pharmacokinetics of pantoprazole in man. International journal of clinical pharmacology and therapeutics, May; 34 (1 Suppl), S7-16.
[6] Yaksh, TL., Reddy, SV. (2011). Studies in the primate on the analgetic effects associated with intrathecal actions of opiates, alpha-adrenergic agonists and baclofen. Anesthesiology, Jun; 54 (6), 451-67.
[7] Khodadad, A., Najafi, M. (2008) The Effect of Baclofen on Treatment of Infancy GERD. Iran J pediatric, Vol 18 (supply).
[8] Cryan, J. F., Kelly, P. H., Chaperon, F., Gentsch, C., et al. (2004). Behavioral characterization of the novel GABAB receptor-positive modulator GS39713 (N, N′-dicyclopentyl-2-methylsulfanyl-5-nitro-pyrimidine-4, 6-diamine): anxiolytic-like activity without side effects associated with baclofen or benzodiazepines. Journal of Pharmacology and Experimental Therapeutics, 311 (3), 952-963.
[9] van der Pol, RJ., Smits, MJ., van Wijk, MP., Omari, TI., et al. (2011). Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics, Mar 29, peds-2010.
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[12] Berquist, WE., Rachelefsky, GS., Kadden, M., Siegel,. Et al. (1981). Gastroesophageal reflux-associated recurrent pneumonia and chronic asthma in children. Pediatrics, 1, 68 (1), 29-35.
[13] Tasker, A., Dettmar, PW., Panetti, M., Koufman, JA., et al. (2002). Is gastric reflux a cause of otitis media with effusion in children? The Laryngoscope, Nov, 112 (11), 1930-4.
[14] Vandenplas, Y. (2006). Gstroesophageal reflux. In: Hyams WR, editor. Pediatric gastrointestinal and liver disease. 3th ed. Philadelphia, Saunders, p. 316-25.
[15] Vadlamudi, NB., Hitch, MC., Dimmitt, R. A, Thame, KA. (2013). Baclofen for the treatment of pediatric GERD. Journal of pediatric gastroenterology and nutrition, 1, 57 (6), 808-12.
[16] Koek, GH., Sifrim, D., Lerut, T., Janssens, J., Tack, J. (2003). Effect of the GABAB agonist baclofen in patients with symptoms and duodeno-gastro-oesophageal reflux refractory to proton pump inhibitors. Gut, 1, 52 (10): 1397-402.
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    Fatemeh Naderi, Hojatolah Jafari Fesharaki, Mehrangiz Khanmoradi. (2022). Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease. American Journal of Biomedical and Life Sciences, 10(4), 102-109. https://doi.org/10.11648/j.ajbls.20221004.11

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    ACS Style

    Fatemeh Naderi; Hojatolah Jafari Fesharaki; Mehrangiz Khanmoradi. Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease. Am. J. Biomed. Life Sci. 2022, 10(4), 102-109. doi: 10.11648/j.ajbls.20221004.11

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    AMA Style

    Fatemeh Naderi, Hojatolah Jafari Fesharaki, Mehrangiz Khanmoradi. Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease. Am J Biomed Life Sci. 2022;10(4):102-109. doi: 10.11648/j.ajbls.20221004.11

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  • @article{10.11648/j.ajbls.20221004.11,
      author = {Fatemeh Naderi and Hojatolah Jafari Fesharaki and Mehrangiz Khanmoradi},
      title = {Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease},
      journal = {American Journal of Biomedical and Life Sciences},
      volume = {10},
      number = {4},
      pages = {102-109},
      doi = {10.11648/j.ajbls.20221004.11},
      url = {https://doi.org/10.11648/j.ajbls.20221004.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajbls.20221004.11},
      abstract = {Gastro Esophageal Reflux Disease (GERD) is a common and chronic disease in children, especially in children under 2 years old. Proton pump inhibitors (PPIs) have been recommended as the effective therapy in GERD. Esomeprazole is a safe and tolerable PPI in pediatrics. Studies have also shown that Baclofen effectively reduces symptoms of GERD in adult, but there are limited studies in pediatric patients. Purpose: This study aimed to compare the effect of Esomeprazole and the combination of Esomeprazole and Baclofen in the treatment of infantile GERD and its related manifestations. Methods: In a randomized clinical trial study, 50 infants with GERD were selected and randomly assigned into two groups receiving Esomeprazole (1mg/kg, once daily for two weeks) or a combination of Esomeprazole (1mg/kg, once daily for two weeks) and baclofen (0.2 mg/kg, once daily for two weeks). Patients were evaluated for reflux symptoms before treatment as well as at one week, two weeks, four weeks, two months and three months after initiation of treatment. The rate of remission of reflux was also determined in two groups. Results: During three months of treatment, improvement of symptoms associated with reflux including sleep disturbance, refusal to eat, restlessness, impaired quality of life, frequency of waking, nausea and regurgitation in the group treated with Esomeprazole plus baclofen were more favorable than those treated with Esomeprazole alone. Conclusion: Addition of baclofen to Esomeprazole can improve reflux disease more rapidly and favorably in infants with GERD.},
     year = {2022}
    }
    

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  • TY  - JOUR
    T1  - Comparison the Effects of Esomeprazole with the Combination of Esomeprazole and Baclofen in the Treatment of Infantile Gastroesophageal Reflux Disease
    AU  - Fatemeh Naderi
    AU  - Hojatolah Jafari Fesharaki
    AU  - Mehrangiz Khanmoradi
    Y1  - 2022/07/20
    PY  - 2022
    N1  - https://doi.org/10.11648/j.ajbls.20221004.11
    DO  - 10.11648/j.ajbls.20221004.11
    T2  - American Journal of Biomedical and Life Sciences
    JF  - American Journal of Biomedical and Life Sciences
    JO  - American Journal of Biomedical and Life Sciences
    SP  - 102
    EP  - 109
    PB  - Science Publishing Group
    SN  - 2330-880X
    UR  - https://doi.org/10.11648/j.ajbls.20221004.11
    AB  - Gastro Esophageal Reflux Disease (GERD) is a common and chronic disease in children, especially in children under 2 years old. Proton pump inhibitors (PPIs) have been recommended as the effective therapy in GERD. Esomeprazole is a safe and tolerable PPI in pediatrics. Studies have also shown that Baclofen effectively reduces symptoms of GERD in adult, but there are limited studies in pediatric patients. Purpose: This study aimed to compare the effect of Esomeprazole and the combination of Esomeprazole and Baclofen in the treatment of infantile GERD and its related manifestations. Methods: In a randomized clinical trial study, 50 infants with GERD were selected and randomly assigned into two groups receiving Esomeprazole (1mg/kg, once daily for two weeks) or a combination of Esomeprazole (1mg/kg, once daily for two weeks) and baclofen (0.2 mg/kg, once daily for two weeks). Patients were evaluated for reflux symptoms before treatment as well as at one week, two weeks, four weeks, two months and three months after initiation of treatment. The rate of remission of reflux was also determined in two groups. Results: During three months of treatment, improvement of symptoms associated with reflux including sleep disturbance, refusal to eat, restlessness, impaired quality of life, frequency of waking, nausea and regurgitation in the group treated with Esomeprazole plus baclofen were more favorable than those treated with Esomeprazole alone. Conclusion: Addition of baclofen to Esomeprazole can improve reflux disease more rapidly and favorably in infants with GERD.
    VL  - 10
    IS  - 4
    ER  - 

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Author Information
  • Hazrat Masoumeh Pediatric Clinical Development Research Center, Qom University of Medical Sciences, Qom, Iran

  • Gastroentrology and Hepatology Diseases Research Center, Qom University of Medical Sciences, Qom, Iran

  • Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran

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