Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study
Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Yu. A. Kucheryavy [verfasserIn] D. N. Andreyev [verfasserIn] E. Yu. Eryomina [verfasserIn] A. A. Gilmanov [verfasserIn] O. V. Nazarova [verfasserIn] Ye. A. Sidneva [verfasserIn] Yu. G. Topalova [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Russisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: Российский журнал гастроэнтерологии, гепатологии, колопроктологии - Gastro LLC, 2020, 32(2022), 4, Seite 38-49 |
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| Übergeordnetes Werk: |
volume:32 ; year:2022 ; number:4 ; pages:38-49 |
| Links: |
Link aufrufen |
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| DOI / URN: |
10.22416/1382-4376-2022-32-4-38-49 |
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| Katalog-ID: |
DOAJ013315285 |
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| 520 | |a Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. | ||
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| 700 | 0 | |a O. V. Nazarova |e verfasserin |4 aut | |
| 700 | 0 | |a Ye. A. Sidneva |e verfasserin |4 aut | |
| 700 | 0 | |a Yu. G. Topalova |e verfasserin |4 aut | |
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10.22416/1382-4376-2022-32-4-38-49 doi (DE-627)DOAJ013315285 (DE-599)DOAJe7588f29099b4b4cbcfc68930a7dbb8c DE-627 ger DE-627 rakwb rus RC799-869 Yu. A. Kucheryavy verfasserin aut Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. gastroesophageal reflux disease extraesophageal symptoms esophagoprotector Diseases of the digestive system. Gastroenterology D. N. Andreyev verfasserin aut E. Yu. Eryomina verfasserin aut A. A. Gilmanov verfasserin aut O. V. Nazarova verfasserin aut Ye. A. Sidneva verfasserin aut Yu. G. Topalova verfasserin aut In Российский журнал гастроэнтерологии, гепатологии, колопроктологии Gastro LLC, 2020 32(2022), 4, Seite 38-49 (DE-627)1698164203 26586673 nnns volume:32 year:2022 number:4 pages:38-49 https://doi.org/10.22416/1382-4376-2022-32-4-38-49 kostenfrei https://doaj.org/article/e7588f29099b4b4cbcfc68930a7dbb8c kostenfrei https://www.gastro-j.ru/jour/article/view/749 kostenfrei https://doaj.org/toc/1382-4376 Journal toc kostenfrei https://doaj.org/toc/2658-6673 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 32 2022 4 38-49 |
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10.22416/1382-4376-2022-32-4-38-49 doi (DE-627)DOAJ013315285 (DE-599)DOAJe7588f29099b4b4cbcfc68930a7dbb8c DE-627 ger DE-627 rakwb rus RC799-869 Yu. A. Kucheryavy verfasserin aut Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. gastroesophageal reflux disease extraesophageal symptoms esophagoprotector Diseases of the digestive system. Gastroenterology D. N. Andreyev verfasserin aut E. Yu. Eryomina verfasserin aut A. A. Gilmanov verfasserin aut O. V. Nazarova verfasserin aut Ye. A. Sidneva verfasserin aut Yu. G. Topalova verfasserin aut In Российский журнал гастроэнтерологии, гепатологии, колопроктологии Gastro LLC, 2020 32(2022), 4, Seite 38-49 (DE-627)1698164203 26586673 nnns volume:32 year:2022 number:4 pages:38-49 https://doi.org/10.22416/1382-4376-2022-32-4-38-49 kostenfrei https://doaj.org/article/e7588f29099b4b4cbcfc68930a7dbb8c kostenfrei https://www.gastro-j.ru/jour/article/view/749 kostenfrei https://doaj.org/toc/1382-4376 Journal toc kostenfrei https://doaj.org/toc/2658-6673 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 32 2022 4 38-49 |
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10.22416/1382-4376-2022-32-4-38-49 doi (DE-627)DOAJ013315285 (DE-599)DOAJe7588f29099b4b4cbcfc68930a7dbb8c DE-627 ger DE-627 rakwb rus RC799-869 Yu. A. Kucheryavy verfasserin aut Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. gastroesophageal reflux disease extraesophageal symptoms esophagoprotector Diseases of the digestive system. Gastroenterology D. N. Andreyev verfasserin aut E. Yu. Eryomina verfasserin aut A. A. Gilmanov verfasserin aut O. V. Nazarova verfasserin aut Ye. A. Sidneva verfasserin aut Yu. G. Topalova verfasserin aut In Российский журнал гастроэнтерологии, гепатологии, колопроктологии Gastro LLC, 2020 32(2022), 4, Seite 38-49 (DE-627)1698164203 26586673 nnns volume:32 year:2022 number:4 pages:38-49 https://doi.org/10.22416/1382-4376-2022-32-4-38-49 kostenfrei https://doaj.org/article/e7588f29099b4b4cbcfc68930a7dbb8c kostenfrei https://www.gastro-j.ru/jour/article/view/749 kostenfrei https://doaj.org/toc/1382-4376 Journal toc kostenfrei https://doaj.org/toc/2658-6673 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 32 2022 4 38-49 |
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10.22416/1382-4376-2022-32-4-38-49 doi (DE-627)DOAJ013315285 (DE-599)DOAJe7588f29099b4b4cbcfc68930a7dbb8c DE-627 ger DE-627 rakwb rus RC799-869 Yu. A. Kucheryavy verfasserin aut Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. gastroesophageal reflux disease extraesophageal symptoms esophagoprotector Diseases of the digestive system. Gastroenterology D. N. Andreyev verfasserin aut E. Yu. Eryomina verfasserin aut A. A. Gilmanov verfasserin aut O. V. Nazarova verfasserin aut Ye. A. Sidneva verfasserin aut Yu. G. Topalova verfasserin aut In Российский журнал гастроэнтерологии, гепатологии, колопроктологии Gastro LLC, 2020 32(2022), 4, Seite 38-49 (DE-627)1698164203 26586673 nnns volume:32 year:2022 number:4 pages:38-49 https://doi.org/10.22416/1382-4376-2022-32-4-38-49 kostenfrei https://doaj.org/article/e7588f29099b4b4cbcfc68930a7dbb8c kostenfrei https://www.gastro-j.ru/jour/article/view/749 kostenfrei https://doaj.org/toc/1382-4376 Journal toc kostenfrei https://doaj.org/toc/2658-6673 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 32 2022 4 38-49 |
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10.22416/1382-4376-2022-32-4-38-49 doi (DE-627)DOAJ013315285 (DE-599)DOAJe7588f29099b4b4cbcfc68930a7dbb8c DE-627 ger DE-627 rakwb rus RC799-869 Yu. A. Kucheryavy verfasserin aut Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. gastroesophageal reflux disease extraesophageal symptoms esophagoprotector Diseases of the digestive system. Gastroenterology D. N. Andreyev verfasserin aut E. Yu. Eryomina verfasserin aut A. A. Gilmanov verfasserin aut O. V. Nazarova verfasserin aut Ye. A. Sidneva verfasserin aut Yu. G. Topalova verfasserin aut In Российский журнал гастроэнтерологии, гепатологии, колопроктологии Gastro LLC, 2020 32(2022), 4, Seite 38-49 (DE-627)1698164203 26586673 nnns volume:32 year:2022 number:4 pages:38-49 https://doi.org/10.22416/1382-4376-2022-32-4-38-49 kostenfrei https://doaj.org/article/e7588f29099b4b4cbcfc68930a7dbb8c kostenfrei https://www.gastro-j.ru/jour/article/view/749 kostenfrei https://doaj.org/toc/1382-4376 Journal toc kostenfrei https://doaj.org/toc/2658-6673 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 32 2022 4 38-49 |
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In Российский журнал гастроэнтерологии, гепатологии, колопроктологии 32(2022), 4, Seite 38-49 volume:32 year:2022 number:4 pages:38-49 |
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RC799-869 Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study gastroesophageal reflux disease extraesophageal symptoms esophagoprotector |
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Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study |
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efficacy of esophageal protector in treating gastroesophageal reflux disease with extraesophageal symptoms: a multicenter, open-label, observational study |
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Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study |
| abstract |
Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. |
| abstractGer |
Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. |
| abstract_unstemmed |
Aim: to assess effects of esophageal protector Alfasoxx on extraesophageal symptoms in patients with GERD.Materials and methods. A prospective open multicenter post-registration observational study was conducted. The study included 546 patients aged 6 to 85 years (the average age of patients is 42.4 ± 16.9 years) with a verified diagnosis of GERD (endoscopically and/or pH-metrically), the presence of extraesophageal symptoms of the disease (according to the results of an objective examination and consultations of specialists), to whom the attending physician prescribed a course of treatment with a medical device Alfasoxx in accordance with the instructions for medical use. The patients were recruited by 51 researchers in 26 cities of Russia. The study in chronological order consisted of a screening visit and two recorded visits (the observation period within the framework of the use of the Alfasoxx esophagoprotector). The screening visit was conducted on the day of the patient's admission. Visit 1 could be conducted on the same day as the screening visit, whereas visit 2 was conducted 4–5 weeks after visit 1 at the end of the course of treatment.Results. According to the results obtained, at the end of the study, 42.7 % (95 % CI: 38.5–46.9) had complete disappearance of extraesophageal GERD symptoms (questionnaire RSI = 0 points). When comparing the average values of the total RSI score before and after treatment, there was also a statistically significant regression from 13.8 points (95 % CI: 13.2–14.4) at visit 1 to 2.0 points (95 % CI: 1.8–2.2) at visit 2. Thus, the decrease in the total score was significant and exceeded 80 % of the initial value. When analyzing the dynamics of individual indicators of the RSI scale before and after treatment, a significant regression in the severity of all symptoms of the disease was noted. In addition, the results showed that the proportion of patients taking antacid-containing drugs at visit 1 significantly decreased from 58.2 % (95 % CI: 54.0–62.4) to 15.2 % (95 % CI: 12.1–18.3) by visit 2. The average score on the Likert scale of satisfaction with treatment was 4.8 (95 % CI: 4.8–4.9), whereas the convenience of using Alfasoxx is 4.7.Conclusion. This prospective observational multicenter study demonstrated that the addition of Alfasoxx to standard GERD therapy contributes to a significant regression of both esophageal and extraesophageal symptoms, as well as a decrease in the need for antacid medications. |
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