Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study
Yu. A. Kucheryavy,
D. N. Andreyev,
E. Yu. Eryomina,
A. A. Gilmanov,
O. V. Nazarova,
Ye. A. Sidneva,
Yu. G. Topalova The EXTRASOXX study team: Amelichkina Margarita Konstantinovna, Belosludtseva Olga Alexandrovna, Belyantseva Natalia Vyacheslavovna, Brodichko Alyona Ivanovna, Buneva Valeria Evgenievna, Burkhanov Rinat Rifkatovich, Vasiliev Roman Vladimirovich, Vershinina Gulnara Atashevna, Gilmanov Albert Alfredovich, Goncharova Ekaterina Yuryevna, Gurikova Irina Anatolyevna, Dudkina Olga Alexandrovna, Egorova Natalia Konstantinovna, Eremina Elena Yuryevna, Ivankova Anna Viktorovna, Kanyuk Irina Georgievna, Karpenko Ksenia Vladimirovna, Kashina Maria Alexandrovna, Krishchenko Valery Nikolaevich, Kuchina Ekaterina Serimzhanovna, Lang Viktor Yakovlevich, Lapshina Olga Nikolaevna, Lakhin Vladimir Vladimirovich, Malyutina Natalia Mikhailovna, Marinchuk Svetlana Aleksandrovna, Melnikova Ekaterina Vladimirovna, Mishcherina Olga Yuryevna, Moiseenko Elena Evgenyevna, Nazarova Veronika Sergeevna, Nazarova Olga Valeryevna, Naidenova Anna Georgievna, Oferina Tatiana Vladimirovna, Pak Ekaterina
Sergeevna, Panenkov Andrey Nikolaevich, Petrova Tatiana Maksimovna, Pilchuk Elena Vladimirovna, Prilepskaya Svetlana Ivanovna, Pushkareva Olga Nikolaevna, Safina Dilyara Damirovna, Safonova Nadezhda Gennadievna, Sekretareva Lada Anatolyevna, Sidneva Evgeniya Aleksandrovna, Smirnova Natalia Vladimirovna, Starodubtsev Yaroslav Vladimirovich, Staseva Irina Vyacheslavovna, Stepkina Yana Mikhailovna, Topalova Yulia Gennadievna, Tribunskaya Svetlana Aleksandrovna, Chikunova Marina Valeryevna, Shanava Olesya Anatolyevna, Shmeleva Elena Valeryevna.
https://doi.org/10.22416/1382-4376-2022-32-4-38-49
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.
About the Authors
Yu. A. Kucheryavy
Ilyinskaya Hospital JSC
Russian Federation
Russian Federation
Yury А. Kucheryavy – Cand. Sci. (Med.), Head of Gastroenterology Department
143421, Moscow Region, Krasnogorsk, Glukhovo settl., Rublevskoe Predmestye str., 2/2
D. N. Andreyev
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
Russian Federation
Russian Federation
Dmitry N. Andreyev — Сand. Sci. (Med.), Associate Professor of Propaedeutics of Internal Diseases and Gastroenterology Department
127473, Moscow, Delegatskaya str., 20, bld. 1
E. Yu. Eryomina
Ogarev Mordovia National State Research University
Russian Federation
Russian Federation
Elena Yu. Eryomina — Dr. Sci. (Med.), Professor, Head of Propaedeutics of Internal Diseases Department
430005, Russian Federation, Republic of Mordovia, Saransk, Bolshevistskaya str., 68
A. A. Gilmanov
Kazan Municipal Children’s Hospital No. 1
Russian Federation
Russian Federation
Albert A. Gilmanov — Сand. Sci. (Med.), Head of Endoscopy Department
420034, Kazan, Dekabristov str., 125a
O. V. Nazarova
Interregional Clinical Diagnostic Center, Outpatient Clinic
Russian Federation
Russian Federation
Olga V. Nazarova — Сand. Sci. (Med.), gastroenterologist, dietitian
420101, Kazan, Karbysheva str., 12a
Ye. A. Sidneva
KaiClinic Medical Center
Russian Federation
Russian Federation
Yevgeniya A. Sidneva — gastroenterologist
603003, Nizhny Novgorod, Ispolkoma str., 6
Yu. G. Topalova
North-Western State Medical University named after I.I. Mechnikov
Russian Federation
Russian Federation
Yuliya G. Topalova — post-graduate student of Internal Diseases, Clinical Pharmacology and Nephrology Department; physician of Internal Medicine Department No. 1
195067, Russia, Saint Petersburg, Piskarevsky Ave., 47
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Kucheryavy Yu.A., Andreyev D.N., Eryomina E.Yu., Gilmanov A.A., Nazarova O.V., Sidneva Ye.A., Topalova Yu.G. Efficacy of Esophageal Protector in Treating Gastroesophageal Reflux Disease with Extraesophageal Symptoms: a Multicenter, Open-Label, Observational Study. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2022;32(4):38-49. https://doi.org/10.22416/1382-4376-2022-32-4-38-49
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