chondroitin-sulfates and Gastroesophageal-Reflux

To review the data about the efficacy of esophagus protective agent based on the fixed combination of hyaluronic acid and chondroitin sulfate dissolved in the bioadhesive carrier (poloxamer 407) in the complex therapy of patients with erosive gastroesophageal reflux disease (GERD).. A search in MEDLINE/PubMed, EMBASE, Cochrane, and Russian Science Citation Index of Scientific Electronic Library electronic databases was performed. Relevant original controlled studies of a fixed combination of hyaluronic acid and chondroitin sulfate as an esophagus protective agent in a population of patients with erosive GERD were included.. Combined therapy with PPI and Alfasoxx is significantly more effective than PPI monotherapy for the epithelialization of esophageal erosions in patients with erosive GERD.. Цель. Обобщить данные об эффективности применения эзофагопротектора, состоящего из фиксированного комплекса гиалуроновой кислоты и хондроитин сульфата, растворенных в биоадгезивном носителе (полоксамер 407), в комплексной терапии пациентов с эрозивной формой гастроэзофагеальной рефлюксной болезни (ГЭРБ). Материалы и методы. Поиск исследований проводился в электронных базах данных MEDLINE/PubMed, EMBASE, Cochrane и Российский индекс научного цитирования на базе Научной электронной библиотеки. Включались релевантные оригинальные исследования контролируемого дизайна с применением фиксированного комплекса гиалуроновой кислоты и хондроитин сульфата в качестве эзофагопротектора на популяции пациентов с эрозивной формой ГЭРБ. Результаты. В итоговый анализ включено 3 исследования с участием 181 пациента с эрозивной формой ГЭРБ. Все работы выполнены по единообразному дизайну с оценкой основных конечных точек (полная эпителизация эрозий пищевода и полное разрешение изжоги) через 28 дней от начала терапии. Метаанализ 3 контролируемых исследований продемонстрировал, что комбинированная терапия с применением ингибиторов протонной помпы (ИПП) и эзофагопротектора достоверно эффективнее монотерапии ИПП для полной эпителизации эрозий пищевода на 28-е сутки лечения (относительный риск 1,267, 95% доверительный интервал 1,082–1,483,

Topics: Chondroitin Sulfates; Gastroesophageal Reflux; Heartburn; Humans; Hyaluronic Acid; Proton Pump Inhibitors; Randomized Controlled Trials as Topic

Several studies have demonstrated the superiority of proton-pump inhibitors (PPIs) in resolving erosive gastro-oesophageal reflux disease (GORD). However, this first line of treatment can fail to control symptoms in around 30% of cases, especially in the presence of non-erosive GORD. In situations where the first line of treatment fails, there is a lack of concordance regarding the best strategy to apply. This study presents a systematic review of the trials which have tested second-line treatments after PPI failure.. The study was conducted according to the PRISMA statement. The systematic review included medical trials written in English which were published between 2000 and 2016 and were retrieved from PubMed and Scopus using the keywords 'PPI-resistant gastro-oesophageal reflux', 'alginate AND gastro-oesophageal reflux', 'hyaluronic acid AND gastro-oesophageal reflux', 'prokinetics AND gastro-oesophageal reflux', 'sucralfate AND gastro-oesophageal reflux' and 'baclofen AND gastro-oesophageal reflux'.. Ten randomised and non-randomised studies were included, which included 1515 patients of both sexes (mean age = 49.19 years, age range = 18-85, males = 700; 46.2%).. A personalised choice of the best treatment for PPI-resistant GORD should be based on the results of an upper endoscopy and pH/MII monitoring. For patients in situations where the first line of treatment fails, we encourage the execution of trials for testing double doses of PPIs against alternative medicaments.

Topics: Baclofen; Benzamides; Chondroitin Sulfates; Domperidone; Drug Combinations; Drug Therapy, Combination; Esophageal pH Monitoring; Gastroesophageal Reflux; Gastrointestinal Agents; Humans; Hyaluronic Acid; Morpholines; Proton Pump Inhibitors; Treatment Failure

Several studies have shown that patients with non-erosive reflux disease (NERD) are less responsive to proton pump inhibitors (PPIs) than those with erosive disease as they belong to different subgroups, in whom factors other than acid can trigger symptoms.. To evaluate whether combined therapy (mucosal protection plus acid suppression) would improve symptom relief compared to PPI treatment alone.. In a multicenter, randomised, double-blind trial, 154 patients with NERD were randomised to receive Esoxx (Alfa Wassermann, Bologna, Italy), a hyaluronic acid-chondroitin sulphate based bioadhesive formulation, or placebo, in addition to acid suppression with standard dose PPIs for 2 weeks. Symptoms (heartburn, acid regurgitation, retrosternal pain and acid taste in the mouth) and health-related quality of life (HRQL) were evaluated before and after treatment. The primary endpoint was the proportion of patients with at least a 3-point reduction in the total symptom score.. At the end of treatment, the primary endpoint was reached by 52.6% of patients taking Esoxx compared to 32.1% of those given placebo (P < 0.01). The same was true also for HRQL, evaluated by means of the Short Form-36 questionnaire, which improved with both treatments, but some items were significantly better after Esoxx plus PPI therapy.. The synergistic effect of Essox with PPI treatment suggests that mucosal protection added to acid suppression could improve symptoms and HRQL in NERD patients.

Topics: Adult; Chondroitin Sulfates; Double-Blind Method; Female; Gastroesophageal Reflux; Heartburn; Humans; Hyaluronic Acid; Italy; Male; Middle Aged; Proton Pump Inhibitors; Quality of Life; Surveys and Questionnaires; Treatment Outcome

Proton pump inhibitors (PPIs) are a major breakthrough in the medical management of gastroesophageal reflux disease (GERD). In several patients with non erosive reflux disease symptoms (NERD) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications.. The aim of this study was to evaluate the effect of a new medical device, based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate (HA+CS), in a bioadhesive carrier, in adults with symptoms of non erosive gastroesophageal reflux and with a low response to PPIs.. Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day run-in period, without endoscopic mucosal breaks, were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days. Relief of cardinal symptoms of GERD was evaluated at the end of each period.. A significant greater Sum of Symptoms Intensity Difference, compared to placebo, was observed after HA+CS treatment (-2.7 vs 0.5 - p < 0.01), being both heartburn (-1.6 vs 0.5 - p < 0.03) and acid regurgitation (-1.1 vs 0.1 - p < 0.03) significantly improved by the medical device. A speed of action ≤ 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo (60% vs 30% - p = 0.05). Total disappearance of symptoms was observed in 50% of the patients compared to 10% during placebo administration (p = 0.01 between group comparison).. A fixed combination of HA+CS has demonstrated to be effective in gastroesophageal reflux control, with a rapid onset of action.

Topics: Administration, Oral; Adult; Aged; Analysis of Variance; Chi-Square Distribution; Chondroitin Sulfates; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Gastroesophageal Reflux; Gastrointestinal Agents; Histamine H2 Antagonists; Humans; Hyaluronic Acid; Italy; Male; Middle Aged; Proton Pump Inhibitors; Time Factors; Treatment Outcome

To evaluate the advantages of using combined therapy of proton-pump inhibitors (PPIs) and esophagoprotector in comparison with basic therapy of PPIs for 4 weeks based on the results of changes in the endoscopic picture.To compare the effectiveness of 4-week PPI therapy and 4-week combination therapy with PPI and esophagoprotector Alfasoxx (sodium hyaluronate, chondroitin sulfate, poloxomer 407) in patients with erosive esophagitis (EE) of any degree according to the Los Angeles Endoscopic Classification.. 81 patients with EE AC according to the Los Angeles endoscopic classification (1994) was enrolled in the study on the basis of the clinic of Peter the Great, Mechnikov North-Western State Medical University. By computer randomization, patients were divided into the control group 40 patients (pantoprazole 40 mg 1 time per day) and the intervention group 41 patients (pantoprazole 40 mg 1 time per day + Alfasoxx 1 sachet qid). The therapy was carried out for 4 weeks. In all patients before and after therapy, the frequency and severity of the main symptoms of gastroesophageal reflux disease (GERD) were assessed, esophagogastroduodenoscopy was performed.. The advantage of combination therapy over standard PPI monotherapy in patients with EE was revealed. According to the results of the control endoscopy, healing of erosions of the esophageal mucosa was observed in 39 out of 41 (95.1%) patients in the intervention group and 32 out of 39 (82.1%) in the control group. The proportion of patients who showed an improvement in the endoscopic picture before and after treatment for 4 weeks by at least 1 level according to the Los Angeles classification was significantly higher in the comparison group 41 patients (100%), while in the control group 33 patients (85%); p0.009. After treatment, the combination therapy group had a lower incidence (p0.01) and severity of heartburn (p0.01). The same results are demonstrated by combination therapy regarding the symptom belching of air: in the study group after treatment, this symptom occurred less frequently (p=0.014), its severity was significantly less than in the control group (p0.01). There was a statistically significant decrease in the need for on-demand antacid therapy in the study group.. In this study involving 81 patients with erosive GERD, the benefits of combination therapy were demonstrated. The addition of Alfasoxx medical device to PPI therapy increases the clinical and endoscopic efficacy of therapy. This positive effect is associated with the esophagoprotective properties of the drug, based on unique pharmacodynamic characteristics. Combination therapy for GERD is preferred in patients with EE. Studies have shown the expediency of using Alfasoxx in case of insufficient effectiveness of classical acid-suppressive therapy for GERD.. Цель. Сравнить эффективность 4-недельной терапии ингибиторами протонной помпы (ИПП) и 4-недельной комбинированной терапии ИПП и эзофагопротектором Альфазокс (натрия гиалуронат, хондроитина сульфат, полоксамер 407) у пациентов с эрозивным эзофагитом (ЭЭ) любой степени по Лос-Анджелесской эндоскопической классификации. Материалы и методы. В исследовании на базе клиники Петра Великого ФГБОУ ВО СЗГМУ им. И.И. Мечникова принял участие 81 пациент с ЭЭ AС по Лос-Анджелесской эндоскопической классификации (1994 г.). Методом рандомизации пациенты распределены в контрольную группу 40 пациентов (пантопразол 40 мг 1 раз в сутки) и группу вмешательства 41 пациент (пантопразол 40 мг 1 раз в сутки + Альфазокс 1 пакетик 4 раза в сутки). Терапия осуществлялась на протяжении 4 нед. У всех пациентов до и после терапии оценивалась частота и выраженность основных симптомов гастроэзофагеальной рефлюксной болезни (ГЭРБ), проводилась эзофагогастродуоденоскопия. Результаты. Выявлено преимущество комбинированной терапии перед стандартной монотерапией ИПП у пациентов с ЭЭ. По результатам контрольной эзофагогастродуоденоскопии заживление эрозий слизистой пищевода наблюдалось у 39 из 41 (95,1%) пациента в группе вмешательства и 32 из 39 (82,1%) пациентов в группе контроля. Доля пациентов, у которых отмечалось улучшение эндоскопической картины после лечения в течение 4 нед как минимум на 1 уровень по Лос-Анджелесской классификации, была достоверно выше в группе сравнения 41 (100%) пациент, в то время как в контрольной группе 33 (85%) пациента; p0,009. После лечения в группе комбинированной терапии отмечалась меньшая частота возникновения (p0,01) и выраженности (p0,01) изжоги. Такие же результаты демонстрирует комбинированная терапия относительно симптома отрыжка воздухом: в исследовательской группе после лечения этот симптом возникал реже (p=0,014), его выраженность была значимо меньше, чем в группе контроля (p0,01). В исследовательской группе статистически значимо уменьшилась потребность в терапии антацидами по требованию. Заключение. В проведенном исследовании с участием 81 пациента с эрозивной ГЭРБ продемонстрированы преимущества комбинированной терапии. Добавление к терапии ИПП медицинского изделия Альфазокс повышает ее клиническую и эндоскопическую эффективность. Данное позитивное влияние ассоциировано с эзофагопротективными свойствами препарата, основанными на уникальных фармакодинамических характеристиках. Комбинированная терапия ГЭРБ предпочтительна у пациентов с ЭЭ. В исследо

Topics: Antacids; Chondroitin Sulfates; Esophagitis; Gastroesophageal Reflux; Humans; Hyaluronic Acid; Pantoprazole; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome

A novel medical device based on hyaluronic acid, chondroitin sulphate plus aluminum hydroxide (GERDOFF®, melt-in-mouth tablets) showed efficacy in reducing GER-related symptoms. This exploratory, open-label study evaluated symptomatic effects of a 14-day treatment with GERDOFF® in GERD patients.. GERD Impact Scale (GIS) questionnaire was filled at baseline visit, after 7 and 14 days of treatment; patients' Global Satisfaction was evaluated at the final visit. Primary endpoint was the reduction of heartburn episodes per week; secondary endpoints were GERD-related symptoms, patients' satisfaction, and safety.. Forty patients were included, 22 were on stable therapy with proton pump inhibitor (PPI). Compared to baseline, the days with heartburn episodes and the GIS score progressively decreased during the first (p<0.0001) and the second week of treatment (p<0.0001). Heartburn episodes per week (p<0.0001) and the GIS score (p<0.0001) decreased in the first and the last 7 days of 14-day treatment and did not differ between patients on and off PPI. The treatment was safe and well-tolerated, and it was rated as very good (46.2%) or good (43.6%) on the satisfaction questionnaire.. GERDOFF® could effectively treat GER symptoms in patients not responding to PPI or alginate-based formulation. ISRCTN_15143752.

Topics: Adult; Aged; Alginates; Antacids; Chondroitin Sulfates; Clinical Trials as Topic; Drug Therapy, Combination; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Patient Satisfaction; Pilot Projects; Product Surveillance, Postmarketing; Proton Pump Inhibitors; Surveys and Questionnaires; Tablets; Treatment Outcome