chondroitin-sulfates and Heartburn

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 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

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