Department of Health Sciences, University Magna Graecia, Catanzaro, Italy.
Eur Rev Med Pharmacol Sci. 2021 Jun;25(11):4128-4138. doi: 10.26355/eurrev_202106_26056.
OBJECTIVE: Proton Pump Inhibitors (PPIs) and traditional antacids are the common standard set of therapy for the management of gastroesophageal reflux disease (GERD) symptoms. The aim of the current study was to evaluate efficacy and safety of a novel galactomannan-based liquid formulation in reducing typical GERD symptoms in patients not taking PPIs. PATIENTS AND METHODS: This was a single-center, randomized, double-blind, placebo-controlled study. Sixty patients met the eligibility criteria and were treated either with the investigational product (RefluG™) or placebo, one sachet three times per day for 14 consecutive days. Symptom intensity/frequency and quality of life were assessed over the course of the study by Reflux Disease Questionnaire (RDQ) and GERD-Health related Quality of life (HRQL) Questionnaire, respectively. The primary endpoint was to determine the number of subjects with at least 30% symptoms reduction from baseline to day 14 compared to placebo. RESULTS: RefluG™ was statistically superior to placebo (p <0.001) as 100% of subjects experienced at least 30% symptoms reduction at the end of the study while none achieved a 30% reduction in the placebo group. For all domains both after 7 and 14 days of treatment, significant improvement in HRQL was seen in the active group in comparison to placebo. Tolerability and safety were good and comparable between groups. CONCLUSIONS: The investigational product was safe and effective as mono-therapy in providing early resolution of troublesome GERD symptoms as well as for improving quality of life.
目的:质子泵抑制剂(PPIs)和传统抗酸剂是治疗胃食管反流病(GERD)症状的常用标准治疗方法。本研究的目的是评估新型半乳甘露聚糖基液体配方在减少未服用 PPI 的患者中典型 GERD 症状的疗效和安全性。
患者和方法:这是一项单中心、随机、双盲、安慰剂对照研究。符合入选标准的 60 名患者接受了研究产品(RefluG™)或安慰剂治疗,每天三次,每次一袋,连续 14 天。通过反流疾病问卷(RDQ)和 GERD 健康相关生活质量(HRQL)问卷分别在研究过程中评估症状强度/频率和生活质量。主要终点是确定与安慰剂相比,从基线到第 14 天至少有 30%的患者症状减轻的人数。
结果:RefluG™ 在统计学上优于安慰剂(p<0.001),因为研究结束时 100%的患者经历了至少 30%的症状减轻,而安慰剂组无一例达到 30%的减轻。在治疗后 7 天和 14 天,所有治疗组的 HRQL 均有显著改善,与安慰剂相比。两组的耐受性和安全性均良好且相当。
结论:研究产品作为单一疗法在提供 GERD 症状的早期缓解以及改善生活质量方面是安全有效的。
Neurogastroenterol Motil. 2023-10
Am J Gastroenterol. 2011-4-26