Alecci Umberto, Bonina Francesco, Bonina Andrea, Rizza Luisa, Inferrera Santi, Mannucci Carmen, Calapai Gioacchino
Italian College of General Practitioners and Primary Care, Florence, Italy.
Department of Drug Sciences, University of Catania, Catania, Italy.
Evid Based Complement Alternat Med. 2016;2016:2581461. doi: 10.1155/2016/2581461. Epub 2016 Oct 12.
Gastroesophageal reflux (GER) is a common, chronic, relapsing symptom. Often people self-diagnose and self-treat it even though health-related quality of life is significantly impaired. In the lack of a valid alternative approach, current treatments focus on suppression of gastric acid secretion by the use of proton pump inhibitors (PPIs), but people with GER have a significantly lower response rate to therapy. We designed a randomized double-blinded controlled clinical study to evaluate the efficacy and the safety of a formulation based on sodium alginate/bicarbonate in combination with extracts obtained from and associated with polyphenols (Mucosave®; ), on GER-related symptoms. Male/female 118 (intention to treat) subjects with moderate GER and having at least 2 to 6 days of GER episodes/week were treated with (6 g/day) or placebo for two months. The questionnaires Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQoL) and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) were self-administered by participants before the treatment and at the end of the treatment. produced statistically significant reduction of GERD-HRQoL and GSAS scores, -56.5% and -59.1%, respectively, in comparison to placebo. Heartburn and acid regurgitation episodes for week were significantly reduced by ( < 0.01). Results indicate that Mucosave formulation provides an effective and well-tolerated treatment for reducing the frequency and intensity of symptoms associated with gastroesophageal reflux.
胃食管反流（GER）是一种常见的慢性复发性症状。尽管与健康相关的生活质量受到显著损害，但人们常常自行诊断和治疗。在缺乏有效替代方法的情况下，目前的治疗主要集中在使用质子泵抑制剂（PPI）抑制胃酸分泌，但GER患者对治疗的反应率明显较低。我们设计了一项随机双盲对照临床研究，以评估一种基于海藻酸钠/碳酸氢盐与从[具体植物名称1]和[具体植物名称2]中提取的与多酚相关的提取物（Mucosave®；[具体公司名称]）的制剂对GER相关症状的疗效和安全性。118名（意向性治疗）患有中度GER且每周至少有2至6天GER发作的男性/女性受试者，分别接受Mucosave（6克/天）或安慰剂治疗两个月。参与者在治疗前和治疗结束时自行填写胃食管反流病-健康相关生活质量问卷（GERD-HRQoL）和胃食管反流病症状评估量表（GSAS）。与安慰剂相比，Mucosave使GERD-HRQoL和GSAS评分在统计学上显著降低，分别降低了56.5%和59.1%。每周的烧心和反酸发作次数因Mucosave而显著减少（P<0.01）。结果表明，Mucosave制剂为减少与胃食管反流相关症状的频率和强度提供了一种有效且耐受性良好的治疗方法。
