Giacosa Attilio, Guido Davide, Grassi Mario, Riva Antonella, Morazzoni Paolo, Bombardelli Ezio, Perna Simone, Faliva Milena A, Rondanelli Mariangela
Department of Gastroenterology, Policlinico di Monza, 20900 Milan, Italy.
Section of Biostatistics, Neurophysiology and Psychiatry, Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.
Evid Based Complement Alternat Med. 2015;2015:915087. doi: 10.1155/2015/915087. Epub 2015 Apr 14.
Objective. Functional dyspepsia (FD) is a frequent clinical finding in western world. The aim of this study is to compare the efficacy of a ginger and artichoke supplementation versus placebo in the treatment of FD. Methods. A prospective multicentre, double blind, randomized, placebo controlled, parallel-group comparison of the supplement and placebo over a period of 4 weeks was performed. Two capsules/day were supplied (before lunch and dinner) to 126 FD patients (supplementation/placebo: 65/61). Results. After 14 days of treatment, only supplementation group (SG) showed a significant amelioration (SG: α S = +1.195 MCA score units (u), P = 0.017; placebo: α P = +0.347 u, P = 0.513). The intercept (α) resulted to be significantly higher in SG than in placebo (α S - α P = +0.848 u, P < 0.001). At the end of the study, the advantage of SG versus placebo persists without variation (β S - β P = +0.077 u, P = 0.542). In SG, a significant advantage is observed for nausea (β S - β P = -0.398 u, P < 0.001), epigastric fullness (β S - β P = -0.241, P < 0.001), epigastric pain (β S - β P = -0.173 u, P = 0.002), and bloating (β S - β P = -0.167 u, P = 0.017). Conclusions. The association between ginger and artichoke leaf extracts appears safe and efficacious in the treatment of FD and could represent a promising treatment for this disease.
目的。功能性消化不良(FD)在西方世界是一种常见的临床症状。本研究的目的是比较补充生姜和洋蓟与安慰剂在治疗FD方面的疗效。方法。进行了一项前瞻性多中心、双盲、随机、安慰剂对照、平行组比较研究,对补充剂和安慰剂进行为期4周的比较。每天给126名FD患者提供两粒胶囊(午餐和晚餐前服用)(补充剂/安慰剂组:65/61)。结果。治疗14天后,只有补充剂组(SG)显示出显著改善(SG组:αS = +1.195 MCA评分单位(u),P = 0.017;安慰剂组:αP = +0.347 u,P = 0.513)。SG组的截距(α)显著高于安慰剂组(αS - αP = +0.848 u,P < 0.001)。在研究结束时,SG组相对于安慰剂组的优势持续存在且无变化(βS - βP = +0.077 u,P = 0.542)。在SG组中,在恶心(βS - βP = -0.398 u,P < 0.001)、上腹部饱胀感(βS - βP = -0.241,P < 0.001)、上腹部疼痛(βS - βP = -0.173 u,P = 0.002)和腹胀(βS - βP = -0.167 u,P = 0.017)方面观察到显著优势。结论。生姜和洋蓟叶提取物的联合使用在治疗FD方面似乎安全有效,可能是这种疾病的一种有前景的治疗方法。