The Effect of Ginger (Zingiber officinalis) and Artichoke (Cynara cardunculus) Extract Supplementation on Functional Dyspepsia: A Randomised, Double-Blind, and Placebo-Controlled Clinical Trial

摘要

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:αS=+1.195MCA score units (u),P=0.017; placebo:αP=+0.347 u,P=0.513). The intercept (α) resulted to be significantly higher in SG than in placebo (αS-αP=+0.848 u,P<0.001). At the end of the study, the advantage of SG versus placebo persists without variation (βS-βP=+0.077 u,P=0.542). In SG, a significant advantage is observed for nausea (βS-βP=-0.398 u,P<0.001), epigastric fullness (βS-βP=-0.241,P<0.001), epigastric pain (βS-βP=-0.173 u,P=0.002), and bloating (βS-βP=-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.