Treatment of functional dyspepsia with enteroplant: a multi-center randomized, double-blind, placebo-controlled, pilot phase II clinical trial

Abstract

Objective To evaluate efficacy and safety of enteroplant in the treatment of patients with functional dyspepsia (FD). Methods From July 2011 to November 2013, 228 patients met Rome Ⅲ criteria were enrolled and divided into high dose, low dose and placebo groups. The assessment of symptoms score, life quality and safety of subjects was conducted at baseline period (one to two weeks), week two of treatment, week four of treatmeat and week two of follow-up. Single factor analysis of variance, Wilcoxon test and χ2 test were used for comparing the differences among three groups. Results The efficacy evaluation was conducted in 198 patients conformed to the protocol, 67 patients in high dose group, 66 patients in low dose group, and 65 patients in placebo group. All the 228 patients received safety evaluation. At week two, four of treatment and week two of follow-up, the total symptom scores of high dose group, low dose group were lower than those of placebo group (week two of treatment 14.57±6.12, 13.68±6.57 vs 18.92±9.54, F=9.051, P 0.05). At week two, four of treatment and week two of follow-up, the efficacy of postprandial fullness discomfort (F=5.139, 14.309, 19.111), early satiation (F=5.480, 13.709, 26.287), upper abdominal pain (F=1.169, 9.224, 24.142) and buring (F=0.156, 4.225, 15.770) was higher in low dose group and high dose group than those of placebo group (all P 0.05). There was no significant difference in the quality of life among the three groups before treatment and week four of treatment (all P>0.05). The adverse reactions primarily included abnormal liver function and dyslipidemia. There was no significant difference in adverse events rate (14.5%, 7.9%, 14.5%, respectively) among the three groups (P>0.05). Conclusions Enteroplant is safe and effective in the treatment of FD, and the efficacy lasts for two weeks after discontinuation. Low dose (260 mg) enteroplant is recommended for FD treatment. Key words: Enteroplant; Functional dyspepsia; Postprandial distress syndrome; Epigastric pain syndrome