Glucomannan for abdominal pain-related functional gastrointestinal disorders in children:A randomized trial

摘要

AIM:To assess the efficacy of glucomannan(GNN) as the sole treatment for abdominal pain-related functional gastrointestinal disorders(FGIDs).METHODS:We conducted a double-blind,placebocontrolled,randomized trial.Patients were recruited among children referred to the Department of Paediatrics,Medical University of Warsaw.Included in the study were children aged 7-17 years with abdominal pain-related FGIDs classified according to the Rome Ⅲ diagnostic criteria.The children were randomly assigned to receive GNN,a polysaccharide of 1,4-D-glucose and D-mannose,a soluble fiber from the Japanese Konjac plant,at a dosage of 2.52 g/d(1 sachet of 1.26 g 2 times a day),or a comparable placebo(maltodextrin) at the same dosage.The content of each sachet was dissolved in approximately 125 mL of fluid and was consumed twice daily for 4 wk.RESULTS:Of the 89 eligible children,84(94%) completed the study."No pain" and "treatment success"(defined as no pain or a decrease ≥ 2/6 points on the FACES Pain Scale Revised) were similar in the GNN(n = 41) and placebo(n = 43) groups [no pain(12/41 vs 6/43,respectively;RR = 2.1,95%CI:0.87-5.07) as well as treatment success(23/41 vs 20/43;RR = 1.2,95%CI:0.79-1.83)].No significant differences between the groups were observed in the secondary outcomes,such as abdominal cramps,abdominal bloating/gassiness,episodes of nausea or vomiting,or a changed in stool consistency.GNN demonstrated no significant influence on the number of children requiring rescue therapy,school absenteeism,or daily activities.CONCLUSION:In our setting,GNN,as dosed in this study,was no more effective than the placebo in achieving therapeutic success in the management of FGIDs in children.