Glucomannan for abdominal pain-related functional gastrointestinal disorders in children: a randomized trial.
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Resum
OBJECTIVE
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, placebo-controlled, 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.
CONCLUSIONS
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.
