Andrea Horvath, Piotr Dziechciarz, Hania Szajewska, Department of Paediatrics, the Medical University of Warsaw, Dzialdowska 1, Poland.
World J Gastroenterol. 2013 May 28;19(20):3062-8. doi: 10.3748/wjg.v19.i20.3062.
To assess the efficacy of glucomannan (GNN) as the sole treatment for abdominal pain-related functional gastrointestinal disorders (FGIDs).
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.
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.
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.
评估葡甘露聚糖（GNN）作为唯一治疗腹痛相关功能性胃肠疾病（FGIDs）的疗效。
我们进行了一项双盲、安慰剂对照、随机试验。招募的患者来自华沙医科大学儿科部门的转诊患者。研究纳入了年龄在 7-17 岁之间、根据罗马 III 诊断标准分类的腹痛相关 FGIDs 的儿童。这些儿童被随机分配接受 GNN（一种来自日本魔芋植物的 1,4-D-葡萄糖和 D-甘露糖的多糖，水溶性纤维），剂量为 2.52 克/天（每天 2 次，每次 1.26 克），或相同剂量的可比安慰剂（麦芽糊精）。每个小袋的内容物溶解在约 125 毫升的液体中，每天两次，持续 4 周。
在 89 名符合条件的儿童中，有 84 名（94%）完成了研究。在 GNN（n = 41）和安慰剂（n = 43）组中，“无疼痛”和“治疗成功”（定义为 FACES 疼痛量表修订版评分降低≥2/6 分）相似[无疼痛（分别为 12/41 和 6/43；RR = 2.1，95%CI：0.87-5.07）以及治疗成功（分别为 23/41 和 20/43；RR = 1.2，95%CI：0.79-1.83）]。两组在次要结局（如腹痛、腹胀/胀气、恶心或呕吐发作、或粪便稠度改变）方面无显著差异。GNN 对需要救援治疗、缺课或日常活动的儿童数量没有显著影响。
在我们的环境中，以本研究中的剂量给予 GNN，在治疗儿童 FGIDs 方面，与安慰剂相比，其疗效并无显著提高。
