Bucci C, Tremolaterra F, Gallotta S, Fortunato A, Cappello C, Ciacci C, Iovino P
Gastrointestinal Unit, Department of Medicine and Surgery, University of Salerno, Via S Allende, 84081, Baronissi, Salerno, Italy.
Tech Coloproctol. 2014 Apr;18(4):345-53. doi: 10.1007/s10151-013-1055-2. Epub 2013 Aug 7.
In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture.
This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation).
Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected.
Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.
近年来，益生菌在肠易激综合征（IBS）治疗中的疗效受到了广泛关注。在这方面，一种共生混合物（Probinul®）已显示出有益效果。本研究的目的是扩展此前发表的关于这种共生混合物的为期4周的随机、双盲、安慰剂对照研究。
这是一项开放标签的前瞻性、部分对照、为期6个月延长期的试点研究，其中患者继续接受共生混合物治疗（第1组），或采用循环给药方式（每月最后2周）从安慰剂转换为共生混合物治疗（第2组）。主要终点是腹胀和肠胃胀气总体缓解的满意度（以有反应者的比例评估）。次要终点是症状严重程度评分（腹胀、肠胃胀气、疼痛和急迫感）和肠道功能评分（频率、大便稠度和排便不尽）的评估。
26例IBS患者完成了6个月的延长期（第1组13例患者，第2组13例患者）。在符合方案分析中，两组随时间有反应者的比例无显著差异，但在第2组中，肠胃胀气有反应者的百分比有所增加（p = 0.07）。此外，第2组在6个月治疗期内肠胃胀气评分显著降低（p < 0.05），而未检测到其他显著差异。
在本为期6个月的延长期研究中，使用这种共生混合物治疗与肠胃胀气缓解的持续性或肠胃胀气新的减轻相关。这些结果需要在大型、长期、随机、安慰剂对照研究中进行更全面的评估。
