Laboratory of Liver, Pancreas and Motility (HIPAM)-Unit of Research in Experimental Medicine, Faculty of Medicine, National Autonomous University of Mexico (UNAM). General Hospital of Mexico "Dr. Eduardo Liceada".
Gastroenterology and Endoscopy in MGP, ABC Medical Center.
J Clin Gastroenterol. 2020 Apr;54(4):e30-e39. doi: 10.1097/MCG.0000000000001242.
We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS).
IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials.
IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores.
A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events.
PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.
评估匹维溴铵 100mg 联合二甲硅油 300mg（简称 PB+S）治疗肠易激综合征（IBS）的疗效和安全性。
IBS 是一种多因素疾病，因此，联合不同作用机制的治疗方法有望有效。PB+S 在一项 IBS 的开放标签临床研究中显示出疗效。然而，目前尚无安慰剂对照试验。
本研究为 12 周、随机、双盲、安慰剂对照研究，纳入 IBS-Rome III 型患者，这些患者在基线评估前一周内至少有 2 天出现腹痛/不适，接受 PB+S（bid）或安慰剂治疗。主要终点是患者每周评估的整体症状改善（Likert 量表）。次要终点包括患者（10cm 视觉模拟量表）和研究者（Likert 量表）评估的腹痛和腹胀严重程度每周改善情况；患者评估的布里斯托粪便类型（稠度）频率和 IBS 生活质量评分。
共 285 例患者（女性占 83%，年龄 36.5±8.9 岁）至少接受了 1 次 PB+S（n=140）或安慰剂（n=145）治疗。两组间整体症状改善无差异（P=0.13）。然而，PB+S 在腹痛（效应大小：31%，P=0.038）和腹胀（33%，P=0.019）方面优于安慰剂。PB+S 可改善 IBS-C 和 IBS-M 患者的粪便类型频率。IBS 生活质量评分和不良反应无差异。
在治疗活动期 IBS 患者时，PB+S 优于安慰剂，可改善腹痛和腹胀。在 IBS-C 和 IBS-M 中，对粪便稠度频率的影响更为显著。
