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一项关于一种专利猕猴桃提取物对便秘型肠易激综合征疗效的随机、安慰剂对照、双盲8周试验。

Randomized, Placebo-Controlled, Double-Blind 8-Week Trial on the Efficacy of A Proprietary Kiwifruit Extract on Constipation-Predominant Irritable Bowel Syndrome.

作者信息

Holtmann Gerald, Talley Nicholas J, Nandurkar Sanjay, Gibson Peter R

机构信息

Department of Gastroenterology and Hepatology Princess Alexandra Hospital Brisbane Queensland Australia.

School of Medicine University of Queensland Brisbane Australia.

出版信息

JGH Open. 2025 Aug 9;9(8):e70250. doi: 10.1002/jgh3.70250. eCollection 2025 Aug.

DOI:10.1002/jgh3.70250
PMID:40786128
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12335029/
Abstract

BACKGROUND

Green kiwifruit ( ) extract improves constipation. This study aimed to determine its efficacy in patients with constipation-predominant irritable bowel syndrome (IBS-C).

METHODS

A randomized, multicenter, double-blind, parallel-group, placebo-controlled trial was conducted in 186 IBS-C patients (Rome III criteria). Patients received either placebo or kiwifruit extract (575 mg twice daily for 4 weeks, followed by 575 mg daily for 4 weeks). Outcomes included measures of bowel movement frequency, Bristol Stool Scores, and abdominal pain and related measures (100 mm visual analog scale). The primary efficacy end point was the combined improvement of the number of complete spontaneous bowel movements and reduction of weekly average abdominal pain symptom score by at least 30% for at least half of the weeks during treatment.

RESULTS

On kiwifruit extract, the proportion of subjects with increased frequency of spontaneous bowel movements (54% vs. 36%,  = 0.012), improved Bristol Stool Score (87 vs. 73%,  = 0.014), and abdominal pain (74% vs. 59%,  = 0.023) was greater than in controls. However, no difference was observed in the combined two-variable primary end point (24% vs. 26%;  = 0.798). In post hoc analyses of 49 subjects with severe pain (≥ 50 mm), kiwifruit extract improved the primary end point (33% vs. 8%,  = 0.028) and normalized or maintained normal bowel actions with kiwifruit extract (44% vs. 24%,  = 0.005).

CONCLUSIONS

In patients with IBS-C, kiwifruit extract improves bowel habits and abdominal pain. The predefined end point for the whole study population was not met because the 30% or greater improvement of pain only occurred in patients with more pain.

TRIAL REGISTRATION

Australian Clinical Trial Research Network (ACTRN 12613001222730).

摘要

背景

绿奇异果提取物可改善便秘。本研究旨在确定其对以便秘为主的肠易激综合征(IBS-C)患者的疗效。

方法

对186例符合罗马III标准的IBS-C患者进行了一项随机、多中心、双盲、平行组、安慰剂对照试验。患者分别接受安慰剂或奇异果提取物(575毫克,每日两次,共4周,随后575毫克,每日一次,共4周)。观察指标包括排便频率、布里斯托大便评分以及腹痛及相关指标(100毫米视觉模拟量表)。主要疗效终点是在治疗期间至少一半的周数内,完全自主排便次数增加且每周平均腹痛症状评分降低至少30%的综合改善情况。

结果

服用奇异果提取物的患者中,自主排便频率增加的比例(54%对36%,P = 0.012)、布里斯托大便评分改善的比例(87%对73%,P = 0.014)以及腹痛改善的比例(74%对59%,P = 0.023)均高于对照组。然而,在综合两个变量的主要终点方面未观察到差异(24%对26%;P = 0.798)。在对49例重度疼痛(≥50毫米)患者的事后分析中,奇异果提取物改善了主要终点(33%对8%,P = 0.028),并且使用奇异果提取物使肠道功能恢复正常或维持正常的比例(44%对24%,P = 0.005)。

结论

在IBS-C患者中,奇异果提取物可改善排便习惯和腹痛。由于疼痛改善30%或更多仅发生在疼痛程度较重的患者中,因此未达到整个研究人群预先设定的终点。

试验注册

澳大利亚临床试验研究网络(ACTRN 12613001222730)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/4ea07fa9e7ca/JGH3-9-e70250-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/b64c5d4e4692/JGH3-9-e70250-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/24dab35f3fa6/JGH3-9-e70250-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/bcea66f209f0/JGH3-9-e70250-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/4ea07fa9e7ca/JGH3-9-e70250-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/b64c5d4e4692/JGH3-9-e70250-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/24dab35f3fa6/JGH3-9-e70250-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/bcea66f209f0/JGH3-9-e70250-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ced/12335029/4ea07fa9e7ca/JGH3-9-e70250-g002.jpg

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