肠易激综合征中与健康相关生活质量结局的安慰剂反应变异性：一项基于臂的网络荟萃分析。
Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.
作者信息
Wang Zhenzhi, Chen Yukun, Li Xinyu, Lin Li, Chen Bozhu, Chen Min, Zheng Hui
机构信息
Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine，No.1166 Liutai Avenue, Wenjiang District, Chengdu, China.
Department of Oncology, Dong Fang Hospital, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Qual Life Res. 2025 Jun;34(6):1553-1568. doi: 10.1007/s11136-025-03927-w. Epub 2025 Feb 25.
OBJECTIVES
The impact of placebo response on health outcomes in various diseases, including IBS, is significant. To better understand the effect of different placebo administration methods on the observed outcomes in IBS studies, this meta-analysis aims to explore research findings on the degree of improvement.
METHODS
The meta-analysis included 45 randomized, double-blind, placebo-controlled clinical trials involving 5174 patients with confirmed IBS (excluding those with significant comorbidities). The trials were designed to compare the efficacy of different placebo interventions. The primary outcome was the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), and secondary outcomes included the Irritable Bowel Syndrome Quality of Life Instrument (IBS-QoL) and the IBS Symptom Visual Analog Scale (VAS). An arm-based Bayesian network meta-analysis was performed to examine the relative effectiveness of the placebo interventions on the outcomes.
RESULTS
The analysis revealed that sham moxibustion exhibited the most significant efficacy in reducing IBS-SSS (MD -260.00, 95% CrIs: -288.00 to -232.00). Additionally, sham FMT resulted in significant improvements in IBS-QOL scores (MD 9.23, 95% CrIs - 3.69 to 22.30). Meanwhile, placebo tablet interventions were found to be the most effective in reducing VAS scores (MD 4.71, 95% CrIs, -1.14 to 11.10). Overall, this synthesis provides detailed insights into the effectiveness of placebos in addressing different outcome measures.
CONCLUSIONS
Sham moxibustion appears to provide subjective benefits for patients' IBS symptoms. However, the evidence for its efficacy is less robust compared to other interventions, as assessed by GRADE. Understanding the placebo effect in IBS management is crucial for clinical practice and drug development, particularly in placebo comparisons.
REGISTRATION ID
INPLASY2024110111. https://doi.org/10.37766/inplasy2024.11.0111 .
目的
安慰剂反应对包括肠易激综合征（IBS）在内的各种疾病的健康结局具有重要影响。为了更好地理解不同安慰剂给药方法对IBS研究中观察到的结局的影响，本荟萃分析旨在探讨关于改善程度的研究结果。
方法
该荟萃分析纳入了45项随机、双盲、安慰剂对照的临床试验，涉及5174例确诊为IBS的患者（不包括有严重合并症的患者）。这些试验旨在比较不同安慰剂干预措施的疗效。主要结局是肠易激综合征严重程度评分系统（IBS-SSS），次要结局包括肠易激综合征生活质量量表（IBS-QoL）和IBS症状视觉模拟量表（VAS）。进行了基于臂的贝叶斯网络荟萃分析，以检验安慰剂干预措施对结局的相对有效性。
结果
分析显示，假艾灸在降低IBS-SSS方面表现出最显著的疗效（MD -260.00，95% CrIs：-288.00至-232.00）。此外，假粪菌移植导致IBS-QOL评分显著改善（MD 9.23，95% CrIs -3.69至22.30）。同时，发现安慰剂片剂干预在降低VAS评分方面最有效（MD 4.71，95% CrIs，-1.14至11.10）。总体而言，本综述提供了关于安慰剂在解决不同结局指标方面有效性的详细见解。
结论
假艾灸似乎为患者的IBS症状提供了主观益处。然而，根据GRADE评估，与其他干预措施相比，其疗效证据的力度较弱。了解IBS管理中的安慰剂效应对于临床实践和药物开发至关重要，特别是在安慰剂比较方面。
注册编号
INPLASY2024110111。https://doi.org/10.37766/inplasy2024.11.0111 。
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