安慰剂对慢性荨麻疹患者瘙痒的影响：随机安慰剂对照试验的系统回顾和元分析》（The Effect of Placebo on Pruritus in Patients with Chronic Urticaria: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials）。
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However, the extent of placebo effect and its influencing factors in the treatment of chronic urticaria are not well understood.</p><p><strong>Objective: </strong>The objective of this systematic review and meta-analysis was to investigate the effect of placebo on pruritus in patients with chronic urticaria and to explore relevant influencing factors.</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science, Cochrane Library, and PsycINFO were searched from inception to 10 July, 2024. Primary outcome included pruritus scores. The secondary outcomes focused on global symptoms and quality of life. Subgroup analyses and meta-regression analyses were conducted based on drug types, sample size, participants' age, and other variables. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and a trial sequential analysis were employed to establish the reliability of evidence.</p><p><strong>Results: </strong>A total of 65 eligible publications (including 67 randomized controlled trials) involving 10,704 patients with chronic urticaria were included. The pruritus scores decreased following placebo treatment (moderate evidence). In addition, favorable results were observed in global symptoms (moderate evidence) and quality of life (low evidence) after placebo treatment. Subgroup analyses indicated that the type of active medication in intervention groups was an influencing factor of placebo effect of pruritus. Meta-regression analyses demonstrated that the anti-pruritic effect of placebo was inversely correlated with sample size and positively correlated with participants' age. 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引用次数: 0
摘要
背景：在临床研究中，安慰剂对慢性荨麻疹患者的止痒作用越来越受到关注。然而，安慰剂效应的程度及其在慢性荨麻疹治疗中的影响因素尚不十分清楚：本系统综述和荟萃分析旨在研究安慰剂对慢性荨麻疹患者瘙痒的影响，并探讨相关影响因素：方法：检索了从开始到2024年7月10日的PubMed、Embase、Web of Science、Cochrane Library和PsycINFO。主要结果包括瘙痒评分。次要结果侧重于整体症状和生活质量。根据药物类型、样本大小、参与者年龄和其他变量进行了分组分析和元回归分析。为确定证据的可靠性，采用了建议评估、发展和评价分级（GRADE）系统和试验序列分析：结果：共收录了65篇符合条件的文献（包括67项随机对照试验），涉及10704名慢性荨麻疹患者。安慰剂治疗后，瘙痒评分下降（中度证据）。此外，安慰剂治疗后在整体症状（中度证据）和生活质量（低度证据）方面也观察到了良好的结果。亚组分析表明，干预组中活性药物的类型是影响瘙痒安慰剂效应的一个因素。元回归分析表明，安慰剂的止瘙痒效果与样本量成反比，与参与者的年龄成正比。试验序列分析进一步证实了安慰剂的止痒效果：结论：慢性荨麻疹患者接受安慰剂治疗后，瘙痒症状得到了显著改善。安慰剂的止痒效果随样本量、参与者年龄和所用活性药物类型的不同而变化。未来的研究应进一步调查安慰剂的效应大小，并阐明其潜在机制：该研究方案已在国际系统综述前瞻性注册中心（PROSPERO）注册，注册号为CRD42023482608。
The Effect of Placebo on Pruritus in Patients with Chronic Urticaria: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.
Background: The anti-pruritic effect of placebo in patients with chronic urticaria has gained increasing attention in clinical research. However, the extent of placebo effect and its influencing factors in the treatment of chronic urticaria are not well understood.
Objective: The objective of this systematic review and meta-analysis was to investigate the effect of placebo on pruritus in patients with chronic urticaria and to explore relevant influencing factors.
Methods: PubMed, Embase, Web of Science, Cochrane Library, and PsycINFO were searched from inception to 10 July, 2024. Primary outcome included pruritus scores. The secondary outcomes focused on global symptoms and quality of life. Subgroup analyses and meta-regression analyses were conducted based on drug types, sample size, participants' age, and other variables. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and a trial sequential analysis were employed to establish the reliability of evidence.
Results: A total of 65 eligible publications (including 67 randomized controlled trials) involving 10,704 patients with chronic urticaria were included. The pruritus scores decreased following placebo treatment (moderate evidence). In addition, favorable results were observed in global symptoms (moderate evidence) and quality of life (low evidence) after placebo treatment. Subgroup analyses indicated that the type of active medication in intervention groups was an influencing factor of placebo effect of pruritus. Meta-regression analyses demonstrated that the anti-pruritic effect of placebo was inversely correlated with sample size and positively correlated with participants' age. A trial sequential analysis provided further support for the anti-pruritic effect of placebo.
Conclusions: A substantial improvement of pruritus after placebo treatment was observed in patients with chronic urticaria. The anti-pruritic effect of placebo varied with sample size, participants' age, and type of active medication used. Future research should further investigate the effect size of placebo and clarify the potential mechanism.
Prospero registration: The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) as CRD42023482608.
期刊介绍：
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
-Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs.
-Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice.
-Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed.
-Studies focusing on the application of drug delivery technology in healthcare.
-Short communications and case study reports that meet the above criteria will also be considered.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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