Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria

LI Xinying; LIU Shanshan; LV Hequn; ZENG Chunli; PENG Yongjun

doi:10.13703/j.0255-2930.20250201-k0001

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Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria

Literature Research | 更新时间：2026-03-16

- Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria
- Chinese Acupuncture & Moxibustion Vol. 46, Issue 3, Pages: 449-456(2026)
- 作者机构：
  
  南京中医药大学附属医院针灸康复科，江苏南京　210029
- 作者简介：
- 基金信息：
- DOI：10.13703/j.0255-2930.20250201-k0001
  CLC：
- Received：01 February 2025，
  
  Online First：26 December 2025，
  
  Published：12 March 2026
- 稿件说明：
移动端阅览
LI Xinying, LIU Shanshan, LV Hequn, et al. Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria[J]. Chinese Acupuncture & Moxibustion, 2026, 46(3): 449-456.
DOI：

LI Xinying, LIU Shanshan, LV Hequn, et al. Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria[J]. Chinese Acupuncture & Moxibustion, 2026, 46(3): 449-456. DOI： 10.13703/j.0255-2930.20250201-k0001.

摘要

目的：

分析针刺治疗慢性荨麻疹（CU）随机对照试验（RCT）结局指标的应用现状，为后续针刺治疗CU的临床研究设计及核心结局指标集的构建提供参考。

方法：

检索中国期刊全文数据库（CNKI）、万方数据知识服务平台（Wanfang）、维普资讯中文期刊服务平台（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、EMbase、Cochrane Library及Web of Science数据库中针刺治疗CU的RCT文献，筛选时间限定为建库至2024年11月30日，提取纳入文献的结局指标并进行分析。

结果：

共纳入60篇文献，提取到中医病证、症状/体征、理化检测、生活质量、远期预后、安全性事件6类指标域。结局指标包含94个，总使用频次539次，使用频次前3位的指标域依次为症状/体征（69.0%）、安全性事件（10.8%）及生活质量（8.3%）。针刺治疗CU的RCT结局指标现状存在主次要结局指标不分、结局指标名称不规范、疗效评定标准不一、疗程及评价时间点差距过大、远期预后关注度低下、不注重伦理审查及研究注册、不重视安全性评价及经济学评估等问题。

结论：

建议尽快构建出针刺治疗CU的核心指标集，以提高临床研究设计的规范性，推动针刺临床研究的发展。

Abstract

Objective

To analyze the current status of outcome measures adopted in randomized controlled trials (RCTs) of acupuncture for chronic urticaria (CU)

and provide the references for the design of subsequent clinical studies and the construction of core outcome set in acupuncture treatment of CU.

Methods

The RCTs of acupuncture for CU were searched from China Journal Full-text Database (CNKI)

Wanfang Data Knowledge Service Platform (Wanfang)

VIP Information Chinese Journal Service Platform (VIP)

SinoMed

PubMed

EMbase

Cochrane Library and Web of Science

from the inception to November 30

2024. The outcomes were extracted and analyzed.

Results

A total of 60 articles were included

and 6 indexes domains were extracted

including TCM syndromes

symptoms/signs

physiological and chemical indexes

quality of life

long-term prognosis and safety events. Ninety-four outcomes were included

with a total application frequency of 539 times

and the top 3 indexes with the most application frequency were symptoms/signs (69.0%)

safety events (10.8%) and quality of life (8.3%). The current application of outcome indexes in RCTs of acupuncture for CU showed the unclear distinction between primary and secondary outcomes

non-standardized names of outcome indexes

inconsistent criteria of efficacy evaluation

large disparity in treatment duration and evaluation time points

low attention to long-term prognosis

and neglect of ethical review

trial registration

safety evaluation and economic assessment.

Conclusion

It is recommended to establish a core outcome set for acupuncture treatment of CU

so as to improve the standardization of clinical research design and promote the development of clinical studies of acupuncture.

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