Development of core outcome set for traditional Chinese medicine interventions in diabetic peripheral neuropathy.
10.19540/j.cnki.cjcmm.20250226.501
- Author:
Lu-Jie WANG
1
;
Liang-Zhen YOU
2
;
Chang CHANG
1
;
Yu-Meng GENG
1
;
Jin-Dong ZHAO
3
;
Zhao-Hui FANG
4
;
Ai-Juan JIANG
1
Author Information
1. Anhui University of Chinese Medicine Hefei 230012, China.
2. Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
3. the First Affiliated Hospital of Anhui University of Chinese Medicine Hefei 230012,China.
4. the First Affiliated Hospital of Anhui University of Chinese Medicine Hefei 230012,China Institute of Health and Medicine, Hefei Comprehensive National Science Center Hefei 230601, China.
- Publication Type:Journal Article
- Keywords:
clinical trial;
core outcome set;
diabetic peripheral neuropathy;
traditional Chinese medicine
- MeSH:
Humans;
Diabetic Neuropathies/drug therapy*;
Medicine, Chinese Traditional/methods*;
Drugs, Chinese Herbal/therapeutic use*;
Retrospective Studies;
Treatment Outcome;
Male;
Female
- From:
China Journal of Chinese Materia Medica
2025;50(14):4071-4080
- CountryChina
- Language:Chinese
-
Abstract:
This study developed a core outcome set(COS) for traditional Chinese medicine(TCM) interventions in diabetic peripheral neuropathy(DPN), standardizing evaluation metrics for TCM efficacy and providing a new framework for DPN treatment and management. A systematic search was conducted across databases, including CNKI, Wanfang, and PubMed, targeting clinical trial literature published between January 1, 2013, and January 1, 2023. The search focused on extracting outcome indicators and measurement tools used in TCM treatments for DPN. Retrospective data collection was performed from January 2018 to June 2023, involving 200 DPN patients hospitalized at the Department of Endocrinology of the First Affiliated Hospital of Anhui University of Chinese Medicine. Additionally, semi-structured interviews were conducted with inpatients, outpatients, their families, and nursing staff to further refine and enhance the list of outcome indicators. After two rounds of Delphi questionnaire survey and consensus meeting, a consensus was reached. The study initially retrieved 3 421 publications, of which 170 met the inclusion criteria after review. These publications, combined with retrospective analysis and semi-structured interviews, supplemented the list of indicators. After two rounds of Delphi surveys, experts agreed on 24 indicators and 6 measurement tools. The final COS determined by expert consensus meeting included 5 domains and 13 outcome indicators: neurological function signs, quality of life, TCM syndrome score, nerve conduction velocity, current perception threshold test, fasting blood glucose, 2 h postprandial blood glucose, glycated hemoglobin, complete blood count, urinalysis, liver function test, kidney function test, and electrocardiogram.
