Placebo Design Methodology for Clinical Trials of Pastes for Acupoint Application
10.13288/j.11-2166/r.2025.10.007
- VernacularTitle:膏剂穴位贴敷临床试验安慰剂的设计思路与方法
- Author:
Xinyan YANG
1
;
Bingyu PU
2
;
Meng WANG
3
;
Jian WANG
1
Author Information
1. Shandong University of Traditional Chinese Medicine，Jinan，250014
2. Linyi Health School of Shandong Province
3. Shandong Academy of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
placebo;
acupoint application;
paste;
clinical trial design
- From:
Journal of Traditional Chinese Medicine
2025;66(10):1011-1016
- CountryChina
- Language:Chinese
-
Abstract:
Reasonable and standardised placebo setting for acupoint application pastes is a key factor for clinical trials to verify the safety and effectiveness of acupoint application. By sorting out the current design status of placebo in the allocation concealment and blind design， paste components， paste location， paste duration in the current clinical trials of acupoint application pastes， it is proposed that there are problems such as low application rate of blinding and non-standardised reporting， insufficient standardisation of placebo settings and lack of systematic research， and lack of uniform standards of the placebo evaluation method. Based on the action mechanism of acupoint application， the idea of setting placebo for acupoint application paste is proposed in terms of replacing the application material， controlling the physicochemical effect produced by transdermal absorption of drugs， and setting the permeability of placebo， in order to enrich the methodological content of the placebo setting for acupoint application， and providing more scientific and reliable clinical evidence of acupoint application.
