文献类型：期刊文献

英文题名：Consideration in Randomized Placebo-Controlled Trial on Neck Pain to Avoid the Placebo Effect in Analgesic Action

作者：Sun, Yue-Li[1,2,3];Yao, Min[1,2,3];Zhu, Yue-Feng[2,4,5];Yin, Meng-Chen[1,2,3];Liu, Jin-Tao[6];Chen, Xin[7,8];Huang, Jin[9];Dai, Yu-Xiang[1,2,3,6];Wang, Wen-Hao[4,5];Ma, Zeng-Bin[2,10];Wang, Yong-Jun[1,2,3];Cui, Xue-Jun[1,2,3]

第一作者：Sun, Yue-Li

通信作者：Wang, YJ[1];Cui, XJ[1];Wang, YJ[2];Cui, XJ[2];Wang, YJ[3];Cui, XJ[3]

机构：[1]Shanghai Univ Tradit Chinese Med, Longhua Hosp, Shanghai, Peoples R China;[2]Shanghai Univ Tradit Chinese Med, Spine Inst, Shanghai, Peoples R China;[3]Key Lab Minist Educ Chron Musculoskeletal Dis, Shanghai, Peoples R China;[4]Fudan Univ, Huadong Hosp, Shanghai, Peoples R China;[5]Fudan Univ, Inst Integrat Med, Inst Geriatr & Gerontol, Shanghai, Peoples R China;[6]Nanjing Univ Chinese Med, Suzhou TCM Hosp, Suzhou, Peoples R China;[7]Gansu Univ Tradit Chinese Med, Lanzhou, Peoples R China;[8]Gansu Univ Tradit Chinese Med, Affiliated Hosp, Lanzhou, Peoples R China;[9]Gansu Prov Hosp TCM, Lanzhou, Peoples R China;[10]Beijing Hosp, Lanzhou, Peoples R China

第一机构：Shanghai Univ Tradit Chinese Med, Longhua Hosp, Shanghai, Peoples R China

通信机构：[1]corresponding author), Shanghai Univ Tradit Chinese Med, Longhua Hosp, Shanghai, Peoples R China;[2]corresponding author), Shanghai Univ Tradit Chinese Med, Spine Inst, Shanghai, Peoples R China;[3]corresponding author), Key Lab Minist Educ Chron Musculoskeletal Dis, Shanghai, Peoples R China.

年份：2022

卷号：13

外文期刊名：FRONTIERS IN PHARMACOLOGY

收录：;Scopus(收录号：2-s2.0-85131730253);WOS:【SCI-EXPANDED(收录号:WOS:000806273400001)】；

基金：This study was supported by the National Key R & D Program of China (2018YFC1704300) and the National Natural Science Foundation of China (81804115,81930116), the Shanghai Sailing Program (18YF1423800), the Program for Innovative Research Team of the Ministry of Science and Technology of China (2015RA4002), the Program for Innovative Research Team of the Ministry of Education of China (IRT1270), the Municipal Science and Technology Commission of Shanghai-TCM Key Project (16401970100), the Shanghai TCM Medical Center of Chronic Disease (2017ZZ01010), and the Essential Drug Research and Development from the Ministry of Science and Technology (2019ZX09201004-003-032).

语种：英文

外文关键词：placebo and nocebo effects; clinical trial; logistic regression; cervical radiculopathy; neck pain

摘要：Background: In neck pain treatment, many therapies are focused on etiology, while it is well-known that placebo analgesia is also present in these therapies. The specific efficacy for etiology may be underestimated by ignoring their actual placebo effect. In this study, a logistic regression analysis is used to explore the risk factors causing different placebo responses in patients with neck pain among two RCTs. The probability of the placebo effect is predicted based on these risk factors.Methods: Trial A and Trial B were similarly designed, randomized, double-/single-blind, placebo-controlled trials in patients treating neck pain with Qishe pill or Shi-style manipulation. Both studies set a placebo pill twice a day or traction for every other day as control. For further analyses on the placebo effect in neck pain management, logistic regression was used to assess subgroup-placebo interactions. The odds ratio assessed a significant influence on the placebo effect.Results: In this pooled analysis, the total number of patients recruited for these two studies was 284, of which 162 patients received placebo treatment (placebo drug or traction for every other day). No statistically significant differences are found at baseline between the participants with placebo effect and non-placebo effect in the gender, age, and disease duration except in VAS and NDI at the initial time. There are numerically more patients with placebo effect in the shorter disease duration subgroup (< 4 months [76%]), higher initial VAS subgroup (>60 mm [90%]), and worse initial NDI subgroup (>24 [72%]) compared with the gender and age subgroup. An ROC curve is established to assess the model-data fit, which shows an area under the curve of 0.755 and a 95% confidence interval of 0.677-0.830. Participants who show placebo effect after 2 weeks have significantly lower VAS scores after 4 weeks, while there is no significant difference in NDI improvement between the two groups after 4 weeks.Conclusion: Neck pain patients with shorter disease duration are more likely to overscore their pain severity, because of their less experience in pain perception, tolerance, and analgesia expectation.