患者期望对针刺治疗膝骨关节炎疗效的影响及期望相关因素分析——一项多中心随机对照试验的二次分析

Influence of Patient Expectations on the Effect of Acupuncture for Knee Osteoarthritis and the Factors Correlated to The Expectations:a Secondary Analysis of a Multicenter Randomized Controlled Trial

目的探索针刺治疗膝骨关节炎(KOA)试验中患者期望对于临床疗效的影响及期望相关因素,为控制相关研究影响因素及提高临床疗效提供借鉴。方法对一项针刺治疗KOA的多中心、随机对照试验进行二次分析。将480例KOA受试者按照1∶1∶1的比例随机分为电针组、手针组和假针组。各组受试者均每周治疗3次,共治疗8周,治疗结束后随访18周。第一次针刺治疗结束后,通过可信度/期望调查问卷进行评估各组患者期望值。治疗前,治疗第4、8周,随访第8、18周进行临床指标评定,包括前期研究中的数字评价量表(NRS)评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)功能亚表评分、总体有效率、NRS有效率和WOMAC功能亚表有效率。采用Spearman相关分析判定患者期望值与不同评价时间点临床指标的相关性。采集的可能对期望值产生影响的因素,包括治疗分组、研究中心、患者基本信息和KOA疾病相关因素,对期望值的影响因素进行单因素分析,将单因素分析结果中有统计学意义的因素应用多因素线性回归分析方法进行统计分析。结果纳入442例受试者数据。各组间期望值差异无统计学意义(P>0.05),因此将总体期望值与各指标进行相关分析。期望与总体有效率、WOMAC功能亚表有效率在各个时间点的相关性分析结果均未显示显著相关性(P>0.05)。期望与随访18周的疼痛NRS评分有效率呈正相关(P<0.05);与各时间点的NRS评分呈负相关(P<0.05);与治疗前WOMAC功能亚表评分呈正相关,与其他时间点呈负相关(P<0.05)。单因素分析结果表明,研究中心、Kellgren-Lawrence(KL)放射学分级和治疗前NRS评分这3个因素与期望值有关(P<0.2)。进一步多因素线性回归分析结果显示,针刺治疗KOA的期望与KL分级、研究中心有关(P<0.05)。KOA放射学分级越高,受试者期望越低;非北京地区的受试者期望值高于北京地区。结论针刺治疗中期望与整个研究期间KOA受试者的NRS评分相关,且相关性可随时间延长而增加,而KL分级和研究中心为受试者期望水平的影响因素,值得研究者与临床医生予以关注。

Objective To explore the influence of patients’expectation on clinical effect and the related factors in the clinical trials of acupuncture for knee osteoarthritis(KOA),so as to provide reference for controlling the influencing factors and improving the clinical effect in future.Methods A secondary analysis of a multi-center randomized controlled trial of acupuncture in the treatment of KOA was performed.A total of 480 KOA patients were randomly assigned to electroacupuncture(EA)group,manual acupuncture(MA)group,and sham acupuncture(SA)group in a ratio of 1∶1∶1.The patients in each group were treated 3 times a week for 8 weeks,and were followed up for 18weeks after treatment.The expectation was evaluated by the Credibility/Expectancy Questionnaire after the first acupuncture treatment.Clinical outcomes included the numerical rating scale(NRS)and the functional subscale of the Western Ontario and McMaster Universities Arthritis Index(WOMAC)in the previous study(evaluation time point:before treatment,the 4th and 8th week of treatment,and the 8th and 18th week of follow-up).Spearman correlation analysis was used to determine the correlation between the overall expectation of patients and clinical outcomes at different evaluation time points.The data of the possible influencing factors were extracted including treatment group,study center,basic patient information and KOA-related factors.Univariate analysis was performed for the influencing factors,and Multivariate analysis was used for those factors with statistical significance in univariate analysis.ResultsFinally,442 patients were included in the statistical analysis.There was no significant difference in expectation between groups(P>0.05),so the correlation analysis was carried out between the overall expectation and each clinical outcome.Between expectation and overall effective rate and the effective rate of WOMAC functional subscale score at each time point,the correlation was not significant(P>0.05).Expectation was positively correlated with the effective rate of NRS score at the 18thweek of follow-up(P<0.05),while negatively correlated with NRS score at each time point(P<0.05).Expectation was positively correlated with the WOMAC score before treatment,while negatively correlated with that at other time points(P<0.05).Univariate analysis showed that three factors including research center,Kellgren-Lawrence(KL)grade,and NRS score before treatment were correlated to the expectation(P<0.2).Further multivariate linear regression analysis showed that the expectation of acupuncture for KOA was correlated to KL grade and research center(P<0.05).The higher the KL grade of KOA,the lower the expectation of patients was;the expectation of patients who were not in Beijing was higher than those in Beijing.Conclusion The expectation in acupuncture treatment is correlated to the NRS score of KOA patients throughout the study period,and the correlation increases over time.The influencing factors of patients’expectation are KL grade and research center.The results of this study can provide reference for related researchers and clinicians in future study and practice.