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Developing a Chinese medicine syndrome differentiation questionnaire for chronic pain patients who use opioid medications

机译：针对使用阿片类药物的慢性疼痛患者制定中医辨证问卷

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Chronic musculoskeletal pain (CMP) is common and associated with reduced quality of life, loss of productivity, and increased health expenditures to the patients and the society. Chronic musculoskeletal pain is increasingly managed with opioid medications (OMs) with many and serious adverse effects and CMP is accompanied with comorbidities and non-pain symptoms. Comorbidities increase the burden to health management and deteriorate quality of life. Chinese medicine (CM) has been used to treat CMP and has its own theory and understanding of CMP. Chinese medicine diagnoses CMP into sub groups called CM patterns based on the presenting pain and non-pain symptoms of CMP patients. However, such an approach has not been evaluated by clinical trials to determine the value of pattern identification in the CM management for CMP, particularly for users of OM for CMP control. In order to establish a basis for further research into CM for CMP, there is a need to identify the CM patterns of CMP and assess their differences with clinical outcomes measured by validated tools. The Objectives of this thesis were to: 1) identify the comorbidities and symptomatologies of CMP through a systematic review; 2) develop and validate a Chinese medicine Pain Questionnaire (CMPQ) for pattern identification in CMP patients who are OM users; 3) differentiate the CM patterns of CMP who use OM for pain control using cluster analysis; and determine the cluster differences in demography, pain intensity, OM consumption, depression, quality of life, and disability; and 4) determine the differences between CM patterns and clinical outcomes of electro acupuncture (EA) based on the change in CMPQ symptoms, pain intensity, OM consumption, depression, and quality of life. Method: A systematic review was carried. Major English databases were searched and restricted to English and Chinese languages publications. Chinese medicine literatures were searched and symptoms and signs related to CMP were extracted. The development of CMPQ was embedded in another electro acupuncture trial. CMP participants were recruited if they use OM and wish to reduce their OM usages. Trial participants were randomised into either real electro acupuncture (EA), sham EA, or no EA groups. The CMPQ data were analysed for validities and reliabilities. Participants’ data were analysed using principal component analysis and K-means cluster analysis. Analysis of variance, multivariate analysis of variance, and Chi square were used to assess the association between the clusters, their demography, and other commonly used outcome measures. Cochran’s Q test was used to assess the changes within the dichotomous CMPQ symptoms. Results: Major English databases were searched for the systematic review and 72 studies were included with 61 of them being categorised into three main groups: chronic spinal pain, arthritis, and fibromyalgia. The findings showed the association between CMP and comorbidities and accompanying pain or non-pain symptoms for chronic spinal pain and arthritis but not for fibromyalgia. Chronic spinal pain (20 studies) was associated with (odds ratio 1.33-7.9) arthritis, headache/migraine, depression, and panic attacks/disorder, hypertension, heart diseases, general anxiety disorder, mood disorder, alcohol use disorder, and digestive ulcer. Arthritis (37 studies) was associated with (odds ratio 1.48 – 8.7) chronic spinal pain, depression, panic disorder, post traumatic stress disorder, heart disease/attack, asthma, headache, any chronic pain, and any physical disease. The current systematic review revealed that 15 fibromyalgia studies did not report odds ratio data on the same comorbidities. The association between comorbidities and fibromyalgia remains unconfirmed. Fibromyalgia patients were found to suffer from fatigue (95%), depression/depressiveness (90.9%), anxiety (77.7%), irritable bowel syndrome (62%), and irritable bladder (58%). Chinese medicine literature was reviewed and a draft CMPQ was developed. Chinese medicine pain questionnaire contained 187 questions in the following six domains: pain regions, pain quality, pain rhythm, pain aggravators, pain alleviators, and other accompanying symptoms. These questions were reviewed by a group of CM researchers for face and content validities. The draft CMPQ was subsequently tested amongst CMP who used OM for pain control. The CMPQ was completed by these subjects four times throughout the trial. In total 108 participants were recruited. The participants mostly had seven or more pain sites (55.6%). Many of them had pain in the back regions (41.6% to 78.2%), lower limbs (40.6% to 48.5%), and shoulder (41.60%), and Most of them had sharp pain (58.4%), pain at a fixed location (42.6%), pain all the time (63.4%), and worse pain when first getting up (42.6%). They were often accompanied with: feeling tired easily (69.20%), insomnia (59.40%), limited movement (56.40%), poor concentration (55.40%), poor memory (48.50%), feeling depressed (47.50%), irritable (45.50%), constipation (44.50%), and low libido (41.60%). Chinese medicine pain questionnaire demonstrated good face validity, content validity, test-retest reliability (Correlation coefficient=0.846 for overall questionnaire), and internal consistency (Cronbach’s α=0.931). The CMPQ data gathered throughout the trial was analysed using principal components analysis to extract 36 factors from the five CMPQ domains (except for pain region). Then the extracted factors were clustered using K-means cluster analysis into six clusters. Cluster four (n=48) and cluster five (n=41) had the largest number of participants and they were diagnosed as CM “heat pattern” (cluster four), and “cold with deficiency pattern” (cluster five) respectively by the CM cluster analysis group experts. Of the remaining clusters, only clusters two and six had more than one participant. Multivariate analysis of variance on their demographic data showed cluster four had the shortest mean pain history (10.14 years) whereas cluster six had the longest pain history (24.71 years). The comparison between the two CM patterns showed the CM “heat pattern” was associated with the better quality of life and mild depression whereas the CM “cold with deficiency pattern” was associated with worse quality of life and moderate depression. The baseline and end of treatment weeks CMPQ data were used. The comparison was within individual changes rather than between group changes. It was shown that real EA was the only group without symptom deterioration, sham EA and no EA both had two symptom deteriorations. Sham EA was the group with most symptom improvements (nine symptoms) followed by no EA (four symptoms) and real EA (two symptoms). To identify which pattern responded better to real EA, CM heat pattern and CM “cold with deficiency” pattern were used as they had more participants. This comparison was within individual changes rather than group changes. The heat pattern subgroup reported improvement in one more symptom on CMPQ in response to real EA than the cold with deficiency pattern subgroup. Baseline and end of treatment weeks data of pain intensity, OM consumption, depression, and quality of life of the three treatment groups and the two CM patterns were compared. These were group mean comparisons and not changes within individuals. There were no differences between the three treatment groups, neither was there any difference in how the two CM patterns responded to the three treatments. In conclusion, this project employed an evidence-based medicine approach to identify symptom presentation in CMP patients who use OM for pain control, developed and validated the CMPQ for clinical sub grouping guided by CM theory and diagnosis. Furthermore, a preliminary analysis on potential relationship between CM patterns and clinical outcome was conducted as part of a multicentre RCT on EA for CMP who used OM. The finding of distinct heat and cold with deficiency patterns in CMP indicates the importance of incorporating some form of heat therapy, such as moxibustion, into future acupuncture studies for chronic pain. The main limitation of this thesis is the small sample size during the evaluation of treatment effect of the three treatments and when the real EA group was further sub grouped into the two CM patterns. Further validation of the CMPQ in larger and different study populations is needed to determine the clinical benefit of CM patterns in clinical practice of EA for CMP. In addition, the use of likert scales instead of a dichotomous format to capture subtle changes after intervention is recommended. It is anticipated that a validated CMPQ may enhance the clinical benefit of multidisciplinary approach for the management of CMP. 1. Xue CC, Helme RD, Gibson S, Hogg M, Arnold C, Somogyi AA, et al. Effect of electroacupuncture on opioid consumption in patients with chronic musculoskeletal pain: protocol of a randomised controlled trial. Trials. 2012;13:169. doi: 10.1186/1745-6215-13-169
机译：慢性肌肉骨骼疼痛（CMP）很常见，并与生活质量下降，生产力下降以及对患者和社会的医疗保健支出增加有关。阿片类药物（OMs）越来越多地管理着慢性肌肉骨骼疼痛，产生许多严重的不良反应，而CMP则伴随着合并症和非疼痛症状。合并症增加了健康管理的负担并降低了生活质量。中医（CM）已被用于治疗CMP，并且对CMP有自己的理论和理解。中医根据CMP患者出现的疼痛和非疼痛症状将CMP诊断为CM模式。但是，这种方法尚未通过临床试验评估，无法确定CMP的CM管理中模式识别的价值，特别是对于CMP控制的OM用户而言。为了为进一步研究CMP的CM建立基础，需要确定CMP的CM模式，并评估它们与经验证工具测量的临床结果的差异。本论文的目的是：1）通过系统的综述来确定CMP的合并症和症状。 2）制定和验证中医疼痛调查表（CMPQ），以识别OM用户的CMP患者； 3）通过聚类分析来区分使用OM控制疼痛的CMP的CM模式；并确定人口统计学，疼痛强度，OM消耗，抑郁，生活质量和残疾方面的集群差异；和4）根据CMPQ症状，疼痛强度，OM消耗，抑郁和生活质量的变化，确定CM模式与电针（EA）临床结果之间的差异。方法：进行系统评价。检索了主要的英语数据库，并且仅限于英语和中文出版物。检索中医药文献，提取与中医相关的症状和体征。 CMPQ的开发被嵌入到另一个电针疗法试验中。如果CMP参与者使用OM并希望减少其OM使用量，则招募他们。试验参与者被随机分为真实电针（EA），假EA或无EA组。分析了CMPQ数据的有效性和可靠性。参加者＆rsquo;使用主成分分析和K-均值聚类分析对数据进行分析。方差分析，方差多元分析和卡方检验用于评估聚类，其人口统计学和其他常用结果度量之间的关联。使用Cochran's Q检验评估二分CMPQ症状内的变化。结果：检索了主要的英语数据库进行系统评价，共纳入72项研究，其中61项被分为三大类：慢性脊柱疼痛，关节炎和纤维肌痛。研究结果表明，CMP与合并症，伴随性疼痛或非疼痛症状之间的关联，对于慢性脊柱疼痛和关节炎，但对于纤维肌痛则没有。慢性脊柱疼痛（20项研究）与关节炎，头痛/偏头痛，抑郁症和惊恐发作/疾病，高血压，心脏病，一般性焦虑症，情绪障碍，饮酒障碍和消化性溃疡相关（几率1.33-7.9） 。关节炎（37项研究）与慢性脊髓痛，抑郁症，恐慌症，创伤后应激障碍，心脏病/发作，哮喘，头痛，任何慢性疼痛和任何身体疾病相关（比值比1.48-8.7）。目前的系统评价显示，有15项纤维肌痛研究未报告相同合并症的比值比数据。合并症和纤维肌痛之间的关联仍不确定。发现纤维肌痛患者患有疲劳（95％），抑郁/抑郁（90.9％），焦虑症（77.7％），肠易激综合症（62％）和膀胱易怒（58％）。审查了中药文献并制定了CMPQ草案。中药疼痛调查表包含以下六个领域的187个问题：疼痛区域，疼痛质量，疼痛节律，疼痛加重剂，缓解疼痛剂和其他伴随症状。一组CM研究人员针对面部和内容有效性对这些问题进行了审查。 CMPQ草案随后在使用OM进行疼痛控制的CMP中进行了测试。在整个试验过程中，这些受试者完成了CMPQ四次。总共招募了108名参与者。参与者大多有七个或更多的疼痛部位（55.6％）。他们中的许多人在背部区域（41.6％至78.2％），下肢（40.6％至48.5％）和肩膀（41.60％）有疼痛，并且大多数人有剧烈的疼痛（58.4％），固定痛位置（42.6％），一直疼痛（63.4％）和刚起床时疼痛加剧（42.6％）。他们经常伴有：容易疲劳（69.20％），失眠（59.40％），运动受限（56.40％），注意力不集中（55.40％），记忆力不佳（48.50％），感到沮丧（47.50％），易怒（45.50％），便秘（44.50％）和性欲低下（41.60％）。中药疼痛调查表显示出良好的面部有效性，内容效度，重测信度（总体调查表的相关系数= 0.846）和内部一致性（Cronbach s = 0.931）。使用主成分分析法分析了整个试验期间收集的CMPQ数据，以从五个CMPQ域（疼痛区域除外）中提取36个因素。然后使用K-均值聚类分析将提取的因子聚类为六个聚类。聚类四（n = 48）和聚类五（n = 41）的参与者数量最多，他们被诊断为CM“热型”。 （第四类），以及“冷落有缺陷模式” （第5组）分别由CM聚类分析组专家组成。在其余的集群中，只有集群2和6具有不止一个参与者。对他们的人口统计数据的方差的多变量分析显示，第四组的平均疼痛史最短（10.14年），而第六组的平均疼痛史最长（24.71年）。两种CM模式之间的比较显示CM“热模式”与较高的生活质量和轻度抑郁症相关，而CM“伴有虚弱感的模式”与生活质量下降和中度抑郁有关。使用基线和治疗周CMPQ数据。比较是在单个更改内进行，而不是在组更改之间进行。结果表明，真正的EA是唯一没有症状恶化的人群，假EA和无EA都有两个症状恶化。 Sham EA是症状改善最多的组（九种症状），其次是无EA（四种症状）和真正的EA（两种症状）。为了确定哪种模式对真实EA的响应更好，CM热模式和CM“缺乏”使用模式，因为他们有更多的参与者。这种比较是在单个更改而不是组更改之内。热型亚组报告说，与虚寒型亚组相比，对真实EA的CMPQ症状改善了更多。比较了三个治疗组和两个CM模式的疼痛强度，OM消耗，抑郁和生活质量的基线和治疗周数据。这些是组平均值比较，而不是个体内部的变化。三个治疗组之间没有差异，两种CM模式对三种治疗的反应也没有差异。总之，该项目采用循证医学方法来识别使用OM进行疼痛控制的CMP患者的症状表现，并开发和验证了CMQ在CM理论和诊断的指导下进行临床分组。此外，作为使用OM的CMP的EA多中心RCT的一部分，对CM模式与临床结果之间的潜在关系进行了初步分析。在CMP中发现明显的热和冷和虚寒模式，这表明将某种形式的热疗法（例如艾灸）纳入未来针对慢性疼痛的针灸研究的重要性。本文的主要局限性在于，在评估三种治疗方案的治疗效果时，以及当将真实EA组进一步细分为两种CM模式时，样本量很小。为了确定CM模式在EA的临床实践中对CMP的临床益处，需要在更大和不同的研究人群中进一步验证CMPQ。另外，建议在干预后使用李克特量表代替二分法来捕获细微的变化。可以预期，经过验证的CMPQ可以增强多学科方法在CMP管理方面的临床益处。 1. Xue CC，Helme RD，Gibson S，Hogg M，Arnold C，Somogyi AA等。电针对慢性肌肉骨骼疼痛患者使用阿片类药物的影响：一项随机对照试验的方案。试用。 2012; 13：169。 doi：10.1186 / 1745-6215-13-169

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