下腰背部疼痛的针刺随机对照试验的临床定性评估

背景：很多随机对照试验和系统综述得出了针刺对下腰背部疼痛无效的结论并且认为针刺和安慰性针刺对于下腰背部疼痛的治疗疗效并没有区别。目的：本研究是从临床的角度，特别是从专业针灸医师的角度来评估近年来发表的有关针刺治疗下腰背部疼痛的随机对照试验和系统综述的价值。数据来源和搜集：对Cochrane图书馆、PubMed／MEDLINE、EMBASE进行检索，检索的时间范围是从2007年1月至2010年1月。本研究共纳入18个用英语写作的关于针刺治疗下腰背部疼痛或者针刺作为治疗手段之一的随机对照试验。评估方法：临床定性批评性价值评估是本文的研究特点。运用临床基本技能和知识以及统计学概念，建立5个价值评估标准对被纳入的随机对照试验和系统综述的质量和可靠性进行价值评估。这种评估方法与随机对照试验中的纳入和排除标准评估很相似。通过使用这种评估方法，尽管随机对照试验和系统综述有较完善的内部有效性，它们之中的不足之处、局限性和错误就会暴露出来。结果：下腰背部疼痛的研究使用了很多种定义。纳入的18个研究中，16个（80％）随机对照试验中没有使用医学诊断；所有的随机对照试验没有使用客观的测量方法去判断研究的结果。由于使用了多种治疗方法或多个治疗师参与治疗，使这些随机对照试验产生了很大的变异；10个（55％）试验运用了针刺联合其他治疗的方法，其中6个（33％）试验使用了非甾体抗炎药或镇痛剂。由于没有使用医学诊断，所有的试验的外部有效性均不可靠。所有这些被纳入的随机对照试验和系统综述都没有使用logistic回归的方法去解决研究中的异质性问题。结论：所有被纳入的随机对照试验在应用本研究设定的价值评估标准衡量时，都不能完全符合这些标准。这些随机对照试验的主要问题在于没有正确的医学诊断和没有客观的测量方法去判断治疗效果，导致了纳入及排除标准制定的不正确，配对的不恰当和数据进入统计分析前记录的不精确。由于治疗效果测量的主观性，随机对照试验和以随机对照试验为基础的系统综述就出现了过于泛化或是含有交叉结论的偏倚估算。此外，在治疗过程中产生的众多变量是很难控制和估算的，这种不确定因素影响了随机对照试验结论的可靠性。基于上述原因，在将来的随机对照试验和系统综述中应该考虑在随机分配之前建立一个恰当的医学诊断和设立一个与临床相关的客观的结局测量方法。

Clinical critical qualitative evaluation of the selected randomized controlled trials in current acupuncture researches for low back pain

Background: Many randomized controlled trials (RCTs) and reviews concluded that acupuncture is not an effective treatment for low back pain (LBP) and there is no difference between real acupuncture and sham acupuncture in the treatment of LBP.Objective: This study aims to evaluate the most recently published RCTs and reviews from the clinical protocol, which is used by professional acupuncturists.Data sources and synthesis: English-language studies were identified through searches of The Cochrane Library,PubMed/MEDLINE and EMBASE, limited to those published between January 2007 and January 2010.Eighteen trials studying conditions related to LBP conditions treated by acupuncture or acupuncture as one of the co-interventions were eligible.Study appraisal methods: A critical clinical qualitative evaluation is the core methodology of this study. The study design employs daily used clinical skills and knowledge with supplementary statistical concepts to evaluate the quality and reliability of the selected RCTs and reviews. Five evaluation criteria were established for the assessment of the selected RCTs and reviews. By implementing the evaluation criteria, which are similar to the inclusion and exclusion criteria used in RCTs, the weaknesses, limitations or errors of RCTs and reviews can be identified, despite the strength of internal validity produced by statistical calculations.Results: Various terms are used when describing LBP conditions. However, 16 RCTs or 88% of the trials did not establish a medical diagnosis. No trials had objective measurements as a clinical standard for assessing outcomes. Furthermore, significant variation existed due to the numerous treatment methods or therapists used in the RCTs included in the study. Various co-interventions were used in 10 or 55% of the trials, among them, 6 or 33% of the trials used non-steroidal anti-inflammatory drugs (NSAID) or analgesics. Due to the lack of diagnostic status, the accuracy of the external validity was put into question. No logistic regression models were used in any of the selected RCTs and reviews to resolve the degree of heterogeneity.Conclusion: All selected RCTs either partially met the evaluation criteria or did not fulfill the evaluation criteria while being compared. The major problem existing in all RCTs was the lack of accurate medical diagnosis and a lack of objective measurements to judge the clinical outcomes, which in turn, created incorrect eligibility criteria, improper matches and inaccuracies in data recording before entry into statistical calculations. As a consequence of the subjective nature of measurements, conclusions of RCTs and RCT-based reviews were biased due to overgeneralized or cross-generalized estimations, which infer that alternative explanations cannot be excluded. In addition, the range of variables created in the treatment procedure was difficult to control or estimate, in turn, threatening the reliability of RCTs' estimations. For these reasons, creating appropriate diagnostic criteria before randomization and constructing a related objective outcome measurement, which are more relevant to clinical practice, should be considered in future RCTs and systematic review studies.