Laboratory for Advances in Consciousness and Health, Department of Psychology, University of Arizona, Tucson, USA.
Explore (NY). 2011 May-Jun;7(3):148-54. doi: 10.1016/j.explore.2011.02.004.
A clinical trial reported in JAMA (Shay et al, 1998), involving acupuncture and amitriptyline in HIV-infected patients, concluded that there was no effect for either acupuncture or amitriptyline on neuropathic pain. However, a recent reassessment of this study showed that there were really three different and independent clinical trials, each with a different research design, which had been combined into a single database and consequently analyzed with a relatively insensitive statistics. When only the first substudy, factorially crossed design involving acupuncture and amitriptyline, was reanalyzed by itself using more powerful statistics, it was found that acupuncture and amitriptyline both worked independently to reduce pain, but also that acupuncture worked best in the absence of amitriptyline, and that there may have been adverse events associated with the combination of the two treatments. The present study reports the reanalysis of the second of the original independent studies involving only acupuncture and sham acupuncture, to determine whether the results confirm acupuncture-related findings from the first substudy.
Subjects were 114 HIV-infected men with pain associated with peripheral neuropathy in the early 1990s, when antiretroviral drug cocktails were just beginning to be available in experimental form.
The second of the independent studies in the original report by Shlay et al involved a single factor with two levels: a 14-week standardized acupuncture regimen and its control (off-point sham acupuncture). In addition, physical functioning at baseline (high or low, based on the Karnofsky scale), was factorially crossed with the acupuncture factor in our analyses. Primary data were reanalyzed using repeated-measures ANCOVA in an intention-to-treat procedure, and categorical data were analyzed by the Pearson chi-square test.
Pain intensity, pain relief, mortality, and attrition.
Whereas the results were inconclusive for the pain measures, acupuncture had a strong and positive effect on attrition and mortality. These results were most pronounced among patients with poorest physical functioning at the beginning of the study. Overall, acupuncture was associated with lower attrition rate (27.6% vs. 44.6%, P = .058), and a zero mortality rate (0% vs. 12.5%, P = .047). This protective effect of acupuncture was visible primarily in subjects in poorer health (0% vs. 23.8%, P = .047).
Acupuncture was clearly effective in reducing attrition and mortality in this sample, especially when health status was taken into account, but results for pain relief were mixed. These results add further evidence that the use of the most sensitive statistics available increases the chance of detecting actual effects due to acupuncture (and other treatments as well). Moreover, these results replicated most of the findings that did not involve the presence of amitriptyline from the initial independent study in this research project. The combined results of these two studies strongly support the importance of recognizing that interactions involving acupuncture and other treatments, may positively as well as negatively modify main effect results in clinical trials, and thus must be recognized and systematically explored. Findings are discussed in terms of their implications for moving toward a whole-systems approach to biomedical research.
在《美国医学会杂志》（JAMA）上发表的一项临床试验报告（Shay 等人，1998 年）涉及接受艾滋病病毒感染的患者的针灸和阿米替林，该报告得出的结论是，针灸或阿米替林对神经病理性疼痛均无影响。然而，最近对这项研究的重新评估表明，实际上有三个不同的、独立的临床试验，每个试验都有不同的研究设计，这些试验被合并到一个单一的数据库中，随后用相对不敏感的统计学方法进行了分析。当仅重新分析第一个亚研究（涉及针灸和阿米替林的析因交叉设计）本身，使用更强大的统计学方法时，发现针灸和阿米替林都可以独立地减轻疼痛，但针灸在没有阿米替林的情况下效果最佳，并且两种治疗方法的联合可能存在不良事件。本研究报告了第二个原始独立研究的重新分析，该研究仅涉及针灸和假针灸，以确定结果是否证实了第一个亚研究中的与针灸相关的发现。
研究对象是 1990 年代初期患有与周围神经病变相关疼痛的 114 名艾滋病病毒感染者，当时抗逆转录病毒药物鸡尾酒疗法刚刚开始以实验形式出现。
Shlay 等人的原始报告中的第二个独立研究涉及一个具有两个水平的单一因素：为期 14 周的标准化针灸方案及其对照（非穴位假针灸）。此外，我们的分析中，基线时的身体功能（根据 Karnofsky 量表分为高或低）与针灸因素析因交叉。主要数据采用意向治疗程序的重复测量方差分析进行重新分析，分类数据采用 Pearson 卡方检验进行分析。
疼痛强度、疼痛缓解、死亡率和失访率。
尽管疼痛测量结果不确定，但针灸对失访率和死亡率有强烈的积极影响。这些结果在研究开始时身体功能最差的患者中最为明显。总体而言，针灸与较低的失访率（27.6%比 44.6%，P=.058）和零死亡率（0%比 12.5%，P=.047）相关。这种针灸的保护作用主要在健康状况较差的患者中可见（0%比 23.8%，P=.047）。
在这个样本中，针灸明显有效降低了失访率和死亡率，尤其是当考虑到健康状况时，但对疼痛缓解的结果则喜忧参半。这些结果进一步证明，使用最敏感的可用统计数据增加了检测实际针灸效果的机会（以及其他治疗方法）。此外，这些结果复制了该研究项目中最初的独立研究中没有涉及阿米替林的大多数发现。这两项研究的综合结果强烈支持这样一种观点，即涉及针灸和其他治疗方法的相互作用可能会对临床试验中的主要效应结果产生积极和消极的影响，因此必须得到承认，并进行系统的探索。研究结果根据其对迈向生物医学研究整体系统方法的意义进行了讨论。
