从英国腰痛治疗指南草案谈循证

Evidence is in the eye of the beholder: The case of the 2016 draft NICE guidelines for low back pain

众说纷纭论循证： 从2016年英国国家健康和临床研究所腰痛治疗指南草案谈起

As the paradigm of evidence-based medicine reaches its adolescence, it is appropriate to acknowledge how the systematic surveying of evidence on a particular clinical topic has constituted a positive advancement in healthcare decision making. But for all the benefits rigorous review methods have to offer, we must remember that no matter how many controls we have in place to minimise bias from the process, ultimately the appraisaland synthesis of research remains a purely human endeavour and with that comes interpretation consistent with a particular, subjective world-view.尽管循证医学方法严格，干预众多，以期最大限度地降低试验过程中产生的偏倚，但毋庸置疑的是，对研究的综合评价由人为完成，这便注定了其结果是主观意识的产物，终将只能与特定的世界观相吻合。

The recent publication of the UK’s National Institute for Health and Care Excellence (NICE) new draft guidelines for the management and treatment of low back pain and sciatica offers a prime example (https://www.nice.org.uk/). Unlike the 2009 guideline which recommended a course of acupuncture, the updated draft, published inMarch 2016, recommended against acupuncture.This is not remarkable in itself:the evidence base is continually changing, which is why guidelines are andshould be routinely updated. 新近出版的由英国国家健康和临床研究所制定的腰痛和坐骨神经痛治疗指南草案恰为上述观点提供了范例。2009年，英国在指南中推荐使用针刺进行治疗，2016颁布的指南中则不再进行推荐。这本身并无可厚非，所循之证有所变化，指南理应随之不断更新。However, Lai suggests that this is not the issue here (page —). In terms of simple pain reduction, compared to usual care,acupuncture’s benefits were found to be above the threshold for clinical relevance (defined as a visual analogue scale difference greater than one, on ascale 1 to10). 但Lai指出这并非问题的关键。单从镇痛而言，针刺的疗效远高于常规疗法，其镇痛范围甚则远超临床所制定的从一至十的阈值。The guideline development committee, before recommending againstits inclusion in the guidelines, acknowledged that compared to usual care,acupuncture demonstrated “clinically important benefits” in pain reduction,improved function and increased quality of life.The same cannot be said of some treatments that were recommended, such as massage therapy or self-management. For cost-effectiveness too, acupuncture (￡3598 per QALY) compared favourably to other interventions. Why then did NICE decide not to recommendit? 指南发展协会在提出反对意见之前，承认相对于常规疗法而言，针灸在缓解疼痛，改善功能，提高生活质量等方面具有非常高的临床效应，远非指南所推荐的按摩或者自我调节等方法可比拟。甚至包括治疗费用在内，针灸也远比其他介入疗法实惠。那么究竟为何英国国家健康和临床研究所不再推荐使用针灸进行治疗了呢？

The guideline development group (GDG),following the NICE precedent with osteoarthritis, decided to base it sacupuncture recommendation on performance over sham before considering its effectiveness compared to usual care 指南发展小组遵循英国国家健康和临床研究所制定骨关节炎治疗指南的先例，重点考虑针刺 与假针的疗效比较，暂不涉及常规疗法。page —. This stipulation, set out at the beginning of the recommendations section in the draft guideline, was not an explicit requirement for any other of the 11 non-invasive interventions. For all of these interventions placebo/sham/attention controls, usual care/waiting list and any other treatment were all designated as allowable comparators. Only for manual therapies was there any other explicit indication of possible preference amongst comparators, where it was noted that the complex nature of the intervention and difficulties with blinding have prompted researchers to opt for pragmatic trials. 手法治疗试验本身的复杂性以及设置盲法的困难性迫使许多研究员转战现况性试验.。And here in lies one of the key issues: acupuncture too exhibits these characteristics but nevertheless a substantial amount of its RCT evidence comes from sham controlled trials.最关键的一个问题就是针刺同样具有以上提及的特点，并且很大一部分RCT试验都是以假针作为对照组。 Is this sufficient reason for the GDG to have followed this unique approach for acupuncture? As Lai points out,such a decision requires at least a proper explanation, if not a prior statement of intent (page —). Merely to cite the osteoarthritis guideline asprecedent is insufficient, for its latest version did not update most of theinterventions (page —).

The rejection of acupuncture in the draft guidelines has been contentious, for it turns on the interpretation, ratherthan the existence, of scientific evidence. 指南草案对针刺疗法的反对备受争议，因为它着眼如何对所循之证进行解释，而非证据本身。Lai commented on the preponderanceof hospital-based medical professionals in the GDG. We might also look to the absence of acupuncture and acupuncture research expertise as a critical factorin the interpretive route followed. Hence the requirements for the acupunctureprofession may be more about developing a pool of researchers and researchleaders, and working with NICE to ensure that their voices are heard, ratherthan just producing more evidence.