Bennett Michael H
Corresponding author: University of New South Wales, Sydney, Australia.
Diving Hyperb Med. 2018 Jun 30;48(2):115. doi: 10.28920/dhm48.2.115.
This report is a product of the VA Evidence-based Synthesis Program. The purpose is to provide "timely and accurate syntheses of targeted healthcare topics …. to improve the health and healthcare of Veterans". The authors have made a comprehensive search and analysis of the literature and make recommendations to assist clinicians in dealing with veterans suffering from either traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD). The report is timely and of great potential impact given the vigorous and lengthy debate among hyperbaric physicians and lay people determined to find an answer for the large numbers of veterans deeply affected with some combination of PTSD and post-concussion dysfunction. The authors lament the evidence on using hyperbaric oxygen treatment (HBOT) for TBI/PTSD has been "controversial, widely debated, and potentially confusing." Unfortunately, this report will not improve that situation. The report is as much a political document as it is evidence-based. That politics are involved is apparent from the outset with the statement "The ESP Coordinating Center is responding to a request from the Center for Compassionate Innovation (CCI)…" The report fails to further illuminate the situation than the many thousands of words already spent on summarising the evidence. Let me save you some time and get to the quick of this report. The authors (rightly) highlight the fact that uncontrolled case series and a randomised, controlled trial (RCT) without blinding or a sham control all suggest HBOT may be of benefit for these Veterans. Somewhat disappointingly, well-controlled, blinded RCTs using a sham exposure to 1.2 or 1.3 ATA breathing air fail to confirm any such benefit. While the conventional interpretation of these data is that there is no reliable evidence of an effect of HBOT, proponents have responded by postulating these control exposures are not 'sham' because they are clinically active. Any putative mechanism remains unknown and unproven outside the context of this clinical area. These exposures just happen to be about equipotent with true HBOT. With this accurate summary, the authors conclude that any effect of HBOT is as yet unclear. They suggest that in Veterans who have not responded to other therapeutic options, the use of HBOT is "reasonable". This conclusion allows for a similar recommendation for any unproven therapeutic option where there is no clearly effective treatment available and is, to this reviewer, unacceptable. While any putative mechanism for low-pressure air exposure owes more to magical thinking than physics, physiology or therapeutics, this is an argument the authors of this report seem to have accepted at some level. The proponents of HBOT have an obligation to both show the greater effectiveness of HBOT than a functional sham and to demonstrate a plausible mechanism. Until then, the strongest recommendation that should be made is that the 'sham' therapy can be used until the case is proven. It is not clear why the proponents of HBOT do not advocate this, given the 'efficacy' seems roughly equal with HBOT. Logic determines one cannot prove a negative. This reviewer agrees it is not possible to definitively prove trivial pressure exposures breathing air may have a comparable effectiveness in treating TBI/PTSD as true HBOT. Using the principle of Occam's razor it seems far more likely any apparent effectiveness is the result of a participation effect in both groups. In my view, the authors of this report have taken an easy option in allowing that HBOT use is reasonable. The tragedy is potentially the waste of time, money and hope this may bring to the very Veterans the authors are charged to serve. I have discussed this issue in more detail previously in the pages of this journal.
本报告是美国退伍军人事务部循证合成项目的成果。其目的是“及时、准确地综合特定医疗保健主题……以改善退伍军人的健康状况和医疗服务”。作者对文献进行了全面检索和分析,并提出建议,以帮助临床医生应对患有创伤性脑损伤(TBI)或创伤后应激障碍(PTSD)的退伍军人。鉴于高压氧治疗医生和普通民众之间进行了激烈而漫长的辩论,决心为大量深受PTSD和脑震荡后功能障碍综合影响的退伍军人找到答案,这份报告很及时,且具有很大的潜在影响力。作者们感叹,关于使用高压氧治疗(HBOT)来治疗TBI/PTSD的证据一直“存在争议,广泛辩论,且可能令人困惑”。不幸的是,这份报告并不会改善这种情况。该报告既是一份基于证据的文件,也是一份政治文件。从一开始的声明“循证合成项目协调中心正在回应同情创新中心(CCI)的请求……”就可以明显看出其中涉及政治因素。该报告未能比已经花费数千字总结证据的情况更深入地阐明现状。让我为你节省一些时间,直接说这份报告的要点。作者(正确地)强调了这样一个事实,即非对照病例系列以及一项没有设盲或假对照的随机对照试验(RCT)都表明HBOT可能对这些退伍军人有益。有点令人失望的是,使用模拟暴露于1.2或1.3ATA呼吸空气的严格对照、设盲的RCT未能证实有任何此类益处。虽然对这些数据的传统解释是没有可靠证据表明HBOT有效果,但支持者回应称,假设这些对照暴露不是“假的”,因为它们在临床上是有效的。在这个临床领域之外,任何假定的机制仍然未知且未经证实。这些暴露恰好与真正的HBOT效果相当。基于这个准确的总结,作者得出结论,HBOT的任何效果目前尚不清楚。他们建议,对于那些对其他治疗选择没有反应的退伍军人,使用HBOT是“合理的”。这个结论对于任何没有经过证实的治疗选择来说都是一样的,即在没有明确有效治疗方法可用的情况下,这一建议是可以的,但对这位评论者来说是不可接受的。虽然任何关于低压空气暴露的假定机制更多是基于神奇的想法,而非物理、生理或治疗学,但这似乎是该报告的作者在某种程度上已经接受的观点。HBOT的支持者有义务既要证明HBOT比功能性假治疗更有效,又要证明一个合理的机制。在此之前,应该提出的最有力建议是,在证明情况之前可以使用“假”治疗。鉴于“假”治疗的“效果”似乎与HBOT大致相同,不清楚为什么HBOT的支持者不提倡这样做。逻辑表明,人们无法证明一个否定的情况。这位评论者同意,确实不可能明确证明呼吸空气的轻微压力暴露在治疗TBI/PTSD方面可能与真正的HBOT具有同等效果。根据奥卡姆剃刀原理,任何明显的效果似乎更有可能是两组中参与效应的结果。在我看来,这份报告的作者选择了一个轻松的选项,即允许使用HBOT是合理的。悲剧在于,这可能会浪费时间、金钱和希望,而这些正是作者们受命为之服务的退伍军人所拥有的。我之前在本杂志的页面上更详细地讨论过这个问题。