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12 Hyperbaric Oxygenation Therapy KCE Reports 74 In 1997 a review reported 35 incidents resulting in 77 human fatalities over almost 70 years of HBOT use, and also in 1997 a fire in a multiplace hyperbaric chamber in Milan caused the death of 10 patients and a nurse, apparently due to a malfunctioning fire suppression system. 1, 15 Again, prevention strategies are of utmost importance, especially when choosing and maintaining the equipment. Key points • Hyperbaric therapy is a treatment, in which patients breathe pure oxygen (or sometimes other gas mixtures) intermittently while inside a treatment chamber at a pressure higher than sea level pressure. • Hyperbaric therapy originated from the treatment of decompression illness over a hundred years ago. • During the last fifty years, several other indications for hyperbaric therapy have been proposed. • A restricted number of indications have been accepted by the two main scientific hyperbaric societies. • When applied under optimal circumstances, hyperbaric therapy is generally safe.
KCE Reports 74 Hyperbaric Oxygenation Therapy 13 3 EVIDENCE FOR CLINICAL EFFECTIVENESS 3.1 INTRODUCTION Since the late nineteen-fifties HBOT has been increasingly used for indications other than decompression illness (DCI). 1, 2, 7 For most of these indications, serious evidence is at best scarce. Part of this lack of evidence is explained by the hyperbaric community as due to the fact that randomised controlled trials are more difficult to conduct for HBOT indications since these conditions are too complex to allow for easy randomisation, or by the fact that these conditions are sometimes so life threatening that inclusion of the patient in a properly randomised controlled trial (RCT) would be considered unethical. 9 Another problem encountered while designing RCTs is the difficulty of blinding to therapy allocation, which can be achieved by either administering pure oxygen in a hyperbaric chamber without raising the pressure for control patients, as done for example in a CO intoxication trial by Weaver et al. 16 or by placing intervention and control patients in the same hyperbaric chamber, raising the pressure but administering different mixtures of gasses. 17, 18 Finally, since many of those trials are relatively small, there is an important risk for selection bias with negative or inconclusive trials less likely to be reported in peer reviewed publications. As a result of those difficulties, many of the current recommendations on ‘accepted’ indications have been obtained by the hyperbaric medical societies through a method of consensus, rather than through evidence based decision making. The evidence considered by those societies is sometimes based on RCTs, but often consists of a combination of in vivo or in vitro studies, animal studies, observational clinical studies and personal experience, while the stated requirement is that the evidence submitted should be ‘at least as convincing as that for any other currently accepted treatment modality for that disorder’. 8 In 2004 the European Committee for Hyperbaric Medicine (ECHM) organised its 7 th European Consensus Conference on Hyperbaric Medicine in Lille (France), to make recommendations on which indication to endorse. 9 The ECHM based this consensus on a mixture of two grading scales, taking into account both the type of recommendation and the evidence supporting this recommendation, as shown in Table 3. It should be noted that for none of the accepted indications level A evidence was available, and many accepted indications were supported on the basis of level C evidence only. Table 3. Type of recommendation and supporting evidence used in ECHM consensus conference Type of recommendation Type 1 Strongly recommended Type 2 Recommended Type 3 Optional Evidence from human studies supporting recommendation Level A Strong evidence of beneficial action based on at least two concordant, large, double-blind, RCT with no or only weak methodological bias) Level B Evidence of beneficial action based on double-blind controlled, randomised studies but with methodological bias, or concerning only small samples, or only a single study Level C Weak evidence of beneficial action based only on expert consensus or uncontrolled studies (historic control group, cohort study, etc.) Source: ECHM. 9 The structure of this chapter is mainly based on the indications that were accepted by this European consensus conference, 9 but other indications have been added when sufficient evidence is available for an assessment. For each of these indications we will summarise the available evidence.
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KCE reports 33 Effects and costs of
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