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affecting the outcome. More rigorous studies in different settings and examining more varied outcomes are required to provide more generalisable evidence to confirm a positive effect. Osteomyelitis The regime of HBOT reported in the single identified study does not seem to be beneficial to patients diagnosed with osteomyelitis in terms of their length of hospital stay, the treatment successes and the risk of recurrence following therapy. However this regime is atypical in several respects of HBOT regimes used for other indications, calling into question the extent to which the findings may be generalisable. Osteoradionecrosis: prevention A single study provides some evidence that exposure to HBOT is more efficacious than penicillin in the prevention of osteoradionecrosis in this population of patients. The patient sample is representative of the potential target population to which inferences are to be applied. Osteoradionecrosis: treatment One study provides some evidence of the efficacy of HBOT in the treatment of osteoradionecrosis. More evidence from properly randomised clinical trials focussing on other outcomes will be needed to determine the effectiveness of HBOT for this indication. Skin graft survival Exposure to HBOT may well demonstrate a beneficial effect on the survival of split skin grafts and myocutaneous flaps, but the studies identified possess serious flaws that strictly limit their generalisability. Results are difficult to interpret in the light of the failure of the studies to adequately describe their patient populations and comparison interventions, and the limited and poorly-described outcomes they measured. Multiple sclerosis The studies do not consistently demonstrate any beneficial effect of HBOT on clinical outcomes of multiple sclerosis. There is little evidence to support the use of HBOT for this indication at this time. Cardiovascular disease conditions: acute myocardial infarction There is no firm evidence to support the use of HBOT for acute myocardial infarction. The studies that examine this issue either do not find beneficial effects on major endpoints or suffer from flaws in design. There is some indication that HBOT used in conjunction with thrombolytic therapy may be beneficial in pain relief although more studies are needed to arrive at a firm and generalisable conclusion. Cardiovascular disease conditions: cerebrovascular disease The collected evidence examines only a small number of clinical outcomes. In these endpoints, the effectiveness of exposure to HBO is conflicting. There is evidence of small improvements in functional status, but these are seen a year after therapy is initiated. Whether these changes are scale-independent is questionable. Of potential concern is the xii <strong>Hyperbaric</strong> oxygen therapy
evidence that exposure to HBO may be no better than placebo or sham therapy. The review concluded that no firm and generalisable evidence is available to support the use of HBOT for cerebrovascular disease at this time. Cardiovascular disease conditions: peripheral obstructive arterial disease A single, small trial provides little evidence of benefit. Some of the methodology used during the trial and the conclusions drawn from it are cause for concern. The study provided no evidence of the efficacy of HBOT for peripheral obstructive arterial disease. Soft tissue injuries: acute ankle sprains A single study provided no evidence to support the use of HBOT for acute ankle sprains. Soft tissue injuries: crush injuries A single study found that exposure to HBOT benefited patients with crush injuries of the lower limbs, although this benefit was mainly reported in terms of decreasing surgical interventions rather than decreased healing time. Studies examining a broader range of outcomes in larger populations are required to generate firmer and more generalisable conclusions. Cluster headaches There is some evidence of a beneficial effect on pain relief and physiochemical outcomes in patients with some forms of cluster headache exposed to HBOT. Concerns about the methodology of the studies and their quality strictly limit their usefulness. These concerns included small sample sizes, inadequate masking, and inability to control for temporal or measurement bias. The Hawthorne effect, in which responses by participants are affected because they know they are being studied, is also an important consideration. Only one of the studies measured clinically relevant outcomes. More rigorous studies in different settings and examining more varied outcomes in bigger groups of patients are required to provide firmer and more generalisable evidence of effect. At this time, the evidence found is insufficient to support the use of HBOT in cluster headaches. Migraine headaches Exposure to HBO seems to provide pain relief for migraine headaches. However, more studies in different settings and examining more varied outcomes in larger groups of patients are required to provide further conclusive evidence of a firm and generalisable effect. Facial paralysis A single report provided some evidence of the benefit of exposure to HBO for subjects with moderate to severe forms of facial paralysis of less than one week duration. Replication of this study to other settings and an examination of other outcomes are required to come to firm and generalisable conclusions. Sudden deafness and acoustic trauma The studies provided conflicting evidence of the efficacy of HBOT in the management of sudden deafness and acoustic trauma. Problems with methodology were common in <strong>Hyperbaric</strong> oxygen therapy xiii
Page 1 and 2: Hyperbaric Oxygen Therapy November
Page 3 and 4: Contents Executive summary.........
Page 5 and 6: Tables Table 1 Measures of disease
Page 7 and 8: Table 45 Functional neurologic scor
Page 9 and 10: Figures Figure 1. Outline of search
Page 11: Effectiveness Published guidelines
Page 15 and 16: No available evidence No evidence w
Page 17 and 18: Introduction The Medicare Services
Page 19 and 20: Multiplace chambers can accommodate
Page 21 and 22: Marketing status of the device The
Page 23 and 24: Table 3 1998 - 1999 self-reported d
Page 25 and 26: Table 6 retrieval. Indication-speci
Page 27 and 28: Phase of Search Initial Search Ful
Page 29 and 30: Conduct of meta-analysis When the d
Page 31 and 32: early as 1995. The guidelines - kno
Page 33 and 34: Table 10 Minimum staff qualificatio
Page 35 and 36: Is it effective? The review assesse
Page 37 and 38: Table 14 Patient criteria of includ
Page 39 and 40: offered ample details. The remainin
Page 41 and 42: characteristics compared to the tre
Page 43 and 44: Assessment of heterogeneity All the
Page 45 and 46: Odds ratio 10 1 0.1 0.01 A sensitiv
Page 47 and 48: Wound healing Two of the five ident
Page 49 and 50: Studies of necrotising soft tissue
Page 51 and 52: Summary Table 25 Survival in patien
Page 53 and 54: Table 29 Therapeutic protocols used
Page 55 and 56: Osteomyelitis The study by Esterhai
Page 57 and 58: Summary The HBO group showed a stat
Page 59 and 60: Summary These results are difficult
Page 61 and 62: outcomes or that decreased the risk
Page 63 and 64:
Anderson et al 80 recruited non-pre
Page 65 and 66:
Summary The collected evidence exam
Page 67 and 68:
Table 46 Major outcomes following t
Page 69 and 70:
Table 50 Therapeutic protocols used
Page 71 and 72:
Table 53 Patient criteria of includ
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Thirty-seven subjects (comparison g
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whose hearing loss was not secondar
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tinnitus (6 versus 3 subjects). Non
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assume that all participants knew o
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Page 83 and 84:
Table 65 Descriptive characteristic
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Page 87 and 88:
These contrasted with the conclusio
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Table 73 Patient criteria of includ
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Summary There are conflicting resul
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Summary separate and previously-stu
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need to insulate patients from outs
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Reactive effects A reactive effect
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Cost of major amputation The hospit
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Sensitivity analysis Table 79 shows
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Table 80 Estimation of incremental
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Sensitivity analysis Table 83 shows
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Conclusions Safety Potential risks
Page 109 and 110:
Recommendations MSAC recommended th
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Appendix B Supporting committee Sup
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Appendix C Studies included in this
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Necrotising soft tissue infections:
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Soft tissue injuries: crush injurie
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Cancer: cervix First Author and Yea
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Appendix D Studies excluded in this
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2. Shandling AH, Ellestad MH, Hart
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5. Woo TCS, Joseph D, Oxer H. Hyper
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22. Kunkler PB, Boulis-Wassif S, Sh
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45. Wiernik G, Perrins D. The radio
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Appendix E Calculation of monoplace
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Hence, the total operating costs of
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Appendix G Reviews received from ot
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Sechrist Industries -- Hyperbaric O
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References 1. Hampson N. Hyperbaric
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31. L'Abbe K, Detsky A, O'Rourke K.
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61. Perrins DJ. Influence of hyperb
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89. DiSabato F, Giacovazzo M, Crist
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117.Plenk HP. Hyperbaric radiation
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