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KCE Reports 74 Hyperbaric Oxygenation Therapy 43
The original publication, 93 which was mentioned in the references of this article as being
submitted to a German journal, was not found in any database. Another document of
Rychlik could be obtained. 94 The input values of this non-peer reviewed document
contained contradictions. For example, the control group consisted of 33 patients, of
which 22, 12 and 11 patients had no, minor or major amputations, respectively. Another
document 95 using data from Rychlik was also excluded. It was assessed as not being a
good economic evaluation with reliable input parameters. Finally, the book chapter of
Persels 90 was not an economic evaluation comparing both costs and effectiveness of
HBOT and alternative treatment.
The study of Mulla et al. 96 applying a regression method to determine the predictors of
length of stay and total patient charges for necrotizing fasciitis was not taken into
account. In this analysis HBOT was not associated with increased costs, nor with an
improvement in survival. As acknowledged by the authors, however, these results were
difficult to interpret due to the small number of patients who received HBOT (n = 19)
and the small number of deaths overall.
The economic evaluations included in our overview are arranged according to
indication. In this part, we provide a short description of the study, results and
conclusions of the authors. Details are provided as far as the raw data are mentioned in
the studies. As a result, more or less detailed data will be provided for each study. In a
following part, we will discuss the economic analyses.
4.3.1 Diabetic foot ulcers
4.3.1.1 Abidia et al. 80
The UK study of Abidia et al. (2003) described a double-blind RCT including a limited
cost comparison for HBOT versus no HBOT in the treatment of diabetic patients with
ischemic, non-healing lower extremity ulcers. Eighteen diabetic patients were recruited
of which two patients withdrew during the course of the study (one in the control
group required urgent vascular intervention and one in the treatment group dropped
out for personal reasons). All patients, their carers and medical assessors were blinded
to the treatment.
Patients were randomly assigned either to receive 100% oxygen (treatment group) or
air (control group), at 2.4 ATA for 90 minutes daily for a total of 30 treatments. Wound
care was standardised for all patients (including offloading, aggressive debridement and
dressing, and antibiotic therapy if there were clinical signs of infection).
The mean total cost of visits for ulcer dressing (£58 per outpatient hospital visit) per
patient in the control group was compared with the respective cost in the treatment
group in addition to the cost of HBOT (£100 for each session) per patient and the cost
of dealing with any complications arising from the treatment.
Patients were assessed at baseline, after 15 and after 30 treatments, and 6 weeks later.
Two more follow-up visits were performed at 6 months and 1 year. Quality of life
(QoL) was measured using the generic form SF-36 and Hospital Anxiety and Depression
scale (HAD scale). The follow-up was discontinued after 1 year because the authors felt
that any difference observed between the two groups beyond one year could not be
confidently attributed to HBOT and was more likely to be due to natural progression of
peripheral arterial disease. 80
Outcomes of this study are shown in Table 7. At 1 year follow up, complete healing was
achieved in five out of eight ulcers in the treatment group compared with none out of
eight ulcers in the control group (p=0.026). Furthermore, the median decrease of the
wound areas was 100% in the treatment group at six weeks follow up compared with
52% in the control group (p=0.027). However, values at 6-month follow-up were 100
and 95% respectively. This study did not show any significant differences in major or
minor amputation rates between the two groups.