BackgroundHyperbaric oxygen therapy, which consists of breathing 100% oxygen under a
higher atmospheric pressure than normal, is utilized worldwide in the
treatment of several diseases. With the growing demand for evidence-based
research, hyperbaric oxygen therapy has been criticized for delivering too
little high-quality research, mainly in the form of randomized controlled
trials. While not always indispensable, the addition of a sham-controlled
group to such a trial can contribute to the quality of the research.
However, the design of a sham (hyperbaric) treatment is associated with
several considerations regarding adequate blinding and the use of pressure
and oxygen. This narrative review discusses information on the sham profile
and the blinding and safety of double-blind trials in hyperbaric medicine,
irrespective of the indication for treatment.MethodsMEDLINE, Embase and CENTRAL were searched for sham-controlled trials on
hyperbaric oxygen therapy. The control treatment was considered sham if
patients were blinded to their allocation and treatment took place in a
hyperbaric chamber, with no restrictions regarding pressurization, oxygen
levels or indication. Studies involving children or only one session of
hyperbaric oxygen were excluded. Information on (the choice of) treatment
profile, blinding measures, patient’s perception regarding allocation and
safety issues was extracted from eligible studies.ResultsA total of 42 eligible trials were included. The main strategies for sham
treatment were (1) use of a lower pressure than that of the hyperbaric
oxygen group, while breathing 21% oxygen; (2) use of the same pressure as
the hyperbaric oxygen group, while breathing an adjusted percentage of
oxygen; and (3) use of the same pressure as the hyperbaric oxygen group,
while breathing 21% oxygen. The advantages and disadvantages of each
strategy are discussed using the information provided by the trials.ConclusionBased on this review, using a lower pressure than the hyperbaric oxygen group
while breathing 21% oxygen best matches the inertness of the placebo.
Although studies show that use of a lower pressure does allow adequate
blinding, this is associated with more practical issues than with the other
strategies. The choice of which sham profile to use requires careful
consideration; moreover, to ensure proper performance, a clear and detailed
protocol is also required.