The benefit of hyperbaric oxygen therapy for burns is not proven

It is currently not proven that patients with burns experience improved wound healing, fewer severe infections or less pain if they receive hyperbaric oxygen therapy (HBOT) in addition to conventional treatment. Even though HBOT has been used in some clinical centres for several decades in patients with burns, no relevant studies are available so far. Therefore, the potential benefits or harms of HBOT cannot currently be assessed with any reliability. This is the result of the final report of the German Institute for Quality and Efficiency in Health Care (IQWiG), published on 5 November 2007. The German Federal Joint Committee (G-BA) commissioned IQWiG to assess the benefits and harms of HBOT as an add-on therapy compared with conventional therapy alone. IQWiG was also asked to assess various types of add-on HBOT compared with each other.

Additional oxygen aims to prevent tissue necrosis

In HBOT, the patient, who is in a pressure chamber, inhales pure oxygen through a mask or a head tent. By increasing the pressure, the amount of oxygen in the blood can be increased. HBOT has been used for decades in the treatment of fire victims to counteract the effects of carbon monoxide poisoning. In this context, it was noted that wounds seemed to heal faster.

Non-randomised studies also considered

Even though the literature search was expanded to include non-randomised studies, IQWiG identified only 6 clinical comparisons that could be considered in the evaluation. These studies included a total of 562 patients. Only one study (including 16 patients) was randomised.

In the largest study with 875 participants, patient characteristics were incompletely reported. Furthermore, results were only published for a subgroup of 286 patients (even though this subgroup analysis had not been planned). Consequently, about two-thirds of study participants were not considered in the publication. Therefore, the overall result cannot ultimately be interpreted, as, for example, it cannot be excluded that treatment may have been changed or discontinued due to adverse events that occurred in patients treated with HBOT. No study included a follow-up of patients beyond their stay in hospital.

Only statements on the therapy goal "wound healing time” are possible

IQWiG did not find scientific evidence for the assumed benefit of HBOT in the studies investigated. Robust conclusions can neither be made for the criteria mortality, blood poisoning (sepsis), surgical interventions, length of hospital stay, and adverse effects and complications, nor for quality of life. Indications that add-on HBOT may have advantages in patients with burns were only available for the therapy goal "wound healing time”. However, these data originate from a very small study including 16 patients, which is over 30 years old. Moreover, methodological issues remain unclear; for this reason, the results of this study can only be interpreted to a limited extent. Furthermore, none of the 5 other studies provided concrete information on wound healing time.

Procedure of report production

IQWiG published the preliminary report on the Internet on 31 May 2007. Comments could be submitted on this version up to 28 June 2007. IQWiG received 3 such comments, which did not, however, contradict the general conclusions of the preliminary report. Additional relevant publications that had not already been identified by IQWiG were not reported. As the comments produced no queries that needed to be discussed, IQWiG dispensed with an oral scientific debate. However, the comments submitted were considered in the final report. Objections referring to the content of the preliminary report are discussed in the final report (see pages 48-50) and are fully presented in a separate document. The final report was sent to the contracting agency, the Federal Joint Committee, on the 6 September 2007.

Contact: Tel.: ++49(0)221-35685-0 E-mail: info@iqwig.de