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Comment on "Hyperbaric Oxygen Therapy for Radionecrosis of the Jaw: A Randomized, Placebo-Controlled, Double-Blind Trial From the ORN96 Study Group"

Department of Oral Maxillofacial Surgery, Leiden University Medical Center, Leiden, and the Department of Hyperbaric Medicine, Academic Medical Center, Amsterdam, the Netherlands

Dirk Jan Bakker

Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands

To the Editor:

The prospective, multicenter, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of hyperbaric oxygen therapy (HBO) for mandibular osteoradionecrosis (ORN) is a large study with strong statistical analysis of the data.¹ Unfortunately, the study contains several minor and even major flaws.

One of the minor flaws seems to be the incorrect citation of the study of Marx et al,² a randomized trial in which the use of HBO versus penicillin in the prevention of ORN is studied (and not HBO and penicillin v penicillin alone as the authors state).

Furthermore, HBO treatment is given twice daily in the present study. This is in contrast with the majority of reports in the literature, in which once per day is the standard treatment.

A major flaw, however, seems to be the fact that the studied group, patients with an ORN, is not well defined. In the literature, it is well recognized that the definition of osteoradionecrosis is difficult. Several authors have stressed this problem or even tried to make a classification.^3-7

The inclusion criteria used in this report consisted of (1) one of the clinical criteria: pain, dysaesthesia in the distribution of the inferior alveolar nerve, areas of bone exposure, trismus, and fistula; and (2) one of the radiographic criteria: increased density, periosteal thickening, diffuse radiolucency, mottled areas of osteoporosis, and sclerosis sequestration.

Of the clinical criteria, in the literature, only areas of bone exposure and fistula are generally recognized as criteria for osteoradionecrosis. The others are mere symptoms that may or may not occur. Of the radiographic criteria, only diffuse radiolucency in combination with bone exposure and sequestration are used as criteria.

Many of the possible combinations as suggested by the authors, for instance, pain and increased density, trismus and mottled areas of osteoporosis, and other combinations, are not sufficient for a diagnosis of osteoradionecrosis.

Therefore, the patient population as reported is not representative for patients with osteoradionecrosis of the mandible. This may furthermore be concluded from the data in Table 1, in which it seems that only approximately half of the patients show exposed bone—the most generally accepted criterion for osteoradionecrosis.

In conclusion, we believe that the present population of patients do not represent a reproducible series of osteoradionecrosis of the mandible, meaning that no conclusions can be drawn from the outcomes of treatment.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

REFERENCES

1. Annane D, Depondt J, Aubert P, et al: Hyperbaric oxygen therapy for radionecrosis of the jaw: A randomized, placebo-controlled double-blind trial from the ORN96 Study Group. J Clin Oncol 22:4893-4900, 2004[Abstract/Free Full Text]

2. Marx RE, Johnson RP, Kline SN: Prevention of osteoradionecrosis: A randomized prospective clinical trial of hyperbaric oxygen versus penicillin. J Am Dent Assoc 111:49-54, 1985[Abstract]

3. Marx RE: A new concept in the treatment of osteoradionecrosis. J Oral Maxillofac Surg 41:351-367, 1983[Medline]

4. Epstein JB, Wong FLW, Stevenson-Moore P: Osteoradionecrosis: Clinical experience and a proposal for classification. J Oral Maxillofac Surg 45:104-110, 1987[Medline]

5. Marx RE, Johnson RP: Studies in the radiobiology of osteoradionecrosis and their clinical significance. Oral Surg Oral Med Oral Pathol 64:379-390, 1987[CrossRef][Medline]

6. Wong JK, Wood RE, Mclean M: Conservative management of osteoradionecrosis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 84:16-21, 1997[CrossRef][Medline]

7. Epstein JB, Meij E van der, McKenzie M, et al: Postradiation osteonecrosis of the mandible. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 83:657-662, 1997[CrossRef][Medline]

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