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Osteonecrosis: The need for an evidence-based approach
LETTERS TO THE EDITOR J Oral Maxillofac Surg 64:1177-1178, 2006
OSTEONECROSIS: THE NEED FOR AN EVIDENCEBASED APPROACH To the Editor:—Marx et al are to be commended for their retrospective review of such a large number of patients with bisphosphonate-associated osteonecrosis of the jaws (J Oral Maxillofac Surg 63:1567, 2005). They have added 40 patients to the 36 Marx described in his 2003 letter to the editor (J Oral Maxillofac Surg 61:1115, 2003). They have also reviewed data sent to them by colleagues on an additional 43 patients. Details of the bisphosphonate therapy, the bone necrosis, medical comorbidities, and dental co-morbidities have been documented for all cases. This review is a case series, a collection of data on 119 patients. Because it is uncontrolled, such a series does not have statistical validity. The statements regarding co-morbidities or precipitating events have no meaning in the absence of a control group. For example, a history of steroid therapy, periodontal disease, or extractions may all be quite common in the cancer population. The only way to determine significance is with a control group. The authors point out that “a controlled, randomized, prospective, blinded study to prove the specific causal relationship between bisphosphonate therapy and exposed bone is not possible.” This statement is not true. Such a study would take a very long time to complete. Given the usefulness of bisphosphonate therapy, it would also be very difficult to organize such a study and to recruit patients. Nevertheless, valid scientific studies are certainly possible. One type is a cohort study, in which bisphosphonate patients are followed prospectively over a period of time. Those who develop osteonecrosis are then compared with those who do not. A second type is a case-control study, in which a group of bisphosphonate patients who have developed osteonecrosis is retrospectively compared with a second group of patients who have not developed the condition. Either type of study could produce statistically significant data. The article contains several of the types of unproven hypotheses, assumptions, and treatment recommendations I discussed in a recent letter (J Oral Maxillofac Surg 63:1555, 2005). We have all been anxious to find a useful treatment protocol for our osteonecrosis patients. Unfortunately, this article does not provide one. Evidencebased medicine is the gold standard for management of any complex disorder. The readership must understand that all recommendations made by the authors are empirical. None is evidence based. Particularly disturbing to
me is the recommendation for long-term antibiotic administration. Antibiotic-resistant organisms and infections are a major problem in hospitals and a growing problem in the outpatient setting. They are related to the heavy use of unnecessary antibiotics. This recommendation is imprudent in the absence of a clinical trial. I am currently following 30 osteonecrosis patients. Twentyfive remain pain-free with minimal local care only. Three have had episodes of cellulitis, which responded to shortterm antibiotics. Two appear refractory to any treatment and may come to a major resection. The authors have reported on one of the largest groups of patients with bisphosphonate-associated osteonecrosis of the jaws to be found at a single institution. I would urge them to find a set of matched controls so that they can make better use of this wealth of clinical material. HARRY C. SCHWARTZ, DMD, MD Los Angeles, CA
doi:10.1016/j.joms.2006.01.005
OFFSHORE MEDICAL DEGREE: ARE YOU A PHYSICIAN OR A DENTIST? To the Editor:—I have been following this fascinating discussion and I would like to make a few points from this side of the pond. In the United Kingdom, oral and maxillofacial surgery was only officially registered with the general medical council as a medical speciality quite recently. However, it has been considered a medical speciality for some time before that because of two main factors. First, all trainees have had to be dually qualified for the last 15 years or so, and many consultants voluntarily undertook the second degree before this. As a result, most trainees and consultants have been medically qualified for the last 15 to 20 years. Second, most oral and maxillofacial surgeons regularly undertake surgery that is clearly not dental surgery. The board with which a speciality is registered is not the only way to judge whether a surgeon is a dentist or a physician. The unique aspect of oral and maxillofacial surgery is that it belongs in both camps and it will not fit comfortably and completely into one or the other. If it is considered a dental speciality, will patients and other members of the medical team be happy that the surgeon transplanting a fibula is a dental surgeon? More worrying are the numbers of talented doubly qualified surgeons who do not want their surgical scope restricted by the effect of
Letters to the Editor are considered for publication (subject to editing and abridgment), provided they are submitted in 1 of 2 ways. If typewritten, they must be submitted in duplicate, signed by all authors, double-spaced, and should not exceed 40 typewritten lines of manuscript text (excluding references). You may also e-mail your Letters to the Editor to [email protected]. The same length limits apply. Letters should not duplicate similar material being submitted or published elsewhere. Letters responding to a recent Journal article must be received within 6 weeks of the article’s publication. Receipt of letters is not acknowledged and there is no guarantee that your letter will be published. We cannot provide prepublication proofs. Submitting the letter constitutes your permission for its publication in any current or subsequent issue or edition of the Journal, in any form or media, now known or hereafter developed.
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OSTEONECROSIS: THE NEED FOR AN EVIDENCEBASED APPROACH To the Editor:—Marx et al are to be commended for their retrospective review of such a large number of patients with bisphosphonate-associated osteonecrosis of the jaws (J Oral Maxillofac Surg 63:1567, 2005). They have added 40 patients to the 36 Marx described in his 2003 letter to the editor (J Oral Maxillofac Surg 61:1115, 2003). They have also reviewed data sent to them by colleagues on an additional 43 patients. Details of the bisphosphonate therapy, the bone necrosis, medical comorbidities, and dental co-morbidities have been documented for all cases. This review is a case series, a collection of data on 119 patients. Because it is uncontrolled, such a series does not have statistical validity. The statements regarding co-morbidities or precipitating events have no meaning in the absence of a control group. For example, a history of steroid therapy, periodontal disease, or extractions may all be quite common in the cancer population. The only way to determine significance is with a control group. The authors point out that “a controlled, randomized, prospective, blinded study to prove the specific causal relationship between bisphosphonate therapy and exposed bone is not possible.” This statement is not true. Such a study would take a very long time to complete. Given the usefulness of bisphosphonate therapy, it would also be very difficult to organize such a study and to recruit patients. Nevertheless, valid scientific studies are certainly possible. One type is a cohort study, in which bisphosphonate patients are followed prospectively over a period of time. Those who develop osteonecrosis are then compared with those who do not. A second type is a case-control study, in which a group of bisphosphonate patients who have developed osteonecrosis is retrospectively compared with a second group of patients who have not developed the condition. Either type of study could produce statistically significant data. The article contains several of the types of unproven hypotheses, assumptions, and treatment recommendations I discussed in a recent letter (J Oral Maxillofac Surg 63:1555, 2005). We have all been anxious to find a useful treatment protocol for our osteonecrosis patients. Unfortunately, this article does not provide one. Evidencebased medicine is the gold standard for management of any complex disorder. The readership must understand that all recommendations made by the authors are empirical. None is evidence based. Particularly disturbing to
me is the recommendation for long-term antibiotic administration. Antibiotic-resistant organisms and infections are a major problem in hospitals and a growing problem in the outpatient setting. They are related to the heavy use of unnecessary antibiotics. This recommendation is imprudent in the absence of a clinical trial. I am currently following 30 osteonecrosis patients. Twentyfive remain pain-free with minimal local care only. Three have had episodes of cellulitis, which responded to shortterm antibiotics. Two appear refractory to any treatment and may come to a major resection. The authors have reported on one of the largest groups of patients with bisphosphonate-associated osteonecrosis of the jaws to be found at a single institution. I would urge them to find a set of matched controls so that they can make better use of this wealth of clinical material. HARRY C. SCHWARTZ, DMD, MD Los Angeles, CA
doi:10.1016/j.joms.2006.01.005
OFFSHORE MEDICAL DEGREE: ARE YOU A PHYSICIAN OR A DENTIST? To the Editor:—I have been following this fascinating discussion and I would like to make a few points from this side of the pond. In the United Kingdom, oral and maxillofacial surgery was only officially registered with the general medical council as a medical speciality quite recently. However, it has been considered a medical speciality for some time before that because of two main factors. First, all trainees have had to be dually qualified for the last 15 years or so, and many consultants voluntarily undertook the second degree before this. As a result, most trainees and consultants have been medically qualified for the last 15 to 20 years. Second, most oral and maxillofacial surgeons regularly undertake surgery that is clearly not dental surgery. The board with which a speciality is registered is not the only way to judge whether a surgeon is a dentist or a physician. The unique aspect of oral and maxillofacial surgery is that it belongs in both camps and it will not fit comfortably and completely into one or the other. If it is considered a dental speciality, will patients and other members of the medical team be happy that the surgeon transplanting a fibula is a dental surgeon? More worrying are the numbers of talented doubly qualified surgeons who do not want their surgical scope restricted by the effect of
Letters to the Editor are considered for publication (subject to editing and abridgment), provided they are submitted in 1 of 2 ways. If typewritten, they must be submitted in duplicate, signed by all authors, double-spaced, and should not exceed 40 typewritten lines of manuscript text (excluding references). You may also e-mail your Letters to the Editor to [email protected]. The same length limits apply. Letters should not duplicate similar material being submitted or published elsewhere. Letters responding to a recent Journal article must be received within 6 weeks of the article’s publication. Receipt of letters is not acknowledged and there is no guarantee that your letter will be published. We cannot provide prepublication proofs. Submitting the letter constitutes your permission for its publication in any current or subsequent issue or edition of the Journal, in any form or media, now known or hereafter developed.
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