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Department of Osteopathic Manipulative Medicine Touro University, College of Osteopathic Medicine–California Vallejo, Calif

To the Editor: I am writing in response to the many recent letters published in JAOA—The Journal of the American Osteopathic Association that question the validity of osteopathic manipulative treatment (OMT), decry a lack of evidence for its efficacy, or piously insist that a physician's practice must be limited to evidence-based methods of treatment.^1–3

I must agree that clinical research into OMT can be scarce and lacking in rigor and is often limited to pilot studies. In addition, some studies indicate a limited efficacy for OMT, concluding that it is clinically equivalent to using a high dose of pain medication.^4,5 Compared with the many well-funded pharmaceutical studies by allopathic researchers, the osteopathic medical profession's evidence for the efficacy of OMT does seem slight. However, I submit that this paucity of evidence is the result of the various factors addressed in this letter.

First, OMT is not a drug. Yet it is often studied using the protocols that pharmaceutical companies use to verify the safety and efficacy of their medications. Researchers who wedge OMT into the double-blind, placebo-controlled research model must construct sham treatments to compare against "real" OMT. However, OMT is the application of a set of procedures and, thus, should be studied using the protocols that evaluate medical procedures. "Sham OMT" is as illegitimate as "sham appendectomy" would be in the study of lower abdominal pain.

Second, many studies of the efficacy of OMT use osteopathic medical students as physician surrogates^6,7 or as surrogates for patients.⁸ The clinical potency of OMT varies widely among practitioners, accumulating with the experience of the physician. Students are our weakest (ie, least experienced) practitioners, so using students to administer OMT—mainly because of their easy availability and low cost—is like a pharmaceutical company using expired drugs in its research. Students cannot generate the clinical potency of seasoned physicians.

Furthermore, students cannot technically apply true OMT, because, by definition, OMT is the application of manually guided forces by a licensed physician.^9,10 Judging the efficacy of OMT by the results achieved by students is a deeply flawed concept and unfair to the seasoned physicians who are able to treat their patients with much greater clinical effect.

Third, OMT is designed to treat sick patients, yet it is mostly studied in healthy subjects, primarily because healthy students are the subjects who are most readily available to the academics conducting research.⁸ The use of healthy subjects can make a big difference in study results. The most that OMT can do is deflect the patient's physiologic mechanisms toward normal/optimal conditions. The size and duration of that deflection are proportional to the clinical skills of, and the time invested by, the osteopathic physician. The amount of measurable deflection toward the normal physiologic state is minimal when the subjects studied are already healthy. An OMT procedure that may be a lifesaving treatment in a very ill patient may just make a healthy subject feel better for a few hours.

For the osteopathic medical profession to conduct OMT research that undeniably demonstrates significant clinical potency, OMT must be studied as it is delivered by seasoned osteopathic physicians to the clinically ill. We must abandon "sham OMT" as a seriously flawed concept and recognize that students are unsuitable for either providing or receiving OMT during research. I recommend the following published articles as examples of studies that not only incorporate these principles, but also demonstrate favorable outcomes for OMT:

• McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic manipulative treatment in the management of acute neck pain in the emergency department: a randomized clinical trial. J Am Osteopath Assoc. 2005;105:57–68. Available at: http://www.jaoa.org/cgi/content/full/105/2/57. Accessed June 6, 2006.
  
• King HH, Tettambel MA, Lockwood MD, Johnson KH, Arsenault DA, Quist R. Osteopathic manipulative treatment in prenatal care: a retrospective case control design study. J Am Osteopath Assoc. 2003;103: 577–582. Available at: http://www.jaoa.org/cgi/reprint/103/12/577. Accessed June 6, 2006.
  
• Mills MV, Henley CE, Barnes LL, Carreiro JE, Degenhardt BF. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Arch Pediatr Adolesc Med. 2003;157: 861–866.
  

These three studies used seasoned osteopathic physicians who treated actual patients, and the conclusions were based on clinical outcomes. Subjective measures, such as pain scores (McReynolds and Sheridan), and objective measures, such as incidence of meconium staining (King et al) and tympanogram quality (Mills et al) were significant. Students were not used as subjects or as surrogate physicians. Sham OMT was not included. Each study demonstrated clear clinical benefits from OMT—benefits beyond the reach of conventional allopathic medicine.

Each of these studies should have justified a change in practice patterns for the osteopathic medical profession: Emergency department physicians now are fully evidence-justified in using OMT instead of injectable nonsteroidal anti-inflammatory drugs; obstetricians in using OMT in prenatal care; and pediatricians in using OMT in cases of chronic otitis media. (Additional research supporting the latter use of OMT was published in the June 2006 issue of JAOA.¹¹)

I wonder, however, did any osteopathic physician shift his or her practice patterns to incorporate (or refer for) OMT after learning that the evidence justifying such a decision is now published in respected journals? If not, perhaps we are less evidence based than we think.

References
1. Cardarelli R. Recurring limitations in OMT research [letter]. J Am Osteopath Assoc. 2006;106:112–113. Available at: http://www.jaoa.org/cgi/content/full/106/3/112-a. Accessed June 6, 2006.

2. Hansen GP. Beyond OMT: time for a new chapter in osteopathic medicine [letter]? J Am Osteopath Assoc. 2006;106:114–116. Available at: http://www.jaoa.org/cgi/content/full/106/3/114. Accessed June 6, 2006.

3. Bledsoe BE. The elephant in the room: does OMT have proved benefit [letter]? J Am Osteopath Assoc. 2004;104:405. Available at: http://www.jaoa.org/cgi/content/full/104/10/405. Accessed June 14, 2006.

4. Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain [published correction appears in N Eng J Med. 2000;342:817]. N Eng J Med.1999; 341:1426 –1431.[Abstract/Free Full Text]

5. Goldstein FJ, Jeck S, Nicholas AS, Berman MJ, Lerario M. Preoperative intravenous morphine sulfate with postoperative osteopathic manipulative treatment reduces patient analgesic use after total abdominal hysterectomy. J Am Osteopath Assoc. 2005;105:273–279. Available at: http://www.jaoa.org/cgi/content/full/105/6/273. Accessed June 14, 2006.

6. Licciardone JC, Stoll ST, Cardarelli KM, Gamber RG, Swift JN Jr, Winn WB. A randomized controlled trial of osteopathic manipulative treatment following knee or hip arthroplasty. J Am Osteopath Assoc. 2004;104:193–202. Available at: http://www.jaoa.org/cgi/content/full/104/5/193. Accessed June 14, 2006.

7. Noll DR, Shores JH, Gamber RG, Herron KM, Swift J Jr. Benefits of osteopathic manipulative treatment for hospitalized elderly patients with pneumonia. J Am Osteopath Assoc. 2000;100:776–782. Available at: http://www.jaoa.org/cgi/reprint/100/12/776. Accessed June 14, 2006.

8. Burns DK, Wells MR. Gross range of motion in the cervical spine: the effects of osteopathic muscle energy technique in asymptomatic subjects. J Am Osteopath Assoc. 2006;106:137–142. Available at: http://www.jaoa.org/cgi/content/full/106/3/137. Accessed June 14, 2006.

9. Glossary Review Committee, for the Educational Council on Osteopathic Principles and the American Association of Colleges of Osteopathic Medicine. Glossary of Osteopathic Terminology. April 2002. Available at: http://www.do-online.osteotech.org/pdf/sir_collegegloss.pdf. Accessed June 6, 2006.

10. American Medical Association. CPT 2006–Current Procedural Terminology–Professional Edition. Chicago, Ill: American Medical Association; 2005.

11. Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006;106:327–334. Available at: http://www.jaoa.org/cgi/content/full/106/6/327. Accessed June 27, 2006.

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