Free
Letters to the Editor  |   July 2007
Study on Recurrent Otitis Media: Potential Value vs Actual Value of OMT
Author Affiliations
  • Robert Orenstein, DO
    Division of Infectious Diseases Mayo Clinic College of Medicine Rochester, Minn
Article Information
Ophthalmology and Otolaryngology / Osteopathic Manipulative Treatment
Letters to the Editor   |   July 2007
Study on Recurrent Otitis Media: Potential Value vs Actual Value of OMT
The Journal of the American Osteopathic Association, July 2007, Vol. 107, 278-279. doi:
The Journal of the American Osteopathic Association, July 2007, Vol. 107, 278-279. doi:
To the Editor: I applaud JAOA—The Journal of the American Osteopathic Association for highlighting original research on the application of osteopathic manipulative treatment (OMT) to commonly encountered clinical problems. However, the JAOA also has a responsibility to ensure that the studies it presents are of a high scientific quality so that its readers are not misled by erroneous conclusions. 
The June 2006 issue's cover read, “Reducing recurrent otitis media with OMT,” and guides readers to an original contribution by Brian F. Degenhardt, DO, and Michael L. Kuchera, DO,1 two leading investigators in osteopathic medical research. Although the abstract and much of the paper discuss the potential value of OMT in reducing the morbidity of acute otitis media (AOM) in children, faults in the study's design and methodology prevent readers from determining the actual value of OMT in this clinical application. 
The intent of the authors is laudable. However, the study suffers from numerous weaknesses that are not addressed satisfactorily by them. The study reports on an uncontrolled, nonrandomized series of 8 referred children with reported histories of recurrent AOM. We are not told how many recruited subjects were excluded from participation in the study or under which of the exclusion criteria. In addition, the authors report, “By 3 years of age, 50% of children will have had more than three episodes of AOM.”1,2 In light of this information, it seems surprising that researchers were unable to recruit more subjects for participation in this study. 
At several places in the report, the authors1 mention that the study lasted 1 year. Figure 2 in the report is, thus, misleading, because the label on its x-axis indicates that the study period lasted from “January 1992 to September 1993.” Furthermore, the JAOA presented 13-year-old data with this study. Is this data the best that the osteopathic medical profession has had to offer on this clinical condition during the past 13 years? 
In addition, the authors1 do not present a standardized definition of AOM or recurrent AOM in their inclusion criteria. Because there is no standardized definition of these diagnoses, readers are left to wonder how the practitioners defined acute and recurrent episodes. What is one pediatrician's AOM may be another's viral respiratory infection. Even the methods of data collection were “not complete enough for us to differentiate between different types of otitis media” (eg, AOM vs otitis media with effusion), as described by the authors.1 
Although Drs Degenhardt and Kuchera refer to previous controlled trials of antimicrobials in recurrent AOM, including Teele and coauthors,3 there is no control group in their study of OMT. Why would the authors like us to believe that a weekly session of OMT for a 15-day period would amend the structural issues that might be associated with recurrent AOM over the course of 1 year? How do we define whether these subjects experienced recurrent episodes or relapses? The study describes the primary outcome as the number of recurrences at 1-year posttreatment. Although the authors report that 5 (62.5%) of 8 subjects had no documented episode of AOM at 1-year follow-up, the follow-up in the study was incomplete for several subjects. 
My interpretation of the data presented by Drs Degenhardt and Kuchera is that Subjects A, B, and E can rightly be called successes; there were no recurrences of AOM in these subjects at 1-year posttreatment. However, the remaining subjects are all potential treatment failures or outright treatment failures. Subject C was lost to follow-up after 8 months, and, thus, 4 months of opportunity for recurrence were missing from the data. Subject G had a persistent effusion at 5-months posttreatment and received systemic steroids as a result—another potential failure. Subject D was an early treatment failure at 6-weeks posttreatment. Subject F, having received antibiotics for a presumed episode of AOM at 7-months posttreatment, was another failure. Subject H had multiple recurrences. Thus, only 3 (37.5%) of 8 subjects, rather than the 5 (62.5%) of 8 claimed,1 had a truly successful outcome at the primary endpoint—a result that is similar to that reported in the placebo arm of Teele and coinvestigators.3 
Finally, in their “Comments” section, Drs Degenhardt and Kuchera attempt to compare their subjects with the placebo group from Teele and colleagues,3 which is an invalid comparison. 
It is difficult to make any conclusions from an underpowered, uncontrolled, nonrandomized, and biased cohort of 8 subjects. While all of us in the osteopathic medical profession would like to believe that OMT is beneficial to our patients, we need to be cautious in how we present and interpret data from clinical trials. Drs Degenhardt and Kuchera, two of our profession's leading researchers, should be especially cautious about reporting lessthan-satisfactory data, as it risks fostering the bias already present in our profession regarding the effectiveness of OMT. 
Whether OMT has any impact upon the course of recurrent AOM remains to be answered by an appropriately structured trial, which I hope the authors will conduct shortly. 
Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopathic Assoc. 2006;106:327-334. Available at: http://www.jaoa.org/cgi/content/full/106/6/327. Accessed May 7, 2007.
Casselbrant ML, Mandel EM. Epidemiology. In: Rosenfeld RM, Bluestone CD, eds. Evidence-Based Otitis Media. Hamilton, Ontario: BC Decker; 1999:117-136.
Teele DW, Klein JO, Word BM, Rosner BA, Starobin S, Earle R Jr, et al. Antimicrobial prophylaxis for infants at risk for recurrent otitis media. Vaccine. 2001;19(suppl 1):S140-S143.