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Letters to the Editor  |   December 2010
Brief Report of a Clinical Trial on the Duration of Middle Ear Effusion in Young Children Using a Standardized Osteopathic Manipulative Medicine Protocol
Author Affiliations
  • David E. Michalik, DO
    Western University of Health Sciences, College of Osteopathic Medicine of the Pacific, Pomona, California
    Assistant Clinical Professor of Pediatrics, University of California, Irvine School of Medicine; Division of Pediatric Infectious Diseases, Miller Children's Hospital of Long Beach, Long Beach, California
Article Information
Ophthalmology and Otolaryngology / Osteopathic Manipulative Treatment / Pediatrics / OMT in the Laboratory
Letters to the Editor   |   December 2010
Brief Report of a Clinical Trial on the Duration of Middle Ear Effusion in Young Children Using a Standardized Osteopathic Manipulative Medicine Protocol
The Journal of the American Osteopathic Association, December 2010, Vol. 110, 738-739. doi:10.7556/jaoa.2010.110.12.738
The Journal of the American Osteopathic Association, December 2010, Vol. 110, 738-739. doi:10.7556/jaoa.2010.110.12.738
To the Editor:  
We read with great interest the preliminary analysis of the prospective, randomized, blinded, controlled study on the use of osteopathic manipulative treatment (OMT) for children with middle ear effusion (MEE) by Steele et al1 in the May 2010 issue. The analysis included the first 9 months of study data; the authors plan to publish final results later this year.1 It is clear that many challenges exist when designing a study that seeks to objectively validate OMT techniques when compared with standard treatment practices. These challenges are compounded for studies that enroll infants and young children. Furthermore, it is best when the design of the study not only validates the OMT techniques, but also is directly applicable to using OMT in a busy medical practice. Because MEE and acute otitis media rank among the most common reasons for visits to pediatric practices, the impact of OMT in reducing morbidity and surgery in patients with these conditions can be substantial. 
A core principle of osteopathic medicine is that structure and function are interrelated. As such, a detailed understanding of eustachian tube development enables one to comprehend the tube's role in pathologic processes. At birth, the eustachian tube is 13 mm long and angled at 10 degrees to the base of the skull.2 An adult's eustachian tube is 33 mm long, with an angle of 45 degrees. By age 7 years, a child's eustachian tube reaches the adult length and angle as a result of vertical elongation of the skull and widening of the skull base's angle.2 In addition, children have smaller surface areas of the tensor veli palatini muscle—an anatomic feature that assists in opening the tube to allow for equalization of pressures and drainage.3 This anatomic characteristic results in decreased drainage and increased reflux of secretions into the middle ear.2 
Combined, the anatomic differences in eustachian tube length and angle and tensor veli palatini surface area in children vs adults account for the frequency of middle ear infections, as well as the added complications of MEE, in children.4 Equally noteworthy is that the lymphatic drainage of the pharynx and nose joins that of the ear to create a plexus, which drains into the retropharyngeal nodes. Obstruction of this plexus contributes to serous otitis media.5 
A discussion about optimal design of studies to investigate the effects of OMT on MEE is important for validation and application of the OMT techniques used. We understand that problems of patient recruitment and retention exist in all facets of clinical research, especially in studies on acute otitis media. Evidence of these problems is the huge discrepancy in recruitment and retention noted between the two referral/treatment sites evaluated by Steele et al.1 We can offer no easy solution; suffice to say that recruitment and retention are best tailored to the patient population studied and the location of that study group. Limiting the number of research sites and practitioners may minimize variability in outcome, though we acknowledge this would come at the expense of reducing sample size. 
Likewise, to minimize confounding results, we believe that a standardized treatment protocol should be used. Many manipulation techniques were performed in the study by Steele et al,1 making interpretation of results difficult—especially considering the possible low enrollment of study participants. 
If one were to prioritize the OMT techniques used in such a study, we believe that direct techniques, such as Galbreath treatment and anterior cervical mobilization, may prove more practical and better suited for MEE analysis than the techniques used by Steele et al.1 Galbreath treatment, developed by William Otis Galbreath, DO, produces effects on several components of the middle ear. It facilitates lymphatic drainage to the jugulodigastric nodes from the pharynx and ear, increases blood flow, releases peripharyngeal fascia, and changes pressure within the middle ear and eustachian tube.5 Galbreath treatment has the added benefits of being easy to perform on young infants and to teach to parents—benefits that may aid in decreasing rates of MEE as a result of more frequent treatments (ie, typically 3 times a day). We do not understand why the treatment interval of 1 week was chosen by Steele et al.1 
Another direct maneuver that may be beneficial in its application—though it would be difficult to perform in pediatric patients—is the Muncie technique, which opens the eustachian tube by intraoral manipulation.6 Although balanced ligamentous tension, myofascial release, and osteopathy in the cranial field were all used in the study by Steele et al1 and can facilitate MEE drainage, these OMT techniques may also be less practical to perform in the office of a busy pediatric practice. Cooperation of a 2-year-old toddler who is the recipient of OMT lasting 15 to 30 minutes seems unlikely. We predict that in the final results of the analysis by Steele et al,1 most patients enrolled in the study will be less than 1 year of age. 
Finally, it is understandable that Steele et al1 used tympanogram and acoustic reflectometer readings to measure MEE in an effort to remain objective. We agree with this strategy, but we believe that these techniques could be backed up by provider visualization of the tympanic membrane coupled with insufflation to visualize mobility. Although these visual techniques may introduce a degree of clinical bias, they provide a realistic measure of MEE resolution that can confirm or refute tympanometry findings, and they minimize tympanometry results that are “not readable.” We realize that the addition of this component is controversial. 
It is encouraging to see formal research being performed in a difficult patient population, and we applaud the efforts of Dr Steele and her colleagues1 to validate OMT in the treatment of children with MEE. We look forward to publication of the final results of the analysis by Steele et al1 in the near future. 
Steele KM, Viola J, Burns E, Carreiro JE. Brief report of a clinical trial on the duration of middle ear effusion in young children using a standardized osteopathic manipulative medicine protocol. J Am Osteopath Assoc. 2010;110(5):278-284. http://www.jaoa.org/cgi/reprint/110/5/278. Accessed September 28, 2010.
Bluestone CD, Doyle WJ. Anatomy and physiology of eustachian tube and middle ear related to otitis media [review]. J Allergy Clin Immunol. 1988;81(5 pt 2): 997-1003.
Doyle WJ, Swarts JD. Eustachian tube-Tensor veli palatini muscle-cranial base relationships in children and adults: an osteological study [published online ahead of print June 30, 2010]. Int J Pediatr Otorhinolaryngol. . (2010). ;74(9):986-990.
Shah N. Otitis media and its sequelae [review]. J R Soc Med. 1991;84(10):581-586.
Galbreath WO. Chronic catarrhal otitis media. J Am Osteopath Assoc.. (1928). ;27(8):639 .
Ruddy TJ. Osteopathic manipulation in eye, ear, nose, and throat disease. In: Barnes MW, ed. 1962 Year Book of Selected Osteopathic Papers. Carmel, CA: Academy of Applied Osteopathy;1962 : 133-140.