Jury Still Out on the Benefits of Surgery for OME

Fran Lowry

January 06, 2014

Clinicians still need good and reliable evidence regarding various types of surgery for treatment of otitis media with effusion (OME), despite the plethora of studies currently available, according to a systematic review of the different surgical techniques used to treat this common disorder.

The review was published online January 6 in Pediatrics.

"The evidence base is clearly limited for infants and adults," write Ina F. Wallace, PhD, from RTI-International, Research Triangle Park, North Carolina, and colleagues. "It is virtually nonexistent for children with major coexisting or congenital conditions, such as those with cleft palate, Down syndrome, and sensorineural hearing loss, who may be disproportionately affected by OME."

The authors note that as many as 90% of children have at least 1 episode of OME by age 10 years. Many episodes resolve spontaneously within 3 months, but 5% to 10% of episodes last more than 1 year, and up to 40% of children have recurrent episodes.

"The near universality of OME in children and the high cost of its treatment make it an important topic for a comparative review of treatment modalities," the authors write.

The researchers compared the effectiveness of surgical strategies, including tympanostomy tubes, myringotomy, and adenoidectomy, currently used for managing OME.

The researchers considered systematic reviews that were recently completed by the Cochrane Collaboration or commissioned by a national government. They identified 5112 citations of surgical and nonsurgical treatment, and from these citations they culled 41 studies for the final analysis.

Of these 41 studies, 11 (8 randomized controlled trials, [RCTs]) compared tubes by design, materials, and size, insertion techniques, or topical prophylaxis therapies by comparing ears in the same child. The evidence from these trials was insufficient for comparing clinical outcomes.

Twelve RCTs compared tympanostomy tubes vs myringotomy or watchful waiting. The evidence from these trials showed that tube placement decreased the time with middle ear effusion by 32% compared with watchful waiting or delayed treatment at 1 year after surgery. When compared with a combined comparison of watchful waiting or myringotomy, tubes reduced effusion by 13% through 2 years after surgery. Evidence for results with longer follow-up was insufficient.

These 12 RCTs also showed that tubes improved hearing in the short-term (up to 9 months after surgery) compared with watchful waiting (up to 6 months after surgery) in comparison with either watchful waiting or myringotomy. However, after 7 to 12 months, the differences in hearing were attenuated and were not statistically significant compared with watchful waiting or myringotomy or at 12 to 18 months compared with watchful waiting alone.

Eleven studies looked at tympanostomy tubes plus adenoidectomy vs myringotomy plus adenoidectomy or adenoidectomy alone. Of these, 2 small studies were unable to find a difference between tubes plus adenoidectomy and adenoidectomy alone in reducing OME recurrence. Three studies comparing tubes and adenoidectomy with myringotomy plus adenoidectomy on OME recurrence showed mixed results, and 5 studies failed to find a difference in hearing between the addition of tubes versus myringotomy.

In addition, the authors found mixed results for hearing in studies that compared the added effect of tubes with adenoidectomy alone.

A single RCT compared radiofrequency myringotomy with and without mitomycin C on both middle ear and hearing outcomes. Most individuals in each group received adenoidectomy. The evidence was insufficient for concluding superiority of either procedure with regard to OME effusion or hearing outcomes.

The review also revealed that tubes and watchful waiting did not differ in language, cognitive, or academic outcomes.

Otorrhea and tympanosclerosis were more common in ears with tubes, whereas adenoidectomy increased the risk for postsurgical hemorrhage.

On the basis of these findings, the authors conclude that "[a]dditional research and better methods are needed to develop a comprehensive evidence base to support decision-making among the various treatment options, particularly in subpopulations defined by age and coexisting conditions."

The study was supported by the Agency for Healthcare Research and Quality for the RTI International-University of North Carolina Evidence-based Practice Center. Dr. Wallace has received funding from RTI International to complete the manuscript. The authors have disclosed no other relevant financial relationships.

Pediatrics. Published online January 6, 2013.

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