Corticosteroid Confusion: Evidence lacking for most conditions, panelists say

San Francisco, Calif.—Although steroids are widely used to treat a variety of otolaryngologic conditions, the short- and long-term side effects remain a concern and fuel the need to better understand their proper role. Contributing to the ongoing controversy over their use are gaps in the evidence, panelists said here Sept. 12 at the American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting.

“The evidence is often contradictory,” said Michael Stewart, MD, to participants in a session he moderated at the 2011 Annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Meeting held here on September 12, “and that is why we are here today.” Dr. Stewart is professor and chair of otolaryngology-head and neck surgery at Weill Cornell Medical College in New York City.

What became apparent in the presentations that followed is that the lack of evidence is a source of frustration for otolaryngologists trying to improve their understanding of when to use steroids in their practice.

One study showed that a single intravenous dose of dexamethasone in patients with peritonsillar abscess reduced fever, aided in a return to normal swallowing, reduced trismus and decreased number of days in the hospital.

Tonsillectomy

One area for which the evidence on the benefits of steroid use is coming into sharper focus is tonsillectomy. Christopher Hartnick, MD, associate professor of otolaryngology at Harvard Medical School and a pediatric otolaryngologist at the Massachusetts Eye and Ear Infirmary in Boston, described the current best data, which collectively suggest that a single intraoperative dose of dexamethasone during tonsillectomy in children is safe and effective.

Evidence of this recommendation comes primarily from two large studies, according to Dr. Hartnick. The first is a Cochrane Review published in August 2011 that included 19 studies with over 1,700 participants (Cochrane Database System Rev. 2011;8:DOI: 10.1002/14651858.CD003997.pub2). The review found that children who received a single intraoperative dose of dexamethasone were half as likely to vomit within the first 24 hours after surgery compared to the placebo group, and had improvement in postoperative pain.

The second set of evidence he cited, the recently published “Clinical Practice Guideline: Tonsillectomy in Children” by the AAO-HNS (Otolaryngol Head Neck Surg. 2011;144(1 Suppl):S1-30), included a strong recommendation for the use of a single dose of intraoperative dexamethasone based on data that showed that it decreased nausea and vomiting.

“These studies both confirm what many otolaryngologists are already doing,” Dr. Hartnick said.

The catch, he said, is one study, included in the AAO-HNS guidelines, that has given many otolaryngologists concern about the safety of steroid use in this setting.

The 2008 study, which included 215 pediatric patients, found an increased risk of postoperative bleeding in children treated with steroids during tonsillectomy (JAMA. 300(22):2621-2630). “When we looked at this study, it gave a lot of us pause because many of us are using steroids, and the question is whether steroids actually put our children at risk for postoperative hemorrhage,” he said.

Because of the confusion and concern generated by this study, Dr. Hartnick and his colleagues are conducting a study looking primarily at the risk of bleeding with steroid use in tonsillectomy. To date, the study has accrued 285 patients out of a goal of 320 patients. “We are looking at all levels of bleeding,” he said, “and hope to have an answer soon.”

Peritonsillar Abscess, Infectious Mononucleosis, Sinus Surgery

Judith Lieu, MD, assistant professor of otolaryngology-head and neck surgery at Washington University in St. Louis, Mo., walked participants through some of the evidence on steroids for peritonsillar abscess, infectious mononucleosis and sinus surgery.

Citing a study (J Laryngol Otol. 2004;118(6):439) that showed that a single intravenous dose of dexamethasone in patients with peritonsillar abscess reduced fever, aided in a return to normal swallowing, reduced trismus and decreased number of days in the hospital, she emphasized that the protocol used in this Turkish study differed from that typically used in the U.S. Before she could recommend steroid use in this setting, she said, a study is needed that more closely mirrors what is done in the U.S.

For infectious mononucleosis, Dr. Lieu focused on an updated Cochrane Review (Cochrane Database System Rev. 2011;(4):DOI:CD004402) that included seven randomized trials, including over 300 children and young adults, and evaluated the safety and efficacy of steroids. The study did not recommend the use of steroids in these patients based on insufficient evidence on symptom control. One major problem with the study, she said, was the exclusion of patients with airway obstruction.

Based on this study, steroids would not be recommended, she said, adding, “However, the main concern for most otolaryngologists is airway compromise, and that particular outcome has not been studied.”

Finally, Dr. Lieu discussed a number of studies that looked at topical and systemic steroids for perioperative and postoperative functional endoscopic sinus surgery (FESS). (See “Studies of Steroid Use and FESS,”)

Overall, she said that the studies suggest that the use of topical nasal steroids—fluticasone proprionate and mometasone furoate—after FESS appears to be helpful in reducing recurrence of nasal polyps and decreasing longer-term symptoms from one to five years. However, she emphasized the diverse outcomes of the studies that make it difficult to definitively recommend the use of steroids in this setting. “I think many of us that do surgery, especially for our patients with polyps, are going to use oral steroids perioperatively to reduce bleeding,” she said. “But this is a field that is ripe for more investigation.”

Bell’s Palsy, Meniere’s Disease, Sudden Hearing Loss

Lorne S. Parnes, MD, professor of otolaryngology and clinical neurological sciences at the University of Western Ontario in London, Ontario, summarized the evidence to date on the use of steroids in a number of conditions. For Bell’s palsy, he said the evidence is compelling and cited a 2010 Cochrane Review (Cochrane Database System Rev. 2010;3:DOI: 10.1002/14651858.CD001942.pub4) that supports the routine use of corticosteroids in the treatment of idiopathic facial paralysis.

Conversely, in Meniere’s disease, the evidence for steroid use is insufficient. “Meniere’s disease is a chronic condition, but most current steroid regimens are very short and limited, and that makes little logical sense to me,” he said, adding that the data for the efficacy of steroids using current regimens is unconvincing but may change with the development of different or better delivery methods.

Dr. Parnes cited evidence from a study (Otol Neurotol. 2011;32(3):393-397) that suggested that combination oral and systemic steroid treatment may be optimal for the problems associated with sudden hearing loss.

Overall, the presenters emphasized the need for more and stronger evidence on which to base the use of steroids in the treatment of many otolaryngologic conditions. ENT Today