Review by Alisa Hayes M.D.
Column organized by Evan Schwarz M.D.
Washington University in St. Louis
Division of Emergency Medicine
Citation: Spiro DM, Tay K, et al. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. Sept 2006;296(10):1235-1241. by Dr. Alisa Hayes
You hear some cries coming from down the hall and as you enter the patient’s room you find a frustrated mother with 2 children (2 and 4 years old) who she reports have been pulling at their ears, acting fussy and have had fever. As you try to wrestle them and that unruly otoscope to get a glimpse at the TMs , you wonder if all those other prescriptions you have written today were worth it, or if these children with otitis media would experience relief from their ear ache without your intervention.
Acute otitis media (AOM) is the number one diagnosis associated with antibiotic prescriptions in children. Previous meta-analyses have suggested a Number Needed to Treat of 17 children to eliminate otalgia in one child at 2 to 7 days post-diagnosis. In 2006, a meta-analysis of six randomized controlled trials suggested that children under age 2-years with bilateral otitis or any age with otorrhea are most likely to benefit from antibiotics as manifest by a reduction in 3-7 day pain scores. The meta-analysis also identified no cases of mastoiditis or other serious complications suggesting the incidence of AOM adverse outcomes is extremely low. With the increasing concern for promotion of antibiotic resistance with unnecessary prescriptions, physicians have started to question the routine prescribing of antibiotics for AOM.
Previous studies of a wait-and-see approach have been done in a pediatrician’s office. This randomized, controlled trial was unique in that it took place in the ED in an environment where patients did not have a pre-existing relationship with the treating physician. This randomized controlled trial was completed over a one year period on children age 6 months to 12 years of age presenting to an emergency department and diagnosed with AOM. The children were randomized to receive either a standard prescription for an antibiotic or a wait-and-see prescription. All children also received ibuprofen and otic analgesic drops for pain control. Follow-up was conducted 3 times to determine outcomes such as rate at which prescriptions were filled, clinical course of the illness, unscheduled returns for medical care, and comfort with the wait-and-see method for future occurrences of otitis media. A wait-and-see prescription was a prescription that included instructions both verbal and written that states the caregiver was only to fill and administer the medication if the child was either not better or is worse in 48 hours from the visit. Parents in the standard group were encouraged to immediately fill the prescription and start treatment. Patients were excluded from the trial is they had intercurrent bacterial infection such as pneumonia, patient appeared “toxic” or was admitted. Other exclusion criteria included immunocompromise, myringotomy tubes or perforated TM, antibiotic use within 7 days, or when unable to be interviewed in follow-up due to language or lack of telephone. AOM was diagnosed and treated at the discretion of the ED physician. Amoxicillin was prescribed in greater than 90% of the cases with high dose treatment being given to most patients less than 2 years of age.
This study showed a statistically significant finding that prescriptions were not filled for 62% of children in the wait-and-see group vs. 13% in the standard prescription group. Parents who filled the wait-and-see prescriptions reported they did so because of fever (60%), otalgia (24%) and fussiness (6%). No serious adverse events occurred in either group and there was no difference in unscheduled medical visits. Otalgia was more common in the wait-and-see group while diarrhea was more common in the standard prescription group.
Overall the wait-and-see prescription for AOM diagnosed in the ED significantly decreases the use of antibiotics. Although there was a slightly longer course of otalgia (0.4 days) in the wait-and-see group, this was balanced against the 2-3 fold higher incidence of diarrhea in the standard prescription group. Not to mention even though there was a statistically significant difference, does 1/2 a day result in a clinically significant difference. The wait-and-see approach may be helpful in decreasing the problem of antibiotic resistance without increasing the risk of complications or return visits for untreated AOM. Although an immediate prescription may decrease the duration of otalgia this must be weighed against the risk of antibiotic use in what, for the most part, is a self-limited disease.
To get the full article please go to http://pmid.us/16968847