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because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
FROM THE LANCET
Key clinical point: Oral prednisone was well tolerated by children with otitis media with effusion, but there was a high rate of spontaneous resolution in the trial.
Major finding: Acceptable hearing was achieved in 73 of 183 children in the oral steroid group and 59 of 180 children in the placebo group, with a number needed to treat of 14.
Study details: A randomized, parallel, double-blinded, placebo-controlled trial of 389 children aged 2-8 years with symptoms of otitis media with effusion.
Disclosures: The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors report no conflicts of interest.
Source: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.