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BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.
POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.
STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.
OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.
RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).
This clinical trial demonstrates that antibiotics are no more effective than placebo for clinically diagnosed acute sinusitis in otherwise healthy children. Children with fulminant sinusitis were excluded from this study, and these recommendations should be taken accordingly. The study had adequate power to detect a small difference in outcomes; however, a replication of this study would strengthen these findings. Parents requesting antibiotics may be educated that there were no major benefits from antibiotics in primary or secondary outcomes measured, and in fact, side effects such as abdominal pain may be higher in children prescribed antibiotics. Approximately 80% of children will improve in 10 days, whether antibiotics are given or not. The most likely explanation for this study result is that relatively few children need antibiotics to recover from their sinusitis and that current clinical diagnostic criteria do not identify which children will benefit from antibiotics.
BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.
POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.
STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.
OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.
RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).
This clinical trial demonstrates that antibiotics are no more effective than placebo for clinically diagnosed acute sinusitis in otherwise healthy children. Children with fulminant sinusitis were excluded from this study, and these recommendations should be taken accordingly. The study had adequate power to detect a small difference in outcomes; however, a replication of this study would strengthen these findings. Parents requesting antibiotics may be educated that there were no major benefits from antibiotics in primary or secondary outcomes measured, and in fact, side effects such as abdominal pain may be higher in children prescribed antibiotics. Approximately 80% of children will improve in 10 days, whether antibiotics are given or not. The most likely explanation for this study result is that relatively few children need antibiotics to recover from their sinusitis and that current clinical diagnostic criteria do not identify which children will benefit from antibiotics.
BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.
POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.
STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.
OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.
RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).
This clinical trial demonstrates that antibiotics are no more effective than placebo for clinically diagnosed acute sinusitis in otherwise healthy children. Children with fulminant sinusitis were excluded from this study, and these recommendations should be taken accordingly. The study had adequate power to detect a small difference in outcomes; however, a replication of this study would strengthen these findings. Parents requesting antibiotics may be educated that there were no major benefits from antibiotics in primary or secondary outcomes measured, and in fact, side effects such as abdominal pain may be higher in children prescribed antibiotics. Approximately 80% of children will improve in 10 days, whether antibiotics are given or not. The most likely explanation for this study result is that relatively few children need antibiotics to recover from their sinusitis and that current clinical diagnostic criteria do not identify which children will benefit from antibiotics.