***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Abstract Objective : To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age . Design : Practice based , double blind , r and omised , placebo controlled trial . Setting : 53 general practice s in the Netherl and s. Subjects : 240 children aged 6 months to 2 years with the diagnosis of acute otitis media . Intervention : Amoxicillin 40 mg/kg/day in three doses . Main outcome measures : Persistent symptoms at day four and duration of fever and pain or crying , or both . Otoscopy at days four and 11 , tympanometry at six weeks , and use of analgesic . Results : Persistent symptoms at day four were less common in the amoxicillin group ( risk difference 13 % ; 95 % confidence interval 1 % to 25 % ) . The median duration of fever was two days in the amoxicillin group versus three in the placebo group ( P=0.004 ) . No significant difference was observed in duration of pain or crying , but analgesic consumption was higher in the placebo group during the first 10 days ( 4.1 v 2.3 doses , P=0.004 ) . In addition , no otoscopic differences were observed at days four and 11 , and tympanometric findings at six weeks were similar in both groups . Conclusions : Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child . This modest effect does not justify prescription of antibiotics at the first visit , provided close surveillance can be guaranteed Objective To determine the long term effects of antibiotic treatment for acute otitis media in young children . Design Prospect i ve three year follow-up study within the framework of a primary care based , double blind , r and omised , placebo controlled trial . Setting 53 general practice s in the Netherl and s. Participants 168 children aged 6 months to 2 years with acute otitis media . Interventions Amoxicillin 40 mg/kg/day in three doses compared with placebo . Main outcome measures Recurrence of acute otitis media ; referral to secondary care ; ear , nose , and throat surgery . Results Acute otitis media recurred in 63 % ( 47/75 ) of children in the amoxicillin group and in 43 % ( 37/86 ) of the placebo group ( risk difference 20 % , 95 % confidence interval 5 % to 35 % ) ; 30 % ( 24/78 amoxicillin ; 27/89 placebo ) of children in both groups were referred to secondary care , and 21 % ( 16/78 ) of the amoxicillin group compared with 30 % ( 27/90 ) of the placebo group had ear , nose , and throat surgery ( risk difference −9 % , −23 % to 4 % ) . Conclusion Recurrent acute otitis media occurred more often in the children originally treated with amoxicillin . This is another argument for judicious use of antibiotics in children with acute otitis media . Trial registration Netherl and s Trial Register NTR1426 Background 10 days of amoxicillin/clavulanic acid high dose and 5 days of cefdinir have been the preferred first- or second-line antibiotics for treatment of children with acute otitis media ( AOM ) since 2004 , as recommended by the American Academy of Pediatrics in the USA , but no head-to-head comparison study has been done . Objective The purpose of the study was to compare the clinical efficacy of amoxicillin/clavulanic acid high-dose therapy for 10 days with cefdinir therapy for 5 days for AOM at recommended doses . Methods This was an investigator-blind trial in young children 6–24 months old with no history of recurrent AOM who were r and omly assigned to amoxicillin/clavulanic acid ( 80 mg/kg/day amoxicillin ) or cefdinir ( 14 mg/kg/day ) , both in two divided doses . The diagnosis of AOM was based on specific clinical criteria by vali date d otoscopists at two AOM research centres . The outcome measure for clinical cure was resolution of all symptoms and signs of AOM except for persistence of middle-ear effusion at test-of-cure ( TOC ) 11–14 days after initiation of antibiotic treatment . Clinical failure was defined as persistence of symptoms and signs of AOM and the need for additional antibiotic therapy . Subjects lost to follow up or who had not taken at least 80 % of the prescribed medication were classified as having an indeterminate response . Compliance was monitored using Medical Electronic Monitoring System ( MEMS ) caps and antibiotic bottle volume measurement at the TOC visit . A logistic regression model was used to estimate the association of age with cure rate . Full interactions in terms of age with treatment were included to estimate any age gradient differential . Results A total of 330 children ( average age 13.1 months ) with AOM were studied . At TOC , 256 children had clinical cure , 69 had clinical failure , and 5 were lost to follow-up . High-dose amoxicillin/clavulanic acid-treated children had a better cure rate ( 86.5 % ) than cefdinir-treated patients ( 71.0 % ; p = 0.001 ) . Cefdinir was correlated with less frequent cure outcomes as children increased in age between 6 and 24 months . The odds ratios for clinical cure per increasing month of age estimated from a logistic regression model for amoxicillin/clavulanic acid high dose and cefdinir treatment groups was 0.992 ( 95 % CI 0.932 , 1.056 ) , p>0.05 and 0.932 ( 95 % CI 0.881 , 0.986 ) , p = 0.01 . The differences in the odds ratios are significant at p<0.002 , indicating a stable clinical cure rate across the ages of children studied for amoxicillin/clavulanic acid and decreasing clinical cure rates as children increased in age for cefdinir . Conclusion In children with bona fide AOM for whom clinical outcomes are assessed by vali date d otoscopists , 10 days of high-dose amoxicillin/clavulanic acid is significantly more effective than 5 days of cefdinir as therapy for AOM . Because of the identified age effect ( correlated to child weight ) , higher doses of cefdinir may have led to a different conclusion ; 10 days of cefdinir may also have led to a different conclusion The presence of otitis media with effusion ( OME ) and high negative pressure ( -200 to -400 mm H2O ) , were investigated in the follow-up of a r and omized double-blind placebo-controlled trial on the efficacy of amoxicillin/clavulanic acid in the treatment of acute otitis media . All children in this study were recruited from a general practice population .  Tympanometry results 1 month from the start of an episode of acute otitis media were taken as outcome criteria . Bilateral middle ear dysfunction was defined as bilateral OME , unilateral OME and contralateral or bilateral high negative pressure . Bilateral middle ear dysfunction was present in 47.9 % of the patients . Of all the investigated factors of possible influence ( age , sex , season , laterality of acute otitis media , therapy , and clinical course of acute otitis media ) , only season showed a statistically significant influence on the persistence of OME/high negative pressure ( P = 0.001 ) . Bilateral middle ear dysfunction was shown to be of prognostic value for the risk of a recurrence of acute otitis media ( odds ratio 3.75 ) IMPORTANCE Antimicrobial treatment reduces the symptoms of acute otitis media ( AOM ) . The effect of antimicrobial treatment on the duration of  middle ear effusion ( MEE )  and concomitant hearing impairment is not known . OBJECTIVE To determine whether the antimicrobial treatment of AOM reduces the duration of MEE . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , placebo-controlled trial involved a total of 84 children with AOM between 6 months and 15 years of age . Participants were recruited from September 14 , 1999 , to January 4 , 2000 ; October 10 , 2005 , to December 16 , 2005 ; and September 22 , 2009 , to June 4 , 2012 , from among children attending an AOM prevention trial and children visiting local outpatient clinics in Oulu , Finl and . INTERVENTIONS Children were r and omly allocated to receive either 40 mg/kg of amoxicillin-clavulanate or a placebo mixture per day for 7 days . MAIN OUTCOMES AND MEASURES The primary outcome measure was the time to the disappearance of MEE as defined by a normal tympanogram finding ( A curve ) from both ears on 2 consecutive measurement days . Parents performed daily tympanometry at home . The study physician performed tympanometry and otoscopy at study entry , after 3 and 7 days , and then weekly until both ears were healthy . The main secondary outcome measures were the time to normal otoscopy findings and the proportion of children without persistent MEE at 14 days and 2 months . RESULTS Middle ear effusion disappeared 2.0 weeks ( 13.7 days ) earlier ( P = .02 ) in the antimicrobial group ( mean time , 2.7 weeks ; 95 % CI , 1.7 - 3.7 ) than in the placebo group ( 4.7 weeks ; 95 % CI , 3.6 - 5.7 ) . Normal otoscopy findings were observed 1.4 weeks sooner in the antimicrobial group than in the placebo group ( P = .02 ) . On day 14 , 69 % of children in the antimicrobial group and 38 % in the placebo group had normal tympanometry findings ( number needed to treat , 3.2 ; 95 % CI , 2.0 - 10.5 ) . On day 60 , 2 children ( 5 % ) in the antimicrobial group and 10 children ( 24 % ) in the placebo group had persistent MEE ( P = .01 ) . CONCLUSIONS AND RELEVANCE Antimicrobial treatment effectively reduced the duration of MEE and possible concomitant hearing impairment in children with AOM . Antimicrobial treatment also reduced the risk for persistent MEE . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01244581 OBJECTIVE Otitis media is 1 of the most frequent diseases of early infancy and childhood and 1 of the most common reasons for children to visit a physician . In the past 2 decades , there has been a substantial increase in the diagnosis of otitis media worldwide . In the United States , 93 % of all children have had at least 1 episode of acute otitis media ( AOM ) by 7 years of age . Otalgia is the hallmark of AOM . Most affected children either complain of earache or manifest behavior that the parents interpret as indicating ear pain . Treatment of the ear pain early in the course of AOM decreases both parental anxiety and the child 's discomfort and accelerates the healing process . The objective of this study was to determine the efficacy and tolerability of naturopathic versus traditional treatment for the management of otalgia commonly associated with AOM in children . METHODS The study was design ed as a double-blind trial in an outpatient community clinic . A total of 171 children who were aged 5 to 18 years and had otalgia and clinical findings associated with middle-ear infection were studied . The children were r and omly assigned to receive treatment with Naturopathic Herbal Extract Ear Drops ( NHED ) or anesthetic ear drops , with or without amoxicillin . On enrollment , the children were assigned by computer-numbered r and omization to receive NHED ( contents : allium sativum , verbascum thapsus , calendula flores , hypericum perfoliatum , lavender , and vitamin E in olive oil ) 5 drops 3 times daily , alone ( group A ) or together with a topical anesthetic ( amethocaine and phenazone in glycerin ) 5 drops 3 times daily ( group B ) , or oral amoxicillin 80 mg/kg/d ( maximum 500 mg/dose ) divided into 3 doses with either NHED 5 drops 3 times daily ( group C ) or topical anesthetic 5 drops 3 times daily ( group D ) . A double-blind design was used , and all ear drops were placed in identical bottles . Treatment was initiated by the nurse in all cases . A single physician ( M.S. ) evaluated and treated all of the patients included in the study and recorded all of the data . The presence or absence of ear pain was assessed over 3 days with a visual analog scale . Ear pain was assessed by a specially devised observational instrument based on previous reports . One side of the instrument consisted of a linear numbered scale , from 1 ( no pain ) to 10 ( worst possible pain ) , and a corresponding color scale , ranging from blue to dark red . The reverse side contained a scale of 5 facial expressions , ranging from broad smile ( no pain ) to a sad and crying face ( worst possible pain ) , and a corresponding color scale , ranging from blue to dark red . RESULTS There were no significant between-group differences in patient age or gender , degree of fever , main symptoms , associated symptoms , and severity or laterality of acute otitis media . Each group had a statistically significant improvement in ear pain over the course of the 3 days . Pat 
    Output:
    
Severe complications were rare and did not differ between children treated with antibiotics and those treated with placebo .
This review reveals that antibiotics have no early effect on pain , a slight effect on pain in the days following and only a modest effect on the number of children with tympanic perforations , contralateral otitis episodes and abnormal tympanometry findings at two to four weeks and at six to eight weeks compared with placebo in children with AOM .
In high-income countries , most cases of AOM spontaneously remit without complications .
Antibiotics are most useful in children under two years of age with bilateral AOM , or with both AOM and otorrhoea .