***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: In an attempt to determine the effect of a decongestant with or without an antihistamine on the ventilatory function of the eustachian tube ( ET ) , two separate studies were conducted in 50 children who had had chronic or recurrent otitis media with effusion ( OME ) and in whom tympanostomy tubes had been inserted previously . The first was a double-blind study that compared the effect of an oral decongestant , pseudoephedrine hydrochloride , with that of a placebo in 22 children who developed an upper respiratory infection ( URI ) during an observation period . Certain measures of ET function were significantly elevated above baseline values during the URI , which was attributed to intrinsic mechanical obstruction of the ET . It was found that the oral decongestants tended to alter these parameters of ET function in the direction of the baseline ( preURI ) values . Even though the effect was statistically significant , the favorable changes in measurements of tubal function were only partial and were more prominent on the second day of the trial after the subjects had received four doses of the decongestant . However , the administration of nasal spray of 1 % ephedrine appeared to have no apparent effect on ET function in these children . The second study was a double-blind crossover design . In this study of 28 children who did not have a URI , the effect of a decongestant-antihistamine combination ( pseudoephedrine hydrochloride and chlorpheniramine maleate ) was compared with that of a placebo . When the subjects were given the decongestant-antihistamine medication , there were favorable changes in certain ET function measures which were not observed when they received the placebo . Again , the response differences between the two groups were statistically significant . Even though these two studies indicated that an oral decongestant appeared to affect favorably the ET function of children who had a URI , and that the combination of an oral decongestant and antihistamine had a similar effect on tubal function in children without a URI , an evaluation of the efficacy of these commonly employed medications must await the results of controlled clinical trials in children with OME Background : The value of tympanometry in detection of middle ear effusion ( MEE ) has been widely studied in otitis media with effusion . There has been no direct comparison of tympanometric and tympanocentesis ( TAP ) findings in acute otitis media ( AOM ) . We compared otoscopic , tympanometric and TAP findings in AOM including cases of AOM without effusion . Methods : In a study of AOM treatment of 90 children , a tympanogram was obtained , and TAP was performed before and after 5 days of treatment . Subjects were followed with otoscopy and tympanometry every 2 weeks for 3 months or until the MEE cleared . Results : In 130 AOM ears , otoscopic , tympanometric and TAP findings were available ; MEE was obtained from 110 ears . Of 20 ears with a dry tap , 18 had abnormal tympanogram and otoscopic findings . With TAP findings as the st and ard , sensitivity and positive predictive value of type B tympanogram were 97 and 87 % , respectively . Of 18 AOM ears yielding dry tap , 2 yielded MEE 5 days later , and 8 continued with evidence of MEE 5 days–12 weeks later . Five subjects with 8 AOM ears yielding dry tap were lost to follow-up ; all had short duration of clinical symptoms . Conclusions : Although otoscopic and tympanometric findings suggested the presence of MEE in AOM , MEE was unobtainable by TAP in 14 % of cases . Dry tap cases likely represent early AOM before accumulation of detectable MEE . However , technical difficulty in obtaining small amounts of or highly viscous MEE could not be excluded . Sensitivity and positive predictive value of abnormal tympanograms in detection of MEE in AOM cases are comparable with those in otitis media with effusion This study was design ed to investigate the efficacy of a decongestant-antihistamine preparation in combination with antibiotic treatment of acute otitis media . The effectiveness of a new Dimetapp ( DIM ) preparation was assessed in comparison with each of its components ( brompheniramine maleate [ BPM ] and phenylephrine hydrochloride [ PEH ] as well as a placebo ( PL ) vehicle in the treatment of acute otitis media . In a r and omized double blind study , 98 children were treated in the emergency department or outpatient medical clinics at Children 's Hospital of Michigan with amoxicillin and either DIM , BPM , PEH , or PL . They were evaluated at two weeks by clinical examination , pneumatoscopy , and tympanometry . Fifty-eight patients ( 59 % ) continued to have evidence of fluid in the middle ear . These patients were continued on the test medications for another two weeks and then reevaluated . There were significant differences between the treatment groups ( DIM , BPM , and PEH ) and the control PL group ; the patients receiving Dimetapp or placebo fared better than those receiving BPM or PEH . However , there was no difference in the overall response between Dimetapp and placebo . Antihistamine-decongestant therapy does not appear to be necessary in the treatment of acute otitis media in children OBJECTIVE Two potent mediators of acute inflammation , histamine and leukotriene B4 ( LTB4 ) , have been shown to play important roles in the pathogenesis and clinical course of acute otitis media ( AOM ) in children . The purpose of this study was to evaluate the ability of adjuvant drugs , antihistamine and corticosteroid , in reduction of the levels of histamine and LTB4 in the middle ear and their ability to improve outcomes of AOM . METHODS Eighty children with AOM ( aged 3 months to 6 years ) were enrolled in a prospect i ve , r and omized , double-blind , placebo controlled study . All children received one dose of intramuscular ceftriaxone and were r and omly assigned to receive either chlorpheniramine maleate ( 0.35 mg/kg per day ) and /or prednisolone ( 2 mg/kg per day ) or placebos three times a day for 5 days . Tympanocentesis was performed at enrollment and after 5 days of adjuvant drug treatment . MEFs were collected for bacterial and viral studies and histamine and LTB4 levels . The subjects were followed for the duration of middle ear effusion or up to 3 months . RESULTS Histamine or LTB4 levels in the MEF after 5 days of treatment were not significantly reduced by adjuvant drug treatment . However , subjects receiving corticosteroid had a lower rate of treatment failure during the first 2 weeks and shorter duration of middle ear effusion . CONCLUSIONS Five day of antihistamine or corticosteroid treatment does not reduce the levels of histamine or leukotriene B4 in the MEF of children with AOM . Positive clinical outcomes of AOM cases associated with corticosteroid treatment needs to be confirmed in a larger clinical trial of children with intact tympanic membranes , who do not receive tympanocentesis This study was performed to investigate the course of spontaneous recovery from otitis media with effusion in children with chronic rhinosinusitis treated in various ways . One hundred forty-one children between 3 and 10 years of age were selected for the presence of chronic rhinosinusitis and unilateral or bilateral otitis media with effusion . The children were assigned at r and om to one of four treatment groups , i.e. , placebo , amoxicillin combined with xylometazoline hydrochloride nose drops , maxillary sinus drainage , or a combination of the latter two forms of therapy . The follow-up period was 6 months . Drainage of the maxillary sinus had no effect on either the recovery of the chronic upper respiratory tract infection or otitis media with effusion . Amoxicillin combined with xylometazoline nose drops had no significant effect on recovery from the upper respiratory tract infection , but did have a small but significant effect on recovery from otitis media with effusion . However , the general tendency of the upper respiratory tract and ears to recover was poor . Persistence of the chronic upper respiratory tract infection during the follow-up period proved to be a negative prognostic factor with respect to cure of otitis media with effusion .  Children with chronic rhinosinusitis as defined in this study appear to have a high risk of developing chronic otitis media with effusion . The results of the study are discussed One hundred fifty-two children were enrolled in a r and omized , controlled clinical trial of the efficacy of phenylephrine hydrochloride nose drops or nasal spray in hastening the resolution of middle ear effusion .  Children with persistent effusion were recruited for the study during a return visit two weeks after an episode of acute otitis media . Forty-six patients ( 30 % ) dropped out of the study , many because they failed to tolerate the medication , especially the nose drops . Another 27 ( 18 % ) had to be excluded because of intercurrent illness or systemic drug therapy . Among those children completing the study , rates of clinical and tympanometric cure during the following four weeks were similar in the drug and placebo groups . In view of the absence of documented clinical efficacy and the practical difficulties inherent in their administration , topical decongestants appear to have a limited role , if any , in treating children with persistent effusion Abstract In this investigation , an oral decongestant was compared with placebo for effects on Eustachian tube function in 13 children with chronic serous otitis media . Objective measurements of Eustachian tube function can be made in patients who have had pressure-equalizing tubes placed through their tympanic membranes to maintain long-term ventilation of the middle ear . In a double-blind crossover study design , 5 children definitely responded to the oral decongestant , 4 children showed no response , and 4 children had a suggestive response . None of the 13 patients responded to the placebo . The oral decongestant evaluated contained  carbinoxamine maleate and pseudoephedrine hydrochloride .  It is concluded this decongestant would benefit some children with chronic serous otitis media , particularly those with allergic rhinitis In order to investigate the influence of an orally administered decongestant , norephedrine , upon the clinical course of acute otitis media and tubal function , a double-blind trial was performed in Copenhagen in December , 1976-February , 1977 , in which 93 patients , aged 6 months to 10 years , with 135 ears with acute otitis media , were treated either with norephedrine or placebo in a r and omized order . Most other treatment was avoided except for pain-relieving baby aspirins . The effect of norephedrine seemed to be no other than that of placebo . Because of this inefficacy of norephedrine the authors have , therefore , a material of patients with acute otitis media where the main treatment was pain-relieving  aspirin . The use and abuse of antibiotics in the treatment of this disease are discussed , and the authors stress the necessity of performing controlled studies of the efficacy of antibiotics in acute otitis media , since such studies do not exist OBJECTIVES To determine whether the adjunctive drugs antihistamine and corticosteroid improve immediate and long-term outcomes of acute otitis media ( AOM ) . STUDY DESIGN Children with AOM ( 3 mos-6 y ) were enrolled in a r and omized , double-blind , placebo-controlled trial . All 179 children received one dose of intramuscular ceftriaxone  and were assigned to receive either chlorpheniramine maleate ( 0.35 mg/kg/d ) and /or prednisolone ( 2 mg/kg/day ) or placebo for 5 days . Main outcome measures were rate of treatment failure during the first 2 weeks , duration of middle ear effusion , and rate of recurrences of AOM to 6 months . RESULTS Clinical outcomes and recurrence rates did not differ significantly with treatment . Children who received antihistamine alone had significantly longer duration of middle ear effusion ( median , 73 days ) than subjects in other treatment groups ( median , 23 to 36 days , P=.04 ) . Temporary normalization of tympanometric findings on day 5 occurred more frequently in the corticosteroid-treated group ( P=.04 ) . CONCLUSIONS Five-day treatment with antihistamine or corticosteroid , in addition to antibiotic , did not improve AOM outcomes . Antihistamine use during an acute episode of OM should be avoided , since the drug may prolong the duration of middle ear effusion . The efficacy of 7- to 10-day treatment of AOM with corticosteroid , in addition to antibiotic , deserves further investigation OBJECTIVE The aim of this study is to investigate the presence of Helicobacter pylori ( HP ) in the middle ear effusion by Campylobacter-like organism ( CLO ) test and whether it has a role in the ethiopathogenesis of chronic otitis media with effusion ( OME ) . STUDY DESIGN A prospect i ve r and omized and controlled study . METHODS This study was performed with 45 patients with the diagnosis of chronic OME and adenoid hypertrophy , between the ages 3 and 13 ( median 6 ) . Thirty patients constituted the study group ( 18 male ( 60 % ) and 12 ( 40 % ) female ) .  Adenoidectomy with myringotomy with ventilation tube insertion were performed to this group . Middle ear effusion and adenoid tissue pieces were collected and H. pylori presence was investigated by " CLO " testing . Fifteen patients of the matching age group ( 9 male ( 66.7 % ) and 6 ( 33.3 % ) female ) constituted the control group to whom adenoidectomy with myringotomy were performed but no middle ear effusion could be determined ( empty myringotomy patients ) . The wash out liquid of middle ear and pieces of adenoid tissue sample s were also collected from the control group . By using  CLO testing  , the presence 
    Output:
    
No benefit was found for early cure rates , symptom resolution , prevention of surgery or other complications .
Validity sub analyses demonstrated that lower quality studies found benefit , while analysis of those studies with higher validity scores found no benefit of treatment .
Given lack of benefit and increased risk of side effects , these data do not support the use of decongestant treatment in children with AOM .
There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results .