***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: 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 . Patients who were given ear drops alone had a better response than patients who were given ear drops together with amoxicillin . Results were better in the NHED group than in the controls . Nevertheless , the findings indicated that the pain was mostly ( 80 % ) self-limited and could be explained simply by the time elapsed . The American Academy of Otolaryngology-Head and Neck Surgery guidelines recommend topical medications as the first line of treatment for ear pain in the absence of systemic infection or serious underlying disease . Because no evidence was found that systemic antibiotics alone improved treatment outcome , if antibiotics do not change the natural course of otitis media , then the main goal of treatment , as in the present study , should be to alleviate the ear pain . The alternative , naturopathic herbal extract medications , may offer many new possibilities in the management of ear pain associated with AOM . Primary care physicians should be aware that at least 10 % of their patients may have tried 1 or more forms of alternative/complementary medicine before presenting for consultation . As it was widely reported in the medical literature , these herb , these herbal extracts have the potential to meet all of the requirements of appropriate medication that could be routinely used in the pediatric patient , namely in vitro bacteriostatic and bacteriocidal activity against common pathogens , immunostimulation ability , antioxidant activity , and anti-inflammatory effects . They are also well-absorbed with good penetration into the tissue surrounding the tympanic membrane . They have been found to enhance local immunologic activity . Finally , herbal extracts are well-tolerated ( owing to their long elimination time ) , easy to administer , and less expensive than the new antibiotics . There are no documented side effects . On the basis of our findings that the group with the most significant treatment effects ( NHED with topical anesthetic ) explained only 7.3 % of the total pain reduction , we propose that sometimes the general practitioner or pediatrician needs to give the human body a chance to repair itself . Nevertheless , if the physician believes that there is an indication for some treatment , especially if the parents are anxious , then a local treatment such as one used in our study might be adequate . CONCLUSIONS This study suggests that in cases of ear pain caused by AOM in children in which active treatment , besides a simple 2- to 3-day waiting period , is needed , an herbal extract solution may be beneficial . Concomitant antibiotic treatment is apparently not contributory The incidence of  acute otitis media and its response to treatment only with nose drops and analgesics ( but without antibiotics or myringotomy ) were assessed over three months by 45 doctors in and around Tilburg . In addition , over 17 months 60 general practitioners assessed the effects of this limited treatment in children aged 2 to 12 years and referred all those in whom the condition took an unsatisfactory course ( either a severe course -- illness continuing beyond three to four days with high temperature or pain , or both -- or persistent discharge after 14 days ) to an ear , nose , and throat specialist . Those referred because of appreciable illness continuing beyond three or four days were entered into a further study , comparing the effects of myringotomy alone , antibiotics alone , and myringotomy and antibiotics combined .  Bacteriology was assessed in all children in whom the course of the condition was unsatisfactory . More than 90 % of an estimated 4860 children seen over 17 months ( estimation based on incidence of severe course in the three month study ) recovered within a few days . The course of the condition was severe in only 126 ( 2.7 % ) patients ; haemolytic streptococci group A were identified in 30 of these 126 patients but Haemophilus influenzae in only one . One hundred of these patients with a severe course entered the trial of treatment , which showed antimicrobial treatment  either alone or in combination to be more effective than myringotomy alone . Whether combined treatment was more effective than antibiotics alone remained unconfirmed .  Acute otitis media in children can be treated with nose drops and analgesics alone for the first three to four days . Patients in whom this regimen is not accompanied by satisfactory recovery can be recognised within a short time and treated by the general practitioner Iontophoresis has been reported as a safe method of tympanic membrane anesthesia but data concerning variations and advances in technique are not available . Normal volunteers were used to determine the effects of varying canal preparation , epinephrine concentration , current level and duration . The two optimal techniques were compared in two groups of ten volunteers . A similar duration of anestheia ( 90 to 115 min . ) was found for both techniques . Clinical application of two techniques for the purpose of myringotomy and /or ventilation tube placement was done in 60 ears of 49 selected private patients with middle ear effusions . Techniques were used at r and om in the first 23 ears with equal success . The newly developed dry canal preparation method using lower current and longer time was preferred , because of convenience and added safety , in the last 37 procedures . Failure of anesthesia occurred once with acute otitis media and once due to electrode displacement . Fifty-eight procedures result ed in successful myringotomy and /or tube placement . Proper case selection , prevention of technical problems , advantages , and practical limitations of this anesthesia method are discussed OBJECTIVE To determine the efficacy and tolerance of Otikon Otic Solution ( Healthy-On Ltd , Petach-Tikva , Israel ) , a naturopathic herbal extract ( containing Allium sativum , Verbascum thapsus , Calendula flores , and Hypericum perforatum in olive oil ) , compared with Anaesthetic ( Vitamed Pharmaceutical Ltd , Benyamina , Israel ) ear drops ( containing ametocaine and phenazone in glycerin ) in the management of ear pain associated with acute otitis media ( AOM ) . DESIGN Children between the ages of 6 and 18 years who experienced ear pain ( otalgia ) and who were diagnosed with eardrum problems associated with AOM were r and omly assigned to be treated with Otikon or Anaesthetic ear drops , which were instilled into the external canal(s ) of the affected ear(s ) . Ear pain was assessed using 2 visual analog scales : a linear scale and a color scale . Pain assessment took place throughout the course of 3 days . The mean score of pain reduction was used to measure outcome . SETTING Primary pediatric community ambulatory centers . PARTICIPANTS One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM . RESULTS Each of the 2 treatment groups were comparable on the basis of age , sex , laterality of AOM , and the effectiveness of ameliorating symptoms of otalgia . The 2 groups were also comparable to each other in the initial ear pain score and in the scores at each application of Otikon or Anaesthetic drops . There was a statistically significant improvement in ear pain score throughout the course of the study period ( P = .007 ) . CONCLUSIONS Otikon , an ear drop formulation of naturopathic origin , is as effective as Anaesthetic ear drops and was proven appropriate for the management of AOM-associated ear pain OBJECTIVE To determine the efficacy of Auralgan otic solution ( combination product of antipyrine , benzocaine , and glycerin ) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media ( AOM ) . DESIGN Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were r and omly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s ) of the affected ear(s ) . All children were also treated with 15 mg/kg of acetaminophen in a single dose . Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10 , 20 , and 30 minutes later ( T0 , T10 , T20 , and T30 , respectively ) . Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score . A baseline ear pain score of at least 3 points was required for study entry . Four outcome measures regarding ear pain score at T10 , T20 , and T30 were used : ( 1 ) proportion of subjects who showed 50 % reduction , ( 2 ) proportion of subjects who showed 25 % reduction , ( 3 ) proportion of subjects who showed a 1 or more point reduction , and ( 4 ) mean score over time . SETTING Primary care center and emergency department of a children 's hospital . PARTICIPANTS Fifty-four children aged 5 to 19 years with ear pain and AOM . RESULTS The Auralgan and placebo groups were comparable regarding age , sex , race , laterality of AOM , and T0 ear pain score . By each of the 4 measures used , the response to treatment consistently favored the Auralgan group , but only at T30 were any differences statistically significant . CONCLUSION In children with AOM-associated ear pain who are treated with acetaminophen , topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes Nimesulide , 4-nitro-2-phenoxymethanesulphonanilide , a new non-steroidal anti-inflammatory drug endowed with potent anti-inflammatory , analgesic and antipyretic activities , was tested at a daily dose of 200 mg b.i.d . against Benzydamine on a double-blind basis , in a r and omized trial with fifty out- patients suffering from inflammatory ear , nose and throat diseases ( otitis media , sinusitis , rhinitis ) .  Nimesulide treatment brought about an immediate and significant improvement in over-all pain , exudation , oedema and headache and produced a rapid lowering in body temperature . The recovery was more rapid and significant in patients with Nimesulide  than in those with Benzydamine . The signs and symptoms under consideration reached almost complete resolution within the set treatment-period of 10 days . Clinical tolerability of Nimesulide was better than that of Benzydamine : one case of moderate gastric pyrosis and drowsiness was complained of by the Nimesulide-treated patients versus eleven cases of gastro-intestinal discomfort , mouth dryness , and /or drowsiness which were complained of by the Benzydamine-treated ACUTE otitis media is an episodic disease in which individual occurrences usually resolve without specific treatment . Sequelae of acute or recurrent infection , however , are often serious and include decreased hearing , chronic mastoiditis , meningitis , cholesteatoma , tympanosclerosis , destruction of the ossicular chain , or facial nerve damage . Specific treatment of the disorder is largely aim ed at preventing or reducing sequelae or complications , rather than affecting the acute episode itself . In a recent review of two Finnish prospect i ve studies , Quarnberg and Palva 1 state : " Treatment of acute otitis media  , which was very straightforward up to the 1950s , has during the era of antibiotics given rise 
    Output:
    
The evidence from these four r and omised controlled trials , only one of which addresses the most relevant question of primary effectiveness , is insufficient to know whether ear drops are effective or not