In a brief summary, antibiotics and antihistamines are not recommended
for ear infection (otitis media). Inserting tubes has a large chance of side effects, including hearing loss from scarring.
Naturopathic treatment is effective, and homeopathic treatment has been effective, both without side effects.
Pediatrics. 2003 May;111(5 Pt 1):e574-9.
Naturopathic treatment for ear pain in children.
Sarrell EM, Cohen HA, Kahan E.
Pediatric and Adolescent Ambulatory
Community Clinic of the General Health Services, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
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 designed 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 randomly
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 randomization 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.
Publication
Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 12728112 [PubMed - indexed for MEDLINE]
Arch Otolaryngol Head Neck Surg. 2003 May;129(5):517-22.
Chronic otitis media with effusion sequelae in children treated with
tubes.
Daly KA, Hunter LL, Lindgren BR,
Margolis R, Giebink GS.
University of Minnesota Otitis Media Research Center, University of Minnesota School of
Medicine, USA. dalyx002@umn.edu
OBJECTIVE: To determine incidence and prevalence of middle ear sequelae and abnormal
tympanometry results among children with chronic otitis media with effusion (OME) who received standard treatment with tympanostomy
tubes. DESIGN: Prospective cohort study. SETTING: Community clinic and academic medical center.Patients A total of 140 children
followed up for 8 years after tube treatment. MAIN OUTCOME MEASURES: Tympanic membrane perforation, atrophy, retraction, hearing
loss, myringosclerosis, low static admittance (SA) and broad-peaked tympanogram, high SA and narrow-peaked tympanogram, and
negative tympanometric peak pressure. RESULTS: Annual incidence of sequelae was typically greater during 3 to 5 years than
6 to 8 years of follow-up. Greatest increases in incidence during the 5-year follow-up were for atrophy (67%), high SA and
narrow-peaked tympanogram (70%), and retraction pocket (47%). Prevalence of these sequelae also increased over time, whereas
low SA and broad-peaked tympanogram and negative tympanometric peak pressure decreased during follow-up. Sequela tended to
become bilateral over time, and concordance of different sequelae in the same ear was low (kappa, 0.05-0.42). CONCLUSIONS:
Annual incidence of sequelae decreased during follow-up. This finding parallels decreasing incidence of OME and tube placement
as children mature and demonstrates that sequelae are more likely to develop during active acute and chronic OME. The cumulative
effect of incidence resulted in few ears free of sequelae by 8 years of follow-up. Based on this cohort of healthy children
with OME, although the risk of sequelae decreased over time, functional and morphologic sequelae were prevalent and may put
children at risk for continuing middle ear problems as they grow into adolescence and adulthood.
PMID: 12759263 [PubMed
- indexed for MEDLINE]
Ann Otol Rhinol Laryngol. 2002 Nov;111(11):1034-9.
Otolaryngological surgery and upper respiratory tract infections
in children: an epidemiological study.
Kvaerner
KJ, Nafstad P, Jaakkola JJ.
The objective of the study was to assess the occurrence of different procedures of
upper airway surgery and estimate their relationship to specific upper respiratory tract infections and constitutional factors.
In a population-based cross-sectional study in Oslo. Norway, of 3,763 preschool children 3 to 4 years of age, the otolaryngological
surgeries adenoidectomy, tonsillectomy, myringotomy, ventilation tube insertion, and combinations of these were the outcome
measures. The results showed that by 4 years of age, 13% (n = 501) had undergone operation, and approximately two thirds of
the operations involved middle ear surgery. Although surgery was related to the occurrence of upper respiratory tract infections,
the type of surgery was not related to the specific infection. In the children with operations, the occurrence of recurrent
otitis media (> or = 3 infections in the previous 12 months) was almost fivefold higher than in children without operations
(adjusted adds ratio [ORadj] = 5.19 [3.15 to 8.54]). A low level of maternal education (ORadj = 1.61 [1.05 to 2.7] compared
to the group with a high level of education) and atopy on the part of the child (ORadj = 1.58 [1.20 to 2.07]) increased the
probability for upper airway surgery independently of the experience of infections. In conclusion, early pediatric otolaryngological surgery is common. The decisions for surgical treatment vary substantially
and are not closely related to the specific infections. The influence of other factors such as maternal education indicates
that decisions for surgery are not entirely based on medical evidence.
PMID: 12450180 [PubMed - indexed for MEDLINE]
Altern Med Rev. 2003 Feb;8(1):28-42.
Can CAM therapies help reduce antibiotic resistance?
MacKay D.
Thorne Research, PO Box 25, Dover, ID 83825, USA.
duffy@thorne.com
The Centers for Disease Control and Prevention (CDC) reported the consumption of 235 million doses
of antibiotics in 2001. It is estimated that 20-50 percent of these were unnecessarily prescribed for viral infections. Bacteria
that antibiotics have controlled in the past are increasingly developing resistance to these drugs. Today, virtually all important
bacterial infections in the United States and throughout the world are becoming resistant. For this reason, antibiotic resistance
is among the CDC's top concerns. A large portion of antibiotics are dispensed by pediatricians treating common outpatient
infectious diseases. The overuse of antimicrobials is beginning to be discouraged as scientific evidence is emerging to support
the use of other therapies. In pediatric practice an emphasis on accurate diagnoses, control of environmental risk factors,
and utilization of complementary and alternative medicine (CAM) therapies could reduce antibiotic prescribing. Antibiotic
resistance poses a growing threat to health. CAM therapies may provide a safer, more effective treatment for many acute infections
of childhood.
Associate Professior
in Clinical Epidemiology, Dept of Social & Preventive Medicine, Medical School, Herston QLD 4006, Australia, 4006. P.Glasziou@spmed.uq.edu.au
BACKGROUND:
Acute otitis media is one of the most common diseases in early infancy and childhood. Antibiotic use for acute otitis media
varies from 31% in the Netherlands to 98% in the USA and Australia. OBJECTIVES: The objective of this review was to assess
the effects of antibiotics for children with acute otitis media. SEARCH STRATEGY: We searched the Cochrane Controlled Trials
Register, MEDLINE, Index Medicus (pre 1965), Current Contents and reference lists of articles from 1958 to January 2000. SELECTION
CRITERIA: Randomised trials comparing antimicrobial drugs with placebo in children with acute otitis media. DATA COLLECTION
AND ANALYSIS: Three reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Ten trials were eligible
but only seven trials, with a total of 2,202 children, included patient-relevant outcomes. The methodological quality of the
included trials was generally high. All trials were from developed countries. The trials showed no reduction in pain at
24 hours, but a 28% relative reduction (95% confidence interval 15% to 38%) in pain at two to seven days. Since approximately
80% of patients will have settled spontaneously in this time, this means an absolute reduction of 5% or that about 17 children
must be treated with antibiotics to prevent one child having some pain after two days. There was no effect of antibiotics
on hearing problems of acute otitis media, as measured by subsequent tympanometry. However, audiometry was done in only
two studies and incompletely reported. Nor did antibiotics influence other complications or recurrence. There were few serious
complications seen in these trials: only one case of mastoiditis occurred in a penicillin treated group. REVIEWER'S CONCLUSIONS:
Antibiotics provide a small benefit for acute otitis media in children. As most cases will resolve spontaneously, this
benefit must be weighed against the possible adverse reactions. Antibiotic treatment may play an important role in reducing
the risk of mastoiditis in populations where it is more common. [This abstract has been prepared centrally.]
A child with earache. Are antibiotics the best treatment?
Del Mar C, Glasziou P.
Centre for General Practice, University
of Queensland. C.DelMar@cgp.uq.edu.au
BACKGROUND: Conventional management of acute otitis media, deduced from pathophysiology,
embodies scant regard to analgesia, but concentrates on the microbiological cure by the use of antibiotics. OBJECTIVE: A commonly
encountered case of uncomplicated acute otitis media in a child of three is presented. An evidence based approach to management
is offered. RESULTS: The search for empirical evidence of patient relevant benefits and harms challenges the conventional
approach. A Cochrane review of the literature on the use of antibiotics for acute otitis media shows that the benefits
of antibiotic use (reduced pain in those children who go on to suffer pain beyond 24 hours) are offset by adverse events from
the antibiotics themselves (gastrointestinal symptoms and rashes). There is insufficient information to be sure about
rare complications of not using antibiotics as well using them, but it seems that in either case, catastrophe is very rare.
DISCUSSION: Thinking in terms of a balance of harms and benefits would result in a decreased proportion of children prescribed
antibiotics for acute otitis media.
Decongestants and antihistamines for acute otitis media in
children.
Flynn CA, Griffin G, Tudiver F.
Department
of Family Medicine, State University of New York Upstate Medical University, Suite 200, 475 Irving Avenue, Syracuse, New York
13210, USA. flynnc@upstate.edu
BACKGROUND: Acute otitis media (AOM) is a common and important source of morbidity in
children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy
is of unclear benefit. OBJECTIVES: To determine the efficacy of decongestant and antihistamine therapy in children with AOM
on outcomes of AOM resolution, medication side effects, and complications of AOM. SEARCH STRATEGY: Comprehensive search of
Cochrane's Controlled Trials Registry, Medline and Embase was conducted. Bibliographic review and requests for information
from study authors and pharmaceutical companies supplemented this. SELECTION CRITERIA: Randomized controlled trials evaluating
decongestant (DC) or antihistamine (AH) treatment for children with AOM were included. Patient-oriented outcomes were considered
most relevant. There were no quality or language restrictions. DATA COLLECTION AND ANALYSIS: Investigators independently evaluated
studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate
relative risks and numbers needed to treat, and homogeneity was assessed using approximate chi-square tests. MAIN RESULTS:
For the combined control groups, healing rates at 2 weeks were high, with rates of persistent AOM <23%. No additional benefit
was demonstrated from intervention subgroupings DC, AH, or any medication (DC and/or AH). Only the combined treatment (DC
+ AH) group demonstrated statistically lower rates of persistent AOM at the 2-week period (RR 0.76, 95% CI, NNT 10.5, 95%
CI). No benefit was found for other outcomes including early or late cure rates, symptom resolution, prevention of surgery
or other complications. There was an increased risk of medication side effects for those receiving an intervention, which
reached statistical significance for the "any medication" and decongestant groupings (NNH 16.6, 14.3 respectively, 95% CI
). Validity subanalyses demonstrated that lower quality studies found benefit, but analysis of those studies with higher validity
scores found no benefit to treatment. REVIEWER'S CONCLUSIONS: Given lack of benefit and increased risk of side effects,
these data do not support the use of decongestant, antihistamine, or combined DC/AH treatment in children with AOM. The
small statistical benefit found in the combination medication group is of small clinical significance and study design may
be biasing the results.
Publication Types:
Review
Review, Academic
PMID: 11869604 [PubMed - indexed for MEDLINE]
Arch Pediatr Adolesc Med. 2001 Jul;155(7):796-9.
Efficacy of naturopathic extracts in the management of ear pain associated
with acute otitis media.
Sarrell EM, Mandelberg
A, Cohen HA.
Pediatric and Adolescent Ambulatory Community Clinic of General Health Services, Hairis 7 Moshav Gan-Haim,
44910 Israel. sarrell@netvision.net.il
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 randomly 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.
Publication Types:
Clinical Trial
Randomized Controlled Trial
PMID: 11434846 [PubMed - indexed for MEDLINE]
Complement Ther Med. 1999 Sep;7(3):132-5.
A randomized comparison of homoeopathic and standard care
for the treatment of glue ear in children.
Harrison
H, Fixsen A, Vickers A.
OBJECTIVE: To pilot a model for determining whether homoeopathic treatment of children
suffering from glue ear is more effective than standard GP care at producing a return to normal hearing (a hearing loss of
less than 20 dB) within 12 months. DESIGN: Non-blind, randomized controlled trial. SETTING: General practice in two locations
in southern England. SUBJECTS: Thirty-three children aged 18 months to 8 years with otitis media with effusion, hearing loss
> 20 dB and an abnormal tympanogram. OUTCOME MEASURES: Hearing loss, tympanogram, referrals to specialists and number of
courses of antibiotics at 12 month follow-up. RESULTS: A higher proportion of children receiving homoeopathic care had a hearing
loss less then 20 dB at follow-up (64 vs 56%), though this difference did not reach statistical significance (95% confidence
interval for the difference between means of -25 and 42%). More homoeopathy patients than controls had a normal tympanogram
(75 vs 31%, P = 0.015). Referrals to specialists and antibiotic consumption was lower in the homoeopathy group, though differences
between groups did not reach statistical significance. CONCLUSION: Further research comparing homoeopathy to standard
care is warranted. Assuming recovery rates of 50 and 30% in homoeopathy and standard care groups respectively, 270 patients
would be needed for a definitive trial.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 10581822 [PubMed - indexed for MEDLINE]
Int J Clin Pharmacol Ther. 1997 Jul;35(7):296-301.
The homoeopathic treatment of otitis media in children--comparisons
with conventional therapy.
Friese KH, Kruse
S, Ludtke R, Moeller H.
Haunersches Kinderspital, Munchen, Germany.
In a prospective observational study
carried out by 1 homoeopathic and 4 conventional ENT practitioners, the 2 methods of treating acute pediatric otitis media
were compared. Group A received treatment with homoeopathic single remedies (Aconitum napellus, Apis mellifica, Belladonna,
Capsicum, Chamomilla, Kalium bichromicum, Lachesis, Lycopodium, Mercurius solubilis, Okoubaka, Pulsatilla, Silicea), whereas
group B received nasal drops, antibiotics, secretolytics and/or antipyretics. The main outcome measures were duration
of pain, duration of fever, and the number of recurrences after 1 year, whereby alpha < 0.05 was taken as significance
level. The secondary measures were improvement after 3 hours, results of audiometry and tympanometry, and necessity for additional
therapy. These parameters were only considered descriptively. The study involved 103 children in group A and 28 children in
group B, aged between 6 months and 11 years in both groups. For duration of pain, the median was 2 days in group A and 3 days
in group B. For duration of therapy, the median was 4 days in group A and 10 days in group B: this is due to the fact that
antibiotics are usually administered over a period of 8-10 days, whereas homoeopathics can be discontinued at an earlier stage
once healing has started. Of the children treated, 70.7% were free of recurrence within a year in group A and 29.3% were
found to have a maximum of 3 recurrences. In group B, 56.5% were free of recurrence, and 43.5% had a maximum of 6 recurrences.
Out of the 103 children in group A, 5 subsequently received antibiotics, though homoeopathic treatment was carried through
to the healing stage in the remaining 98. No permanent sequels were observed in either group.
Effect of homoeopathic medicines on daily burden of symptoms
in children with recurrent upper respiratory tract infections.
de Lange de Klerk ES, Blommers J, Kuik DJ, Bezemer PD, Feenstra L.
Vakgroep Epidemiologie en Biostatistiek,
Faculteit der Geneeskunde, Vrije Universiteit, Amsterdam, Netherlands.
OBJECTIVE--To investigate the intrinsic effects
of individually prescribed homoeopathic medicines. DESIGN--Randomised double blind placebo controlled study. SETTING--Paediatric
outpatient department of university hospital. PATIENTS--175 children with frequently recurring upper respiratory tract infections.
Of the 170 children evaluable, 86 were randomised to homoeopathic medicines (47 boys, 39 girls; median age at start 4.2 years;
median number of episodes in past year 4) and 84 to placebo (43 boys, 41 girls; median age at start 3.6 years; median number
of episodes in past year 4). MAIN OUTCOME MEASURES--Mean score for daily symptoms, number of antibiotic courses, and number
of adenoidectomies and tonsillectomies over one year of follow up. RESULTS--The mean daily symptom score was 2.61 in the placebo
group and 2.21 in the treatment group (difference 0.41; 95% confidence interval -0.02 to 0.83). In both groups the use
of antibiotics was greatly reduced compared with that in the year before entering the trial (from 73 to 33 in the treatment
group and from 69 to 43 in the placebo group). The proportion of children in the treatment group having adenoidectomies was
lower in the treatment group (16%, 8/50) than in the placebo group (21%, 9/42). The proportion having tonsillectomies was
the same in both groups (5%). CONCLUSION--Individually prescribed homoeopathic medicines seem to add little to careful
counselling of children with recurrent upper respiratory tract infection in reducing the daily burden of symptoms, use of
antibiotics, and need for adenoidectomy and tonsillectomy.
Use of antibiotics in preventing recurrent acute otitis media
and in treating otitis media with effusion. A meta-analytic attempt to resolve the brouhaha.
Williams RL, Chalmers TC, Stange KC, Chalmers FT, Bowlin SJ.
MetroHealth
Clement Center, Cleveland, OH.
OBJECTIVE--To determine the efficacy of antibiotics for prophylaxis of recurrent otitis
media and treatment of otitis media with effusion (OME) in children. DATA SOURCES--MEDLINE from 1966 through April 1993, textbooks,
Current Contents, and bibliographies of selected articles. STUDY SELECTION--Thirty-three studies initially identified were
reviewed by three blinded reviewers assessing study quality and suitability for inclusion. Twenty-seven met inclusion criteria
for the meta-analyses. DATA EXTRACTION--We abstracted quantitative data and calculated rate differences (RDs) using tympanometry
as the preferred outcome measure. DATA SYNTHESIS--Nine studies of antibiotic prophylaxis of recurrent otitis media with 958
subjects had an RD of 0.11 (95% confidence interval [Cl], 0.03 to 0.19) favoring antibiotic treatment. Twelve studies of short-term
patient outcomes of OME with 1697 subjects had an RD favoring antibiotics of 0.16 (95% Cl, 0.03 to 0.29), while eight studies
using the ear as the outcome measure with 2052 ears studied had an RD of 0.25 (95% Cl, 0.10 to 0.40). No significant difference
was shown between placebo and antibiotics (RD, 0.06; 95% Cl, -0.03 to 0.14) in the eight studies of longer-term outcome of
OME. Subgroup analyses by antibiotic grouping, duration of treatment, and duration of disease did not show significant differences.
CONCLUSIONS--Antibiotics appear to have beneficial but limited effect on recurrent otitis media and short-term resolution
of OME. Longer-term benefit for OME has not been shown. The findings are limited by the failure of most studies to consider
potential confounders and by inability to identify groups of patients most likely to benefit.
Antimicrobial therapy for otitis media with effusion ('secretory'
otitis media).
Cantekin EI, McGuire TW,
Griffith TL.
Department of Otolaryngology, University of Pittsburgh, PA.
OBJECTIVE--To determine the effectiveness
of antimicrobial treatment for otitis media with effusion ("secretory" otitis media) in children. DATA SOURCE--We report the
reexamination of a previously published study by Mandel et al that evaluated the efficacy of a 2-week course of antimicrobials
(amoxicillin trihydrate) with and without a 4-week course of an oral decongestant-antihistamine combination in a double-blind,
placebo-controlled, randomized trial involving 518 infants and children with otitis media with effusion. DATA SYNTHESIS--At
4 weeks, amoxicillin efficacy as determined by a tympanometric criterion (P = .121) or by a measure of improvement in hearing
(P = .311) was insignificant. Only by otoscopic judgment, which is shown to contain a systematic bias as used in this
clinical trial, could an argument be made for a marginal efficacy of amoxicillin at the 4-week end point. Logistic regression
analyses of the combined effects of treatment and prognostic factors showed no significant differences between placebo- and
antibiotic-treated groups for unilateral effusions and for bilateral effusions. When subjects with unilateral and bilateral
effusions were combined, the estimated efficacy of antibiotic treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry
(P = .171). We also demonstrate the sensitivity of outcome to diagnostic measures used and provide statistical evidence questioning
the validity of otoscopic observations in this study. Six weeks after the termination of amoxicillin therapy, the recurrence
of effusion was two to six times higher in the amoxicillin-treated children than in those treated with placebo (P = .001),
and resolution of effusion was not significantly different among antibiotic and placebo groups (13.6% and 11.3%, respectively;
P = .477). CONCLUSIONS--Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment
of persistent asymptomatic middle-ear effusions in infants and children.
