Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.37972.678345.0D (Published 26 February 2004) Cite this as: BMJ 2004;328:487
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The Editor when making his "Choices" and Koivunen P. et al. when
writing their paper "Adenoidectomy versus chemoprophylaxis and placebo for
recurrent acute otitis media in children under 2 years: randomised,
controlled trial." appeared unaware of the surgical scoop they had on
their hands.
'DESIGN Randomised, double blind, controlled trial.'implies that
neither the patient(understandable if under 2), the parents, the relatives
and the staff (including the surgeon) did not know if the patient had
undergone an operation or was taking medicines! If this were true then
other surgeons should be told about this not 'general' but 'global
anaesthetic' so they can better assess their surgical interventions
against this gold standard of clinical research.
If it were not true then the rest of the paper should be viewed with
great caution.
Competing interests:
I am an ENT surgeon
Competing interests: No competing interests
The main difficulty with this article is the lack of differentiation
between acute
otitis media (AOM), and otitis media with effusion (OME). AOM implies the
presence of middle ear effusion (MEE) with associated symptoms such as
fever, otalgia, otorrhea, or irritability. On the other hand, OME refers
to MEE
in the absence of acute symptoms. AOM and OME represent a spectrum of
disease.
In our opinion, the protocol used lead to confusion in diagnosis and
over
treatment of ear disease and thus decreased the study’s capacity to
effectively evaluate the use of adenoidectomy and chemoprophylaxis for AOM
in this population. Indeed, the outcome measure qualifying the presence of
MEE for more than 2 months as treatment failure is inappropriate because
it
can take up to 3 months for MEE to resolve after AOM(1) .
Furthermore, given that the prevalence of MEE on screening is
currently
estimated at 20%(2) , and that all children with MEE received antibiotic
treatment upon screening followed by myringotomy within 2 weeks of
persistent MEE followed by tubes and treatment assignment after 2 months
of
MEE, we consider that the authors were inappropriately biased towards
treatment and subsequent enrollment.
There is no indication as to the occurrence of AOM symptoms during
this
enrollment period, suggesting that authors effectively enrolled and
treated
patients with a history of recurrent AOM but without symptoms of AOM at
the
time of enrollment or treatment (hence enrolling patients with current
OME).
Similarly, follow-up assessment of ear status by an otolaryngologist at an
interval of at least every 4 months (suggesting that some patients were
seen
at intervals less than 4 months) is likely to have resulted in bias
towards
treatment failure because of the length of time required for MEE to
resolve.
Finally, analysis of secondary outcome measures in table 3 reveals a
low
incidence of AOM after enrollment suggesting that most treatment failures
were inappropriately attributed to MEE lasting more than 2 months.
Therefore, this study was biased against the potential positive
impact of
adenoidectomy and prophylactic pharmacotherapy because of an
inappropriate outcome measure.
(1)Rovers, M.M., Schilder, A.G.M., Zielhuis, G.A., Rosenfeld, R.M.
Otitis Media.
Lancet 2004;363:465-73.
(2)Casselbrant, M.L., Mandel, E.M. Epidemiology. In: Rosenfeld, R.M.,
Bluestone C.D., eds. Evidence-based otitis media. Hamilton, ON: BC Decker,
1999;117-36.
Competing interests:
None declared
Competing interests: No competing interests
The conclusion "We cannot recommended it as the primary method of
prophylaxis for children aged under 2 years." As said the recommendation
is for the recurrent acute otitis media only. The possible efficacy of
adenoidectomy to reduce chronic middle ear disease is not considered in
this study, and it is to be remembered that the recommendation to avoid
adenoidectomy does not mean that the operation should not be performed at
all in this age.
The investigation was made for common, but limited clinical and
pathological conditions; to investigate the acute episode and the
usefulness of the adenoidectomy in profylaxis against renewed episodes.
Acute otitis media is benign disease in most of cases. Severe
complications are nowadays rare. Even chronic otitis media has / seems to
have reduced in incidence along the last century.
But we still have chronic otitis media, reducing the capacity of
middle ear function, its aeration, causing atelectasis and impairing the
hearing. Atelectasis and chronic middle ear infection is more harmful for
the future function of the middle ear than recurrent acute otitis episodes
or even chronic, inflammatory secretory otitis media.
Competing interests:
None declared
Competing interests: No competing interests
I agree with the authors and would like to share my experiences.
In my practice, i have seen that feeding the child flat on it's back, is
more responsible for the acute attacks of otis media than any other cause.
I ask routinely whether the child is being fed while lying flat on
his back and the answer is mostly yes. Avoidance in the future is very
helpful in reducing the otitis media attacks.
Second most common cause is the cattarrh of the upper respiratory tract
and treating it with anti allergics and decongestants is very helpful.
Competing interests:
None declared
Competing interests: No competing interests
oter preventive methods
i want to add that i noticed that aom and even chronic suppurative
otitis media are highly associated with socioeconomical status of the
patient as i noticed that they are high in low socioeconomical status may
be because of bad feeding habbit, delay doctors consultation even if they
do, they didnot consult a specialist one, also i want to add that in a
case with recurrent otitis media, if they recieve treatment early if upper
respiratory infection occur it will decrease incidice of reperforation of
the tympanic membrane and when i said treatment i mean antibiotic and
nasal decongestant
Competing interests:
None declared
Competing interests: No competing interests