Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38210.827917.7C (Published 16 September 2004) Cite this as: BMJ 2004;329:651All rapid responses
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It is very interesting to have a randomised controlled trial of this
number of participants with a surgical intervention. The study added no
benefit to E.N.T. practice in the UK. The common practice in the UK decided on
the criteria for Tonsillectomy and Adenoidectomy years ago. The
methodology of this study raises some questions. It is not clear how the
randomisation has been conducted?. Was there any definition for
adenotonsillar hypertrophy which was the question of the study?.
Having a recorded stored data in a thermometer is unique for this study,
but is it valid and specific for throat infection or tonsillitis in an
eight year old child?
The study conducted the results depending on questionnaires. How reliable
are these questionnaires? Do they really reflect on the child’s health?
This study needs to answer many questions before it can be considered a
transformer of our practice.
Competing interests:
None declared
Competing interests: No competing interests
Rapid response
Effectiveness of adenotonsillectomy in Children(1) opens up more
discussion. It reiterates the Paradise criteria(2) for tonsillectomy.
Currently the guidelines vary in different units for listing the patients
for tonsillectomy regarding the frequency of tonsillitis and
adenotonsillectomy may be undertaken for less number of attacks.
The study also shows that there was no difference between the
surgical vs conservative management after 6 months upto 24 months. The
fact that sleep and eating patterns initially improved but no difference
after 24 months calls for the need for a multicentered randomised trial to
be undertaken.
The study could have included throat swab being taken while child is
having fever to differentiate between viral
and bacterial tonsillitis or any other upper respiratory tract infection.
This may help to reduce unwanted antibiotics usage in the community for
presumed tonsillitis. It also opens up further questions regarding the
indications of tonsillectomy and perhaps whether some children are exposed
to unnecseeary surgery and complications from it in some parts of the
world where the indications are not rigidly adhered to.
There is a limitation in the current study as about 50 children out
of 149 (3) allocated for watchful waiting group underwent
adenotonsillectomy also need to be taken into account while interpreting
the results.
References
1.Birgit K van staaji,emma H Van den Akker, Maroeska M Rovers, Gerrit
Jan Hordijk, arno W Hoes, Anne G M Schilder. Effectiveness of
adenotonsillectomy in children with mild symptoms of throat infections or
adenotonsilar hypertrophy: open, randomised controlled trial.Bmj
2004:329;651-654.
2.ParadiseJ, Bluestone C, Bachman R etal-Efficacy of tonsillectomy
for recurrent throat infection in severely affected children:results of
parallel randomised and nonrandomised control trials.N Eng J Med
1984:310:674-83.
3.Little P.Commentary: Watchful waiting is useful for children with
recurrent throat infection.BMJ 2004:329: 654.
Competing interests:
None declared
Competing interests: No competing interests
At present adenotonsillectomy is not carried out if children are
having mild symptoms unless there is some other general condition
warranting tonsillectomy. It has been the practice for many decades. I am
surprised that adenotonsillectomy is carried out for mild symptoms. How
can this be justified? Is it ethical?I do not see any benefit in carrying
out the above study. I feel the energy and resources could have been used
towards a useful study.
I am surprised that this has been accepted for publication.
Competing interests:
None declared
Competing interests: No competing interests
Anne Schilder and her Dutch colleagues are to be congratulated on the
successful completion of what remains a rare clinical research achievement
- an randomised controlled trial of surgical intervention.
In the UK, the Health Technology Assessment funded NESSTAC study
(North-East England and Scotland Study of Tonsillectomy and
Adenotonsillectomy in Childhood) is well under way, and now recruiting in
five sites: Newcastle upon Tyne, Liverpool, Manchester, Bradford and
Glasgow. As lead clinical investigator, I am encouraged by the Dutch
findings that we are addressing a worthwhile question on the cost-
effectiveness of what remains one of the commonest inpatient surgical
procedures in childhood.
The UK tonsil and adenoid practice is undoubtedly different from that
in the Netherlands. The NESSTAC study reflects these differences, with an
inclusion age range from four to 15 years of age. The Dutch study
recruited children aged 2 to 8 years: in the UK, tonsillectomy for reasons
other than obstructive symptoms is very uncommon under that age of 4
years. The NESSTAC entry threshold is 4 attacks in two consecutive years,
or more than 6 in one year - it is not surprising, therefore to a UK
otolaryngologist that surgery confers little benefit in children with two
or fewer sore throats preoperatively. Finally, adenoidectomy is performed
in most UK centres for separate indications - such as severe nasal block,
not merely as an adjunct to tonsillectomy in the management of recurrent
sore throat.
Thus, while it is encouraging that the Dutch group have successfully
completed a surgical trial in childhood, the results of the NESSTAC study
will address a different population of children and deliver results across
a broad range of clinical, health related quality of life and
socioeconomic domains.
Competing interests:
None declared
Competing interests: No competing interests
Sir,
We read with interest the large study by van Staaij BK et al (1) and
the commentary by Little P (2).
This large open, multi-centre randomised controlled trial was carried
out in the Netherlands. The paper states that all the patients randomised
had been send and assessed as appropriate according to current medical
practice. The paper itself makes no mention of the fact that these
practices vary from country to country. In the UK most ENT departments
would use the SIGN guidelines (3), which acknowledge that there is a
paucity of high quality evidence fro surgical intervention. Following the
SIGN guidelines, however, would mean that many of the children in the
randomised group would have been placed on a “watch and wait” policy. This
would appear to have been confirmed by the 34% in the watchful waiting
group who underwent adenotonsillectomy.
Tonsillectomy itself is of benefit in preventing sore throats due to
tonsillitis. Recurrent upper respiratory, infection, the commonest cause
of a fever in that age group, is not an indication for adenoidectomy and
therefore we are unsure as to how much information is added by the primary
outcome of a fever alone.
We agree with the authors that watchful waiting in children with mild
symptoms of throat infections or adenotonsillar hypertrophy is
appropriate.
1. Van Staaij BK, Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder
AG. Effectiveness of adenotonsillectomy in children with mild symptoms of
throat infections or adenotonsillar hypertrophy: open, randomised
controlled trial. BMJ 2004; 329: 651-654
2. Little P. Commentary: Watchful waiting is useful for children with
recurrent throat infections. BMJ 2004; 329: 654
3. Scottish Intercollegiate Guidelines Network. 1999. www.sign.ac.uk
Competing interests:
None declared
Competing interests: No competing interests
The well presented paper by van Staaij et al highlights the need for
clincians to carefully consider the effectiveness of surgical intervention
in children with mild symptoms of adenotonsillar disease.
In the abridged article, however, the very important information regarding
intervention rates is ommitted. In England, the intervention rate is
approximately 50% of the rate in the Netherlands. Interestingly, the rate
in Northern Ireland approximates the very high Dutch rate of surgical
intervention.
For the UK readership of the hard copy, this vital information is missing,
and the Dutch practice, may incorrectly be preceived as current practice
in England. Many ENT surgeons, GP's and paediatricians use guidelines such
as those from SIGN, (Scottish Intercollegiate Guidelines Network), to
inform decision making when discussing with parents surgical treatment
versus watchful waiting.
It is also disappointing that adenotonsillectomy has been considered as a
single intervention: for many years, in the UK, these have been considered
operations for different indications, that are however, sometimes
indicated together in the same age group.
The more interesting and important question is surely why there is such
variation in surgical rates in different parts of the UK and in the
Netherlands in comaprison to the rest of Europe?
Competing interests:
None declared
Competing interests: No competing interests
Sir,
Van Staaij BK et al (1) reported the inefficacy and the risk of the
intervention of adenotonsillectomy in children with mild symptoms of
throat infections or adenotonsillar hypertrophy. However, the need to
perform a pragmatic randomised controlled trial (RCT) without pragmatic
clinical indications is questionable.
We agree that frequent throat infections and obstructive sleep apnoea are
adequate indications for adenotonsillectomy. Anyway, the summary of
evidences based on RCT on the effectiveness of tonsillectomy comparing
with non surgical management in children with "severe" recurrent
tonsillitis show controversial results and gaps in the evidence, because
no RCT found improvement in major outcomes, as general wellbeing,
development or behaviour (2). Moreover, there is evidence of the
inefficacy of adenotonsillectomy in children with milder symptoms. A
previous RCT by Paradise J et al (3), concluded that "the modest benefit
conferred by tonsillectomy or adenotonsillectomy in children moderately
affected with recurrent throat infection seems not to justify the inherent
risks, morbidity, and cost of the operations”. So, on the basis of
previous evidences, the choice of design a RCT to study children with mild
symptoms of throat infections is not pertinent and ethically doubtful,
given also the risk related to the surgical procedures and the cost for
the whole health system.
Many studies showed a lack of agreement among general practitioners,
paediatricians and otolaryngologists about the management of children with
recurrent tonsillitis (4).
In Netherlands for example, during 1998 115 per 10,000 children underwent
adenotonsillectomy, 65% was performed without clear evidence of efficacy
(1). In Italy tonsillectomy rate during 2000 was 94.3 per 10,000 among
children aged 4-9 years, with a large variation across regions (5).
National guidelines have recently been agreed (5).
The wide variation in attitude toward tonsillectomy will probably continue
until the decision-making process of doctors involved in the treatment of
children with recurrent tonsillitis is better understood. Implementation
of evidence-based guidelines is a long time process and need major
commitment.
Federico Marchetti, consultant paediatrician
fedemarche@tin.it
Marzia Lazzerini, specialist registrar in paediatrics
Giorgio Longo, consultant paediatrician
Clinica Pediatrica, IRCCS Burlo Garofolo, Università di Trieste,
Via dell'Istria 65/1, 34100 Trieste, Italy
Competing interests: None declared
1.Van Staaij BK, van den Akker, EH, Rovers MM, Hordijk GJ, Hoes AW,
Schilder AGM. Effectiveness of adenotonsillectomy in children with mild
symptoms of throat infections or adenotonsillar hypertrophy: open,
randomised controlled trial. BMJ 2004;329:651-0
2.McKerrow W. Recurrent Tonsillitis. In: Clinical Evidence 7, June 2002,
pp477-80. London: BMJ Publishing Group, 2002
3.Paradise J, Bluestone C, Colborn D, Bernard B, Rockette H, Kurs-Lasky M.
Tonsillectomy and adenotonsillectomy for recurrent throat infection in
moderately affected children. Pediatrics 2002;110:7-15
4.Capper R, Canter RJ. Is there agreement among general practitioners,
paediatricians and otolaryngologists about the management of children with
recurrent tonsillitis? Clin Otolaryngol 2001;26(5):371-8.
5.Italian Ministry of Health, National Institute of Health, Agency of
Public Health Lazio Region, LINCO Project. The clinical and organisational
appropriateness of tonsillectomy and adenoidectomy
http://www.pnlg.it/LG/007tonsille/tonsillectomy.pdf
Competing interests:
None declared
Competing interests: No competing interests
Sir,
We read with interest and with concern the paper of van Staaij and
colleagues.1 The authors have conducted a large study that has
examined the effectiveness of adenotonsillectomy in children with
mild symptoms of throat infection or adenotonsillar hypertrophy.
Their conclusion is that adenotonsillectomy confers no major
clinical benefits over watchful waiting. We are concerned that the
conclusion may lead the reader into a false sense of security over
the safety of watchful waiting. The paper states that children with
suspected obstructive sleep apnoea have been excluded because
they scored more than 3.5 on Brouillette’s obstructive sleep
apnoea score.2 A more recent publication from Brouillette has
indicated that, whilst a score of greater than 3.5 is suggestive of
OSA, a score of less than this does not distinguish OSA from
primary snoring.3 Children with OSA are therefore unlikely to
have been excluded from the cohort described in the paper by van
Staaij. Several authors have demonstrated improvement in
neurocognitive outcome in children with OSA following
adenotonsillectomy4-6 and we are concerned that this important
outcome measure was not included in the van Staaij paper and
was not recognised as a limitation of the study in their discussion.
The result of watchful waiting in children with adenotonsillar
hypertrophy and OSA may deny these children potential for
behavioural and neurocognitive improvement.
1. Van Staaij BK, Akker EH, Rovers MM, Hordijk GJ, Hoes AW,
Schilder AG. Effectiveness of adenotonsillectomy in children with
mild symptoms of throat infections or adenotonsillar hypertrophy:
open, randomised controlled trial. Bmj 2004.
2. Brouilette R, Hanson D, David R, Klemka L, Szatkowski A,
Fernbach S, et al. A diagnostic approach to suspected obstructive
sleep apnea in children. J Pediatr 1984;105(1):10-4.
3. Brouillette RT, Morielli A, Leimanis A, Waters KA, Luciano R,
Ducharme FM. Nocturnal pulse oximetry as an abbreviated testing
modality for pediatric obstructive sleep apnea. Pediatrics
2000;105(2):405-12.
4. Blunden S, Lushington K, Kennedy D, Martin J, Dawson D.
Behavior and neurocognitive performance in children aged 5-10
years who snore compared to controls. J Clin Exp Neuropsychol
2000;22(5):554-68.
5. Goldstein NA, Fatima M, Campbell TF, Rosenfeld RM. Child
behavior and quality of life before and after tonsillectomy and
adenoidectomy. Arch Otolaryngol Head Neck Surg
2002;128(7):770-5.
6. Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A,
Friger M, Tarasiuk A, et al. Adenotonsillectomy improves
neurocognitive function in children with obstructive sleep apnea
syndrome. Sleep 2003;26(8):999-1005.
Competing interests:
None declared
Competing interests: No competing interests
Sirs,
In assessing the effectiveness of adenotonsillectomy in children with mild
symptoms of throat infections or adenotonsillar hypertrophy, Single
Patient Based Medicine (SPBM) helps doctors more efficaciously than EBM
(2) (See web-site HONCode 233736, www.semeioticabiofisica.it:
Constitutions. SPBM). In fact, although, the authors of an intriguing paper
state that, studying large number of patients, no clinically relevant
differences were found for health related quality of life, and
adenotonsillectomy was more effective in children with a history of three
to six throat infections than in those with none to two, not all young
subjects with tonsillar infection are equal, as regards the
presence of rheumatic constitutions, CAD real risk (3,4,5), kidney
condition, a.s.o. Therefore, in my opinion, doctors must know both EBM and
SPBM, which, in addition, provide physician with an efficacious objective
therapeutic monitoring.
1) Van Staaij B.K., Van den Akker E.M. et al. Effectiveness of
adenotonsillectomy in children with mild symptoms of throat infections or
adenotonsillar hypertrophy: open, randomised controlled trial
BMJ 2004;329:651 (18 September), doi:10.1136/bmj.38210.827917.7C
(published 10 September 2004)
2) Stagnaro Sergio, Stagnaro-Neri Marina. Introduzione alla Semeiotica
Biofisica. Il Terreno oncologico”. Travel Factory SRL., Roma, 2004.
http://www.travelfactory.it/semeiotica_biofisica.htm
3) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico-
Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la
definizione della Single Patient Based Medicine. Ediz. Travel Factory,
Roma, (in press).
4) Stagnaro S. Pivotal role of Biophysical Semeiotic Constitutions in
Primary Prevention. Cardiovascular Diabetology.2003, 2:1,
http://www.cardiab.com/content/2/1/13/comments#5753
5) Stagnaro S. A clinical efficacious maneouvre, reliable in bed-side
diagnosing coronary artery disease, even initial or silent, as well as
“heart coronary risk”. 3rd TCVC Argentine Congress of Cardiology,
September 2003 . http://www.fac.org.ar/tcvc/marcoesp/marcos.htm
Competing interests:
None declared
Competing interests: No competing interests
Re: Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial
Dear Editor,
Both our own practical experience and the fact that the number of peritonsillar abcesses / tonsil-related admissions for emergency appears to be on the rise – (due to the fact that fewer adenotonsillectomies are performed?) - motivated us to take a closer look at one of the important articles with regard to this subject.1,2,3 We are of the opinion that the conclusion of said article is untenable. That is why we present our not so ‘rapid response’ to an article published in 2004.
The authors state that adenontonsillectomy shows no clinical benefits over watchful waiting in children with mild complaints. But, let’s get our facts straight:
Out of the total number of eligible children only 25% were randomized in the end. The authors state that they found no major differences between included children and those who were eligible but not included, and refer to a previously published article.4 When we read that article, however, we notice that the group of children that was not randomized was –as expected- in worse condition. Approximately 10% (significant) more breathing difficulties, and 9% (significant) more tonsils showed abnormal appearance.
Then we notice the subsequent crossover of 34%; a very significant number. The original BMJ article only makes mention of the intention-to-treat analysis. Recently, the first author also presented the per-protocol analysis.5 Comparison of these analysis’ shows that the children who crossed from one group to the other had fever approximately 8-days, whereas the remaining children in the watchful waiting group and the children in the intervention group had an average 5 days of fever. (Calculated as follows: (149*5,93 - 99*4,8)/50 = 8,2. Although this calculation may not be absolutely correct - due to personal years instead of persons - it can not be too far of.)
Despite the afore-mentioned double selection, the group that underwent surgery fares better than the watchful waiting group, both clinically and in their quality of life.
In short, it appears that adenotonsilllectomy may indeed offer major benefits, even in children with only mild complaints. (Notice that for children with more serious complaints -Paradise criteria / high Brouillette's score- an adenotonsillectomy has already proven to be a good treatment option.2) This is in accordance with the results of Wilson et al., and sufficient reason to remain ‘sharp’ when evaluating the factors that may lead to this indication.6 Therefore, it is imperative to carefully consider the grounds before we withhold these children the obvious benefits of surgery. We are of the opinion, that the low incidence of fairly mild complications does not justify a physician’s refusal to surgically intervene when the clinical picture requires, and well-informed parents request such intervention.
References
1) http://www.bbc.co.uk/news/health-13433055
2) Van Staaij BK, Van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AGM. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. BMJ 2004 Sep 18;329(7467):651
3) De Ru JA, Martens EP, Tabor MP, Van Wermeskerken GKA. Adenotonsillectomie bij kinderen: een kritische kanttekening bij de ZATT-richtlijn. Ned Tijdschr KNO Heelk. 2012;18:27-29
4) Van den Akker EH, Rovers MM, Van Staaij BK, Hoes AW, Schilder AGM. Representativeness of trial populations: an example from a trial of adenotonsillectomy in children. Acta Otolaryngol 2003;123:297-301
5) Van Staaij. Commentaar op kanttekening bij ZATT-richtlijn. Ned Tijdschr KNO Heelk. 2012;18:30-1
6) Wilson JA, Steen IN, Lock CA, Eccles MP, Carrie S, Clarke R, Kubba H, Raine CH, Zarod A, Bond J. Tonsillectomy: a cost-effective option for childhood sore throat? Further analysis of a randomized controlled trial. Otolaryngol Head Neck Surg 2012;146:122-128
Competing interests: No competing interests