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The PITCH studies and
editorial have been made available for free by the BMJ because it is "in the
public interest" (1)
However, when reading the PITCH studies it is unclear
why it can contribute to the health of the public. On the contrary it can
actually cause harm. (2) This oversight by the BMJ is due to the fact that
the study is based on two outdated assumptions: fever is bad and collusion
with parents to suppress fever is best. (3)
Dr Harnden appraised the study with a more open mind
and challenged the above two assumptions by thinking outside of the box.
However, in his discourse, he fell unfortunately for these two reigning
paradigms after all. The fact that a placebo was not used in the study makes
it unable to advice on the effects of analgesics on the healing process in
feverish children. Furthermore, an exploration of the benefits of fever and
an exploration of indications in the medical literature of possible (long
term) adverse effects of anti-inflammatory medicines that suppress the
natural healing process was not pursued. Probably 'peer-paradigm' pressure
made him collude with the unscientific and emotive advice of the study and
he stepped into the box 'what this study adds' by adding the last two
sentences to his editorial. (4)
The PITCH studies don't appear to have been designed in
the children's best interest and as such can be viewed as unethical. Also
the study did not pursue or discussed new avenues but maintained outdated
assumptions.
The ongoing consequences for children and parents of
publications of studies that maintain fever phobia calls for a serious
professional inquiry and discussion in the public domain, particularly with
reference to the GMC guidance: 'Doctors should always act in the best
interest of children and young people. This should be the guiding principle
in all decisions which may affect them.' (5)
Others have also noted that fever phobia is still being
maintained despite information in the medical literature spanning some
decades indicating that elevated temperatures in infectious childhood
diseases do not need treatment. (6,7) Children are a non-vocal group and
pharmacovigilance doesn't seem to be a priority for researchers as it is for
vocal groups as, for example, menopausal women (HRT) or adults with
osteoarthritis (COX2). However, there are more possible casualties due to
analgesics in children. (8, 9)
Research departments, national institutes, public
health departments and medical journals can help to address the above two
assumptions with for example, the following research areas:
·
the incidence of children needing dialysis due to ibuprofen
http://www.bmj.com/cgi/content/full/336/7637/171-b
·
the number of overdoses due to concomitant use of OTC (over
the counter) drugs
http://www.dailymail.co.uk/pages/live/articles/health/womenfamily.html?in_article_id=508914&in_page_id=1799
·
raised liver function test due to paracetamol
http://www.bmj.com/cgi/content/full/333/7559/141
·
is paracetamol use related to the current surge in NASH
(non-alcoholic steatosis hepatis)
·
It is illogical to prescribe an anti-inflammatory medicine in
case of infection.
·
Parents are giving their children analgesics as a panacea for
a variety of conditions like sniffles, coughs, sleep problems, grumpiness,
nausea etc. It would be good to document the home use of these medicines
that work against the healing process of inflammation.
·
Why are parents using analgesics as a panacea, are the adverts
on the products misleading?
·
Cox II inhibitors and third generation COC have been taken off
the market due to risks that are incomparably low as compared to the number
of adverse events involved with anti-inflammatory products in children. HRT
is now only advised for women for symptom control and only for short
duration and not as a panacea. Is this selective pharmacovigilance due to
the fact that young children are a non-vocal group?
·
Increase in empyemas in children due to paracetamol
(anti-inflammatory) use?
http://www.bmj.com/cgi/content/full/332/7553/1333
·
Are children who are given regular paracetamol and ibuprofen
more likely to develop lower respiratory tract infections?
·
The diurnal variation of an uncomplicated (viral) childhood
fever needs to be established as the temperature rises and falls during a
24-hour period. This observation is important as it can be used to explain
the fever process to parents. (Circadian rhythms)
http://www.ncbi.nlm.nih.gov/pubmed/17164515?ordinalpos=13&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
·
The process of the distribution of the heat needs to be
confirmed, that a temperature develops from the top of the body (head/trunk)
into the hands and feet and that after the elevated temperature has also
been established in the extremities, the fever will start to fall and the
child starts to perk up again.
- Is paracetamol associated with chronic
non-communicable diseases other than asthma, eczema and hay fever?
·
Has the management advice by health professionals to parents
with feverish children changed since the NICE guidance and following NICE
guidance?
http://www.nice.org.uk/usingguidance/sharedlearningimplementingniceguidance/shared_learning_implementing_nice_guidance.jsp
·
What is the current understanding in the public about fever
with reference to the 2 myths (that fevers get too high and deaths ensues or
at least have a febrile convulsion)?
·
How about promoting evidence-based childhood fever management
through a peer education programme based on the theory of planned behaviour?
E.g. Journal of Clinical Nursing. 16(10):1966-79, 2007 Oct.
·
When the NICE guidance has been adopted amongst doctors and
the public with reference to not treating the temperature, and building
confidence in parents that fever is part of a healing process, will that
result in a reduction of admissions to paediatric wards?
·
Is research like the PITCH study, which is research into the
temperature lowering effect of paracetamol and ibuprofen, unethical? Why
lower the temperature? Are these studies contributing to fever phobia?
·
How common are paediatric-wards-protocols instructing the
nursing staff to administer analgesics and or mechanical cooling depending
on the hight of the temperature and do these warrant notifications to the
National Patient Safety Agency
http://www.npsa.nhs.uk/health/reporting/reportanincident
·
Is the (perceived) suffering in children with fever due to
parents' and doctors' misconception of the fever process
http://www.capmh.com/content/1/1/7
·
In general what are the benefits of fever? There is very
little research into this. E.g. European Journal of Immunology.
37(10):2856-67, 2007 Oct. Fever is associated with improved survival during
infection in endothermic and ectothermic species although the protective
mechanisms are largely undefined.
·
Is the outdated advice to parents 'to control' or 'to manage'
a fever resulting in draconian mechanical cooling measures and accidental
overdoses by the parents and is this a child protection issue?
·
How much can the health service save by appropriately
informing doctors and parents about the natural fever process.
Research into these areas can help to make the PITCH
studies and editorial contribute to the health of the public, which can
result in savings by alleviating the burden of iatrogenic diseases.
1.
http://www.bmj.com/help/pop/isfree.dtl
- Havinga W. Time to counter
'fever phobia'! Br J Gen Pract. 2003 Mar;53(488):253.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=14694712
- Havinga W.
PITCH: an indication of the level of
emotion in relation to childhood fevers.
http://www.bmj.com/cgi/eletters/337/sep02_2/a1302#201799
- Harnden, A. Antipyretic treatment for feverish young
children in primary care. BMJ 337: a1409-a1409
[Full text]
-
http://www.gmc-uk.org/guidance/archive/GMC_0-18.pdf Good Medical
Practice and 0-18 years: guidance for all doctors states that doctors
must safeguard and protect the health and well-being of children and young
people. Well-being includes their physical and emotional welfare.
-
Drug
and Therapeutics Bulletin 2008;46:17-21
http://dtb.bmj.com/cgi/content/full/46/3/17
- Child Adolesc Psychiatry Ment Health. 2007; 1: 7.
Managing childhood fever and pain – the comfort loop Jacqui Clinch and
Stephen Dale
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1971248
- Beasley R, Clayton T, Crane J,
et al.
Association between paracetamol use in infancy and childhood, and risk of
asthma, rhinoconjunctivitis, and eczema in children aged 6–7 years:
analysis from Phase Three of the ISAAC programme. Lancet
2008; 372:1039–1048
- Green S. Acute poisoning: understanding 90% of cases
in a nutshell. Postgraduate Medical Journal 2005;81:204-216.
http://pmj.bmj.com/cgi/content/full/81/954/204
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In the interest of the public.
