Single blind, randomised, comparative study of the Bug Buster kit and over the counter pediculicide treatments against head lice in the United Kingdom
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.38537.468623.E0 (Published 11 August 2005) Cite this as: BMJ 2005;331:384All rapid responses
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The UK health charity Community Hygiene Concern (CHC) was set up in
1988 to help families facing repeated infestation with head lice. CHC
identified the need to develop the means of detecting asymptomatic lice
early. This could be used to diagnose the many light, but contagious,
cases and to monitor the outcome of treatment. We feel the goal must be
successful self-care, given that head lice affect most families from the
time the first child begins to socialise with other children. The
responsibility for detection and treatment necessarily falls on parents
with health professionals in a supporting role (1). Achieving this
required sound science firmly rooted in social reality. The charity found
that action research (2), a practical problem-solving methodology, offers
an appropriate way to tackle this task. By revisiting old assumptions and
making new observations during extensive fieldwork, in a process of
retrospective understanding and prospective action, Bug Busting wet
combing was developed. Initially it was used for reliable detection,
collectively applied by an informed community on national Bug Busting Days
(3, 4).
We found that lice immersed in moisture are temporarily immobilised,
and ordinary shampooing delivers moisture to the roots of the hair, the
main habitat of lice. We found that a subsequent liberal application of
any ordinary conditioner facilitates combing and prolongs the time the
lice remain still. These actions are simple for most families to
undertake, using convenient products in the usual way. Shampoo is
designed to lift dirt and grease from the scalp during lathering, and
conditioner is intended to make wet hair manageable. We found that
application of the conditioner directly to dry hair is comparatively
inefficient. This is contrary to the intended mode of action of
conditioner. We also found that the substitution of oil is inefficient
and messy, liable to drip and stain, and requires several shampooings to
remove it afterwards.
Our belief that the fine tooth combs in the 1998 Bug Buster kit are
superior (5) is based on the results of action research. We found that
the more rounded tooth points of other models can slip over lice. The
precise balance between the bevel-edged teeth and slim back of the 1998
Bug Buster comb makes insertion at the roots of the hair, under the lice,
easier. A thicker handle interferes with this balance. Closely spaced
teeth, suitable for nit removal, are a problem for louse detection. If
the comb removes nits effectively, lice can become lodged between the
teeth and are difficult to clean out. Also they can remain unnoticed,
only to be combed back onto the head at a subsequent stroke. Lice are
often undamaged by this experience and can re-establish if combed back
before dehydration weakens them. For the 1998 Bug Buster comb we worked
out the tooth spacing that is narrow enough to trap a newly hatched louse,
but wide enough to allow comfortable passage through the hair. With this
spacing, lice can also be easily removed from the comb by wiping both
sides on kitchen paper. It is important to be able to do this at the 2nd,
3rd and 4th Bug Busting sessions in order to check their maturity (see Bug
Buster kit v pediculicides for head lice: clarification of the evidence,
above).
Our research showed the importance of completing louse removal prior
to attempting nit removal, knowledge that we share with users of the Bug
Buster Kit. In the instructions, we define the life-stages as the ‘egg’
that the louse cements to the hair shaft, ‘nit’, which is the empty
eggshell left after the ‘nymph’ has hatched, and the ‘full-grown louse’,
emerging after the three nymphal stages are complete. We inform readers
that eggs and lice are difficult to see on the head, and an egg may be
cemented to the hair shaft so close to the root that it is difficult to
get a comb underneath.
Only if asymptomatic, but contagious, contacts are simultaneously
diagnosed and treated (3,4), does treatment of obvious cases of head lice
result in control, even when the product used is effective. Additionally,
there is no formulated product in use today in the UK which will kill
louse eggs with certainty. Action research brought about the discovery
that the Bug Buster combs, used according to the instructions packed with
them in the kit, constitute a stand-alone remedy. This has potential as a
treatment because the Bug Buster kit is an economical, reusable product
that families can always keep to hand. However, we consider that the main
contribution of the Bug Buster kit remains its convenience for detecting
lice and checking the efficacy of any medication, as both actions are
crucial to control. Like Annells (6), we welcome the work of researchers
in this field who face the challenge of “devising trial designs which are
congruent with real world situations”.
Community Hygiene Concern, Reg Charity No: 801371, Manor Gardens
Centre, 6-9 Manor Gardens, London N7 6LA
www.chc.org
References
1 Community Hygiene Concern. Our Comments on the Cochrane Review 2002
http://www.chc.org/bugbusting/cochrane.cfm
2 Carr W, Kemmis S. Becoming Critical. England & USA: Falmer
Press, 1986: 179-213.
3 Ibarra J, Hall DMB. Head Lice in Schoolchildren. Archives of
Disease in Childhood 1996;75:471-3.
4 DH The prevention and treatment of head lice. London:Department of
Health, 2000 http://www.dh.gov.uk/assetRoot/04/07/59/63/04075963.pdf;
printed leaflet available free to schools from: Department of Health, PO
Box 777, London SE1 6XH (Email:doh@prolog.uk.com).
5 Community Hygiene Concern. Head Lice: The gentle skill of Bug
Busting… fun without tears. Shared Wisdom 2000; 5:4-5.
6 Annells M. Guest Editorial: Eliminating head lice: itching to do
the research. Journal of Clinical Nursing 2004;13:785-6.
Competing interests:
Community Hygiene Concern is a charity, part-funded by sales of Bug Busting materials on a non-profit making basis.
Competing interests: No competing interests
Roberts (http://bmj.bmjjournals.com/cgi/eletters/331/7513/384) raises
some interesting points regarding the interpretation of our study but
seems to be unclear as to our primary objectives. Our trial (1) was
designed to evaluate effectiveness (not efficacy) of common over the
counter (OTC) treatments for head lice, matching as closely as possible
“real life” use in the community. Whether or not this reflects good
clinical practice in terms of study design was less of a concern than
obtaining a true reflection of success / failure of these products as used
in homes across the Country, which we feel is of most value to health
professionals and families alike at this juncture. To clarify further we
respond to each of the points raised by Roberts in turn :
1&2) Fine tooth combs – we were very careful to verify the
situation regarding the BB kits used in our and the earlier trial by
Roberts et al. (2) with the suppliers, Community Hygiene Concern (CHC),
prior to submission. Since the comments by Roberts we have again checked
with CHC and it is clear that their study was conducted with the earlier
1996 pilot kit, and ours used the current kit. The earlier pilot kit
contained 2 different fine tooth combs both of which were subsequently
considered by CHC to be difficult to use or less effective against small
nymphs, which is why a set of new fine tooth combs were developed for use
in the new BB kit. CHC will, I am sure, provide details of how they
made these suggested improvements and I would encourage them to do so in
this forum. Whilst both Roberts and ourselves acknowledge several
possible reasons for the marked difference in cure rates for BB between
our trials, we still believe that as the fine tooth comb is the “active”
component of the BB kit, any improvements made in its design which may
assist removal of lice is likely to have a significant influence on cure
rate. To this end we would like to see future work on comparative
efficacy of different fine tooth combs, particularly if this form of
physical control of lice is to be adopted more widely in the absence of
effective pediculicides.
2) We are aware Roberts & colleagues used 2 applications of
malathion with the second “7 days later”; our use of the phrase “2 doses
6 days apart” is the same, as in both cases re-treatment is on the 7th
day. In any event, predetermined double-dosing has always been an
unlicensed use, is not mentioned in any product instructions, and the
British National Formulary is not a frequent publication on the coffee
tables of British homes.
2a) Types of participants – In line with our principle of
evaluating products in a “real life” manner, all those entering our study
believed their child had head lice and were actively seeking treatment.
Unlike the trial by Roberts and his colleagues (2) , we did not send a
team of health professionals into schools actively screening cases to
recruit, the majority of which, presumably, were unknown to their
families at that time and thus unlikely to have sought treatment in the
normal course of events. Whilst we do not dispute the value of such
recruitment methods, given the considerable resources to undertake it,
we feel ours is more representative and better reflects cases which are
actually treated in the community as a whole. Similarly, our study was
open to anyone walking into any of the 22 GP Health Centres enlisted in
our study areas who saw the trial advertised on posters there or in
pharmacies in the area. The reason recruitment numbers varied from region
to region was simply the number of recruiting GP’s in any location and /
or the length of time they participated in the trial.
2b) Training offered participants – Roberts seems to have
misunderstood our protocol. We state “We provided no additional
information on how to use the products other than that supplied with the
products” and “Participants were visited at home by the study co-
ordinator or local study nurse or were asked to return to their surgery
for follow-up”. Contrary to Roberts belief that a higher cure rate for
Bug Busting (BB) may have been a result of our study team “training”
participants, we again followed the principle of “real life” where the
users simply followed instructions on each product. Our study nurses were
blind to treatment allocation and only visited the participant for the
final success / failure assessment at follow-up. This is considerably less
“training” than was offered by Roberts and co-workers where “parents
received a standard oral explanation of how to use the treatment” and
“Instructions were repeated until the parent was satisfied that he or she
understood the method”.
2c) Method of assessing cure rate – It is true that BB is commonly
described as a course of wet combing “four times over two weeks”, however
the BB Kit we evaluated includes clear and concise information (in cartoon
form for non-English speaking users) and even an unambiguous day-by-day
calendar which shows on exactly which days the combing is done throughout
that period. The concept of BB is based on the biology of the head louse;
the removal of adults & most nymphs with the fine-tooth comb on day 1
stops new eggs being laid, a second session on day 5 removes nymphs
hatching or too small to remove easily on day 1 before they reach adult
hood (and thus no new eggs), the third and fourth sessions on days 9 and
13 do the same. Therefore, by the 4th session on day 13 there should be
no more viable un-hatched eggs, so our end-point assessment 2 days later
is, we believe, an accurate measure of success / failure. Whilst
Roberts points out there may be viable eggs at this point, we would argue
that for viable eggs to be present there must have been adults there to
lay them, which would have been recorded as a treatment failure by our
study team. The point made by Roberts about prolonging BB to include
additional sessions is very important. The suppliers of the BB kit state
that should adult lice be found at sessions 2, 3 or 4, either as a result
of missed nymphs in earlier sessions or through reinfestation, the regime
is extended to account for the possibility of new eggs being laid. If one
accepts that BB as a treatment could have a variable endpoint beyond our
chosen day 15 assessment, then our cure rate is actually an underestimate
of its true potential.
(1092 words)
1) N Hill, G Moor, M M Cameron, A Butlin, S Preston, M S
Williamson, and
C Bass. Single blind, randomised, comparative study of the Bug Buster
kit and over the counter pediculicide treatments against head lice in the
United Kingdom. BMJ 2005;331:384-387 (13 August),
doi:10.1136/bmj.38537.468623.E0 (published 5 August 2005)
2) Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet
combing with malathion for treatment of head lice in the UK: pragmatic
randomised controlled trial. Lancet 2000;356:540-44.
Competing interests:
As listed in original article.
Competing interests: No competing interests
We wish to put on record that the dates displayed on the various Bug
Buster kits are copyright dates. In 1998, Community Hygiene Concern
published, and widely circulated, a Primary Health Care Guide to Common UK
Parasitic Diseases (1). It has a detailed entry on Bug Busting wet
combing, which explains how the procedure remedies head infestation by
methodically removing lice, without having to remove eggs, which is
difficult because they are cemented firmly to the hair shafts. The four
combing sessions on days 1, 5, 9 and 13 which are required to break the
life-cycle are set out in a diagram. Illustrations show the current bright
yellow Bug Buster comb and preparation of tightly curled hair to enable
the Bug Buster to pass through easily. The 1998 Bug Buster kit itself did
not become available until April 1999, due to funding difficulties. Apart
from the comb illustrations, the method set out in all Bug Buster kit
instructions is essentially the same. Only when Roberts and colleagues
described the kit they submitted to trial (2) did we know it was the 1996
prototype.
In their evaluation, Hill and colleagues (3) asked families to follow
product instructions at home (without any training by nurses). Those
allocated to the 1998 Bug Buster kit had access to vital information that
louse eggs hatch over a ten day period and lice may become full-grown in
six days, and that mature lice readily migrate during head to head
contact, whilst younger stages tend to remain on the head where they
hatch. The kit user is encouraged to distinguish full-grown lice from
nymphal stages (actual size pictures are provided). A family is able to
diagnose reinfestation when full-grown lice are found at the 2nd , 3rd or
4th Bug Busting session and apply the knowledge that lice emerging from
any new egg-laying can be combed off in three more half-weekly sessions.
Thus kit users were in an advantageous position compared to
pediculicide users who might be tempted to believe suggestions, printed on
the packet, that a single application kills lice and their eggs. Double
dosing must be instigated by a health professional and requires
explanation as it is still an unlicensed use, even though long recommended
in the British National Formulary.
However, participants assigned to the Bug Buster kit were open to
reinfestation for ten days longer before assessment on day 15, than those
assigned to pediculicide, assessed on day 5. It is probable therefore
that this lowered the ‘cure’ rate for kit users. Nevertheless, they could
have recognised reinfestation and moreover, gone on to gain sustainable
control, because the Bug Buster kit is reusable. In a pilot trial Plastow
and colleagues reported a 53% success rate at first use and 100%
eradication by day 24 in participant families assigned to the current Bug
Buster kit (4). This evidence supported the decision to allow it on NHS
prescription by general practitioners and nurse prescribers, free for
children.
Community Hygiene Concern, Reg Charity No: 801371, www.chc.org,
bugbusters2k@yahoo.co.uk
References
1 Ibarra J. Pediculosis. In: Figueroa J, Hall S, Ibarra J, eds.
Primary Health Care Guide to Common UK Parasitic Diseases. Community
Hygiene Concern, London, 1998: 1-24.
2 Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet
combing with malathion for treatment of head lice in the UK: a pragmatic
randomized controlled trial. Lancet 2000; 356:540-4.
3 Hill N, Moor G, Cameron MM, Butlin A, Preston S, Williamson MS,
Bass C. Single blind, randomised, comparative study of the Bug Buster kit
and over the counter pediculicide treatments against head lice in the
United Kingdom.BMJ, doi:10.1136/bmj.38537.468623.EO (published 5 August
2005)
4 Plastow L, Luthra M, Powell R, Wright J, Russell D, Marshall MN.
Head lice infestation: bug busting vs. traditional treatment. Journal of
Clinical Nursing 2001; 10: 775-783.
Competing interests:
Community Hygiene Concern is a charity, part-funded by sales of the Bug Buster Kit on a non-profit making basis.
Competing interests: No competing interests
Personal experience seems always to be derided and experimental trial
data preferred; so it's good to have one's preferences and predjudices
confirmed by a trial! My experience with both patients and, more closely,
with my own children at home is that the most effective treatment is
regular "bug busting". Further, that in many cases the problem is only
"solved" but cutting long hair short, drastically thinning thick hair
(both of which measures make bug busting vastly easier), or moving to
secondary school (at which age presumably there is less head to head
contact). Chemicals seem to work best to reduce a very heavy infestation
to a population more easily managed by bug busting.
Competing interests:
None declared
Competing interests: No competing interests
Hill et al. (2005) compared the efficacy of the Bug Buster kit with
two pediculicides containing 0.5% malathion or 1% permethrin, which
according to Downs et al. (1) were effective in 13% and 36% of the treated
individuals, respectively. The authors used only a single treatment regime
while it has been previously found that just 8% of outlets provided
additional information of double dosing when a pediculicide was purchased.
Participants in the trial treated with the insecticide were examined 5
days after treatment, while those using the Bug Buster kit were examined
at day 15; the ovicidal activity was not evaluated. They observed a cure
rate of 17% for malathion and 10% for permethrin.
To our knowledge, there is no pediculicide that kills 100% of the eggs
after a single treatment (2). An exception is the 1% permethrin cream
rinse, which has a residual activity of several weeks and also kills the
lice which hatch from eggs. However, in the U.K, as in many parts of the
world, head lice have become resistant to this insecticide and therefore
permethrin based pediculicides became ineffective for head lice treatment.
The authors came to the conclusion that the Bug Buster kit was four times
more effective than current over the counter pediculicides for eliminating
head lice and they raise the question whether the cure rate of only 57%
which was observed with the Bug Buster kit is still unacceptable and may
not provide an efficient treatment against head lice.
Firstly, the authors can only conclude that these combs are better that
the two pediculicides examined and not better, than the “over the current
over the counter pediculicides”. Secondly, comparing a bad treatment
modality one with an even worse does make it a good one.
Systematic use of the louse comb over the 10-day period during which
the eggs hatch, can remedy an infestation. However, this technique is
indicated especially for children with short or medium-length, straight or
wavy hair. Three clinical studies in the U.K. showed that Bug Buster combs
are capable of removing the entire population of lice from the hair in
38–53% of the children treated in this way (3-5). In the USA, daily
combing with the Licemeister comb in conjunction with the use of a
pediculicidal treatment (Nix) was compared to the treatment with this
pediculicide but without. It was shown that the combing arm was not more
effective than the group randomized to not receive a Licemeister (6).
It would be more than difficult to achieve a cure rate of approximately
85%, which would seem rather acceptable, when wet combing is being used
for all kinds of hair. In none of the studies above the efficacy of
combing was related to the structure of the hair. Combing, however, should
always be an integral part of any pediculicidal treatment in order to
remove live and dead lice, eggs and nits. In addition, a louse comb should
be used for the diagnosis of a louse infestation, for verification that
treatment with a pediculicide was successful as well as for the removal of
eggs and nits. Louse combs of various materials and design are available.
Apart from the type of comb used, the frequency and thoroughness of
combing could be very important. Unfortunately, there are no data or
reference from the study in Ghent, Belgium, which according to the authors
reported promising findings on treatment with wet combing.
References
1. Downs AMR, Stafford KA, Harvey I, Coles GC. Evidence for double
resistance to permethrin and malathion in head lice. BMJ 1999;141:508-11.
2. Mumcuoglu KY. Prevention and treatment of head lice in children.
Pediatr. Drugs 1999;1: 211-8.
3. Bingham P, Kirk S, Hill N, Figueroa J. The methodology and operation
of a pilot randomized control trial of the effectiveness of the bug
busting method against a single application of insecticide product for
head louse treatment. Public Health 2000;114:265-8.
4. Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet combing
with malathion for treatment of head lice in the UK: pragmatic randomised
controlled trial. Lancet 2000;356:540-4.
5. Plastow L, Luthra M, Powell R, Wright J, Russell D, Marshall MN. Head
lice infestation: bug busting vs. traditional treatment. J. Clin. Nursing
2001;10: 775-83.
6. Meinking TM, Clineschmidt CM, Chen C, Kolber MA, Tipping RW, Furtek CI,
Villar ME, Guzzo CA. An observer-blinded study of 1% permethrin crème
rinse with and without adjunctive combing in patients with head lice. J.
Pediatrics 2002;141:665-70.
Competing interests:
None declared
Competing interests: No competing interests
Hill et al (BMJ 5 August 2005, Single blind, randomised, comparative
study of the Bug Buster kit and over the counter pediculicide treatments
against head lice in the United Kingdom) offer as the main reason why
their results differ markedly from our own that the combs we used in our
RCT (1) were inferior to those marketed by CHC from 1998 onwards. It is
unclear to us why this claim is relied on or how it has been verified for
the following reasons:
1) a previously published claim by Community Hygiene Concern that the
combs we used were inferior was questioned by us, and no evidence of
difference in effectiveness produced (2).
2) the combs used in our study were delivered from CHC on 25 March
1999.
If the authors are unable to provide evidence to support their claim
that the combs we used in our study were clinically inferior to those
currently marketed by CHC, then the claim should be qualified or
withdrawn. Their statement that malathion was applied in our study six
days apart is also incorrect – the protocol was a week apart, as
recommended in the British National Formulary and clearly stated in our
report (1).
We suggest there are several other reasons which are more likely to
explain why they report a higher cure rate for wet combing than we found,
related to type of participants, training offered participants, and method
of assessing cure rate:
a) The authors do not report a response rate, how many participants
were invited to take part in the study and how many agreed, but based on
numbers recruited in some centres this may have been low. This makes it
impossible to judge how representative the study sample was. Our sample
was based on screening 4037 children in 24 randomly selected schools, with
a subsequent trial participation rate of 84% (1).
b) The level of training in Bug busting given parents by the study
coordinator is not reported, but involved a home visit. In our study we
limited our verbal and written guidance to parents to that replicable in
normal clinical practice (1).
c) It has is standard CHC advice that Bug Busting consists of wet
combing “four times spaced over two weeks”
(http://www.chc.org/bugbusting/faq.cfm, 5 August 2005) and that if adult
lice are found after the first session that this period is extended.
However, Hill et al assessed outcome on day 15 without exception, when
combing would only just be completed or continuing, whereas we found it
necessary to vary assessment of outcome depending on the duration of
treatment actually applied by participants. Hill et al do not report the
duration for treatment by participants. We found that only 16% of users
completed the Bug Busting treatment course by 14 days (1). Therefore the
outcome assessment of Hill et al is likely to have been carried out when
the majority of participants had not completed Bug Busting and were still
actively wet combing to remove lice. As the assessment did not include
viable eggs, many of cases categorised as “cured” may be false negatives,
and the cure rates reported in the Bug Busting group is likely to
considerably over estimate actual cure rates at the completion of the
course of Bug Busting.
Sincerely
R J Roberts
National Public Health Service for Wales
References
1. Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet
combing with malathion for treatment of head lice in the UK: pragmatic
randomised controlled trial. Lancet 2000;356:540-44.
2. Roberts RJ, Casey D, Morgan DA, Petrovic M. Treatment of head lice
[correspondence]. Lancet 2000;356:2007-08.
Competing interests:
None declared
Competing interests: No competing interests
Professional carer experience
I have unfortunately, increasing experience of treating young
children with chronically infected scalp eczema secondary to adverse
reactions to pediculicides prescribed for head lice infestation.
In my previous job role as Health Visitor I experienced the local
community's frustration at the ever present head lice 'problem' and the
failure of current head lice policy as a 'controlling' measure. Despite
current research and anecdotal evidence, local and national head lice
policy continues to advocate the use of insecticides as 'first-line'
treatment in the management and control of head lice infection. Our
children therefore continue to be exposed to potentially harmful chemicals
which are unlicensed in 'double' doses and 'appear' ineffective in a large
number of cases, all at a huge cost to the NHS.
As a result of my experience of treating head lice and supporting the
affected families, I personally find the Bug Busting Method superior in
eradicating headlice than that of treatment with chemicals. Giving parents
education about head lice and their 'life-cycle' along with the Bug
Busting Kit relieves parental distress and hands them control over their
'unpleasant' situation.
Common sense tells me that it is far better to first recommend a
treatment that will 'do no harm', at a reduced cost to the NHS and which
most importantly hands responsibility and control of head lice infestation
to the affected family.
Competing interests:
None declared
Competing interests: No competing interests