Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Assessment of Bug Busting cure rate not reliable
- Richard J Roberts (5 August 2005)
-
The Bug Buster kit and its use for the treatment of head lice
- Kosta Y. Mumcuoglu (9 August 2005)
-
Personal experience
- Mick A Leach (12 August 2005)
-
Bug Buster kit v pediculicides for head lice: clarification of the evidence
- Joanna Ibarra, Clarice Wickenden (17 August 2005)
-
Re. “Assessment of Bug Busting cure rate not reliable” – Author’s reply
- Dr. Nigel Hill, Dr. Mary Cameron (lecturer, LSHTM) (18 August 2005)
-
The history of Bug Busting
- Joanna Ibarra, Frances Fry, Clarice Wickenden and Jane Lesely Smith. (4 September 2005)
-
Professional carer experience
- Nicola J Broad (20 November 2005)
|
|
|||
|
Richard J Roberts, Consultant NPHS, Hendy Road, Mold, Flintshire, CH7 1PZ
Send response to journal:
|
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we used in our study were clinically inferior to those currently marketed by CHC, then the claim should be qualified or withdrawn.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
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 |
|||
|
|
|||
|
Kosta Y. Mumcuoglu, Senior Research Fellow Department of Parasitology, Hebrew University-Hadassah Medical School, Jerusalem 91120, Issrael
Send response to journal:
|
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 |
|||
|
|
|||
|
Mick A Leach, GP Harrogate, HG1 4QD
Send response to journal:
|
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 |
|||
|
|
|||
|
Joanna Ibarra, Programme Co-ordinator Community Hygiene Concern, Manor Gardens Centre, 6-9 Manor Gardens, London N7 6LA, Clarice Wickenden
Send response to journal:
|
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. |
|||
|
|
|||
|
Dr. Nigel Hill, Medical Entomologist London School of Hygiene & Tropical Medicine, WC1E 7HT, Dr. Mary Cameron (lecturer, LSHTM)
Send response to journal:
|
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. |
|||
|
|
|||
|
Joanna Ibarra, Programme Co-ordinator CHC, Reg Charity No: 801371, Manor Gardens Centre, 6-9 Manor Gardens, London N7 6LA, Frances Fry, Clarice Wickenden and Jane Lesely Smith.
Send response to journal:
|
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 bugbusters2k@yahoo.co.uk 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. |
|||
|
|
|||
|
Nicola J Broad, Community Paediatric Dermatology Specialist Nurse Ashton, Leigh and Wigan Primary Care Trust
Send response to journal:
|
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 |
|||