Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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The method of detection affects the outcome
- Joanna Ibarra, Frances Fry, Clarice Wickenden, Jane L. Smith (17 June 2005)
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Head Lice: standards in clinical trial design
- Alice Olsen (22 June 2005)
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Re: Head Lice: standards in clinical trial design - authors' reply
- Ian F Burgess, Christine M Brown, Peter N Lee (24 June 2005)
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Hair conditioners for head lice
- Martin J Wilkinson (29 June 2005)
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Re: Head Lice: Standards in clinical trial design – authors’ reply
- Joanna Ibarra, Clarice Wickenden (14 August 2005)
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Control of head lice
- Gerald.c Coles, Anthony M.R.Downs, Kathryn A. Stafford (30 October 2005)
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What use dimeticone?
- Ian F Burgess (25 January 2006)
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Raising the standard of the labelling and instruction leaflets of treatments for head lice
- Joanna Ibarra, Frances Fry, Clarice Wickenden and Jane L. Smith (4 April 2006)
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Joanna Ibarra, Programme Co-ordinator CHC, Manor Gardens Centre, 6-9 Manor Gdns, London N7 6LA, Frances Fry, Clarice Wickenden, Jane L. Smith
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It was helpful to find considerable detail in the electronic BMJ Online First report by Burgess and colleagues of a randomised controlled equivalence trial of 4% dimeticone lotion for the treatment of head infestation (1). The trial is welcome as in depth studies of alternatives to conventional insecticides are very necessary. However, we have reservations on some methodological points. We agree that fine-tooth combing dry hair is valid to confirm active infestation in trial entrants. However, the sensitivity of the detection method used to assess the outcome of treatment will affect the result, less reliable methods producing over-optimistic results. The authors have not justified the choice of combing dry hair at this stage, in preference to the bug busting wet combing (BBWC) method previously recommended (2). This is odd because lice are described moving swiftly away from disturbance during the application of lotion to dry hair. This same reaction to combing in dry hair can allow some lice to escape detection. Thoroughly wet lice remain motionless facilitating their removal with a fine-tooth comb. BBWC makes doubly sure that lice are not missed: firstly shampooed hair prepared with ample conditioner is combed and then the combing is repeated in the rinsed hair (3). We suggest that the 69% cure rate with dimeticone reported in this study should be verified using BBWC. The fact that some louse eggs hatch at least 10 days post laying is not addressed in this study. On the evidence available, two applications,, made a week apart, of any formula that does not kill the egg stage with certainty, may not finally eradicate infestation. In practice, we consider it is wise to follow the Department of Health advice to make a thorough check for lice 5 days and 12 days after the initiation of treatment to assess progress (4). Joanna Ibarra, Programme Co-ordinator, Frances Fry, Development Worker, Clarice Wickenden, Project Co-ordinator, Jane Leseley Smith, Project Worker Community Hygiene Concern, Reg Charity No: 801371 www.chc.org, bugbusters2k@yahoo.co.uk References 1 Burgess IF, Brown CM, Lee PN. Treatment of head louse infestation with 4% dimeticone lotion: randomised controlled equivalence trial. BMJ, doi:10.1136/bmj.38497.506481.8F(10 June 2005). 2 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 insecticide product for head louse treatment. Public Health 2000; 114:265-268. 3 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 4 Department of Health. The Prevention and Treatment of Head Lice. DOH, London, 2000 Competing interests: Community Hygiene Concern is a charity, part-funded by sales of the Bug Buster Kit on a non-profit making basis. |
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Alice Olsen, project leader De Frie Fugle Frederiksberggade 6, 4 DK1459 Copenhagen K
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22 June 2005 Response to Burgess, Brown & Lee Head Lice: standards in clinical trial design Head lice infest children all over the world nowadays, a troublesome and time-consuming problem, so any serious attempts to find non-toxic products/methods to get rid of them are to be appreciated. However, I have a general reservation about the evaluation of cure rates by loosely comparing pre- and post- treatment louse counts, as Burgess and colleagues (1) have done. In the trial they describe, accurate data on which to base the comparison have not been collected. In Denmark a device has been developed, called Lice Snatcher (2). Attached to a household vacuum cleaner, it removes hatched lice from dry hair. It filters them into a detachable box; the lice can then be counted and classified into developmental stages. They remain live and healthy and can be returned unharmed to the head afterwards. Treatment with medication can then proceed with an accurate knowledge of the degree of infestation on the head. If the pre-treatment infestation consists entirely of full-grown adults, it is recent, as mature lice migrate from head to head and smaller lice usually remain on the head where they hatch. If all three nymphal stages and full-grown lice are present, the infestation has been active for some time. A post-treatment test should be made when the medication has been washed off and the hair dried to establish its capacity to kill lice, and again on days 4, 8 and 12 to test its capacity to kill eggs. Head louse eggs hatch during a period of 10 days post-oviposition. Therefore if the tests on days 4, 8 and 12 reveal any 1st and 2nd stage nymphs, the treatment is not ovicidal. Head lice are ectoparasites and must be looked upon as such; the cure is not necessarily medication, which can have dubious side-effects. My trials using the Bug Buster Kit (3) to check the accuracy of the Lice Snatcher showed that it was just as efficient as bug busting wet combing at removing lice from the head (unpublished findings). Both these physical methods can break the life-cycle on the basis of systematically removing lice from the head. To compare the effort required to use these ‘slow’ physical methods with medication, data are required on whether the formula stains clothing and bedding and how easily it can be washed from the head after application (especially if multiple applications are involved). No information on this or other points in relation to the consumer acceptability of 4% dimeticone lotion is given by Burgess and colleagues (1). In my opinion the issues I raise above must be resolved to set uniform standards for clinical trials of treatments for head lice. 443 words Alice Olsen, M.sc. biology Project Leader Idéværkstedet De Frie Fugle www.friefugle.dk www.hovedlus.dk Måløvhøjvej 24, DK2750 Ballerup Denmark alice@hovedlus.dk References 1 Burgess IF, Brown CM, Lee PN. Treatment of head louse infestation with 4% dimeticone lotion: randomised controlled equivalence trial. BMJ, doi:10.1136/bmj.38497.506481.8F(10 June 2005). 2 www.LiceSnatcher.com 3 Ibarra J, Fry F, Wickenden C, Smith JL. Head lice: Accurate knowledge of the life-cycle is essential to achieve control. bmj.com Rapid Responses for Sladden and Johnston, 330 (7501) 1194-1198. Competing interests: None – I have not and have never had any commercial interests in ‘louse products’. I was formerly an employee of the Danish Pest Control Laboratory 1980-97. Sponsored by the Danish Ministry of Environment, in 1999 I evaluated the Bug Buster Kit and found bug busting wet combing is a consumer friendly and efficient method for the detection and control of head lice. Competing interests: None declared |
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Ian F Burgess, director Insect R&D Limited SG8 6QZ, Christine M Brown, Peter N Lee
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There is always some uncertainty about the sensitivity of any methodology used for assessment of head louse infestation. Curiously this infestation is one of the few infectious conditions in which absolute cure could possibly be determined. However, purity of results must be subservient to ethical considerations, especially in paediatric studies. We cannot imagine any ethics committee granting authorisation for a study in which every participant is effectively cured prior to admission, and then being reinfected, just so investigators could demonstrate exactly how many insects were killed by yet another intervention. Also we can just envisage the look on the faces of some of the parents of our participants had we proposed to reapply the several hundred, or sometimes thousands, of lice that would have been removed from their children had we gone down this path. In a few cases it would have taken all day just to count the lice from children who were reportedly regularly treated using the bug busting wet combing method of treatment prior to enrolment in the study. If the Lice Snatcher is only as effective as the Bug Buster kit, as reported by Ms Olsen, it would not have improved the sensitivity of our detection method as the one trial of Bug busting as a detection method (1) showed poor sensitivity compared with scalp inspection (2), which in turn has been shown to be less sensitive than dry combing (3). Ian F Burgess, Christine M Brown, Peter N Lee. References: 1. De Maeseneer J, Blokland I, Willems S, Vander Stichele R, Meersschaut F. Wet combing versus traditional scalp inspection to detect head lice in schoolchildren: observational study. BMJ 2000; 321: 1187-8. 2. Berger MY, Bueving HJ, Konig S, Schouten BWV. Wet combing no better than classical scalp inspection to detect head lice. BMJ http://bmj.bmjjournals.com/cgi/eletters/321/7270/1187#11085 (1 December 2000) 3. Mumcuoglu KY, Friger M, Ioffe-Uspensky I, Ben-Ishai F, Miller J. Louse comb versus direct visual examination for the diagnosis of head louse infestations. Pediatr Dermatol 2001; 18: 9-12. Competing interests: IFB has been a consultant to various makers of pharmaceutical products, alternative therapies, and combs for treating louse infestations. PNL has analysed similar studies for other pharmaceutical companies. |
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Martin J Wilkinson, Associate Dean West Midlands Deanery, B15 2SQ
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Dear Sir, This is not the first report on non-insectiside treatments. I stopped using insecticides a year or so a go after reading the article in the BJGP(1) using Dove hair conditioner for headlice. I cured my daughter after a 12 month recurrent infestation, and now have treated many patients succesfully. I have used several conditioners and apply them neat to dry hair in a quantity of about 100mls. This "goo" is is worked into the scalp and left for 60 minutes then washed off. The theory is that it suffocates the blighters by blocking their oxygen pores. Yours sincerely, Dr Martin Wilkinson 1. Eames E. Simple and Effective Treatment for Headlice. British Journal of General Practice. 2004:54;786 Competing interests: None declared |
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Joanna Ibarra, Programme Co-ordinator Manor Gardens Centre, 6-9 Manor Gardens, London N7 6LA, Clarice Wickenden
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There are many combing methods in current use for the detection and treatment of head lice. In comparisons of their effectiveness it is necessary to be precise. Burgess, Brown and Lee do not state how many of their trial participants had been provided with a genuine Bug Buster Kit (www.chc.org) with which to undertake wet combing.(1) A Bug Buster Kit contains all the appropriate combs and step by step illustrated instructions for their use plus essential information on breaking the life-cycle by methodical louse removal, e.g. that the incubation period of the egg can last 10 days. It cannot be supposed that parents told to use a ‘nit comb’ with conditioner are testing bug busting wet combing. Also, Burgess, Brown and Lee are mistaken in thinking that the Kit was submitted to trial by De Maeseneer and colleagues.(2) The Belgian observational study used a derivative of the bug busting wet combing protocol, adapted for mass screening in school, where hair wetting was substituted for hair washing.(3) For measuring the outcome of treatment the most sensitive method should be used. It remains to be proved in a scientifically designed trial that combing dry hair with a fine-tooth comb is superior to using a Bug Buster comb according to the manufacturer’s instructions. Moreover, without a co-ordinated programme to detect asymptomatic cases and treat them at the same time as obvious cases, the recommended ‘whole school approach’, described in the Department of Health leaflet ‘The Prevention and Treatment of Head Lice’(4), much expenditure of professional and parental time and on products, is wasted. Community Hygiene Concern, Reg Charity No: 801371 www.chc.org bugbusters2k@yahoo.co.uk References 1 Burgess IF, Brown CM, Lee PN. Treatment of head louse infestation with 4% dimeticone lotion: randomised controlled equivalence trial. BMJ, doi:10.1136/bmj.38497.506481.8F(10 June 2005). 2 De Maeseneer J, Blokland I, Willems S, Vander Stichele R, Meersschaut F. Wet combing versus traditional scalp inspection to detect head lice in schoolchildren: observational study. BMJ 2000;321:1187-1188. 3 Fry F, Ibarra J, Smith J, Wickenden C. Wet combing to eradicate head lice. J R Soc Med. 2002;95:630-1. 4 www.dh.gov.uk/assetRoot/04/07/59/63/04075963.pdf; available free to schools from: Department of Health, PO Box 777, London SE1 6XH (Email:doh@prolog.uk.com) 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: Community Hygiene Concern is a charity, part-funded by sales of the Bug Buster Kit on a non-profit making basis. |
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Gerald.c Coles, Visiting Research Fellow University of Bristol, Langford House, Bristol BS40 5DU, Anthony M.R.Downs, Kathryn A. Stafford
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In their review entitled ‘More common skin infections in children' Sladden and Johnston1 suggest that head lice control can be achieved with a 12 hour application of either 5% permethrin as a dermal cream (off licence) or 0.5% malathion and that there is good evidence that both treatments are effective. However, evidence for resistance to both products has been well documented2. A recently published article evaluating the efficacy and safety of a 4% dimeticone lotion recorded a 70% cure rate with 16 of the 127 participants reporting side effects3. It is neither necessary to use neurotoxic chemicals, nor silicone based products which also require washing off, or to go as far as shaving off hair4 to control head lice. A coconut derived emulsion shampoo (CDE) (Lice Attack®) applied by parents three times in two weeks to dry hair and washed off after 20 minutes produced a 96% efficacy and, when then used twice weekly as a shampoo, controlled newly acquired infestations5. Hundreds of thousands of bottles have been sold in Europe and we are not aware of any side effects other than stinging of eyes, which is well known with many shampoos. In the USA, where the product is sold over the web with a money back guarantee for customers not completely satisfied, no one has ever asked for their money back. The product has no added insecticides and has been very well received by the participants in our trials. It is perhaps unfortunate that the BMJ turned down our manuscript describing the results with CDE and chose to publish on a less effective silicone-based treatment with recorded side effects. This decision has delayed making both doctors and parents aware of this excellent novel method of head lice control using CDE. Anthony M.R. Downs, Department of Dermatology, Royal Devon Hospital, Exeter, Devon, Gerald C.Coles, Kathryn A. Stafford, Department of Clinical Veterinary Science, University of Bristol, Langford House, Bristol BS40 5DU. Gerald.c.coles@bristol.ac.uk Competing interests: none declared 1 Sladden MJ, Johnston GA. More common skin infections in children. BMJ 2005;330:1194-89 (21 May) 2 Downs, AMR, Stafford, KA, Hunt, LP, Ravenscroft, JC, Coles, GC Widespread insecticide resistance in head lice to the over-the-counter pediculocides in England, and the emergence of carbaryl resistance. Br J Dermatol. 2002; 146: 88-93 3 Burgess IF, Brown CM, Lee PN. Treatment of head louse infestation with 4% dimetic0ne lotion: randomised control equivalence trial. BMJ 2005;330:1423-1427 (18 June) 4 Lwegaba A. Shaving can be safer head lice treatment than insecticides. BMJ 2005; 330: 1510 (June 25) 5 Downs AMR, Connolly M, Stafford KA, Kennedy CTC, Coles GC. A family based trial of a coconut derived emulsion (CDE) shampoo for head lice control Br J Dermatol (abstract) 2005 (in press) Competing interests: None declared |
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Ian F Burgess, Director Medical Entomology Centre, Insect R&D Limited, Shepreth, Royston, SG8 6QZ
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Since publication of the report of our clinical study using 4% dimeticone lotion to treat head louse infestation,[1] I have received numerous enquiries about just how dimeticone fits in with current approaches to head louse treatment. More recently I have been made aware of a related debate that has circulated amongst members of the Public Health Environmental Group (PHMEG) and has also been raised by several of the local Minor Ailment and Pharmacist prescribing schemes. The questions centre upon two points: 1.When the Stafford Group reported to the PHMEG [2] it was at a time when scientific interest in head lice was still in the doldrums and many of the guidance points included were based on experience, common sense, and the best of the older literature. There was little direct guidance on treatment, other than that what evidence was available indicated that insecticides had a higher level of evidence in their favour than otherwise and there were no or fewer alternative options. It was also advised, for example, that treatments should not be applied further down long hair than the positioning of a ponytail band simply because the authors agreed that a single 50mL bottle should be spread no further and that under normal circumstances lice would not be found far away from the scalp. However, when we used 4% dimeticone we found that the highly mobile fluid spread along hair shafts and lice “fled” from it, moving away from the scalp necessitating application of the product to the tips of the hairs. We found a similar effect, but to a lesser degree, with the aqueous phenothrin comparator meaning that the guidance requires some updating at least in that respect. We also found that some guidance on quantities of product used are required as the doses we had used to obtain an adequate coverage and a good therapeutic effect were greater than any previous investigators had indicated.[1] 2.When several of the Minor Ailment Pharmacy prescribing schemes were set up, I was asked to provide introductory guidance for staff involved, including sessions on louse biology and treatment. At the time the best guidance I was able to offer on insecticide treatment was based on what we could determine from in vitro studies, determination of resistance distribution patterns, and latterly from the one clinical study of the time comparing malathion with wet combing.[3] That evidence suggested the treatment most likely to be successful in dealing with most head louse infestations was alcoholic malathion lotion. As a result, several of the schemes adopted this formulation as their first line treatment option. Where alcoholic malathion failed, or where it was unsuitable for a patient, different options were adopted by different groups, none of which offered a clear solution to the problem. How does 4% dimeticone fit into the current prescribing schemes? The answer is that it offers an alternative option for treatment. Where that option is placed is a matter for local policy makers. However, as we stated in our report, the product is odourless and non irritant and will not be affected by resistance to conventional insecticides.[1] Since some of the products most favoured by prescribers for those with sensitive skin and asthma appear to be those most likely to fail due to insecticide resistance [4] it would seem reasonable that this factor should be a starting point for those deciding policies related to head louse treatment, and they should also consider it as an alternative that may help reduce the overall prevalence of lice by reducing some of the risks of treatment failure for those families with longer term infestations. Irrespective of policy, it will be the public who will ultimately guide the decision making process by buying treatment over the counter. Most are prepared to try something new, especially if they have already experienced large-scale treatment failure with other medications. Ian F Burgess ian@insectresearch.com References 1.Burgess IF, Brown CM, Lee PN. Treatment of head louse infestation with 4% dimeticone lotion: randomised controlled equivalence trial BMJ. 2005; 330 (7505): 1423-5 2.Stafford Group. Head lice: evidence-based guidelines based on the Stafford Report. J Fam Health Care. 2002; 12 (Suppl): 1-21. 3.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; 356:540-44. 4.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. 2005; 331: 384-7. Competing interests: IB is a consultant to various companies making pediculicides and combs |
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Joanna Ibarra, Programme Co-ordinator Community Hygiene Concern, Manor Gardens Centre, London N7 6LA, Frances Fry, Clarice Wickenden and Jane L. Smith
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The National Health Service (NHS) seeks to promote self-care for minor ailments such as head lice, with health professionals in a supporting role. Burgess, Brown and Lee suggest the problem of under- dosing in the community with formulated products could be improved with “better instructions for use and improved information at the primary care level” (1). We agree and furthermore we consider that inadequate labelling and product instructions, running in tandem with guidelines for health professionals (2, 3) which give conflicting advice, are a major obstacle to successful eradication. This rebounds on health professionals at a huge cost to the NHS (4). Failure to base treatment recommendations on an accurate knowledge of the life-cycle of the head louse (5) compounds the confusion. It must be acknowledged that there is no formulated product available which kills eggs with certainty, and some perform so poorly against hatched lice that “they potentially expose users to repeat applications without any important reduction in infestations” (6). The situation is illustrated by a report to the Welsh Assembly in 2003 of an 8.3% prevalence rate of head lice in primary school children, double that reported in 2000 (7). Across the UK distress and anger prevail among parents whose expectations of a solution are raised by promises on product labelling e.g. “a single application ... will kill head lice and their eggs”, “for the fast effective treatment of head lice and their eggs” and then dashed. In the interest of the public health and fairness to product users, evidence should be produced by clinical evaluation in the UK community where parents follow the manufacturers’ instructions. Information on the quantity to use, the time to leave it on the head, and the number of applications is required. The practicality of the application and removal methods should be assessed. Realistic statements such as “Enough for one application to shoulder length hair”, “X minutes/hours application time” and “X number of applications required to complete treatment” should appear on a product label. For products containing insecticides to which lice become resistant, the date of the last clinical evaluation should be displayed with the percentage success rate. An accurate statement on the incubation period of head louse eggs, the consequent need to make a thorough check for lice 5 and 12 days after treatment applications, and the appropriate practical tips about product use should always be included in the instructions. We call for an open debate of these issues which places the regulatory framework in the public domain. Joanna Ibarra, Programme Co-ordinator,
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) Burgess IF, Brown CM, Lee PN. (2005)Treatment of head louse infestation with 4% dimeticone lotion: randomised controlled equivalence trial. BMJ 330: 1423-5 (Full text Online first, BMJ, doi:10.1136/bmj.38497.506481.8F(10 June 2005) (2) Joint Formulary Committee. British National Formulary, entry 13.10.4, Parasiticidal preparations. London: British Medical Association and Royal Pharmaceutical Society of Great Britain, 1981- (updated March and September each year) (3) Aston R, Duggal H, Simpson J, advised by Burgess I, Medical Entomology Centre, Cambridge. Head lice. Report for Consultants in Communicable Disease Control (CCDCs) 1998 (www.fam- english.demon.co.uk/phmeghl.htm) (4) Board NJ. Professional carer experience. http://bmj.bmjjournals.com/cgi/eletters/331/7513/384 (20 November 2005) (5) Buxton P A. The Louse. An account of the lice which infest man, their medical importance and control. London: Edward Arnold & Co, 1947 (6) 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 2005; 311: 384-6 (Full text Online first, BMJ, doi:10.1136/bmj.38537.468623.EO (5 August 2005) (7) Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet combing with malathion for treatment of head lice in the UK: a pragmatic randomised controlled trial. Lancet 2000;356: 540-4 Competing interests: Community Hygiene Concern is a charity, part-funded by sales of the Bug Buster Kit on a non-profit making basis. |
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