HeadLice.Org Hot Spots

BMJ 1995;311:604-608 (2 September)

General practice

Systematic review of clinical efficacy of topical treatments for head lice

Robert H Vander Stichele, general practitioner,a Els M Dezeure, school health services physician,a Marc G Bogaert, clinical pharmacologist a

a Heymans Institute of Pharmacology, University of Ghent, De Pintelaan, 185, B-9000 Ghent, Belgium

Correspondence to: Dr Vander Stichele.


Objectives: To collect and evaluate all trials on clinical efficacy of topical treatments for head lice.
Design: Systematic review of randomised trials identified from following data sources: Medline, International Pharmaceutical Abstracts, Science Citation Index, letters to key authors and companies, and hand search of journals.
Setting: Trials in schools or communities.
Subjects: Patients infested with lice.
Main outcome measure: Cure rate (absence of live lice and viable nits) on day 14 after treatment.
Results: Total of 28 trials were identified and evaluated according to eight general and 18 lice specific criteria. Of the 14 trials rated as having low to moderate risk of bias, seven were selected as they used the main outcome measure. These seven trials described 21 evaluations of eight different compounds and placebo (all but two evaluations were of single applications). Only permethrin 1% creme rinse showed efficacy in more than two studies with the lower 95% confidence limit of cure rate above 90%.
Conclusions: Only for permethrin has sufficient evidence been published to show efficacy. Less expensive treatments such as malathion and carbaryl need more evidence of efficacy. Lindane and the natural pyrethrines are not sufficiently effective to justify their use.

Key messages

  • Key messages

  • In this systematic review we found only 28 randomised trials on clinical efficacy of topical treatments for head lice

  • Of these trials, only seven were of acceptable methodological quality and measured outcome at 14 days after treatment (the optimum time to assess clinical efficacy)

  • Of the eight different compounds evaluated, only permethrin 1% creme rinse showed efficacy in more than two studies with a lower 95% confidence limit of cure rate above 90%

  • Only for permethrin has sufficient evidence been published to show efficacy: less expensive treatments such as malathion and carbaryl need more evidence of efficacy, while lindane and the natural pyrethrines are not sufficiently effective to justify their use


Head lice are among the most common of human ectoparasites, though they are not vectors of serious diseases
and in many cases do not cause symptoms.1 2 3 Treatment with natural pyrethrines has been known for more
than 100 years, and lindane has been used since the second world war. The synthetic pyrethrines were
marketed in the 1950s, malathion and carbaryl in the '60s, and permethrin in the '80s. Although products
abound, the prevalence of head lice remains high and epidemics occur regularly despite all efforts at
control.3 4 5 Problems such as fear of insects (entomophobia), fear of stigmatisation, and denial of infection by
patients and schools may cause under-treatment, overtreatment, and unnecessary prophylaxis, which can lead
to development of resistance and insufficient control of epidemics.6 Furthermore, many of the commercially
available treatments might be underdosed, incorrectly labelled, or ineffective.

Our aim was to collect and evaluate all trials of clinical efficacy of topical treatments for head lice.7 8


We searched for trials of topical treatments for people infested with head lice (Pediculus humanus capitis) in
which the outcome was measured clinically by inspection of the scalp to determine cure rate (absence of live
lice and viable nits).


We searched the medical literature in Medline (1966 to March 1995 using the MESH keywords "Pediculosis,"
"Lice," "Pediculus"), in International Pharmaceutical Abstracts, and in the Science Citation Index without
restriction for language of publication. We scanned the references of all identified clinical trials. We sent letters
requesting information about unpublished studies to seven key authors in the subject, to the pharmaceutical
companies active in this subject, and to the World Health Organisation centre Vector Biology Control. We
hand searched journals in which key references were published for comments, letters, or corrections in the year
after publication of the key reference.


We focused on clinical efficacy--the result of pediculicidity, ovicidity, and residual activity--and so we chose
cure rate as the main outcome measure for clinical evaluation. The cure rate is the percentage of patients cured
after application of the treatment (the 95% confidence interval=p +/- 1.96 (square root p (100-p)/n), where p is
the sample percentage and n the number of subjects in the study). Determination of the cure rate by experienced
evaluators--on the basis of visual inspection for viable nymphs in nits, hatching nymphs, and adult lice (with a
x 10 magnifying lens)--has an acceptable specificity and sensitivity.9 We considered an interval of 14 days
between treatment and evaluation to be optimal as this would allow evaluation of the combined effect of
pediculicidity (on living lice), ovicidity (on ripening eggs), and residual activity (on hatching nymphs and
reinfesting lice).

We evaluated all identified clinical trials with regard to eight general criteria of quality in clinical trials (adapted
from Chalmers et al10) and 18 criteria specific for head lice treatment (see table I). We developed these specific
criteria after studying the literature to systematically screen the trials for flaws in design, execution, or reporting.
Firstly, we made a structured abstract of each clinical trial according to recommended guidelines.11 Each of us
then independently assessed the trials. Trials were rejected if four or more flaws in general criteria or 12 or more
flaws in treatment specific criteria were found. The remaining trials were rated as having a low risk of bias if less
than eight specific criteria were flagged, or a moderate risk of bias if otherwise. Again, we set these cut off
points for rating of quality after studying the literature. The structured abstracts, assessment scores, and overall
ratings were submitted to an advisory panel (four physicians and a community pharmacist) and discussed until
consensus was reached. Of the trials of acceptable methodological quality, we selected those in which the main
outcome measure was the cure rate at 14 days after treatment.

TABLE I--Criteria of quality in evaluation of design, execution, and
reporting of trials on clinical efficacy of topical treatment for head lice
Item No Criterion
  1      Randomisation procedure
  2      Concealment of allocation to patients
  3      Concealment of allocation to investigators
  4      Precision of definition of exclusion criteria
  5      Handling and reporting of drop outs
  6      Ethical procedures*
  7      Statistical procedures
  8      Appropriateness of conclusions
                          Treatment specific
  1      Documentation of prior exposure of screened population to
          pesticides (therapeutic or agricultural)
  2      Documentation of history of previous lice treatment and
          comorbidity of index patients
  3      Quality of informed consent procedure (involvement of parents)
  4      Inclusion criteria (definition of "current" head lice infection)
  5      Specification of the formulation of active ingredients
  6      Storage and manipulation of pharmaceutical compound
  7      Time and season of study
  8      Prevalence of lice in study area
  9      Standardisation of cotreatment and swimming
 10      Identity of applicants and evaluators
 11      Application procedure
 12      Intensity of tracing contacts
 13      Use of nit combs
 14      Documentation of pediculicidity
 15      Documentation of ovicidity
 16      Documentation of residual activity
 17      Documentation of cure rate
 18      Adverse events reported
*More relevant to good clinical practice than evaluation of bias.



We identified 28 trials of clinical efficacy, 27 from the computer databases12 13 14 15 16 17 18 19 20 21 22 23 24 25
27 28 29 30 31 32 33 34 35 36 37 38 and one supplied by an author in reply to our request.39 We also identified
an internal document of the Wellcome company describing a series of 11 small (11<n<74) unpublished
comparative trials of permethrin and malathion performed between 1983 and 1986 and apparently yielding
high cure rates for permethrin and malathion.40 As we decided not to accept the company's demands for
confidentiality, the full texts of these studies were not made available to us and these trials were not included in
the analysis. Hand searching did not reveal additional relevant reports of trials. The search in the Science
Citation Index showed only limited citing activity in this field. An official of WHO confirmed that the debate on
the choice of head lice treatment for the list of essential drugs had been based on expert opinion without a
formal literature review. Narrative reports of studies and older reports of treatment campaigns41 42 43 44 45
were not included in the analysis.

Four studies were not controlled,12 18 26 39 three studies (two of malathion and one of permethrin) were
placebo controlled,15 21 23 and the remaining 21 studies were comparisons between two or more active
substances. We rated the quality of the identified trials according to the criteria in table I and rejected 14 of the
trials because of an excess of general or treatment specific flaws (table II). Seven trials were excluded from the
analysis, although their methodological quality was acceptable, because the cure rate was not determined on
day 14 after treatment (three measured cure rate on day 7,15 21 38 and four measured it on day 21 or later16 29
32). The characteristics of the excluded trials are listed in table III.

TABLE II--Assessment of 28 trials according to eight general and 18 treatment specific criteria of quality
                                         General item No*                                   Treatment specific item No*
Study                          1   2  3  4  5  6  7  8    Total    1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18    Total    Risk of bias
                                             Trials of acceptable quality with cure rate at day 14
Maunder14                 F      F  F                 3       F   F   f       F   F                F         F              f    f               9      Moderate
Brandenburg et al22           F     F  F              3       F               F   F   F                                f                         5       Low
Taplin et al23                      F                 1                                                      f         f         f               3       Low
Bowerman et al24              F        F              2       F   f           F   F                                    f    f    f               7       Low
Carson et al27                F     F                 2                   f   F       f   f                            f    f    f               7       Low
DiNapoli et al28              F     F  F              3                       F       f   f        F                   f    f    f               7       Low
Clore et al36                    F  F                 2           F       f   F   F       f                  f         f    f    f               9      Moderate
                                          Trials of acceptable quality without cure rate at day 14
Taplin et al15            F                           1       F   F       F   F   f                                         f    f               7       Low
Mathias et al16                     F  F  F           3                       F   F   F       F         f              f         f    f          8      Moderate
Urcuyo et al21                   F  F                 2           F           F   F   F                      f                   f    f    f     8      Moderate
Miller et al29                      F                 1       F   F           F   F   f   F             f    F              f    f              10      Moderate
Kyle30                              F  F              2       f   f           F   F   f                 f    F         f    f    f              10      Moderate
Sexton et al32                      F  F              2       f   f           F   F   F   f             f    F         f    f    f              11      Moderate
Chosidow et al38              F                 F     2       f   F           F                                        f    f    F    f          7       Low
                                                       Trials of unacceptable quality
Blommers et al12          F         F  F  F           4       F   F   F       F       F   F   F    F    F    F         f    F    F    F         14       High
Preston et al13                     F  F  F     F     4       F   F   f       F   F   f            f    f    F         F    F    f              12       High
De Boer17                     F  F  F  F  F           5       F   f   F       F   F   F   F        f    f              f    f    f    f         13       High
De Boer et al18           F      F  F  F  F           5       F   F   f       F   F   f   f             f    F         f    f    f              12       High
Mazas et al19             F      F     F  F           4       f   F   F       F   F   F   f   F    f         F                   f    f    F    13       High
Donaldson et al20                   F  F              2       F   f           F       f   F        f    f    F         f    f    f    f    f    13       High
Armoni et al25            F         F  F        F     4       F   F   f       F   F   F   f             f    f                        f         10       High
Mazas et al26             F         F  F  F           4       F   F   F   f   F   F   f   F             f    F                   f    f    f    13       High
Rousset et al39           F      F  F  F  F           5       F   F   F   f   F   F   F   F                  F         f         f              11       High
Mathias et al31               F     F     F     F     4           F   F   f   F   f   F       F              f                                   8       High
Doss et al33                        F  F              2       f   f           F   F   F   F        f    f    F         f    f    f              12       High
Jolley et al34                      F                 1       f   f           F   F   f   f   F         f    F         f    f    f              12       High
Fan et al35               F         F  F  F           4       F   F   F       F           F   F    f         F         f    f    f         f    12       High
Burgess et al37           F   F     F     F     F     5       F   F       f               F                  F         f         F    F          8       High
*See table 1 for details of items.
F=major flaw; f=minor flaw.

TABLE III-Overview of clinical trials excluded from analysis
                                                                                                                                                  Percentage difference in
                                                                                                                             No of                 cure rate from highest
                                                  Treatment (single application                                      index           Cure         outcome (95% confidence
 Study                                            unless stated otherwise)                                         patients         rate (%)             interval)
                                                     Trials of acceptable quality without cure rate at day. 14
Taplin et al (cure rate at day 7)15          Malathion 0.5% lotion                                                  65               95
                                                  Control vehicle                                                        47               45            50 (35 to 65)*
Matthias et al (cure rate at day 28-40)16    Malathion 0.5% lotion                                                  29               76
                                                  Lindane 1% shampoo                                                     33               78             2 (0 to 23)
Urcuyo et al (cure rate at day 7)21          Malathion 0.5% lotion                                                  61               85
                                                  Control vehicle                                                        58                7            78 (67 to 89)*
Miller et al (cure rate at day 21)29         (delta)-Phenothrin 0.2% lotion                                         32              100
                                                  (delta)-Phenothrin 0.2% lotion                                         24              100             0
Kyle (cure rate at day 21)30                 (delta)-Phenothrin 0.2% shampoo                                        39               87
                                                  Malathion 0.5% lotion                                                  38               82             5 (0 to 21)
Sexton et al (cure rate at day 21-28)32      (delta)-Phenothrin 0.2% shampoo                                        27               96
                                                  Carbaryl 0.5% lotion                                                   23               87             9 (0 to 25)
Chosidow et al (cure rate at day 7)38        Malathion 0.5% lotion                                                  94               95
                                                  (delta)-Phenothrin lotion                                              95               39            56 (45 to 67)*
                                                               Trials of unacceptable quality
Blommers et al12                             Lindane 1% lotion+                                                    110
Preston et al13                              Carbaryl 0.5% lotion                                                    5
                                                  Carbaryl 1% gel shampoo                                                26
De Boer17                                    Malathion 0.5% lotion                                                  51
                                                  Bioallethrin 1.8%+butoxide                                             76
De Boer et al18                              Malathion 0.5% lotion                                                  51
Mazas et al19                                Permethrin 1% lotion                                                   10
                                                  Permethrin 1% lotion                                                   10
Donaldson et al20                            (delta)-Phenothrin 0.2% shampoo                                        42
                                                  Carbaryl 1.5% gel shampoo                                              34
Armoni et al25                               Pyrethrin 0.3%+butoxide shampoo                                        50
                                                  Pyrethroid 0.66%+butoxide spray                                        50
                                                  Malathion 0.4% lotion                                                  50
                                                  Carbaryl 0.6% shampoo                                                  50
                                                  Carbaryl 0.5% lotion                                                   50
Mazas et al26                                Malathion 0.5% lotion                                                  37
Rousset et al39                              Bioallethrin 0.66%+butoxide spray                                     100
Mathias et al31                              Lindane 1%                                                             25
                                                  Pyrethrin 0.3%+butoxide                                                28
Doss et al33                                 (delta)-Phenothrin 0.2% lotion                                         50
                                                  Malathion 0.5% lotion                                                  23
                                                  Carbaryl 0.5% lotion                                                   28
Jolley et al34                               (delta)-Phenothrin 0.2% shampoo                                        25
                                                  Carbaryl 0.5% shampoo                                                  25
Fan et al35                                  Permethrin 1% creme rinse                                             529
                                                  Bioallethrin 0.66% spray                                              314
                                                  Malathion 1% lotion                                                   519
                                                  Lindane 1% powder                                                     249
Burgess et al37                              Synergised pyrethrin mousse                                            42
                                                  Permethrin 1% creme rinse                                              10
*Significant difference (zero not included in 95% confidence interval of difference).
+Two applications.

The remaining seven trials were of acceptable methodological quality and had the cure rate on day 14 as main
outcome measure.14 22 23 24 27 28 36 Five of the trials had an overall quality rating of low risk of bias, while two
had a moderate risk of bias (table II). Three trials were conducted in an area with high background prevalence
of head lice (>50% of screened population).14 23 24


In the seven selected trials 21 individual evaluations of topical treatments were performed, comparing placebo
and eight compounds (lindane, bioresmethrin, chlorphenamide, (delta)-phenothrin, pyrethrin, malathion, carbaryl,
and permethrin), and all but two evaluations27 36 were of single applications (table IV). We juxtapositioned the
results obtained in different trials for the same compounds, and the figure shows the cure rates for each
compound. The cure rate with placebo was 6%,23 showing the lack of placebo effect and spontaneous
remission with this condition. We found six evaluations of lindane; in none of them did the lower confidence limit
of the cure rate exceed 90%, and in two trials even the upper confidence limit was below 90%. For the natural
pyrethrines (pyrethrin, bioresmethrin, chlorphenamide, and (delta)-phenothrin), all the evaluations resulted in
cure rates with lower confidence limits below 90%. Only one evaluation was available for carbaryl 0.5% lotion
and malathion 0.5% lotion, both giving cure rates with lower confidence limits above 90%. We found five
evaluations of permethrin 1% creme rinse (in a single application of 10 minutes) with cure rates of nearly 100%
and lower 95% confidence limits above 90%. Two of these studies were high quality studies in populations with
a high background prevalence of head lice (>50% of screened population infested).23 24

TABLE IV--Overview of included trials
                                                                                                        Percentage difference in
                                                                 No of             Cure rate (%)        cure rate at day 14 from
                          Ttreatment (single applications       index          -------------------      highest outcome (95%
Study                     unless stated otherwise)             patients         Day 7      Day 14       confidence interval)
Maunder14            Carbaryl 0.5% lotion                    81                        100
                          Carbaryl 0.5% shampoo                   64                         97            3 (0 to 7)
                          Bioresmethrin 0.2% lotion               49                         92            8 (0 to 7)
                          Chlorphenamide 0.2% lotion              93                         86           14 (7 to 21)*
                          Lindane 0.5% lotion                     97                         91            9 (3 to 15)*
                          Lindane 1% shampoo                      57                         86           14 (5 to 23)*
                          Malathion 0.5% lotion                  108                         98            2 (0 to 5)
Brandenburg et al22  Permethrin 1% creme rinse              257              99         99
                          Lindane 1% shampoo                     251              92         85           14 (9 to 19)*
Taplin et al23       Permethrin 1% creme rinse               29             100         97
                          Control vehicle                         34               9          6           91 (81 to 100)*
                          Lindane 1% (non-random)                 30              67         43
Bowerman et al24     Permethrin 1% creme rinse              195              99         98
                          Lindane 1% shampoo                      99              90         76           22 (13 to 31)*
Carson et al27       Permethrin 1% creme rinse               27              96        100
                          Pyrethrin 0.3% lotion+                  31              45         94            6 (0 to 14)
Di Napoli et al28    Permethrin 1% creme rinse              107              98         96
                          Permethrin 0.3% lotion                 106              85         62           34 (24 to 44)*
Clore et al36        Lindane 1% shampoo+                     30              80         93
                          Permethrin 1% creme rinse               32              91         87            6 (0 to 21)
                          Pyrethrin 0.3% five brands              31              79         86            7 (0 to 18)
*Significant difference (zero not included in 95% confidence interval of difference).
+Two applications.

We also made an intrastudy comparison of the two largest trials.22 24 Both trials were of high quality and
compared single applications of permethrin 1% creme rinse with lindane 1% shampoo. The odds ratio of
treatment failure for lindane versus permethrin was 15.11 (95% confidence interval 4.60 to 49.62) in one
study22 and was 15.28 (5.13 to 45.52) in the second study.24 After performing a Breslow-Day test for
homogeneity of odds ratios (P=0.99), we obtained the Mantel-Haenszel summary odds ratio of 15.18 (7.99
to 28.84). Hence, the risk of treatment failure was likely to be at least eight times higher with lindane than with


Our aim was to collect details of all trials on the clinical efficacy of treatment for head lice and to describe the
results of the trials that were not invalidated by too many flaws. To our surprise, we found only 28 published


We cannot exclude the possibility that important research findings were missed by our method of retrieval. We
did not engage in a hand search of core journals, as recommended for structured reviews,46 because there did
not seem to be a core group of journals, where research publications are concentrated,47 for this subject. Our
failure to obtain the full text of unpublished trials comparing permethrin with malathion excluded evidence for the
efficacy of malathion.

In this first systematic approach to the treatment of head lice it was not possible to determine the acceptance
criteria a priori. The rating system was instead developed after study of the identified trials. We chose cure rate
at 14 days as the main outcome measure since it was the most commonly used criterion for efficacy and is, in
our opinion, the most appropriate outcome measure. We preferred not to consider the cure rate at seven days,
as hatching of nymphs can take longer than this48 and as a week is too short to evaluate the effect of residual
activity on reinfestation (which is important in stopping transmission during epidemics).49 We have, however,
presented cure rates at day 7 and beyond day 14 (tables III and IV), but these results do not challenge the
overall conclusions of our review.


We presented the efficacy data of each active ingredient by juxtaposition of treatment groups from the seven
selected trials. This procedure is methodologically weak but has the advantage of extracting at least some of the
limited knowledge from the clinical studies. The representation of the confidence intervals in the figure should be
interpreted with caution, as many of the results fall in the extreme end of the range of cure rates, where
confidence intervals based on the sample percentage tend to shrink to zero.

                                                 No of
Control vehicle                                 patients
(Taplin et al23)                              34
1% Shampoo (Clore et al36)*                   30
0.5% Shampoo (Maunder14)                      97
1% Shampoo (Maunder14)                        57
1% Shampoo (Brandenburg et al22)             251
1% Shampoo (Bowerman et al24)                 99
1% Shampoo (Taplin et al23)                   30
Pyrethrin 0.3% lotion (Carson et al27)*       31
Bioresmethrin 0.2% lotion (Maunder14)         49
Chlorphenamide 0.2% lotion (Maunder14)        93
Pyrethrin 0.3% (five brands)(Clore et al36)   31
0.5% Lotion (Maunder14)                       81
0.5% Shampoo (Maunder14)                      64
0.5% Lotion (Maunder14)                      108
1% Creme rinse (Carson et al27)               27
1% Creme rinse (Brandenburg et al22)         257
1% Creme rinse (Bowerman et al24)            195
1% Creme rinse (Taplin et al23)               29
1% Creme rinse (DiNapoli et al28)            107
1% Creme rinse (Clore et al36)                32
0.3% Lotion (DiNapoli et al28)               106
*Double application                                           0   10   20   30   40   50   60   70   80   90   100
                                                                           Cure rate at day 14 (%)
Cure rates (95% confidence intervals) at day 14 after treatment for head lice. (Filled rectangles indicate high
background prevalence (>50% of screened population infested). Products were applied once unless
indicated otherwise)

Within the seven selected trials it was difficult to make sensible intrastudy comparisons. The sample size of two
of the trials27 36 was insufficient for testing relevant differences. Two trials were selected despite flaws in
randomisation, one because of the comparison with placebo23 and one because of the range of products
tested.14 The relevance of testing a product against itself in an underdosed formulation in one study28 can be
questioned. Hence, we limited ourselves to the comparison of the two bigger high quality trials, which compared
permethrin with lindane.22 24


We made no attempt to formally weigh criteria such as side effects, toxicity, and cost. In the course of reviewing
the literature, we found only one large scale postmarketing surveillance of safety, which provided evidence for
the safety of permethrin.50

Theoretically, products with residual activity might facilitate selection of resistant strains of head lice, and
proposals have been made for a rotational or mosaic treatment strategy.49 51 There is no convincing evidence
for a need for such a strategy, but development of resistance should be monitored if the therapeutic arsenal
diminishes to a few products of proved efficacy.


The number of well conducted trials of clinical efficacy in this subject of medical and economic importance is
limited, and recommendations for treatment published in the medical literature are not sufficiently sustained by
the results of research. Our list of treatment specific criteria could be a starting point for evaluation of new trials
in the subject. Moreover, inspection of the figure leads us to recommend that only products with an expected
cure rate of over 90% should be tested and that this should be done in trials with sufficient power to establish
cure rates with a lower confidence limit above 90%. We propose the use of equivalence testing (testing for
non-null hypothesis) and of the odds ratio of treatment failure with its 95% confidence interval, as the {chi}2 test
might not be valid for testing differences in cure rates near 100%. Future research on head lice treatments should
preferably test single applications of compounds, as was the case in almost all the acceptable clinical trials in this
study. Any treatment for lice might be effective if it is applied repeatedly over a short interval.52 We found many
examples of instructions on labels encouraging multiple application, especially with products that lacked well
documented efficacy. In some cases these instructions clearly played on people's entomophobia to stimulate
consumption, as has been stated by others.6

We are indebted to the members of the advisory panel: C Carton, army pest control physician; J M Kaufman,
endocrinologist; G Laekeman, professor of pharmacy; K Seynaeve, school health services physician; and
E Van Hecke, dermatologist. We thank D De Bacquer for statistical advice and A Herxheimer for critical
comments on the manuscript.

Funding: This study was supported by a grant from the Belgium Ministry of Health.

Conflict of interest: None.

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(Accepted 14 July 1995)

© 2003 BMJ Publishing Group Ltd


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