Professional Documents
Culture Documents
van der Wouden JC, van der Sande R, van Suijlekom-Smit LWA, Berger M, Butler CC, Koning
S
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2010, Issue 2
http://www.thecochranelibrary.com
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Topical: 10% Australian lemon myrtle oil vs. vehicle (olive oil), Outcome 1 Complete clearance
or > 90% reduction after 3 weeks. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 2.1. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 1 Complete clearance after 4 weeks. . .
Analysis 2.2. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 2 Partial clearance after 4 weeks. . . . .
Analysis 2.3. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 3 Complete clearance after 12 weeks. . .
Analysis 2.4. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 4 Partial clearance after 12 weeks. . . .
Analysis 3.1. Comparison 3 Topical: 10% benzoyl peroxide cream vs. 0.05% tretinoin cream (ITT), Outcome 1 Free of
lesions after 6 weeks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 4.1. Comparison 4 Topical: 10% KOH vs. saline, Outcome 1 Clinical cure at medium-term follow-up (3
months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 5.1. Comparison 5 Topical: 10% povidone iodine and 50% salicylic plaster vs. 10% povidone iodine alone,
Outcome 1 Clinical cure at end of study (duration unknown). . . . . . . . . . . . . . . . . .
Analysis 6.1. Comparison 6 Topical: 10% povidone iodine and 50% salicylic acid plaster vs. 50% salicylic plaster alone,
Outcome 1 Clinical cure at end of study (duration unknown). . . . . . . . . . . . . . . . . .
Analysis 7.1. Comparison 7 Topical: 10% povidone iodine vs. 50% salicylic acid plaster, Outcome 1 Clinical cure at end of
study (duration unknown). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 8.1. Comparison 8 Topical: 5% sodium nitrite in 5% salicylic acid vs. 5% salicylic acid alone, Outcome 1 Clinical
cure at medium-term follow-up (3 months). . . . . . . . . . . . . . . . . . . . . . . .
Analysis 9.1. Comparison 9 Topical: 10% phenol/70% alcohol vs. 70% alcohol (ITT), Outcome 1 Complete clearance at
end of study (max 6 months). . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 10.1. Comparison 10 Topical: 12% salicylic acid vs. 70% alcohol (ITT), Outcome 1 Complete clearance at end of
study (6 months max). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 11.1. Comparison 11 Topical: 12% salicylic acid vs. 10% phenol/70% alcohol (ITT), Outcome 1 Complete
clearance at end of study (max 6 months). . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 12.1. Comparison 12 Systemic: cimetidine vs. placebo, Outcome 1 Clinical cure at medium-term follow-up (4
months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 13.1. Comparison 13 Systemic: calcarea carbonica vs. placebo, Outcome 1 Improvement at end of study (duration
unknown). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
1
2
2
4
4
6
11
13
14
14
15
19
34
37
38
38
39
39
40
40
41
41
42
42
43
43
44
44
45
45
46
46
47
47
47
48
48
[Intervention Review]
of General Practice, Erasmus MC, University Medical Center, Rotterdam, Netherlands. 2 Department of Pediatrics,
Erasmus MC - University Medical Center, Rotterdam, Netherlands. 3 Department of Primary Care and Public Health, School of
Medicine, Cardiff University, Cardiff, UK
Contact address: Johannes C van der Wouden, Department of General Practice, Erasmus MC, University Medical Center, PO Box
2040, Rotterdam, 3000 CA, Netherlands. j.vanderwouden@erasmusmc.nl.
ABSTRACT
Background
Molluscum contagiosum is a common skin infection, caused by a pox virus. The infection will usually resolve within months in people
with a normal immune system. Many treatments have been used for molluscum contagiosum but a clear evidence base supporting
them is lacking.
This is an updated version of the original Cochrane Review published in Issue 2, 2006.
Objectives
To assess the effects of management strategies (including waiting for natural resolution) for cutaneous, non-genital molluscum contagiosum in otherwise healthy people.
Search strategy
In June 2009 we updated our searches of the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled
Trials (CENTRAL) in The Cochrane Library (Issue 2, 2009), MEDLINE, EMBASE, and LILACS. We also searched ongoing trials
registers, reference lists, and contacted pharmaceutical companies and experts in the field.
Selection criteria
We investigated randomised controlled trials (RCTs) for the treatment of molluscum contagiosum. We excluded trials on sexually
transmitted molluscum contagiosum and in people with lowered immunity (including those with HIV infection).
Data collection and analysis
Two authors independently selected studies, assessed methodological quality, and extracted data from selected studies.
Interventions for cutaneous molluscum contagiosum (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Eleven studies, with a total number of 495 participants, examined the effects of topical (9 studies), systemic, and homoeopathic
interventions (1 study each). Limited evidence was found for the efficacy of sodium nitrite co-applied with salicylic acid compared to
salicylic acid alone (risk ratio (RR) 3.50, 95% confidence interval (CI) 1.23 to 9.92); for Australian lemon myrtle oil compared to its
vehicle, olive oil (RR 17.88, 95% CI 1.13 to 282.72); and for benzoyl peroxide cream compared to tretinoin (RR 2.20, 95% CI 1.01
to 4.79). No statistically significant differences were found for 10 other comparisons, most of which addressed 2 topical treatments.
Study limitations included no blinding (four studies), many dropouts (three studies), and no intention-to-treat analysis; small study
sizes may have led to important differences being missed. None of the evaluated treatment options were associated with serious adverse
effects.
Authors conclusions
No single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum. The update identified
six new studies, most of them reporting on interventions not included in the original version. However, the conclusions of the review
did not change.
BACKGROUND
Epidemiology
Molluscum contagiosum occurs worldwide but is much more frequent in certain geographic areas with warm climates, like Fiji,
Congo, and Papua New Guinea. Infection is rare in children under
the age of one year, and typically occurs in the two to five year old
age group (Rogers 1998). The age of peak incidence is reported
as being between the ages of 2 and 3 years in Fiji (Postlethwaite
1967), and between 1 and 4 years in the Congo (formerly Zaire)
(Torfs 1959). In Papua New Guinea the annual attack rate for
children under 10 years of age was 6% (Sturt 1971). For developed countries, population-based occurrence rates are scarce. In
a large questionnaire study among parents of children attending
kindergartens and elementary schools the reported prevalence of
molluscum contagiosum was 5.6% and 7.4% respectively (Niizeki
1984). Much higher prevalence rates have been reported during
outbreaks in closed communities (Overfield 1966).
In the United States, from 1990 to 1999 the estimated number of physician visits for molluscum contagiosum was 280,000
per year (Molino 2004). One out of 6 Dutch children aged 15
years have visited their doctor for molluscum contagiosum at least
once (Koning 1994). There is generally no difference in incidence
between males and females (Sturt 1971; Relyveld 1988; Koning
1994). However, an unequal sex ratio was found in studies from
Japan (Niizeki 1984), Alaska (Overfield 1966), and Fiji (Hawley
1970), where boys were affected more often. This is probably due
to habits associated with the spread of the infection, such as swimming (Postlethwaite 1967; Niizeki 1984). Outbreaks may occur
among children who bathe or swim together. A history of eczema
was found in 62% of children with molluscum contagiosum in
Australia (Braue 2005). In the adolescent and adult age groups
sexual transmission becomes important.
Natural history
The estimated incubation period varies from 14 days to 6 months.
Lesions enlarge slowly and may reach a diameter of 5 to 10 mm in
6 to 12 weeks (Sterling 1998). After trauma (for example, scratching), or spontaneously after several months, inflammatory changes
result in the production of white fluid, crusting, and eventual destruction of the lesions. However, new lesions tend to appear as the
old ones resolve as a consequence of the virus spreading to other
areas of skin. The duration both of the individual lesion and of the
entire episode is highly variable. Crops of molluscum may appear
to come and go for several months, and although most cases are
self limiting and resolve within six to nine months, some may persist for more than three or four years. Follow-up studies (Liveing
1878; Hawley 1970) confirm these figures and show that individual lesions are unlikely to persist for more than two months.
A Japanese study described spontaneous resolution on average 6.5
months after infection in 205 out of 217 children (94.5%) affected
by molluscum contagiosum (Takemura 1983). One month after
the first consultation with the dermatologist, 23% of the children
were cured.
Particularly in atopic people (who are prone to asthma, hay fever,
or eczema), there is a tendency for a patch of eczema (which is
often particularly itchy) to develop around one or more of the lesions a month or more after their onset (De Oreo 1956; Beaulieu
2000). Erythema annulare centrifugum (a widespread rash of red
inflammatory rings) has also been reported (Vasily 1978). Chronic
conjunctivitis and superficial punctate keratitis may similarly complicate lesions on or near the eyelids (Haellmigk 1966; Redmond
2004). The eczema and conjunctivitis subside spontaneously when
the molluscum lesion is removed.
Molluscum contagiosum behaves differently in HIV-infected individuals. As immunodeficiency progresses, molluscum contagiosum becomes more common and resistance to therapy increases.
Frequently, multiple lesions in atypical areas such as the face and
neck can be found. Only limited data are available on the course
of the disease in this group of people.
METHODS
Types of studies
Randomised controlled trials (RCTs) for the treatment of molluscum contagiosum. Trials on sexually transmitted molluscum contagiosum and in people with lowered immunity (including those
with HIV infection) were excluded.
Types of participants
People with a diagnosis of molluscum contagiosum, except for
those with lowered immunity or sexually transmitted molluscum
contagiosum.
In general, treatment is based on a clinical diagnosis only, as molluscum contagiosum is an easy diagnosis to make and confusion
is rare among clinicians. Therefore additional diagnostic criteria,
such as histological examination and laboratory investigations,
were considered unnecessary.
Types of interventions
All treatments aimed at eradicating molluscum contagiosum lesions, including:
physical interventions;
systemic treatments;
topical agents; and
awaiting natural resolution.
Studies on other aspects of the treatment of molluscum contagiosum, for example, on reducing pain in the studies that used analgesic EMLA (eutectic mixture of local anaesthetics) cream (Juhlin
1980; de Waard 1990), were excluded.
Primary outcomes
OBJECTIVES
Secondary outcomes
(a) Medium and long-term clinical cure (after three months and
six months, respectively)
(b) Medium and long-term improvement (after three months and
six months, respectively)
(c) Time to cure
(d) Recurrences after 3, 6, and 12 months
(e) Adverse effects of treatment such as pain, blistering, sensitisation, scarring, erosion, and pigmentary changes
(f ) Spread to other people
(g) Disease-related quality of life
Measures (b) and (g) were not initially specified in the protocol, but
were added afterwards since improvement at the end of the study
was frequently the most commonly reported outcome measure,
and disease-related quality of life was considered to be a relevant
additional measure.
Electronic searches
We updated our searches for relevant trials in the following
databases:
Cochrane Skin Group Specialised Register (8th June 2009)
using the term mollusca*.
The Cochrane Central Register of Controlled Trials in The
Cochrane Library Issue 2, 2009 using the search strategy in
Appendix 1.
MEDLINE (OVID) (from March 2004 to 8th June 2009)
using the search strategy in Appendix 2 which has been
developed from the Cochrane Highly Sensitive Search Strategy
for identifying randomised trials in MEDLINE (Higgins 2008).
EMBASE (OVID) (from March 2004 to 8th June 2009)
using the search strategy in Appendix 3.
LILACS (Latin American and Caribbean Health Service
Information database) (from March 2004 to 8th June 2009)
using the strategy in Appendix 4.
Ongoing trials
We searched the following registers of ongoing trials on 30th January 2009 using the term molluscum.
Reference lists
Selection of studies
Two authors independently read all abstracts or titles of identified trials. If one of the authors considered the article potentially
relevant, a full-text copy of the article was obtained for further
consideration. Two authors independently examined all full-text
copies to determine whether or not they met our inclusion criteria.
Disagreements were resolved by discussion between the authors,
with referral to a third author when necessary.
Trials on sexually transmitted molluscum contagiosum and in people with lowered immunity (including those with HIV infection)
were excluded, in order to increase homogeneity of studies. If the
full-text of studies was not available published abstracts were considered for the review.
If an RCT included a variety of skin diseases, including molluscum
contagiosum, the number of molluscum participants needed to
be at least five in the active treatment and placebo groups. This
criterion was added after the protocol was approved when a study
was found which included 10 molluscum participants with a 9:1
distribution over the 2 treatment groups (Caballero 1996).
If the setting of the study was not explicitly mentioned in the text,
it was assumed to be carried out at the affiliation of the first author.
Data synthesis
Trials relevant to the focus of this review were examined in greater
detail. We provide a narrative synthesis of included trials, presenting the characteristics of trials and their results.
For studies with a similar type of intervention, meta-analyses were
planned to calculate a weighted treatment effect across trials using
a random-effects model (DerSimonian and Laird model). Similar
comparisons between two interventions were made in only two
studies. For dichotomous outcomes, we expressed the results as risk
ratios (RR) with 95% confidence intervals (CI) and as a number
needed to treat (NNT) where appropriate.
For continuous outcomes, the results were to be expressed as
weighted mean differences (WMD) with 95% CI. For time to
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies; Characteristics of ongoing studies.
Results of the search
For the first version of this review, searches were performed in
March 2004. Seventeen abstracts were generated by searching the
Cochrane Central Register of Controlled Trials database in The
Cochrane LIbrary ; 131 abstracts from MEDLINE, 148 abstracts
from EMBASE, and 45 from LILACS. From these abstracts, some
of which were duplicates, 18 studies were considered possibly to
be RCTs and the full text was obtained. A further 17 studies were
identified from the bibliographies of retrieved studies and the full
text of these studies were also obtained. In November 2008 search
strategies were re-run, 12 additional studies were considered possibly to be RCTs and full text was obtained. The papers discussed
a variety of treatment options for molluscum contagiosum. (See
Table 1 for treatment options for molluscum contagiosum found
in the literature). A further search in June 2009 prior to publication did not yield any new studies.
Treatment modality
Surgical treatments
Cryotherapy
Curettage
Topical treatments
Included studies
Other studies
Caballero 1996; Barton 2002;
Salmanpour 2006
Hanna 2006
de Waard 1990
Quan 2000
Electric cauterisation
He 2001
Weller 1999
Pricking
Wishart 1903
Hammes 2001
Acidified nitrite
Ormerod 1999
Burke 2004
Benzoyl peroxide
Saryazdi 2004
Bromogeramine
Cantharidin
Grfe 2000
He 2001
Hanna 2006
Cidofovir
Diphencyprone
Griseofulvin
Salmanpour 2006
Imiquimod
Milkweed
Ohkuma 1990
Phenol
Leslie 2005
Weller 1999
Syed 1994; Teilla-Hamel 1996;
Markos 2001
Potassium hydroxide
(Continued)
Retinoic acid
Salicylic acid
Niizeki 1999
Saryazdi 2004
Combinations of above
Cimetidine
Davis 1896
Antony 2001
Manchanda 1997a
Griseofulvin
Singh 1977
Cope 1915
Topical therapy
Blinding
Seven of the studies were described as double-blind (Bazza;
Manchanda 1997b; Ormerod 1999; Antony 2001; Short 2006;
Burke 2004; Theos 2004). However, none of them provided information about the visual similarity of treatments, nor whether
blinding was maintained throughout follow-up. Ormerod reported brown staining on the skin in six participants with active
treatment, but none of the controls, which may have unblinded
the assessment of outcomes (Ormerod 1999).
Effects of interventions
10
less than two (i.e. for each cure achieved, two people need to be
treated). The mean number of treatment days was 38 (standard
deviation (SD) 20) in the treatment group and 49 (SD 25) in the
control group. Brown staining was reported in 6 of the 16 participants using the active treatment. Four out of 16 participants
(25%) stopped the active treatment because of irritation and lack
of efficacy. Two additional participants, who were cured, complained of significant irritation.
The results of the study by Hanna et al (Hanna 2006) could not
be included in the analysis, as the outcome (cure rate) was only
reported in number of visits, but not stating at what time these
visits took place.
Theos 2004 (see above for results after 4 weeks) also assessed cure
after 12 weeks. Application of 5% imiquimod cream resulted in
complete clearance in 4/12 patients versus 1/11 of the control
group who received vehicle cream (RR 3.67, 95% CI 0.48 to
28.00) (Analysis 2.3). Partial clearance was observed in 8/12 versus
2/11 patients (RR 3.67, 95% CI 0.98 to 13.67) (Analysis 2.4).
None of these differences were statistically significant.
Leslie 2005 was the only study assessing cure after a maximum of
6 months. Application of 10% phenol compared to 70% alcohol
resulted in 17/41 versus 16/36 cured patients (RR 0.93, 95% CI
0.56 to 1.56) (Analysis 9.1). Salicylic acid (12%) compared to 70%
alcohol resulted in 21/37 versus 16/36 cured patients (RR 1.28,
95% CI 0.81 to 2.02) (Analysis 10.1). None of these differences
were statistically significant.
Salicylic acid compared to phenol resulted in 21/37 versus 17/41
cured patients (RR=1.37, 95% CI 0.86 to 2.17, not significant) (
Analysis 11.1).
DISCUSSION
11
12
Figure 1. Risk of bias table: review authors judgements about each methodological quality item for each
included study.
13
AUTHORS CONCLUSIONS
Implications for practice
No reliable evidence-based recommendations can be given for the
treatment of molluscum contagiosum at present. We were unable
to include outcomes of randomised controlled trials that addressed
physical destruction of molluscum lesions. Until robust evidence
emerges for effective and safe treatment, clinicians should consider
expectant management, i.e. awaiting spontaneous resolution of
the molluscum lesions.
ACKNOWLEDGEMENTS
The authors thank Jack Menke, Sanjay Gajadin, and Marjolein
Tasche for their assistance when writing the first version of our
review. The authors would also like to thank Adrie Hollestein,
Daan Muris, Kazutomo Ohkuma, Tony Ormerod, Jane Sterling,
and Hywel Williams for drawing our attention to relevant studies.
Drs. Manchanda, Kazutomo Ohkuma, and Anthony Ormerod
kindly provided additional information regarding their studies,
and Kate Short and Mohammed Bazza generously sent us their
full paper before it was submitted for publication. The editorial
base provided help in tracing and translating papers. We also thank
Himiko Luiken for translating the unique study on the natural
history of molluscum contagiosum by Tsukasa Takemura and colleagues, and Taixiang Wu for interviewing Dr He on details of her
14
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15
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19
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Antony 2001
Methods
Double-blind randomised placebo-controlled trial. Method of generation of randomisation sequence is unclear, as is concealment of allocation. No intention-to-treat analysis.
UK, Department (Dept) of Dermatology
Participants
38 patients (1 to 16 years, M/F 18/20) were enrolled, for 19 patients complete data were
obtained, 8 of which had been randomised into the treatment arm. 19 patients withdrew
from the study, no data on reasons for withdrawal
Interventions
35 mg/kg/day cimetidine, given once daily as oral suspension versus a matching placebo
Outcomes
Complete clearance after 4 months treatment. Reduction of lesions. Adverse events: not
mentioned
Notes
Risk of bias
Item
Authors judgement
Description
Unclear
Allocation concealment?
Unclear
Blinding?
All outcomes
Yes
Quote:
Double-blind
placebocontrolled; The dose of cimetidine was
35 mg/kg1 /day 1 ; The placebo group
received a manufactured placebo. Probably done, placebo-controlled, both suspensions
Unclear
Unclear
Unclear
20
Antony 2001
(Continued)
Unclear
Bazza
Methods
Randomised controlled trial. Body sides were randomised left-right. UK, Dept of Dermatology
Participants
Interventions
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Unclear
Allocation concealment?
Unclear
Blinding?
All outcomes
Yes
Unclear
Bazza
(Continued)
Unclear
Unclear
Unclear
Burke 2004
Methods
Participants
Interventions
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Yes
Quote: Children were randomized to active treatment or vehicle (virgin olive oil) by
blindly choosing a token numbered from
1 to 100. Odd numbers were assigned to
active treatment even numbers to vehicle
Allocation concealment?
Yes
Quote: Children were randomized to active treatment or vehicle (virgin olive oil) by
blindly choosing a token numbered from
1 to 100. Parents and physicians were
blinded to treatment protocol. A treatment
key was held by a participating pharmacist
(no patient contact) until study completion
Blinding?
All outcomes
Yes
22
Burke 2004
(Continued)
Yes
Unclear
Unclear
Unclear
Hanna 2006
Methods
Participants
Interventions
Four arms: curettage; topical cantharidin 0.7%; topical salicylic acid 16.7% + lactic acid
16.7%; topical imiquimod cream 5%
Outcomes
Number of visits required. Intervals between study visits not reported, so outcome data
not suitable for inclusion
Notes
Total number of patients unclear. Percentage of group 3 in table 1 does not correspond
to number mentioned in text
Risk of bias
Item
Authors judgement
Description
Yes
Quote: The randomization list was generated by specialized computer software (PCPLAN, Dalal, 1996)
Allocation concealment?
Unclear
Quote: The randomization list was generated by specialized computer software (PCPLAN, Dalal, 1996). Insufficient information
23
Hanna 2006
(Continued)
Blinding?
All outcomes
No
Unclear
Not reported
Not reported
Unclear
Unclear
Unclear
Leslie 2005
Methods
Randomised controlled trial. UK, outpatient departments of teaching hospital and district general hospital
Participants
Interventions
Topical salicylic acid 12%, or phenol 10% with 70% alcohol, or 70% alcohol
Outcomes
Notes
Risk of bias
Item
Authors judgement
Description
Yes
Allocation concealment?
No
Blinding?
All outcomes
No
24
Leslie 2005
(Continued)
Unclear
Unclear
Unclear
Unclear
Manchanda 1997b
Methods
Participants
14 molluscum patients (age and sex unknown) randomised into the treatment arm, 6
patients were randomised to receive plain sugar globules as a placebo (personal communication Dr Manchanda). 10 patients were aged below 10 years, 7 from 10 to 20 and 3
were from the age group 21 to 30 years (personal communication with Dr Manchanda)
Interventions
Different potencies of a homeopathic drug called calcarea carbonica daily for 15 days (n
= 14) versus sugar globules (placebo). Unclear which patients received what potency
Outcomes
Notes
Paper reports on (1) cross-over study (2) parallel study. The cross-over study was excluded,
because less than 5 patients in one of the arms
Risk of bias
Item
Authors judgement
Description
Unclear
25
Manchanda 1997b
(Continued)
Allocation concealment?
Unclear
Blinding?
All outcomes
Yes
Yes
Only 15 days
Unclear
Unclear
Unclear
Ohkuma 1990
Methods
Randomised controlled trial (written correspondence Dr Ohkuma), the method of generation of randomisation sequence remained unclear, as was the concealment of allocation. It was also unclear if participants were analysed according to the group to which
they were randomised (intention-to treat analysis) and how blinding was performed.
Japan, Department of Dermatology
Participants
35 patients with molluscum contagiosum, aged between 2 and 9 years (M/F 21/14)
Interventions
3 interventions were compared: 10% povidone iodine solution combined with 50%
salicylic acid plaster (n = 20), iodine alone (n = 5) and salicylic plaster alone (n = 10)
Outcomes
Time to cure
Adverse events
Study duration unknown
Notes
26
Ohkuma 1990
(Continued)
Risk of bias
Item
Authors judgement
Description
Unclear
Allocation concealment?
Unclear
Blinding?
All outcomes
No
Unclear
Unclear
Unclear
Unclear
Ormerod 1999
Methods
Group sequential double-blind randomised trial. All participants were analysed according
to group assignment (intention-to-treat). Two patients did not complete the trial. UK,
Department of Dermatology
Participants
30 molluscum patients were enrolled, with 16 in the acidified nitrite group and 14
controls, with a median age of 6 years, 22 girls and 8 boys. Exclusion criteria were age
below 1 year of age, pregnant or lactating women, and taking immunosuppressive drugs
or known to have HIV infection
Interventions
5% sodium nitrite co-applied daily with 5% salicylic acid under occlusion versus identical
cream with 5% salicylic acid omitting sodium nitrite
Outcomes
27
Ormerod 1999
(Continued)
Notes
Risk of bias
Item
Authors judgement
Description
Unclear
Allocation concealment?
Unclear
Blinding?
All outcomes
No
Unclear
Unclear
Unclear
Unclear
No compliance data. Duration and number of lesions were very similar (communication with author)
Saryazdi 2004
Methods
Participants
Interventions
Topical benzoyl peroxide 10% cream versus tretinoin 0.05% cream, 2 times daily (TD)
for 4 weeks
Outcomes
28
Saryazdi 2004
(Continued)
Notes
Information based on abstract, proportions cured used for estimating absolute numbers.
Abstract published in 2004 - unclear when study was carried out
Risk of bias
Item
Authors judgement
Description
Unclear
Not reported
Allocation concealment?
Unclear
Not reported
Blinding?
All outcomes
Unclear
Investigator masked
Unclear
Not reported
Not reported
Unclear
Unclear
Unclear
Short 2006
Methods
Participants
20 children from a paediatric dermatology clinic, age range 2 to 12 years, M/F 6/14.
Exclusion criteria were known immunodeficiency and facial lesions
Interventions
Application of 10% potassium hydroxide solution twice daily applied with a cotton
swab, continued until the lesions showed signs of inflammation (n = 10). The control
group received saline (n = 10)
Outcomes
Time to resolution
Adverse events
Study duration 3 months
Notes
Number of patients who completed the study differs between unpublished paper (18/20)
and published paper (19/20). Latter number included in corrected version of 2009
update (December 2009).
29
Short 2006
(Continued)
Risk of bias
Item
Authors judgement
Description
Unclear
Quote: The children were randomly allocated by the dispensing pharmacist to receive one of two treatments. Insufficient
information.
Allocation concealment?
Unclear
Quote: The children were randomly allocated by the dispensing pharmacist to receive one of two treatments. Central allocation: Pharmacy-controlled
Blinding?
All outcomes
Yes
Yes
Unclear
Unclear
Unclear
Theos 2004
Methods
Participants
Interventions
Outcomes
Complete or partial clearance (> 30% decrease from baseline lesion count)
30
Theos 2004
(Continued)
Notes
Risk of bias
Item
Authors judgement
Description
Unclear
Allocation concealment?
Unclear
Blinding?
All outcomes
Yes
Yes
Unclear
Unclear
Unclear
Barton 2002
Caballero 1996
RCT comparing 2 types of cryotherapy for cutaneous skin lesions: 124 patients, among which 10 molluscum
patients, distributed 9:1 over 2 arms
Chatproedrai 2007
31
(Continued)
de Waard 1990
Study on analgesic effect of lidocaine/prilocaine (EMLA) cream before physical therapy. Not a focus of this
review (n = 83)
He 2001
Large parallel controlled study (n = 1656), with 4 arms, no randomisation (personal communication with
Dr He through Taixiang Wu)
Juhlin 1980
Study on analgesic effect of lidocaine/prilocaine (EMLA) cream before physical therapy. Not a focus of this
review (n = 24)
Manchanda 1997a
Cross-over study with different types of warts (n = 43), 10 molluscum patients. 1 of the treatment arms
(placebo first?) had less than 2 patients
Rosendahl 1988
Study on analgesic effect of lidocaine/prilocaine (EMLA) cream before physical therapy. Not a focus of this
review (n = 55)
Salmanpour 2006
Syed 1994
RCT, n = 150, mainly genital lesions, which is not a focus of this review
Syed 1998
RCT, n = 100, mainly genital lesions, which is not a focus of this review
Weller 1999
Controlled trial (n = 16), comparing phenol ablation and physical expression. Lesions were unit of treatment
and analysis. No randomisation
Yabut-Catalasan 2003
Controlled trial, N=34, aged 2 to 12 years. 10% potassium hydroxide versus placebo. Not randomised, but
alternate assignment
32
Methods
Participants
Molluscum patients
Interventions
Outcomes
Starting date
January 2008
Contact information
jacquelyn.coloe@osumc.edu
Notes
33
Comparison 1. Topical: 10% Australian lemon myrtle oil vs. vehicle (olive oil)
No. of
studies
No. of
participants
31
Statistical method
Risk Ratio (M-H, Fixed, 95% CI)
Effect size
17.88 [1.13, 282.72]
No. of
studies
No. of
participants
1
1
1
23
23
23
23
Statistical method
Effect size
Comparison 3. Topical: 10% benzoyl peroxide cream vs. 0.05% tretinoin cream (ITT)
No. of
studies
No. of
participants
30
Statistical method
Risk Ratio (M-H, Fixed, 95% CI)
Effect size
2.2 [1.01, 4.79]
No. of
studies
No. of
participants
60
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
1.68 [0.36, 7.75]
34
Comparison 5. Topical: 10% povidone iodine and 50% salicylic plaster vs. 10% povidone iodine alone
No. of
studies
No. of
participants
25
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
1.67 [0.85, 3.30]
Comparison 6. Topical: 10% povidone iodine and 50% salicylic acid plaster vs. 50% salicylic plaster alone
No. of
studies
No. of
participants
30
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
1.43 [0.95, 2.16]
Comparison 7. Topical: 10% povidone iodine vs. 50% salicylic acid plaster
No. of
studies
No. of
participants
15
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
0.86 [0.38, 1.95]
Comparison 8. Topical: 5% sodium nitrite in 5% salicylic acid vs. 5% salicylic acid alone
No. of
studies
No. of
participants
30
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
3.5 [1.23, 9.92]
35
No. of
studies
No. of
participants
77
Statistical method
Risk Ratio (M-H, Fixed, 95% CI)
Effect size
0.93 [0.56, 1.56]
Comparison 10. Topical: 12% salicylic acid vs. 70% alcohol (ITT)
No. of
studies
No. of
participants
73
Statistical method
Risk Ratio (M-H, Fixed, 95% CI)
Effect size
1.28 [0.81, 2.02]
Comparison 11. Topical: 12% salicylic acid vs. 10% phenol/70% alcohol (ITT)
No. of
studies
No. of
participants
78
Statistical method
Risk Ratio (M-H, Fixed, 95% CI)
Effect size
1.37 [0.86, 2.17]
No. of
studies
No. of
participants
19
Statistical method
Risk Ratio (M-H, Random, 95% CI)
Effect size
1.1 [0.43, 2.84]
36
No. of
studies
No. of
participants
20
Statistical method
Effect size
Analysis 1.1. Comparison 1 Topical: 10% Australian lemon myrtle oil vs. vehicle (olive oil), Outcome 1
Complete clearance or > 90% reduction after 3 weeks.
Review:
Comparison: 1 Topical: 10% Australian lemon myrtle oil vs. vehicle (olive oil)
Outcome: 1 Complete clearance or > 90% reduction after 3 weeks
Study or subgroup
Favours vehicle
n/N
n/N
9/16
0/15
100.0 %
16
15
100.0 %
Burke 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours vehicle
10
100
37
Analysis 2.1. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 1 Complete clearance after 4
weeks.
Review:
Study or subgroup
Favours imiquimod
Favours vehicle
n/N
n/N
2/12
0/11
100.0 %
12
11
100.0 %
Theos 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
10
Favours vehicle
100
Favours imiquimod
Analysis 2.2. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 2 Partial clearance after 4 weeks.
Review:
Study or subgroup
Favours imiquimod
Favours vehicle
n/N
n/N
7/12
0/11
100.0 %
12
11
100.0 %
Theos 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours vehicle
10
100
Favours imiquimod
38
Analysis 2.3. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 3 Complete clearance after 12
weeks.
Review:
Study or subgroup
Favours imiqumod
Favours vehicle
n/N
n/N
4/12
1/11
100.0 %
12
11
100.0 %
Theos 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours vehicle
10
100
Favours imiquimod
Analysis 2.4. Comparison 2 Topical: 5% imiquimod vs. vehicle, Outcome 4 Partial clearance after 12 weeks.
Review:
Study or subgroup
Favours imiquimod
Favours vehicle
n/N
n/N
8/12
2/11
100.0 %
12
11
100.0 %
Theos 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours vehicle
10
100
Favours imiquimod
39
Analysis 3.1. Comparison 3 Topical: 10% benzoyl peroxide cream vs. 0.05% tretinoin cream (ITT), Outcome
1 Free of lesions after 6 weeks.
Review:
Comparison: 3 Topical: 10% benzoyl peroxide cream vs. 0.05% tretinoin cream (ITT)
Outcome: 1 Free of lesions after 6 weeks
Study or subgroup
benzoyl peroxide
tretinoin
n/N
n/N
11/15
5/15
100.0 %
15
15
100.0 %
Saryazdi 2004
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours tretinoin
10
100
Analysis 4.1. Comparison 4 Topical: 10% KOH vs. saline, Outcome 1 Clinical cure at medium-term followup (3 months).
Review:
Study or subgroup
Bazza
Short 2006
10% KOH
saline
n/N
n/N
Risk Ratio
Weight
17/20
17/20
58.5 %
7/10
2/10
41.5 %
30
30
100.0 %
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.1 0.2
0.5
Favours saline
10
Favours KOH
40
Analysis 5.1. Comparison 5 Topical: 10% povidone iodine and 50% salicylic plaster vs. 10% povidone iodine
alone, Outcome 1 Clinical cure at end of study (duration unknown).
Review:
Comparison: 5 Topical: 10% povidone iodine and 50% salicylic plaster vs. 10% povidone iodine alone
Outcome: 1 Clinical cure at end of study (duration unknown)
Study or subgroup
Povid Iodine
n/N
n/N
20/20
3/5
100.0 %
20
100.0 %
Ohkuma 1990
Risk Ratio
Weight
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
Favours iodine
10 100 1000
Favours iodine + sal
Analysis 6.1. Comparison 6 Topical: 10% povidone iodine and 50% salicylic acid plaster vs. 50% salicylic
plaster alone, Outcome 1 Clinical cure at end of study (duration unknown).
Review:
Comparison: 6 Topical: 10% povidone iodine and 50% salicylic acid plaster vs. 50% salicylic plaster alone
Outcome: 1 Clinical cure at end of study (duration unknown)
Study or subgroup
Ohkuma 1990
Iodine + Salicylic
Salicylic alone
n/N
n/N
Risk Ratio
Weight
20/20
7/10
100.0 %
20
10
100.0 %
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.5
0.7
Favours salicyl
1.5
41
Analysis 7.1. Comparison 7 Topical: 10% povidone iodine vs. 50% salicylic acid plaster, Outcome 1 Clinical
cure at end of study (duration unknown).
Review:
Comparison: 7 Topical: 10% povidone iodine vs. 50% salicylic acid plaster
Outcome: 1 Clinical cure at end of study (duration unknown)
Study or subgroup
Povidone Iodine
n/N
n/N
Risk Ratio
Weight
Ohkuma 1990
3/5
7/10
100.0 %
10
100.0 %
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.2
0.5
Favours iodine
Analysis 8.1. Comparison 8 Topical: 5% sodium nitrite in 5% salicylic acid vs. 5% salicylic acid alone,
Outcome 1 Clinical cure at medium-term follow-up (3 months).
Review:
Comparison: 8 Topical: 5% sodium nitrite in 5% salicylic acid vs. 5% salicylic acid alone
Outcome: 1 Clinical cure at medium-term follow-up (3 months)
Study or subgroup
Ormerod 1999
Acidified nitrite
n/N
n/N
Risk Ratio
Weight
12/16
3/14
100.0 %
16
14
100.0 %
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.1 0.2
0.5
Favours salicyl
10
42
Analysis 9.1. Comparison 9 Topical: 10% phenol/70% alcohol vs. 70% alcohol (ITT), Outcome 1 Complete
clearance at end of study (max 6 months).
Review:
Study or subgroup
Favours phenol/alcohol
Favours alcohol
n/N
n/N
17/41
16/36
100.0 %
41
36
100.0 %
Leslie 2005
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours phenol/alcohol
10
100
Favours alcohol
Analysis 10.1. Comparison 10 Topical: 12% salicylic acid vs. 70% alcohol (ITT), Outcome 1 Complete
clearance at end of study (6 months max).
Review:
Study or subgroup
Favours alcohol
n/N
n/N
21/37
16/36
100.0 %
37
36
100.0 %
Leslie 2005
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
10
100
Favours alcohol
43
Analysis 11.1. Comparison 11 Topical: 12% salicylic acid vs. 10% phenol/70% alcohol (ITT), Outcome 1
Complete clearance at end of study (max 6 months).
Review:
Comparison: 11 Topical: 12% salicylic acid vs. 10% phenol/70% alcohol (ITT)
Outcome: 1 Complete clearance at end of study (max 6 months)
Study or subgroup
Favours phenol
n/N
n/N
21/37
17/41
100.0 %
37
41
100.0 %
Leslie 2005
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours salicylic
10
100
Favours phenol
Analysis 12.1. Comparison 12 Systemic: cimetidine vs. placebo, Outcome 1 Clinical cure at medium-term
follow-up (4 months).
Review:
Study or subgroup
Cimetidine
Placebo
n/N
n/N
Risk Ratio
Weight
Antony 2001
4/8
5/11
100.0 %
11
100.0 %
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.2
0.5
Favours placebo
Favours cimetidine
44
Analysis 13.1. Comparison 13 Systemic: calcarea carbonica vs. placebo, Outcome 1 Improvement at end of
study (duration unknown).
Review:
Study or subgroup
Calcium Carbonicum
Placebo
n/N
n/N
13/14
1/6
100.0 %
14
100.0 %
Manchanda 1997b
Risk Ratio
Weight
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
0.02
0.1
Favours placebo
10
50
APPENDICES
Appendix 1. Cochrane search strategy
#1(molluscum contagiosum):ti,ab,kw
#2(mollusca):ti,ab,kw
#3MeSH descriptor Molluscum Contagiosum explode all trees
#4(#1 OR #2 OR #3)
#5SR-SKIN
#6(#4 AND NOT #5)
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WHATS NEW
Last assessed as up-to-date: 7 June 2009.
7 December 2009
Amended
Unpublished data (Short 2002) has now been published as Short 2006.
HISTORY
Protocol first published: Issue 2, 2004
Review first published: Issue 2, 2006
46
22 July 2009
21 June 2008
Amended
6 December 2005
Substantive amendment
CONTRIBUTIONS OF AUTHORS
Link with editorial base and co-ordination of contributions from co-authors: JCvdW
Protocol: JCvdW, SG, with contributions from all
Searches: SG, JM, JCvdW. Update 2009: RvdS, JCvdW
Screening abstracts: SG, JM, JCvdW. Update 2009: RvdS, JCvdW
Obtaining copies of trials: SG, JCvdW. Update 2009: RvdS, JCvdW
Assessing full papers for inclusion: SK, LvSS, MYB, JCvdW. Update 2009: RvdS, JCvdW
Extracting data from trials: CB, MYB, SK, JCvdW. Update 2009: RvdS, JCvdW
Assessing methodological quality: SG, SK, MB, JCvdW. Update 2009: RvdS, JCvdW
Data entry: JM, JCvdW. Update 2009: RvdS, JCvdW
Text of review: JM, JCvdW, with contributions from all. Update 2009: RvdS, JCvdW, with contributions from co-authors.
Consumer feedback on synopsis: MJAT
DECLARATIONS OF INTEREST
Anthony Ormerod who acted as a clinical content expert is also the author of one of the included trials. There has been no conflict of
interest.
SOURCES OF SUPPORT
Internal sources
Department of General Practice, Erasmus MC, Rotterdam, Netherlands.
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External sources
No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)
Anti-Infective Agents, Local [therapeutic use]; Cimetidine [therapeutic use]; Hydroxides [therapeutic use]; Molluscum Contagiosum
[drug therapy; therapy]; Phytotherapy [methods]; Potassium Compounds [therapeutic use]; Povidone-Iodine [therapeutic use]; Randomized Controlled Trials as Topic; Remission, Spontaneous; Salicylic Acid [therapeutic use]; Sodium Nitrite [therapeutic use]
48