Comment and clinical implications

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The quality of reporting in studies was generally poor, with small numbers of patients. It is

Table 17.6 Randomised controlled trials that have evaluated treatments for clinically infected atopic eczema

Study

Interventions and

Study population

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

and sample size

description

measures

results

reporting

and follow up

Oral antimicrobials

Salo et al.

Oral erythromycin

42 adults admitted

Parallel-group,

Investigator and

At the end of treatment,

Method of

Difficult to evaluate since

19887

aclstrate (EA) 400 mg

with clinically

randomised,

patient assessment

75% and 83% of those in

randomisation and

two "actives" were being

(Finland)

three times dally v

Infected atopic

double-blind

of treatment efficacy

the EA and ES groups

concealment unclear;

compared In the presence

oral erythromycin

eczema. Most had

study; 5-12 days

on a 5-polnt scale

respectively showed

no ITT analysis

of inpatient care and

stearate (ES) 500 mg

bacteriological

"good" or "very effective"

potent co-treatment; that

three times dally for

Isolates of S. aureus

Improvement; similar

7 patients with clinically

5-12 days (topical

and four had

results according to

Infected eczema did not

steroids and

combined

patients; gastrointestinal

have positive bacteriology

emollients)

staphylococcal/

side-effects similar In

underscores the difficulty

streptococcal

both groups

understanding the link

infection

between disease and

bacteria

Weinberg

Oral cefadroxil

33 children with

Parallel-group,

Clinical clearance of

Of 30 evaluable patients,

Method of

Results clearly In favour

et al. 19922

50 mg/kg/day In two

bacterlologlcally

randomised,

infection; eczema

all 13 In the cefadroxil

randomisation and

of cefadroxil for these

(South

equal doses 1/

confirmed Infected

double-blind

severity; number of

group no longer had

concealment unclear;

children with Infected

Africa)

placebo for 2 weeks

atopic eczema

study; 2 weeks

patients with positive

clinical evidence of

no description of

atopic eczema; poor

(no mention of

caused by either

cultures; global

superinfection at the end

blinding; no ITT

quality of reporting

co-treatments)

S. aureus or mixed

Improvement

of the study, compared

analysis

staphylococcal/

with 6 of 15 In the

streptococcal

placebo group. Positive

infection

Isolates fell from 13 to 4

and from 17 to 9 In the

cefadroxil and placebo

groups, respectively

Study

Interventions and

Study population

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

and sample size

description

measures

results

reporting

and follow up

Topical treatments

Wachs and

Betamethasone

83 patelnts with

Prospective,

Global assessment

Improvement over

Method and

Treatment responses were

Maibach,

valerate cream v

Infected moderate-

randomised,

and overall severity;

baseline on a scale of

concealment of

slightly larger for

1976"

gentamicln/

to-severe atopic

parallel study;

degree of inflamm

0-10: betamethasone/

randomisation

steroid/antibiotic

(USA)

betamethasone

dermatitis

22 days

ation; degree of Infec

gentamicln group

unclear; study

combination but none

valerate versus

tion, erythema, prur

baseline score of 6-1

described as double

were statistically

gentamlcin cream

itus, pustules, crus

reduced to 1-0; betameth

blind; 4 dropouts; no

significant; bacterial

three times dally

ting, exudation,

asone group 6-1 reduced

ITT analysis

growth similar In all three

veslculatlon,

to 1-8; gentamlcin group

groups

llcheniflcation

6-6 reduced to 4-2

Hjorth etai.

0-1% betamethasone

60 atopic dermatitis

Prospective,

Bacteriological

Data for mean atopic

Method and

More data requested from

198516

17-valerate 1/

patients with

randomised,

swabs; clinical

dermatitis score not given;

concealment of

author but Is sadly

(Denmark)

betamethasone 17-

"potentially Infected"

left-right, parallel

symptoms: vesicles,

only result Is investigator

randomisation

deceased. Study provides

valerate plus 2%

atopic eczema

study; 7 days

oedema, erythema,

preference: 29 no

unclear; study

no evidence of Improved

fusidic acid

duration

excoriation, crusting,

preference, 22 preferred

described as double

efficacy of betamethasone/

llcheniflcation, Itching

betamethasone plus

blind; no dropouts or

fusidic acid combination

fusidic acid, 9 preferred

withdrawals

above betamethasone alone

betamethasone alone

in Infected atopic eczema

Wilkinson

0-1% betamethasone

43 Infected or

Prospective,

Severity of lesions

95% patients (91%

Method and

Impossible to assess the

and Leigh

plus 2% fusidic acid

potentially Infected

randomised,

asssessed by patient

doctors) felt lesions

concealment of

additional benefit of

198517 (UK)

cream v 0-1 %

atopic eczema

parallel study; 2

and doctor as either

Improved after

randomisation

antibiotics In the absence

betamethasone plus

patients

weeks duration

very severe, severe,

betamethasone plus

unclear; study

of a steroid-only group

0-5% neomycin

moderate, mild,

fusidic acid after 2 weeks

described as double

cream two or three

minimal, or absent;

versus 100% patients

blind, 9 withdrawals

times dally

swabs taken for

(100% doctors) with

and dropouts but

Infection

betamethasone plus

unclear which type

Study

Interventions and

Study

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

population and

description

measures

results

reporting

sample size

and follow up

neomycin; no separate

of eczema these

data for bacteriological

patients had (7 types

efficacy for atopic

of dermatoses

dermatitis

reported)

Thacl etat.

2% fusldlc acid plus

59 patients with

Prospective,

Bacteriological tests;

Overall clinical response

Method and

Abstract only; only results

199915

0-1% betamethasone

potentially Infected

randomised,

signs and symptoms

assessed by Investigator

concealment of

reported In text given

(Germany)

cream 1/2% fusldlc

atopic dermatitis

parallel study;

on a four-point scale;

as "clearance" or "marked

randomisation

acid plus 0-1%

10 days duration

Investigator-assessed

Improvement" In 92% of

unclear; study

betamethasone

overall clinical

fusldlc acld/betame-

described as double-

ointment vs ointment

response

thasone cream group, In

blind; no withdrawals

vehicle twice dally

84% of fusldlc acld/beta-

or dropouts

methasone ointment

mentioned

group, and 25% of

ointment vehicle group;

no statistically significant

difference between the

two formulations

Meenan13

0-1% hydrocortisone

40 children with

Prospective,

Pruritus, erythema,

"Both treatments produced

Method and

Another unlnformatlve

1988

17-butyrate plus 3%

eczema for

randomised,

llchenlfl cation,

a highly significant

concealment of

study because both

(Eire)

chlorqulnaldol

3 months to 14 years

parallel study;

oozlng/crustlng,

(P<0-001) linear reduction

randomisation

agents contain an

(Locold C) 1/0-1%

with secondary

14 days duration

scaling; skin swabs

In the scores for all para

unclear; study

antlmlcroblal/antl septic,

triamcinolone aceton-

Infection

for Infection; patient

meters, no significant

described as double-

and no steroid-only

Ide plus 0-25% neo

and physician global

difference between treat

blind; no data on

comparator

mycin plus 0-025%

scores

ments"; "highly significant

withdrawals or

gramicidin plus

reduction In Infection for

dropouts given

nystatin (Trladcortyl")

both treatments (P<0-001)

Table 17.6 (Continued)

Study

Interventions and comparator

Study population and sample size

Trial design, description and follow up

Outcome measures

Main reported results

Quality of reporting

Comment

Zienicke

Prednicarbate 0-25%

180 patients with

Prospective,

Redness, swelling,

Clinical score at baseline

Method and

Duplicate publication23; no

1993"

cream v

superlnfected atopic

randomised,

papulovesicles,

of over 25 for both drugs

concealment of

clinical or statistical

prednicarbate 0-25%

eczema

parallel study;

vesicles, pustules,

reduced to 13-5 for

randomisation

difference between

cream plus

34 days duration

bullae, papules,

prednicarbate and 13 for

unclear; study

groups

didecyldimethylamm-

oozing, crusting and

prednicarbate plus

described as double-

onlumchlorlde 0-25%

scaling on a score of

didecyldimethyl-

blind; 44

1-5

ammonlumchlorlde; 30%

withdrawals/dropouts;

of patients still had

no ITT analysis

S. aureus at day 34

compared with 100%

at start

Table 17.7 Randomised controlled trials that have evaluated antiseptics for atopic eczema

Study

Interventions and comparator

Study population and sample size

Trial design, description and follow up

Outcome measures

Main reported results

Quality of reporting

Comment

Stalder et al.

Proprietary brand

20 children aged 5

Parallel-group,

Bacterial counts;

Total severity score fell

Poor quality of

Difficult to Interpret such

199210

of chlorhexldine

months to 9 years;

double-blind,

composite clinical

from 8-8 at day 0 to 5-7 at reporting with very

a small study which

(France)

solution compared

no details of whether

randomised study;

severity score;

the end of the 7 days for

few methodological

compares two active

against 1:20 000

they were clinically

1 week duration

patient-reported

chlorexidlne and from

details

treatments; clinical

dilution of potassium

Infected

tolerance

11-1 to 8-8 for the

tolerance data were useful

permanganate

permanganate group

solution for 7 days

(P= 0-63).

In addition to topical

Intensity and number of

desonide (topical

affected sites also

steroid)

showed very little

difference between the

two groups.

Bacterial counts fell

substantially In both

groups but they were not

statistically significant

(P= 0-37) and baseline

scores In the two groups

were quite different.

Clinical tolerance was

"good" in both groups

Harper

Standard proprietary

30 children aged

Randomised

Composite sign and

On the basis of 26

Method of

Study published In a

199522

bath emollient (Olla-

1-9 years with recur

crossover study of

symptom score (max.

evaluable patients, the

randomisation

"round table" discussion

(England)

tum) 1/ the same with

rent Infections

two 4-week

100), patient

change from baseline

described, but no ITT

document sponsored by

added

and/or frequent

treatment periods

recorded global

score (baselines scores

analysis; statistical

the manufacturer.

Study Interventions and

Study population

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

and sample size

description

measures

results

reporting

and follow up

antiseptic 6% w/w

exacerbation

with a 2-week

overall Impression,

not given) was 9-0 for

tests of change In

Difficult to Interpret In view

benzalkonlum

wash-out period In

and global change

those using the antiseptic

scores from baseline

of the wrong statistical

chloride and 2%

between

scales

emollient compared with

for each treatment

tests used and missing

trlclosan (Ollatum

2-7 for those with regular

separately rather than

patient-reported data

plus)

emollient at 4 weeks.

the appropriate test of

Patient-rated scores were

the difference In score

not significantly different

changes between the

between the two

two treatments

treatments (data not

shown)

Holland et ai. Comparison of a

15 patients aged

Parallel-group,

Clinical scores of

At the end of 4 weeks'

No description of

Difficult to Interpret the

199523 standard proprietary

4-34 years with

randomised,

signs, symptoms and

treatments, clinical scores

randomisation

lack of efficacy In such

(England) bath emollient

moderate-to-severe

double-blind

extent and bacterial

In the emollient/antiseptic

process or ITT

a small study with high

(Ollatum) 1/ same

atopic eczema with

study; 4 weeks

counts

group had fallen more

analysis; although

dropout rate

emollient with 6%

S. aureus on their

duration

than those In the emol-

described as a

w/w benzalkonlum

skin

llent-only group, but these

parallel study, patients

chloride and 2%

were not statistically

were paired for

trlclosan (Ollatum

significant. There was no

matching pre-

plus)

statistically significant

treatment S. aureus

difference In S. aureus

population densities

counts between the two

groups at the end of the

treatment period.

Five dropouts In the

emollient-only group

Study

Interventions, and

Study population

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

and sample size

description

measures

results

reporting

and follow up

Sasai-

Comparison of

22 children aged

Parallel-group,

Colony counts of

Colony counts decreased

Although described

Difficult to interpret

Takedatsu

spraying Infants with

2-56 months with

randomised,

S. aureus; composite

by around 50% In the

as randomised, this is

because the correct

et al. 199726

water twice a day for

mild-to-moderate

double-blind

grading score;

active but not In the water

suspect because

statistical comparison was

(Japan)

1 week or an acid

atopic eczema

study; 1 week

scores for Itching and

group (though baseline

authors state that the

not done and because of

electrolytic water

duration

sleep disturbance

scores were quite different).

22 patients were

the short duration of the

(pH<2.7) using a

Global severity scores fell

"arbitrarily divided by

study.

spray gun (no

from 9 to 5 In the active

a referee physician

Some serious concerns

co-treatment allowed

group compared with a

Into two groups of 11";

about the study quality.

In this period)

rise from 7 to 8 In the

blinding also seems

The ethics of spraying an

water group; scores for

unlikely because of

acid onto young infants Is

itching and sleep also

the taste and

also questionable

decreased in the active

sensation of the acid

group but not in the water

group.

Although the authors

found a statistically

significant change in all

of these measures for the

active group compared

with baseline, they did

not do the appropriate

test of difference between

the two groups

Hlzawa

Daily povidone-

16 volunteers with

Right-left,

Physician-assessed

Of 15 evaluable patients,

Unclear method and

Inconclusive study In view

et al. 199825

Iodine solution to one

atopic eczema aged

investigator-

before and after

physicians reported an

concealment of

of threat of unblindlng,

blinded

Study Interventions and

Study population

Trial design,

Outcome

Main reported

Quality of

Comment

comparator

and sample size

description

measures

results

reporting

and follow up

(Japan) arm versus nothing

12-29 years with

comparison study;

photographs; colony

improvement In the

randomisation;

short duration and failure

else on opposite side

similar eczema

1 week duration

counts of after of S.

povidone-treated sites

Investigator masking

to perform the appropriate

(emollients only)

lesions In each

aureus

(P<0-01), but not on the

suspect as Iodine

statistical tests. Worth

elbow fold

control sites.

stains the skin

pursuing In a larger

Bacterial colonisation

double-blind study as

was significantly reduced

povidone Iodine Is a

on the treated but not

cheap antiseptic with

the untreated sites.

good antl-staphylococcal

No summary data of

properties.

differences between

treatments reported

Breneman 1 -5% triclocarban bar

50 patients with

Prospective,

Rating scale of extent

Mean global Improvement

Method of

Although the authors

etat. 200124 1/placebo soap

moderately severe

randomised,

and severity of

scores from start of

randomisation and

claim a statistically

(USA)

atopic eczema

double-blind

disease Including

treatment through to end

concealment not

significant Improvement In

study; 14-day

Itch; investigators

of regression period

given; blinding difficult

the group using the

standardisation

global evaluation of

shown on graph only.

to assess; one

antibacterial soap

period followed by

change from day 0 to

Comment that global

dropout because of

throughout, no actual data

42-day treatment

days 14, 28 and 42

Improvement was

adverse event

are given. The data shown

period and 21-day

on a scale of - 5-5;

significantly greater In

mentioned; not clear

In graphical form show a

regression period

bacterial counts and

antibacterial than placebo

how many dropouts

marked difference In

topical steroid usage

(no P value or CI given)

altogether and not

baseline scores, followed

were also recorded

group. Microbiology

clear if ITT; lack of

by a parallel degree of

results shown on graph -

actual data for most

Improvement In each

selected only patients

results

group

with S. aureus at start.

Cl, confidence interval; ITT, Intention-to-treat

Cl, confidence interval; ITT, Intention-to-treat common practice to prescribe a short course of oral antibiotics in acute infected eczema. There is some evidence to support this, and no evidence of a detrimental effect. In contrast, there is no evidence to support the use of longer-term antibiotics in people with atopic eczema whose skin is colonised with S. aureus, and there is some evidence that use of such antibiotics may promote antibiotic resistance.

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