Additional probiotic therapy lowers SCORAD index

Division of Allergy Immunology,
Department of Pediatrics,
Faculty of Medicine,
University of Sumatera Utara, Medan

Correspondence :
dr. Jessica Ekaputri
Division of Allergy Immunology,
Department of Paediatrics,
Faculty of Medicine,
University of Sumatera Utara,
Jl. Dr. Mansyur No. 5 Medan,
Sumatera Utara 20155.
Email: jessicaekaputri58@gmail.com

Univ Med 2016;35:68-74
DOI: 10.18051/UnivMed.2016.v35.68-74
pISSN: 1907-3062 / eISSN: 2407-2230

This open access article is distributed under
a Creative Commons Attribution-Non
Commercial-Share Alike 4.0 International
License

ABSTRACT

UNIVERSA MEDICINA
May-August, 2016May-August, 2016May-August, 2016May-August, 2016May-August, 2016 Vol.35 - No.2 Vol.35 - No.2 Vol.35 - No.2 Vol.35 - No.2 Vol.35 - No.2

Additional probiotic therapy lowers SCORAD index
in children with atopic dermatitis

Jessica Ekaputri*, Rita Evalina*, and Melda Deliana*

BACKGROUND
Atopic dermatitis (AD) is a common skin disease that is usually chronic,
relapsing, causing pruritus and frequent in children. The pathogenesis of
AD involves genetic, immunological and environmental factors causing
skin barrier dysfunction and dysregulation of the immune system. Probiotic
treatment has been claimed to offer several functional properties including
stimulation of the immune system and plays an important role in AD.
The objective of this study was to evaluate the effect of probiotic therapy
on atopic dermatitis in children.

METHODS
A randomized controlled trial was conducted on 62 children suffering
from AD from December 2015 to January 2016. AD severity was assessed
based on the scoring of atopic dermatitis (SCORAD) index. Subjects
were divided into two groups consisting of 32 and 30 children, the probiotic
(probiotic + emollient) and control (emollient) groups, respectively.
SCORAD index was re-evaluated after 2 weeks of therapy. The data was
analyzed using Mann Whitney test.

RESULTS
After the intervention, the mean SCORAD index in the probiotic group
was significantly much lower than the control group (18.09 ± 8.59 vs
23.21 ± 8.71; p=0.001). The mean decrease in SCORAD index in the
probiotic group was 40.4 %, much higher than the control group 25.2%.
The number needed to treat (NNT) score of probiotic treatment was 5.3.

CONCLUSION
The addition of probiotics to conventional therapy effectively lowers
SCORAD index by 40.4% in atopic dermatitis. The impact of probiotics
on SCORAD indices is thought to be attained by modification of the
immunogenicity of potential allergens.

Keywords: Atopic dermatitis, SCORAD, probiotic, children

DOI: http://dx.doi.org/10.18051/UnivMed.2016.v35.68-74

Univ Med Vol. 35 No.2

INTRODUCTION

Atopic dermatitis (AD), or eczema, is a
common skin disease that is usually associated
with other atopic diseases such as allergic rhinitis
and asthma. AD is usually chronic, relapsing,
causing pruritus and common in children, usually
starting in early childhood.(1-3) AD comprises a
broad clinical spectrum of mild to severe age-
related disorders.(4,5) AD pathogenesis involves
genetic, immunological and environmental factors
causing skin barrier dysfunction and dysregulation
of the immune system.(6)

Scoring of AD (SCORAD) is a scoring
system that was developed to assess the severity
of atopic dermatitis by measuring the extent of
the area involved, and the intensity of the
subjective symptoms of pruritus and sleep
disturbance.(7) AD requires a holistic assessment
and its treatment remains a challenge, because it
requires an efficient short-term acute symptom
control, without affecting the overall treatment
plan that is aimed at long-term stabilization,
preventing flare-ups and avoiding the side effects
of the treatment.(8.9)

A probiotic is an oral supplement or food
product that contains viable microorganisms in
amounts sufficient to change the microflora of
the host and have a potential beneficial effect on
health.(10) Supplying probiotics plays a role in the
prevention and treatment of allergic disease, but
the mechanism underlying the immunomodulatory
effects is still uncertain.(11) The meta-analysis by
Elazab et al.(12) shows that probiotic therapy in
the prenatal period and early life reduces the risk
of atopic sensitization and total IgE level in
children but does not reduce the risk of asthma.
The meta-analysis by Boyle et al.(13) shows the
opposite where probiotics have the effect of
significantly decreasing the symptoms and
severity of AD. Another study showed different
results, in that there was no benefit from
supplementation with B. lactis or L. paracasei in
the treatment of eczema, when given as an adjunct
to basic topical treatment, and no effect on the
progression of allergic disease from age 1 to 3
years.(14)

The decrease in SCORAD indices caused
by probiotics is thought to occur through
modification of immunogenicity of potential
allergens. The variable effects of probiotics on
allergic diseases is likely influenced by the type
of probiotic given, and by environmental and host
factors.(15)

On the basis of the abovementioned
information, the purpose of the study was to
evaluate the effect of the probiotic supplements
to conventional therapy towards the SCORAD
index of children with atopic dermatitis.

METHODS

Research design
A r a n d o m i s e d c o n t r o l l e d t r i a l w a s

conducted on selected pediatric patients with
atopic dermatitis at two Posyandu (integrated
health care stations) in Medan from December
2015 to January 2016.

Research subjects
The study population consisted of pediatric

patients with atopic dermatitis. The research
sample comprised the population that met the
inclusion criteria, i.e. children aged 1 month to
5 years who satisfied the Hanifin and Rajka
criteria for atopic dermatitis. The exclusion
criteria were refusal of the children’s parents to
provide medication, children with malnutrition
and other skin diseases. We used the sample size
c a l c u l a t i o n m e t h o d f o r c o m p a r i n g t w o
independent proportions.(16) To calculate the
sample size, we used a study by Yesilova et al.(17)

who reported a standard deviation of the
SCORAD index of 13.4 and 6.1, respectively,
in the probiotic therapy group and conventional
therapy-only group. The calculated sample size
per group was 28, which was estimated to be
adequate to detect a 30% difference between the
two groups using a two-tailed test, an alpha of
0.05 and power of 80%.

Measurements
Anamnesis, physical examination, and

anthropometric measurements were performed,

including the measurement of height and weight
of all research subjects. Height was measured in
an upright position without footwear, from the
feet to the top of the head using a GEA statue
meter and expressed in meters (m). Weight was
also measured in an upright position using Camry
digital scales, and expressed in kilograms (kg).
An assessment of body mass index (BMI) was
also carried out, the BMI being expressed in units
of kg/m2. All measurements were carried out at
the time of the examination of the subject. The
severity of atopic dermatitis of each group was
rated based on SCORAD index. SCORAD is a
clinical tool used to assess the extent and severity
of eczema. Dermatologists may use this tool
before and after treatment to determine whether
the treatment has been effective.

Intervention
Patients who met the inclusion criteria were

included in the study and were divided into two
groups by simple randomization i.e. a group that
received a probiotic along with conventional
therapy (probiotic group) and a group that
received conventional therapy only (control
group). The probiotic group was given a probiotic
orally, administered twice daily for two weeks
along with the conventional therapy such as
topical emollients, applied three times daily after
bathing. The probiotic was given twice a day in
the form of a powder containing a mixture of L.
acidophilus, B. longum, and S. thermophilus,
each in amounts of 1x107 CFU/g. The control
group was given conventional therapy such as
topical emollients applied three times a day after
bathing, for two weeks. The research samples
were monitored for two weeks to assess the
severity of atopic dermatitis based on SCORAD
index after the intervention.

Statistical analysis
The Kolmogorov-Smirnov normality test

was used to assess the normal distribution of the
data. The independent t-test was to be used on
normally distributed data to establish the
differences in SCORAD index between case and

control groups before and after intervention, and
the differences in the decline of SCORAD indices
between the two groups, while for non-normally
distributed data the Mann-Whitney test was to be
used. The number needed to treat test was used to
assess the effectiveness of probiotic therapy.
Statistical analysis was performed with the SPSS
statistical package for Windows, version 17.0, and
a p-value of <0.05 was considered statistically
significant.

Ethical clearance
The study protocol was approved by the

Health Research Ethical Committee, Faculty of
Medicine, University of Sumatera Utara (695/
KOMET/FKUSU/2015). All study subjects
signed written informed consent after having
been informed about the aims and benefits of
the study.

RESULTS

During the study period, 62 subjects
suffering from atopic dermatitis were obtained and
divided into two groups. The probiotic group of
32 subjects were given a probiotic along with
conventional therapy, while the remaining 30
subjects were only given conventional therapy
(control group) (Figure1).

There were no significant differences in
gender, mean age, and family history of atopy
between the two study groups (p=0.422, 0.269,
and 1.000; respectively) at base-line (Table 1).
Before the intervention, the mean SCORAD index
was 30.33 ± 12.96 in the probiotic group and
31.05 ± 10.54 in the control group, there being
no significant differences between the SCORAD
index of the two groups (p=0.522) (Table 1).

After the intervention, it appears that the
mean SCORAD index in the probiotic group was
significantly much lower than the control group
(18.09 ± 8.59 vs 23.21 ±8.71, p=0.010). The
mean decrease in SCORAD index in the
probiotic group was much more than in the
control group (12.23 ± 6.46 vs 7.83 ± 5.49,
p=0.001) (Table 2).

Ekaputri, Evalina, Deliana Probiotic in atopic dermatitis

Univ Med Vol. 35 No.2

Figure 1. Flow diagram

Table 1. Demographics and family history of atopy at base-line by treatment group

a Chi square test, b Mann Whitney test, c Fisher’s exact test

The number needed to treat was 5.3, meaning
that it takes five people to achieve an effect of
improvement in the SCORAD values by giving
probiotics (Table 3).

DISCUSSION

The mean age of children with atopic
dermatitis was 2.51 ± 1.59 years and 2.80 ± 1.37
years in the probiotic group and the control group,
respectively. Atopic dermatitis is known to be
often found during early infancy with an incidence
rate of 85% starting before the age of 5 years.(1.2)

In the study no significant differences were found
in mean age between the two groups.
After the intervention, there was a significant
difference in the mean SCORAD index between
the two groups. The above results are similar to

those found in the study conducted by Yesilova et
al.(17) regarding the administration of a probiotic
containing B. bifidum, L. acidophilus, L. casei
and L. salivarius which showed reductions in
SCORAD score and in serum IL-5, IL-6, and IgE
levels of atopic dermatitis patients. Likewise, the
meta-analytical study by Yao et al.(18) showed
significantly lowered SCORAD scores between
probiotic and placebo groups. The opposite was
found in the meta-analytical study by Boyle et
al.(13) in which probiotics did not significantly
reduce AD symptoms compared with placebo.
Other meta-analytical studies also found variable
probiotic effects in AD.(14,20) Highly heterogenous
conditions, including differences in probiotic
preparations, study populations and the final
results of measurement can directly affect the
comparative results of these studies.

Previous studies only evaluated the decrease
in SCORAD index and other parameters in AD.
In the present study, an analysis of the number
needed to treat (NNT) was conducted between
the two groups and resulted in an NNT of 5.3,
which means that it takes five children to get the
effect of improving the value of SCORAD. This
value indicates that the administration of the
probiotic is quite effective as an adjunctive
therapy to reduce the severity of atopic
dermatitis.

AD is found among 15-30% of children and
2-10% of adults, having increased up to 2 or 3
times in industrialized countries over the past
three decades. Atopic dermatitis often begins in
early infancy (known as early onset AD). Forty-
five percent of all cases of AD starts in the first
6 months of life, 60% in the first year and 85%
before the age of 5 years.(1.2)

The treatment of AD is intended to
overcome itchiness, to repair the skin barrier and
to reduce inflammation. The successful treatment
of AD relies on a multi-disciplinary approach to
education of patients and their families, skin care
optimalization, anti-inflammatory medication
and treatment of skin infections.(2)

The relationship between atopy and the
intestinal environment comes from the hypothesis
that a deficiency of intestinal microflora in
children with atopy will interfere with the
required development of the immune response
and the normal intestinal mucosal barrier.(21) The
microbial intestinal flora or microbiome

Table 2. Mean differences in SCORAD between groups after two weeks of intervention

* Mann Whitney test

Table 3. Number needed to treat of probiotic treatment

contributes to the pathogenesis of allergic disease
because of its effect on mucosal immunity.
Exposure to the normal microbial flora in early
life results in the Th-1 / Th-2 lymphocyte balance
changing in favor of Th-1 cells.(22)

According to the Food and Agriculture
Organization (FAO)/World Health Organization
(WHO), probiotics are defined as as live
microorganisms which when administered in
adequate amounts, confer a health benefit on the
host. Health benefits have mainly been
demonstrated for specific probiotic strains of the
following genera: Lactobacillus, Bifidobacterium,
Saccharomyces, Enterococcus, Streptococcus,
Pediococcus, Leuconostoc, Bacillus, Escherichia
coli.(23,24) These microorganisms are fermentative,
obligate or facultative anaerobic, usually non-
motile, having different shapes and the majority
typically producing lactic acid.(10) The levels of
Lactobacillus and Bifidobacterium are
significantly decreased in the fecal samples of
infants and children with AD, demonstrating the
therapeutic potential of probiotic supplementation
in AD.(25)

There are no specific directions for probiotic
dose in atopic dermatitis. Probiotic treatment is
more often based on the directions of the probiotic
manufacturers. In the present study, the probiotic
given twice a day was a mixture of L.acidophilus,
B.longum, and S.thermophilus, each to the
amount of 1x107CFU/g. The probiotic was
administered for 2 weeks to assess the severity of
atopic dermatitis based on SCORAD index.

Ekaputri, Evalina, Deliana Probiotic in atopic dermatitis

Univ Med Vol. 35 No.2

This study has limitations which include lack
of control and monitoring of patient compliance
during the intervention period. Monitoring was
only done on the amount of drugs given to the
patients, as shown by the fact that no medication
was returned by patients during the study.

The results of this study provide new insights
into the role of immunologic factors in atopic
dermatitis and administration of probiotics can
modulate the immune system, thereby improving
the symptoms of atopic dermatitis. A broader
study is needed to determine the exact mechanisms
and the benefits of probiotics in the treatment of
atopic dermatitis.

CONCLUSIONS

The addition of probiotics to conventional
therapy effectively lowered the SCORAD index
in atopic dermatitis compared to conventional
therapy. This result could be a consideration to
using probiotics for the treatment of atopic
dermatitis. The impact of probiotics on SCORAD
indices is thought to be attained by modification
of the immunogenicity of potential allergens.

CONFLICT OF INTERESTS

No conflict of interest to be declared.

ACKNOWLEDGEMENT

We would like to thank all study subjects
who participated in the study, and all colleagues
who advised us in writing this report.

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