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Abstract

Background: Hand eczema is one of the most common dermatologic diseases requiring treatment but common therapeutics such as corticosteroids and anti-histamines have numerous side effects. So, use of herbal agents, which generally have no major side effects, may be useful especially if their efficacy is established. Malva Sylvestris (MS) is a tropical plant in Iran with cooling characteristics. Hence, in this study, its efficacy in of the treatment of hand eczema was evaluated. Methods: In this randomized clinical trial, 50 patients with hand eczema who were visited at Shohada-e Tajrish and Loghman hospitals, Tehran, Iran, between 2006 and 2008, were recruited and divided into two groups. In the first group, MS 4% ointment was applied twice a day and in the other group, placebo ointment was usd. The efficacy and side effects were evaluated three and six weeks after beginning of the treatment. Results: Mean age of the patients was 37.3 years and 35.6 years in MS and placebo groups, respectively (P > 0.05). There were no therapeutic adverse effects in the groups. There was a statistically significant difference in all measured scores between two groups in the first and second follow-up sessions (P < 0.0001). Conclusion: Malva Sylvestris seems to be a safe and effective therapeutic modality for the treatment of hand eczema and can be used as an optimal substitute for corticosteroids and anti-histamines.
131
Original article
Iranian Journal of Dermatology, Vol 13, No 4, Winter 2010
Malva Sylvestris in the treatment of hand eczema
Background: Hand eczema is one of the most common dermatologic
diseases requiring treatment but common therapeutics such as
corticosteroids and anti-histamines have numerous side effects.
So, use of herbal agents, which generally have no major side
effects, may be useful especially if their efficacy is established.
Malva Sylvestris (MS) is a tropical plant in Iran with cooling
characteristics. Hence, in this study, its efficacy in of the treatment
of hand eczema was evaluated.
Methods: In this randomized clinical trial, 50 patients with hand
eczema who were visited at Shohada-e Tajrish and Loghman
hospitals, Tehran, Iran, between 2006 and 2008, were recruited
and divided into two groups. In the first group, MS 4% ointment
was applied twice a day and in the other group, placebo ointment
was usd. The efficacy and side effects were evaluated three and
six weeks after beginning of the treatment.
Results: Mean age of the patients was 37.3 years and 35.6 years
in MS and placebo groups, respectively (P > 0.05). There were no
therapeutic adverse effects in the groups. There was a statistically
significant difference in all measured scores between two groups
in the first and second follow-up sessions (P < 0.0001).
Conclusion: Malva Sylvestris seems to be a safe and effective
therapeutic modality for the treatment of hand eczema and can
be used as an optimal substitute for corticosteroids and anti-
histamines.
Keywords: Malva Sylvestris, herbal drugs, dermatitis, eczema, treatment
Behrooz Barikbin, MD
Afsaneh Maarefat, MD
Rayhaneh Rahgoshai, MD
Hamideh Moravvej, MD
Nahid Mohtasham, MD
Maryam Yousefi, MD
Skin Research Center, Shahid
Beheshti University of Medical
Sciences, Tehran,Iran
Corresponding Author:
Maryam Yousefi, MD
Skin Research Center, Shahid
Beheshti University of Medical
Sciences, Tehran,Iran
E-mail: myousefi_md@yahoo.com
INTRODUCTION
Hand eczema is one of the most common
dermatological diseases requiring treatment
1,2
but the treatment usually fails due to the
relapsing feature of hand eczema
3
. On the
other hand, use of conventional drugs such as
corticosteroids and anti-histamines for a long
time is not without adverse effects
4-6
. Hence,
using some natural drugs, especially herbal
ones, would be beneficial. Also, there has been
a resurgence in publics demand for herbal
remedies in recent years
7
. Three categories of
herbs used for people with hand eczema: anti-
inflammatories and herbs that affect the immune
system (immunomodulators), astringents (herbs
that bind to fluids and exudates so they are only
helpful when weeping eczema is present), and
herbs that affect the liver (also called alterative,
are poorly researched). Herbal drugs are usually
without considerable side effects and if their
efficacy is established, they can be of use for
the treatment of atopic dermatitis and hand
eczema
8
.
Among available herbal derivatives, the
efficacy of some such as Phenol, Chamomile,
Calendula, Chickweed, Menthol and Aloe Vera has
been established, especially due to their cooling
characteristics and few side effects
8
. However,
the efficacy of other herbal agents with cooling
Iran J Dermatol 2010; 13: 131-4
Received:June 27, 2010
Accepted: September 16, 2010
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properties may also be evaluated in clinical settings
among volunteer subjects. One of these plants
is Malva Sylvestris (MS). This plant is a tropical
species which grows in some regions of the Middle
East, especially Iran. It is also one of the most
important medicinal species in southern Italy. MS
is important in topical remedies for the treatment
of heat- and diaper- rash, bruise and some other
common diseases in Italy
9,10
. It is documented that
phytoalexin, malvone A (2-methyl-3-methoxy-5,6-
dihydroxy-1,4-naphthoquinone) is also induced
in MS
11
. MS leaves and flowers contain high
amounts of mucilage which is made up of complex
carbohydrates and gives MS most of its soothing
activity, though flavonoids and anthocyanidins
may also contribute. In herbal medicine, MS is
classified as a demulcent—a soothing agent that
counters irritation and mild inflammation
12,13
.
Although this plant is used as a drug in traditional
medicine, there is no academically performed
clinical trial about it and therefore, this study was
conducted to compare the efficacy of this agent
with placebo.
PATIENTS AND METHODS
In this randomized clinical trial, 123 patients
with hand eczema who were visited at Shohada-
e-Tajrish and Loghman-e-Hakim hospitals,
Tehran, Iran, from 2007 to 2008, were recruited.
Among them, 50 patients with hand eczema were
included based on clinical symptoms, physical
examination, and personal and family history. Two
dermatologists examined all patients to exclude
other differential diagnoses, such as hand psoriasis,
and confirmed the clinical diagnosis of hand eczema.
Pregnant women, patients with allergic reactions/
anaphylaxis to MS, and history of corticosteroid or
anti-histamine consumption in the last six weeks
or use of topical steroid in the last three weeks
were excluded.
After receiving explanation regarding the study
protocol, all participants signed informed consent
forms (according to Helsinki Declaration). We
then divided the patients into two groups using
a table of random numbers. Group A received MS
4% ointment in a tube without a label and group
B received placebo in a similar tube which only
contained eucerin. Both groups were given with
similar instructions to use the ointments twice
daily. Only one finger tip unit was used for each
affected 2-3% of the body surface which was equal
to one hand (four FTUs for both hands every day).
All patients were followed up for six weeks after
treatment.
Both groups were similar regarding demographic
features (P>0.05). The therapeutic results for
erythema, edema, excoriation, lichenification,
dryness, oozing, and itching (according to
calculated scores) were compared between the two
groups three and six weeks after beginning of the
treatment. The severity of erythema, excoriation
and lichenification was evaluated according to
the eczema area severity index (EASI) scoring
(Table 1)
14
. Edema, dryness, itching, and oozing
were also scored similar to the EASI severity
section.
Statistical analysis
Data were analyzed using SPSS (version 13.0)
software [Statistical Procedures for Social Sciences;
Chicago, Illinois, USA]. Independent-sample T,
Chi square, and Fisher Exact tests were used for
comparison. P values less than 0.05 were considered
significant.
RESULTS
Thirty-eight patients were female and 12 were
male. Both groups were sex-matched (18 and
20 female patients in MS and placebo groups,
respectively). Mean age of the patients was
37.3 and 35.6 years in MS and placebo groups,
respectively (P > 0.05). No therapeutic adverse
effects were seen in the two groups. Table 2
shows the outcomes at baseline and after three
and six weeks. There was a statistically significant
difference between two groups for all measured
scores at the first and second follow-up sessions
(P < 0.0001).
Severity
erythema, infiltration/population,
lichenification, and excoriation
Score
None 1
Mild 2
Moderate 3
Severe 4
Table 1. Eczema Area and Severity Index (EASI) scoring system
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Malva Sylvestris in the treatment of hand eczema
133
Iranian Journal of Dermatology, Vol 13, No 4, Winter 2010
DISCUSSION
Hand eczema is a common dermatologic disease
worldwide
1,2
. The relapsing characteristic of the
disease is the main issue of concern in patients
4
.
In this study, 50 patients were evaluated. Our
results showed that MS had a good efficacy without
side effects in the treatment of hand eczema in
comparison with placebo.
MS is a tropical plant which grows in Southern
Europe and Asia. Its leaves, flowers, and shoots
are used for therapeutic reasons. It has been
historically used as a medicine, internally as a
demulcent using its seed extract or boiled young
leaves, and externally as an emollient
15,16
. There
are few reports regarding its efficacy in the
treatment of dermatologic disorders, especially
hand eczema and it has proved to be a safe and
effective therapeutic modality
9,15,16
.
Cortic o s t e roids a nd a n t i-histami n e s , a s
conventional therapeutics, are generally used with
caution due to their side effects while herbal agents
are generally well-tolerated.
Previous studies have documented the efficacy
of MS in the treatment of some other diseases,
especially febrile ones
16,17
. Also, this agent has been
used as a softener in some conditions
16
. Although
MS is classified as a demulcent, our study proved
its efficacy in successful treatment of hand eczema
for the first time. Hence, the importance of our
study lies in introducing a new herbal modality for
treating hand eczema. Another interesting finding
was that this medicine caused no side effects, even
allergic reactions. Also, all patients were willing
to attend the follow-up sessions.
In conclusion, our study showed that MS, as a
safe and effective therapeutic modality, can be used
as an optimal substitute for corticosteroids and
anti-histamines for the treatment of hand eczema.
Finally, it is suggested that further studies with
longer follow-up periods be conducted to confirm
our findings.
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Baseline 3
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week 6
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week Baseline 3
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th
week
Mean erythema score 1.5 1.1 0.6 1.4 1.3 1.2
Mean edema score 0.8 0.5 0.3 0.8 0.8 0.7
Mean excoriation score 1.5 1 0.6 1.6 1.5 1.5
Mean lichenification score 1.6 1.2 0.7 1.7 1.8 1.7
Mean dryness score 2 1.4 0.9 2.1 2 1.9
Mean itching score 0.2 0.1 0.1 0.3 0.4 0.4
Mean oozing score 1.7 1.2 0.8 1.7 1.6 1.5
*There was a statistically significant difference between two groups in all features (P < 0.0001)
Table 2. Severity scores at baseline and after three and six weeks in the two groups*
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In order to preserve the ancestral knowledge, an ethnopharmacological study has been carried out in two councils belonging to Trás-os-Montes region a small area located in the northern of Portugal. In that area, medicinal plants, most of the species wild, are still in use among farmers, shepherds and other people who live far from villages and built-up areas. Among the 46 people that were interviewed (mean age of 66 years old), 88 species belonging to 42 families of vascular plants were identified for treatment of various human ailments. An ethnopharmacological report is made consisting of species names, vernacular names, popular uses of the plants and their pharmacological properties. The most dominant family is Lamiaceae (18%) and the most frequently part of the plant used for the treatment of diseases are leaves (37.9%). The largest number of taxa is used to treat gastrointestinal disorders (73.9%).
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Malva sylvestris is widely used in Mediterranean and European traditional medicine and ethnoveterinary for the treatment of external and internal inflammation, as well as injuries. Moreover, its use is not only limited to therapeutic purposes; but also the species is locally regarded as a food wild herb. Considering that antioxidants and free radical scavengers can exert also an anti-inflammatory effect, the extracts of different parts of the medicinal/edible plant M. sylvestris (leaves, flowers, immature fruits and leafy flowered stems) were compared for their nutraceutical potential (antioxidant properties) and chemical composition. Particularly, mallow leaves revealed very strong antioxidant properties including radical-scavenging activity (EC(50)=0.43 mg/mL), reducing power (0.07 mg/mL) and lipid peroxidation inhibition in lipossomes (0.04 mg/mL) and brain cells homogenates (0.09 mg/mL). This part of the plant is also the richest in nutraceuticals such as powerful antioxidants (phenols, flavonoids, carotenoids, and tocopherols), unsaturated fatty acids (e.g. alpha-linolenic acid), and minerals measured in ash content.
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