2016

HOMEOPATHY FOR ECZEMA, PSORIASIS, AND

SEBORRHOEIC DERMATITIS

HEALTH TECHNOLOGY ASSESSMENT SECTION

MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
1
007/2016
DISCLAIMER
This technology review is a brief report, prepared on an urgent basis, which
draws on restricted reviews from analysis of pertinent literature, on expert opinion
and / or regulatory status where appropriate. It has been subjected to an external
review process. While effort has been made to do so, this document may not fully
reflect all scientific research available. Additionally, other relevant scientific
findings may have been reported since completion of this review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS),

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

i
Prepared by:

Dr Khadijah binti Abdul Rahim

Senior Assistant Director
Health Technology Assessment Section (MaHTAS)
Medical Development Division
Ministry of Health Malaysia

Reviewed by:

Dr Junainah Sabirin
Senior Principal Assistant Director
Health Technology Assessment Section (MaHTAS)
Medical Development Division
Ministry of Health Malaysia

External reviewers:

Datin Dr Asmah binti Johar

Senior Consultant Dermatologist
Department of Dermatolgy
Hospital Kuala Lumpur
(Head of Dermatolgy Services, Ministry of Health)

Dr Sabeera Begum binti Kader Ibrahim

Consultant Paediatric Dermatologist
Department of Paediatrics
Hospital Kuala Lumpur

Asst. Prof. Dr Ibrahim Usman Mhaisker

Dean of the Faculty of Traditional and Complementary Medicine
Cyberjaya University College of Medical Sciences (CUCMS)

DISCLOSURE

The author of this report has no competing interest in this subject and the
preparation of this report is totally funded by the Ministry of Health, Malaysia.

ii
EXECUTIVE SUMMARY

Background

Chronic skin diseases are common among the general population. Many factors
may contribute to the cause, development and burden of chronic skin diseases,
such as genetic, immunologic, environmental and psychological factors.

Atopic dermatitis, a type of eczema, for instance, involves a genetic component

that can interact with environmental components, either irritants or allergens.
Eczema was the most frequently treated condition at homeopathic hospitals in
the United Kingdom. In Malaysia, it affects two in every ten individuals. Psoriasis,
another common chronic skin disease, is currently understood as a multi-genetic
disease causing a strong immune system disturbance with inflammatory skin
manifestations. It affects about two to three percent of Malaysians. On the other
hand, seborrheic dermatitis is a common inflammatory skin condition that causes
flaky, white to yellowish scales on the skin and commonly involves the scalp. Its
incidence is one to three percent of the general adult population.

Homeopathy is one of the most popular forms of complementary and alternative

medicine worldwide and in Malaysia. The Traditional and Complementary
Medicine (TCM) Act 2013 had been gazetted in 2013 whereby homeopathy is
recognised as one of the TCM modalities in Malaysia. The clinical effectiveness
of homeopathy treatment including for skin diseases remains controversial and
there are discrepancies between outcomes of different studies. Thus, this
systematic review was requested by the Senior Principal Assistant Director of the
Traditional and Complementary Division, mainly to look at the effectiveness and
safety of homeopathic treatment for three of the common non-infectious skin
diseases in Malaysia namely eczema, psoriasis and seborrheic dermatitis.

Objective/ aim

The objective of this systematic review was to assess the effectiveness, safety
and cost/ cost-effectiveness of homeopathy for eczema, psoriasis, and
seborrheic dermatitis.

Results and conclusions

A total of 66 titles were identified through the Ovid interface and PubMed. Seven
relevant articles were included in this review: one systematic review, two
randomised controlled trials, one non-randomised interventional study, two pre
and post intervention studies and one case report. However, there are several
limitations whereby some of the included studies have small sample size. The
homeopathic and conventional treatments in some studies were not specified.

iii
Apart from that, some of the studies retrieved were observational studies, which
are considered to have higher risk of bias.

a. Effectiveness

Eczema:
There was limited fair level of retrievable evidence to suggest that
there was no significant difference between homeopathic therapy and
conventional therapy. However, some of the included studies have
small sample size. The pre and post intervention study by Donsky H
and Clarke D in 2007 which showed improvement in eczema with a
topical homeopathic therapy, Reliva, when compared with before
treatment, may suggest a role for homeopathic therapy. The mean
Eczema Area Severity Index (EASI) scores in the patients decreased
significantly by 75%, 91% and 97% after four, eight and 12 weeks of
treatment, respectively.

Psoriasis:
There was very limited fair level of retrievable evidence that showed
homeopathic treatment was effective in treating and improving the
quality of life of psoriasis patients. However, in a randomised
controlled trial specific to a homeopathic therapy, the area of skin
applied with the homeopathic treatment and the placebo was small
(4.0 cm x4.0 cm).

Seborrheic dermatitis:
There was very limited fair level of retrievable evidence to suggest that
a low-dose oral homeopathic formulation improved seborrheic
dermatitis (one study). There was a significant difference in the mean
percentage change in the Seborrhea Area and Severity Index (SASI)
between the active group (38.54 42.13) and the placebo group (-
10.82 66.16, P= 0.0302). On a similar note, the improvement in SASI
in the placebo group was also significant after the crossover to the
active medication group (41.64 39.45) at week 20 as compared to
before crossover (-16.40 50.12, P= 0.0035).

b. Safety

There was no significant difference in reported adverse events of homeopathy for

eczema, psoriasis, and seborrhea compared to conventional or placebo
treatments. However, there was a case report of a serious complication of
childhood bullous pemphigoid with a life-threatening course in a baby who was
receiving homeopathic drugs for atopic dermatitis.

iv
c. Cost/ Cost effectiveness

There was no cost-effectiveness analysis retrieved. One costanalysis in a non-

randomised interventional study of the effectiveness of homeopathic versus
conventional therapy in usual care of atopic eczema in children showed that the
total costs were significantly higher in the homeopathic group (216.99, 95% CI:
154.12, 279.87) as compared to conventional group (99.93, 95% CI: 53.75,
146.12) in which the respective physicians contacts was one of the main cost
drivers. The cost of homeopathic treatment per session in Malaysia is about
RM50.

Methods

Electronic databases were searched through the Ovid interface: Ovid MEDLINE
In-process and other Non-indexed citations and Ovid MEDLINE 1946 to
present, EBM Reviews - Cochrane Central Register of Controlled Trials
February 2016, EBM Reviews - Cochrane Database of Systematic Reviews -
2005 to April 7 2016, EBM Reviews Database of Abstracts of Reviews of
Effects 1st Quarter 2016, EBM Reviews - Health Technology Assessment 1st
Quarter 2016, EBM Reviews NHS Economic Evaluation Database 1st Quarter
2016, Embase 1988 to 2016 week 15. Searches were also run in PubMed.
Google was used to search for additional web-based materials and information.
Additional articles were identified from reviewing the references of retrieved
articles.

v
 HOMEOPATHY FOR ECZEMA, PSORIASIS, AND
SEBORRHOEIC DERMATITIS

1. BACKGROUND

Skin conditions put a large burden on the healthcare systems worldwide.

According to the Global Burden of Disease 2010 Study, all skin conditions
combined were the fourth leading cause of non-fatal disease burden at the
global level.1 Collectively, skin conditions ranged from the second to
eleventh cause of years lived with disability at the country level. 2 In
particular, chronic skin diseases are common among the general
population. Many factors may contribute to the cause, onset, development
and burden of chronic skin diseases, such as genetic, immunologic,
environmental and psychological factors.3,4

Eczema for instance, involves a genetic component in the form of a

general allergic over-sensitivity (atopic dermatitis) or an environmental
component, as caused by irritants or other allergens (contact dermatitis).4
In fact, atopic dermatitis involves a genetic component that can interact
with environmental components, either irritants or allergens. It is a chronic,
inflammatory skin disease marked by intense itching, erythematous
papules and vesicles in the acute stage. Eczema is a common skin
condition which affects 10-20% of children and one to three percent of
adults worldwide, and two in every ten individuals in Malaysia.5 It was the
most frequently treated condition at homeopathic hospitals in the United
Kingdom. Psoriasis, another common chronic skin disease, is currently
understood as a multi-genetic disease causing a strong immune system
disturbance with inflammatory skin manifestations.4 Similar to worldwide
statistics, it affects about two to three percent of Malaysians. It is a
condition that results in localised or extensive inflamed scaly skin lesions
that can affect any part of the skin. It frequently occurs on the scalp,
elbows, knees and shins.6 On the other hand, seborrheic dermatitis is a
common inflammatory skin condition that causes flaky, white to yellowish
scales on the skin. The flaking most often occurs on the scalp, eyebrows,
nasolabial folds and behind the ears. Its incidence peaks during three age
periods - in the first three months of life, during puberty, and in adulthood
ranging from 40 to 60 years of age. The incidence is one to three percent
of the general adult population. Men are affected more frequently than
women in all age groups, suggesting that seborrhea may be associated
with sex hormones such as androgens.7

Alternative medicines are commonly used in patients with dermatologic

conditions, with homeopathy being one of the most common. 8 In fact, it is
claimed that homeopathy is one of the most popular forms of
complementary and alternative medicine in Malaysia and elsewhere.9 The

1
 Traditional and Complementary Medicine (TCM) Act 2013 had been
gazetted in 2013 in which homeopathy is recognised as one of the TCM
modalities in Malaysia. The claims made for the clinical effects of
homeopathy including for skin diseases are controversial and there are
discrepancies between outcomes of different studies. Thus, this
systematic review was requested by Senior Principal Assistant Director of
the Traditional and Complementary Division, mainly to look at the
effectiveness and safety of homeopathic treatment for three of the
common skin diseases in Malaysia namely eczema, psoriasis, and
seborrhea or more popularly known as seborrheic dermatitis.

2. OBJECTIVE / AIM

The objective of this systematic review was to assess the effectiveness,

safety and cost/ cost- effectiveness of homeopathy for eczema, psoriasis,
and seborrheic dermatitis.

3. TECHNICAL FEATURES

Homeopathy was developed by Samuel Hahnemann (1755-1843), a

German physician, and is based on the law of similar and the law of
infinitesimals, also known as the principle of potency or potentiation
through dilution. The first law denotes the assumption that likes are cured
by likes, in which certain symptoms can be cured when a drug is given
that is able to induce the same symptoms in a healthy individual. In this
context, homeopathy can be considered as a regulative therapy aimed at
inducing counterregulation.8,10

The law of infinitesimals defines the rule that the appropriate drug has to
be given in high dilutions, and that the higher the dilution, the greater the
effect, whereby an agent becomes more powerful the more it is diluted.8,10
Earlier, it was believed that high dilutions of homeopathy medicines
virtually do not contain even a single molecule of the original starting
substance. However, recent studies show that homeopathy dilutions do
contain nanoparticles of starting substance in all potencies.11

The homeopathic armamentarium includes plants, minerals, and metals

that are potentially dangerous such as poisonous ivy, arsenic, and
thalium. While homeopathic medicines are generally harmless due to their
extreme dilution, toxic amounts are occasionally administered.
Nevertheless, homeopaths argue that initial aggravation upon treatment
initiation make up an optimal reaction following an appropriate choice.10

2
 Most of the conditions treated by homeopathic practitioners are chronic or
recurrent. Initially, a very detailed history is taken from the patient, a
clinical examination is performed, and all signs and symptoms are
recorded. Attention is paid to alternating or unusual symptoms and
information is sought on the conditions providing relief or aggravation of
symptoms, such as weather or activity. The symptoms are then matched
to remedies using either a homeopathic repertory or pattern
recognition.12

Homeopathic remedies are often known as potencies and are prepared

through a process of serial dilution with vigorous shaking. Methods of
prescribing vary among homeopathic practitioners12:
Classical (individualised): single remedy prescribed based on
patients presentation and history
Complex: more than one remedy used concurrently
Fixed: same single agent used for a group of patients
Isopathy: preparation based on causal agent
Phytotherapy: administration of herbs or low potencies of herbs

4. METHODS

4.1 Searching

Electronic databases were searched through the Ovid interface: Ovid

MEDLINE In-process and other Non-indexed citations and Ovid
MEDLINE 1946 to present, EBM Reviews - Cochrane Central Register of
Controlled Trials February 2016, EBM Reviews - Cochrane Database of
Systematic Reviews - 2005 to April 7 2016, EBM Reviews Database of
Abstracts of Reviews of Effects 1st Quarter 2016, EBM Reviews - Health
Technology Assessment 1st Quarter 2016, EBM Reviews NHS
Economic Evaluation Database 1st Quarter 2016, Embase 1988 to 2016
week 15. Searches were also run in PubMed. Google was used to search
for additional web-based materials and information. Last search was done
on 12th April 2016. Search was limit to humans. Additional articles were
identified from reviewing the references of retrieved articles. Appendix 1
showed the detailed search strategies.

4.2 Selection

A reviewer screened the titles and abstracts against the inclusion and
exclusion criteria and then evaluated the selected full text articles for final
article selection.

3
 The inclusion and exclusion criteria were:

Inclusion criteria
Problems Patients with eczema, psoriasis, or seborrheic dermatitis

Interventions Homeopathic treatment

Comparators Conventional treatment/ placebo/ no comparator

Outcomes Improvement in lesion

Improvement in symptoms
Quality of life
Safety (adverse events)
Cost/ cost-effectiveness

Study design Health Technology Assessment (HTA), Systematic Review (SR),

Randomised Controlled Trial (RCT), Non Randomised
Controlled Trial, cohort studies, case control studies, pre and
post intervention studies, cross sectional studies, case series,
case reports

English full text articles

Exclusion criteria
Study design Studies conducted in animals/ laboratory studies and narrative
reviews

Non English full text articles

Relevant articles were critically appraised using Critical Appraisal Skills

Programme (CASP) and graded according to US/ Canadian Preventive
Services Task Force (Appendix 2). Data were extracted and summarised
in evidence table as in Appendix 3.

5. RESULTS AND DISCUSSION

A total of 66 titles were identified through the Ovid interface and PubMed:
45 for eczema, 17 for psoriasis and four for seborrheic dermatitis. Seven
relevant articles were included in this review: one systematic review, two
randomised controlled trials, one non-randomised interventional study, two
pre and post intervention studies and one case report.

4
5.1 EFFECTIVENESS

5.1.1 Eczema

A systematic review conducted by Ernst E in 2012 aimed at evaluating

and summarising the evidence from controlled clinical trials testing the
efficacy of homeopathy as a treatment for eczema. Data were not pooled
and only qualitative assessment of the data was carried out. The review
included only three trials by which two were non-randomised. One non-
randomised controlled trial by Keil et al. involved 118 children with
eczema; the homeopathic group received non-specified treatment by
homeopaths whereas the control group received conventional treatment
that was also not specified. Another non-randomised trial by Witt et al.
included 135 children with atopic eczema by which the homeopathic
treatment in the homeopathic group was not specified; the control group
also received conventional treatment that was not specified as well. The
two non-randomised trials suggested therapeutic equivalence between
homeopathy and conventional therapy. The randomised controlled trial
(RCT) included in this review involved a small number of subjects; 24
patients from which only 14 completed the study. The experimental group
was given individualised homeopathic treatment for 32 weeks whereas the
control group received placebo, which was not specified. The RCT
showed a marginal superiority of placebo over homeopathy. From the
authors view, all of these studies had methodological limitations.13, level I

A more recent non-randomised interventional study by Roll S et al. in 2013

compared the effectiveness of homeopathic versus conventional therapy
in the usual care of atopic eczema in children. The study was conducted
in Berlin, Germany involving 135 children (48 homeopathy, 87
conventional), looking at the effectiveness and the costs involved in a
long-term follow-up of 36 months. The children and their parents were
recruited at either homeopathic or conventional doctors practices. Thus,
the parents preference towards treatment of atopic eczema generated the
groups to be compared. The recruitment of homeopathic doctors was
through the association of homeopathic doctors in Berlin, while doctors for
conventional treatment were chosen from address lists or by
recommendation. Children in the homeopathic group received
individualised homeopathy, which was not specifically mentioned in this
study. Among the treatment received by children in the conventional
group, some of which were also received by some of the children in the
homeopathic group, were corticosteroids, topical calcineurin inhibitors,
antihistamines and basic skin care. The SCOring Atopic Dermatitis
(SCORAD) at 36 months which was the main outcome of the study
showed no significant differences between groups: mean for homeopathy
group was 13.68 2.91, 95% Confidence Interval (CI): 7.88, 9.48
compared to conventional group 14.90 2.25, 95% CI: 10.41, 19.05

5
 (P=0.741). The study also looked at the Children Dermatology Life Quality
Index (CDLQI) as a measure of the participating childrens quality of life.
Similarly, the CDQLI showed no significant difference: mean for
homeopathy group was 2.2, 95% CI: 1.4, 3.4 versus conventional 1.8,
95% CI: 1.2, 2.8 (P=0.627).14, level II-2

Donsky H and Clarke D in 2007 conducted a small pre and post

intervention study in the United States to determine the efficacy and safety
of Reliva, a homeopathic product for topical administration in adult
patients with atopic dermatitis. The active ingredient of Reliva is
Psorberine, a proprietary extract from Mahonia aquifolium 10% cream
formulated in an emulsion cream base. The study was carried out for a
period of 12 weeks and involved 42 patients, from which only 30
completed the study. Patients were provided with Reliva and instructed
on the application of a thin layer of it three times per day to affected areas
on the skin. The main study outcome was improvement in Eczema Area
and Severity Index (EASI) scores. The study found that the mean EASI
scores in the patients decreased significantly by 75%, 91% and 97% after
four, eight and 12 weeks of treatment, respectively (Table 1). Subject
Reported Evaluation of Treatment at 12 weeks showed that compared
with before treatment, 93% of patients rated the effectiveness of treatment
as better or much better, 83.4% rated itching as better or much
better and 93.3% rated the appearance of rash as better or much
better.15, level II-2

Table 1: EASI scores in per-protocol group

Week Mean (SD) Median (range)
0 2.01 (1.54) 1.50 (0.5-5.6)
4 0.50 (0.84) 0.20 (0-4.0)
8 0.16 (0.43) 0.0 (0-2.0)
12 0.06 (0.18) 0.0 (0-0.8)

5.1.2 Psoriasis

In 2009, Witt CM, Ludtke R and Willich SN carried out a pre and post
intervention study in Germany to evaluate details and effects of
homeopathic treatment in patients with psoriasis on usual medical care.
Eighty two adult primary care patients were followed up for two years. The
study looked into the mean scores for severity of the psoriasis diagnosis,
severity of all other diagnoses at baseline (physician assessment),
severity of all complaints (patient assessment) using numeric rating scale
(NRS; 0 =no complaints, 10 =maximum severity) and quality of life (QoL)
scores. Other diagnoses at baseline included migraine, allergic rhinitis,
psoriatic arthropathy, hypertension, chronic sinusitis, allergy and
dermatitis. The mean NRS showed that the strongest improvement in all

6
 diagnoses (including psoriasis) and medical complaints was seen in the
first three months; this continued during the full observation period. By the
end of study period, all changes since baseline in severity of diagnoses
and complaints were of large effect size (Cohens d 1.02-2.09 [Cohens d:
>0.8 large, >0.5 medium, >0.2 small]). The health-related QoL improved
similarly but with smaller effect size; physical component score: Cohens d
0.26, mental component score: Cohens d 0.49. Reductions in the use of
conventional medicines and health care services were observed as well.
Use of conventional medicines was reduced by five percent while use for
health care services was reduced between 7 to 46%.16, level II-2

Bernstein S et al. in 2006 conducted a RCT in the United States and

Canada to assess the efficacy and safety of the topical cream, Reliva
which contains M. aquifolium extract, in 200 patients with mild to moderate
plaque psoriasis. The active group (n=100) received active ingredient (M.
aquifolium 10%), and the placebo group (n=100) received the same
formulation without the active ingredient. Subjects in both groups applied
the product twice a day to the selected area- a 4.0 cm x4.0 cm area of
skin that typified the patients psoriasis. This area was selected by the
investigator, using a precut template. All patients were followed up for a
period of 12 weeks. The study found statistically significant improvement
from baseline in Psoriasis Area Severity Index (PASI) between the active
(mean reduction -3.39) and control (mean reduction -0.09) groups, P=
0.0095. The Quality of Life Index (QLI) also showed significant
improvement with mean change of QLI in active group of 23.6, compared
with placebo group -3.88 (P= 0.0001).17, level II-1

5.1.3 Seborrheic dermatitis

A randomised controlled trial by Smith SA, Baker AE and Williams JH

published in 2002 was conducted to evaluate the therapeutic potential of a
low-dose oral homeopathic medication consisting of potassium bromide,
sodium bromide, nickel sulphate, and sodium chloride. The trial was
carried out in Oklahama and included a considerably small number of
subjects (41). Twenty-one of them were randomised into the active
intervention group while the remaining 20 into the control group. For the
first 10 weeks of the study, the patients all of whom were blinded to the
treatment, took the assigned study medication and were evaluated at 0, 5
and 10 weeks. The intervention group received the above-mentioned
homeopathic medication in a vehicle of purified water and 20% ethyl
alcohol whilst the control group received placebo consisting of the vehicle
only. The patients self-administered the study drug on an eight-hour fasted
stomach at the beginning of the day, before consuming anything other
than water. At the end of 10 weeks all patients crossed over to the active
medication for an additional 10-week open study. The study reported that

7
 for the first 10 weeks, there was a significant improvement in the primary
study outcome which was the disease state as depicted by mean
percentage change in the Seborrhea Area and Severity Index (SASI)
between the active group (38.54 42.13) and the placebo group (-10.82
66.16, P= 0.0302). On a similar note, the improvement in disease state in
the placebo group was also significant after the crossover to the active
medication group (41.64 39.45) at week 20 as compared to before
crossover (-16.40 50.12, P= 0.0035).17, level II-1

5.2 SAFETY

Kuenzli S et al. in 2004 reported a case of childhood bullous pemphigoid

with a life-threatening course in a nine month old baby girl who developed
the condition while receiving homeopathic drugs for skin lesions thought to
represent atopic dermatitis. Since the child was two months old, she had
an eczematous nummular eruption which was treated with topical and oral
homeopathic remedies. At seven months of age, she developed intense
itching followed by the appearance of bullous lesions on the palms and
soles. The child was admitted to a specialised homeopathic hospital
where she was treated with calcium, sulphur, lycopodium, mercurius,
cantharis, rhus toxicodendron, calcium carbonicum, sepia and
tuberculinum for her skin condition. With this treatment, the skin lesion
worsened, spreading to the entire body and the childs general condition
became poor; she had asthenia, dehydration and malnutrition.
Investigation of skin biopsy was characteristic of bullous pemphigoid.
Institution of oral prednisolone in association with sulfapyridine resulted in
rapid improvement of her general condition and skin disease.10, level III

In the study by Roll S et al. it was reported that two patients in the
homeopathy group (5.3%) and five in the conventional group (8.2%)
reported adverse events (P= 0.704). The adverse events that occurred
included pruritus, burning sensation, reddening, dry /flaky skin, burns,
herpes zoster and allergic reaction, with one child in the conventional
group needing hospitalisation due to worsening of the atopic eczema with
additional streptococcal infection.14, level II-2

Donsky H and Clarke D in their study reported that three patients

complained of itching and/ or burning when using the Reliva cream for
atopic dermatitis.13, level II-2 Similarly, Bernstein S in his RCT reported no
significant side effects in either group when using the cream for psoriasis -
one patient in the active group complained of staining from the cream,
while in the control group, one patient reported a rash and two others
reported a burning sensation when applying the cream. 17, level II-1
In the RCT by Smith SA, Baker AE and Williams JH, there was no
significant difference (P= 0.7999) between the frequency of adverse
events for the active group as compared to the placebo group (0.24

8
 versus 0.24). The most frequent adverse events were stomach upset,
stomach pain and nausea. These adverse events were considered mild
and infrequent. As for laboratory parameters (standard serum chemistry
profile, complete blood count, and urinalysis), small but statistically
significant shifts from baseline occurred for some parameters in the active-
treatment, placebo-treatment-before-crossover and placebo-after-
crossover-to-active groups. However they remained well within the normal
lab references and were not considered to be causally related to the study
medication.18, level II-1

5.3 COST/ COST- EFFECTIVENESS

There was no cost-effectiveness analysis retrieved. However, Roll S et al.

in their non-randomised interventional study of the effectiveness of
homeopathic versus conventional therapy in usual care of atopic eczema
in children conducted a cost comparison analysis between the two
groups at months 31 to 36 from baseline. Total costs were significantly
higher in the homeopathic group (216.99, 95% CI: 154.12, 279.87),
compared to conventional group (99.93, 95% CI: 53.75, 146.12), P=
0.004 whereby the respective physicians contacts were one of the main
cost drivers, particularly contacts with the study doctor.14 In Malaysia, the
cost of homeopathic treatment per session in general is about RM50,
lower than the amount that patients are willing to pay, which is RM65. 19
Information on the cost of homeopathic treatment specifically for skin
disease is not available.

5.4 LIMITATIONS

This technology review has several limitations. The selection of studies

was done by one reviewer. Although there was no restriction in language
during the search but only full text English articles were included in this
report. Some of the included studies have small sample size. The
homeopathic and conventional treatments in some studies were not
specified. Apart from that, some of the studies retrieved were
observational studies, which are considered to have higher risk of bias.

6. CONCLUSION

6.1 Effectiveness

Eczema:
There was limited fair level of retrievable evidence to suggest that
there was no significant difference between homeopathic therapy

9
 and conventional therapy. However, one pre and post intervention
study showed improvement in eczema with Reliva, a topical
homeopathic therapy, when compared with before treatment.

Psoriasis:
There was very limited fair level of retrievable evidence that
showed homeopathic treatment was effective in treating and
improving the quality of life of psoriasis patients.

Seborrheic dermatitis:
There was very limited fair level of retrievable evidence to suggest
that a low-dose oral homeopathic formulation improved seborrheic
dermatitis (one study).

6.2 Safety

There was no significant difference in reported adverse events of

homeopathy for eczema, psoriasis, and seborrhea compared to
conventional or placebo treatments. However, there was a case report of
a serious complication of childhood bullous pemphigoid with a life-
threatening course in a baby who was receiving homeopathic drugs for
atopic dermatitis.

6.3 Cost/ Cost -effectiveness

There was no cost-effectiveness analysis retrieved. One cost analysis in

a non-randomised interventional study of the effectiveness of homeopathic
versus conventional therapy in usual care of atopic eczema in children
showed that the total costs were significantly higher in the homeopathic
group as compared to conventional group in which the respective
physicians contacts was one of the main cost drivers. The cost of
homeopathic treatment per session in Malaysia is about RM50.

10
7. REFERENCES

1. Hollestein ML, Nijsten T. An insight into the Global Burden of Skin

Diseases. J Invest Dermatol. 2014; 134:1499-1501

2. Hay RJ, Johns NE, Williams HC et al. The Global Burden of Skin Disease
in 2010: an analysis of the prevalence and impact of skin conditions. J
Invest Dermatol. 2014;134:1527-1534

3. Itamura R. Effect of homeopathic treatment of 60 Japanese patients with

chronic skin disease. Complement Ther Med. 2007;15(2):115-120

4. Jong MC, Ermuth U, Augustin M. Plant-based ointments versus usual care

in the management of chronic skin diseases: a comparative analysis of
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459

5. Itchy skin: a survey reveals low awareness of eczema in Malaysia.

Available at http://www.thestar.com.my/lifestyle/health/2012/05/06/itchy-
skin/. Accessed on 11/04/2016.

6. FAQ on psoriasis. Available at

http://www.dermatology.org.my/psoriasis_faq.html. Accessed on
11/04/2016.

7. Borda LJ, Wikramanayake TC. Seborrheic dermatitis and dandruff: a

comprehensive review. J Clin Investigat Dermatol. 2015;3(2):1-10

8. Smolle J. Homeopathy in dermatology. Dermatologic Therapy.

2003;16:93-97

9. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a

systematic review of published case reports and case series. Int J Clin
Pract. 2012;66(12):1178-1188

10. Kuenzli S, Grimatre M, Krischer J et al. Childhood bullous pemphigoid:

report of a case with life-threatening course during homeopathy treatment.
Pediatric Dermatology. 2004;21(2):160-163

11. Chikramane PS, Suresh AK, Bellare JR et al. Extreme homeopathic

dilutions retain starting materials: a nanoparticulate perspective.
Homeopathy. 2010;99:231-242

12. OMeara S, Wilson P, Bridle C et al. Homoeopathy. Qual Saf Heath Care.
2002;11:189-194

11
13. Ernst E. Homeopathy for eczema: a systematic review of controlled
clinical trials. Br J Dermatol. 2012;166:1170-1172

14. Roll S, Reinhold T, Pach D et al. Comparative effectiveness of

homeopathic vs. conventional therapy in usual care of atopic eczema in
children: long-term medical and economic outcomes. PLoS One.
2013;8(1):e54973

15. Donsky H, Clarke D. Reliva, a Mahonia Aquifolium extract for the

treatment of adult patients with atopic dermatitis. Am J Ther. 2007;14:442-
446
16. Witt CM, Ludtke R, Willich SN. Homeopathic treatment of patients with
psoriasis - a prospective observational study with 2 years follow-up. J Eur
Acad Dermatol Venereol. 2009;23:538-543

17. Bernstein S, Donsky H, Gulliver W et al. Treatment of mild to moderate

psoriasis with Relieva, a Mahonia aquifolium extract a double-blind,
placebo-controlled study. Am J Ther. 2006;13:121-126

18. Smith SA, Baker AE, Williams JH. Effective treatment of seborrheic
dermatitis using a low dose, oral homeopathic medication consisting of
potassium bromide, sodium bromide, nickel sulphate, and sodium chloride
in a double-blind, placebo controlled study. Altern Med Rev. 2002;7(1):59-
67

19. National Health and Morbidity Survey 2015: Traditional and

Complementary Medicine (Volume IV). Available at
http://www.iku.gov.my/images/IKU/Document/REPORT/NHMS2015-
VolumeIV.pdf. Accessed on 13/06/2016.

12
8. APPENDIX

8.1 Appendix 1: LITERATURE SEARCH STRATEGY

Ovid MEDLINE In-process & other Non-Indexed citations and

OvidMEDLINE 1948 to present

1 ECZEMA/ (9854)
2 eczema*.tw. (15476)
3 (eczematous adj1 dermatiti*).tw. (303)
4 1 or 2 or 3 (19328)
5 PSORIASIS/ (28859)
6 psorias?s.tw. (29645)
7 (pustulosis adj1 ((palmoplantaris or palmaris et plantaris or palms) and
soles)).tw. (10)
8 (pustular psoriasis of palm* and sole*).tw. (4)
9 5 or 6 or 7 or 8 (37011)
10 DERMATITIS, SEBORRHEIC/ (2445)
11 seborrh?ea.tw. (603)
12 (seborrh?e* adj1 dermatiti*).tw. (1387)
13 10 or 11 or 12 (3313)
14 HOMEOPATHY/ (4328)
15 hom?eopath*.tw. (4454)
16 14 or 15 (5835)
17 4 and 16 (45)
18 9 and 16 (17)
19 13 and 16 (4)

13
OTHER DATABASES
EBM Reviews - Cochrane Central
Register of Controlled Trials
EBM Reviews - Cochrane
Database of Systematic Reviews
EBM Reviews - Health Same MeSH, keywords, limits used as
Technology Assessment per MEDLINE search
EBM Reviews Database of
Abstracts of Reviews of Effects
EBM Reviews NHS Economic
Evaluation Database
EMBASE

PubMed

((((((((ECZEMA[MeSH Terms]) OR eczema*[Title/Abstract]) OR eczematous

dermatiti*[Title/Abstract]) OR dermatiti*, eczematous[Title/Abstract])) OR
(((WARTS[MeSH Terms]) OR verruca*[Title/Abstract]) OR wart*[Title/Abstract]))
OR (((((((PSORIASIS[MeSH Terms]) OR psoriases[Title/Abstract]) OR
psoriasis[Title/Abstract]) OR palmoplantaris pustulosis[Title/Abstract]) OR
(pustular psoriasis of palms[Title/Abstract] AND soles[Title/Abstract])) OR
pustulosis palmaris et plantaris[Title/Abstract]) OR (pustulosis of
palms[Title/Abstract] AND soles[Title/Abstract])))) AND (((HOMEOPATHY[MeSH
Terms]) OR homeopath*[Title/Abstract]) OR homoeopath*[Title/Abstract])

14
8.2 Appendix 2

DESIGNATION OF LEVELS OF EVIDENCE

I Evidence obtained from at least one properly designed randomized

controlled trial.

II-I Evidence obtained from well-designed controlled trials without

randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic

studies, preferably from more than one centre or research group.

II-3 Evidence obtained from multiple time series with or without the
intervention. Dramatic results in uncontrolled experiments (such as the
results of the introduction of penicillin treatment in the 1940s) could also
be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience;

descriptive studies and case reports; or reports of expert committees

SOURCE: US/ CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris

2001)

15
 Appendix 3
Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics

1. Ernst E. Systematic review I 3 controlled trials: Homeopathy i. Conventional NA All studies had methodological
Homeopathy for 1 randomised, 2 of any type treatment limitations.
eczema: a Objective: to summarise and non randomised ii. Placebo
systematic critically evaluate the The two non-randomised trials
review of evidence from controlled i. Keil et al. suggest therapeutic equivalence
controlled clinical trials testing the - comparative between homeopathy and
clinical trials. Br efficacy of homeopathy as a cohort study conventional therapy. The studies
J Dermatol. treatment for eczema -118 children with lacked sufficient detail about
2012;166:1170- eczema treatments administered and both
1172 Methods: Electronic were open to selection and other
searches were conducted in ii. Witt et al. biases.
Medline, Embase and the - comparative
Cochrane Library. No cohort study The RCT shows a marginal
restrictions on time or -135 children with superiority of placebo over
language. Hand search for atopic eczema homeopathy. Only 14 of 24 patients
further relevant studies from completed the study.
departmental files, other iii. Siebenwirth et
systematic reviews and al.
bibliographies of the - RCT
retrieved studies were also - 24 patients with Authors conclusion: The available
done. Limit to human study. eczema trial data do not demonstrate
The methodological quality homeopathic remedies to be
of included trials was efficacious as a treatment of
estimated using the Jadad eczema
score.

Selection criteria: all

controlled clinical trials of
any type of homeopathy in
patients with any type of
eczema

16
 Evidence Table: Effective
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics

2. Roll S, Non-randomised II-2 135 children Homeopathic Conventional 36 months Main outcome was SCORAD
Reinhold T, interventional study - - 48 therapy therapy (SCORing Atopic Dermatitis) at 36
Pach D et al. homeopathy, 87 months. Further outcomes were
Comparative Objective: to describe conventional quality of life, conventional medicine
effectiveness of the effectiveness and consumption, safety and disease-
homeopathic the costs involved in the Inclusion related costs at 6, 12 and 36 months
vs. long-term follow-up after criteria: after baseline.
conventional 36 months. - children 1-
therapy in 14yrs with SCORAD showed no significant
usual care of Children were recruited atopic eczema differences between groups: mean for
atopic eczema from January 2005 to - disease homeopathy group 13.68 2.91, 95%
in children: June 2006. Data was duration of at CI 7.88 to 9.48 vs conventional group
long-term collected until October least 6months 14.90 2.25, 95% CI 10.41 to 19.05
medical and 2009, allowing a total - fulfilled 3 of 4 (P=0.741).
economic observation period of Williams
outcomes. 36months per patient. criteria, Childrens QoL CDLQI (Children
PLoS One. Study was multi-centre - Three-Item- Dermatology Life Quality Index) also
2013;8(1):e549 in Berlin, Germany. The Score (TIS) showed no significant difference:
73 children and their between 2 to 7. mean for homeopathy grp 2.2, 95%
parents were recruited CI 1.4 to 3.4 vs conventional 1.8, 95%
at either homeopathic or Exclusion CI 1.2 to 2.8 (P=0.627).
conventional doctors criteria:
practices and had - other dermal Total costs were significantly higher in
already made their own disease, severe the homeopathic group (217 Euro,
choice of therapy. Thus, medical or 95% CI 154.1 to 279.9), compared to
the parents preference psychological conventional group (99.9 Euro, 95%
towards treatment disease CI 53.7 to 146.1), P=0.005).
generated the groups to - oral or iv
be compared. corticosteroids
Homeopathic doctors during last
were recruited by the 3months before
organisation of study entry
homeopathic doctors in -psychotherapy,
Berlin. Doctors for allergy
conventional treatment desensitisation

17
 Evidence Table: Effective
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics

(paediatricians or or additional Authors conclusion: in this long-term

dermatologists) were complementary study after three years, while unable
chosen from address therapy during to rule out residual confounding but
lists or via last 3 months taking patient preferences into
recommendation. before study account, treatment at homeopathic
entry 135 doctors was similar, yet not superior
After conventional case children to treatment at conventional doctors
taking, screening and - - 48 for children with mild to moderate
recruitment, patients homeopathy, 87 atopic eczema, but still had higher
were enrolled into the conventional costs.
study. The baseline
data for the main
outcome measure,
SCORAD were
assessed by 2
specifically trained staff
members who were
blinded to treatment
assignment. Other
baseline data were
obtained with
questionnaires. Each
patient was assigned to
only one rater for the
whole study period.
After the rating, the
homeopathic case,
taking and the following
treatment or the
conventional treatment
began. Follow-up data
were obtained also by
ratings and
questionnaires.

18
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics

3. Donsky H, Pre and post intervention II-2 - 42 patients Reliva cream - Patients were Main outcome was improvement in
Clarke D. enrolled, from (homeopathic assessed at EASI scores.
Reliva, a Objective: to assess the which 12 product baseline (day
Mahonia efficacy and safety of patients containing 0) and at 4, 8 EASI scores in per-protocol group:
Aquifolium Relieva, a topical cream, in dropped out. Psorberine, a and 12 weeks Time Mean (SD) Median
extract for adult patients with atopic Thus, 30 proprietary after initiation point (range)
the treatment dermatitis (AD). patients extract from of treatment. 0 2.01 (1.54) 1.50 (0.5-5.6)
of adult completed the Mahonia 4 wks 0.50 (0.84) 0.20 (0-4.0)
patients with Patients were recruited study (n=30). aquifolium 8 wks 0.16 (0.43) 0.0 (0-2.0)
atopic from clinical private 10% cream 12 wks 0.06 (0.18) 0.0 (0-0.8)
dermatitis. practices, the local college formulated in
Am J Ther. student population, local Inclusion an emulsion
The mean EASI scores decreased
2007;14:442- newspaper advertisements criteria: cream base)
by 75%, 91% and 97% after 4, 8
446 and by word of mouth. - Patients 18 - for topical
and 12 weeks of treatment,
Eligibility was assessed 80 years old administration
respectively (all P<0.05).
through telephone pre- with atopic
screening. Patients who dermatitis on
Subject Reported Evaluation of
passed were invited to 10% or less of
Treatment at 12-weeks showed
participate in the study. their body and
93% of patients rated the
in good overall
effectiveness of treatment as
Participation began with an health
better or much better, 83.4%
initial visit (day 0), which
rated itching as better or much
included completion of Exclusion
better and 93.3% rated the
consent forms, a screening criteria:
appearance of rash as better or
health questionnaire, and a - Patients using
much better. No patient indicated
physical examination. topical AD
a score of much worse and only 1
Patients were provided with medications in
person (3.3%) indicated worse for
Relieva and instructed on the past 2wks;
5 out of the 7 questions.
the application of a thin systemic (oral,
layer of it 3x per day to intravenous,
infected areas on the skin. intramuscular,
intradermal)
Patients selected to medications
participate in the study for AD in the
were provided with past 28 days;

19
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics
instructions to complete
required forms. At 4, 8 and past 28 days;
12 weeks after initiation of or any
treatment, the physician steroids,
visited the patients, immunosuppr
evaluated the treatment area essive agents,
and completed an Eczema and COX-2
Area and Severity Index antiinflammato
(EASI) score form for each ry drugs.
patient. The EASI scores are - Pregnant,
rated as follows: lactating
3 severe, 2 moderate, 1- women,
mild, 0- none. At 12 weeks, women not
all patients completed a taking
Subject Reported Evaluation medically
of Treatment form and a approved birth
side effect form. The control, or
Subject Reported Evaluation women
of Treatment form asked planning to
patients to rate: become
i. The effectiveness of pregnant
treatment within 30 days
ii. Itching of the start of
iii. Appearance of rash study.
iv. State of mind
v. Social activities
vi. Work activities
vii. Sleep
The ratings for each question
were:
i. Much worse
ii. Worse
iii. Same
iv. Better
v. Much better

20
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
The
4. Witt CM, Ludtke Pre and post intervention II-2 82 patients Homeopathic - 24 months Outcome measures: Severity of the
R, Willich SN. (prospective multi-centre - 42 females, 40 psoriasis diagnosis, mean severity of all
Homeopathic observational study) males baseline diagnoses (physician
treatment of assessment), mean severity of all
patients with Objective: to establish Inclusion criteria: complaints (patient assessment) and
psoriasis - a data on use and effects of - Adults 17 QoL scores.
prospective homeopathy under years old
observational conditions of usual care suffering from Other diagnoses at baseline were
study with 2 psoriasis migraine, allergic rhinitis, psoriatic
years follow-up. Patients were included - study arthropathy, hypertension, chronic
J Eur Acad consecutively upon their physicians were sinusitis, allergy and dermatitis.
Dermatol first consultation with a required to have
Venereol. participating physician and passed certified The strongest improvement of all
2009;23:538- followed up for 24 months training in diagnoses and medical complaints was
543 using standardised classical seen in the first 3 months; it continued
questionnaires. homeopathy and during the full observation period.
3 years of
At baseline (before experience in its All changes since baseline, in severity of
treatment), patients practice diagnoses and complaints were of large
independently from their effect size (Cohens d 1.02-2.09). The
physicians recorded the health-related QoL improved similarly but
complaints that instigated with smaller effect size; physical
homeopathic treatment, component score 0.26, mental
and rated their severity on component score 0.49).
a numeric rating scale
(NRS; 0 =no complaints, Reductions in use of conventional
10 =maximum severity). medicines and health care services were
Health related quality of observed.
life (QoL) was recorded
with the MOS SF-36.

The first questionnaires

were handed out by study
physicians and completed
before treatment. Patients

21
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
The
sent them in sealed
envelopes directly to the
study office, from where
they received follow-up
questionnaires at 3, 12
and 24 months, with every
complaint being
transferred to the follow-
up questionnaires to
ensure continuous
assessment. At the same
times (0, 3, 12 and 24
months), the participating
physicians recorded up to
four diagnoses per patient
and assessed their
severity on identical
NRSs. On a continuous
basis, they recorded the
homeopathic treatment
and use of any
conventional therapy.

* Effect sizes were

presented by Cohens d:
>0.8 large, >0.5 medium,
>0.2 small.

22
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
The
5. Bernstein S, Randomised controlled- II-1 200 patients (100 Reliva cream Placebo 12 weeks Primary outcome: Psoriasis Area
Donsky H, trial, double blinded active, 100 (homeopathic (Same Severity Index (PASI). A higher score
Gulliver W et al. placebo) product formulation indicates more active disease.
Treatment of mild Objective: to assess the containing without
to moderate efficacy and safety of the 171 patients Psorberine, a active Secondary outcomes: patients quality of
psoriasis with topical cream, Reliva, in completed the proprietary ingredient) life and adverse events as assessed
Reliva, a patients with mild to study (97 active, extract from using the Quality of Life Index (QLI)
Mahonia moderate plaque 74 control) Mahonia questionnaire. Maximum score is
aquifolium psoriasis aquifolium correlated with very active disease, and
extract a Inclusion criteria: 10% cream the minimum score of zero indicated no
double-blind, The clinical trial was - 18 to 80 years formulated in quality of life impact.
placebo- conducted at 6 sites in - in good overall an emulsion
controlled study. the United States and health cream base) Mean PASI scores intent-to-treat
Am J Ther. Canada between August - with current for topical population:
2006;13:121-126 2004 and February mild to moderate administration Week Active Placebo
2005. Subjects were psoriasis
recruited from the clinical covering less 0 6.93 (2.6) 6.85 (2.9)
private practice setting, than 10-15% of 12 -3.39 (3.59) -0.09 (4.85)
local college student the body P= 0.0095
population, local
newspaper ads, and Exclusion Mean QLI intent-to-treat population:
word of mouth. Patient criteria: Week Active Placebo
eligibility was assessed - painful or
through a telephone pre- inflamed lesions
0 60.2 54.7
screening visit before - intertriginous
entry into the study. psoriasis 12 23.6 (31.3) -3.88 (41.71)
- extremely P= 0.0001
During the initial visit hypertrophic
(week 0), subjects were lesions and
evaluated for eligibility severe psoriasis
and completed a - patients using
screening health topical psoriasis
questionnaire and a brief medications
physical exam. Qualified within the past 2
participants were weeks, and

23
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
randomised into either The
the active or placebo those taking
treatment group. The systemic
active group received medications for
active ingredients (M. psoriasis in the
aquifolium 10%), and the past 28 days,
placebo group received those using
the same formulation steroids,
without active ingredient. immunosuppress
Subjects in both groups ive medications,
applied the product twice and COX-2 anti-
a day to the selected inflammatory
area- a 4.0cm x4.0cm drugs, and those
area of skin that typified using any
the patients psoriasis. medication
This area was selected conflicting with
by the investigator, using the product
a precut template. ingredients
- women
At the initial visit (week planning to
0), a PASI evaluation become
was performed by the pregnant within
physician and each 90 days of the
patient completed the start of study and
QLI questionnaire. pregnant or
Participants then lactating women
returned at 4,8 and 12 not taking
weeks. At each visit, medically
patients completed the approved birth
QLI. The physician control
conducted a second
PASI evaluation at week
12. Study medications
were provided at the
time of visits.

24
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for seborrheic dermatitis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics

6. Smith SA, Randomised controlled-trial II-1 41 patients A liquid Placebo 10 +10 weeks Primary outcome: the percent
Baker AE, - 21 males, 20 homeopathic consisting of improvement in Seborrhea Area and
Williams JH. Objective: to evaluate the females medication vehicle only Severity Index (SASI); the SASI rates
Effective therapeutic potential of a - 20 randomised consisting of both the degree of involvement and
treatment of low-dose oral administration into placebo potassium severity for seborrheic dermatitis and
seborrheic of potassium bromide, group, 21 into bromide, dandruff on the head as a single number
dermatitis sodium bromide, nickel active group sodium on a scale of 1 to 48.
using a low sulphate, and sodium bromide, nickel
dose, oral chloride in a homeopathic Inclusion criteria: sulphate and Other outcomes: safety- which included
homeopathic formulation. Patients with sodium a satisfactory exam at each 5-week visit
medication typical chloride in a and satisfactory laboratory results as
consisting of Patients were recruited from seborrheic vehicle of compared to baseline at weeks 10 and
potassium the dermatology practice of dermatitis or purified water 20, and adverse events.
bromide, Steven A. Smith and by dandruff with a and 20% ethyl
sodium local advertisement in minimum of 20% alcohol. Percentage change in SASI between
bromide, Tulsa, Oklahama. The affected scalp placebo and active treatment:
nickel active and placebo groups surface area, a wk placebo active
sulphate, and were assigned coded minimum of 20% Mean SD Mean SD P
sodium names by the study monitor affected face value
chloride in a and randomised in blocks of surface area, or 5 8.43 68.99 35.18 35.48 0.191
5
double-blind, four. The study investigator a minimum of 10 - 66.16 38.54 42.13 0.030
placebo was given a list of the 20% combined 10.82 2
controlled randomised, coded dose affected scalp
study. Altern groups. and surface Percentage change in SASI in placebo
Med Rev. area. Once group before and after crossover:
2002;7(1):59- For the first 10 weeks the admitted to the wk placebo active
67 blinded patients took the study, patients Mean SD Mean SD P
assigned study medication were required to value
and were evaluated at 0, 5 discontinue all 5 11.20 60.84 21.21 79.70 0.660
and 10 weeks. At the end of concomitant vs 6
15
10 weeks all patients, seborrhea 10 - 50.12 41.64 39.45 0.003
crossed over to the active medications for 2 vs 16.40 5
medication for an additional weeks before 20
10-week open study. beginning and
The patients self- throughout the

25
 Evidence Table: Effectiveness
Question: How effective is homeopathic treatment compared with conventional treatment for seborrheic dermatitis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics
administered the study drug study.
on an 8-hour fasted
stomach at the beginning of Exclusion
the day, before consuming criteria:
anything other than water. Children under
Only water was consumed 12 years,
at least 30 minutes after patients with
taking the medication. The inadequate renal
recommended dosing function, women
schedule depended on the who were
patients weight. pregnant or
Compliance was measured breastfeeding,
by comparing volume of other
solution returned at next papulosquamous
visit to the number of doses diseases.
theoretically taken based on
the daily dosage.

26
Evidence Table: Safety
Question: How safe is homeopathic treatment compared with conventional treatment?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up Effect size comments
patient (if
characteristics applicable)
The
1. Kuenzli S, Case report III A 9-month old girl developed bullous
Grimatre M, pemphigoid with a life-threatening
Krischer J et al. course while she was receiving
Childhood homeopathic drugs for atopic
bullous dermatitis.
pemphigoid:
report of a case Since the age of 2-months, she had
with life- an eczematous nummular eruption
threatening which was treated with topical and oral
course during homeopathic remedies. At 7-months
homeopathy old, she developed intense itching
treatment. followed by the appearance of bullous
Pediatric lesions on the palms and soles. The
Dermatology. child was admitted to a specialised
2004;21(2):160- homeopathic hospital where she was
163 treated with calcium, sulphur,
lycopodium, mercurius, cantharis, rhus
toxicodendron, calcium carbonicum,
sepia and tuberculinum for her skin
condition. With this treatment, the skin
lesion worsened, spreading to the
entire body and the childs general
condition became poor; she had
asthenia, dehydration and malnutrition.

Skin biopsy of a bulla showed

features characteristic of bullous
pemphigoid. Institution of oral
prednisolone and sulfapyridine
resulted in rapid improvement of her
general condition and skin disease.

27
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics

2. Roll S, Non-randomised II-2 135 children Homeopathic Conventional 36 months 2 patients in the homeopathy group
Reinhold T, interventional study - - 48 therapy therapy (5.3%) and 5 patients in the
Pach D et al. homeopathy, 87 conventional group (8.2%) reported
Comparative Objective: to describe conventional adverse events (p=0.704). Adverse
effectiveness of the effectiveness and events that occurred included
homeopathic the costs involved in the Inclusion pruritus, burning sensation,
vs. long-term follow-up after criteria: reddening, dry/ flaky skin, burns,
conventional 36 months. - children 1- herpes zoster and allergic reaction,
therapy in 14yrs with with 1 child in the conventional group
usual care of Children were recruited atopic eczema needing hospitalisation due to
atopic eczema from January 2005 to - disease worsening of the atopic eczema with
in children: June 2006. Data was duration of at additional streptococcal infection.
long-term collected until October least 6months
medical and 2009, allowing a total - fulfilled 3 of 4
economic observation period of Williams
outcomes. 36months per patient. criteria,
PLoS One. Study was multi-centre - Three-Item-
2013;8(1):e549 in Berlin, Germany. The Score (TIS)
73 children and their between 2 to 7.
parents were recruited
at either homeopathic or Exclusion
conventional doctors criteria:
practices and had - other dermal
already made their own disease, severe
choice of therapy. Thus, medical or
the parents preference psychological
towards treatment disease
generated the groups to - oral or iv
be compared. corticosteroids
Homeopathic doctors during last
were recruited by the 3months before
organisation of study entry
homeopathic doctors in -psychotherapy,
Berlin. Doctors for allergy
conventional treatment desensitisation

28
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics

(paediatricians or or additional
dermatologists) were complementary
chosen from address therapy during
lists or via last 3 months
recommendation. before study
entry 135
After conventional case children
taking, screening and - - 48
recruitment, patients homeopathy, 87
were enrolled into the conventional
study. The baseline
data for the main
outcome measure,
SCORAD were
assessed by 2
specifically trained staff
members who were
blinded to treatment
assignment. Other
baseline data were
obtained with
questionnaires. Each
patient was assigned to
only one rater for the
whole study period.
After the rating, the
homeopathic case,
taking and the following
treatment or the
conventional treatment
began. Follow-up data
were obtained also by
ratings and
questionnaires.

29
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics

3. Donsky H, Pre and post intervention II-2 - 42 patients Reliva cream Patients were 3 patients reported itching and/ or
Clarke D. enrolled, from (homeopathic assessed at burning when using the cream and
Reliva, a Objective: to assess the which 12 product baseline (day dropped out of the study at weeks
Mahonia efficacy and safety of patients containing 0) and at 4, 8 1.5, 2, and 5.
Aquifolium Relieva, a topical cream, in dropped out. Psorberine, a and 12 weeks
extract for adult patients with atopic Thus, 30 proprietary after initiation
the treatment dermatitis (AD). patients extract from of treatment.
of adult completed the Mahonia
patients with Patients were recruited study (n=30). aquifolium
atopic from clinical private 10% cream
dermatitis. practices, the local college formulated in
Am J Ther. student population, local Inclusion an emulsion
2007;14:442- newspaper advertisements criteria: cream base)
446 and by word of mouth. - Patients 18 - for topical
Eligibility was assessed 80 years old administration
through telephone pre- with atopic
screening. Patients who dermatitis on
passed were invited to 10% or less of
participate in the study. their body and
in good overall
Participation began with an health
initial visit (day 0), which
included completion of Exclusion
consent forms, a screening criteria:
health questionnaire, and a - Patients using
physical examination. topical AD
Patients were provided with medications in
Relieva and instructed on the past 2wks;
the application of a thin systemic (oral,
layer of it 3x per day to intravenous,
infected areas on the skin. intramuscular,
intradermal)
Patients selected to medications
participate in the study for AD in the
were provided with past 28 days;

30
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for eczema?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics
instructions to complete
required forms. At 4, 8 and past 28 days;
12 weeks after initiation of or any
treatment, the physician steroids,
visited the patients, immunosuppr
evaluated the treatment area essive agents,
and completed an Eczema and COX-2
Area and Severity Index antiinflammato
(EASI) score form for each ry drugs.
patient. The EASI scores are - Pregnant,
rated as follows: lactating
3 severe, 2 moderate, 1- women,
mild, 0- none. At 12 weeks, women not
all patients completed a taking
Subject Reported Evaluation medically
of Treatment form and a approved birth
side effect form. The control, or
Subject Reported Evaluation women
of Treatment form asked planning to
patients to rate: become
viii. The effectiveness of pregnant
treatment within 30 days
ix. Itching of the start of
x. Appearance of rash study.
xi. State of mind
xii. Social activities
xiii. Work activities
xiv. Sleep
The ratings for each question
were:
vi. Much worse
vii. Worse
viii. Same
ix. Better
x. Much better

31
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
The
4. Bernstein S, Randomised controlled- II-1 200 patients (100 Reliva cream Placebo 12 weeks No significant side effects were reported
Donsky H, trial, double blinded active, 100 (homeopathic (Same by either group. One patient in the active
Gulliver W et al. placebo) product formulation group complained of staining from the
Treatment of mild Objective: to assess the containing without cream. In the control group, 1 patient
to moderate efficacy and safety of the 171 patients Psorberine, a active reported a rash and 2 others reported a
psoriasis with topical cream, Reliva, in completed the proprietary ingredient) burning sensation when applying the
Reliva, a patients with mild to study (97 active, extract from cream.
Mahonia moderate plaque 74 control) Mahonia
aquifolium psoriasis aquifolium
extract a Inclusion criteria: 10% cream
double-blind, The clinical trial was - 18 to 80 years formulated in
placebo- conducted at 6 sites in - in good overall an emulsion
controlled study. the United States and health cream base)
Am J Ther. Canada between August - with current for topical
2006;13:121-126 2004 and February mild to moderate administration
2005. Subjects were psoriasis
recruited from the clinical covering less
private practice setting, than 10-15% of
local college student the body
population, local
newspaper ads, and Exclusion
word of mouth. Patient criteria:
eligibility was assessed - painful or
through a telephone pre- inflamed lesions
screening visit before - intertriginous
entry into the study. psoriasis
- extremely
During the initial visit hypertrophic
(week 0), subjects were lesions and
evaluated for eligibility severe psoriasis
and completed a - patients using
screening health topical psoriasis
questionnaire and a brief medications
physical exam. Qualified within the past 2
participants were weeks, and

32
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for psoriasis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comments
patient applicable)
characteristics
randomised into either The
the active or placebo those taking
treatment group. The systemic
active group received medications for
active ingredients (M. psoriasis in the
aquifolium 10%), and the past 28 days,
placebo group received those using
the same formulation steroids,
without active ingredient. immunosuppress
Subjects in both groups ive medications,
applied the product twice and COX-2 anti-
a day to the selected inflammatory
area- a 4.0cm x4.0cm drugs, and those
area of skin that typified using any
the patients psoriasis. medication
This area was selected conflicting with
by the investigator, using the product
a precut template. ingredients
- women
At the initial visit (week planning to
0), a PASI evaluation become
was performed by the pregnant within
physician and each 90 days of the
patient completed the start of study and
QLI questionnaire. pregnant or
Participants then lactating women
returned at 4,8 and 12 not taking
weeks. At each visit, medically
patients completed the approved birth
QLI. The physician control
conducted a second
PASI evaluation at week
12. Study medications
were provided at the
time of visits.

33
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for seborrheic dermatitis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics

5. Smith SA, Randomised controlled-trial II-1 41 patients A liquid Placebo 10 +10 weeks There was no significant difference
Baker AE, - 21 males, 20 homeopathic consisting of (p=0.7999) between the frequency of
Williams JH. Objective: to evaluate the females medication vehicle only adverse events for the active group as
Effective therapeutic potential of a - 20 randomised consisting of compared to the placebo group. The
treatment of low-dose oral administration into placebo potassium most frequent adverse events were
seborrheic of potassium bromide, group, 21 into bromide, stomach upset, stomach pain and
dermatitis sodium bromide, nickel active group sodium nausea. These adverse events were mild
using a low sulphate, and sodium bromide, nickel and infrequent.
dose, oral chloride in a homeopathic Inclusion criteria: sulphate and
homeopathic formulation. Patients with sodium Changes in lab parameters over time
medication typical chloride in a were evaluated for the active-treatment,
consisting of Patients were recruited from seborrheic vehicle of placebo treatment before crossover and
potassium the dermatology practice of dermatitis or purified water placebo after crossover to active groups.
bromide, Steven A. Smith and by dandruff with a and 20% ethyl Small but statistically significant shifts
sodium local advertisement in minimum of 20% alcohol. from baseline occurred for some
bromide, Tulsa, Oklahama. The affected scalp parameters in the groups. However they
nickel active and placebo groups surface area, a remained well within the normal lab
sulphate, and were assigned coded minimum of 20% references and were not considered to
sodium names by the study monitor affected face be causally related to the study
chloride in a and randomised in blocks of surface area, or medication.
double-blind, four. The study investigator a minimum of
placebo was given a list of the 20% combined
controlled randomised, coded dose affected scalp
study. Altern groups. and surface
Med Rev. area. Once
2002;7(1):59- For the first 10 weeks the admitted to the
67 blinded patients took the study, patients
assigned study medication were required to
and were evaluated at 0, 5 discontinue all
and 10 weeks. At the end of concomitant
10 weeks all patients, seborrhea
crossed over to the active medications for 2
medication for an additional weeks before
10-week open study. beginning and
The patients self- throughout the

34
 Evidence Table: Safety
Question: How effective is homeopathic treatment compared with conventional treatment for seborrheic dermatitis?

Bibliographic Study LE Number of Intervention Comparison Length of Outcome measures/ General

citation Type / Methodology patients and follow up (if Effect size comment
patient applicable)
characteristics
administered the study drug study.
on an 8-hour fasted
stomach at the beginning of Exclusion
the day, before consuming criteria:
anything other than water. Children under
Only water was consumed 12 years,
at least 30 minutes after patients with
taking the medication. The inadequate renal
recommended dosing function, women
schedule depended on the who were
patients weight. pregnant or
Compliance was measured breastfeeding,
by comparing volume of other
solution returned at next papulosquamous
visit to the number of doses diseases.
theoretically taken based on
the daily dosage.

35