J Tradit Complement Med. 2016 Oct; 6(4): 395–398.
Published online 2015 Sep 19. doi: 10.1016/j.jtcme.2015.08.006
PMCID: PMC5067857
Abstract
The
objective of this study was to assess the effectiveness of a specific
composition of a traditional herbal preparation (DurrDerma) in adult
patients with moderate to severe skin psoriasis. The preparation is a
newly developed topical combination containing plant-based extracts
traditionally used in skin disease as black cumin, olive oil, tea tree
oil, cocoa butter completed by vitamin A and vitamin B12. We documented
the effectiveness of the preparation in a first case series. A total of
12 patients (8 males and 4 females, 21–86 y) with manifest and
treatment-resistant psoriasis were included and treated for 12 weeks.
All patients were assigned to twice-daily treatment with the DurrDerma
preparation. Treatment success as determined by the Psoriasis Area and
Severity Index (PASI) score, the body surface area, and the dermatology
life index was achieved (PASI reduction of >75%) in 10 of the 12
treated patients (83%). The remaining two patients showed a PASI
reduction of ≤50%. In 5 of the patients PASI reduction was achieved
<12 weeks (between week 3–11). The beneficial effect in responder
patients might be explained by a synergistic anti-oxidative and anti
inflammatory activity of all components present in DurrDerma. We
conclude that the new preparation using a traditional approach seems to
be a promising complementary treatment for psoriasis.
Keywords: psoriasis, complementary medicine, traditional, black cumin, topical treatment
1. Introduction
Psoriasis
affects 2–3% of the European populations, and less commonly other
populations of other countries, i.e. Far East and China.1, 2
To date, there is no doubt that psoriasis is an immune-mediated
disorder as reflected by T cell hyperactivity and the production of
multiple proinflammatory cytokines, such as tumour necrosis factor alpha
(TNF- α) and Interleukin (IL)-2, IL-12, IL-17, IL-22 or IL-23.3, 4, 5 Nevertheless, all available treatment options remain largely unspecific, and many patients do not achieve the desired outcome.6, 7
Topical agents including corticosteroids, vitamin D analogous,
Tazarotene, coal tar, and dithranol are predominantly used for mild
disease, and systemic agents including photochemotherapy, methotrexate,
ciclosporin, retinoids fumarates, and biological agents are used for
severe disease.8, 9 None of these treatment options has fully met the needs of affected patients.6, 7 The question whether a combination therapy of biologic and systemic agents may improve treatment outcome is yet unclear.6, 7
Thus, there is a need for alternative and well-tolerable treatment for
psoriasis. In fact, many affected patients are using or seeking new
therapeutic options, including complementary and alternative medicine.10, 11, 12
In
this observational case series study, we documented the effectiveness
and tolerability of DurrDerma in adult patients with active moderate to
severe psoriasis vulgaris. The active ingredients of DurrDerma are black
cumin as the main component, and olive oil, tea tree oil, cocoa butter,
vitamin A and vitamin B12 as further components.
2. Patients and methods
A
total of 12 unselected out-patients with moderate (n = 6) to severe
(n = 6) psoriasis as diagnosed by a dermatologist or experienced general
practitioner and characterized by a Psoriasis Area and Severity Index
(PASI) score of ≥10 (Table 1)
were treated with DurrDerma. Patients had to had a disease endurance of
>3 months and at least one conventional previous treatment approach.
Patients were informed about the available treatment with the Durrderma
preparation. Treatment duration was scheduled for 12 weeks and tubes of
200 g and boxes with 500 g were handed out as anticipated for proper
use during the planned 12-week treatment period. Patients were asked to
apply the cream twice daily and hereby to cover all skin lesions with a
thin layer of cream.
Demographic baseline characteristics of treated patients.
The
preparation relates to compositions comprising black cumin oil
(>10%), olive oil (>10%), tea tree oil (<0,09%), cocoa butter
(<4%), vitamin A (<0,05%) and vitamin B12 (<0,05%). The
advantage is the innovative composition itself.
The
essential oil components of black cumin oil are thymoquinones which have
been shown to have anti-oxidative, anti-inflammatory, anti
proliferative, anti-allergic and anti-bacterial activities, as well as
immunomodulatory and immunotherapeutic characteristics. Olive oil
contains a high concentration of polyphenols, in particular
hydroxytyrosol. It has been shown to have anti-oxidative,
anti-inflammatory and anti-microbial activities. Tea tree oil is mainly
composed of various terpinens. It has anti-oxidative and
anti-inflammatory activities.
Cocoa butter is extracted
from cocoa beans and contains various anti-oxidants that are related to
catechines and epicatechines, as well as others that are related to
procyanidines and polyphenols.
Vitamin A has anti-oxidative activity and is one of the cells physiological anti-oxidants.
Vitamin
B12 is a water-soluble vitamin with a key role in the normal
functioning of the brain and nervous system, as well as for the
formation of blood. It affects inter alia DNA synthesis and regulation,
fatty acid synthesis and energy production.
All
patients were evaluated for 12 weeks and assessments of disease activity
with calculation of PASI took place at baseline and at the time points
of 2,4, 8 and 12 weeks after initialization of treatment by the treating
physician.
In addition, all patients
completed a patient's questionnaire assessing satisfaction with
treatment and side effects. Furthermore compliance with the recommended
application was asked by interview. Written informed consent was
obtained from all patients prior to treatment with DurrDerma. There was
no selection of patients by age, gender, localization and severity of
disease, or previous treatments.
3. Results
Patients
were aged from 18 to 86 years and had a confirmed diagnosis of
psoriasis for longer than 3 months. The majority of patients had
received previous standard topical and/or a systemic therapy but were
treatment-resistant. Only two patients had no previous standard
treatment (Table 1, nos. 6 and 8).
Initially,
the vast majority of patients (n = 10) showed a mild to moderate
increase of local inflammation with increased reddening of the affected
skin area (Table 2)
for a short period of time. However, during continuous observation and
under sustained treatment a gradual and pronounced clinical improvement
became obvious in almost all cases within a few weeks. A PASI reduction
of >75% was observed in 10 of the 12 treated patients, in 3 patients
already before the 12-week assessment, in the other 7 patients after 12
weeks of treatment (Table 2).
The remaining two patients showed a PASI reduction of ≤50%, at week 4
and 8. The treatment effects in the early responders was maintained
until the 12-week assessment.
Outcome of treated patients (Assessment at week 12).
One
of the non-responder patients (no.12) had autoimmune thrombocytopenia
which required continuous treatment with Nplate (thrombopoietin receptor
agonist). Whether Nplate would have an impact on psoriasis treatment
remains obscure.
Of note, one of the well
responding patients had a treatment course of topical tea tree oil (also
an ingredient of DurrDerma) before starting the DurrDerma application.
This patient reported that the previous use of tea tree oil alone was
ineffective but resulted in an exacerbation of the disease and
discontinuation of this treatment after two weeks.
3.1. Safety
The
preparation was well tolerated. There were no relevant adverse events. A
mild exacerbation of the skin inflammation was a common initial
response (2–4 days after treatment initialization) with a subsequent
consistent improvement of the disease state thereafter. Some of the
patients complained about the fatty characteristic of the preparation
and the related pollution of clothes.
4. Discussion
This
case series study was initiated to determine by a first documentation
the effectiveness and tolerability of DurrDerma, a traditional herbal
preparation in a new specific combination formula, in patients with
manifest and treatment-resistant psoriasis. Independent of previous
treatment and severity of disease, 10 of the 12 treated patients with
the new herbal preparation were well responding and 2 patients
moderately responding. Most intringuingly, psoriasis signs not only
improved but completely disappeared following treatment in 4 patients
and nearly disappeared in further 6 of the patients (Fig. 1).
Thus, a clinical meaningful effect of the preparation might be possible
and should be tested and evaluated by means of a randomized controlled
clinical trial. As treatment options in severe psoriasis are limited and
the safety profile, so far, seems good, further research is warranted.
Skin status of the back of one patient before and after 12 week treatment with the preparation.
The
question by which mechanisms DurrDerma works remains speculative.
However, based on the fact that psoriasis is an immune-mediated disease,3, 4, 5 and that oxidative stress is playing a key role in this process,13, 14, 15, 16, 17, 18, 19, 20 it seems likely that anti-oxidative products, such several food constituents,21, 22
may have a positive effect on psoriasis. The DurrDerma composition
contains different natural and herbal products which have potential
anti-oxidative and/or anti-inflammatory effects. Black cumin oil is
obtained from the seeds of Nigella Sativa and contains thymoquinones,
which have been shown to have anti-oxidative, anti-inflammatory, anti
proliferative, anti-allergic and anti-bacterial activities, as well as
immunomodulatory and immunotherapeutic characteristics.23, 24, 25, 26, 27
Similarly, olive oil contains a high concentration of polyphenols which
have by large similar effects as thymoquinones from Nigella Sativa.28, 29, 30
Tea
tree oil is obtained from leaves of Melalenca alternifolia which has
anit-oxidative, anti-inflammatory, anti-bacterial, anti-viral, and
anti-fungal acivities.31, 32, 33
Cocoa
butter is extracted from cocoa beans which also contain various
antioxidants, i.e. catechines, epicatechines, procyanidines, and
polyphenols.34 Vitamin B12 is involved in blood production, DIVA synthesis and regulation.35
Thus,
DurrDerma may provide a therapeutic effect that is not based on an
isolated substance, but rather on a synergistic combination of various
prophylactic, therapeutic, anti-inflammatory, immunological and
anti-microbial activities. The synergistic effect is supported by the
observation that one patient (no. 4), previous to the application of the
preparation in this case observation, used tea tree oil which, however,
led to continous worsening of his psoriasis. In addition, there is
empirical observation that many such affected patients appear to have
used olive oil without effect.
The
question why DurrDerma initially induces a transitory negative effect on
psoriasis remains obscure. However, some topical drugs, such as coal
tar and anthralin have been described also to cause a flare-up (Koebner
phenomenon) in patients with active psoriasis.36, 37
We do not know if the initial (mild) aggravation is a precondition for
the retarded and lasting treatment effect. Of note, patients need to be
informed about this treatment kinetic to ensure compliance. Clearly, the
safety of the preparation needs to be assessed in larger studies.
However, on the background of current existing preclinical and botanical
research data of the components of the preparation, no specific safety
concerns are expected.
5. Conclusion
In
conclusion, the observations in this case series study point to a
promising and clinically relevant beneficial effect of the DurrDerma
preparation in patients with skin psoriasis. Further clinical trials are
warranted.
Footnotes
Peer review under responsibility of The Center for Food and Biomolecules, National Taiwan University.
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