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Alternative treatments for atopic dermatitis: a selected review

Authors:

Abstract

Atopic dermatitis (AD) is a chronic itchy, inflammatory skin disease that is extremely difficult to treat. Effective therapeutic agents are limited in number, and may have long-term toxic side-effects. Frustrated by these realities, many patients stop seeking help from conventional physicians and turn to alternative medical approaches. These can include so-called natural products, herbal products and over-the-counter (OTC) treatments. Herbs and medications share a common history, as most of our well-known medications were derived from plants. However, herbal remedies are largely unregulated. Many may have scientific merit and clinical benefit, but they are still scientifically invalid and inadequately monitored. Dermatologists need information about the effects of herbal remedies in order to better serve their patients.
Volume 7 • Number 2 • February 2002
Atopic dermatitis (AD) is a chronic itchy, inflammatory skin
disease that usually develops in early childhood and is commonly
seen in individuals with a personal or family history of similar
skin disease or asthma. Persistence of AD has been reported in
60% of adults who had the disease as children.
1
It is notorious for
its recalcitrant and chronically recurrent nature.
1
Along with the
usual therapy of topical steroids, general skin care, and topical
antibiotics there are also systemic methods of treating this
disorder, which have already been well described.
2,3
Because effective medical treatments for this condition are
limited in number, many patients have turned to alternative
therapies
1,4
, including so-called natural products, herbal products
and OTC treatments, many of which remain unproven.
In a questionnaire study of 227 patients with AD, who had used
alternative medicine, the majority stated that their main reason
for trying such treatments was the lack of a satisfactory effect
from the physician provided therapy. They also reported that the
main sources of information about alternative therapies were
people without skin disease, and the media. After using
alternative treatments, the majority of patients reported no
improvement or even aggravation of their skin disorder.
5
Most patients have heard about at least one friend who improved
after receiving a natural treatment. While it may have been the
treatment itself that helped, there may have been other factors as
well, e.g., such treatment providers seem to offer a comfortable
atmosphere for their clients and often allow them to express their
own views of their problems.
3
They may also spend more time
with them than physicians are willing or able to do.
A system of medical practice making use of all measures that
have proven to be of value in the treatment of disease is referred
to as allopathic medicine. Occasionally, some of the
recommended modalities are intended not to replace
conventional medicine, but to complement it. Complementary or
alternative medicine can be classified into herbal therapy
(treatments using plant species), and non-herbal therapies, such
as homeopathy, acupuncture, aromatherapy and more than 10
other modalities.
6
Herbs
Herbs and medications share a common history, as most of our
well-known medications were derived from plants. Herbal
remedies are marketed commonly as pills, capsules, tinctures or
dietary supplements and are largely unregulated. According to
US federal legislation that was enacted in 1994, herbs and other
dietary supplements can be marketed without testing for safety or
effectiveness. Broad and vague claims are allowed, and the US
FDA does not have to approve packaging or sales information
EDITOR-IN-CHIEF: Stuart Maddin ASSOCIATE EDITOR (International): Hugo Degreef, Catholic University, Leuven: ASSOCIATE EDITOR (Canada): Jason Rivers
INTERNET EDITOR: Harvey Lui PUBLICATIONS EDITOR: Penelope Gray-Allan EDITORIAL ADVISORY BOARD: Kenneth A. Arndt, Beth Israel Hospital & Harvard Medical School, Boston;
Wilma Fowler Bergfeld, Cleveland Clinic, Cleveland; Jan D. Bos, University of Amsterdam, Amsterdam; Enno Christophers, Universitäts-Hautklinik, Kiel; Richard L. Dobson, Medical University
of South Carolina, Charleston; Jeffrey S. Dover, Harvard Medical School, Boston; Boni E. Elewski, University of Alabama, Birmingham; Barbara A. Gilchrest, Boston University School of
Medicine, Boston; W. Andrew D. Griffiths, St. Johns Institute of Dermatology, London; Aditya K. Gupta, University of Toronto, Toronto;Vincent C.Y. Ho, University of British Columbia, Vancouver;
Mark Lebwohl, Mount Sinai Medical Center, New York; James J. Leyden, University of Pennsylvania, Philadelphia; Howard I. Maibach, University of California Hospital, San Francisco;
Larry E. Millikan, Tulane University Medical Center, New Orleans; Takeji Nishikawa, Keio University School of Medicine, Tokyo; Constantin E. Orfanos, Freie Universitäts Berlin,
Universitätsklinikum Benjamin Franklin, Berlin; Stephen L. Sacks, Viridae Clinic Sciences, Vancouver; Alan R. Shalita, SUNY Health Sciences Center, Brooklyn; Richard Thomas, Vancouver
General Hospital, Vancouver; Stephen K. Tyring, University of Texas Medical Branch, Galveston; John Voorhees, University of Michigan, Ann Arbor; Klaus Wolff, University of Vienna, Vienna
Alternative Treatments For Atopic Dermatitis:
A Selected Review
R.B. Vender, MD, FRCPC
DermaTrials Research and Department of Medicine, McMaster University, Hamilton, Ontario, Canada
ABSTRACT
Atopic dermatitis (AD) is a chronic itchy, inflammatory skin disease that is extremely difficult to treat. Effective therapeutic agents
are limited in number, and may have long-term toxic side effects. Frustrated by these realities, many patients stop seeking help from
conventional physicians and turn to alternative medical approaches. These can include so-called natural products, herbal products
and over-the-counter (OTC) treatments. Herbs and medications share a common history, as most of our well-known medications
were derived from plants. However, herbal remedies are largely unregulated. Many may have scientific merit and clinical benefit,
but they are still scientifically invalid and inadequately monitored. Dermatologists need information about the effects of herbal
remedies in order to better serve their patients.
Key Words: herbal remedies, dietary supplements, atopic dermatitis
Indexed by the US National Library of Medicine and MEDLINE
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
2
before a product reaches the market. Consumers essentially have
no protection against misleading or fraudulent claims made by
herbal manufacturers. Most are not subjected to the strict
rigorous approval processes that traditional drugs are. Most have
not been tested against the gold standard controlled clinical trial,
and thus have no verifiable claim with respect to their safety and
efficacy. Products may be contaminated or may contain varying
amounts of active ingredients. Some have no active ingredients.
7
Up to 30% of herbal patent remedies imported from China have
been laced with potent pharmaceuticals such as steroids and
phenacetin, that should only be available by prescription.
4
Despite the lack of monitoring and quality control, the public tends
to perceive herbal remedies as "natural" and therefore harmless.
This misconception can be dangerous not only because of potential
risks inherent in the therapies, but also because patients may fail to
inform their physician that they are using alternative medicines.
Many herbal remedies may have scientific merit and clinical
benefit. Most may be safe, effective and reliable. However,
adequate testing of herbal remedies and randomized controlled
trials are necessary. The reclassification of herbal medicines as
substances to be regulated by governmental agency is also
essential. Herbal therapy is still scientifically invalid and
inadequately monitored.
4,7
This unconventional practice may be
misleading to patients with chronic skin diseases.
8
General population surveys in the US report that only about 40%
of patients discuss the complimentary medicines they take with
their physicians. There are at least 25 different forms of
complimentary or alternative treatment modality groups.
9
Dermatologists should consider discussing these treatments with
patients, and must be aware of the recent literature available with
respect to alternative therapies.
10-12
Chinese Herbal Treatments
The most commonly used herbal formulations are based on
Chinese medicines, and have been reviewed in the literature.
13,14
Chinese herbs are traditionally used in very complex mixtures
where an unknown number of compounds may be acting
synergistically.
14,15
Although the pursuit of the active component
may be of paramount importance for research and therapeutic
application, the mixture of the herbs work well because of an
interaction of different compounds within the mixture. Whether
or not Chinese herbal therapy (CHT) contains one or more active
compounds, it does represent a potential source of novel
therapeutic compounds.
16
Rustin and Poulter
17
describe the principles of CHT along with
its history using the yin and yang theory, i.e., traditional Chinese
physicians perceive skin disease as a breakdown in the essential
relationship between the yin nourishment and yang activity. Such
a crisis allows the subsequent invasion of the body by pathogenic
factors such as wind, heat and dampness, which further
exacerbate the skin. In these circumstances, CHT seeks to rid the
hostile pathogens and to realign the fundamental yin and yang
balance. Sheehan, et al, published a summary of double blind
clinical trials confirming the efficacy of CHT along with
pharmacological actions of individual herbal components listed
in detail (see Table 1).
18-21
Zemaphyte%
Very few studies are available regarding the use of traditional
CHT products. Sheehan, et al, carried out an 8-week study of 40
adults with long-standing difficult-to-treat AD. This was a
double-blind crossover study with patients randomized to receive
an oral Chinese herbal mixture known as Zemaphyte
®
(Phytopharm PLC) or an inactivated herb placebo. There were
significant improvements noted in itching, erythema, the ability
to sleep, and surface damage in the treatment group. In terms of
potency and quantity required, topical corticosteroid use was
reduced while on active treatment, when compared to those
taking placebo.
18
A similar trial with 47 children showed the
same results over 8 weeks of active treatment. The pharmacology
and mechanisms of action were unknown. There was no evidence
of hematological, renal or hepatic toxicity.
19
A one-year open follow-up study using Zemaphyte
®
with 37
children from the previous study had 10 (27%) patients withdraw
because of inadequate response. Four of the responding patients
withdrew early because the treatment was unpalatable. Also,
preparation required boiling some of the herbal constituents in
600ml water for 90 minutes, which was considered too long by
some patients. Of the remaining 23 patients, seven experienced a
90% reduction in severity and were able to stop the treatment
within 6 months to 1 year. Sixteen patients required continuous
treatment, though their treatments were reduced from one each
day to one every 5 days. In total, 18 out of 23 patients (78%)
demonstrated a 90% reduction in severity at the end of the study.
A reversible asymptomatic elevation of the transaminase level
was seen at 7-14 times normal in two patients. Approximately
33% of the patients had a mild diarrhea in the first few weeks of
treatment.
20
A further long term open trial, included 17 adult patients
21
who
were volunteers from the original trial.
18
At the end of one year,
12 of the 17 adults, or 71% had a greater than 90% reduction in
severity and the other five patients had a 60% reduction in
severity. No patients withdrew. There were no laboratory
abnormalities seen in these adults, and mild diarrhea was the only
major complaint.
21
An open trial comparing the original decoction used by Sheehan,
et al
18
to a new granular preparation showed no difference in
efficacy. However, patients receiving the granular preparation did
comment on the increased palatability and ease of
administration.
22
Commonly, Zemaphyte
®
(Phytopharm PLC) contains a mixture
of 10 herbs with some known pharmacological agents and action.
Analysis of these herbs revealed that none of them had
nonsteroidal anti-inflammatory activities, but some displayed
steroid like or antihistaminic like activities. One ingredient
displayed immunosuppressive activity.
23
Latchman, et al,
discovered that Zemaphyte
®
is associated with a reduction of
serum IgE complexes and that it targets the immunologic features
that seem to be involved in the pathogenesis of AD.
24
A more detailed study of the immune mechanisms in the skin of
patients with AD using Zemaphyte
®
and other non-defined
3
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
Chinese herbal therapies revealed that there were no significant
changes in cell numbers (T-Cell subsets, macrophages, or
dendritic cells) in normal skin, but a reduction of CD23 (a low-
affinity IgE receptor) - bearing antigen presenting cells was
reported.
25,26
Down regulation of the low-affinity receptors for
IgE on antigen-presenting cells in patients with AD may
contribute to the benefit observed following treatment with
Zemaphyte
®
.
27
Decreases are also seen in levels of soluble IL-2
receptors and soluble vascular adhesion molecules.
16
mixture of Chinese herbs that she had ingested for about three
years.
33
Soderberg
34
used an open study design with 9 AD patients
taking "herbal medicine" for a 3 week period and found that 5
patients’ condition had worsened. Similar drop-outs were reported
in an open trial where six of eight patients withdrew because of
exacerbation of their disease.
35
Other side-effects have been
reported with the use of CHT, but not specifically in AD patients.
17
Keane et al.
36
studied 11 Chinese herbal creams obtained from
patients attending general and pediatric dermatology outpatient
Alternative Rx - Herb Double- Outcome Side-effects
Investigators blinded
Chinese Herbal Therapy - Zemaphyte
®
yes Mixed Diarrhea, increase in transaminases,
Sheehan et al
18
, Fung
28
and generic Reversible dilated cardiomyopathy, reversible
mixtures acute hepatic illness related, fatal hepatic necrosis,
nephropathy, exacerbation of disease
Chamomile mild extract – Kamillosan
®
yes Mild superiority vs. Possible allergic contact dermatitis from
Patzelt-Wenczler
39
0.5% hydrocortisone; non-trade brand
marginal difference
vs. placebo
Evening primrose oil – Efamol
®
or yes Mixed Rare
Lovell,
43
Schalin-Karila,
44
Epogam
®
Wright,
45
Gehring,
46
Bamford,
50
Hederos
51
Shiunko – Higaki
52
? yes Mixed ?
Witch Hazel – Norman
38
N/A no Anecdotal ?
Burdock - Norman
38
N/A no Anecdotal ??
Aloe vera - Norman
38
N/A no Anecdotal Allergic contact dermatitis
Oolong Tea – Uehara
55
N/A no Anecdotal ?
There have also been negative effects reported for this remedy. In
a study using Zemaphyte
®
with 40 patients, 37 completed the
trial. There seemed to be a general trend of clinical improvement,
however there was no statistically significant treatment effect of
the herbal therapy or placebo in the four clinical parameters
studied (erythema, surface damage, lichenification, and scaling).
Hematological, renal and liver function tests were all normal
throughout the trial. The investigators concluded that further
research was required to evaluate the efficacy of this herbal
medication.
28
Other Chinese Herbal Therapies
Reversible dilated cardiomyopathy was reported in one patient who
received 2 weeks of therapy from a Chinese herbalist in Soho,
London. The CHT mixture contained more than 30 herbal
components.
29
Two patients suffered a reversible acute hepatic
illness after taking traditional Chinese herbs,
30
and another patient
was reported to have suffered fatal hepatic necrosis.
31
Another case
of hepatoxicity was reported, though the exact herbs were not
stated.
32
A19-year-old female with AD presented with symptomatic
nephropathy from aristolochic acid that contained an undefined
clinics. High-resolution gas chromatography and mass
spectrometry were used to determine their content. Eight of the
11 creams contained dexamethasone. All of these creams had
been used in sensitive skin areas including facies and folds.
They concluded that greater regulations need to be imposed on
Chinese herbalists to prevent the illegal and inappropriate
prescribing of potent steroids.
Herbs
Dried and fresh flowers of the chamomile plant have been used
medicinally around the world for many years. In vitro chamomile
extracts inhibit both lipoxygenase and cyclooxygenase, and can
also inhibit histamine release.
38
Kamillosan
®
cream contains a
mild chamomile extract as the active ingredient, which
demonstrated no chamomile related allergen potential, and has
been used for local therapy of AD. In a partially double blind and
randomized study carried out as a half side comparison, the
cream was compared with hydrocortisone 0.5% cream, and with
the vehicle cream as the placebo in patients suffering from
medium degree AD. After a 2-week treatment, a mild superiority
was demonstrated when compared to hydrocortisone 0.5% and a
Table 1:
Alternative Treatments for Atopic Dermatitis
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
4
marginal difference was found when compared to the placebo.
39
However, allergic contact dermatitis from chamomile used in
phytotherapy (i.e., the use of vegetable drugs in medicine) has
been reported.
40
Evening primrose oil (Efamol
®
, NUMICO) has been reported to
benefit children with AD.
41,42
This medication is usually taken
orally. Several randomized, double-blind studies found evening
primrose oil to be more effective in treating the signs and
symptoms of AD.
43-45
In a vehicle-controlled study of its effect
on barrier function in AD, topical evening primrose oil in an
amphiphilic and in a stable water-in-oil emulsion was compared
in 20 AD patients. Evening primrose oil proved to have a
stabilizing effect on the stratum corneum barrier, but this was
apparent only in the water-in-oil emulsion and not in the
amphiphilic emulsion. Therefore, the vehicle is extremely
important.
46
A defect in the function of the enzyme delta-6-desaturase has
been postulated as a factor in the development of AD. The
rationale for using evening primrose oil rests in this functional
defect. Delta-6-desaturase converts linoleic acid to gamma
linoleic acid, and evening primrose oil is rich in gamma linoleic
acid.
47
Supplementation with oral evening primrose oil for AD
patients has demonstrated moderate and favorable fatty acid
changes in their epidermis.
48
Topically applied gamma-linoleic
acid has also been shown to be effective for treating AD because
of its anti-pruritic and anti-inflammatory effects.
49
However,
gamma-linoleic acid (GLA) contains pyrolizidine alkaloids,
which can cause hepatotoxicity with chronic consumption.
4
No
toxicity data for topical preparations of evening primrose oil is
available. Data on its effectiveness in treating AD is mixed,
however. In a double blind, blocked crossover design with
random assignment of 123 patients
50
and another double blind,
placebo-controlled study of 60 AD children in Sweden using
Epogam
®
(Scotia) produced similar negative results.
51
AD was
unresponsive to evening primrose oil. Treatment of AD with
GLA remains controversial.
11
Shiunko
Shiunko is a topical medication made from herbal extracts and is
used to treat a range of conditions including AD. In a vehicle-
controlled study of nine patients, Shiunko was effective in four
patients when compared to petrolatum, but in only one patient when
compared with 3.5% saltwater. This herb has antibacterial effects on
Staphylococci and this is the proposed mechanism of action.
52
This may be similar to the beneficial effects seen with topical
fusidic acid (Fucidin Intertulle
®
, Leo Pharma), which is not an
herbal preparation, but a topical antibacterial agent.
53,54
Other
alternative remedies listed to help eczema, but not necessarily
AD include Witch Hazel, burdock and aloe vera
38
and Oolong
tea.
55
Proper studies are very scant.
Herbal Allergens
Cosmetics, shampoos, herbal creams, and ingested herbal
remedies and tonics may also contain Compositae plant
extractions. The Compositae family includes plants such as the
artichoke, burdock, chamomile, chrysanthemum, marigold,
ragweed, and sunflower. The most common allergen in this
family is the sesquiterpene lactones, present in the oleoresin
fraction of the leaf, stem, flower and possibly pollen. Compositae
dermatitis is most frequently seen in middle-aged and elderly
people presenting with an air-borne or direct contact dermatitis.
37
Conclusion
Plant substances have been used as medicines for thousands of
years. Recent research indicates that some herbs offer
considerable medicinal benefits. Currently, the level of interest in
alternative treatments by the general public continues to increase.
Some patients who obtain care from dermatologists use OTC
herbal remedies.
38
Dermatologists need information about the effects of herbal
remedies in order to better serve their patients.
38
It is also
important for dermatologists to give their patients the opportunity
to be heard and understood. The greatest resource is time, and it
should be offered and used effectively.
2
Acknowledgments
Thanks to R. Gottshalk, S. Maddin, F. Murphy, G.E. Piérard, P.
Roth, K. Scully, F. Tabassum, and J. Wismer for their suggestions
in preparing his manuscript.
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atopic dermatitis: effect on fatty acids in neutrophils and epidermis. Lipids
26(7):557-60 (1991 Jul).
49. Lotti TM, Menchini G, Comacchi C, Ghersetich I. Treatment Pearls from
Europe. Derm Clinics 16(3):631-41 (1998 Jul).
50. Bamford JT, Gibson RW, Renier CM. Atopic eczema unresponsive to
evening primrose oil (linoleic and gamma-linolenic acids). J Am Acad
Dermatol 13(6):959-65 (1985 Dec).
51. Hederos CA, Berg A. Epogam evening primrose oil treatment in atopic
dermatitis and asthma. Arch Dis Child 75(6):494-7 (1996 Dec).
52. Higaki S, Morimatsu S, Morohashi M, Yamagishi T, Hasegawa Y.
Susceptibility of Propionibacterium acnes, Staphylococcus aureus and
Staphylococcus epidermidis to 10 Kampo formulations. J Int Med Res
25(6):318-24 (1997 Nov-Dec).
53. Symposium Report: Eighth congress of the European Academy of
Dermatology and Venereology. Amsterdam Sept 1999; Leo Pharmaceutical
Products.
54. Ramsay CA, Savoie JM, Gilbert M, et al: The treatment of atopic dermatitis
with topical fucidic acid and hydrocortisone acetate. J Eur Acad Dermatol
Venerol 7(suppl 1):S15-22 (1997).
55. Uehara M, Sugiura H, Sakurai K. A trial of oolong tea in the management of
recalcitrant atopic dermatitis. Arch Dermol 137(1):42-3 (2001 Jan).
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Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
6
Drug Class Generic/Trade/ Indiction Approving
Company Names Regulatory Agency
Anti-acne Azelaic Acid For the topical treatment of mild-to-moderate US FDA
Agents Finevin
®
Cream 20% inflammatory acne.
Berlex Laboratories
Clindamycin 1%, Benzoyl Peroxide 5% Labeling change: the product can now be stored US FDA
BenzaClin™ at room temperature for up to 2 months after
Dermik Laboratories being dispensed by a pharmacy.
Ethinylestradiol, Norethindrone Acetate Additional indication: for the treatment of US FDA
Estrostep
®
moderate acne in women over 15 years of age.
Pfizer
Tazarotene For the treatment of acne vulgaris. US FDA
Tazorac
®
0.1%
Allergan
Tretinoin Gel For the treatment of acne vulgaris. TPP – Canada
Retin-A Micro Microsphere
®
AP Pharma/Johnson & Johnson Canada
Antibacterial Cefuroxime, Dextrose for Injection For the treatment of skin and skin structure infections, US FDA
Agents Zinacef
®
lower respiratory tract infections,urinary tract infections,
GlaxoSmithKline septicemia, meningitis, gonorrhea, bone and joint infections.
Ciprofloxacin ANDA tentatively approved for this generic form of US FDA
Geneva Pharmaceuticals Bayers Cipro
®
for the treatment of urinary tract, skin
and other infections.
Moxifloxacin HCl Additional indication: as a once daily treatment for US FDA
Avelox
®
uncomplicated skin and skin structure infections due to
Bayer Staphylococcus aureus and Streptococcus pyogenes.
Antifungal Caspofungin Acetate For the treatment of invasive aspergillosis in US FDA
Agents Cancidas
®
patients who do not respond to, or cannot
Merck tolerate other antifungal therapies.
Butenafine HCl Switched to OTC for the topical treatment of US FDA
Lotrimin Ultra
®
1% Cream symptomatic inflammatorytinea pedis, tinea cruris and
Schering-Plough tinea corporis due to Epidermophyton rubrum.
Butenafine HCl Additional indication: for the treatment of tinea US FDA
Mentax
®
1% Cream (pityriasis) versicolor caused by Malassezia furfur,
Bertex Pharmaceuticals previously known as Pityrosporum orbiculare.
Clotrimazole, Betamethasone For the treatment of a variety of fungal conditions. It is US FDA
Dipropionate Cream bioequivalent to Schering-Plough’s Lotrisone
®
cream.
Taro Pharmaceuticals
Antihistamine Desloratidine To be given once daily for the symptoms of European Commission
Aerius™ & Neoclarityn™ 5mg. tablets chronic idiopathic urticaria in adults and of the European Union
Schering-Plough children >12 years of age.
Levocetirizine For the treatment of seasonal allergic rhinitis, German
Xyzal
®
/Xusal
®
perennial allergic rhinitis, and chronic Regulatory
Sepracor idiopathic urticaria Authorities
Antimetabolite Methotrexate For the treatment of neoplastic disease, psoriasis and US FDA
Agents Trexall
®
rheumatoid arthritis. Trexall
®
represents new dosage
Barr Laboratories/DuPont Pharmaceuticals strengths in 5, 7.5, 10, and 15mg tablets.
Antipsoriatic Calcipotriol, Betamethasone Dipropionate For the treatment of psoriasis TPP – Canada
Agents Dovobet
®
Ointment
Leo Pharma
Antiviral Varicella Zoster Immune Globulin This product is a highly purified and specialized antibody TPP – Canada
Agents VariZIG
®
against the varicella zoster virus that causes chicken pox.
Cangene
Valacyclovir HCl A shorter course of therapy: the new 500mg. caplets can US FDA
Valtrex
®
500mg. caplets be prescribed as a 3-day course administered twice daily.
GlaxoSmithKline
Atopic Pimecrolimus For the treatment of mild-to-moderate atopic dermatitis US FDA
Dermatitis Elidel
®
Cream 1% in patients >2 years of age.
Novartis Pharmaceuticals
Drug Treatments for Skin Disease Introduced in 2001
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
7
Drug Class Generic/Trade/ Indiction Approving
Company Names Regulatory Agency
Depigmenting Xtrac™ Excimer Laser System For the treatment of psoriasis and vitiligo. US FDA
Agents PhotoMedex
Enzyme Recombinant Human Iduronidase Granted Orphan Drug Status for the proprietary treatment US FDA
Replacement (IDUA) of mucopolysaccharidosis I.
Therapy Novazyme Pharmaceuticals
Agalsidase Alfa For long-term treatment in patients with Norwegian Medicines
Replagal™ Fabry’s disease. Agency
Transkaryotic Therapies (TKT) NZs Reg. Authority
Iceland’s Regulatory
Authority
Agalsidase Beta For the long-term enzyme replacement therapy in European
Fabrazyme™ patients with a confirmed diagnosis of Fabry’s disease. Commission of the
Genzyme European Union
Hair Growth Eflornithine HCl For the reduction of unwanted facial hair in women. US FDA
Vaniqa
®
Cream 13.9% TPP - Canada
Westwood-Squibb
HIV/AIDS Amprenavir Conditional Notice of Compliance: to be used with TPP – Canada
Agenerase
®
other antiretroviral agents for the treatment of HIV-1
Glaxo Wellcome infection.
HIV Drug Resistance Test This test can identify which HIV medications have US FDA
Trugene® HIV-1 Genotyping Test become ineffective because of the virus’ mutation in
Visible Genetics individual patients.
Tenofovir Disoproxil Fumerate For the treatment of HIV infection when taken in US FDA
Viread
®
combination with other antiretroviral agents
Gilead Sciences
Valganciclovir For the treatment of cytomegalovirus (CMV) retinitis US FDA
Valcyte
®
in AIDS patients
Hoffmann-LaRoche
Hormonal Transdermal 17-Beta Estradiol For the treatment of menopausal symptoms and for the Netherlands’
Preparation Estradot
®
prevention of postmenopausal osteoporosis. Regulatory
Novartis Pharmaceuticals Canada Authority
Human Skin Biologically Active Dressing For patients undergoing hand reconstruction to treat US FDA
Construct Composite Cultured Skin (CCS)
®
recessive dystrophic epidermolysis bullosa, a rare
Ortec International genetic disorder.
Monoclonal Infliximab For the treatment of severe, active and fistulizing TPP – Canada
Antibody Remicade
®
Crohn’s Disease in adult patients who have not
Centocor responded to conventional treatment
Mouth and Amlexanox For the treatment of aphthous ulcers. UK MCA
Throat Aptheal
®
5% Paste
Product Strakan Ltd.
Neurotoxins Botulinum Toxin Type A Additional indication: for the treatment of glabellar TPP – Canada
BOTOX
®
lines associated with corrugator and/or procerus
Allergan muscle activity.
Oncologic Arsenic Trioxide Orphan drug designation given for the treatment of European Commission
Agents Trisenox
®
multiple myeloma and myelodysplastic syndromes. of the European Union
Cell Therapeutics
Oral Drospirenone/Ethinyl Estradiol Contains the progestin drospirenone, which exhibits US FDA
Contraceptive Yasmin
®
antimineralocorticoid activity and influences water and
Berlex Laboratories electrolyte balance. Reduces sebum output.
Photodynamic Aminolevulinic Acid HCl For the treatment of Actinic Keratosis of the face TPP – Canada
Therapy Levulan® Kerastick™ Photodynamic and scalp.
Therapy
Draxis Health/DUSA Pharmaceuticals
Sunscreens Mequinol 2%, Tretinoin 0.01% For the treatment of solar lentigines and related TPP – Canada
Solagé® Topical Solution hyperpigmented lesions.
Westwood Squibb
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 7 No. 2 February 2002
8
Skin Therapy Letter:(ISSN 1201–5989) Copyright 2002 by SkinCareGuide.com. The Skin Therapy Letter
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Update on Drugs
Class Name/Company Approval Dates and Comments
Drug News
Photodynamic
Therapy
Photodynamic Therapy
Metvix
®
PDT
Photocure ASA
New Zealand’s regulatory authority gave marketing authorization in
February 2002, for the treatment of actinic keratosis and basal-call
carcinoma in patients for whom traditional therapies are unsuitable.
This treatment is already approved in 14 European countries and
applications are pending in Australia, the US and Switzerland.
Etanercept
Enbrel
®
Immunex
The US FDA approved this product in January 2002, for the
treatment of psoriatic arthritis.
Drug
Interactions
According to an article published in the British Journal of Clinical Pharmacology* St. John’s Wort, which is a
popular herbal treatment for depression, increases P-glycoprotein expression. As a result, patients taking drugs
that act as P-glycoprotein substrates, such as indinavir and cyclosporin, should not take this herbal remedy.
*British Journal of Clinical Pharmacology 53:75-82 (2002)
New Topical
Delivery System
CollaGenex Pharmaceuticals has licensed a novel dermal and transdermal drug delivery system named
Restoraderm
®
. This technology is designed to enhance the dermal delivery of a variety of active
ingredients, and is based on the ability of certain lipid compositions to enhance the natural skin barrier to
facilitate dermal and transdermal delivery. This technology is currently still under development.
HIV/AIDS
Antibacterial
Agent
Moxifloxacin HCl IV
Avelox
®
Bayer
The US FDA approved an IV formulation of this antibacterial agent in
December 2001, for the treatment of community-acquired pneumonia,
uncomplicated skin and skin structure infections, acute bacterial
sinusitis, and acute bacterial exacerbations of chronic bronchitis in
adults. Avelox is also available in tablet form. The IV and tablet forms
are bioequivalent, so no dosing adjustment is required.
Antihistamine
Desloratidine Syrup &
Disintegrating Tablets
Schering-Plough
Antipsoriatic
Agent
The Committee for Proprietary Medicinal Products of the European
Agency for the Evaluation of Medicinal Products (EMEA) issued a
positive opinion recommending approval of these formulations in
January 2002 for the treatment of seasonal allergic rhinitis and
chronic idiopathic urticaria. The syrup is recommended for patients
>2 years of age, and the disintegrating tablets are labeled for
patients >12 years of age.
Depigmenting
Agent
Hydroquinone, Tretinoin &
Flucinolone Cream
Tri-Luma
®
Hill Dermaceuticals
The US FDA approved this cream in January 2002, for the short-
term treatment of moderate to severe melasma of the face in the
presence of sun-avoidance measures, including sunscreen use.
Bristol-Myers Squibb Canada announced that Videx ED
®
(didanosine) is now available for sale in Canada
as of January 2, 2002. This nucleoside analogue is used to treat adults who are infected with HIV, with a
dosage of 1 capsule daily.
... Recently, new topical calcineurin inhibitors, including tacrolimus ointment and pimecrolimus cream, have been used for monotherapy treatment of AD to replace conventional treatments (such as corticosteroids); however, their efficacy was not sufficient to successfully treat AD. Therefore, a large number of patients have turned to alternative medicinal approaches (38), which include natural products and herbal medicines. The application of herbal medicines has a long history due to their use in folk medicine, and most well-known medications are derived from plants (22,23,29). ...
... The application of herbal medicines has a long history due to their use in folk medicine, and most well-known medications are derived from plants (22,23,29). Although the mechanisms of action of numerous herbal remedies have not yet been fully elucidated, their clinical benefit has been proven by a large number of scientific studies (32,38,39). ...
Article
Full-text available
Chamaecyparis obtusa has been traditionally used as an antibiotic agent and in cosmetics for the prevention of microorganism infection and skin troubles. Atopic dermatitis (AD) is a chronic inflammatory skin disease that encompasses immunologic responses, susceptibility factors and compromised skin-barrier function. Use of plant medicines in therapeutic treatment of AD has recently been suggested as an alternative therapeutic option. The present study examined the effect of elemol, an active component of Chamaecyparis obtusa, on AD using in vivo and in vitro models. RBL-2H3 cells were stimulated with concanavalin A and dinitrophenyl human serum albumin, and atopic dermatitis was induced in BALB/c mice by topical application of 2,4-dinitrochlorobenzene (DNCB) prior to elemol treatment. The mRNA expression was evaluated by reverse transcription quantitative polymerase chain reaction, and the levels of β-hexosaminidase and serum immunoglobulin E (IgE) were examined by ELISA. Histological changes were also performed by microscopy. Elemol attenuated the onset of AD-like skin lesions, reduced serum IgE levels and decreased mast cell infiltration into the dermis and hypodermis. In addition, elemol downregulated the transcriptional expression of several pro-inflammatory cytokines, including TNF-α, IL-1β, IL-6 and IκBα, in the skin of the DNCB‑induced animal models of AD. In the RBL-2H3 mast cell line, elemol significantly inhibited the mRNA expression of IL-4 and IL-13, and further attenuated the release of β-hexosaminidase from mast cells. Histological examination revealed that elemol significantly ameliorated the DNCB-induced dermal destruction in mice. The results of the present study suggested that elemol may have therapeutic potential in the treatment of AD due to its immunosuppressive effects.
... Clinically, consequent symptoms such as pruritus, facial or extensor eruptions, relapsing dermatitis and lichenification were described as a diagnostic standard of AD by Hanifin and Rajika [31]. Alternative treatments from natural herbs have been suggested to prevent and improve AD in recent studies [32]. In our previous study, Derma-H as an effective topical ointment reduced pruritus and inflammation by inhibiting NGF-TrKA signal pathway in DNCB-induced AD skin lesions [23]. ...
Article
Full-text available
Atopic dermatitis (AD) is a chronic cutaneous disorder that is characterized by severe eczematous inflammation, swelling, and lichenification. Activation of T helper (Th)-22 cells by allergens leads to epidermal hyperplasia with hyperkeratosis at the chronic phase of AD. Derma-Hc is composed of five natural herbs with anti-AD effects, such as Astragalus membranaceus BUNGE, Schizonepeta tenuifolia Briq., Cryptotympana pustulata Fabr., Angelica sinensis Diels, Arctium lappa L. In this study, the ameliorative effect of Derma-Hc on cutaneous lichenification in 2,4-dinitrochlorobenzne (DNCB)-induced AD was investigated. The dorsal skin of mice was sensitized with DNCB to induce AD-like skin lesions. The dermatitis score and frequency of scratching were evaluated. Thickness of epidermis and dermis was measured by staining with H&E. In addition, infiltration of the mast cell was observed by staining with toluidine blue. Then, desmosomal cadherin, DSC1 was examined by immunofluorescence. Pathological mechanisms involved in lichenification were analyzed in AD-like skin lesions and TNF-α + IFN-γ-treated with human keratinocytes including keratinocyte differentiation genes and JAK1-STAT3 signaling pathway with IL-22 by RT-PCR and western blotting. Topical treatment of Derma-Hc improved AD-like symptoms such as dryness, edema and lichenefication and decreased the number of scratches. Histopathological analysis demonstrated that Derma-Hc significantly inhibited epidermal hyperplasia, hyperkeratosis, and mast cells infiltration. In addition, the level of DSC1 was highly expressed in the epidermis by Derma-Hc. Moreover, mRNA expression level of FLG, an epidermal differentiation complex gene, was recovered by Derma-Hc treatment. KLK5 and KLK7 were markedly reduced to normalize keratinocyte differentiation in dorsal skin tissues and human keratinocytes. On the other hand, Derma-Hc restored expression level of SPINK5. In addition, Derma-Hc inhibited IL-22 via the blockade of JAK1-STAT3 signal pathway. Taken together, Derma-Hc, a natural herbal formula, regulated keratinocyte differentiation and inhibited epidermal hyperplasia with hyperkeratosis. Therefore, Derma-Hc could be a promising candidate for treating chronic AD through modulating signaling of IL-22-associated skin lichenification.
... Depending on severity, antihistamines, systemic corticosteroid, immunosuppressant, antibiotics, allergen-specific immunotherapy, or phototherapy may be used [6][7][8]. Complementary and alternative medicine treatments are used in patients with AD, especially when there is no response to conventional therapies or side effects occurring [9][10][11]. ...
Article
Full-text available
Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796 ; date of registration: April 13, 2018).
... In addition, certain VOCs from plants have been reported to have antioxidant and anti-inflammatory activities, and some can directly act as anti-inflammatory reagents (7,27). Although the mechanisms behind certain herbal remedy effects have not been fully elucidated, many such remedies have been reported to have scientific merit and clinical benefit in treating patients (7,8,25,(28)(29)(30). ...
Article
Full-text available
Chamaecyparis obtusa (C. obtusa) and Pinus densiflora (P. densiflora) have been traditionally used as antibiotic, antinociceptive and anti-inflammatory agents in Asian folk medicine. Recent studies have demonstrated antioxidant, antiproliferative and anti-inflammatory effects of C. obtusa and P. densiflora extracts. In the present study, volatile organic compounds (VOCs) of C. obtusa and P. densiflora were examined to determine whether they have anti-inflammatory capabilities. To evaluate the anti-inflammatory effects of VOCs of C. obtusa and P. densiflora, lipopolysaccharide (LPS) was administered to the lung by nasal injection and to the whole body by intraperitoneal injection. Alterations in serum immunoglobulin E (IgE) levels and prostaglandin E2 (PgE2) were examined using ELISA. LPS-increased serum IgE and PgE2 levels were recovered by administration of dexamethasone and VOCs of C. obtusa and P. densiflora. Levels of mRNA expression of inflammatory cytokines were determined in an LPS-induced inflammation mouse model. Reverse transcription-quantitative polymerase chain reaction was used to determine the mRNA expression levels of cyclooxygenase 2, interleukin (IL)-1β, tumor necrosis factor (TNF)-α and IL-13 in peripheral blood mononuclear cells. The expression of all examined cytokine mRNAs increased by LPS was suppressed by dexamethasone and VOCs of C. obtusa and P. densiflora. Similar tendencies were observed in lung tissues and cells obtained via bronchoalveolar lavage. The results of the present study suggested that VOCs of C. obtusa and P. densiflora, through their immunosuppressive activities, may have therapeutic potential in the treatment or prevention of inflammation.
... Chinese herbs are part of the traditional Chinese medicine which consists of Chinese herbs administered orally or topically, acupuncture, diet and exercise. 171,172 CHM is promoted as treatment for AE, taken orally as decoction, usually consisting of about 10 different herbs. The first positive RCTs of CHM in the treatment of AE outside China were published by Sheehan in 1992. ...
Article
Full-text available
This guideline was developed as a joint interdisciplinary European project, including physicians from all relevant disciplines as well as patients. It is a consensus‐based guideline, taking available evidence from other guidelines, systematic reviews and published studies into account. This second part of the guideline covers antimicrobial therapy, systemic treatment, allergen‐specific immunotherapy, complementary medicine, psychosomatic counselling and educational interventions, whereas the first part covers methods, patient perspective, general measures and avoidance strategies, basic emollient treatment and bathing, dietary intervention, topical anti‐inflammatory therapy, phototherapy and antipruritic therapy. Management of AE must consider the individual clinical variability of the disease. Systemic immunosuppressive treatment with cyclosporine, methotrexate, azathioprine and mycophenolic acid is established option for severe refractory cases, and widely available. Biologicals targeting the T helper 2 pathway such as dupilumab may be a safe and effective, disease‐modifying alternative when available. Oral drugs such as JAK inhibitors and histamine 4 receptor antagonists are in development. Microbial colonization and superinfection may cause disease exacerbation and can require additional antimicrobial treatment. Allergen‐specific immunotherapy with aeroallergens may be considered in selected cases. Psychosomatic counselling is recommended especially in stress‐induced exacerbations. Therapeutic patient education (‘Eczema school’) is recommended for children and adult patients. General measures, basic emollient treatment, bathing, dietary intervention, topical anti‐inflammatory therapy, phototherapy and antipruritic therapy have been addressed in the first part of the guideline.
... [2] Because effective medical treatments for this condition are limited in number, due to few side effects like skin thinning, skin aging, skin cancer etc. [8] Many patients have turned to therapies which include natural and herbal products. [9] ...
Article
Full-text available
Objective: To evaluate the safety and efficacy of a formulation, Dewderm AD cream, in patients with mild-tomoderate atopic dermatitis (AD). Methods: Thirty six subjects with mild-to-moderate AD aged between 5–55 years were enrolled in the study. All 36 patients were instructed to apply Dewderm AD cream twice daily on the affected area for 60 days irrespective of their visits to the clinic. Subjects underwent evaluation of efficacy parameters, such as effect of skin surface hydration and assessment of disease severity, quality of life at the end of the treatment, and photographs were taken before and after the treatment (i.e. on day 60) to assess clinical improvement of the severity of AD. Results: Treatment with Dewderm AD cream showed statistically significant improvement in all the efficacy parameters at different time points from baseline to end of the study. A statistically significant (p < 0.05) increase in mean skin surface hydration with 54.86% improvement at visit 5 was observed when compared to baseline. SCORAD score showed 80.22% reduction in the severity of skin lesions by the end of the treatment period suggesting progressive improvement in the disease severity. Similarly, the investigator‟s global assessment (IGA) scale also showed a statistically significant reduction of 67.01% from baseline 2.69 ± 0.47 to 0.88 ± 0.40 at the end of the study (p < 0.05). The DLQI score also demonstrated a statistically significant decrease (p < 0.05) from baseline to end of the study. Additionally, photograph comparing before and after treatment showed gradual clinical improvement in severity of AD of the affected area at the end of the study in subjects who had skin lesions at baseline. No adverse events were reported during the study. Conclusion: Dewderm AD cream was very effective in treating mild-to-moderate AD by significantly reducing the disease severity without any side effects. Hence, the formulation is an effective and safe treatment option in patients with mild-to-moderate AD.
... Methods of treating this disorder generally include the application of topical steroids or antibiotics and general skin care. As the number of available treatments is limited and several side effects are reported, certain patients opt for alternative treatments such as natural products (4,5). Various pharmacological compounds from natural products have been developed that ...
Article
Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder. The present study investigated the effects of Amomum xanthioides extract (AXE) on AD‑like skin inflammation using a Dermatophagoides farinae extract (DFE) and 2,4‑dinitrochlorobenzene (DNCB)‑induced mouse AD model. Hematoxylin and eosin staining results demonstrated that repeated DFE/DNCB exposure markedly increased the thickening of the dermis and epidermis, in addition to the infiltration of eosinophils and mast cells. However, oral administration of AXE reduced these histopathological alterations in a dose‑dependent manner. Elevated serum histamine, total and DFE‑specific immunoglobulin E (IgE), and IgG2a were also decreased by treatment with AXE. In addition, reverse transcription‑quantitative polymerase chain reaction (RT‑qPCR) results demonstrated that the mRNA expression of tumor necrosis factor (TNF)‑α, interferon (IFN)‑γ, interleukin (IL)‑4, IL‑13, IL‑31 and IL‑17A was reduced in ear skin following AXE administration in AD mice. Fluorescence‑activated cell sorting demonstrated that the population of CD4+/IL‑4+, CD4+/IFN‑γ+ and CD4+/IL‑17A+ cells in draining lymph nodes was also significantly decreased in AXE‑treated mice compared with AD mice without AXE treatment. Furthermore, keratinocytes that were stimulated with TNF‑α and IFN‑γ exhibited increased gene expression of pro‑inflammatory cytokines and chemokines, including TNF‑α, IL‑1β, IL‑6, IL‑8, C‑C motif chemokine ligand (CCL)17 and CCL22, as determined by RT‑qPCR. However, upregulation of these genes was reduced by AXE pretreatment. Based on these results, we hypothesize that AXE may be useful in the treatment of allergic skin inflammation, particularly AD.
Article
Full-text available
This guideline was developed as a joint interdisciplinary European project, including physicians from all relevant disciplines as well as patients. It is a consensus‐based guideline, taking available evidence from other guidelines, systematic reviews and published studies into account. This first part of the guideline covers methods, patient perspective, general measures and avoidance strategies, basic emollient treatment and bathing, dietary intervention, topical anti‐inflammatory therapy, phototherapy and antipruritic therapy, whereas the second part covers antimicrobial therapy, systemic treatment, allergen‐specific immunotherapy, complementary medicine, psychosomatic counselling and educational interventions. Management of AE must consider the individual clinical variability of the disease; highly standardized treatment rules are not recommended. Basic therapy is focused on treatment of disturbed barrier function by hydrating and lubricating topical treatment, besides further avoidance of specific and unspecific provocation factors. Topical anti‐inflammatory treatment based on glucocorticosteroids and calcineurin inhibitors is used for flare management and for proactive therapy for long‐term control. Topical corticosteroids remain the mainstay of therapy, whereas tacrolimus and pimecrolimus are preferred in sensitive skin areas and for long‐term use. Topical phosphodiesterase inhibitors may be a treatment alternative when available. Adjuvant therapy includes UV irradiation, preferably with UVB 311 nm or UVA1. Pruritus is targeted with the majority of the recommended therapies, but some patients may need additional antipruritic therapy. Antimicrobial therapy, systemic anti‐inflammatory treatment, immunotherapy, complementary medicine and educational intervention will be addressed in part II of the guideline.
Article
There is a substantial and growing interest in complementary alternative medicine (CAM) in the general population. This paper aims to answer in how far patients with atopic eczema use CAM and, if they do, which techniques. Furthermore, the evidence basis of the efficacy of CAM in the use for atopic eczema should be reviewed. For that purpose randomized controlled trials were searched systematically. In Germany, about 46% of the general population and up to 51% of inpatients with eczema use CAM. Acupuncture, homeopathy, diets and supplements comprise the most popular techniques. Better educated, middle-aged women use CAM more frequently. In general, the evidence basis concerning studies on the efficacy and safety of CAM for atopic eczema with appropriate size and quality is limited. Most studies were found on essential fatty acids and Chinese herbs, whereby the results remain conflicting. There was not enough evidence to assess the efficacy of acupuncture, homeopathy, and salt baths. A single study on bioresonance showed no superiority compared to a sham procedure. Single studies indicated beneficial effects for topical hypericum, autologous blood injection, massage therapy, and vitamin E. These results must be confirmed by future studies. CAM are frequently used in atopic eczema, the evidence basis for that, however, is limited.
Article
For effective management of atopic dermatitis, it is important to introduce a therapeutic agent which although having the fewest side effects, has the greatest anti-inflammatory effect. In the course of screening anti-inflammatory agents, we obtained BSASM composed of several plant extracts. This study was designed to investigate anti-inflammatory and immunomodulatory effects of BSASM. As a first step, NF-κB luciferase reporter assay was performed to know the involvement of BSASM in the production of proinflammatory cytokines because NF-κB element has been known to play a major role in expression of cytokine genes such as interleukin-8 (IL-8) or tumor necrosis factor-α (TNF-β). LPS (lipopolysaccharide)-induced NF-κB activation was inhibited by BSASM. In addition, we found the fact that BSASM inhibits LPS-induced production of IL-8 and TNF-α proinflammatory cytokines, indicating BSASM has and-inflammatory effect. In interleukin-2 (IL-2) luciferase reporter assay in Jurkat T cells, BSASM reduced PHA (Phytohemagglutinin)-induced IL-2 luciferase activity, suggesting the possibility that BSASM might also have an immunomodulatory function in T cell-mediated immune response. Based on these results, we suggest the possibility that BSASM can be introduced to improve symptom of immune-related skin diseases, namely, atopic dermatitis.
Article
Background: Zemaphyte™ is a mixture of plant extracts based on a traditional Chinese herbal therapy (CHT) that is used in the treatment of atopic dermatitis (AD). It has proven to be effective in double-blind placebo-controlled clinical trials and long-term studies for the treatment of both adult and pediatric atopic dermatitis. The aim of this review is to update the reader on the clinical and research aspects of this therapy. Methods/data base: The in vitro and in vivo data suggest that this herbal mixture is able to modulate a number of immunological pathways involving different mediators and these findings may explain the therapeutic benefits in AD. These include direct effects on specific antigen-presenting cell populations, lymphocytes, and mast cells as measured in vitro. Clinical data have focused on the measurement of specific serum markers of disease activity following treatment. Results: Using in vitro systems it has been shown that Zemaphyte™ causes the downregulation of the low-affinity immunoglobulin E (IgE) receptor (CD23) on monocytes and Langerhans cells, enhancement of interleukin 10 (IL-10), tumor necrosis factor α (TNF-α), and prostaglandin E2 (PGE2) production by monocytes and dendritic cells, inhibition of lymphocyte IL-4 production, and blocking histamine release from mast cells. Treating patients with Zemaphyte™ was shown to reduce the levels of soluble vascular cellular adhesion molecule (VCAM) in the serum of patients. Conclusion: Understanding the mode of action of CHT and other therapies will lead to a better understanding of the complex immunological processes which are involved in AD and hopefully lead to better treatment.
Article
Aim To compare the clinical efficacy of a cream combination containing 2% fusidic acid and 1% hydrocortisone acetate in the treatment of patients with mild to moderate atopic dermatitis.Subject Atopic dermatitis and efficacy of antibacterial and antiinflammatory topical therapy.Methods Randomized, double blind, prospective, parallel group trials.Results Study I, involving 186 patients, compared the combination 2% fusidic acid and 1% hydrocortisone acetate with 1% hydrocortisone cream. Analysis was performed on patients who had pathogens at entry and on the total patient population. Study II, involving 68 patients, compared the combination 2% fusidic acid and 1% hydrocortisone acetate with 2% fusidic acid cream. Analysis was the same as in study I.Results of study I in patients with pathogens at baseline showed a significant difference in favour of the combination (P = 0.04) in terms of the primary efficacy criterion which was a combination of clinical and bacteriological efficacy measures. When all patients in the study were analyzed there was no significant difference between the two groups. The combination was significantly more effective in removing pathogens than 1% hydrocortisone cream (P < 0.0001).Results of study II in all patients showed that the combination was significantly better than 2% fusidic acid cream (P = 0.04) in terms of the primary efficacy criterion. Both preparations were highly successful in eradicating pathogens.Pooled analysis of studies I and II showed a difference with respect to the primary efficacy criterion among the 3 preparations in the order Fucidin 2% plus HC 1% cream > HC 1% cream > Fucidin 2% cream in all patients and in those with pathogens (P = 0.007 for all patients and P = 0.01 for those with pathogens). Similarly, regarding the reduction in sign/symptom score a significant difference among the 3 preparations existed (P = 0.009 for all patients and P = 0.01 for those with pathogens). Adverse events with the combination were minimal.Conclusion 2% fusidic acid and 1% hydrocortisone acetate cream is an effective therapy in patients with mild to moderate degrees of atopic dermatitis.
Article
Aberrant expression of CD23 (low affinity IgE receptor) on cells of the monocyte/macrophage series in peripheral blood and lesional skin of patients with atopic eczema has been demonstrated. It is not known whether this abnormality results from a fundamental systemic problem of the monocytes of these patients or reflects local changes to cell populations within the skin tissues. This study was designed to determine whether this aberrant expression was caused by local cutaneous influences on mature cells or fundamental changes in monocyte differentiation. The possible relationship between these aberrations and clinical severity was also investigated by repeating these immunopathological studies after a course of efficacious treatment with Chinese herbal therapy (CHT). Peripheral blood mononuclear cells were obtained from patients with atopic eczema before, and after 8 weeks of treatment. Efficacy of CHT was quantified on clinical grounds. Monocytes were isolated by adherence to plastic and cultured for up to 7 days. Samples were harvested at 2, 5 and 7 days of culture and cytospins prepared. Immunocytochemical staining to identify phenotypic subsets was performed on the monocytes at time 0 and on maturing cells from culture. This immunocytology was quantified using computerized image analysis equipment to determine the emergence of macrophage subsets and their level of CD23 expression. Biopsies were taken from lesional skin before and after treatment and immunohistology was performed on cryostat sections to determine the number of antigen presenting cells expressing CD23 as well as the level of expression of these molecules. The results showed that increased numbers of monocytes from patients with atopic eczema express CD23 at day 0 and that cultured monocytes from these patients differentiate faster during the 7 day culture period as compared to normal controls. Efficacious treatment did not affect the number of peripheral blood monocytes expressing CD23. However, treatment did lead to a significant decrease in the number of CD23+ mature macrophages in the skin as well as a reduction in the level of expression of this moiety. These results demonstrate that changes in clinical severity are more closely related to the expression of CD23 on mature antigen presenting cells in lesional skin rather than to differentiating peripheral blood monocyte CD23 expression. These results suggests that local factors within lesional skin govern the accumulation and the expression of CD23 on mature macrophages and that these factors may be more relevant to the pathogenesis of the disease than aberrations in CD23 expression that may occur systemically.
Article
#ENTITYSTARTX02022; To determine whether Chinese herbal creams used for the treatment of dermatological conditions contain steroids. #ENTITYSTARTX02022; 11 herbal creams obtained from patients attending general and pediatric dermatology outpatient clinics were analyzed with high resolution gas chromatography and mass spectrometry. #ENTITYSTARTX02022; Departments of dermatology and clinical biochemistry. #ENTITYSTARTX02022; Presence of steroid. #ENTITYSTARTX02022; Eight creams contained dexamethasone at a mean concentration of 456 mug/g (range 64 to 1500 mug/g). All were applied to areas of sensitive skin such as face and flexures. #ENTITYSTARTX02022; Greater regulation needs to be imposed on Chinese herbalists to prevent illegal and inappropriate prescribing of potent steroids.
Article
Recently a defect in the function of the enzyme delta-6-desaturase has been discussed as a major factor in the development of atopic eczema. Delta-6-desaturase is responsible for the conversion of linoleic acid to gamma linolenic acid. Several plants, including evening primrose, are known to be fairly rich in gamma linolenic acid. Hence, substitution of gamma linolenic acid in patients prone to developing atopic eczema seems like a feasible concept. During the last few years different clinical trials have been performed. Controlled trials following a parallel study design showed marked improvement in atopic eczema. Patients treated with the drug showed less inflammation, dryness, scaling and overall severity compared to controls. Although these findings have been supported by meta-analysis, there is still conflicting evidence in trials based on a crossover design alone, demonstrating a decrease in itching. At present, evening primrose oil in doses used for the treatment of atopic eczema is considered safe. However, still more trials addressing both efficacy and safety are needed to make a final decision.
Article
Severe and widespread atopic eczema often fails to respond adequately to currently available therapies. Following the observation of substantial benefit in patients receiving oral treatment with daily decoctions of traditional Chinese medicinal plants, we undertook a placebo-controlled double-blind trial of a specific prescription formulated for widespread non-exudative atopic eczema. Forty-seven children were given active treatment and placebo in random order, each for 8 weeks, with an intervening 4-week wash-out period. Thirty-seven children tolerated the treatment and completed the study. Response to active treatment was superior to response to placebo, and was clinically valuable. There was no evidence of haematological, renal or hepatic toxicity. These findings anticipate a wider therapeutic potential for traditional Chinese medicinal plants in this disease, and other skin diseases.