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A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis
Abstract
Only a few clinical trials have been published on the topical treatment of atopic dermatitis with herbal ointments. An ointment containing extracts from Mahonia aquifolium, Viola tricolor and Centella asiatica has previously been studied in open uncontrolled trials with children. However, no data exist on adult patients in a randomized controlled trial.
A total of 88 patients with mild-to-moderate atopic dermatitis were enrolled in a double-blind, vehicle-controlled, randomized, half-side comparison. Patients between 18 and 65 years of age were treated for 4 weeks with an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica. The primary endpoint was a summary score for erythema, edema/papulation, oozing/crust, excoriation and lichenification according to a 4-point scale. Secondary efficacy variables were assessment of pruritus severity (10 cm VAS) and a global assessment of effectiveness as well as tolerability.
The study ointment reduced the primary and secondary endpoints slightly more than the base cream which was used as vehicle; the differences were not statistically significant. Since the climatic conditions during the study duration varied from very mild and sunny to very cold and dry, a post-hoc subanalysis was performed with a subset of 64 patients whose treatment was at a mean outside temperature of 10 degrees C or less. Under these conditions the primary endpoint showed high statistical significance.
In this trial, an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica could not be proven to be superior to a base cream for patients with mild-to-moderate atopic dermatitis. However, a subanalysis indicated that the cream might be effective under conditions of cold and dry weather.
... To circumvent the toxicity of steroid-based drugs, several researchers have conducted clinical trials of complementary or alternative medicines. However, the efficacy and safety as well as the therapeutic mechanisms of these medicines remain unclear (16,17). ...
... Moreover, some LAB strains such as Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium lactis are effective in the treatment of AD in mice and humans (14,17). However, to date, these results have not been obtained consistently (16). It is also reported that the effectiveness of this treatment may vary with the type of LAB strain used (6). ...
Atopic dermatitis (AD) is a chronic inflammatory skin disease with a complex etiology that encompasses immunologic responses. AD is frequently associated with elevated immunoglobulin (Ig) E levels, and common environmental factors contribute to its pathogenesis. Several recent studies have documented the role of specific lactic acid bacteria in the treatment and prevention of AD in humans and mice. In this study, the efficacy of Duolac ATP, a probiotic preparation, was determined in a mouse model with AD-like skin lesions. Alterations in the cytokine levels and histological staining suggested the alleviation of AD. The in vivo test showed that T helper (Th)2 cytokines, IgE, interleukin (IL)-4, and IL-5, were significantly downregulated, whereas Th1 cytokines, IL-12p40 and interferon (IFN)-γ, were upregulated in all groups of mice treated with Duolac ATP compared to that observed in the group of mice treated with 1-chloro-2,4-dinitrobenzene (DNCB) alone. Moreover, the scratch score decreased in all mice treated with Duolac ATP. Staining of the dorsal area of the mice in each group with hematoxylin and eosin and toluidine blue further confirmed the alleviation of AD in mice orally treated with Duolac ATP. These results suggest that Duolac ATP inhibits the development of AD-like skin lesions in NC/Nga mice by suppressing the Th2 cell response and increasing the Th1 cell response. Thus, Duolac ATP is beneficial and effective for the treatment of AD-like skin lesions.
... 18 Inconsistent findings have been reported for the effectiveness of fish oil in the treatment of psoriasis. 19 Of the herbal products, topical application of mahonia aquifolium 20,21 and St. John's wort 22 were shown to be effective in atopic dermatitis. Despite the large body of literature on CAM in the management of chronic skin diseases, most studies in this area are of low quality, not controlled or repeated or with conflicting results. ...
... Several open-label or placebo-controlled clinical studies have shown beneficial effects of similar mahonia aquifolium extracts in patients with psoriasis [27][28][29] and atopic dermatitis, 20,21 possibly explained by its anti-inflammatory and antibacterial properties. 21 These studies however, all Values are expressed as percentage with 95% confidence intervals (CI) and cumulative number (n) of patients of total is depicted. All CI's are adjusted for difference in disease severity between the two groups at baseline. ...
To assess the outcome and safety of plant-based ointments versus usual care in the management of chronic skin diseases.
Prospective mono-centric comparative analysis. Patients were recruited at an outpatient dermatology clinic and treated with plant-based ointments or care as usual. Main outcome criterion was the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' at 6, 12 and 24 months. Secondary outcome criteria were quality of life (SF-12 and EQ-5D), patient satisfaction and safety of treatment.
A total of 112 patients with chronic skin diseases were evaluated of which 44 were treated with plant-based ointments (PO) and 68 received usual care (UC). The majority of patients suffered from psoriasis (PO: 50%; UC: 56%) or eczema (PO: 41%; UC: 32%) and were treated with homoeopathic topical ointments containing mahonia or cardiospermum or usual care creams containing calcipotriene and corticosteroids. The only significant difference in baseline status between the two groups was in disease severity score (PO: 1.8±0.7 versus UC: 2.4±0.8, p=0.0004). After two years, the main outcome of responders to treatment was 52.3% (95%-CI: 36.1-64.9) in the ointment and 41.2% (95%-CI: 20.4-42.2) in the UC group. Change in SF-12 (2 years compared to baseline), adjusted for baseline disease severity, was not significantly different between both groups; PO: 5.4 (95%-CI: 3.4-7.3) versus UC: 3.2 (95%-CI: 1.5-4.9). The adjusted EQ-5D was found to be significantly different between the two groups after two years, in favour of the ointment group; PO: 0.113 (95%-CI: 0.052-0.174) and UC: -0.008 (95%-CI: -0.055-0.038). Other secondary outcome parameters such as patient satisfaction and number of adverse drug reactions were comparable.
The outcome of this study suggests at least therapeutic equivalence between plant-based ointments and usual care management of chronic skin diseases. As this non-randomised study was open to selection and other bias, further rigorous studies are needed to demonstrate the effectiveness of these topical products.
... 67 A few clinical studies also had been done to evaluate the efficacy of C. asiatica in various activities proven in various experimental trials. In these studies, C. asiatica is proven to possess wound healing properties, 68 cognition & mood enhancing activity, 69 anxiolytic activities, 70 and antidepressant activity. 71 Gohil et al., in their review of C. asiatica, have concluded that a review of various studies on this plant is indicative of its multiple uses in clinical practice, mainly to stabilize or improve relative age decline of cognition functions. ...
Memory is an essential function of our cognition that helps us to remember events, learn lessons and preserve emotions; to live each day with new learning and optimum behavior. There have been talks on using safe nootropic drugs to enhance Memory in healthy patients with memory disorders. The ancient sages of Ayurveda and Vedic civilizations advocate learning and memorizing many hymns and verses by their pupils. It leads to the discovery of the cognition and memory enhancing drugs known as Medhya Rasayana. Ayurveda possesses a treasure of Medhya Rasayana, known as nootropics. This review aims to elaborate on and explain the Ayurvedic concept of memory and nootropics about the contemporary concept. Online research databases like DHARA, Ayush Research Portal, Pubmed, Google Scholar, etc., were searched for relevant research articles by applying adequate keywords. Ayurvedic concepts of Buddhi, acquisition of knowledge, Medha, and Medhya Rasayana were reviewed from Ayurvedic classics. This paper discusses the contemporary concept of memory along with its classification, mechanisms of production, and probable mode of its enhancement. The well-described Ayurvedic concept of the cognitive process and Medha and Pragya (intellect) have been analyzed, elaborated, and explained as per contemporary knowledge. A few Medhya drugs like Brahmi (Bacopa monnieri), Mandookaparni (Centella asiatica), Shankhpushpi (Convolvulus pluricaulis), and Vacha (Acorus calamus) are analyzed for their properties explained in Ayurveda and their neuropharmacological activities in the light of recent experimental and clinical studies. The probable two groups based upon the mode of action of Medhya drugs- one which promotes Dhriti and the other which promotes Medha (mainly Dhi & Smriti) are also discussed. In conclusion, memory enhancement in healthy and pathological states is requisite in today's competitive world. With its vast treasure of Medhya drugs, Ayurveda can greatly help in this field
... A further study compared a topical preparation of Mahonia aquifolium, Viola tricolor and Centella asiatica with the vehicle cream in 88 patients and could not find significant differences. 165 A subgroup analysis revealed superiority of the plant preparation under dry and cool weather conditions. ...
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.
... One trial involving a herbal treatment was reported after 2000. Klövekorn and colleagues 436 conducted a placebo-controlled within-person trial in south Germany. A herbal topical cream available in Germany as Ekzevowen derma ® , in the UK as Linderma ® and in the USA as Dermavex ® (Weber & Weber GmbH & Co.) was used as the treatment. ...
Eczema is a very common chronic inflammatory skin condition.
Objectives
To update the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) systematic review of treatments for atopic eczema, published in 2000, and to inform health-care professionals, commissioners and patients about key treatment developments and research gaps.
Data sources
Electronic databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Skin Group Specialised Register, Latin American and Caribbean Health Sciences Literature (LILACS), Allied and Complementary Medicine Database (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched from the end of 2000 to 31 August 2013. Retrieved articles were used to identify further randomised controlled trials (RCTs).
Review methods
Studies were filtered according to inclusion criteria and agreed by consensus in cases of uncertainty. Abstracts were excluded and non-English-language papers were screened by international colleagues and data were extracted. Only RCTs of treatments for eczema were included, as other forms of evidence are associated with higher risks of bias. Inclusion criteria for studies included availability of data relevant to the therapeutic management of eczema; mention of randomisation; comparison of two or more treatments; and prospective data collection. Participants of all ages were included. Eczema diagnosis was determined by a clinician or according to published diagnostic criteria. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. We used a standardised approach to summarising the data and the assessment of risk of bias and we made a clear distinction between what the studies found and our own interpretation of study findings.
Results
Of 7198 references screened, 287 new trials were identified spanning 92 treatments. Trial reporting was generally poor (randomisation method: 2% high, 36% low, 62% unclear risk of bias; allocation concealment: 3% high, 15% low, 82% unclear risk of bias; blinding of the intervention: 15% high, 28% low, 57% unclear risk of bias). Only 22 (8%) trials were considered to be at low risk of bias for all three criteria. There was reasonable evidence of benefit for the topical medications tacrolimus, pimecrolimus and various corticosteroids (with tacrolimus superior to pimecrolimus and corticosteroids) for both treatment and flare prevention; oral ciclosporin; oral azathioprine; narrow band ultraviolet B (UVB) light; Atopiclair™ and education. There was reasonable evidence to suggest no clinically useful benefit for twice-daily compared with once-daily topical corticosteroids; corticosteroids containing antibiotics for non-infected eczema; probiotics; evening primrose and borage oil; ion-exchange water softeners; protease inhibitor SRD441 (Serentis Ltd); furfuryl palmitate in emollient; cipamfylline cream; and
Mycobacterium vaccae
vaccine. Additional research evidence is needed for emollients, bath additives, antibacterials, specialist clothing and complementary and alternative therapies. There was no RCT evidence for topical corticosteroid dilution, impregnated bandages, soap avoidance, bathing frequency or allergy testing.
Limitations
The large scope of the review coupled with the heterogeneity of outcomes precluded formal meta-analyses. Our conclusions are still limited by a profusion of small, poorly reported studies.
Conclusions
Although the evidence base of RCTs has increased considerably since the last NIHR HTA systematic review, the field is still severely hampered by poor design and reporting problems including failure to register trials and declare primary outcomes, small sample size, short follow-up duration and poor reporting of risk of bias. Key areas for further research identified by the review include the optimum use of emollients, bathing frequency, wash products, allergy testing and antiseptic treatments. Perhaps the greatest benefit identified is the use of twice weekly anti-inflammatory treatment to maintain disease remission. More studies need to be conducted in a primary care setting where most people with eczema are seen in the UK. Future studies need to use the same core set of outcomes that capture patient symptoms, clinical signs, quality of life and the chronic nature of the disease.
Funding
The National Institute for Health Research Programme Grants for Applied Research programme.
... The pharmacology of V. tricolor has been studies lesser than the other plants. The flowers of this plant are a rich source of many secondary metabolites with anti inflammatory effect such as saponins, flavonoids, salicylic acid, carboxylic phenolic acids (caffeic acid, coumaric acids) and mucilages and have been used in a wide variety of skin disease such as eczema, seborrhea, impetigo and acne [28]. Therefore, the results of this study not only provided partial experimental evidence for the therapeutic efficacy of V. tricolor in the treatment of skin inflammatory disease, but also would be beneficial to the future studies and exploitation of this plant. ...
... 13 In particular, herbal extracts of V. tricolor have been described to treat inflammatory diseases 4 such as inflammatory atopic dermatitis or psoriasis. 14,15 Although plants contain a number of different bioactive substances, 16 a recent study highlighted that a cyclotide-enriched V. tricolor extract inhibited the proliferation of activated peripheral blood mononuclear cells. 13 Earlier it has been demonstrated that cyclotides isolated form V. tricolor are anti-proliferative agents against cancer cell lines. ...
Cyclotides are plant-derived mini proteins. They are genetically-encoded as precursor proteins that become post-translationally modified to yield circular cystine-knotted molecules. Due to this structural topology cyclotides resist enzymatic degradation in biological fluids and hence they are considered as promising lead molecules for pharmaceutical applications. Despite ongoing efforts to discover novel cyclotides and analyze their biodiversity, it is not clear how many individual peptides a single plant specimen can express. Therefore, we investigated the transcriptome and cyclotide peptidome of Viola tricolor. Transcriptome-mining enabled the characterization of cyclotide precursor architecture and processing sites important for biosynthesis of mature peptides. The cyclotide peptidome was explored by mass spectrometry and bottom-up proteomics using the extracted peptide sequences as queries for database searching. In total 164 cyclotides were discovered by nucleic acid and peptide analysis in Viola tricolor. Therefore, violaceous plants at a global scale may be source to as many as 150,000 individual cyclotides. Encompassing the diversity of Viola tricolor as combinatorial library of bioactive peptides, this commercially-available medicinal herb may be a suitable starting point for future bioactivity-guided screening studies.
... Application of topical CA preparations were shown to be beneficial in decreasing the scarring seen during wound healing, appearing to be related to the stimulation of maturation of the scar by the production of type I collagen and the resulting decrease in the inflammatory reaction and myofibroblast production [71] . In a randomized, double-blind, vehicle-controlled, half-side comparison study, undertaken to determine if it could also improve mild-to-moderate atopic dermatitis in adults, eighty-eight participants were randomly applied the treatment ointment and the placebo control to either the left or right side of the body for 4 weeks (2 applications per day) after which erythema, edema, oozing, and excoriation were assessed [72] . No significant improvements were detected in the treatment group as compared to the control group; however, further analysis of patients living in colder climates showed a significant improvement in the treated areas. ...
... The pharmacology of V. tricolor has been studies lesser than the other plants. The flowers of this plant are a rich source of many secondary metabolites with anti inflammatory effect such as saponins, flavonoids, salicylic acid, carboxylic phenolic acids (caffeic acid, coumaric acids) and mucilages and have been used in a wide variety of skin disease such as eczema, seborrhea, impetigo and acne [28]. Therefore, the results of this study not only provided partial experimental evidence for the therapeutic efficacy of V. tricolor in the treatment of skin inflammatory disease, but also would be beneficial to the future studies and exploitation of this plant. ...
... In a previously conducted, double-blind, clinically vehiclecontrolled, randomized, half-side comparison with 88 adult patients suffering from mild to moderate AD, the same ointment was not superior to the vehicle after four weeks of treatment. However, a subanalysis indicated that the cream might be effective under conditions of cold and dry weather (17) ...
Botanical extracts have been used for cosmetic and therapeutic purposes in the form of fresh plants or dried or extracted plant material since ancient times. These extracts are often registered as botanical medicine, also referred to as herbal medicine, phytotherapy, or phytomedicine (1). Today, increasing numbers of patients and consumers are asking for plant-based therapeutic preparations as a complementary dermatologic therapy. Botanical therapies are considered as therapeutic alternatives, as agents of safer choice in comparison to conventional therapy, or sometimes as the only effective therapeutic way remaining to treat a certain skin disease. The cosmetic industry is expanding the use of botanicals by introducing plant extracts, herbs, fl owers, fruits, and seed oleates into their products, prom-ising a gentler, more organic approach to beauty. Botanical-based cosmetics are well ac-cepted by the consumers because they are said to possess the ability to detoxify, hydrate, strengthen, stimulate, relax, and balance the skin and hair. These products with active compounds are collectively referred to as "cosmeceuticals" (2)— a portmanteau of cos-metic and pharmaceutical. Because the use of botanicals in dermatologic products is becoming increasingly pop u-lar, clinicians need to learn about their effi cacy and possible side effects. The present chap-ter mainly focuses on botanicals that have been investigated in clinical trials. However, experimental research on botanicals was also considered to a limited extent when it seemed promising for product development in the near future. The present chapter reviews the results of controlled clinical studies on botanicals used in dermatology. Plant-derived single compounds already established in dermatological therapy such as dithranol, salicylates, or podophyllotoxin are also discussed (Table 3.1). In the following sections, the botanicals are discussed under the dermatological indications where they have been studied or would be primarily indicated according to their mode of action (Table 3.2). Most of the studies on botanical extracts have been performed with topical preparations. Where appropriate, studies with botanical food supplements are con-sidered as well. Finally, the most important limitations for the use of botanicals in derma-tology are outlined. Literature references were obtained between December but also "UV-protection" and "sunscreen." To provide the reader with information on the quality of the studies, each study was classifi ed according to the levels of evidence (LOE) A-D suggested by the U.K. National Health Ser vice (3). In brief, LOE-A is assigned to consistent, randomized, con-trolled clinical trials and cohort studies; LOE-B is assigned to consistent retrospective co-horts, exploratory cohorts, outcome researches, case-control studies, or extrapolations from LOE-A studies; LOE-C is assigned to case-series studies or extrapolations from LOE-B studies; LOE-D is assigned to expert opinions without explicit critical appraisal or based on physiology, bench research, or fi rst principles. Whenever possible, the level of evidence was indicated for each study in squared brackets, for example, as [LOE-A].
... Piana et al. showed the antinociceptive and anti-inflammatory activities of V. tricolor in the ultraviolet-B-induced skin burn [32]. There are also some researches which verified the anti-inflammatory activity of V. tricolor in traditional medicine [9,33]. ...
In the present study, the cytotoxic and apoptogenic properties of hydroalcoholic extract and ethyl acetate (EtOAc), n-butanol, and water fractions (0-800 μg/mL) of Viola tricolor were investigated in Neuro2a mouse neuroblastoma and MCF-7 human breast cancer cells. In addition, antiangiogenic effect of EtOAc fraction was evaluated on chicken chorioallantoic membrane (CAM). The quality of EtOAc fraction was also characterized using high performance liquid chromatography (HPLC) fingerprint. Cytotoxicity assay revealed that EtOAc fraction was the most potent among all fractions with maximal effect on MCF-7 and minimal toxicity against normal murine fibroblast L929 cells. Apoptosis induction by EtOAc fraction was confirmed by increased sub-G1 peak of propidium iodide (PI) stained cells. This fraction triggered the apoptotic pathway by increased Bax/Bcl-2 ratio and cleaved caspase-3 level. Moreover, treatment with EtOAc fraction significantly decreased the diameter of vessels on CAM, while the number of newly formed blood vessels was not suppressed significantly. Analysis of quality of EtOAc fraction using HPLC fingerprint showed six major peaks with different retention times. The results of the present study suggest that V. tricolor has potential anticancer property by inducing apoptosis and inhibiting angiogenesis.
... For instance, Viola betonicifolia treatments reduce edema produced by carrageenan and histamine (Muhammad et al., 2012). Furthermore, studies showed that ointment with Viola tricolor reduced the erythema and edema in patients with mild to moderate atopic dermatitis (Klövekorn et al., 2007). Silver sulfadiazine is the most commonly used topical treatment for burn injury, and several studies have shown it to be effective to treat burn injuries (Khorasani et al., 2009;Maenthaisong et al., 2007). ...
... No significant differences were observed between ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica alcohol extracts and the base. However, a sub-analysis indicated that the formulation might be useful under conditions of cold and dry weather (Klövekorn et al., 2007). ...
Acne vulgaris (acne) is a cutaneous pleomorphic disorder of the pilosebaceous unit involving abnormalities in sebum production and is characterized by both inflammatory (papules, pustules and nodules) and non-inflammatory (comedones, open and closed) lesions. Propionibacterium acnes and Staphylococcus epidermidis are common pus-forming microbes responsible for the development of various forms of acne. This disease remains a common condition in industrialized societies, with many mainstream treatment options available. There are
many acne products on the market, and making an appropriate selection can be daunting. Common therapies that are used for the treatment of acne include topical, systemic, hormonal, herbal and combination therapy. Topically used agents are benzoyl peroxide, antibiotics and retinoid. Systemically used agents are antibiotics and isotretinoin. However, all such treatments carry risks and none is completely satisfactory. Natural alternatives are gaining greater research support, and have much to offer clinically in this disorder.
This review focuses primarily on herbal treatments for acne that show scientific evidence of clinical efficacy, as well as the more common herbs shown to be useful in the treatment of this dermatologic disorder.
... A further study compared a topical preparation of Mahonia aquifolium, Viola tricolor and Centella asiatica with the vehicle cream in 88 patients and could not find significant differences. 111 A subgroup analysis revealed superiority of the plant preparation under dry and cool weather conditions. Plant extracts are prone to induce contact sensitization and subsequent contact allergy. ...
The existing evidence for treatment of atopic eczema (atopic dermatitis, AE) is evaluated using the national standard Appraisal of Guidelines Research and Evaluation. The consensus process consisted of a nominal group process and a DELPHI procedure. Management of AE must consider the individual symptomatic variability of the disease. Basic therapy is focused on hydrating topical treatment, and avoidance of specific and unspecific provocation factors. Anti-inflammatory treatment based on topical glucocorticosteroids and topical calcineurin inhibitors (TCI) is used for exacerbation management and more recently for proactive therapy in selected cases. Topical corticosteroids remain the mainstay of therapy, but the TCI tacrolimus and pimecrolimus are preferred in certain locations. Systemic immune-suppressive treatment is an option for severe refractory cases. Microbial colonization and superinfection may induce disease exacerbation and can justify additional antimicrobial treatment. Adjuvant therapy includes UV irradiation preferably with UVA1 wavelength or UVB 311 nm. Dietary recommendations should be specific and given only in diagnosed individual food allergy. Allergen-specific immunotherapy to aeroallergens may be useful in selected cases. Stress-induced exacerbations may make psychosomatic counselling recommendable. 'Eczema school' educational programs have been proven to be helpful. Pruritus is targeted with the majority of the recommended therapies, but some patients need additional antipruritic therapies.
... Application of topical CA preparations were shown to be beneficial in decreasing the scarring seen during wound healing, appearing to be related to the stimulation of maturation of the scar by the production of type I collagen and the resulting decrease in the inflammatory reaction and myofibroblast production[71]. In a randomized, double-blind, vehicle-controlled, half-side comparison study, undertaken to determine if it could also improve mild-to-moderate atopic dermatitis in adults, eighty-eight participants were randomly applied the treatment ointment and the placebo control to either the left or right side of the body for 4 weeks (2 applications per day) after which erythema, edema, oozing, and excoriation were assessed[72]. No significant improvements were detected in the treatment group as compared to the control group; however, further analysis of patients living in colder climates showed a significant improvement in the treated areas. ...
In recent times, focus on plant research has increased all over the world. Centella asiatica is an important medicinal herb that is widely used in the orient and is becoming popular in the West. Triterpenoid, saponins, the primary constituents of Centella asiatica are manly believed to be responsible for its wide therapeutic actions. Apart from wound healing, the herb is recommended for the treatment of various skin conditions such as leprosy, lupus, varicose ulcers, eczema, psoriasis, diarrhoea, fever, amenorrhea, diseases of the female genitourinary tract and also for relieving anxiety and improving cognition. The present review attempts to provide comprehensive information on pharmacology, mechanisms of action, various preclinical and clinical studies, safety precautions and current research prospects of the herb. At the same time, studies to evaluate the likelihood of interactions with drugs and herbs on simultaneous use, which is imperative for optimal and safe utilization of the herb, are discussed.
... With a cream that has been on the market since many years consisting of a combination of mahonia (Mahonia aquifolium), pansy (Viola tricolor hortensis) and Indian pennywort (Centella asiatica) a vehicle-controlled, double-blind, randomized study as a half-side comparison was performed on 88 adults with mild to moderate atopic dermatitis. After four weeks of treatment no superiority of the combination preparation in comparison to vehicle was found [19] (LOE-A). ...
Plant extracts and isolated compounds are increasingly used in cosmetics and food supplements to improve skin conditions. We first introduce the positive plant monographs with dermatological relevance of the former German Commission E. Subsequently clinical studies with botanicals for atopic dermatitis, psoriasis, acne, condylomata acuminata and herpes simplex are discussed. The best studies have been conducted with atopic dermatitis and psoriasis patients. Mahonia aquifolium, Hypericum perforatum, Glycyrrhiza glabra and certain traditional Chinese therapies have been shown to be effective in the treatment of atopic dermatitis. Mahonia aquifolium, Indigo naturalis and Capsicum frutescens are effective treatments for psoriasis. Green tea extract and tea tree oil have been investigated in the treatment of acne. Podophyllin and green tea extract are effective treatments for condylomata acuminata. Balm mint and a combination of sage and rhubarb have been shown to be effective in the treatment of herpes simplex in proof of concept studies.
Background: Skin moisture management is important for maintaining healthy skin and treating inflammatory skin diseases, and skin barrier function can be assessed by measuring trans-epidermal water loss (TEWL) and skin moisture content.
Aim: This study was designed to investigate the effects of a topical cream containing 17% herbal extract (Cream17) on skin barrier function.
Materials and methods: In this study, the ability of investigational product (IP) to improve skin barrier function was investigated in 33 subjects using a randomized and assessor-blinded four-week clinical trial. In our study, the effects of IP on TEWL, skin water content, and the degree of itching were investigated.
Results: After four weeks of application, TEWL was significantly reduced by IP ( p < .001), and skin water content was significantly increased ( p < .001) compared to non-treated control. In addition, topical application of IP significantly lowered the visual analog scale at the second and fourth weeks after treatment commencement as compared with those in the untreated control group (visit 3 at the second week, p < .05; visit 4 at the fourth week, p < .001).
Conclusion: These results indicate that Cream17 can improve the skin barrier function, which is important for managing dry skin conditions such as atopic dermatitis.
Atopic dermatitis (AD) is the most common dermatological diagnosis during pregnancy. Treatment of AD during pregnancy can be challenging, due to the unpredictable course and the fact that the therapy needs to be safe for both the mother and the fetus. Here we present an up-to-date appraisal of the literature on the treatment options available for AD in patients planning pregnancy, during pregnancy, and during breastfeeding. All patients with AD are recommended to supplement any medical treatment with daily applications of emollients. The first step in the medical treatment for AD during pregnancy are topical corticosteroids, and/or topical tacrolimus. If required, UV-light therapy can also be considered. Treatment with systemic therapy during pregnancy should always rely on a careful risk-benefit assessment and be based on shared-decision making between the treating physician and patient. The first-line systemic treatment option is cyclosporine A, whereas azathioprine may be considered in patients already receiving this treatment prior to pregnancy. Systemic glucocorticoids may also be used. Treatment with systemic JAK inhibitors is not recommended, whereas treatment with mycophenolate mofetil and methotrexate is contraindicated. Targeted therapy with dupilumab is not generally recommended, due to lack of experience in human pregnancies, yet some case-reports on their use are emerging. These recommendations are based on the authors appraisal of existing literature and the current recommendation from the European Task Force on Atopic Dermatitis. It is always the responsibility of the treating physician to stay updated on the newest guidelines and literature when treating patients with AD during pregnancy.
Ethnopharmacological relevance:
Topical Chinese herbal medicine (CHM) is commonly used to relieve atopic dermatitis (AD); however, the up-to-date evidence concerning the effectiveness of topical CHM on treating AD is lacking. Moreover, the CHM prescriptions are often too complicated to realize the overall mechanisms of CHM, especially when compared to western medicines (WM).
Aim of the study:
To evaluate the effectiveness of topical CHM for treating AD by conducting a meta-analysis on randomized clinical trials (RCTs).
Methods:
Twenty RCTs comparing topical CHM to active control/placebo were included in the final analysis. The primary outcome was the symptom scores changed from baseline and the effectiveness rate was the secondary outcome. Subgroup analysis on different initial symptom severity and the different interventions in control groups was performed. System pharmacology analysis was performed to explore core CHM and possible pharmacological mechanisms of CHM for AD.
Results:
Compared with active/blank placebo, topical CHM seemed more effective (SMD: -0.35, 95 %CI: -0.59 to -0.10, p-value = 0.005, I2 = 60%). The effectiveness rate was higher (RR: 1.29, 95 %CI 1.15-1.44, p-value <0.00001, I2 = 71%). In subgroup analysis, mild and moderate AD patients with topical CHM were more effective than placebo (SMD: -0.28, 95 %CI -0.56 to -0.01, p-value = 0.04, I2 = 5%; -0.34, 95%CI -0.64 to -0.03, p-value = 0.03, I2 = 0%, separately). Topical CHM has 1.25 times more effective than the topical glucocorticoid (95 %CI 1.09-1.43, p-value = 0.001, I2 = 64%). Core CHMs, such as Phellodendron chinense C.K. Schneid., Sophora flavescens Ait., Cnidium monnieri (L.) Cusson, and Dictamnus dasycarpus Turcz., had effects on the pathways on immune and metabolism systems different from WM.
Conclusion:
Our results exploit the potential role of CHM on treating AD, especially for mild and moderate AD.
Actaea racemosa (AR) also known as Cimicifuga racemosa, is a perennial plant from Ranunculaceae family which was used as traditional remedies in treatment of various condition like rheumatoid muscular pain, headache, inflammation and dysmenorrhea. Actaea racemosa was basically native to Canada and the Eastern United State. This chapter proposed the ethnopharmacological uses of Actaea racemosa, and its phytochemical properties. Specifically, in this article we focused on use of Actaea racemose for menopausal and post-menopausal symptoms management. Electronic databases including PubMed and Scopus were searched for studies on Actaea racemose and its administration in management of menopausal symptoms. Chem Office software was also used in order to find chemical structures. The key words used as search terms were Cimicifuga racemose, Actaea racemose, Ranunculaceae, Black cohosh, Menopausal symptoms. We have included all relevant animal and human studies up to the date of publication. The analysis on Actaea racemose showed various indications for different plant’s extracts. Approximately 131 chemical compounds have been isolated and identified from Actaea racemosa. According to recently studies, the most important chemicals known of the Actaea racemosa are phenolic compounds, chromones, triterpenoids, nitrogen-containing constituents. In addition, in vivo and in vitro studies reported wide range of pharmacological activities for Black cohosh like attenuating menopausal symptoms. Mechanism of action for some ethnomedicinal indications were made clear while some of its activities are not confirmed by pharmacological studies yet. Further investigations on its pharmacological properties are necessary to expand its clinical effective use. Also, additional large clinical trials are recommended for clarifying the effect of Black cohosh.
Centella asiatica (CA) or Gotu cola is an herbal plant from the Apiaceae family with a long history of usage in different traditional medicines. It has long been used for the treatment of various ailments such as central nervous system (CNS), skin and gastrointestinal disorders especially in the Southeast Asia. This chapter focused on the phytochemical constituent and pharmacological activities of CA based on preclinical and clinical studies. Additionally, botanical description and distribution, traditional uses, interactions, and safety issues are reviewed. Electronic databases of Google Scholar, Scopus, PubMed, and Web of Science were searched to obtain relevant studies on the pharmacological activities of CA. Approximately, 124 chemical compounds including triterpenoids, polyphenolic compounds, and essential oils have been isolated and identified from CA. Ethnomedicinal applications of CA mostly include treatment of gastrointestinal diseases, wounds, nervous system disorders, circulatory diseases, skin problems, respiratory ailments, diabetes and sleep disorders in various ethnobotanical practices. Pharmacological studies revealed a wide range of beneficial effects of CA on CNS, cardiovascular, lung, liver, kidney, gastrointestinal, skin, and endocrine system. Among them, neuroprotective activity, wound healing and treatment of venous insufficiency, as well as antidiabetic activity seem to be more frequently reported. At the moment, considering various health benefits of CA, it is marketed as an oral supplement as well as a topical ingredient in some cosmetic products. Additional preclinical studies and particularly randomized controlled trials are needed to clarify the therapeutic roles of CA.
Patients with atopic dermatitis (AD) exhibit various symptoms, especially itching. Recently, herbal medicines (HMs) are being used in combination with antihistamines for the treatment of AD in Korea. While oral antihistamines can alleviate itching, HMs appear to exert anti-inflammatory effects with minimal side effects. However, there is little evidence regarding the effectiveness and safety of using HMs in combination with antihistamines for AD.
Background:
Complementary and alternative interventions are becoming increasingly utilized as adjuncts to conventional treatment of atopic dermatitis (AD). While the number of studies continues to grow, the vastness of the subject coupled with the relatively poor quality and small size of the studies limit their usefulness to clinicians.
Purpose:
Our aim was to comprehensively review randomized controlled trials (RCTs) of complementary and alternative therapies for AD.
Methods:
Searches were performed on PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, and the Global Resource for EczemA Trial (GREAT) databases, focusing on RCTs of alternative or complementary AD therapies, with a sample size of ≥10, through March 2015 and limited to the English language. A total of 70 manuscripts met the inclusion criteria and were included in the final analysis.
Results:
There is at least some level I evidence to support the use of acupuncture and acupressure, stress-reducing techniques such as hypnosis, massage, and biofeedback, balneotherapy, herbal preparations (with many important caveats), certain botanical oils, oral evening primrose oil, vitamin D supplementation, and topical vitamin B12. Many other therapies either have sufficient data to suggest that they are ineffective, or simply do not have enough evidence to formulate a verdict.
Conclusions:
Careful review of the literature reveals several promising therapies in this domain; such findings may help direct further research that is necessary to bolster clinical recommendations for alternative or complementary treatments of AD.
Despite the availability of medicines with proven efficacy, many patients use complementary or alternative medicines (CAMs) to manage atopic eczema (AE). Due to the lack of objective information on topical CAMs, this systematic review (SR) evaluates current evidence of efficacy and safety of topical herbal preparations in AE. Using Cochrane SR methodology, PubMed, Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (via EBSCO), MEDLINE (via EBSCO), Proquest Health and Medical Complete, GREAT and CAM-QUEST were searched from inception until June 2014. Bibliographies of retrieved studies were hand-searched for further relevant trials. All controlled clinical trials of topical herbal medicines for AE in humans of any age were included regardless of the control intervention or randomisation. Only English publications were considered. Eight studies met the inclusion criteria. Seven investigated extracts of single plants and one an extract from multiple plants. Only two studies that showed a positive effect were considered to have a low risk of bias across all domains (those of licorice gel and Hypericum perforatum). In these two, the test product was reported to be superior to placebo. Despite variations in diagnostic criteria and lack of validated tools for outcome assessments in one of these, the promising results may warrant continued research in better designed studies. No meta-analysis was performed due to heterogeneity in all studies. There is currently insufficient evidence of efficacy for any topical herbal extract in AE. Many studies had methodological flaws and even those showing efficacy were single trials with small patient cohorts. This article is protected by copyright. All rights reserved.
Objectives To make comprehensive feature of clinical trials using herbal medicine and their results by today, then help a strategy for herbal medication-derived clinical studies in the future. Methods Through medical website (Pubmed EBSCO Medline), foreign clinical literatures about atopic dermatitis and herbal medicine were searched. And domestic clinical literatures about atopic dermatitis using internet website (OASIS) and hand-searching. Analysis was performed according to distribution mainly by subject, study design, number by year and its efficacy. Results and Conclusions Seventy-nine (Domestic literatures: Fifty, Foreign literatures: Twenty-nine) literatures were selected according to inclusion criteria of clinical study. 80% of domestic clinical literatures were observational studies, 50% of foreign were intervention. There were six adverse effect case studies, two follow-ups, one case report, four translational and four uncontrolled clinical trials in foreign literatures. And nineteen case reports, eighteen case series, two follow-up and five uncontrolled clinical studies in domestic. Six RCTs have established by four external herb therapy and two decoctions in Korea, showed positive effects. Three out of four external applications RCTs, four out of seven decoctions showed positive results in foreign studies. This study revealed the current status of atopic dermatitis clinical research using herbal drugs. To put clinical trials to use of herbal medicine in the treatment atopic dermatitis, scientific and objective-based studies should be needed.
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 which techniques. Furthermore the evidence basis on the efficacy of CAM in the use for atopic eczema should be reviewed. For that purpose randomised 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 should no superiority compared to a shame procedure. Single studies indicated beneficial effects for topical hypericum, autologous blood injection, massage therapy,Vitamin E and D, and topical Viatmin B12. These results must be confirmed by future studies. CAM are frequently used in atopic eczema, the evidence basis for that, however, is limited.
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.
Mahonia is an important medicinal plant that has been widely used for the treatment of human diseases for centuries. To explore the molecular mechanisms underlying the different pharmacological functions of Mahonia, organ-specific proteomics was performed. The protein profiles of leaves, stems, and roots from 2-year-old Mahonia plants were determined using gel-free/label-free proteomic technique. A total of 304, 314, and 182 proteins were identified in the leaves, stems, and roots, respectively, and included 36 common proteins. In leaves, the most abundant proteins were related to photosynthesis. Furthermore, the technique of polyethylene glycol fractionation was used to identify low-abundance proteins in leaves. Using this approach, oxidative pentose phosphate-related proteins were identified in the leaves. In stems, the main functional categories of proteins were protein synthesis and redox ascorbate/glutathione metabolism. In roots, the identified proteins were mainly related to protein synthesis, stress, and amino acid metabolism. Of the 36 common proteins identified in three organs, the abundance of calreticulin was markedly higher in roots than that detected in stems and leaves. A number of roots-specific proteins, including S-adenosylmethionine synthetase and (S)-tetrahydroprotoberberine oxidase, which are involved in the biosynthesis of alkaloids, were identified. Consistent with this finding, the levels of the alkaloids which were columbamine, jatrorrhizine, palmatine, tetrandrine, and berberine, were markedly higher in roots compared to those detected in stems and leaves. Taken together, these results suggest that alkaloid biosynthesis is ab important function in Mahonia roots.
Atopic dermatitis (AD) is a chronic inflammatory skin disease, with a complex etiology encompassing immunologic responses. AD is frequently associated with elevated serum immunoglobulin (Ig) E levels and is exacerbated by a variety of environmental factors, which contribute to its pathogenesis. However, the etiology of AD remains unknown. Recently, reports have documented the role of lactic acid bacteria (LAB) in the treatment and prevention of AD in humans and mice. The LAB, Lactobacillus casei (LC), is frequently used in the treatment of AD. To identify the active component of LC, we screened fractions obtained from the ion exchange chromatography of LC extracts. Using this approach, we identified the candidate protein, P14. We examined whether the P14 protein has anti-atopic properties, using both in vitro and in vivo models. Our results showed that the P14 protein selectively downregulated serum IgE and interleukin-4 cytokine levels, as well as the AD index and scratching score in AD-like NC/Nga mice. In addition, histological examination was also effective in mice. These results suggest that the P14 protein has potential therapeutic effects and that it may also serve as an effective immunomodulatory agent for treating patients with AD.
Background: Psoriasis is a common chronic skin disease which usually appears as white and silvery spots on the skin. The purpose of this study is to investigate the effect of berberine on patients with psoriasis. Materials and Methods: This double-blind clinical trial was conducted on 60 psoriasis patients who referred to Imam Khomeini Hospital, Ahvaz, between July and December 2011. The patients were randomly divided into two equal groups that applied berberine and placebo to the treatment of their lesions twice a day. Lesions severity rate in the patients was assessed 7 times using a Psoriasis Area Severity Index (PASI). Data were analyzed by ANOVA with repeated measurements and Chi-square using SPSS software. Results: After 6 months, severity of lesions showed a significant decrease in the group receiving the berberine cream compared with the placebo group so that the mean PASI score of the group receiving berberine decreased from 3.99 to 2.11 while in the placebo group this decreased from 3.98 to 3.71. Mean difference in PASI score was not significant before receiving the treatment till the third month in berberine and placebo groups, but in the fourth to sixth months it was statistically significant (p=0.013). Conclusion: Berberine cream was more effective than the placebo in reduction of skin lesions of psoriasis patients. Therefore, it is recommended that plant-based drugs, like berberine, be used more besides the main medications of patients.
Atopic dermatitis (AD) is characterized as a multi-factorial inflammatory skin disease that has been increasing worldwide. Previously, we demonstrated that FPG, which is Platycodon grandiflorum (PG) fermented by Lactobacillus plantarum (LP), increases the level of interferon (IFN)-gamma in mouse splenocytes in vitro. In this study, we investigated the effects of FPG in an animal model of AD, with a particular emphasis on its effects on T helper (Th)1 and Th2 immune responses. To assess the potential use of FPG for the inhibition of AD, we established a model of AD-like skin lesions in NC/Nga mice. Immunoglobulin isotypes (Igs) and Th1/Th2 cytokines in the sera and spleens of AD-like mice were examined. In addition, histological examination was also performed. AD symptoms in skin lesions improved following oral administration of FPG. IgE secretion was significantly down-regulated, and this was accompanied by decreased levels of interleukin (IL)-4 and IgG1 and increased serum levels of IL-12p40 and IgG2a in FPG-treated animals. In splenocytes, the production of the Th1 cytokines IL-12p40 and IFN-gamma was up-regulated, while the levels of the Th2 cytokines IL-4 and 5 were down-regulated by FPG treatment. These results suggest that FPG inhibits the development of AD-like skin lesions in NC/Nga mice by suppressing the Th2 cell response and increasing the Th1 cell responses. Our results indicate that FPG is safe and effective for the prevention of AD-like skin lesions.
The goal of this study was to perform a meta-analysis on randomized controlled trials of topical therapies compared against their vehicles, and systemic therapies compared against their placebos, and to record how these therapies changed the magnitude of pruritus associated with atopic dermatitis. A systematic search of the literature was performed using Medline, Embase, and the Cochrane Controlled Clinical Trials Register, as well as follow-up references in retrieved articles. Data regarding the magnitude of the change in pruritus was extracted from eligible publications and categorized according to the type of treatment modality. Standard inverse variance fixed-effects meta-analysis was used to calculate the pooled estimates for randomized controlled trials falling under each type of treatment. Overall, the topical treatments were more successful at reducing atopic pruritus compared to the systemic treatments. Calcineurin inhibitors were the most effective antipruritic agent.
Plant-derived elements used for pharmacological applications constitute an increasing research field. Centella asiatica is widely used mainly as an extract (TECA). Triterpenic fractions, the primary constituents of Centella asiatica, produce a wide range of preventive and therapeutic effects. The modulation of collagen production and deposition in wound healing is of primary importance. TECA is also used to treat several microcirculatory problems, inflammatory skin conditions (leprosy, lupus, varicose ulcers, eczema, atopic dermatitis, psoriasis) and also intestinal problems, fever, amenorrhea and genitourinary conditions. Cognitive functions, anxiety and mental impairment may be also affected by TECA administration. New applications in neurology include nerve growth factor enhancement and applications in neurological degenerative conditions. Interaction with other products is also indicated in this document. The multiplicity of actions of TECA is associated to six important mechanisms, all inter-connected and modulating each other: 1) edema - and capillary filtration - control; 2) a strong antioxidant power, effective on several forms of oxidative stress associated to inflammation or infections and synergic with other antioxidant products; 3) an anti-inflammatory action; 4) a modulation of the collagen production avoiding slower scarring or faster, hyperthrophic scarring and cheloids; 5) a modulating action of local growth factors; 6) a modulation of angiogenesis. This "status" paper - resulting from an expert meeting held in Cobham, Surrey, indicates most of the therapeutic potential of TECA, still to be explored in further studies. The status paper constitutes the basis for a consensus document on TECA to be developed in the next future. This "status" paper opens a new window on an ancient but still partially unexplored product that may become an important value in prevention and treatment of several pre-clinical and risk conditions and in clinically significant disease both as a single products and in association with other 'natural' products.
Botanical extracts and single compounds are increasingly used in cosmetics but also in over-the-counter drugs and food supplements. The focus of the present review is on controlled clinical trials with botanicals in the treatment of acne, inflammatory skin diseases, skin infections, UV-induced skin damage, skin cancer, alopecia, vitiligo, and wounds. Studies with botanical cosmetics and drugs are discussed, as well as studies with botanical food supplements. Experimental research on botanicals was considered to a limited extent when it seemed promising for clinical use in the near future. In acne therapy, Mahonia, tea tree oil, and Saccharomyces may have the potential to become standard treatments. Mahonia, Hypericum, Glycyrrhiza and some traditional Chinese medicines appear promising for atopic dermatitis. Some plant-derived substances like dithranol and methoxsalen (8-methoxypsoralen) [in combination with UVA] are already accepted as standard treatments in psoriasis; Mahonia and Capsicum (capsaicin) are the next candidates suggested by present evidence. Oral administration and topical application of antioxidant plant extracts (green and black tea, carotenoids, coffee, and many flavonoids from fruits and vegetables) can protect skin from UV-induced erythema, early aging, and irradiation-induced cancer. Hair loss and vitiligo are also traditional fields of application for botanicals. According to the number and quality of clinical trials with botanicals, the best evidence exists for the treatment of inflammatory skin diseases, i.e. atopic dermatitis and psoriasis. However, many more controlled clinical studies are needed to determine the efficacy and risks of plant-derived products in dermatology. Safety aspects, especially related to sensitization and photodermatitis, have to be taken into account. Therefore, clinicians should not only be informed of the beneficial effects but also the specific adverse effects of botanicals used for dermatologic disorders and cosmetic purposes.
The term complementary or alternative medicine encompasses numerous diverse therapeutic concepts, ranging from as herbal medicine, diet with essential fatty acids, and probiotics, to acupuncture. The main focus of these treatment methods is inflammatory skin disease, in particular atopic dermatitis. Although integrative medicine enjoys increasing popularity, particularly in industrialized countries, clinical studies that meet the double-blind, placebo-controlled standard are rare or nonexistent. The aim of this contribution is to provide the various concepts of integrative medicine.
Complementary and alternative medicines (CAMs) are used in more than 80% of the world's population and are becoming an increasing component of the US health care system, with more than 70% of the population using CAM at least once and annual spending reaching as much as $34 billion. Since the inception of the National Center for Complementary and Alternative Medicine, there has been an enormous increase in the number of basic science and therapy-based clinical trials exploring CAM. The subspecialty of allergy and immunology represents a particularly fertile area with a large number of CAM therapies that have been shown to affect the immune system. Recent work has uncovered potential biochemical mechanisms involved in the immunomodulatory pathway of many supplemental vitamins (A, D, and E) that appear to affect the differentiation of CD4(+) cell T(H)1 and T(H)2 subsets. Other research has shown that herbs such as resveratrol, quercetin, and magnolol may affect transcription factors such as nuclear factor-kappaB and the signal transducer and activator of transcription/Janus kinase pathways with resultant changes in cytokines and inflammatory mediators. Clinically, there have been hundreds of trials looking at the effect of CAM on asthma, allergic rhinitis, and atopic dermatitis. This article reviews the history of CAM and its use among patients, paying special attention to new research focusing on herbals, phytochemicals, and vitamins and their potential interaction with the immune system.
Little is known about the prevalence of atopic eczema outside Northern Europe.
We sought to describe the magnitude and variation in the prevalence of atopic eczema symptoms throughout the world.
A cross-sectional questionnaire survey was conducted on random samples of schoolchildren aged 6 to 7 years and 13 to 14 years from centers in 56 countries throughout the world. Those children with a positive response to being questioned about the presence of an itchy relapsing skin rash in the last 12 months that had affected their skin creases were considered to have atopic eczema. Children whose atopic eczema symptoms resulted in sleep disturbance for 1 or more nights per week were considered to have severe atopic eczema.
Complete data was available for 256,410 children aged 6 to 7 years in 90 centers and 458,623 children aged 13 to 14 years in 153 centers. The prevalence range for symptoms of atopic eczema was from less than 2% in Iran to over 16% in Japan and Sweden in the 6 to 7 year age range and less than 1% in Albania to over 17% in Nigeria for the 13 to 14 year age range. Higher prevalences of atopic eczema symptoms were reported in Australasia and Northern Europe, and lower prevalences were reported in Eastern and Central Europe and Asia. Similar patterns were seen for symptoms of severe atopic eczema.
Atopic eczema is a common health problem for children and adolescents throughout the world. Symptoms of atopic eczema exhibit wide variations in prevalence both within and between countries inhabited by similar ethnic groups, suggesting that environmental factors may be critical in determining disease expression. Studies that include objective skin examinations are required to confirm these findings.
Herbal therapy is becoming increasingly popular among patients and physicians. Many herbal preparations are marketed to the public for various ailments including those of the skin. Herbal therapies have been used successfully in treating dermatologic disorders for thousands of years in Europe and Asia. In Germany, a regulatory commission oversees herbal preparations and recommended uses. In Asia, herbal treatments that have been used for centuries are now being studied scientifically. Currently, the United States does not regulate herbal products, as they are considered dietary supplements. Therefore, there is no standardization of active ingredients, purity, or concentration. There are also no regulations governing which herbs can be marketed for various ailments. This has made learning about and using these treatments challenging. Information compiled in a practical fashion may enable more patients to benefit from these treatments currently used worldwide. We reviewed the herbal medications that show scientific evidence of clinical efficacy, as well as the more common herbs shown to be useful in the treatment of dermatologic disorders. The safety of each herb has been addressed to better enable the physician to know which herbal therapies they may want to begin to use in practice. Common drug interactions and side effects of herbal medicines that may be seen in the dermatologic setting were also studied.
Glycyrrhiza glabra L. has been used in herbal medicine for skin eruptions, including dermatitis, eczema, pruritus and cysts. The effect of licorice extract as topical preparation was evaluated on atopic dermatitis. The plant was collected and extracted by percolation with suitable solvent. The extract was standardized, based on Glycyrrhizinic acid by using a titrimetry method. Different topical gels were formulated by using different co-solvents. After standardizing of topical preparations, the best formulations (1% and 2%) were studied in a double-blind clinical trial in comparison with base gel on atopic dermatitis over two weeks (30 patients in each group). Propylene glycol was the best co-solvent for the extract and Carbopol 940 as gelling agent showed the best results in final formulations. The quantity of glycyrrhizinic acid was determined 20.3% in the extract and 19.6% in the topical preparation. Two percent licorice topical gel was more effective than 1% in reducing the scores for erythema, oedema and itching over two weeks (p<0.05). The results showed that licorice extract could be considered as an effective agent for treatment of atopic dermatitis.
To study the efficacy and tolerability of borage oil, which contains a high concentration of gamma linolenic acid, in children and adults with atopic eczema.
Single centre, randomised, double blind, placebo controlled, parallel group trial.
Acute district general hospital in Nuneaton, England.
151 patients, of whom 11 failed to return for assessment, leaving an evaluable population of 140 (including 69 children).
Adults received four capsules of borage oil twice daily (920 mg gamma linolenic acid), and children received two capsules twice daily, for 12 weeks.
Change in total sign score at 12 weeks measured with the six area, six sign, atopic dermatitis (SASSAD) score (primary endpoint); symptom scores, assessed on visual analogue scales; topical corticosteroid requirement, assessed on a five point scale; global assessment of response by participants; adverse events and tolerability.
The mean SASSAD score fell from 30 to 27 in the borage oil group and from 28 to 23 in the placebo group. The difference between the mean improvements in the two groups was 1.4 (95% confidence interval -2.2 to 5.0) points in favour of placebo (P = 0.45). No significant differences occurred between treatment groups in the other assessments. Subset analysis of adults and children did not indicate any difference in response. The treatments were well tolerated.
Gamma linolenic acid is not beneficial in atopic dermatitis.
Unlabelled:
The global incidence of atopic eczema is escalating. While new treatment options are becoming available, previous treatments with certain confirmed benefits are still worth investigating as safe and effective therapies. One such treatment, Efamol evening primrose oil (EPO), was proven efficacious in a 1989 meta-analysis of randomized, double-blind, placebo-controlled clinical trials. A decade of further testing and subsequent independent reanalysis of 26 clinical studies including 1207 patients presented here, establishes that Efamol EPO has a simultaneous, beneficial effect on itch/pruritus, crusting, oedema and redness (erythema) that becomes apparent between 4 and 8 weeks after treatment is initiated. However, the magnitude of this effect is reduced in association with increasing frequency of potent steroid use. This and other confounding variables that are now being reported in the literature may account for historically reported inconsistent patient response. Recent research has uncovered unique complexities in fatty acid metabolism and immune response in the atopic condition beyond those previously reported and may well have identified a subcategory of non-responders and has helped established those that can consistently derive significant benefit. Further research is needed to provide a better understanding of the physiology behind this complex disorder and the beneficial role that fatty acids can play in its development and management.
Conclusion:
Efamol EPO has a simultaneous, beneficial effect on itch/pruritus, crusting, oedema and redness (erythema) that becomes apparent between 4 and 8 weeks after treatment is initiated. However, the magnitude of this effect is reduced in association with increasing frequency of potent steroid use.
In einer offenen monozentrischen Studie nach GCP-Richtlinien wurde die Wirksamkeit und Verträglichkeit der pflanzlichen Heilsalbe Ekzevowen® derma bei 27 Kindern mit leichter bis mittelschwerer atopischer Dermatitis über 2 bis maximal 4 Wochen untersucht. Symptome wie Juckreiz, Rötung, Ödem/Papelbildung, Nässen/Krusten, Exkoriation und Lichenifizierung verbesserten sich durch die Behandlung deutlich. Bei 22 % der Patienten konnte eine vollständige Abheilung erzielt werden, bei weiteren ca. 60 % erfolgte eine Besserung. Die meisten Patienten würden die Studiensalbe auch zukünftig bei Beschwerden wieder einsetzen, deren Verträglichkeit von über 90 % als sehr gut oder gut bewertet wurde.
Atopic dermatitis is an inflammatory skin disease characterized by dryness and itch of the skin. In this study, we measured the phospholipid content and the fatty acid pattern of lesional and lesion-free epidermal keratome biopsies on 15 patients. For comparison, epidermal biopsies were obtained from healthy individuals undergoing plastic surgery. The phospholipid content of atopic epidermis was nearly twice as high as in healthy epidermis. Monounsaturated fatty acids in the phosphoglycerides were significantly increased (p less than 0.001) and n-6 fatty acids were significantly decreased (p less than 0.001) in lesional atopic epidermis compared to lesion-free epidermis. The content of esterified arachidonic acid in phosphatidylcholine from lesional epidermis was only 49% of that found in healthy epidermis (p less than 0.001). The content of free arachidonic acid was 47% higher (p less than 0.05), whereas the content of free long-chain saturated fatty acids was decreased by 29% (p less than 0.01), in lesional compared to lesion-free atopic epidermis. The disease severity, calculated as an arbitrary index, correlated inversely with the n-6 fatty acid content of lesion-free atopic epidermis (r = -0.89, p less than 0.001). Our findings suggest that atopic epidermis is characterized by an increased activity of phospholipase A2 and an incomplete transformation of phospholipids into other lipid classes.
In a double-blind, randomized, paired trial lasting 14 days in 72 patients with moderately severe atopic eczema, hamamelis distillate cream (5.35 g hamamelis distillate with 0.64 mg ketone/100 g) was compared with the corresponding drug-free vehicle and 0.5% hydrocortisone cream, and reductions of the basic criteria of severe atopic eczema (delta values of the sum scores), i.e. itching, erythema and scaling, were evaluated. Thirty-six patients in each group were treated, which allowed the detection of a 10% difference between verum and control (confirmatory study). Effects were compared using Wilcoxon's test. The mean sum scores of the basic criteria of the test areas were 5.3-5.5. All treatment regimens significantly reduced itching, erythema and scaling after 1 week. Hydrocortisone proved superior to hamamelis distillate. The basic criteria scores decreased by 2.7 and 1.6, respectively. The delta values of the minor criteria and the global rating of efficacy were also used to indicate the difference between these preparations. Hamamelis distillate cream, however, did not differ from the vehicle. Mean delta values of basic criteria were 1.8 and 2.0, respectively. All preparations were well tolerated. Unwanted cutaneous reactions occurred in six patients, although due to their inflammatory nature and their confinement to vehicle-treated patients, they may not represent true adverse effects but rather a lack of efficacy. The results prove the superiority of low-dose hydrocortisone cream over hamamelis distillate cream, and the therapeutic outcome following this preparation was no better than following the base preparation. The mild, yet unmistakable anti-inflammatory effect of hamamelis cream in experimental models of inflammatory skin disease was thus not reflected by an efficacy in patients with atopic eczema greater than that obtained from the base preparation.
In this review, we discuss some common herbal preparations historically used for dermatologic conditions and recent studies that support their use. The traditional practice of topically treating dermatologic conditions with plant-derived medicines predates the cultures of ancient Egypt and remains vital today in the industrialized cultures of both the United States and Europe. Recent scientific studies lend support to some of the claims of herbal practitioners for the safety and efficacy of many herbs. The studies also elucidate, in some cases, the mechanisms by which these herbs act. With the growing interest in alternative and complementary therapies, practitioners need more information. Clinical studies and collected observations will help define specific indications for choice of herbal treatment based on both the skin disorder and the unique characteristics of the patient involved.
Atrophy is a distressing side effect of potent corticosteroids. After open application of a high potency steroid, we monitored atrophogenicity by a variety of non-invasive methods.
Volar forearms were treated twice daily for 3 or 4 weeks, with clobetasol propionate cream (Temovate). The following methods were used: 1) confocal microscopy, 2) transepidermal water loss (TEWL), 3) dimethyl sulfoxide whealing, 4) sodium hydroxide erosions, 5) analysis of stratum corneum lipids, and 6) B-scan ultrasound.
Confocal microscopy revealed thinning of the epidermis, decreased microvasculature and decreased size of keratinocytes. Evaporimetry demonstrated transepidermal water loss. Whealing to dimethyl sulfoxide was enhanced. Sodium hydroxide erosions formed more quickly. The amount of ceramides, cholesterol, and free fatty acids was reduced. Ultrasound showed thinning of the dermis.
Non-invasive methods are very useful for quantifying the atrophogenicity of topical corticosteroids.
The frequent clinical observation that the course of atopic eczema, a skin disease involving a disturbed cutaneous barrier function, is influenced by climate and weather motivated us to analyse these relationships biometrically. In the Swiss high-mountain area of Davos the intensity of itching experienced by patients with atopic eczema was evaluated and compared to 15 single meteorological variables recorded daily during an entire 7-year observation period. By means of univariate analyses and multiple regressions, itch intensity was found to be correlated with some meteorological variables. A clear-cut inverse correlation exists with air temperature (coefficient of correlation: -0.235, P < 0.001), but the effects of water vapour pressure, air pressure and hours of sunshine are less pronounced. The results show that itching in atopic eczema is significantly dependent on meteorological conditions. The data suggest that, in patients with atopic eczema, a certain range of thermo-hygric atmospheric conditions with a balance of heat and water loss on the skin surface is essential for the skin to feel comfortable.
To review some of the promising natural remedies within dermatology to explore their potential clinical benefit in supplementing conventional drugs.
MEDLINE searches from January 1966 through October 2000 and Science Citation Index searches from January 1974 through October 2000 were conducted.
Primary importance was given to in vivo and in vitro controlled studies, the results of which encourage further exploration.
The controls used, the statistical approach to analysis, and the validity of the experimental method analyzed were considered particularly important. Data were independently extracted by multiple observers.
Natural remedies seem promising in treating a wide variety of dermatologic disorders, including inflammation, phototoxicity, psoriasis, atopic dermatitis, alopecia areata, and poison oak.
The alternative medications presented seem promising, although their true effects are unknown. Many of the presented studies do not allow deduction of clinical effects. Further experimentation must be performed to assess clinical benefit.
The incidence of atopic dermatitis is increasing, and this poses a major burden on health care costs. A precise understanding of the genetic and immunologic mechanisms is crucial for development of effective treatment strategies for atopic dermatitis. Various studies indicate that it has a multifactorial cause, with activation of complex immunologic and inflammatory pathways. The current review will examine recent advances that have been made in our understanding of the genetic and pathophysiologic prerequisites that form the basis of this common recalcitrant skin disorder.
Herbal medicine is again popular and its widespread use demands that we assess its effectiveness objectively. The evidence in this area has grown considerably in recent years, not least due to the endeavors of the Cochrane Collaboration. They show amongst other things that it is possible to evaluate herbal medicines in much the same way as conventional drugs. By far the biggest hindrance to research into herbal medicine is the lack of funds available for this line of scientific investigation. In view of the present popularity of herbal medicine it seems necessary to overcome obstacles to rigorous research and establish which herbal medicines do more good than harm for which conditions.
