Emollients for preventing atopic eczema: Cost-effectiveness analysis of the BEEP trial.

BACKGROUND: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. OBJECTIVE: To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis. METHODS: A within-trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost-effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost-effectiveness analysis. Secondary analysis, undertaken as a cost-utility analysis, reports incremental cost per Quality-Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU-9D at 2 years. RESULTS: At 2 years, the adjusted incremental cost was £87.45 (95% CI -54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI -0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI -0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, -£106.89 (95% CI -354.66, 140.88) and the proportion without eczema was -0.0329 (95% CI -0.0659, 0.0002). The 5-year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group. CONCLUSIONS: In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high-risk children does not appear cost-effective.

Formulation and assessment of hydroxyzine HCL solid lipid nanoparticles by dual emulsification technique for transdermal delivery.

Hydroxyzine HCL (HHCL) is an antihistamine, used for the treatment of allergic skin conditions. The purpose of this study was to achieve a dual phase drug delivery rate across the intact skin, to enhance HHCL permeation through the stratum corneum, to assess the peripheral H1-antihistaminic activity and the extent to which HHCL was systemically absorbed from transdermal gel loaded with solid lipid nanoparticles (SLNs), as well as to avoid its extreme bitterness. According to 23 factorial design, eight formulations of HHCL-SLNs were prepared by the double emulsification method. Lipid type (XA), surfactant concentration (XB) and co-surfactant concentration (XC) were the independent variables. All formulations were characterized for their surface morphology, particle size, entrapment efficiency and in-vitro drug release study. The optimized formula that provides greater desirability was then incorporated into the transdermal gel. In addition, the efficacy of the developed gel was tested in-vivo using 2,4-Dinitrochlorobenzene induced atopic dermatitis as lesion model in mice. F4 showed an average diameter 111 nm ± 0.03, zeta potential - 30 MV ± 2.4 and EE 75.2% ± 4.4. TEM images showed spherical, smooth morphology with uniform particles distribution. In-vivo study demonstrated potent antipruritic efficacy of transdermal gel in atopic dermatitis such as induced lesions compared to HHCL gel. Hence, HHCL solid lipid nanoparticles transdermal gel may be considered as potential for delivery of HHCL and alternatively to traditional oral use.

Emollient creams and bath oils do not prevent atopic eczema. / Fuktighetskrem og oljebad forebygger ikke atopisk eksem.

Emollient creams and bath oils do not prevent atopic eczema in infants. Emollients are nevertheless important for those who suffer from eczema.

Atopic dermatitis.

Atopic dermatitis is a common inflammatory skin disorder characterised by recurrent eczematous lesions and intense itch. The disorder affects people of all ages and ethnicities, has a substantial psychosocial impact on patients and relatives, and is the leading cause of the global burden from skin disease. Atopic dermatitis is associated with increased risk of multiple comorbidities, including food allergy, asthma, allergic rhinitis, and mental health disorders. The pathophysiology is complex and involves a strong genetic predisposition, epidermal dysfunction, and T-cell driven inflammation. Although type-2 mechanisms are dominant, there is increasing evidence that the disorder involves multiple immune pathways. Currently, there is no cure, but increasing numbers of innovative and targeted therapies hold promise for achieving disease control, including in patients with recalcitrant disease. We summarise and discuss advances in our understanding of the disease and their implications for prevention, management, and future research.

A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial.

BACKGROUND: Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of developing AD, preventative application of lipid-rich emollients may reduce the risk of developing AD. This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial in the primary care setting. METHODS: Infant-parent dyads are recruited from a primary care practice participating through one of four practice-based research networks in Oregon, Colorado, Wisconsin, and North Carolina. Eligible dyads are randomized to the intervention (daily use of lipid-rich emollient) or the control (no emollient) group (n = 625 infants in each) and are followed for 24 months. The primary outcome is the cumulative incidence of physician-diagnosed AD and secondary outcomes include caregiver-reported measures of AD and development of other atopic diseases. Data collection occurs via chart review and surveys, with no study visits required. Data will be analyzed utilizing intention-to-treat principles. DISCUSSION: AD is a common skin condition in infants that affects quality of life and is associated with the development of other atopic diseases. If a safe intervention, such as application of lipid-rich emollients, in the general population effectively decreases AD prevalence, this could alter the guidance given by providers regarding routine skin care of infants. Because of the pragmatic design, we anticipate that this trial will yield generalizable results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03409367. Registered on 11 February 2018.

What's new in atopic eczema? An analysis of systematic reviews published in 2016. Part 3: nomenclature and outcome assessment.

This review forms part of a series of annual updates that summarize the evidence base for atopic eczema (AE). It presents the key findings from 11 systematic reviews published in 2016 that focus on AE outcome assessment, disease impact and nomenclature. Systematic reviews on the treatment and prevention of AE are summarized in Part 1 of this update, and systematic reviews on the epidemiology of and risk factors for AE are summarized in Part 2. Six reviews summarized what outcome measurement instruments have been used in published AE trials, or summarized validation studies for the available instruments. These reviews were used to inform consensus decisions by the Harmonising Outcome Measures for Eczema initiative. Although validated instruments exist for clinical signs and patient-reported symptoms, there are currently no validated instruments for capturing quality of life or long-term control. Four reviews examined the impact of AE on children and their families, but few studies were included. One birth cohort study found no association between AE and educational attainment at 11 years. AE has a moderate impact on health-related quality of life and a substantial impact on family life. AE is a major risk factor for occupational hand dermatitis, and it is advised that young atopic individuals are informed about high-risk occupations. Further efforts are required to standardize the nomenclature for AE, which is also commonly known as 'atopic dermatitis' or 'eczema', and preferred terms vary around the world.

Economic value of using partially hydrolysed infant formula for risk reduction of atopic dermatitis in high-risk, not exclusively breastfed infants in Singapore.

INTRODUCTION: Previous trials have demonstrated reductions in atopic dermatitis (AD) incidence when healthy, high-risk, non-exclusively breastfed infants were fed until four months of age with 100% whey-based partially hydrolysed formula (PHF-W) versus standard cow's milk formula (CMF). We assessed the cost-effectiveness of this intervention in Singapore. METHODS: Modelling techniques were used to simulate, from birth to Month 30, the incidence and clinical/economic burden of AD in high-risk, non-exclusively breastfed infants fed with PHF-W or CMF for up to four months. Epidemiologic and clinical data were from a local comparative trial. Expert opinion informed AD treatment patterns and outcomes. Outcomes included reduction in AD risk, time spent with AD, days without AD flare, quality-adjusted life years (QALYs) and direct/indirect costs. Multivariate probabilistic sensitivity analysis was used to assess model parameter uncertainty. RESULTS: Over 30 months, with the use of PHF-W instead of CMF, the proportion of children who developed AD and the time spent with AD decreased by 16.0% (28.3% vs. 44.3%) and 6.4 months, respectively, while time without AD flare and QALYs increased by 14.9 days and 0.021 QALYs per patient, respectively. Estimated AD-related discounted costs per child for PHF-W and CMF were SGD 771 and SGD 1,309, respectively (net savings: SGD 538). PHF-W was less expensive and more effective than CMF for 73%, and cost less than SGD 50,000 per QALY for 87% of all multivariate simulations. CONCLUSION: Early short-term nutritional intervention with PHF-W instead of CMF may reduce AD incidence and costs for healthy, high-risk, non-exclusively breastfed infants in Singapore.

Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial.

BACKGROUND: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis). METHODS: This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires. DISCUSSION: This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases. TRIAL REGISTRATION: ISRCTN registry; ID: ISRCTN21528841 . Registered on 25 July 2014.

ASSESSMENT OF A STABLE COSMETIC PREPARATION BASED ON ENZYMATIC INTERESTERIFIED FAT, PROPOSED IN THE PREVENTION OF ATOPIC DERMATITIS.

Atopic dermatitis is one of the most common skin disorders seen in infants, children and adults. Proper prevention might slow the atopic symptoms. The purpose of the work was a sensory analysis, an evaluation of moistening properties and stability of emulsions based on an enzymatic interesterified fat blend (mutton tallow and walnut oil) and homogenized at different revolutions and different contents of thickener. The emulsions were evaluated with respect to sensory and skin moisturizing properties by 78 respondents. Stability tests, particle size, distribution, dispersity index, morphology structure of the emulsions were determinated too. Taking into consideration all properties of the emulsions, emulsion IV (containing 0.9 g carboxymethyl cellulose and homogenized at 18000 rpm) and emulsion V (1.5 g of carboxymethyl cellulose and homogenized at 24000 rpm) were found to be of optimum composition. The emulsions exhibited good stability, were highly rated in sensory terms and displayed optimum moistening properties. It has been proven that model emulsions based on interesterified fats containing partial acylglicerols, with optimum carboxymethyl cellulose content and specific revolutions at the time of homogenization are an opportunity for developing preparations targeted at skins requiring special care (e.g., with atopic dermatitis or psoriasis). The work proved the use of enzymatic process to create the emulsifier, which represents the innovative contribution of this work. Also it showed an additional application of enzymatic interesterified fats which since has been used only in food industries.

Cost-effectiveness of Prophylactic Moisturization for Atopic Dermatitis.

Importance: Emerging evidence suggests that the use of moisturizers on newborns and infants (ie, from birth to 6 months of age) is potentially helpful in preventing the development of atopic dermatitis. Objective: To investigate the cost-effectiveness of using a daily moisturizer as prevention against atopic dermatitis among high-risk newborns. Design, Setting, and Participants: In a cost-effectiveness analysis, the average cost of total-body moisturization using 7 common moisturizers from birth to 6 months of age was determined for male and female infants. We assumed the same unit of weight per moisturizer used for a given body surface area. Based on previously reported data (relative risk reduction of 50%), the incremental gain in quality-adjusted life-years (QALYs) was determined using a 6-month time window. The cost-effectiveness of each moisturizer was determined by assuming equal efficacy. A sensitivity analysis was conducted by varying the relative risk from 0.28 to 0.90. Interventions: Use of prophylactic moisturizing compounds. Main Outcomes and Measures: The primary outcomes were the incremental cost-effectiveness values ($/QALY) for each moisturizer in preventing atopic dermatitis during a 6-month time window. Results: The calculated amount of daily all-body moisturizer needed at birth was 3.6 g (0.12 oz) per application, which increased to 6.6 g (0.22 oz) at 6 months of age. Of the 7 products evaluated, the average price was $1.07/oz (range, $0.13/oz-$2.96/oz). For a 6-month time window, the average incremental QALY benefit was 0.021. The sensitivity analysis showed that the incremental gain of QALY ranged from 0.0041 to 0.030. Petrolatum was the most cost-effective ($353/QALY [95% CI, $244-$1769/QALY) moisturizer in the cohort. Even assuming the lowest incremental QALYs for the most expensive moisturizer, the intervention was still less than $45 000/QALY. Conclusions and Relevance: Overall, atopic dermatitis represents a major health expenditure and has been associated with multiple comorbidities. Daily moisturization may represent a cost-effective, preventative strategy to reduce the burden of atopic dermatitis.

Hydrolyzed Formula for Every Infant?

Presently, hydrolyzed formulas (HF) are used primarily in infants that cannot be exclusively breastfed, those with cow's milk allergy and for primary prevention of allergic disease, but HFs are increasingly being used worldwide, begging the question if they may be recommended as the optimal choice for all standard-risk, full-term, non-exclusively breastfed infants. Data regarding the nutritional adequacy of modern-day HFs are scarce and lack long-term data suggesting that growth in infants fed HF versus an intact protein formula (IPF) is different. While human breast milk is the optimal source of nutrition for multiple reasons, a 2006 systematic review determined there were no comparable long-term studies regarding prolonged use of HFs versus breastfeeding. Meta-analyses of formula consumption and risk of atopic dermatitis (AD) have found that infants fed partially HF compared to IPF had a lower risk of AD, but there are significant limitations to these studies, making conclusions about the general use of HFs problematic. Costs should be considered in decision-making regarding the choice of the formula, but global comparison of this is difficult given large cost differences in different countries. Despite the issues raised here, the desire to provide concrete recommendations of widespread HF use needs to be balanced carefully in order not to overstate claims of benefit. Long-term studies are needed to investigate the feasibility of HF as a routine feeding option for healthy, standard-risk infants. Because of the paucity of data, routine use of HF as an equivalent option to breastfeeding or IPF cannot be supported at present based on available scientific evidence.

Economic evidence for the prevention and treatment of atopic eczema: a protocol for a systematic review.

BACKGROUND: Eczema, synonymous with atopic eczema or atopic dermatitis, is a chronic skin disease that has a similar impact on health-related quality of life as other chronic diseases. The proposed research aims to provide a comprehensive systematic assessment of the economic evidence base available to inform economic modelling and decision making on interventions to prevent and treat eczema at any stage of the life course. Whilst the Global Resource of Eczema Trials (GREAT) database collects together the effectiveness evidence for eczema, there is currently no such systematic resource on the economics of eczema. It is important to gain an overview of the current state of the art of economic methods in the field of eczema in order to strengthen the economic evidence base further. METHODS/DESIGN: The proposed study is a systematic review of the economic evidence surrounding interventions for the prevention and treatment of eczema. Relevant search terms will be used to search MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Economic Evaluation Database, Health Technology Assessment, Cumulative Index to Nursing and Allied Health Literature, EconLit, Scopus, Cost-Effectiveness Analysis Registry and Web of Science in order to identify relevant evidence. To be eligible for inclusion studies will be primary empirical studies evaluating the cost, utility or full economic evaluation of interventions for preventing or treating eczema. Two reviewers will independently assess studies for eligibility and perform data abstraction. Evidence tables will be produced presenting details of study characteristics, costing methods, outcome methods and quality assessment. The methodological quality of studies will be assessed using accepted checklists. DISCUSSION: The systematic review is being undertaken to identify the type of economic evidence available, summarise the results of the available economic evidence and critically appraise the quality of economic evidence currently available to inform future economic modelling and resource allocation decisions about interventions to prevent or treat eczema. We aim to use the review to offer guidance about how to gather economic evidence in studies of eczema and/or what further research is necessary in order to inform this. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015024633.

Atopic dermatitis.

Atopic dermatitis (also known as atopic eczema) is a chronic inflammatory skin disease that is characterised by intense itching and recurrent eczematous lesions. Although it most often starts in infancy and affects two of ten children, it is also highly prevalent in adults. It is the leading non-fatal health burden attributable to skin diseases, inflicts a substantial psychosocial burden on patients and their relatives, and increases the risk of food allergy, asthma, allergic rhinitis, other immune-mediated inflammatory diseases, and mental health disorders. Originally regarded as a childhood disorder mediated by an imbalance towards a T-helper-2 response and exaggerated IgE responses to allergens, it is now recognised as a lifelong disposition with variable clinical manifestations and expressivity, in which defects of the epidermal barrier are central. Present prevention and treatment focus on restoration of epidermal barrier function, which is best achieved through the use of emollients. Topical corticosteroids are still the first-line therapy for acute flares, but they are also used proactively along with topical calcineurin inhibitors to maintain remission. Non-specific immunosuppressive drugs are used in severe refractory cases, but targeted disease-modifying drugs are being developed. We need to improve understanding of the heterogeneity of the disease and its subtypes, the role of atopy and autoimmunity, the mechanisms behind disease-associated itch, and the comparative effectiveness and safety of therapies.

Cost-effectiveness of partially hydrolyzed whey protein formula in the primary prevention of atopic dermatitis in high-risk urban infants in Southeast Asia.

BACKGROUND: Atopic dermatitis (AD) is one of the most common skin conditions among infants. Proteins found in cow's milk formula (CMF) have been found to be attributable to heightened AD risk, particularly in infants with familial AD heredity. Previous studies have suggested that intervention with partially hydrolyzed formula in nonexclusively breastfed infants can have a protective effect against AD development. OBJECTIVE: The aim of the present study was to compare the estimates of the economic impact of reducing the AD incidence by feeding a partially hydrolyzed whey-based formula (PHF-W) instead of a standard CMF to high-risk nonexclusively breastfed urban infants for the first 17 weeks of life in the Philippines, Malaysia, and Singapore. METHODS: In each country, a mathematical model simulated AD incidence and burden from birth to 6 years of age of using PHF-W versus CMF in the target population using data from the German Infant Nutritional Intervention study. The models integrated literature, current cost and market data, and expert clinician opinion. Modeled outcomes included AD risk reduction, time spent after AD diagnosis, AD symptom-free days, quality-adjusted life years (QALYs), and costs (direct and indirect). Outcomes were discounted at 3% per year. Costs were expressed in USD. RESULTS: Feeding high-risk infants PHF-W instead of CMF resulted in an estimated absolute 14% (95% CI 1-24) AD risk reduction, a 0.69-year (95% CI 0.25-1.13) reduction in the time spent after AD diagnosis per child, reductions of 16-38 AD days, and gains in 0.02-0.04 QALYs, depending on the country. The per-child AD-related 6-year cost-saving estimates of feeding high-risk infants with PHF-W versus CMF were USD 739 in Singapore, USD 372 in Malaysia, and USD 237 in the Philippines.

Atopic dermatitis - all you can do from the outside.

Atopic dermatitis (AD) affects both the epidermal barrier and the immune system and, as such, therapy needs to address both. Skin cleansing supported by emollients and moisturizers is the primary topical therapy when treating patients with AD. However, it should be remembered that the direct use of emollients on inflamed skin is poorly tolerated and that the flares need to be treated effectively, usually by topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). This contribution outlines a number of strategies for effectively managing AD, from reactive therapy using TCS and TCI to proactive therapy. Proactive therapy is an alternative, evidence-based, immunologically founded treatment approach, based on the fact that normal-looking, nonlesional skin of patients with AD is not normal. The advantage of the proactive approach is that the patients are in control of their disease and are actively involved in its management. The avoidance of external irritants is recommended wherever possible.

Assessment of serum 25-hydroxyvitamin d levels in children with atopic dermatitis: correlation with SCORAD index.

BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory skin disorder with an immunologic basis. It may have negative medical and social impacts on a patient and his family. OBJECTIVES: To assess serum level of vitamin D among children with AD and determine its association with AD severity using the AD Scoring System Index. STUDY DESIGN: A case-control study. PATIENTS AND METHODS: Twenty-nine patients with AD in the age group between 2 and 12 years were enrolled in the study. The severity of the disease was determined by the AD scoring system. Thirty controls were recruited. Serum levels of 25-hydroxyvitamin D3 [25(OH)D3] were tested using commercial automated chemiluminescent microparticle immunoassay. RESULTS: The mean value of vitamin D in children with AD was much lower than normal value, and there was a significant difference in the mean values of vitamin D between children with AD (5.4±1.9 ng/mL) and the controls (28.9±2.4 ng/mL). Serum 25(OH)D levels were found to be significantly higher in mild AD (14.6±3.5 ng/mL) compared with moderate (5.5±3.1 ng/mL) or severe AD (0.3±0.1 ng/mL); P<0.001. CONCLUSION: Patients with AD have lower serum vitamin D levels than normal. Vitamin D deficiency might be related to the severity of AD.

Improved emollient use reduces atopic eczema symptoms and is cost neutral in infants: before-and-after evaluation of a multifaceted educational support programme.

BACKGROUND: Parents and carers of children with eczema often underuse emollient therapy, essential to repairing and protecting the defective skin barrier in atopic eczema. Educational interventions delivered by specialist dermatology nurses in hospital settings have been shown to improve emollient use and reduce symptoms of atopic eczema, but benefits of community-based interventions are uncertain. Support and information about appropriate care may often be inadequate for patients and carers in the community. METHODS: A multifaceted educational support programme was evaluated as a method of increasing emollient use and reducing atopic eczema in children. Support provided for parents and carers included an educational DVD, online daily diary and telephone helpline. The before and after study included 136 British children and their parents, providing baseline and 12 week follow-up data while receiving the programme. Measures included emollient use, POEM and PEST scores, and cost of care. RESULTS: Average emollient use increased by 87.6 g (95% CI: 81.9 to 119.5 g, p = 0.001) from baseline with the change being immediate and persistent. The POEM score reduced on average by 5.38 (95% CI: 4.36 to 6.41, p = 0.001), a 47% reduction from baseline. Similarly the PEST score reduced on average by 0.61 (95% CI: 0.47 to 0.75, p = 0.001), a 48% reduction from baseline. Sleep disturbance was reduced by 1.27 nights per week (95% CI: 0.85 to 1.68, p = 0.001) and parental feeling of control improved by 1.32 points (95% CI: 1.16 to 1.48, p = 0.001). From the NHS perspective, the programme was cost neutral overall within the study period. CONCLUSION: A community-based multifaceted educational support programme greatly increased emollient use, reducing symptoms of atopic eczema and general practitioner contacts, without increasing cost. Significant benefits may accrue to the families and carers of children with atopic eczema due to improved sleep patterns and greater feeling of control. PEST, a new simple measure of acute and remitting atopic eczema severity designed to help parents and children to monitor and manage eczema, merits further evaluation.

Breastfeeding practice and its association with respiratory symptoms and atopic disease in 1-3-year-old children in the city of Riyadh, central Saudi Arabia.

BACKGROUND: Saudi Arabia has a declining rate of breastfeeding and increasing levels of childhood asthma and atopic disease. In highly economically developed countries, breastfeeding of children at high risk of atopic disease reduces the likelihood of atopic dermatitis, wheezing associated with respiratory infections, and possibly asthma. This study investigated the prevalence of breastfeeding and its association with wheezing/asthma and atopic disease in 1-3-year-old children in Riyadh, Saudi Arabia. SUBJECTS AND METHODS: A cross-sectional study of children attending routine "well-baby" clinics in three Saudi State Hospitals in Riyadh. An interviewer administered a questionnaire to collect data on sociodemographics, breastfeeding, wheezing symptoms, asthma, and atopic disease. RESULTS: In total, 622 children 1-3 years old were recruited. Of these, 75% of children were ever breastfed, and 36% of children were fully breastfed, with 20% of children being fully breastfed for ≥ 3 months. Increasing duration of full breastfeeding was associated with a reduced likelihood of maternal reporting of her child having "ever wheezed," "wheezed' in the last 12 months," and "ever having asthma," with adjusted odds ratio for full breastfeeding ≥ 12 months versus never breastfed of 0.51 (95% confidence interval 0.29-0.90), 0.48 (0.26-0.88), and 0.46 (0.22-0.94), respectively. No associations were demonstrable between full or ever breastfeeding and atopic dermatitis/eczema, irrespective of family history of atopic disease. CONCLUSIONS: Although breastfeeding does not protect children from developing eczema in Riyadh, full breastfeeding is associated with reduced childhood wheezing and possibly asthma. Further efforts should be made to promote breastfeeding in Saudi Arabia.

Cost-effectiveness analysis, prevention of atopic dermatitis by oral application of bacterial lysate in newborns/small children.

OBJECTIVES: The aim of this analysis was to determine the cost-effectiveness compared to placebo of prophylactic treatment with sterile bacterial lysate (Escherichia coli and Enterococcus faecalis) (verum) of newborns/small children with heredity for atopy [atopic dermatitis (AD)]. Infants were followed from the age of 5 weeks until 3 years of age. During this time, the number of children with AD who were treated with verum or placebo was observed at eight visits. Cost-effectiveness analyses were performed at different time points. METHODS: A randomized, double-blind placebo-controlled clinical trial performed in Germany included 606 newborns. After randomization, n = 303 patients were classified in the placebo group and n = 303 in the verum group. A total of 119 participants left the study, so data from n = 250 patients of the placebo group and n = 237 patients of the verum group were available for analysis. At the beginning of the study, newborns were treated prophylactically with bacterial lysate or placebo for 26 weeks. After this, children were observed until the age of 3 years. A systematic literature research was done to evaluate treatment costs of atopic eczema in newborn/small children. Finally, 17 publications were included and checked for searched treatment costs of AD. A study was then initiated to evaluate the direct costs to statutory health insurance. Based on the described clinical trial, a decision tree model was developed. Using the evaluated direct costs and prevalence according to the clinical trial, the developed model can be used in cost-effectiveness analyses. RESULTS: The focus of the analyses was on the subgroup "single heredity for atopy" in clinical trials. Cost-effectiveness analysis showed an advantage for bacterial lysate after 3 years. To further support this result a model extension was executed; the model was expanded from 3 to 6 years. Cost-effectiveness of bacterial lysate was also proven after 6 years. CONCLUSION: Prophylactic treatment with bacterial lysate of infants with single heredity for atopy for 26 weeks in the 1st year of life is cost-effective at the age of 3 and 6 years, i.e. prophylactic use of bacterial lysate generated lower costs by leading to lower prevalence compared to placebo.