The concept of evidence-based medicine (EBM) has become a global standard for contemporary clinical practice. In the field of dermatology and allergology in Japan, however, progress of EBM movement seems to be a little slow. In this article, basic idea, concept and terminology of EBM are explained for dermatologists. Necessity and methodology of systematic review of treatments and prevention for atopic dermatitis are also addressed.

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[in Japanese]

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The purpose of this article is to review the effectiveness of the therapeutic use of topical corticosteroids to atopic dermatitis based on the information derived from randomized controlled trials (RCTs) of which level of evidence is 2b or above. More than ten kinds of topical corticosteroids were assessed by RCTs with placebo and most of them showed their effectiveness. Many RCTs about topical corticosteroids versus topical corticosteroids were published and showed significant improvement in subject after 1-6 weeks of use. Six RCTs showed no sinificant difference between topical antimicrobial plus corticosteroid combinations and topical corticosteroids alone. The papers described wet wrap treatments by using RCT design did not assess the difference between wet wrap and placebo but between pre and post. Five RCTs showed long term relapse prevention by pulsed application of mometasone furoate, fluticasone propionate or vetamethasone valerate without no serious systemic adverse effects or skin atrophy.

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The efficacy and safety of tacrolimus (FK506) ointment on atopic dermatitis (AD) was evaluated on EBM. 59 clinical studies has been so far published among 182 English and 171 Japanese papers selected by the keywords, tacrolimus and AD. Several randomized, double-blind, multicenter studies successfully showed the effectiveness of tacrolimus ointment on AD and the consecutive studies also claimed no severe side effects except some adverse events such as transient irritation at the site of application. The similar effectiveness of tacrolimus ointment compared to very strong class topical corticosteroid was further confirmed in randomized, double-blind, multicenter study. In conclusion, the clinical efficacy and safety of tacrolimus ointment on AD has been established on EBM.

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Previous evidence base studies were evaluated for treatments of allergen elimination/restriction diet therapy in atopic dermatitis. These were 5 studies of effictive results for restriction diets in childhood atopic dermatitis with randomized controlled trials (RTCs) and some evidence to support egg and milk-free diets in egg allergic or unselected atopic eczema. There was no evidence to support the validity for the use in adult patients. There was insufficient evidence to make recommendations on maternal allergen avoidance for disease prevention.
Although there were some study results on delayed positive reactions for blind challenges, patch test, lymphoblast genesis test relatid foods in atopic eczema in some random sequence, there was insufficient evidence to support the clinical efficacy for allergen elimination diet.

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The importance of skin-care in the treatment of atopic dermatitis is widely accepted by dermatologists. However, the clinical evidence about the benefits of the treatment has not been fully established. Cochrane Group and British Medical Journal Publishing Group have systematically reviewed the randomized control studies (RCTs) on skin-care in the treatment of atopic dermatitis. Despite of their rigorous searching efforts, they stated that they could find only 5 RCTs. We found one additional RCT published after these systematic reviews. In these reports, the effect of the use of emollients, such as urea, ammonium lactate and other OTC moisturizing creams, have been studied in terms of transpidermal water loss and/or clinical symptoms. However, it has not been made clear how the emollients should be used in the treatment of atopic dermatitis, especially in relation to corticosteroid. Clinical trials to answer the questions whether the use of emollients may have steroid-sparing effects or not, and whether they could maintain or elongate the period of remission in the treatment of atopic dermatitis.

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As the number of atopic dermatitis patients, especially standardized therapy-resistant adult patients, is recently increasing, oriental medicine represented by Kampo therapy shows a tendency to be in great demand by the patients. It is, therefore, important to evaluate efficacy of Kampo therapy for atopic dermatitis objectively. The aim of this study was to examine efficacy and usefulness of an evidence-based Kampo therapy for patients with atopic dermatitis. Of 20 reports selected, there were a few randomized controlled trials and most of studies were non-randomized, non-parallel case series. These results suggest that the number of studies to evaluate efficacy of Kampo therapy and high levels of evidence in the primary clinical reserch for atopic dermatitis are limited at present. Taking into account some unique aspects of the management of Kampo therapy, which is distinct from Western medicine, and difficulty of case-control studies using an adequate placebo, original evaluating methods for Kampo therapy should be introduced in order to critically appraise efficacy of an evidence-based Kampo therapy for atopic dermatitis.

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[in Japanese]

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BACKGROUND: Considering about health-related quality of life (QOL) is an important issue in various medical fields. On the other hand reports of clinical investigation are nowadays becoming to be evaluated reflecting evidence based medicine (EBM). The aim of this paper is to review the articles about QOL of atopic dermatitis and to find out what is the relation of QOL research and EBM. METHODS: 40 papers which include both QOL and atopic dermatitis as key words were referred from Medline. They were written from 1993 to 2002. RESULTS: They were classified into four groups for their contents. 16 papers were described using QOL as one of the disease outcome measurements after each treatment. 14 papers were survey reports about the measurement of QOL in atopic dermatitis patients. 5 papers were about the establishment of the QOL questionnaire. 5 papers were review articles about QOL in dermatology. All but one questionnaire that were used in each research were validated by psychometric statistical method. CONCLUSIONS: Every research about QOL is based on EBM. And it is the worldwide current that QOL measurement is required when the clinical investigation is performed based on EBM.

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Relationship between stress and skin symptoms is often seen in the treatment of patients with atopic dermatitis. Especially, most cases that make resistance to ordinary dermatological treatment have psychosomatic aspect. However, the psychosomatic diagnosis and treatment of them are not well known to dermatologists. In order to help such medical treatment, “Psychosomatic questionnaire for atopic dermatitis patients” was made by the Japanese society of atopic dermatitis treatment and “Psychosomatic scale of atopic dermatitis” was made in the guidelines of the diagnosis and treatment for psychosomatic diseases by the psycho-neurological disease trust research of the Ministry of Health, Labor and Welfare. These two questionnaires showed that a distinction rate, reliability and validity were about 70% with statistical analyses. We herewith introduce these two questionnaires.

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