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Background: In Western medicine, the application of topical steroids and oral antihistaminic or antiallergic agents is the main treatment option for atopic dermatitis (AD). However, instead of these therapies the disease may remain intractable in some patients, resulting in long-term exposure to these chemical agents and consequently leading to concerns about possible adverse drug reactions., Methods: In the present open-label clinical study, the efficacy and safety of a novel multi component TCM therapy approach for AD was investigated. Therefore, 94 patients received the formula I (10 crude drugs) orally, combined with both the lotion II (7 crude drugs), and the ointment III (8 crude drugs). Each crude drug was extracted with boiling water in a defined manner, concentrated, and reworked into the preparations. Standardized scores were used for evaluating the severities of AD (clinical severity 0-4) and pruritus (pruritus score 0-4)., Results: Both scores had significantly improved at the end of a 12 month treatment (P<0.001). Eosinophil ratio and serum IgE levels, which were elevated in AD patients, were significantly reduced at the end of therapy (P<0.01). In 32 of 94 treated patients the condition markedly improved, in 59 cases AD improved, and in 3 patients there was a slight improvement with no case of ineffective treatment. There was no hint of renal or hepatic toxicity or any other adverse effects., Conclusion: The present study confirms that the 3 newly developed herbal TCM combination preparations are clinically efficacious on AD, accomplishing a significant reduction in both clinical and pruritus scores as well as in eosinophil ratios and serum IgE levels., (© 2013 S. Karger GmbH, Freiburg.)