Severe and widespread atopic eczema often fails to respond adequately to currently available therapies. Following the observation of substantial benefit in patients receiving oral treatment with daily decoctions of traditional Chinese medicinal plants, we undertook a placebo-controlled double-blind trial of a specific prescription formulated for widespread non-exudative atopic eczema. Forty-seven children were given active treatment and placebo in random order, each for 8 weeks, with an intervening 4-week wash-out period. Thirty-seven children tolerated the treatment and completed the study. Response to active treatment was superior to response to placebo, and was clinically valuable. There was no evidence of haematological, renal or hepatic toxicity. These findings anticipate a wider therapeutic potential for traditional Chinese medicinal plants in this disease, and other skin diseases.

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The opportunity to continue treatment was offered to the parents of 37 children who had completed a double-blind placebo-controlled trial of a specific formulation of Chinese medicinal herbs for atopic eczema. The parents elected for continued treatment in every case, and the progress of the children was monitored over the following 12 months. The aim was to achieve a substantial clinical improvement, and thereafter to reduce treatment frequency progressively while maintaining this benefit. At the end of the year, 18 enjoyed at least 90% reductions in eczema activity scores, and five showed lesser degrees of improvement. Fourteen children withdrew from the study, 10 due to lack of response, and four because of unpalatability of treatment or difficulty in the preparation of treatment. By the end of the year, seven of the children were able to discontinue treatment without relapse. The other 16 required treatment to maintain control of their eczema, but only four of these still required daily treatment. Asymptomatic elevation of serum aspartate aminotransferase to 7-14 times normal values was noted on one occasion in two children whose eczema was so well controlled that the therapy was stopped. Liver function tests were normal 8 weeks later. We conclude that Chinese medicinal herbs provide a therapeutic option for children with extensive atopic eczema which has failed to respond to other treatments. In the medium term, it proved helpful for approximately half the children who originally took part in our placebo-controlled trial. The possibility that it may provoke hepatic abnormalities requires further study.(ABSTRACT TRUNCATED AT 250 WORDS)

ABSTRACT. Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients.Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety.Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicletreated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site.Conclusion A topic dermatitis (AD) is a recurrent inflammatory skin disease, with intense pruritus as its hallmark symptom, and often follows a chronic, relapsing course. 1 It frequently affects children, with symptoms developing in 65% of patients before 1 year of age and in 90% by 5 years of age. 2 Although many children will outgrow the condition by 10 years of age, 60% remain symptomatic as adults. 2 If not outgrown in childhood, the condition progresses to adulthood, with recurrent flares that may be severe and sometimes debilitating. The prevalence of AD in the United States is projected to be between 7% and 17% of school-aged children and has increased greatly over the past 40 years. 3 Several quality-of-life issues have been reported in children with AD, including sleep disturbances, changes in activity, irritability, and self-consciousness. 4-8 AD exacts a marked toll on the children and their families through both direct and indirect financial expenses of medical care. Even more significant are the stressful impacts of sleep deprivation, missed school and work, and the time spent on the dai...

Adult patients with severe atopic eczema who had completed a double-blind placebo-controlled crossover trial of a specific formulation of Chinese herbal therapy were offered continued therapy for 1 year. Of 31 patients who completed the original placebo-controlled study and after a washout period and 2 months of further treatment, 17 continued treatment (group 1), 11 chose not to continue treatment (group 2), one was lost to follow-up and two patients originally in group 1 decided to stop treatment and became pregnant. At the end of the year, 12 of the patients in group 1 had greater than 90% reduction and the remaining five had greater than 60% reduction in clinical scores compared with baseline values. Clinical scores of patients in group 2 gradually deteriorated so that by the end of the year the difference between groups 1 and 2 was highly significant (P = 0.005 and P = 0.002 for erythema and surface damage, respectively). At the end of the year no patient in group 1 felt able to discontinue treatment permanently, but eight patients were on an alternate-day regimen by 6 months and remained on this regimen until the end of the year, and seven were able to control their eczema with a 1 in every 3 day treatment by the end of the year. The remaining two patients continued on daily treatments. Toxicology screening revealed no abnormalities in either full blood counts or biochemical parameters in any patient on continued treatment. Improvement in disease was not associated with any significant change in serum IgE level or peripheral blood lymphocyte subsets.(ABSTRACT TRUNCATED AT 250 WORDS)