A controlled trial of traditional Chinese herbal medicine in Chinese patients with recalcitrant atopic dermatitis. A controlled trial of traditional Chinese medicinal plants in widespread non-exudative atopic eczema. Efficacy of traditional Chinese herbal therapy in adult atopic dermatitis.
There have been published reports from the United Kingdom of good responses to the use of traditional Chinese herbal medicine (Zemaphyte, Phytopharm Plc, Cambridge, UK) in treating recalcitrant atopic dermatitis. We conducted a double-blind, placebo-controlled, cross-over study among Chinese patients with recalcitrant atopic dermatitis using this same herbal preparation.
                Forty patients were recruited. They were given Zemaphyte and placebo in random order, each for 8 consecutive weeks with a 4-week wash-out period in between. Scores based on the severity and extent of four clinical parameters (erythema, surface damage, lichenification and scaling) were recorded at baseline and at 4-weekly intervals throughout the 20-week trial period.
                Thirty-seven patients completed the trial. There was a general trend of clinical improvement with time throughout the trial period in both patient groups, irrespective of whether they received Zemaphyte or placebo first. Zemaphyte, however, offered no statistically significant treatment effect over placebo for all four clinical parameters, except for lichenification at week 4. There were no significant carry-over effects. Blood tests for hematologic, renal and liver functions were all normal throughout the trial.
                Zemaphyte did not seem to benefit Chinese patients with recalcitrant atopic dermatitis in our study. Further research is required to evaluate its efficacy. 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. There has been considerable interest in traditional Chinese herbal therapy (TCHT) as a new treatment for atopic dermatitis. To establish the efficacy and safety of this treatment, a daily decoction of a formula containing ten herbs that has been found to be beneficial in open studies was tested in a double-blind placebo-controlled study. 40 adult patients with longstanding, refractory, widespread, atopic dermatitis were randomised into two groups to receive 2 months' treatment of either the active formulation of herbs (TCHT) or placebo herbs, followed by a crossover to the other treatment after a 4-week washout period. The main outcome measures were extent and severity of erythema and surface damage as judged by standardised body scores. The patients' own assessments of the overall response to treatment were also sought. The geometric mean score for erythema at the end of active treatment was 12.6 (95% confidence interval [CI] 5.9 to 22.0) and at the end of the placebo phase was 113 (65 to 180). The geometric mean score for surface damage was 11.3 (5.8 to 21.8) and 111.0 (68 to 182), respectively. The 95% CI for the mean geometric ratio for the two values with active treatment was 0.04 to 0.22 for erythema (p less than 0.0005) and 0.04 to 0.27 for surface damage (p less than 0.0005). Of the 31 patients who completed the study and expressed a preference, 20 preferred that phase of the trial in which they received TCHT whereas 4 patients preferred placebo (p less than 0.02). There was a subjective improvement in itching (p less than 0.001) and sleep (p less than 0.078) during the TCHT treatment phase. No side-effects were reported by the patients although many commented on the unpalatability of the decoction. TCHT seems to benefit patients with atopic dermatitis. Palatability of the treatment needs to be improved and its safety assured.
Chinese herbal mixtures may be effective in the treatment of atopic eczema. However, only four small poorly reported RCTs of the same product, Zemaphyte, were found and the results were heterogeneous. Further well-designed, larger scale trials are required, but Zemaphyte is no longer being manufactured.