COMPARATIVE EFFICACY OF HAMAMELIS DISTILLATE AND HYDROCORTISONE CREAMIN ATOPIC ECZEMA

In a double-blind, randomized, paired trial lasting 14 days in 72 pati ents with moderately severe atopic eczema, hamamelis distillate cream (5.35 g hamamelis distillate with 0.64 mg ketone/100 g) was compared w ith the corresponding drug-free vehicle and 0.5% hydrocortisone cream, and reductions of the basic criteria of severe atopic eczema (Delta v alues of the sum scores), i.e. itching, erythema and scaling, were eva luated. Thirty-six patients in each group were treated, which allowed the detection of a 10% difference between verum and control (confirmat ory study). Effects were compared using Wilcoxon's test. The mean sum scores of the basic criteria of the test areas were 5.3-5.5. All treat ment regimens significantly reduced itching, erythema and scaling afte r 1 week. Hydrocortisone proved superior to hamamelis distillate. The basic criteria scores decreased by 2.7 and 1.6, respectively. The Delt a values of the minor criteria and the global rating of efficacy were also used to indicate the difference between these preparations. Hamam elis distillate cream, however, did not differ from the vehicle. Mean Delta values of basic criteria were 1.8 and 2.0, respectively. All pre parations were well tolerated. Unwanted cutaneous reactions occurred i n six patients, although due to their inflammatory nature and their co nfinement to vehicle-treated patients, they may not represent true adv erse effects but rather a lack of efficacy. The results prove the supe riority of low-dose hydrocortisone cream over hamamelis distillate cre am, and the therapeutic outcome following this preparation was no bett er than following the base preparation. The mild, yet unmistakable ant i-inflammatory effect of hamamelis cream in experimental models of inf lammatory skin disease was thus not reflected by an efficacy in patien ts with atopic eczema greater than that obtained from the base prepara tion.