Non-steroidal Anti-inflammatory Agents and the Skin

In a double-blind, randomized, paired trial lasting 14 days in 72 patients with moderately severe atopic eczema, hamamelis distillate cream (5.35 g hamamelis distillate with 0.64 mg ketone/100 g) was compared with the corresponding drug-free vehicle and 0.5% hydrocortisone cream, and reductions of the basic criteria of severe atopic eczema (delta values of the sum scores), i.e. itching, erythema and scaling, were evaluated. Thirty-six patients in each group were treated, which allowed the detection of a 10% difference between verum and control (confirmatory 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 treatment regimens significantly reduced itching, erythema and scaling after 1 week. Hydrocortisone proved superior to hamamelis distillate. The basic criteria scores decreased by 2.7 and 1.6, respectively. The delta values of the minor criteria and the global rating of efficacy were also used to indicate the difference between these preparations. Hamamelis distillate cream, however, did not differ from the vehicle. Mean delta values of basic criteria were 1.8 and 2.0, respectively. All preparations were well tolerated. Unwanted cutaneous reactions occurred in six patients, although due to their inflammatory nature and their confinement to vehicle-treated patients, they may not represent true adverse effects but rather a lack of efficacy. The results prove the superiority of low-dose hydrocortisone cream over hamamelis distillate cream, and the therapeutic outcome following this preparation was no better than following the base preparation. The mild, yet unmistakable anti-inflammatory effect of hamamelis cream in experimental models of inflammatory skin disease was thus not reflected by an efficacy in patients with atopic eczema greater than that obtained from the base preparation.

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“…Bufexamac and other cyclooxygenase inhibitors are only marginally efficacious [18][19][20]. Therapeutic alternatives, however, are few.…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy of hamamelis distillate and hydrocortisone cream in atopic eczema

Schäfer‐Korting

Klövekorn³

et al. 1995

Eur J Clin Pharmacol

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Anti-inflammatory activity of hamamelis distillate applied topically to the skin

Körting

Schäfer‐Korting

Hart

et al. 1993

Eur J Clin Pharmacol

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The anti-inflammatory activity of hamamelis distillate has been evaluated with respect to drug concentration (0.64 mg/2.56 mg hamamelis ketone/100 g) and the effect of the vehicle (O/W emulsion with/without phosphatidylcholine (PC) in an experimental study. The effects were compared with those of chamomile cream, hydrocortisone 1% cream and 4 base preparations. Erythema was induced by UV irradiation and cellophane tape stripping of the horny layer in 24 healthy subjects per test. Skin blanching was quantified by visual scoring and chromametry. Drug effects were compared with one another and with an untreated control area, as well as with any action due to the vehicle. UV-induced erythema at 24 h was suppressed by low dose hamamelis PC-cream and hydrocortisone cream. Hydrocortisone appeared superior to both hamamelis vehicles, hamamelis cream (without PC) and chamomile cream. The latter preparation was also less potent than hamamelis PC-cream. Erythema 4 to 8 h after the stripping of the horny layer was suppressed by hydrocortisone (P < or = 0.05). Inflammation was also less pronounced following low dose hamamelis PC-cream and chamomile cream. Hamamelis PC-cream, however, appeared less potent than hydrocortisone. In general, visual scoring was more discriminatory than chromametry. The results have demonstrated an anti-inflammatory activity of hamamelis distillate in a PC-containing vehicle. A fourfold increase of drug concentration, however, did not produce an increase in activity.

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Non-steroidal Anti-inflammatory Agents and the Skin

Cited by 2 publications

References 25 publications

Comparative efficacy of hamamelis distillate and hydrocortisone cream in atopic eczema

Comparative efficacy of hamamelis distillate and hydrocortisone cream in atopic eczema

Anti-inflammatory activity of hamamelis distillate applied topically to the skin

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