Prospective, Randomised Placebo-Controlled Double-Blind Study – Chronic Plaque PsoriasisApril 4, 2012
PROSPECTIVE, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND STUDY ON THE EFFICACY AND SAFETY OF A SERIES OF HERBAL SKIN-CARE PRODUCTS FOR STABLE CHRONIC PLAQUE PSORIASIS
Harald Maier, Peter Donath, Michael Tirant, Dragana Relic, Shahla Farokhnia, Herbert Hönigsmann, Adrian Tanew
Division of Special and Environmental Dermatology, Department of Dermatology, University of Vienna Medical School
At present, topical cortisone is still the mainstay of therapy for stable chronic plaque psoriasis as long as the affected skin area is not too extensive. However, there is growing concern among patients about possible side effects of steroid therapy. A recent study showed that overall, 42 % patients were unsatisfied with the current management of their skin disease. This is the reason why, like in other medical specialities, patients with psoriasis more and more, turn to complementary treatment options such as magnetic field resonance therapy, traditional Chinese medicine (TCM) and herbal medicine. It is the young, the well-educated, patients with higher income, women and patients with chronic disease who are most open-minded to complementary methods. Actually, a flourishing market for complementary health products has developed. Unfortunately, most providers refuse to have their products tested according to international scientific standards. Advertising is merely based on anecdotal reports and the single opinions of (mostly prominent) persons. At the very best, uncontrolled clinical observations are presented.
We assessed the efficacy and safety of an Australian series of herbal skin-care products (Dr. Michaels ® skin-care products for psoriasis) for the management of stable chronic plaque psoriasis. The producer claims that the skin disease improves significantly within a 6 to 8 weeks treatment course.
Methods: Inclusion criteria were: male or female patients with light to medium chronic plaque psoriasis. No other antipsoriatic treatment was allowed. Any antipsoriatic therapy had to be discontinued at least 2 weeks previously. We chose a prospective, randomized, double-blind design. As control we used a series of three common fatty skin-care products which contained no active ingredient. The guidelines for the use were identical for both product series. All skin lesions except the scalp were treated. The cleansing gel was distributed generously on the lesions and washed off after three to five minutes with warm water. Afterwards the lesion was covered with the ointment. After the ointment had dried up the patients applied a thin layer of skin conditioner. The procedure was performed twice daily over a period of 8 weeks. Before treatment, after 2, 4, 6 and 8 weeks a blind observer assessed the Psoriasis Area Severity Index (PASI). The values of scalp involvement were not included. Standardized photos of typical lesions were taken before and after 2, 4, 6 and 8 weeks treatment. For statistical analysis we used Mann-Whitney-U Test made with SPSS for Windows.
Results: We assigned 34 (15 f /19 m) patients to our study population. 14 patients of the group which was treated with the herbal products and 10 patients of the control group completed the treatment course. Before therapy the mean PASI score of the group with the herbal products was 6.8±2.4 SD, and 5.5±2 SD in the control group, respectively. After the 8 weeks treatment course the mean PASI score reduction in the herbal group was 1.02±1.01 SD, which is equivalent to a PASI score reduction of 89%±14.9 SD. The respective values in the control group were 4.1±1.7 SD and 22%±28.7 SD. Three patients in the herbal and three patients in the control group reported mild and transient side effects (irritative dermatitis, folliculitis).
DISCUSSION: This study shows that the herbal skin-care products tested improve mild to moderate stable chronic plaque psoriasis significantly. One strength of this study is the clear study design which is regarded as the gold standard of clinical tests. As is well known, the PASI is a standardized internationally accepted evaluation score which in the hands of an experienced clinician is a reliable assessment tool.
It was so obvious in the study course that the verum products were superior to the placebo preparations. Except for coal tar which is present in only the cleansing gel, none of the listed herbal ingredients is a known antipsoriatic remedy.
Therefore, an analysis for undeclared drugs (cortisone, calcipotriol, macrolides) was undertaken although the producer (who is one of the authors, M.T.) gave a statement of innocuousness and provided the complete list of constituents and the respective material safety data sheets. Two samples of different batches of each product were analysed. None of the products contained any of the compounds mentioned above.
CONCLUSIONS: The products tested already fulfil a lot of aspects addressed by the European Parliament in the proposal for a directive on traditional herbal medicinal products. Our investigation demonstrates that complementary methods may play a role in dermatologic therapy as far as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. Dr Michaels skin-care products can be used successfully in the treatment of stable chronic plaque psoriasis.no comments | posted in Clinical Trials,News