Mehrzad Mehrbani1, Rasool Choopani2, Alireza Fekri3, Mitra Mehrabani4, Mahmoud Mosaddegh5, Mehrnaz Mehrabani6. 1. Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Department of Dermatology, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran. 4. Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: mmehrabani@hotmail.com. 5. Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 6. Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Atopic dermatitis is a common chronic inflammatory skin condition that is on the rise and adversely affects quality of life of the affected individual. Dry skin and pruritus, major characteristics of this disease, are associated with the dysfunction of the skin barrier. Though mild cases of the disease can be controlled with antihistamines and topical corticosteroids, moderate-to-severe cases often require treatment with immunomodulatory drugs, which have many side effects. It is now more common to use complementary and alternative medicines in the treatment of atopic dermatitis. In traditional Iranian medicine, the use of whey with the aqueous extract of field dodder (Cuscuta campestris Yunck.) seeds in severe and refractory cases of atopic dermatitis is common and has no side effects. The aim of this study was to assess the efficacy and safety of whey associated with dodder seed extract in the treatment of moderate-to-severe atopic dermatitis in adults. MATERIALS AND METHODS: The study was a randomized, double-blind placebo control trial that was conducted on 52 patients with moderate-to-severe atopic dermatitis for 30 days. In this study patients received freeze dried whey powder with spray dried water extract of field dodder or the placebo for 15 days. At baseline (week zero), after the end of the 15 day treatment period (week three) and 15 days after stopping the drug or placebo (follow-up/week five), patients were evaluated in terms of skin moisture, elasticity, pigmentation, surface pH and sebum content on the forearm with Multi Skin Test Center® MC1000 (Courage & Khazaka, Germany) and the degree of pruritus and sleep disturbance in patients were also recorded. RESULTS:42 patients completed 30 days of treatment with the medicine and the follow-up period. At the end of the follow-up period a significant increase in skin moisture and elasticity in the group receiving whey with dodder was observed compared with the placebo group (p<0.001). There was a significant difference between the two groups regarding the pruritus after 15 days of receiving treatment or the placebo (p<0.05), and at the end of the 30-day study period the difference was clearly significant (p<0.001). Sleep disturbance showed significant changes at the end of follow-up period (p<0.05). There was no significant difference between the two groups concerning changes in skin pigmentation, however, a significant decrease was observed in the group receiving whey associated with dodder seed extract over time (p<0.001). There were no significant alterations in skin surface pH and the amount of sebum between the two groups. Temporary side effects were reported including anorexia and mild gastrointestinal problems in drug use. It is noteworthy that in this study despite the fact that patients received whey with dodder for just 15 days, moisture and elasticity of the skin continued to increase in the second half of the study (follow-up period). This shows that the effect of whey with dodder is not transient and this drug really helped skin barrier reconstruction and accelerated the healing process of skin. This positively influenced the skin parameters and consequently the improvement of pruritus and sleep disturbance. CONCLUSIONS: The results indicate that whey associated with dodder seed extract can serve as a promising alternative for the treatment of moderate-to-severe atopic dermatitis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2013121415790N1.
RCT Entities:
ETHNOPHARMACOLOGICAL RELEVANCE: Atopic dermatitis is a common chronic inflammatory skin condition that is on the rise and adversely affects quality of life of the affected individual. Dry skin and pruritus, major characteristics of this disease, are associated with the dysfunction of the skin barrier. Though mild cases of the disease can be controlled with antihistamines and topical corticosteroids, moderate-to-severe cases often require treatment with immunomodulatory drugs, which have many side effects. It is now more common to use complementary and alternative medicines in the treatment of atopic dermatitis. In traditional Iranian medicine, the use of whey with the aqueous extract of field dodder (Cuscuta campestris Yunck.) seeds in severe and refractory cases of atopic dermatitis is common and has no side effects. The aim of this study was to assess the efficacy and safety of whey associated with dodder seed extract in the treatment of moderate-to-severe atopic dermatitis in adults. MATERIALS AND METHODS: The study was a randomized, double-blind placebo control trial that was conducted on 52 patients with moderate-to-severe atopic dermatitis for 30 days. In this study patients received freeze dried whey powder with spray dried water extract of field dodder or the placebo for 15 days. At baseline (week zero), after the end of the 15 day treatment period (week three) and 15 days after stopping the drug or placebo (follow-up/week five), patients were evaluated in terms of skin moisture, elasticity, pigmentation, surface pH and sebum content on the forearm with Multi Skin Test Center® MC1000 (Courage & Khazaka, Germany) and the degree of pruritus and sleep disturbance in patients were also recorded. RESULTS: 42 patients completed 30 days of treatment with the medicine and the follow-up period. At the end of the follow-up period a significant increase in skin moisture and elasticity in the group receiving whey with dodder was observed compared with the placebo group (p<0.001). There was a significant difference between the two groups regarding the pruritus after 15 days of receiving treatment or the placebo (p<0.05), and at the end of the 30-day study period the difference was clearly significant (p<0.001). Sleep disturbance showed significant changes at the end of follow-up period (p<0.05). There was no significant difference between the two groups concerning changes in skin pigmentation, however, a significant decrease was observed in the group receiving whey associated with dodder seed extract over time (p<0.001). There were no significant alterations in skin surface pH and the amount of sebum between the two groups. Temporary side effects were reported including anorexia and mild gastrointestinal problems in drug use. It is noteworthy that in this study despite the fact that patients received whey with dodder for just 15 days, moisture and elasticity of the skin continued to increase in the second half of the study (follow-up period). This shows that the effect of whey with dodder is not transient and this drug really helped skin barrier reconstruction and accelerated the healing process of skin. This positively influenced the skin parameters and consequently the improvement of pruritus and sleep disturbance. CONCLUSIONS: The results indicate that whey associated with dodder seed extract can serve as a promising alternative for the treatment of moderate-to-severe atopic dermatitis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2013121415790N1.