The efficacy of whey associated with dodder seed extract on moderate-to-severe atopic dermatitis in adults: A randomized, double-blind, placebo-controlled clinical trial
The efficacy of whey associated with dodder seed extract on moderate-to-severe atopic dermatitis in adults: A randomized, double-blind, placebo-controlled clinical trial
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DOI：
10.1016/j.jep.2015.07.003
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发表时间：
2015-08-22
影响因子：
5.4
通讯作者：
Mehrabani, Mehrnaz
中科院分区：
文献类型：
--
作者：
Mehrbani, Mehrzad;Choopani, Rasool;Mehrabani, Mehrnaz
民族药理学相关性：特应性皮炎是一种常见的慢性炎症性皮肤病，正在上升，并对受影响个体的生活质量产生不利影响。皮肤干燥和瘙痒是该病的主要特征，与皮肤屏障功能障碍有关。虽然轻度病例可以用抗组胺药和局部皮质类固醇控制，但中度至重度病例通常需要用免疫调节药物治疗，这有许多副作用。现在，使用补充和替代药物治疗特应性皮炎更为常见。在传统的伊朗医学中，使用乳清与田野菟丝子（Cuscuta campestris Yunck.）种子在严重和难治性异位性皮炎的情况下是常见的，没有副作用。本研究的目的是评估乳清与菟丝子提取物在治疗中度至重度异位性皮炎adultes.Materials和方法的有效性和安全性：这项研究是一项随机，双盲安慰剂对照试验，进行了52例中度至重度异位性皮炎30天。在这项研究中，患者接受了15天的冷冻干燥乳清粉与喷雾干燥的水提取物或安慰剂。基线时（第0周），15天给药期结束后（第3周）和停药或安慰剂后15天（随访/第5周），使用Multi Skin Test Center MC 1000对患者前臂的皮肤水分、弹性、色素沉着、表面pH值和皮脂含量进行评估结果：42例患者完成了30天的药物治疗和随访期。在随访期结束时，与安慰剂组相比，观察到接受含菟丝子乳清的组的皮肤水分和弹性显著增加（p < 0.001）。在接受治疗或安慰剂15天后，两组之间的瘙痒有显著差异（p < 0.05），在30天研究期结束时，差异明显显著（p < 0.001）。睡眠障碍在随访结束时有显著性变化（p < 0.05）。关于皮肤色素沉着的变化，两组之间没有显著差异，然而，随着时间的推移，在接受与菟丝子提取物相关的乳清的组中观察到显著降低（p < 0.001）。两组间皮肤表面pH值和皮脂量无显著变化。据报道，暂时的副作用包括厌食症和轻度胃肠道问题的药物使用。值得注意的是，在这项研究中，尽管患者仅接受了15天的乳清和菟丝子，但皮肤的水分和弹性在研究的后半段（随访期）继续增加。这表明乳清与菟丝子的作用不是短暂的，这种药物确实有助于皮肤屏障重建，加速皮肤愈合过程。这对皮肤参数产生了积极的影响，从而改善了瘙痒和睡眠障碍。结论：结果表明，乳清与菟丝子提取物可以作为一个有前途的替代治疗中度至重度特应性皮炎。(C)2015爱思唯尔爱尔兰有限公司版权所有。
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. (C) 2015 Elsevier Ireland Ltd. All rights reserved.