Abbasi Shirin, Kamalinejad Mohammad, Babaie Delara, Shams SeyedMohammad, Sadr Zahra, Gheysari Mehdi, Askari Vahid Reza, Rakhshandeh Hassan
Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Complement Ther Med. 2017 Dec;35:85-91. doi: 10.1016/j.ctim.2017.10.003. Epub 2017 Oct 13.
Atopic dermatitis (AD) is a common, chronic, relapsing and inflammatory skin disease characterized by pruritus and xerosis (dry skin). Its prevalence is on the increase worldwide, particularly in children. As the pathogenesis of AD involves a complex interaction of genetic, environmental and immunological factors, its definitive treatment is difficult.
This clinical trial was designed as equivalence study to investigate the effect of aqueous extract of edible dried fig fruit on the severity of AD as measured with scoring atopic dermatitis (SCORAD), in comparison with Hydrocortisone 1.0% as the routine treatment of AD and base cream as a placebo.
Forty five children aged 4 months to 14 years with mild to moderate AD (SCORAD <50) were randomly assigned, in a double blind manner, to three treatment groups in order to perform a randomised, double blinded, placebo-controlled clinical trial. The patients were instructed to apply their allocated creams twice a day for two weeks.
The randomised, placebo-controlled trial indicates that the new treatment had significantly increased efficacy in terms of reducing the SCORAD index, pruritus and intensity scores in comparison with Hydrocortisone 1.0% (p<0.05) and the placebo failed to ameliorate the symptoms.
Safety, efficacy, tolerability, and symptom relief were considerable in fig fruit extract in comparison with hydrocortisone 1.0%. This clinical trial suggests that fig fruit extract can be used instead of low potent corticosteroid in mild to moderate cases of AD.
特应性皮炎（AD）是一种常见的慢性复发性炎症性皮肤病，其特征为瘙痒和皮肤干燥。在全球范围内，其患病率呈上升趋势，尤其是在儿童中。由于AD的发病机制涉及遗传、环境和免疫因素的复杂相互作用，其确切治疗较为困难。
本临床试验设计为等效性研究，旨在比较食用干无花果果实水提取物与1.0%氢化可的松（作为AD的常规治疗药物）及基质乳膏（作为安慰剂）相比，对以特应性皮炎评分（SCORAD）衡量的AD严重程度的影响。
45名年龄在4个月至14岁之间的轻度至中度AD患儿（SCORAD<50）以双盲方式随机分配到三个治疗组，以进行随机、双盲、安慰剂对照的临床试验。患者被指示每天两次涂抹分配的乳膏，持续两周。
随机、安慰剂对照试验表明，与1.0%氢化可的松相比，新治疗方法在降低SCORAD指数、瘙痒和强度评分方面具有显著更高的疗效（p<0.05），且安慰剂未能改善症状。
与1.0%氢化可的松相比，无花果果实提取物在安全性、疗效、耐受性和症状缓解方面表现良好。本临床试验表明，在轻度至中度AD病例中，无花果果实提取物可替代低效皮质类固醇使用。
