地中海饮食和牛皮癣患者:MEDIPSO随机临床试验。

IF 11 1区 医学 Q1 DERMATOLOGY
Javier Perez-Bootello, Emilio Berna-Rico, Carlota Abbad-Jaime de Aragon, Leticia Goni, Zenaida Vazquez-Ruiz, Fernando Neria, Ruth Cova-Martin, Jorge Naharro-Rodriguez, Asuncion Ballester-Martinez, Cristina Pindado-Ortega, Diana Monge, Andrew Blauvelt, Pedro Jaen, Nehal Mehta, Joel M Gelfand, Miguel A Martinez-Gonzalez, Álvaro Gonzalez-Cantero
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引用次数: 0

摘要

重要性:尽管人们对饮食在牛皮癣预防和治疗中的作用越来越感兴趣,但缺乏随机临床试验。地中海饮食以其抗炎和心脏代谢益处而闻名,这可能与牛皮癣的病理生理有关。目的:评估16周地中海饮食干预是否会改善轻至中度牛皮癣患者的严重程度。设计、环境和参与者:MEDIPSO(地中海饮食对牛皮癣患者的影响)是一项开放标签、单中心、单盲(评估者)随机临床试验,于2024年2月至2025年3月在西班牙马德里的一家皮肤科转诊诊所进行。参与者是接受稳定局部治疗的轻度至中度银屑病(银屑病面积和严重程度指数[PASI]为2-10,分数越高表示病情最大)的成年人。干预:参与者按1:1随机分为干预组和对照组。干预组接受了为期16周的由营养师指导的地中海饮食计划,包括营养咨询、教育材料和每周提供特级初榨橄榄油。对照组在没有营养师监督的情况下接受标准的低脂饮食建议。主要结局和测量:主要结局是PASI从基线到第16周的变化。次要结局包括地中海饮食依从性、人体测量和代谢参数、血清炎症细胞因子和患者报告结局的变化。报告基线时的估计边际均值(emm)以及从基线到第16周的变化,干预效果表示为组间差异。结果:在筛选的45名个体中,38名参与者入组并随机化(平均[SD]年龄46.4[12.8]岁,25名男性[65.8%]);其中干预组19例,对照组19例;37人(97.4%)完成了研究。干预组第16周EMM PASI变化为-3.4 (95% CI, -4.4至-2.4),对照组为0.0 (95% CI, -1.0至1.0);组间EMM差异为-3.4 (95% CI, -4.8至-2.0;P)结论和相关性:该随机临床试验发现,接受稳定局部治疗的轻至中度疾病患者,16周的地中海饮食干预可显著改善银屑病严重程度。这些发现表明,将饮食策略作为牛皮癣治疗的辅助疗法可能是有益的。试验注册:ClinicalTrials.gov标识符:NCT06257641。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Mediterranean Diet and Patients With Psoriasis: The MEDIPSO Randomized Clinical Trial.

Importance: Despite growing interest on the role of diet in the prevention and treatment of psoriasis, randomized clinical trials are lacking. The Mediterranean diet is known for its anti-inflammatory and cardiometabolic benefits, which may be relevant to psoriasis pathophysiology.

Objective: To assess whether a 16-week Mediterranean diet intervention would improve psoriasis severity in patients with mild to moderate disease.

Design, setting, and participants: MEDIPSO (Impact of the Mediterranean Diet on Patients With Psoriasis), an open-label, single-center, single-blinded (evaluator) randomized clinical trial, was conducted from February 2024 to March 2025 at a dermatology referral clinic in Madrid, Spain. Participants were adults with mild to moderate psoriasis (Psoriasis Area and Severity Index [PASI] of 2-10, with higher scores indicating maximal disease) receiving stable topical therapy.

Interventions: Participants were randomized 1:1 to the intervention or control group. The intervention group received a 16-week, dietitian-guided Mediterranean diet program, including nutritional counseling, educational materials, and weekly provision of extra virgin olive oil. The control group received standard low-fat dietary advice without dietitian supervision.

Main outcomes and measures: The primary outcome was the change in the PASI from baseline to week 16. Secondary outcomes included changes in Mediterranean diet adherence, anthropometric and metabolic parameters, serum inflammatory cytokines, and patient-reported outcomes. Estimated marginal means (EMMs) at baseline and for the change from baseline to week 16 were reported, with the intervention effect presented as the between-group difference.

Results: Among 45 individuals screened, 38 participants were enrolled and randomized (mean [SD] age, 46.4 [12.8] years; 25 males [65.8%]); 19 were randomized to the intervention group and 19 were randomized to the control group; 37 individuals (97.4%) completed the study. The EMM PASI change at week 16 was -3.4 (95% CI, -4.4 to -2.4) in the intervention group and 0.0 (95% CI, -1.0 to 1.0) in the control group; the between-group EMM difference was -3.4 (95% CI, -4.8 to -2.0; P < .001). Nine of 19 participants in the Mediterranean diet group (47.4%) achieved PASI 75 (a 75% reduction in PASI) compared with none in the control group. A significant reduction in EMM hemoglobin A1c (glycated hemoglobin) was observed in the intervention group as compared with the control group (between-group EMM difference, -4.1 mmol/mol [95% CI, -6.9 to -1.3 mmol/mol]; P = .01).

Conclusions and relevance: This randomized clinical trial found that a 16-week Mediterranean diet intervention significantly improved psoriasis severity in patients with mild to moderate disease receiving stable topical therapy. These findings suggest that incorporating dietary strategies may be beneficial as an adjunctive therapy in psoriasis management.

Trial registration: ClinicalTrials.gov Identifier: NCT06257641.

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来源期刊
JAMA dermatology
JAMA dermatology DERMATOLOGY-
CiteScore
14.10
自引率
5.50%
发文量
300
期刊介绍: JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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