Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: the BEE RCT.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Matthew J Ridd, Sian Wells, Stephanie J MacNeill, Emily Sanderson, Douglas Webb, Jonathan Banks, Eileen Sutton, Alison Rg Shaw, Zoe Wilkins, Julie Clayton, Amanda Roberts, Kirsty Garfield, Lyn Liddiard, Tiffany J Barrett, J Athene Lane, Helen Baxter, Laura Howells, Jodi Taylor, Alastair D Hay, Hywel C Williams, Kim S Thomas, Miriam Santer
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A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing.</p><p><strong>Objective: </strong>To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema.</p><p><strong>Design: </strong>Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks.</p><p><strong>Setting: </strong>Primary care (78 general practitioner surgeries) in England.</p><p><strong>Participants: </strong>Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents.</p><p><strong>Interventions: </strong>Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked.</p><p><strong>Main outcome measures: </strong>The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. 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引用次数: 0

Abstract

Background: Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing.

Objective: To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema.

Design: Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks.

Setting: Primary care (78 general practitioner surgeries) in England.

Participants: Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents.

Interventions: Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked.

Main outcome measures: The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks.

Results: A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2-8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences - cream-lotion 0.42 (95% confidence interval -0.48 to 1.32), gel-lotion 0.17 (95% confidence interval -0.75 to 1.09), ointment-lotion -0.01 (95% confidence interval -0.93 to 0.91), gel-cream -0.25 (95% confidence interval -1.15 to 0.65), ointment-cream -0.43 (95% confidence interval -1.34 to 0.48) and ointment-gel -0.18 (95% confidence interval -1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial.

Limitations: Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds.

Conclusions: The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them.

Future work: Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and 'novel' emollients.

Trial registration: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.

乳液、乳膏、凝胶和软膏治疗儿童湿疹的比较:BEE随机对照试验。
背景:润肤剂推荐用于湿疹(特应性湿疹/皮炎)儿童。由于缺乏对不同类型润肤剂的有效性和可接受性的正面比较,导致了处方的“试错”方法。目的:比较四种常用润肤剂治疗儿童湿疹的有效性和可接受性。设计:2021年完成的四组平行、单独随机、优势随机临床试验,采用嵌套定性研究。在≈4周和≈16周时,对父母/儿童进行了有目的的抽样调查。背景:英国初级保健(78例全科医生手术)。参与者:6个月至12岁患有湿疹的儿童,湿疹的严重程度至少较轻,对研究润肤剂或其成分没有已知的敏感性。干预措施:研究四种类型的乳液、乳膏、凝胶或软膏中具有相同特征的润肤剂,以及常规护理,并使用基于网络的随机系统进行分配。参与者没有戴口罩,评估湿疹区域严重程度指数得分的研究人员也戴口罩。主要结果指标:主要结果是16周内以患者为导向的湿疹测量评分。次要结果是52周内以患者为导向的湿疹测量评分、16周时湿疹面积严重程度指数评分、生活质量(特应性皮炎生活质量、儿童健康实用性9维度和欧洲生活质量5维度,五级版本,评分)、16周皮炎家庭影响和满意度。结果:共有550名儿童被随机分配接受乳液(分析主要结果131/分配137)、乳膏(137/140)、凝胶(130/135)或软膏(126/138)。基线时,86.0%的参与者是白人,46.4%是女性。中位(四分位间距)年龄为4(2-8)岁,以患者为导向的湿疹测量中位得分为9.3(SD 5.5)。没有证据表明在前16周内,不同类型的润肤剂的以患者为主导的湿疹测量平均得分存在差异(总体p=0.765):经调整的以患者为主的湿疹测量成对差异-乳膏0.42(95%置信区间-0.48至1.32)凝胶乳液0.17(95%置信区间-0.75至1.09)、软膏乳液-0.01(95%可信区间-0.93至0.91)、凝胶霜-0.25(95%置信间隔-1.15至0.65)、软膏霜-0.43(95%置信间距-1.34至0.48)和软膏凝胶-0.18(95%置信程度-1.11至0.75),疾病严重程度或英国诊断标准的应用,并且在任何次要结果上各组之间没有差异。各组每周使用指定润肤剂、非指定润肤药和局部皮质类固醇的中位数相似。乳液和凝胶的总体满意度最高。不良反应的数量没有差异,也没有显著的不良事件。在嵌套的定性研究中(n=44名父母,n=25名儿童),对乳膏和软膏的可接受性的看法差异最大,但所有类型的问题都有报道。有效性可能优于可接受性。家长们更喜欢吸奶器和奶瓶,而不是浴缸,并报告说,由于参加了试验,他们对润肤剂的了解和使用有所提高。局限性:家长和临床医生没有被分配。这些发现可能不适用于同类型的非研究润肤剂,也不适用于来自不同种族背景的儿童。结论:四种润肤剂效果相同。对同一种润肤剂的满意度各不相同,不同的父母/孩子喜欢不同的润肤剂。用户需要能够从一系列润肤剂中进行选择,才能找到适合自己的润肤剂。未来的工作:未来的工作可能集中在如何最好地支持不同润肤剂类型的共同决策,以及其他石蜡基、非石蜡和“新型”润肤剂的评估。试验注册:该试验注册为ISRCTN84540529和EudraCT 2017-000688-34。资金:该项目由美国国立卫生与保健研究所(NIHR)健康技术评估计划(HTA 15/130/07)资助,并将在《健康技术评估》上全文发表;第27卷第19期。有关更多项目信息,请访问NIHR期刊图书馆网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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