Jabbar-Lopez Z K, Ezzamouri B, Briley A, Greenblatt D, Gurung N, Chalmers J R, Thomas K S, Frost T, Kezic S, Common J E A, Danby S, Cork M J, Peacock J L, Flohr C
Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.
Women's Health, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.
Clin Exp Allergy. 2022 Mar;52(3):405-415. doi: 10.1111/cea.14071. Epub 2021 Dec 12.
Observational studies suggest an increased risk of eczema in children living in hard versus soft water areas, and there is, therefore, an interest in knowing whether softening water may prevent eczema. We evaluated the feasibility of a parallel-group assessor-blinded pilot randomized controlled trial to test whether installing a domestic ion-exchange water softener before birth in hard water areas reduces the risk of eczema in infants with a family history of atopy.
Pregnant women living in hard water areas (>250 mg/L calcium carbonate) in and around London UK, were randomized 1:1 antenatally to either have an ion-exchange water softener installed in their home or not (ie to continue to receive usual domestic hard water). Infants were assessed at birth and followed up for 6 months. The main end-points were around feasibility, the primary end-point being the proportion of eligible families screened who were willing and able to be randomized. Clinical end-points were evaluated including frequency of parent-reported doctor-diagnosed eczema and visible eczema on skin examination. Descriptive analyses were conducted, and no statistical testing was performed as this was a pilot study.
One hundred and forty-nine families screened were eligible antenatally and 28% (41/149) could not have a water softener installed due to technical reasons or lack of landlord approval. Eighty of 149 (54%) were randomized, the primary end-point. Two participants withdrew immediately after randomization, leaving 39 participants in each arm (78 total). Attrition was 15% (12/78) by 6 months postpartum. All respondents (n = 69) to the study acceptability questionnaire reported that the study was acceptable. Fifty-six of 708 (7.9%) water samples in the water softener arm were above the hard water threshold of 20 mg/L CaCO . At 6 months of age 27/67 infants (40%) developed visible eczema, 12/36 (33%) vs. 15/31 (48%) in the water softener and control groups, respectively, difference -15% (95% CI -38, 8.3%), with most assessments (≥96%) remaining blinded. Similarly, a lower proportion of infants in the water softener arm had parent-reported, doctor-diagnosed eczema by 6 months compared to the control arm, 6/17 (35%) versus 9/19 (47%), difference -12% (95% CI -44, 20%).
A randomized controlled trial of water softeners for the prevention of atopic eczema in high-risk infants is feasible and acceptable.
NCT03270566 (clinicaltrials.gov).
观察性研究表明，生活在硬水地区而非软水地区的儿童患湿疹的风险增加，因此，人们对了解软化水是否可以预防湿疹很感兴趣。我们评估了一项平行组评估者盲法试点随机对照试验的可行性，以测试在硬水地区出生前安装家用离子交换软水器是否能降低有特应性家族史的婴儿患湿疹的风险。
居住在英国伦敦及其周边硬水地区（碳酸钙含量>250mg/L）的孕妇，在产前以1:1的比例随机分为两组，一组在家中安装离子交换软水器，另一组不安装（即继续使用普通家用硬水）。婴儿在出生时进行评估，并随访6个月。主要终点围绕可行性，主要终点是被筛查的符合条件且愿意并能够随机分组的家庭比例。评估了临床终点，包括家长报告的医生诊断的湿疹频率和皮肤检查中可见的湿疹。进行了描述性分析，由于这是一项试点研究，未进行统计检验。
149个被筛查的家庭在产前符合条件，其中28%（41/149）由于技术原因或未获得房东批准而无法安装软水器。149个家庭中的80个（54%）被随机分组，这是主要终点。两名参与者在随机分组后立即退出，每组各剩39名参与者（共78名）。产后6个月时的失访率为15%（12/78）。所有回复研究可接受性问卷的受访者（n = 69）均表示该研究是可接受的。软水器组708个水样中有56个（7.9%）高于20mg/L碳酸钙的硬水阈值。在6个月大时，27/67名婴儿（40%）出现可见湿疹，软水器组和对照组分别为12/36（33%）和15/31（48%），差异为-15%（95%CI -38, 8.3%），大多数评估（≥96%）保持盲态。同样，与对照组相比，软水器组在6个月时家长报告的、医生诊断的湿疹婴儿比例较低，分别为6/17（35%）和9/19（47%），差异为-12%（95%CI -44, 20%）。
针对高危婴儿预防特应性湿疹的软水器随机对照试验是可行且可接受的。
NCT03270566（clinicaltrials.gov）
