Rabago David, Kille Tony, Mundt Marlon, Obasi Chidi
Department of Family and Community Medicine Pennsylvania State University Hershey Pennsylvania USA.
Department of Surgery, Division of Otolaryngology University of Wisconsin School of Medicine and Public Health Madison Wisconsin USA.
Laryngoscope Investig Otolaryngol. 2020 Jul 7;5(4):613-620. doi: 10.1002/lio2.425. eCollection 2020 Aug.
To assess the efficacy of saline nasal irrigation (S-NI) and xylitol nasal irrigation (X-NI) for chronic rhinosinusitis in participants with Gulf War illness (GWI).
This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05.
Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high.
This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population.
1b, individual randomized controlled trial.
评估盐水鼻腔冲洗（S-NI）和木糖醇鼻腔冲洗（X-NI）对患有海湾战争综合征（GWI）的慢性鼻窦炎患者的疗效。
这项为期26周的三臂（1:1:1）随机对照试验研究了符合GWI标准且患有中重度慢性鼻窦炎和疲劳症状的退伍军人。所有参与者均接受慢性鼻窦炎（CRS）的标准治疗；此外，S-NI组或X-NI组的参与者每天使用2%盐水或5%木糖醇溶液进行两次鼻腔冲洗。结果包括疾病特异性生活质量（主要指标；鼻窦结局测试[SNOT-20]；0-100分）、总体生活质量（简明健康状况调查简表36）和疲劳（多维疲劳指数）。结果评估者对分组情况不知情。意向性分析采用重复测量模型；在双侧α水平为0.05时评估统计学显著性。
随机分组（N = 40）产生了三组在性别（男性，80%）、年龄（53.8±7.8岁）、病程（19.8±7.7年）和疾病严重程度（SNOT-20评分为48.5±12.7分）方面相似的组。年龄和性别调整后的组间比较显示，与对照组相比，X-NI组参与者在8周时（13.5分，95%置信区间[CI]-27.9至0.9）和26周时（15.4分，95%CI -30.1至-0.6）的SNOT-20评分有所改善。与对照组相比，S-NI组参与者在26周时改善了13.4分（95%CI -28.8，2.1）。与一般人群中对照组的SNOT-20相比，两个鼻腔冲洗组的改善程度均接近最小临床重要差异。组间次要结局无差异。两个冲洗组的满意度都很高。
这项随机对照试验表明，用盐水或木糖醇进行鼻腔冲洗可改善患有GWI的参与者的慢性鼻窦症状，改善评分与一般人群相似。
1b，个体随机对照试验。
