Purpose

To determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study.

Methods

Patients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events.

Results

Among 22 patients assigned to ω3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change −0.6 points, 95% confidence interval [CI], (−10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change −0.5 points; 95% CI (−1.2, 0.3)), corneal staining (−0.3 points; 95% CI (−1.2, 0.3)), tear break-up time (−0.8 s; 95% CI (−2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (−2.0, 3.2)). Rates of adverse events were similar in both groups.

Conclusion

Among patients who received ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3.

ClinicalTrials.gov number NCT02128763.

中文翻译：

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干眼评估和管理（DREAM）扩展研究-对患有干眼症的患者停用omega-3脂肪酸补充的一项随机临床试验。

目的

通过在DREAM研究第一年分配给ω3补充剂的患者中进行的随机戒断试验，确定继续或终止使用omega-3（ω3）脂肪酸补充剂的效果。

方法

在初次试验中最初分配给ω3（3000 mg）12个月的患者，按1：1比例随机分配给ω3活性补品或安慰剂（精制橄榄油），持续12个月。主要结果是眼表疾病指数（OSDI）得分的变化。次要结果包括结膜染色，角膜染色，泪液破裂时间，Schirmer试验和不良事件的改变。

结果

在22位分配给ω3的患者和21位接受安慰剂补充的患者中，治疗组之间第12个月到第24个月OSDI得分的平均变化相似（变化的平均差异为-0.6分，置信区间[CI]为95％，（-10.7、9.5 ），p = 0.91）。各组之间结膜染色的平均变化（平均变化的差异为-0.5点; 95％CI（-1.2，0.3）），角膜染色的平均变化（-0.3点; 95％CI（-1.2，0.3））无显着差异，撕裂时间（-0.8 s; 95％CI（-2.6，0.9））和Schirmer测试（0.6 mm，95％CI（-2.0，3.2））。两组的不良事件发生率相似。

结论

在初次试验中接受ω3补充剂12个月的患者中，与继续使用ω3的患者相比，那些中断使用ω3额外12个月的患者的预后没有明显恶化。

ClinicalTrials.gov编号NCT02128763。