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首页> 外文期刊>Journal of Parkinsonism and Restless Legs Syndrome >Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome
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Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

机译：改善腿不安定综合征患者的睡眠。第二部分：振动疗法和FDA批准用于治疗躁动性腿综合征的药物的荟萃分析

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Background: Vibratory stimulation pads have been shown to improve sleep in patients with restless legs syndrome (RLS) to a greater extent than sham therapy. The current gold standard of treatment is drugs approved by the US Food and Drug Administration (FDA) for use in RLS. The aim of this meta-analysis was to compare the efficacy and safety of vibratory stimulation pads, sham pads, and drugs approved by the FDA for use in RLS. Methods: We searched the PubMed, Embase, and clinical trial websites to identify the relevant randomized, double-blind, and placebo-controlled or sham-controlled studies. Fifteen studies including a combined total of 3455 patients with at least moderately severe primary RLS met our search criteria. Efficacy was defined as the standardized mean difference in sleep improvement between treatment and controls. Safety was assessed by comparing the odds ratios of any adverse events and adverse events leading to study withdrawal between treatment and control subjects. Results: Improvement in Medical Outcomes Study (MOS) sleep inventory scores from baseline was significantly greater in patients treated with vibratory stimulation pads than in those receiving sham pads (Hedges's g, standardized mean difference ?0.39, P ≤ 0.02). There was no difference in improvement in sleep scores between patients treated with vibratory stimulation pads (?0.39) and those receiving an approved RLS drug (?0.44, P > 0.70). The risk of any adverse event or withdrawal because of an adverse event was not significantly different between patients treated with vibratory stimulation pads and those assigned to sham pads (Mantel-Haenszel odds ratio 2.16 [P > 0.14] and 1.39 [P > 0.80], respectively). The odds ratios for patients reporting any adverse events and adverse events leading to withdrawal were not significantly different between patients treated with vibratory stimulation pads (2.16 and 1.39, respectively) and those who received approved RLS drugs (2.11 [P > 0.89] and 2.07 [P > 0.82], respectively, mixed-effects model). Conclusion: For patients with moderately severe RLS, vibratory stimulation pads were more effective than sham pads for improving sleep, as effective as FDA-approved RLS drugs, and as safe as both sham pads and FDA-approved RLS drugs.
机译：背景：与假疗法相比，振动刺激垫已显示出在更大程度上改善了躁动腿综合征（RLS）患者的睡眠。当前的治疗金标准是由美国食品和药物管理局（FDA）批准用于RLS的药物。这项荟萃分析的目的是比较振动刺激垫，假垫和FDA批准用于RLS的药物的功效和安全性。方法：我们搜索了PubMed，Embase和临床试验网站，以鉴定相关的随机，双盲，安慰剂对照或假对照对照研究。总共15项研究（包括3455例至少具有中度重度原发性RLS的患者）符合我们的搜索标准。疗效定义为治疗与对照组之间睡眠改善的标准化平均差。通过比较任何不良事件和导致研究退出的治疗对象与对照组之间的不良事件的比值比来评估安全性。结果：用振动刺激垫治疗的患者的医疗结果研究（MOS）睡眠库存得分相对于基线水平的改善显着高于接受假垫的患者（Hedges's g，标准平均差异为0.39，P≤0.02）。接受振动刺激垫治疗的患者（≥0.39）与接受批准的RLS药物治疗的患者（≥0.44，P> 0.70）的睡眠得分改善无差异。振动刺激垫治疗的患者和假刺激垫治疗的患者发生任何不良事件或因不良事件而退出的风险均无显着差异（Mantel-Haenszel比值比为2.16 [P> 0.14]和1.39 [P> 0.80]，分别）。报告任何不良事件和导致戒断的不良事件的患者的比值比在使用振动刺激垫治疗的患者（分别为2.16和1.39）和接受批准的RLS药物的患者（2.11 [P> 0.89]和2.07 [ P> 0.82]，分别为混合效应模型）。结论：对于中度重度RLS的患者，振动刺激垫在改善睡眠方面比假垫更有效，与FDA批准的RLS药物一样有效，并且与假垫和FDA批准的RLS药物一样安全。

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