Xinrui Wen, Jie Yu, Genying Zhu, Jinhua Wang, Yangyang Sun, Jiajia Zhou, Jiaye Cai, Fanxia Meng, Yi Ling, Yi Sun, Jiajia Zhao, Fangping He, Qisheng Cheng, Chuan Xu, Jian Gao, Jingqi Li, Benyan Luo
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Assessments were conducted using the Coma Recovery Scale-Revised (CRS-R), electroencephalography (EEG), and polysomnography (PSG) before and after the intervention, with follow-up CRS-R evaluations performed 6 months post-treatment.</p><p><strong>Results: </strong>Compared to the placebo, melatonin demonstrated a significant improvement in CRS-R scores after a 2-week period in patients with unresponsive wakefulness syndrome (UWS) (F<sub>group*time</sub> = 6.86, P = 0.032; F<sub>group</sub> = 4.03, P = 0.045) and this improvement was particularly pronounced in visual scores (F<sub>group*time</sub> = 7.03, P = 0.030; F<sub>group</sub> = 4.90, P = 0.027). Moreover, patients with UWS who received melatonin exhibited a higher relative spectral density of the alpha band in the frontal lobe compared to those who received placebo (F<sub>time-mel</sub> = 4.55, P = 0.033) and benefited for their prognosis after 6 months (Pseudo R<sup>2</sup> = 0.370, F = 12.03, P = 0.034).</p><p><strong>Conclusions: </strong>Overall, melatonin intervention seems to have a better response in UWS patients with preserved sleep cycles. These positive effects may not be solely attributed to improvements in the patients' sleep quality.</p><p><strong>Trail registration: </strong>ClinicalTrials.gov: NCT05285124.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"22 1","pages":"576"},"PeriodicalIF":7.0000,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616348/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial.\",\"authors\":\"Xinrui Wen, Jie Yu, Genying Zhu, Jinhua Wang, Yangyang Sun, Jiajia Zhou, Jiaye Cai, Fanxia Meng, Yi Ling, Yi Sun, Jiajia Zhao, Fangping He, Qisheng Cheng, Chuan Xu, Jian Gao, Jingqi Li, Benyan Luo\",\"doi\":\"10.1186/s12916-024-03793-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Sleep is essential for the recovery of patients with disorders of consciousness (DoC). 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引用次数: 0
摘要
背景：睡眠对意识障碍（DoC）患者的康复至关重要。然而，很少有针对睡眠的方法被应用。褪黑素已被证明可以提高睡眠效率，而且几乎没有副作用。本研究探讨了褪黑素对长期DoC患者的益处，以及相关的潜在机制。方法：将46例延长的DoC患者随机分为褪黑素治疗组和安慰剂组。在干预前后使用昏迷恢复量表（CRS-R）、脑电图（EEG）和多导睡眠图（PSG）进行评估，并在治疗后6个月进行随访CRS-R评估。结果：与安慰剂相比，褪黑素对无反应性觉醒综合征（UWS）患者治疗2周后的CRS-R评分有显著改善(f组*时间= 6.86,P = 0.032；f组= 4.03,P = 0.045)，这种改善在视觉评分上尤为明显(f组*时间= 7.03,P = 0.030；f组= 4.90,P = 0.027)。此外，与安慰剂组相比，接受褪黑素治疗的UWS患者额叶α带的相对谱密度更高（Ftime-mel = 4.55, P = 0.033）， 6个月后的预后受益（伪R2 = 0.370, F = 12.03, P = 0.034）。结论：总体而言，褪黑激素干预似乎对睡眠周期保持不变的UWS患者有更好的疗效。这些积极的影响可能不仅仅是由于患者睡眠质量的改善。试验注册：ClinicalTrials.gov: NCT05285124。
Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial.
Background: Sleep is essential for the recovery of patients with disorders of consciousness (DoC). However, few approaches targeting sleep were applied. Melatonin has been shown to enhance sleep efficiency with virtually no side effects. This study explored melatonin's benefits for patients with prolonged DoC, as well as the underlying mechanisms involved.
Methods: A cohort of 46 patients with prolonged DoC were randomly assigned to either the melatonin treatment group or the placebo group. Assessments were conducted using the Coma Recovery Scale-Revised (CRS-R), electroencephalography (EEG), and polysomnography (PSG) before and after the intervention, with follow-up CRS-R evaluations performed 6 months post-treatment.
Results: Compared to the placebo, melatonin demonstrated a significant improvement in CRS-R scores after a 2-week period in patients with unresponsive wakefulness syndrome (UWS) (Fgroup*time = 6.86, P = 0.032; Fgroup = 4.03, P = 0.045) and this improvement was particularly pronounced in visual scores (Fgroup*time = 7.03, P = 0.030; Fgroup = 4.90, P = 0.027). Moreover, patients with UWS who received melatonin exhibited a higher relative spectral density of the alpha band in the frontal lobe compared to those who received placebo (Ftime-mel = 4.55, P = 0.033) and benefited for their prognosis after 6 months (Pseudo R2 = 0.370, F = 12.03, P = 0.034).
Conclusions: Overall, melatonin intervention seems to have a better response in UWS patients with preserved sleep cycles. These positive effects may not be solely attributed to improvements in the patients' sleep quality.
期刊介绍：
BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
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