Background: Tardive dyskinesia (TD) is characterized by abnormal and involuntary movements. Importantly, TD could cause considerable personal suffering and social and physical disabilities.
Aims: This meta-analysis based on randomized controlled trials (RCTs) systematically assessed the therapeutic effect and tolerability of melatonin for TD in schizophrenia.
Methods: A computerized and systematical search of both Chinese (Wanfang Data, Chinese National Knowledge Infrastructure (CNKI), SINOMED) and English (PubMed, PsycINFO, Embase, Cochrane Library databases) databases, from their inception until June 8, 2017, was conducted by two independent authors. The severity of TD symptoms were the primary outcome measure and analyzed using a random effects model by the Review Manager (RevMan) Version 5.3. Quality evaluation of included RCTs was conducted using the Cochrane risk of bias and Jadad scale. The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system recommendation grading method was used to assess the overall quality level of meta-analytic outcomes.
Results: Four RCTs (n=130) were identified and analyzed. Three RCTs used double blind and 1 RCT used masked assessors using the Cochrane risk of bias, and 3 RCTs were rated as high quality based on Jadad scale. Compared with the control group, adjunctive melatonin was superior in reducing the severity of TD as measured by the Abnormal Involuntary Movement Scale (AIMS) (4 RCTs, n=130, weighted mean difference (WMD): -1.52 (95% confidence intervals (CI): -3.24, 0.20), p=0.08; I2 =0%) although the improvement did not reach a significant level. The overall evidence quality of the improvement of TD symptoms, according to GRADE approach, was rated as "Low". The data on the ADRs and cognitive effect were limited.
Conclusions: This meta-analysis shows that melatonin has potential for improving TD symptoms in schizophrenia. Future higher quality and larger RCTs are warranted to confirm the findings.
背景: 迟发性运动障碍(TD) 的临床特征是异常不自主 运动。 TD 具有严重的不可逆的致残性和社会功能损害。.
目的: 此荟萃分析基于随机对照试验 (RCTs) 文献系统 评估褪黑素对精神分裂症患者迟发性运动障碍的临床 疗效和安全性。.
方法: 两位独立评估者从以下数据库对相关的临床随 机对照试验 （RCT） 文献进行检索( 万方数据、中国 知网 (CNKI)、中国生物医学文摘数据库和 PubMed、 PsycINFO、 Embase、 Cochrane Library 数据库) ， 检索时 间截止于 2017 年 6 月8 日。 以 TD 症状严重程度为主 要结局指标， 采用 Rev Man 5.3 版本进行统计分析， 对 RCTs 的质量评估采用 Cochrane 风险评估偏倚和 Jadad 量表来评估各种偏倚的风险性。 采用 GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) 系统推荐分级方法对 meta- 分析结果的整体 证据质量水平进行分级评价。.
结果: 最终筛选确定 4 个RCTs(n = 130)。 3 个 RCTs 采 用双盲法， 1 个 RCT 单盲， 根据 Cochrane 风险评估偏 倚和 Jadad 量表显示 3 个 RCTs 的疗效评估指标的证据 质量被评定为“ 高质量”。 与对照组相比， 根据不自 主运动量表 (AIMS) 评定褪黑素可改善 TD 严重程度 (4 个 RCTs, n = 130， 加权平均差值 (WMD):-1.52(95%CI: -3.24,0.20), p = 0.08; I2 = 0%)， 但尚没有达到显著差异。 根据等级方法， 改善 TD 症状的 meta 分析结果的整体 证据质量被评为“ 低”， 而关于不良反应和认知损害方 面则数据太少。.
结论: 荟萃分析表明， 褪黑素或可改善精神分裂症 TD 症状。 但仍有待今后更高质量和更大样本的 RCTs 验证。.
Keywords: Tardive dyskinesia; antipsychotic; melatonin; meta-analysis.