Insomnia and its treatments—trend analysis and publication profile of randomized clinical trials

Viviane Akemi Kakazu, Marcia Assis, Andrea Bacelar, Andréia Gomes Bezerra, Giovanna Lira Rosa Ciutti, Silvia Gonçalves Conway, José Carlos Fernandes Galduróz, Luciano F. Drager, Mariana Pery Khoury, Ingrid Porto Araújo Leite, Ygor de Matos Luciano, Dalva Poyares, Sergio Tufik, Gabriel Natan Pires
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Abstract

This study aimed to describe the publication profile of randomized controlled trials (RCTs) for insomnia. A systematic review of RCTs regarding interventions for non-comorbid insomnia in adults retrieved 132 RCTs: 58 related to pharmacological treatments, 71 to non-pharmacological treatments, and 3 to both interventions. The treatments with the biggest publication profile were digital CBT-I (dCBT-I) (n = 35), in-person CBT-I (n = 28) and zolpidem (n = 22). Regarding dCBT-I, the median publication year is 2019, with 1.13 ± 1.91 RCTs published per year. Regarding zolpidem, the median publication year is 2008, with 0.71 ± 0.97 RCTs per year. Regarding in-person CBT-I, the median publication year is 2018, with 0.90 ± 1.14 RCTs per year. The majority of the available RCTs are on non-pharmacological interventions, particularly CBT-I (mostly in the 2000s) and dCBT-I (mostly in the last decade), although presenting a reduced methodological quality in comparison to pharmacological interventions. These data suggest an increasing focus on non-pharmacological interventions for insomnia.

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失眠症及其治疗方法--随机临床试验的趋势分析和出版概况
本研究旨在描述失眠症随机对照试验(RCT)的出版概况。我们对有关成人非合并失眠症干预措施的 RCT 进行了系统回顾,共检索到 132 项 RCT,其中 58 项涉及药物治疗,71 项涉及非药物治疗,3 项涉及两种干预措施:其中58项涉及药物治疗,71项涉及非药物治疗,3项涉及两种干预措施。发表论文最多的治疗方法是数字CBT-I(dCBT-I)(35例)、面对面CBT-I(28例)和唑吡坦(22例)。关于 dCBT-I,发表年份的中位数是 2019 年,每年发表 1.13 ± 1.91 篇 RCT。关于唑吡坦,发表年份的中位数为 2008 年,每年发表的 RCT 为 0.71 ± 0.97 篇。关于面对面 CBT-I,中位发表年份为 2018 年,每年发表 0.90 ± 1.14 篇 RCT。现有的研究性临床试验大多是关于非药物干预的,尤其是 CBT-I(大多是在 2000 年代)和 dCBT-I(大多是在最近十年),尽管与药物干预相比,其方法学质量有所下降。这些数据表明,对失眠的非药物干预越来越受到重视。
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