Zia Ul Haq Muhammad, Mansoor Javeria, Lima Dos Santos Celia C, Perez Ramos Aida A, Pinzon Cueva Emilio, Harzand Arash
Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Community Health Sciences, Aga Khan University, Karachi, Pakistan.
Cochrane Database Syst Rev. 2025 Sep 16;9(9):CD016159. doi: 10.1002/14651858.CD016159.
This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Critical objective To assess the effects of oral melatonin supplementation (immediate‑release (IR) and controlled‑/sustained‑release CR/SR; any dose; ≥ 1 week) versus placebo or no treatment on change in systolic and diastolic blood pressure (SBP, DBP) in adults. Important objectives To examine dose‑response relationships between melatonin dose and changes in SBP and DBP. To assess effects by key participant and intervention characteristics (prespecified subgroups): baseline blood pressure status; concomitant antihypertensive medication use; presence of diagnosed sleep disorder/insomnia; melatonin formulation (IR versus CR/SR); blood pressure measurement method (office versus ambulatory versus home; daytime versus nocturnal); age (< 65 versus ≥ 65 years); sex. To evaluate adverse events (serious and non‑serious) and select patient‑important outcomes (quality of life, sleep quality). To describe any reported longer‑term cardiovascular outcomes (e.g. incident cardiovascular disease events, mortality) when sufficient data are available. These analyses are exploratory given anticipated sparse data.
这是一项Cochrane系统评价（干预措施）的方案。目标如下：关键目标评估口服补充褪黑素（速释（IR）和控释/缓释（CR/SR）；任何剂量；≥1周）与安慰剂或不治疗相比，对成人收缩压和舒张压（SBP、DBP）变化的影响。重要目标研究褪黑素剂量与SBP和DBP变化之间的剂量反应关系。根据关键参与者和干预特征（预先设定的亚组）评估效果：基线血压状况；同时使用抗高血压药物；已诊断的睡眠障碍/失眠的存在情况；褪黑素剂型（IR与CR/SR）；血压测量方法（诊室测量与动态血压监测与家庭自测；日间与夜间）；年龄（<65岁与≥65岁）；性别。评估不良事件（严重和非严重）并选择对患者重要的结局（生活质量、睡眠质量）。当有足够数据时，描述任何报告的长期心血管结局（如心血管疾病事件发生率、死亡率）。鉴于预期数据稀少，这些分析为探索性分析。
