Melatonin for blood pressure control in adults.

Abstract

Objectives: 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.