Controlled‐release oral melatonin supplementation for hypertension and nocturnal hypertension: A systematic review and meta‐analysis

The Journal of Clinical Hypertension
Q2
Apr 2022
Citations:26
Influential Citations:6
Systematic Reviews / Meta-Analyses
87
S2 IconPDF Icon

Enhanced Details

Methods
Adults with hypertension enrolled in four randomized controlled trials (one parallel design and three crossover designs), totaling 137 participants. Mean age 56.36 years; mean BMI 28.01 kg/m2; approximately 55% male; 5.65% had diabetes mellitus. Trials conducted in Israel, Italy, the Netherlands, and the USA. Melatonin used as the sole intervention with comparison to placebo or no treatment; outcomes assessed by ambulatory BP monitoring.
Intervention
Melatonin regimens across four RCTs: 2 mg controlled-release (CR) nightly for 4 weeks; 5 mg immediate-release (IR) nightly for 4 weeks; 2.5 mg CR nightly for 3 weeks; 24 mg CR nightly for 4 weeks. Taken orally at night before bedtime.
Results
Controlled-release melatonin may modestly reduce asleep systolic BP by about 3.6 mmHg and did not produce significant changes in asleep diastolic BP, daytime SBP/DBP, or 24-h BP. Sleep metrics improved (sleep efficiency and total sleep time) and melatonin was safe and well-tolerated. However, evidence is low to very low quality due to small samples, short duration, and risk-of-bias concerns; no cardiovascular outcomes were reported. Adequately powered RCTs are needed. CR melatonin could be considered to aid sleep in hypertensive patients, but not as a primary antihypertensive therapy.
Limitations
Small number of trials (n=4) with small sample sizes; short duration (3–4 weeks); three crossover designs with potential carryover effects; unclear risk-of-bias in most trials; heterogeneity in formulations (CR vs IR) and doses; no reported cardiovascular outcomes; limited external validity (mostly Western populations).

Abstract

Oral melatonin is a potential alternative treatment for hypertension and nocturnal hypertension. However, high‐quality and relevant meta‐analyses are lacking. This meta‐analysis aimed to investigate whether oral melatonin supplementation reduces dayt...