June 13, 2014
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Melatonin supplementation failed to affect BP of black adults

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NEW YORK — Black adults with hypertension experienced no change in diastolic or systolic BP after 4 weeks of melatonin supplementation, according to data presented at the American Society of Hypertension Annual Scientific Meeting.

Researchers conducted two phase 2, randomized, double blind, crossover trials that each included 40 black adults with essential hypertension who were treated with fewer than three drugs at baseline. Participants in both trials were randomly assigned 4 weeks of oral melatonin or placebo, before switching to the other treatment for an additional 4 weeks. The melatonin dose was 8 mg in one trial and 24 mg in the other trial. The primary outcome of both studies was change in nighttime diastolic and systolic BP.

Medication adherence was high in both the trial that studied 8 mg melatonin (96%) and the trial that studied 24 mg melatonin (100%).

The researchers observed no significant effect of melatonin on diastolic or systolic BP during the day or night vs. placebo. In the trial that studied 8 mg melatonin, the only evaluated factor that was significantly different between the melatonin and placebo groups was daytime pulse, which was higher in the placebo group (84.6 bpm vs. 81 bpm; P=.01). This difference was not observed in the trial that studied 24 mg melatonin.

Both studies demonstrated no difference in mean arterial pressure at any time of the day, nocturnal dipping, urinary dopamine, noradrenaline or adrenaline excretion, plasma e-selectin or p-selectin levels, and total sleep time.

Adverse effects were similar in both the melatonin and placebo groups. The most common effects reported included fatigue, daytime drowsiness and early morning awakening. The incidence of any adverse effects was more common in the 24-mg melatonin study, in both the placebo (69.4% vs. 50% in the 8-mg study) and melatonin (58.3% vs. 47.2% in the 8-mg study) groups.

During a presentation, Frederick Rahbari-Oskoui, MD, MS, assistant professor of medicine at Emory University School of Medicine, said both doses studied are much higher than the typical melatonin supplement dose of 3 mg to 5 mg.

“Controlled-release melatonin at 8 mg or 24 mg daily did not affect daytime or nighttime BP in two overlapping cohorts of African Americans with essential hypertension,” Rahbari-Oskoui said. “The catecholamine-lowering response of melatonin may be impaired in African Americans.” – by Adam Taliercio

For more information:

Rahbari-Oskoui FF. Abstract LB-OR-04. Presented at: American Society of Hypertension 2014 Annual Scientific Meeting; May 16-20, 2014; New York.

Disclosure: Rahbari-Oskoui reports serving on an ad-hoc advisory board for Otsuka Pharmaceuticals, royalties from UpToDate, and research support from the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Complementary and Alternative Medicine.