A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial.

What Was Tested

The paper reports a study of Melatonin, published as a randomized controlled trial.

To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders.

Who Took Part

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study.

Subjects could also volunteer for two ancillary studies on melatonin and actigraphy.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The participants were allocated by chance, so the Melatonin group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Melatonin.

A placebo (an inactive look-alike) gave the Melatonin group a baseline to be compared against.

Randomized placebo-controlled trial, in a Population-based setting.

Evaluation criteria included i) perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii) sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii) night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a subsample of subjects.

What Was Measured

The subject headings attached to it are Actigraphy, Dietary Supplements, Fatty Acids, Unsaturated, Humulus, Melatonin, Phytotherapy and Plant Extracts.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Melatonin.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2010 (BMC complementary and alternative medicine), a journal based in England.

More context: all human trials.