Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

Autor: Naomi Perry, Amy Gibbs, Sarah Benson, Greg Murray, Andrew Scholey, Jerome Sarris
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
insomnia
Placebo-controlled study
nutritional supplements
Pittsburgh Sleep Quality Index
lactium
0302 clinical medicine
Sleep Initiation and Maintenance Disorders
Insomnia
Medicine
Magnesium
Single-Blind Method
030212 general & internal medicine
Sleep disorder
Nutrition and Dietetics
complementary medicines
Ziziphus
clinical trial
sleep disturbance
Treatment Outcome
Acute Disease
Female
medicine.symptom
Zizyphus
lcsh:Nutrition. Foods and food supply
Adult
medicine.medical_specialty
lcsh:TX341-641
Placebo
LZComplex3
Article
Humulus lupulus
03 medical and health sciences
Young Adult
Double-Blind Method
Humans
Effects of sleep deprivation on cognitive performance
Adverse effect
Humulus
Dose-Response Relationship
Drug

business.industry
medicine.disease
Vitamin B 6
Discontinuation
Sleep Aids
Pharmaceutical

Physical therapy
Plant Preparations
business
Sleep
030217 neurology & neurosurgery
Food Science
Zdroj: Nutrients, Vol 9, Iss 2, p 154 (2017)
Nutrients; Volume 9; Issue 2; Pages: 154
Nutrients, 9(2):154
Nutrients
ISSN: 2072-6643
Popis: Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.
Databáze: OpenAIRE