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 |
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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 |
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