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

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    Author
    Scholey, A; Benson, S; Gibbs, A; Perry, N; Sarris, J; Murray, G
    Date
    2017-02-01
    Source Title
    Nutrients
    Publisher
    MDPI
    University of Melbourne Author/s
    Sarris, Jerome; Murray, Gregory
    Affiliation
    Melbourne School of Psychological Sciences
    Psychiatry
    Metadata
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    Document Type
    Journal Article
    Citations
    Scholey, A., Benson, S., Gibbs, A., Perry, N., Sarris, J. & Murray, G. (2017). Exploring the Effect of Lactium(TM) and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial. NUTRIENTS, 9 (2), https://doi.org/10.3390/nu9020154.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/258198
    DOI
    10.3390/nu9020154
    Abstract
    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.

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