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Nutrients 2017, 9(2), 154; doi:10.3390/nu9020154

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

1
Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia
2
ARCADIA Mental Health Research Group, The Professorial Unit, The Melbourne Clinic, Department of Psychiatry, Melbourne University, Richmond VIC 3121, Australia
3
Psychological Sciences and Statistics, Swinburne University of Technology, Hawthorn VIC 3122, Australia
*
Author to whom correspondence should be addressed.
Received: 26 July 2016 / Revised: 19 January 2017 / Accepted: 13 February 2017 / Published: 17 February 2017
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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. View Full-Text
Keywords: lactium; Zizyphus; Humulus lupulus; nutritional supplements; complementary medicines; sleep disturbance; insomnia; LZComplex3; clinical trial lactium; Zizyphus; Humulus lupulus; nutritional supplements; complementary medicines; sleep disturbance; insomnia; LZComplex3; clinical trial
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Scholey, A.; Benson, S.; Gibbs, A.; Perry, N.; Sarris, J.; Murray, G. Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial. Nutrients 2017, 9, 154.

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