title: Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial.
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.
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia. andrew@scholeylab.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Scholey
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia. sarahbenson@swin.edu.au.
authors.forename: Sarah
authors.initials: S
authors.lastname: Benson
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia. Amygibbs57@gmail.com.
authors.forename: Amy
authors.initials: A
authors.lastname: Gibbs
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia. naomiperry21@gmail.com.
authors.forename: Naomi
authors.initials: N
authors.lastname: Perry
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn VIC 3122, Australia. jsarris@unimelb.edu.au.|ARCADIA Mental Health Research Group, The Professorial Unit, The Melbourne Clinic, Department of Psychiatry, Melbourne University, Richmond VIC 3121, Australia. jsarris@unimelb.edu.au.
authors.forename: Jerome
authors.initials: J
authors.lastname: Sarris
authors.affiliation: Psychological Sciences and Statistics, Swinburne University of Technology, Hawthorn VIC 3122, Australia. gwm@swin.edu.au.
authors.forename: Greg
authors.initials: G
authors.lastname: Murray
mesh_terms: D000208:Acute Disease; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D027582:Humulus / Q000737:chemistry; D008274:Magnesium / Q000008:administration & dosage; D008297:Male; D028321:Plant Preparations / Q000494:pharmacology*; D016037:Single-Blind Method; D012890:Sleep / Q000187:drug effects*; D000068776:Sleep Aids, Pharmaceutical / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D025101:Vitamin B 6 / Q000008:administration & dosage; D055815:Young Adult; D031957:Ziziphus / Q000737:chemistry*
chemical_list: D028321:Plant Preparations; D000068776:Sleep Aids, Pharmaceutical; D025101:Vitamin B 6; D008274:Magnesium
keywords: Humulus lupulus; LZComplex3; Zizyphus; clinical trial; complementary medicines; insomnia; lactium; nutritional supplements; sleep disturbance