PMID- 28218661
OWN - NLM
STAT- MEDLINE
DCOM- 20170731
LR  - 20181113
IS  - 2072-6643 (Electronic)
IS  - 2072-6643 (Linking)
VI  - 9
IP  - 2
DP  - 2017 Feb 17
TI  - Exploring the Effect of Lactium and Zizyphus Complex on Sleep Quality: A 
      Double-Blind, Randomized Placebo-Controlled Trial.
LID - 10.3390/nu9020154 [doi]
LID - 154
AB  - 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.
FAU - Scholey, Andrew
AU  - Scholey A
AD  - Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 
      VIC 3122, Australia. andrew@scholeylab.com.
FAU - Benson, Sarah
AU  - Benson S
AD  - Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 
      VIC 3122, Australia. sarahbenson@swin.edu.au.
FAU - Gibbs, Amy
AU  - Gibbs A
AD  - Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 
      VIC 3122, Australia. Amygibbs57@gmail.com.
FAU - Perry, Naomi
AU  - Perry N
AD  - Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 
      VIC 3122, Australia. naomiperry21@gmail.com.
FAU - Sarris, Jerome
AU  - Sarris J
AD  - Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 
      VIC 3122, Australia. jsarris@unimelb.edu.au.
AD  - ARCADIA Mental Health Research Group, The Professorial Unit, The Melbourne 
      Clinic, Department of Psychiatry, Melbourne University, Richmond VIC 3121, 
      Australia. jsarris@unimelb.edu.au.
FAU - Murray, Greg
AU  - Murray G
AD  - Psychological Sciences and Statistics, Swinburne University of Technology, 
      Hawthorn VIC 3122, Australia. gwm@swin.edu.au.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170217
PL  - Switzerland
TA  - Nutrients
JT  - Nutrients
JID - 101521595
RN  - 0 (Plant Preparations)
RN  - 0 (Sleep Aids, Pharmaceutical)
RN  - 8059-24-3 (Vitamin B 6)
RN  - I38ZP9992A (Magnesium)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Humulus/chemistry
MH  - Magnesium/administration & dosage
MH  - Male
MH  - Plant Preparations/*pharmacology
MH  - Single-Blind Method
MH  - Sleep/*drug effects
MH  - Sleep Aids, Pharmaceutical/*therapeutic use
MH  - Sleep Initiation and Maintenance Disorders/*drug therapy
MH  - Treatment Outcome
MH  - Vitamin B 6/administration & dosage
MH  - Young Adult
MH  - Ziziphus/*chemistry
PMC - PMC5331585
OTO - NOTNLM
OT  - Humulus lupulus
OT  - LZComplex3
OT  - Zizyphus
OT  - clinical trial
OT  - complementary medicines
OT  - insomnia
OT  - lactium
OT  - nutritional supplements
OT  - sleep disturbance
COIS- A.S. has received presentation honoraria, travel support and/or clinical trial 
      grants from Abbott Nutrition, Arla Foods, Australian Wine Research Institute, 
      Barilla, Bayer Healthcare, Blackmores, Cognis, Cyvex, Dairy Health Innovation 
      Consortium, Danone, Ginsana, GlaxoSmithKline Healthcare, Masterfoods, Martek, 
      Naturex, Nestle, Novartis, Red Bull, Sanofi, Unilever, Verdure Sciences, Wrigley, 
      J.S. is supported by a CR Roper Fellowship at The University of Melbourne. J.S. 
      reports no specific direct conflict of interest; general disclosures involve 
      presentation honoraria, travel support, clinical trial grants, or book royalties 
      from Integria Healthcare & MediHerb, Pfizer, Taki Mai, Bioceuticals & Blackmores, 
      Soho-Flordis, Healthworld, HealthEd, Elsevier, Chaminade University, 
      International Society for Affective Disorders, Complementary Medicines Australia, 
      ANS, Society for Medicinal Plant and Natural Product Research, Omega-3 Centre, 
      and the National Health and Medical Research Council. The sponsor was involved in 
      the design of the study. G.M., S.B., A.G. and N.P. report having no specific 
      direct conflicts of interest".
EDAT- 2017/02/22 06:00
MHDA- 2017/08/02 06:00
PMCR- 2017/02/01
CRDT- 2017/02/21 06:00
PHST- 2016/07/26 00:00 [received]
PHST- 2017/01/19 00:00 [revised]
PHST- 2017/02/13 00:00 [accepted]
PHST- 2017/02/21 06:00 [entrez]
PHST- 2017/02/22 06:00 [pubmed]
PHST- 2017/08/02 06:00 [medline]
PHST- 2017/02/01 00:00 [pmc-release]
AID - nu9020154 [pii]
AID - nutrients-09-00154 [pii]
AID - 10.3390/nu9020154 [doi]
PST - epublish
SO  - Nutrients. 2017 Feb 17;9(2):154. doi: 10.3390/nu9020154.