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.
Highlights
Insomnia is defined by disturbances in sleep quality together with impairment of daytime functioning, for example fatigue and low mood [1]
This study evaluated the efficacy of LZComplex3 in improving sleep quality in otherwise-well individuals with sleeping difficulties
Improvements in sleep quality were seen over a two-week treatment period with LZComplex3, a persistent placebo response was observed and there was no significant treatment effect compared with placebo
Summary
Insomnia is defined by disturbances in sleep quality together with impairment of daytime functioning, for example fatigue and low mood [1]. Disturbances in sleep quality include difficulty getting to sleep, staying asleep or experiencing non-restorative sleep despite adequate opportunity for sleep [1]. Insomnia can occur as an acute episode, usually triggered by factors such as ill health, change of medication or circumstances, or stress [5]. Such sleep disturbances generally resolve without treatment once the trigger is eliminated. People can turn to short-term use of medications (typically hypnotics such as a benzodiazepine) or herbal
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