Effects of Melissa officinalis Phytosome on Sleep Quality: Results of a Prospective, Double-Blind, Placebo-Controlled, and Cross-Over Study.

2024-12-04
Nutrients 16(23)
- Francesco Di Pierro
- Davide Sisti
- Marco Rocchi
- Annalisa Belli
- Alexander Bertuccioli
- Massimiliano Cazzaniga
- Chiara Maria Palazzi
- Maria Laura Tanda
- Nicola Zerbinati

PubMed: 39683592
DOI: 10.3390/nu16234199

Study Design

Type: Randomized Controlled Trial (RCT)
Population: participants with mild anxiety and insomnia
Methods: prospective, double-blind, placebo-controlled, and cross-over study of a Melissa officinalis highly standardised extract formulated as Phytosome™ (MOP)
Blinding: Double-blind
Funding: Unclear

Rigorous Journal

Background

Melissa officinalis standardised extracts, characterised by the presence of hydroxycinnamic acids, have been experimentally demonstrated to be endowed with anti-anxiety and anti-insomnia pharmacological actions. These effects, probably attributable, at least in part, to the role played by rosmarinic acid on GABA-T, have not always been observed in a reproducible manner in humans, perhaps due to the poor bioavailability of these compounds.

Methods

as nutraceuticals and botanicals could be an alternative option to prescription medications for alleviating symptoms of mild anxiety and insomnia, we have verified in a prospective, double-blind, placebo-controlled, and cross-over study the supporting role on sleep quality played by a Melissa officinalis highly standardised extract, formulated as Phytosome™ (MOP) to improve the oral bioavailability of its active polyphenolic components.

Results

results showed a significant reduction in the ISI score in the treated group, with an average of 6.8 ± 4.1 compared to 9.7 ± 3.7 in the placebo group, indicating a significant reduction of 2.9 points (p = 0.003). The SWS phase duration increased by an average of 15%, while the REM phase decreased by 10%. Additionally, 87% of participants in the treated group reported improved sleep quality, compared to 30% in the placebo group, with significant differences measured by chi-square test (χ²₍₄₎ = 21.01, p = 0.0003), highlighting the effects due to Melissa officinalis L. No significant changes in physical activity or anxiety levels were observed.

Conclusions

these findings suggest that MOP may represent a natural and safe alternative to traditional pharmacological treatments for insomnia.