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

Autor: Di Pierro F; Department of Medicine and Technological Innovation, University of Insubria, 21100 Varese, Italy.; Microbiota International Clinical Society, 10123 Torino, Italy.; Scientific & Research Department, Velleja Research, 20125 Milano, Italy., Sisti D; Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029 Urbino, Italy., Rocchi M; Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029 Urbino, Italy., Belli A; Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029 Urbino, Italy., Bertuccioli A; Microbiota International Clinical Society, 10123 Torino, Italy.; Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029 Urbino, Italy., Cazzaniga M; Microbiota International Clinical Society, 10123 Torino, Italy.; Scientific & Research Department, Velleja Research, 20125 Milano, Italy., Palazzi CM; Microbiota International Clinical Society, 10123 Torino, Italy., Tanda ML; Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy., Zerbinati N; Department of Medicine and Technological Innovation, University of Insubria, 21100 Varese, Italy.
Jazyk: angličtina
Zdroj: Nutrients [Nutrients] 2024 Dec 04; Vol. 16 (23). Date of Electronic Publication: 2024 Dec 04.
DOI: 10.3390/nu16234199
Abstrakt: 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 ( χ 2 (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.
Databáze: MEDLINE