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"Oils, Volatile - pharmacology"
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The efficacy of lavender oil on fatigue and sleep quality in patients with hematological malignancy receiving chemotherapy: a single-blind randomized controlled trial
2025
Purpose
The aim of this study is to evaluate how aromatherapy with the inhalation of lavender oil affects fatigue and sleep quality in patients with hematological malignancies undergoing chemotherapy.
Methods
This randomized, parallel-group study was carried out in the Adult Bone Marrow Transplant unit and Hematology-Oncology clinics between January 2022 and April 2023. A total of 120 patients were assigned to experimental and control groups by randomization. The study was completed with 100 patients including 50 in the experimental group and 50 in the control group. Lavender essential oil was applied to the experimental group for 20 min prior to going to bed every night for 5 consecutive days. Physiological saline solution was applied to the control group in the same way. A Participant Information Form, the Richards-Campbell Sleep Questionnaire, and the Piper Fatigue Scale were used as data collection tools.
Results
The experimental group showed a significantly higher sleep quality (
p
= 0.001) and had a significantly lower PFS scores (
p
= 0.001) compared to the control group. Also, the mean scores of the experimental group on the Behavioral, Sensory, and Cognitive subscales were statistically significantly lower than the scores of the control group (
p
< 0.05). Variables of lavender aromatherapy and total sleep quality accounted for 17.1% of the variance in fatigue levels (
R
2
= 0.171).
Conclusions
Consequently, it was determined that aromatherapy with lavender essential oil significantly alleviated fatigue and lowered PFS total and subscale scores in patients with hematological malignancies undergoing chemotherapy. Also, sleep quality significantly enhanced in the overall PFS and its subscales.
Trial registration.
NCT05808296. Date of Registration: 30 March 2023.
Journal Article
No Abuse Potential of Silexan in Healthy Recreational Drug Users: A Randomized Controlled Trial
2021
Abstract
Background
Silexan is a lavender essential oil with established anxiolytic and calming efficacy. Here we asked whether there is a potential for abuse in human patients.
Methods
We carried out a phase I abuse liability single-center, double-blind, 5-way crossover study in healthy users of recreational central nervous system depressants. They received single oral doses of 80 mg (therapeutic dose) and 640 mg Silexan, 2 mg and 4 mg lorazepam (active control) and placebo in randomized order, with 4- to 14-day washout periods between treatments. Pharmacodynamic measures included validated visual analogue scales assessing positive, negative, and sedative drug effects and balance of effects; a short form of the Addiction Research Center Inventory; and a drug similarity assessment. The primary outcome measure was the individual maximum value on the drug liking visual analogue scale during 24 hours post-dose.
Results
Forty participants were randomized and 34 were evaluable for pharmacodynamic outcomes. In intraindividual head-to-head comparisons of the drug liking visual analogue scale maximum value, both doses of Silexan were rated similar to placebo whereas differences were observed between Silexan and lorazepam and between placebo and lorazepam (P < .001). These data were supported by all secondary measures of positive drug effects and of balance of effects. Differences between placebo and both doses of Silexan were always negligible in magnitude. Moreover, Silexan showed no sedative effects and was not perceived to be similar to commonly used drugs that participants had used in the past.
Conclusions
Silexan did not exhibit any abuse potential in a standard abuse potential detection screen study and is unlikely to be recreationally abused.
Journal Article
Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial
by
Hashempur, Mohammad Hashem
,
Shariat, Abdolhamid
,
Taghizadeh, Mohsen
in
Administration, Topical
,
Adolescent
,
Adult
2017
[Display omitted]
•Migraine headache is reported as the most common neurological disorder.•Rose (Rosa damascena Mill.) oil is traditionally used for treatment of migraine headache in Traditional Persian Medicine.•Syndrome differentiation model is used popularly in traditional medicine researches.•Syndrome differentiation can help in selection of patients who may benefit from topical Rose oil in short-term pain relief in migraine headache.•Rose oil is effective in pain relief of patients with HOT type migraine headache based on syndrome differentiation.
To evaluate the effect of topical formulation of Rosa damascena Mill. (R. damascena) oil on migraine headache, applying syndrome diffrentiation model.
Forty patients with migraine headache were randomly assigned to 2 groups of this double-blind, placebo-controlled cross-over trial. The patients were treated for the first 2 consecutive migraine headache attacks by topical R. damascena oil or placebo. Then, after one week of washout period, cross-over was done. Pain intensity of the patients' migraine headache was recorded at the beginnig and ten-sequence time schadule of attacks up to 24h. In addition, photophobia, phonophobia, and nausea and/or vomitting (N/V) of the patients were recorded as secondary outcomes. Finally, gathered data were analysed in a syndrome differentiation manner to assess the effect of R. damascena oil on Hot- and Cold-type migraine headache.
Mean pain intensity of the patients' migraine headache in the different time-points after R. damascena oil or placebo use, was not significantly different. Additionally, regarding mean scores of N/V, photophobia, and phonophobia severity of the patients, no significant differences between the two groups were observed. Finally, applying syndrome differentiation model, the mean score of migraine headache pain intensity turned out to be significantly lower in patients with “hot” type migraine syndrome at in 30, 45, 60, 90, and 120min after R. damascena oil application compared to “cold” types (P values: 0.001, 0.001, <0.001, <0.001, and 0.02; respectively).
It seems that syndrome differentiation can help in selection of patients who may benefit from the topical R. damascena oil in short-term relief of pain intensity in migraine headache. Further studies of longer follow-up and larger study population, however, are necessitated for more scientifically rigorous judgment on efficacy of R. damascena oil for patients with migraine headache.
Journal Article
Increase in diastolic blood pressure induced by fragrance inhalation of grapefruit essential oil is positively correlated with muscle sympathetic nerve activity
by
Okazaki, Kazunobu
,
Imai, Daiki
,
Ota, Akemi
in
Aromatherapy
,
Autonomic nerve
,
Autonomic nervous system
2020
Fragrance inhalation of essential oils is widely used in aromatherapy, and it is known to affect blood pressure (BP) and heart rate (HR) via autonomic control of circulation. In this study, we aimed to test the hypothesis that the changes in hemodynamics with fragrance inhalation were observed along with changes in muscle sympathetic nerve activity (MSNA). In study 1, thirteen healthy men were exposed to fragrance stimulation of grapefruit essential oil for 10 min, and BP, HR, and MSNA were continuously measured. In study 2, another nine healthy men were exposed to the same fragrance stimulation; responses in BP and HR were continuously measured, and plasma noradrenaline and cortisol concentrations were determined. We found that diastolic BP increased significantly during fragrance inhalation, while the other variables remained unchanged in both studies. Although MSNA burst frequency, burst incidence, and total activity remained unchanged during fragrance inhalation, we found a significant linear correlation between changes in diastolic BP in the last 5 min of fragrance inhalation and changes in MSNA burst frequency. The plasma cortisol concentration decreased significantly at 10 min of fragrance inhalation, though the noradrenaline concentration remained unchanged. These results suggest, for the first time, that changes in BP with fragrance inhalation of essential oil are associated with changes in MSNA even with decreased stress hormone.
Journal Article
The effects of Thymus capitatus essential oil topical application on milk quality: a systems biology approach
2025
Essential oils (EO) are known for their antibacterial and anti-inflammatory properties and can be used as an alternative to reduce the reliance on antimicrobials in dairy cattle. While many studies have explored the beneficial properties of EO in vitro, their effects on milk quality and milk microbiota, when applied directly to the udder skin, remain relatively unknown. This study aimed to investigate the impact of Thymus capitatus essential oil (TCEO), known for its high antibacterial and antioxidant properties, on milk microbiota using 16S rRNA sequencing, the lipidomic profile via liquid chromatography-quadrupole time-of-flight mass spectrometry, udder skin microbiota, and inflammatory biomarkers of dairy cows at the end of lactation. Sixteen-quarters of 12 Holstein cows were selected, and TCEO was topically applied to the udder skin twice a day for 7 days. Milk was collected aseptically on days 0, 7, 21, and 28 before morning farm milking. The results showed no significant changes in microbiota composition after the EO treatment in alpha and beta diversity or taxonomical composition at the phylum and genus levels. TCEO induced limited changes in the milk lipidome, primarily affecting diacylglycerols at T21. The treatment did not affect inflammatory biomarkers, milk sensory properties, or quality. Our study is the first to demonstrate that a local application of 10% TCEO on cow’s quarters does not significantly alter milk quality or microbiota composition in milk and skin. More studies should be conducted to ensure the safe use of TCEO in dairy cows and explore its potential benefits on antibiotic-resistant bacteria as an alternative or support for antibiotic therapy.
Journal Article
Efficacy of preprocedural mouth rinses (Chlorhexidine, essential oil, and hydrogen peroxide) in reducing bacterial aerosols during dental scaling
by
Azadnia, Arian
,
Rahimi, Farshad
,
Khalifehzadeh, Shabnam
in
Adult
,
Aerosols
,
Anti-Infective Agents, Local - therapeutic use
2025
Aim
This study aimed to compare the efficacy of mouth rinsing with chlorhexidine, essential oil, and hydrogen peroxide mouthwashes in reducing bacterial infection in aerosols produced during dental scaling.
Materials and methods
Eighty subjects were randomly assigned to four groups. Ten minutes before treatment, participants rinsed for 1 min with 10 mL of either chlorhexidine, essential oil, hydrogen peroxide, or water. Blood agar plates were used to collect aerosols during the scaling procedure, with plates placed at the patient’s chest, dentist’s chest, and assistant’s chest. Plates were exposed for 30 min during and after treatment, incubated at 37 °C for 48 h, and the total number of colony-forming units (CFUs) was counted and analyzed using SPSS-24 software.
Results
The mean age of participants was 35.01 years, with 57.5% female and 42.5% male. A statistically significant difference was observed in the number of bacterial colonies on the patient’s chest plates (882.56 CFUs), dentist’s chest (99.84 CFUs), and assistant’s chest (48.49 CFUs) (p value < 0.001). Chlorhexidine mouthwash significantly reduced bacterial growth compared to the other groups.
Conclusion
Rinsing with chlorhexidine mouthwash before dental treatment effectively reduces bacterial contamination in aerosols, thereby lowering the risk of infection for dental personnel and patients.
Clinical trial number
Not applicable
Journal Article
Effects of Silexan on the Serotonin-1A Receptor and Microstructure of the Human Brain: A Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study with Molecular and Structural Neuroimaging
by
Kasper, Siegfried
,
Hahn, Andreas
,
Wadsak, Wolfgang
in
Adult
,
Anti-Anxiety Agents - pharmacology
,
Brain - anatomy & histology
2015
Background:Recently, Silexan, a patented active substance comprised of an essential oil produced from Lavandula angustifolia flowers, has been authorized in Germany as a medicinal product for the treatment of states of restlessness related to anxious mood. Its efficacy has been shown in several forms of anxiety disorders. Findings from preclinical and clinical studies attribute a major role to the serotonin-1A receptor in the pathogenesis and treatment of anxiety.Methods:To elucidate the effect of Silexan on serotonin-1A receptor binding, 17 healthy men underwent 2 positron emission tomography measurements using the radioligand [carbonyl-11C]WAY-100635 following the daily intake of 160mg Silexan or placebo for a minimum of 8 weeks (randomized, double-blind, cross-over design). Additionally, structural magnetic resonance imaging and voxel-based morphometry analysis was performed to determine potential effects on gray matter microstructure.Results:Serotonin-1A receptor binding potential was shown to be significantly reduced following the intake of Silexan compared with placebo in 2 large clusters encompassing the temporal gyrus, the fusiform gyrus and the hippocampus on one hand as well as the insula and anterior cingulate cortex on the other hand. No effects of Silexan on gray matter volume could be detected in this investigation.Conclusion:This positron emission tomography study proposes an involvement of the serotonin-1A receptor in the anxiolytic effects of Silexan.The study was registered in the International Standard Randomized Controlled Trial Number Register as ISRCTN30885829 (http://www.controlled-trials.com/isrctn/).
Journal Article
Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial
2024
Background
The rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome.
Methods
In this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards.
Results
Multivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use.
Conclusions
By establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity.
Trial registration
The trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.
Journal Article
Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an In Situ Model of Oral Biofilm Growth: A Randomised Clinical Trial
by
Suárez-Quintanilla, David
,
Quintas, Víctor
,
Donos, Nikolaos
in
Adult
,
Anti-Infective Agents, Local - pharmacology
,
Antibacterial activity
2015
To evaluate the in situ antiplaque effect after 4 days of using of 2 commercial antimicrobial agents in short term on undisturbed plaque-like biofilm.
An observer-masked, crossover randomised clinical trial on 15 oral and systemically healthy volunteers between 20-30 years who were randomly and sequentially allocated in the same group which performed 3 interventions in different randomised sequences.
The participants wore an appliance in 3 different rinsing periods doing mouthwashes twice a day (1/0/1) with essential oils, 0.2% chlorhexidine or sterile water (negative control). At the end of each 4-day mouthwash period, samples were removed from the appliance. Posteriorly, after bacterial vital staining, samples were analysed using a Confocal Laser Scanning Microscope.
Bacterial vitality, thickness and covering grade by the biofilm after 4 days of applying each of the mouthwashes.
The essential oils and the 0.2% chlorhexidine were significantly more effective than the sterile water at reducing bacterial vitality, thickness and covering grade by the biofilm. No significant differences were found between the 0.2% chlorhexidine and the essential oils at reducing the bacterial vitality (13.2% vs. 14.7%). However, the 0.2% chlorhexidine showed more reduction than the essential oils in thickness (6.5 μm vs. 10.0 μm; p<0.05) and covering grade by the biofilm (20.0% vs. 54.3%; p<0.001).
The essential oils and 0.2% chlorhexidine showed a high antiplaque effect. Although the 0.2% chlorhexidine showed better results with regard to reducing the thickness and covering grade by the biofilm, both antiseptics showed a high and similar antibacterial activity.
Daily essential oils or 0.2% chlorhexidine mouthwashes are effective when reducing dental plaque formation in the short term. Although 0.2% chlorhexidine continues to be the \"gold standard\" in terms of antiplaque effect, essential oils could be considered a reliable alternative.
ClinicalTrials.gov NCT02124655.
Journal Article
The effect of aromatherapy intervention with Bergamot and Grapefruit essential oils on premenstrual syndrome and menstrual symptoms: a randomized controlled trial
by
Özer, Esra
,
Döner, Şerife İrem
,
Dağ Tüzmen, Hafize
in
Adult
,
Alternative medicine
,
Analgesics
2025
Background
Premenstrual syndrome and menstrual symptoms adversely affect approximately 80–95% of women of reproductive age. Aromatherapy interventions are used to reduce premenstrual syndrome and menstrual symptoms. This study was conducted to determine the effect of aromatherapy intervention with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.
Methods
Ninety women with premenstrual syndrome were included the study. Participants were randomly divided into 3 groups: Bergamot(
n
= 30), Grapefruit(
n
= 30), Placebo(
n
= 30). Participants in each group were made to smell pure essential oil for 30 min 3 times a day for 4 days during the luteal phase of the menstrual cycle. The used was repeated in 3 menstrual cycles. “Premenstrual Syndrome Scale (PMSS)” was used to evaluate premenstrual syndrome and “Menstrual Symptom Questionnaire (MSQ)” was used to evaluate menstrual symptoms. All measurements were performed before and after the study.
Results
The results showed that grapefruit essential oil was effective in reducing PMSS total score (
p
= 0.010) and sub-scale scores (depressive affect, anxiety, fatigue, depressive thoughts, appetite changes, sleep changes and bloating (
p
< 0.001), irritability (
p
= 0.024), pain (
p
= 0.047)). Although grapefruit essential oil had no effect on the total score of the MSQ. Grapefruit essential oil was found to be effective in reducing the MSQ scale sub-scale scores (menstrual pain symptoms (
p
= 0.024) and the use of coping methods with menstrual pain (
p
= 0.011)). Bergamot essential oil was found to be effective in reducing PMSS total score (
p
= 0.001) and PMSS sub-scale scores depressive affect (
p
= 0.013), irritability (
p
= 0.034), depressive thoughts and appetite changes (
p
= 0.026), pain (
p
= 0.001)). In addition, there was no effect on the menstrual syndrome scale and its sub-dimensions (
p
> 0.05).
Conclusion
Grapefruit essential oil was effective in reducing both premenstrual syndrome and menstrual symptoms, whereas bergamot essential oil was only effective in reducing premenstrual symptoms.
Trial registration number
NCT06289764 (2024-02-01).
Journal Article