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Group 4A Safety and Efficacy of Lavender Oil

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by

Whitney Bernreuter

on 15 September 2015

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Transcript of Group 4A Safety and Efficacy of Lavender Oil

Is Lavender Oil Safe and Efficacious in the Treatment of Anxiety?
Literature Review
Purpose
to evaluate the use, safety, and efficacy of lavender essential oil in the treatment of minor anxiety
Objectives
Describe the pathophysiology of anxiety
List the common medications used to treat anxiety
Discuss the pharmacology and clinically significant adverse effects and drug interactions of Benzodiazepines, SSRI's, and SNRI's
Identify strengths and limitations of primary literature evaluating lavender oil in the treatment of anxiety
Formulate an evidence-based therapeutic plan for patients with anxiety
Background
Conclusion
What is Anxiety?
Anxiety can be classified as a disorder (GAD) or as an episode.
Why Do We Care ?
As pharmacists we will have someone came to the pharmacy and ask for a product to treat anxiety.
Everyone experiences anxiety at some point in their life!
Some people experience more anxiety than others.
Anxiety can decrease your quality of life and interfere with normal everyday activities.
Anxiety disorders are the most common mental illness in the U.S..
Treatment
Conventional
Alternative
Lavandula angustifolia


Research Method
A multi-center, double-blind, randomized study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder
Is lavender an anxiolytic drug? A systematic review of randomized clinical trials

Pathophysiology
Hypersensitivity of autonomic nervous system ( increased NE release)
Chronic over activity of alpha 2 receptors leads to down regulation of these auto-receptors.
Decreased GABA activity.
Abnormalities with serotonin.
It is both psychological and physical.
Symptoms
A-anxiety
N- non focused
X- excessive motion (restlessness)
I- insomnia
E- energy (fatigue)
T- tension (muscles)
Y- yelling (irritable)
Used topically, orally, and via inhalation for treatment of many disease states.
Lavender inhaled or taken orally best treats anxiety.
Working on GABA- A receptors.
Safety
Shown to be safe when inhaled at appropriate concentrations.
Possibly unsafe in children when used topically
Gynecomastia in prepubescent boys
ADR: reversible neutropenia after high oral doses in patients with malignancy , CNS depression, additive effects with narcotics, N/V, dyspepsia, and anorexia
Is it Feasible?
Cost
Essential oil 1 fl. oz. = $7.59
Lavender 450 mg Capsules #30 = $15.00
Counseling
Essential oil must be diluted before being taken orally. (concentration is crucial)
Potential Drug Interactions
Warfarin and Plavix
NSAID'S
CNS depressants
Lab Drug Interaction
Decreased cholesterol levels.
Due to decreasing serum cholesterol.
Lavender
Have You Ever Googled Anxious Pharmacy Student?
Do you recognize anyone?
Study Design
General features:
Multi-center
Double Blinded
Randomized
2 Parallel Treatment Groups

Enrollment Criteria:
Age 18-65
Diagnosis of GAD
Outpatient Treatment by General Practitioner
HAM-A Score <19 (Anxiety and Tension >1)

Prior to the trial each group received placebo for one week to ensure a wash-out current medications.

Study Design
Patients (n=77) were enrolled for the 6 week trial and were randomized into two treatment groups:
Silexan 80mg (n=40)
Lorazepam 0.5mg (n=37)

Patients were evaluated based on HAM-A Score:
Response = 50% Reduction in Score
Remission = Score of less than 10

Safety was evaluated based on:
Vital Signs
12 Lead ECG
Lab Work

Study Design
Databases searched:
Medline
EMBASE
Psychinfo (via OVID)
AMED
CINAHL
The Cochrane Library

Search Terms used:
Anxiety
Stress
Lavender


Results
A total of 440 trials were found pertaining to lavender and anxiety relief. Only 15 of these trials met the inclusion criteria.



Inclusion Criteria:
RCT
Human subjects with or without clinical anxiety
Any type of pure lavender preparation

Exclusion Criteria:
Non-Randomized
No Control
Additional Ingredients

Should not delay conventional treatment.

If a patient is already using lavender for minor anxiety we will tolerate it.

We would not recommend a patient start initiation of lavender to treat anxiety.
Conventional Chronic Therapy (GAD)
SSRI's
Drugs: Fluoxetine, escitalopram, citalopram, and sertraline,
ADR: Sexual dysfunction, anorexia, N/V, and anxiety
Drug interactions: MAO-I, Linezolid, 2D6 substrates
Cost Range: $8.95 - $67.95
SNRI's
Drugs: Venlafaxine, desvenlafaxine, and duloxetine
ADR: Tachychardiea, sexual dysfunction, increased blood pressure, and tremor
Drug interactions: MAO-I, 2D6 inhibitors, Linezolid
Cost range: $108.95 - $215.95
Results and Conclusion
HAM-A Scores in both groups decreased similarly during the 6 week period (CI=90%)

HAM-A Scores:
Baseline: 25+/-4
Silexan: 11.3+/-6.7
Lorazepam: 11.6+/-6.6

This study demonstrated that Silexan is as effective as Lorazepam for the treatment of GAD in adults.
General Adverse Effects:
CNS depression
Blurred vision
Dizziness
Unsteadiness
Hangover effect
Drug Drug Interactions:
CNS depressants
Barbiturates
Opiods
Ethanol
CYP 450
Except Lorazepam
References
1. Benzodiazepines. In: Lexi-Drugs Online. Hudson (OH): Lexi-Comp. Inc; [updated 10/22/14; accessed 10/7/14]. http://cronline.comezproxy.samford.edu/lco/actio/doc/retrieve/docid/gdh_f
2. HHS resource page. U.S. Department of Health and Human Services Web Site.http://www.guidline.gov/content
3. Lavender. In: Lexi-Drugs Online. Hudson (OH): Lexi-Comp, Inc.;[updated not listed; accessed 10/7/14]. http://www.crlonline.com.ezproxy.samford.edu/lco/action/doc/rerieve/docid/disandroc/3852627
4. Lavender. In: Natural Standard. Somerville, (MA): Natural Standard. [updated: not listed; accessed 10/6/14].http://naturalmedicines-therapeuticsresearch-com.ezproxy.samford.edu/databases/foodds,-herbs-supplements/professional.aspx
5. Perry R, Terry R, Watson E. Is lavender an anxiolytic drug? A systematic review of randomized clinical trials. Phytomedicine. 2012; 19(8-9):825-835.
6. Woelk H, Schlafke S.A multi-center, double-blind, randomized study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine. 2010; 17(2):94-99.


So Before You Ask Us Questions We have a Question for You!
Conclusion
Use of forms of lavender therapy such as aromatherapy and massage are not supported by good evidence

Oral administration of lavender oil is promising, and more attention should be placed on research involving this dosage form

By: Sean Altendorf, Blaise Aziagba, Whitney Bernreuter and Kellie Cameron
Limitations
Inability to Blind
Variety of Treatment Conditions
Under Reporting of Dropouts
Publication Bias

Now Its Your Turn !
Additionally, these trials showed lavender have a relatively safe side effect profile and no sedative effects or potential for abuse.
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Full transcript