Journal of Herbal Medicine 6 (2016) 18–23

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Journal of Herbal Medicine

journal homepage: www.elsevier.com/locate/hermed

Research paper

Effect of lavender essential oil as a prophylactic therapy for migraine: A

randomized controlled clinical trial
Shahram Rafiea , Forough Namjoyanb , Fereshteh Golfakhrabadib , Fatemeh Yousefbeykc,
Alireza Hassanzadeha,*
a
Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
b
Department of Pharmacognosy, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
c
Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran

A R T I C L E I N F O A B S T R A C T

Article history: There is no cure for migraine, but preventive treatments are usually applied to reduce the frequency and
Received 1 March 2015 severity of headache attacks. The purpose of this study was to investigate the effect of lavender as a
Received in revised form 6 September 2015 prophylactic therapy for migraine in a randomized controlled clinical trial. This double-blind and
Accepted 12 January 2016
placebo-controlled study was conducted over a period of three months. Patients were assessed for
Available online 14 January 2016
migraine impact at the baseline and at the end of the study, using the Migraine Disability Assessment
Scores (MIDAS) questionnaire. In the case group, after three months of lavender therapy, the MIDAS score
Keywords:
was reduced. The reduction in MIDAS score was significant (P < 0.05), when compared to the baseline and
Migraine
Headache
also control group. During the treatment, participants did not report any complaints or side effects. The
Prophylaxis results of this present study report that the frequency and severity of migraine incidents were reduced in
MIDAS those participants using lavender therapy during the three month trial.
Lavandula stoechas L. ã 2016 Elsevier GmbH. All rights reserved.

1. Introduction frequency and severity of a headache (D’Amico et al., 2006; Lipton

Migraine is influenced by various factors such as diet, hormonal
disorders, digestive problems, autoimmune disturbances, struc-
tural imbalances, mental stress and lifestyle (Fantasia, 2014). It is a
common and disabling disorder amongst adults and children,
although it more often affects women (Magis and Schoenen, 2011).
Irrespective of age, migraine can spontaneously occur in an
individual, but migraine often starts between ages 10 and 30
(Magis and Schoenen, 2011). The migraine pain is often accompa-
nied by a variety of symptoms which may include nausea, blurred
vision, vomiting, sensitivity to light, and noise (Fantasia, 2014).
The following medications are commonly used to prevent
migraine: beta-blockers, flunarizine, topiramate, valproate, ami-
triptyline, venlafaxine, gabapentin, magnesium and botulinum
toxin type A (Chayasirisobhon, 2013). None of the drugs used in
migraine prophylaxis are uniformly effective for patients. There are
minimal but still reported side effects associated with common
medications (Chayasirisobhon, 2013; Prior et al., 2010).
There is no cure for migraine, but supplements and medicinal
herbs can be used to prevent migraine attacks and reduce the
* Corresponding author. Fax: +98 6133743012.
E-mail address: Hassanzadeh.a@ajums.ac.ir (A. Hassanzadeh).
et al., 2003). In addition, the use of traditional medicine and
medicinal plants is increasing worldwide. Therefore, the study of
their clinical efficacy and the conduct of further clinical trials
regarding medicinal herbs is required as a matter of priority. The
results of such research can be used for further investigations into
pharmaceutical formulations and also to improve our knowledge
regarding herbal medicine treatment in its own right. Some
medicinal herbs have shown capability in the treatment of
migraine prophylaxis. Feverfew (Tanacetum parthenium), for
example, was found to be effective in the prevention of migraine.
The active constituents of feverfew are sesquiterpene and lactones,
especially parthenolide (Johnson et al., 1985; Bohlmann and Zdero,
1986; Murphy et al., 1988). Butterbur (Petasites hybridus root) has
shown efficacy in migraine prophylaxis (Lipton et al., 2004). This
plant acts by the inhibition of peptide leukotriene biosynthesis and
interference in the inflammatory cascade associated with migraine
(Eaton, 1998; Sheftell et al., 2004; Grossman and Schmidrams,
2000).
The genus Lavandula (common name: lavender) is comprised of
about 25–30 species of flowering plants in the Lamiaceae
(Labiatae) family (Behbahani et al., 2013; Effati-Daryani et al.,
2015). Native to France and the western Mediterranean these
flowering plants are cultivated worldwide for their volatile oil
(Behbahani et al., 2013; Effati-Daryani et al., 2015). The leaves of

http://dx.doi.org/10.1016/j.hermed.2016.01.003
2210-8033/ ã 2016 Elsevier GmbH. All rights reserved.
 S. Rafie et al. / Journal of Herbal Medicine 6 (2016) 18–23 19

lavender can be used in aromatherapy; lavender aromatherapy
shows positive effects on hemodynamic indices among patients
with acute coronary syndrome (Nategh et al., 2015). In another
study, lavender essential oil was found to reduce the level of
anxiety in patients undergoing coronary artery bypass graft
surgery (Seifi et al., 2014). A recent evaluation showed the positive
effect of lavender essential oil, in reducing anxiety in patients
undergoing curettage. It may therefore be concluded that lavender
aromatherapy can be used in supportive therapy alongside
orthodox treatment (Bakhsha et al., 2014).
Lavender essential oil has been used traditionally for the
treatment of colds, digestion, flatulence, upset stomach, liver,
gallbladder problems and loss of appetite (Katona et al., 2010; Kim
et al., 2007). In addition, this genus is beneficial for stress, anxiety,
exhaustion, headaches, migraines, insomnia and depression (Seifi
et al., 2014; Katona et al., 2010; Kim et al., 2007). Lavandula stoechas
L. which is generally called Ustkhuddus in the Persian language, is a
low-growing and evergreen herb (Lim, 2014). There are some
reports about its spasmolytic (Gedney et al., 2004), sedative
(Buchbauer et al., 1991), antihypertensive (Koto et al., 2006),
antimicrobial (Inouye et al., 2001) and antifungal (D’Auria et al.,
2005) properties. Moreover, the analgesic effect of lavender oil has
been investigated in previous studies (Yip and Tse, 2006; Gedney
et al., 2004). The efficacy of lavender oil in anxiety disorders has
also been reported (Morris, 2002). The purpose of this study was to
investigate the effect of lavender essential oil as a prophylactic
therapy for migraine in a placebo-controlled clinical trial.
2. Materials and methods
2.1. Preparation of lavender essential oil and placebo
The aerial parts of L. stoechas L. were collected from the
Zardband Botanical Garden of Iran in May 2014. Identification and
authentication was carried out by botanists in Zardband Botanical
Garden and a voucher specimen deposited in their herbarium. The
samples were crushed and the essential oil was obtained by the
hydrodistillation method using a Clevenger type apparatus
(Advanced Technocracy Inc., India), according to the European
Pharmacopoeia (1975) (Maisonneune, 1975; Golfakhrabadi et al.,
2015). The oil was dried over anhydrous sodium sulphate and kept
at 4  C in a sealed brown vial until required. 1 ml of essential oil was
obtained from 100 g of the dried plant. The oil yield of the plant was
determined as 1% v/w. This essential oil was dissolved in a
hydroalcoholic solvent (ethanol/water 80/20) and was decanted
into 20 ml bottles. The ratio of essential oil to solvent was 1:3. The
lavender extract was standardized based on linalyl acetate (0.6%)
and linalool (0.4%).
The placebo was prepared using the hydroalcoholic solvent
with a number of approved color additives added to have the same

Enrollment Assessed for eligibility (n=65)

Excluded (n=5)

♦ Not meeting inclusion criteria (n= 4)

♦ Declined to participate (n=1)

♦ Other reasons (n=0)

Randomized (n= 60)

Allocation
Allocated to intervention (n= 30) Allocated to intervention (n= 30)

♦ Received allocated intervention (n=30) ♦ Received allocated intervention (n=30)

♦ Did not receive allocated intervention (give ♦ Did not receive allocated intervention (give
reasons) (n=0 ) reasons) (n= 0)

Follow-Up

Lost to follow-up (3 unavailable for assessment Lost to follow-up (2 unavailable for assessment
visit) (n=3) visit) (n=2)

Discontinued intervention (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)

Analysis

Analyzed (n=27) Analyzed (n=28)

♦ Excluded from analysis (Dropped out) (n=0) ♦ Excluded from analysis (Dropped out) (n=0 )

Fig. 1. Study flowchart (CONSORT format).

20 S. Rafie et al. / Journal of Herbal Medicine 6 (2016) 18–23
physical form, packaging and labeling as the lavender extract. The
lavender extract or placebo was supplied in bottles of 20 ml and
divided among Groups 1 and 2 to be used by the patients (n = 30 in
both groups). The patients dissolved 10 drops of lavender extract or
placebo in a cup of water and drank it each evening. A physician
prescribed the placebo or lavender extract to patients based on the
number labeled on each vial. The physician and supplier of the
lavender or placebo were blind to the contents. The pharmacist
was the only one who was aware of the numbers that were
assigned to the lavender or placebo groups.
2.2. Study design and target group
This double-blind and placebo-controlled study was conducted
for three months, during which period data was collected and
analyzed. This study was approved by Ahvaz Jundishapur
University of Medical Sciences Ethics Committee. In addition,
the trial was registered in the Iranian Registry of Clinical Trials
under the number IRCT2014081218776N1. Participants were males
and females between the ages of 20 and 39 years referred to
Golestan hospital, Ahvaz, Khouzestan province, Iran. Criteria for
inclusion were a long-term history of migraine attacks diagnosed
according to the International Headache Society (IHS) criteria for
migraine without aura (Headache Classification Committee of the
International Headache Society, 1998). Patients with 2–8 attacks
per month for at least one year were included in this study. Sixty
patients (women and men) between the ages of 15 and 50 were
enrolled after a careful medical history and relevant physical
examination of the sample patients. Furthermore, the participants
were not taking any additional prophylactic treatment and any
current medication being taken for migraine had been reported as
ineffective. Women of child-bearing age were allowed to partici-
pate in this study if they had a negative pregnancy test and agreed
to use contraceptive protection for the duration of the study. The
criteria for exclusion included presentation with other types of
headache, pregnancy, breastfeeding, hypertension, severe heart
problems, renal and liver dysfunction, use of other medicinal herbs
or receiving prophylactic treatment, depression and other
psychiatric disorders or not taking the lavender extract for over
three days during the study. Additionally, patients should not have
taken acute anti-migraine drugs more than twice a week during
the course of the three month trial.
Sixty patients were enrolled in this study, all of whom received
tablets of propranolol 40 mg per day (i.e. their current medication),
together with either a placebo or lavender extract as a preventive
treatment every night. The sixty patients were randomized into
two groups. Group 1 (n = 30) received 10 drops of lavender extract
[linalyl acetate (0.6%) and linalool (0.4%)] every night for three
months and Group 2 (n = 30) received 10 drops of a matching
placebo (Fig. 1). Random group assignments were done using a
simple random allocation strategy, by way of a randomized block
method. The eligible patients were ‘blinded’ to the treatment they
received and written informed consent was obtained from every
Table 1
Demographics and baseline characteristics of the study population.
Variable
Age (years) (mean  SD)
Range
Gender
Male
Female
MIDAS scores (mean  SD)
No. of headache days per month (mean  SD)
Headache severity (mean  SD)
study subject prior to the trial. A physician prescribed samples
(lavender extract or placebo) to the patients according to the label
numbers. The pharmacist was aware of the numbers assigned to
the lavender extract or placebo.
Patients were aware of the migraine impact at the baseline and
end of the study, using Migraine Disability Assessment Scores
(MIDAS) questionnaire (Stewart et al., 1999). There was a five item
self-report questionnaire that assessed the number of days the
patient lost or limited their activities including work, school,
household and recreational activities, as well as family and social
relationships, within the last three months. The results of the
MIDAS show a total score reflecting the grades of migraine, where a
score of 0–5 shows Grade I migraine, a score of 6–10 indicates
Grade II migraine, a score of 11–20 shows Grade III and a score
higher than 20 reflects Grade IV migraine. In addition, there were
two questions relating to the number of headache days and
headache severity during the past three months. Patients with
headache severity were scored between 0 and 10. The score of
10 indicates the highest intensity of headache.
2.3. Statistical analysis
The data are reported as mean  standard deviation. Changes in
the MIDAS score, frequency and intensity of headache from
baseline to the end of the treatment period were analyzed for
statistical significance using a paired-sample t-test. Statistical
significance was considered at P < 0.05.
3. Results
In this study, the efficacy of lavender essential oil as a
prophylactic therapy for migraine was investigated. Table 1 shows
the demographic data of the study population. There were
20 female and 10 male patients in the treatment group and
22 female and 8 male in the control group. The average age of
patients in the group receiving lavender was 30.40  8.92 and the
average age of patients receiving placebo was 27.70  7.00. There
were no significant differences between patients with regard to
age or gender in treatment and placebo groups (P > 0.05). Sixty
patients were enrolled in this study. One patient discontinued the
treatment with lavender on day 14 and two patients on day
30 when they were unavailable for the assessment visit. In
addition, two patients also discontinued treatment in the placebo
group, on day 8 and day 12, when they were unavailable for the
assessment visit. The other 55 patients successfully completed the
3-month study for prophylactic therapy of migraine and were
included in this analysis.
The MIDAS scores in the case and the control groups at the
beginning of the study were 41.07  10.95 and 41.33  11.74,
respectively. Therefore, the MIDAS scores in the two groups were
not significant (P = 0.93). In the case group, after three months of
lavender therapy, the MIDAS score was reduced to 18.10  5.87.
When compared to baseline, the changes in MIDAS score were
Case group Control group P value
(n = 30) (n = 30)
30.39  8.9 27.66  7.00 0.21
15–50 15–50
0.44
10 8
20 22
41.07  10.95 41.33  11.74 0.93
7.32  1.12 7.22  1.05 0.73
7.03  1.13 7.00  1.27 0.91
 S. Rafie et al. / Journal of Herbal Medicine 6 (2016) 18–23 21

P=0.73
8
7.22 7.32
7

Number of headache dayys (mean±SD)

P=0.001
6
P=0.001
5
5
4.14
4 Control group
3.46
Case group
3
2.28
2

0
Base line First month Third month

Fig. 2. Comparison of the number of headache days at baseline, first month and third month after lavender therapy.

significant (P = 0.001). During the treatments, participants did not
report any complaints or side effects.
In the control group, the MIDAS score after the intervention was
reduced to 29.18  9.62. When compared to the baseline, the
changes in MIDAS score were statistically significant (P = 0.001).
When compared to the placebo group, the changes in the MIDAS
score after intervention in the group receiving lavender became
significant (P = 0.001). The reduction of 55.93% in MIDAS score over
three months attests to the clinical significance of lavender effect.
At the baseline, in the case group, 26 of 30 patients had Grade IV
migraine and four had Grade III migraine on the MIDAS scale.
Following three months of therapy, in the group receiving lavender,
five patients remained at Grade IV and 19 Grade IV patients were
re-graded to Grade III. Three Grade III patients were re-graded to
Grade II and one was re-graded to Grade I. Three patients
discontinued the treatment with lavender.
The headache frequency per month in the case group at the
baseline and at the end of the study were 7.32  1.12 vs. 2.28  0.76
(P = 0.001), and in the control group were 7.22  1.05 vs. 5.00  1.35
(P = 0.001), showing a significant reduction (Fig. 2). The headache
severity in the group receiving lavender before and after
treatments were 7.03  1.13 vs. 4.14  1.23 (P = 0.001), and in the
group receiving placebo were 7.00  1.27 vs. 4.66  0.91 (P = 0.001),
this showed a significant reduction (Fig. 3). Compared to the
control group, the changes in headache severity and frequency,
after the three months of lavender therapy in the case group was
significant (P < 0.05). The headache frequency and intensity in the
treatment group, after one month of lavender therapy were
3.46  0.83 and 4.14  1.04, respectively.
4. Discussion
In this clinical trial, all participants were previously being
treated with propranolol and after agreeing to participate in this
study, also received lavender extract as an adjunct to that
treatment. At the end of the study, the improvement of headache
severity and frequency in the case group compared to the control
group after adjunct therapy with lavender extract was significant
(P < 0.05). Headache severity in the case group was reduced to
41.1% in the first month and 52.35% in the third month, indicating
that lavender reduced headache intensity by approximately 50%
during the trial period. In the case group, the frequencies of

P=0.91
8
7 7.03
7
P=0.001
P=0. 001
Headache severity (mean±SD)

6
5.15
5 4.66
4.14
4 Control group
3.35
Case group
3

0
Base line First month Third month

Fig. 3. Comparison of headache severity at baseline, first month and third month after lavender therapy.
22 S. Rafie et al. / Journal of Herbal Medicine 6 (2016) 18–23
headache attacks at the end of the first and third month were
reduced to 52.73 and 68.85% respectively, representing a reduction
of more than 60% in headache frequency.
In agreement with this study, Sasannejad et al. (2012) found
positive results when investigating the efficacy of lavender
essential oil inhalation in migraine treatment. In their study,
patients inhaled lavender essential oil for 15 min, following which
their headache intensity was recorded in 30 min intervals for 2 h.
The results show that lavender essential oil inhalation was
significantly effective in acute management of migraine attacks,
with no side effects in the treatment.
The oral ingestion of essential oil of lavender has shown efficacy in
generalized anxiety disorder, as well as exhibiting an antidepressant
effect and improved general mental health and quality of life (Kasper
et al., 2014). In another study, aromatherapeutic use of lavender
essential oil in patients in intensive care units showed significant
improvement in their anxiety levels (Dunn et al., 1995). Previous
studies showed that linalyl acetate has a narcotic effect while linalool
has a sedative effect; hence, lavender has traditionally been used as a
sleep aid (Tisserand and Balacs, 1999; Re et al., 2000). Alaoui-Ismaili
et al. (1997) showed that lavender essential oil induces changes in the
autonomic nervous system and creates positive emotional states
(Alaoui-Ismaili et al., 1997). Another study showed the aromathera-
peutic use of analgesic effect of lavender oil in patients undergoing
laparoscopic adjustable gastric banding; significantly less analgesic
drugs were required in patients receiving lavender as compared with
placebo (Kim et al., 2007). The active compounds of lavender
essential oil are linalool and linalyl acetate. In this study, the lavender
essential oil was standardized based on linalyl acetate (0.6%) and
linalool (0.4%). Previous studies have indicated the efficacy of
lavender, for the treatment of anxiety disorders and for its calming,
analgesic and sedative effects. These findings indicate that the herb
has a physiological effect on the nervous system. These actions,
especially the analgesic effect, show that lavender oil may be useful
for the reduction of migraine frequency and intensity.
5. Conclusion
The results of this present study report that the frequency and
severity of migraine incidents were reduced in those participants
using lavender therapy during the three month trial. Essential oil of
lavender shows significant promise for its efficacy in the
prevention of migraine however since the use of lavender extract
was concomitant with propranolol, the patients’ current orthodox
treatment, these results must be viewed with caution in regard to
possible synergy between the two treatments. Since this is a small
study, a further and larger scale randomized controlled investiga-
tion of the efficacy of treatment with lavender extract alone, is
necessary to confirm these results.
Conflict of interest
The authors declare that there is no conflict of interest.
Acknowledgement
This research was supported by Ahvaz Jundishapur University
of Medical Sciences, Ahvaz, Iran (Grant number: ajums.
REC.1392.214).
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