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- Chamomile (Matricaria chamomilla syn. M. recutita, Asteraceae)
- Migraine Headaches
- Essential OIl
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Date:
10-15-2018 | HC# 091811-602
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Re: Topical Chamomile Oleogel Reduces Symptoms of Migraine without Aura
Zargaran A, Borhani-Haghighi A, Salehi-Marzijarani M,
et al. Evaluation of the effect of topical chamomile (Matricaria
chamomilla L.) oleogel as pain relief in migraine without aura: a
randomized, double-blind, placebo-controlled, crossover study. Neurol Sci. May 2018;39(8):1345-1353. doi:10.1007/s10072-018-3415-1.
Medicinal oils have been a popular form of herbal
medicine administration since the days of ancient Persia. Precise pharmaceutical
recipes refined and recorded over more than a millennium describe specific
procedures for the preparation of chamomile (Matricaria chamomilla syn. M.
recutita, Asteraceae) oil. There is an effort underway in Iran to update
chamomile oil preparation to current standards. A new preparation is formulated
as an oleogel — a semisolid, non-greasy product that is more pleasing to modern
consumers. This product is standardized based on chamazulene and apigenin constituents
using modern instrumentation. A wave of clinical research studies is evaluating
the product's safety and efficacy for various conditions. For example, this
same preparation has previously been found to provide therapeutic effects in
knee osteoarthritis and carpal tunnel syndrome.
Migraine is a type of headache characterized by
pulsing, chronic, usually one-sided attacks. It is the third most common
chronic disorder and affects 10-20% of people. Migraine headaches can occur
with or without an aura. Migraine without aura is more common. None of the conventional
drugs for migraine provide complete relief. The most effective group of drugs, the
triptans, is contraindicated in patients with cardiovascular disease.
In this crossover, double-blind, clinical trial,
researchers evaluated the efficacy of chamomile oleogel for migraine headache without
aura.
Chamomile flowers for the study were purchased from a
traditional herb shop. The plant material was verified by the botanist Miss
Sedigheh Khademian of the Herbarium Center, School of Pharmacy, Shiraz
University of Medical Science. Sesame (Sesamum
indicum; Pedaliaceae) oil was supplied by Golkaran Co. The researchers have prepared the
same chamomile oleogel product for other studies and followed an identical
procedure. They began with 200 g plant powder boiled in 2.5 L of distilled
water for three hours in a Clevenger apparatus. They obtained 5 g of essential
oil from this process, which they reserved for later in the process. Next, they
filtered the powder from the water and simmered the water extract in an
unspecified amount of sesame oil until no water remained,
which took about three hours. They cooled the oil and then added the reserved
essential oil. To create an oleogel, 5.5% colloidal silicon dioxide was added
to the medicated oil. For the placebo, researchers combined 10% chamomile oil
with 90% paraffin and added 5.0% colloidal silicon dioxide.
The medicated oil contained 2% essential oil, a sample
of which the researchers analyzed using gas chromatography (GC) and mass
detection. Table 1 provides information about 19 components accounting for
97.64% of the essential oil. They used GC and flame ionization detection to measure
the chamazulene content, which was 4.48 ± 0.01 μL/mL. Using spectrophotometry, they measured 75.43 ± 0.51 mg/L polyphenols and
28.63 ± 0.79 mg/L flavonoids in the oleogel. High performance liquid chromatography
confirmed apigenin as the main flavonoid, at 0.165 ± 0.006 mg/g in the oleogel.
The extraction ratio was 71%, from which they calculated apigenin content in
the final product of 0.233 mg/g.
One hundred patients with migraine without aura (as
defined by the Headache Classification Committee of the International Headache Society)
were recruited at the Imam Reza Clinic of Shiraz University of Medical Sciences,
in Shiraz, Iran. Included patients were ages 18 to 65 years, had at least a one-year
history of migraine, and their first attack occurred before age 50. Patients
were excluded if they had a history of any neurological disorders other than migraine,
used any prophylactic remedies for migraine within one month of the beginning
of the study, had severe headache not responding to at least three types of
abortive medications, had headache lasting more than 15 days per month for a
period of three or more months, had a history of skin lesions and eczema, had a
hypersensitive reaction in the temporal and forehead areas, were breast
feeding, were pregnant, could not read, were at risk of committing suicide, or
had psychiatric comorbidities.
Each patient was randomized into the drug-placebo
group or the placebo-drug group. They were instructed to apply 2 mL of the
trial medication on the forehead and temporal area, back to behind the ears at
onset of a migraine attack. After using the first medication for two attacks,
they then had a 14-day washout period, after which they used the other test
medication for two migraine attacks. Patients filled out a visual analog scale
(VAS) questionnaire for each attack. The questionnaire included pain level as
well as status of other migraine-related symptoms such as nausea, vomiting,
sensitivity to light and sensitivity to sound at minutes 15, 30, 45, and hours one,
two, six, and 24 following application of the medication. If the pain was
intolerable after two hours, patients were to use a conventional medication and
stop recording data for that attack.
Seventy-two patients completed the trial. Their mean
age with standard deviation was 37 ± 9.3 years. There were no significant
differences in demographic information between those completing treatment in
the placebo-drug and the drug-placebo groups. Of the 28 patients who dropped
out of the study, two experienced hypersensitivity to the chamomile oleogel,
two used analgesics before the two-hour mark, one took an antidepressant drug, six
did not complete VAS forms, seven left Shiraz, and eight left the study for
unknown reasons.
The researchers used a mixed-effect model to compare
drug to placebo. The fixed effects were sequence of treatment, period of
treatment, type of drug, and time. Outcomes included percentage of pain-free
and pain-relief at two hours after medication, recurrence, relapse, sustained
pain relief, sustained pain-free response at 24 hours, and alleviation of
associated symptoms.
Chamomile oleogel
was significantly superior to placebo for all outcome measures (P<0.05)
starting at 30 minutes after application and continuing beyond. Two hours after
application, 29.2% of attacks in the chamomile group were pain-free, as opposed
to 2.1% in the placebo group (P=0.001). Also, at two hours after application,
85.4% in the chamomile group experienced pain relief, as opposed to 19.4% of
the placebo group (P=0.001). Patients in the placebo group had a recurrence
rate of 46.4% compared to 13% in the chamomile group (P=0.008). Patients in the
chamomile group also reported significantly longer pain-free times, less nausea
and vomiting, and less light and sound sensitivity compared to those receiving
placebo.
The researchers theorize that the effects of the
chamomile oleogel are due to chamazulene and apigenin reducing nitric release,
flavonoids inhibiting cyclooxygenase-2, phenolic compounds inhibiting
inflammatory markers, and sesamin from the sesame oil contributing
anti-inflammatory and analgesic effects. These study results were comparable to
studies that used a similar design to test other compounds. The chamomile
preparation in this study had superior results compared to a previous study
using a 10% menthol solution. This study using chamomile oleogel also had
results comparable to studies using some conventional analgesics.
The chamomile oleogel tested in this study acts
quickly, presumably faster than an oral medication would. Another advantage of
topical remedies for migraine is that migraine is often associated with nausea
and vomiting, which can make oral administration of medication problematic.
Hypersensitivity to chamomile is a well-known
phenomenon. Four patients, 4% of the 100 patients included in the study,
experienced hypersensitivity reactions. This is within the range to be
expected. None of the reactions caused major complications. Standardized chamomile
oleogel can be considered a safe and effective treatment for migraine without
aura in individuals who are not sensitive to chamomile.
The authors make no statement regarding conflicts of
interest.
–Anne Louise Merrill
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