ORIGINAL ARTICLE
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
Arman Zargaran
1,2
&
Afshin Borhani-Haghighi
3,4
&
Mohammad Salehi-Marzijarani
5
&
Pouya Faridi
6
&
Saeid Daneshamouz
7
&
Amir Azadi
7
&
Hossein Sadeghpour
8
&
Amirhossein Sakhteman
8
&
Abdolali Mohagheghzadeh
1,6
Received: 29 November 2017 /Accepted: 20 April 2018
#
Springer-Verlag Italia S.r.l., part of Springer Nature 2018
Abstract
Phytotherapy is a source of finding new remedies for migraine. Traditional chamomile oil (chamomile extraction in sesame oil) is a
formulation in Persian medicine (PM) for pain relief in migraine. An oleogel preparation of reformulated traditional chamomile oil
was prepared and then standardized based on chamazulene (as a marker in essential oil) and apigenin via gas chromatography (GC)
and high-performance liquid chromatography (HPLC) methods, respectively. A crossover double-blind clinical trial was performed
with 100 patients. Each patient took two tubes of drug and two tubes of placebo during the study. Visual analog scale (VAS)
questionnaires were filled in by the patients and scores were given, ranging from 0 to 10 (based on the severity of pain) during
24 h. Other complications like nausea, vomiting, photophobia, and phonophobia were also monitored. There was 4.48 ± 0.01 μl/ml
of chamazulene and 0.233 mg/g of apigenin in the preparation (by correcting the amount with extraction ratio). Thirty-eight patients
in the drug-placebo and 34 patients in the placebo-drug groups (a total number of 72 patients as per protocol) completed the process in
the randomized controlled trial (RCT). Adapted results from the questionnaires showed that pain, nausea, vomiting, photophobia, and
phonophobia significantly (p < 0.001) decreased by using chamomile oleogel on the patients after 30 min. Results supported the
efficacy of chamomile oleogel as a pain relief in migraine without aura.
Keywords Persian medicine
.
Chamomile
.
Neurological sciences
.
Migraine
Introduction
Migraine is one of the most common types of headache iden-
tified as a pulsating, chronic, and mostly one-sided (unilateral)
attack [1]. It prevails in about 10–20% of the population [2].
Women are more affected by migraine. It has been reported
that migraine is the third most prevalent disorder and the sev-
enth highest specific cause of disability. There is even evi-
dence showing temperamental dysregulation and suicidal be-
havior in migraine patients, particularly women [3]. Migraine
imposes an annual cost of about 27 million Euros to European
societies due to patients’ decreasing efficacy at work and los-
ing working days [4, 5]. There are two main types of mi-
graine—with aura and without aura. Migraine without aura
is the most common kind.
There are three main groups of classical drugs used for pain
relief in migraine—triptans or agonists of serotonin 5-HT1B/
1D receptor; ergot alkaloids (ergotamine and dihydroergota-
mine); and non-steroidal anti-inflammatory drugs (NSAIDs)
[6–8]. Although triptans are the most effective, they have some
limitations like cardiovascular comorbidities [6]. Ergot
* Abdolali Mohagheghzadeh
mohaghegh@sums.ac.ir
1
Pharmaceutical Sciences Research Center, and Department of
Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy,
Shiraz University of Medical Sciences, Shiraz, Iran
2
Department of Traditional Pharmacy, School of Persian Medicine,
Tehran University of Medical Sciences, Tehran, Iran
3
Clinical Neurology Research Center, Shiraz University of Medical
Sciences, Shiraz, Iran
4
Department of Neurology, Shiraz University of Medical Sciences,
Shiraz, Iran
5
Department of Biostatistics, Faculty of Medicine, Shiraz University
of Medical Sciences, Shiraz, Iran
6
Research Office for the History of Persian Medicine, Shiraz
University of Medical Sciences, Shiraz, Iran
7
Department of Pharmaceutics, School of Pharmacy, Shiraz
University of Medical Sciences, Shiraz, Iran
8
Department of Medicinal Chemistry, School of Pharmacy, Shiraz
University of Medical Sciences, Shiraz, Iran
Neurological Sciences
https://doi.org/10.1007/s10072-018-3415-1
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