Research Article
Evaluation of a Polyherbal Formulation on the Management of
MigraineHeadachesduetoFunctionalDyspepsia:ADouble-Blind,
Randomized, Placebo-Controlled Clinical Trial
Majid Anushiravani,
1
Seyed Mousal-Reza Hosseini,
2
Karim Nikkhah,
3
Shabnam Niroumand,
4
Ali Reza Derakhshan,
1
Roshanak Salari,
5
Ali Gholampour,
1
and Vahid Reza Askari
1,6,7
1
Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences,
Mashhad, ran
2
Department of Gastroenterology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, ran
3
Department of Neurology, Ghaem Medical Centre, Mashhad University of Medical Sciences, Mashhad, ran
4
Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, ran
5
Department of Pharmaceutical Sciences in Persian Medicine, School of Persian and Complementary Medicine,
Mashhad University of Medical Sciences, Mashhad, ran
6
nternational UNESCO Center for Health•Related Basic Sciences and Human Nutrition,
Mashhad University of Medical Sciences, Mashhad, ran
7
ran Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, ran
CorrespondenceshouldbeaddressedtoAliGholampour;gholampoura1@mums.ac.irandVahidRezaAskari;askariv@mums.ac.ir
Received 27 January 2022; Revised 13 August 2022; Accepted 15 September 2022; Published 3 December 2022
Academic Editor: Talha Bin Emran
Copyright © 2022 Majid Anushiravani et al. Tis is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
A holistic concept based on traditional Persian medicine (TPM) describes a headache with a gastrointestinal (GI) origin (gastric•
headache). Although the neurological manifestations of this headache are similar to those of other headaches, its etiology is diferent.
Considering its simultaneous efects on the brain and GI system, a formulation was designed based on this concept. Tis study aimed
to determine the safety and efcacy of the designed formulation on migraine headache (MH) associated with functional dyspepsia
(FD). A total of 75 diagnosed cases of MH patients with concurrent FD were randomly divided equally into 3 groups: (i) the
polyherbal formulation, sodium valproate (VPA), and amitriptyline group, (ii) VPA, amitriptyline, and polyherbal formulation
placebo group, and (iii) the polyherbal formulation and VPA placebo group. Te primary outcomes, including frequency, duration,
and severity of MH attacks, were measured at baseline and weeks 4, 8, and 12. However, secondary outcomes, including the Headache
Impact Test 6 (HIT•6) Questionnaire and Parkman’s score, were evaluated at baseline and end of treatment. Te frequency, duration,
and severity of migraine (P < 0.001 for all cases), HIT•6 (P < 0.001 for all cases), and FD (P < 0.001 for all cases) scores at the end of
treatment showed a signifcant decrease in the 3 groups compared to the baseline. However, the diferences in those variables between
the 3 groups were not signifcant at the end of the study. Te polyherbal formulation alone may improve the symptoms of migraine
patients and other groups. Tis efect could be due to improving digestion and FD in migraine patients.
1.Introduction
Te International Headache Society (IHS) has classifed
headaches into primary and secondary types. Primary head•
aches include migraine, tension•type, and cluster headaches
[1]. Migraine headache (MH) is described as a chronic neu•
rovascular disorder in the brain, characterized by unilateral
throbbing pain [2, 3]. It is recognized as one of the top 10
debilitating diseases worldwide. According to the burden of
disease study in 2013, this disorder was ranked the sixth cause
Hindawi
Evidence-Based Complementary and Alternative Medicine
Volume 2022, Article ID 9872933, 12 pages
https://doi.org/10.1155/2022/9872933