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. 2022 Dec 3:2022:9872933.
doi: 10.1155/2022/9872933. eCollection 2022.

Evaluation of a Polyherbal Formulation on the Management of Migraine Headaches due to Functional Dyspepsia: A Double-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 , Vahid Reza Askari  1   6   7
Affiliations

Evaluation of a Polyherbal Formulation on the Management of Migraine Headaches due to Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Majid Anushiravani et al. Evid Based Complement Alternat Med. .

Abstract

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 different. Considering its simultaneous effects on the brain and GI system, a formulation was designed based on this concept. This study aimed to determine the safety and efficacy 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. The 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. The 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 significant decrease in the 3 groups compared to the baseline. However, the differences in those variables between the 3 groups were not significant at the end of the study. The polyherbal formulation alone may improve the symptoms of migraine patients and other groups. This effect could be due to improving digestion and FD in migraine patients.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Flowchart of the study. Group 1: the polyherbal formulation capsule∗ 1500 mg (two capsules of 750 mg) three times a day, + Depakine® tablet 200 mg twice a day + Amitriptyline tablet 10 mg once a day; Group 2: Depakine® tablet 200 Mg twice a day + Amitriptyline 10 mg once a day + the polyherbal formulation placebo capsule three times a day; Group 3: the polyherbal formulation capsule 1500 mg (two capsules of 750 mg) three times a day + Depakine® placebo tablet twice a day.
Figure 2
Figure 2
Frequency, duration and severity of MH attacks (per month) in three groups throughout the study period from week 0 to week 12. Group 1: the polyherbal formulation capsule∗ 1500 mg (two capsules of 750 mg) three times a day, + Depakine® tablet 200 mg twice a day + Amitriptyline tablet 10 mg once a day; Group 2: Depakine® tablet 200 Mg twice a day + Amitriptyline 10 mg once a day + the polyherbal formulation placebo capsule∗ three times a day; Group 3: the polyherbal formulation capsule 1500 mg (two capsules of 750 mg) three times a day + Depakine® placebo tablet twice a day.
Figure 3
Figure 3
A schematic overview of the current study. ∗PHF is an abbreviation for polyherbal formulation.
See this image and copyright information in PMC

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