A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study

Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Dietary supplement: Antemig

Detailed Description

Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.

The day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine [QVM]) and the Hospital Anxiety and Depression Scale (HADS).

The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance.

• Study Type: Observational
• Enrollment (Actual): 132

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients were recruited by general practitioners (GPs). Patients had to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)

Description

Inclusion Criteria:

• to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
• to suffer from migraine for more than one year
• to be less than 50 years old at migraine onset
• to have had at least two migraine attacks during the month before recruitment

Exclusion Criteria:

• migraine with aura with motor symptoms (hemiplegic migraine)
• more than 15 migraine attacks per month
• abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months
• prophylactic treatment taken for less than 3 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the number of days with migraine headache at the 3rd Month	3rd month of supplementation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days with migraine headache per month	during the 1st month
Number of days with migraine headache per month	during the 3rd month
Intensity of migraine headache evaluated with a 5 points Likert Scale	during the 1st month
Intensity of migraine headache evaluated with a 5 points Likert Scale	during the 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms	during the 1st month of observation, 1st, 2nd and 3rd month
Associated symptoms evaluated with Scorecard of potential symptoms	during the 1st month
Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire	during the 3rd month
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire	baseline
Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire	end of the 3rd month
Compliance followed with patient logbook	3 months
Safety followed with side effects register	3 months

Collaborators and Investigators

• Sponsor: PiLeJe

Publications and helpful links

General Publications

• Guilbot A, Bangratz M, Ait Abdellah S, Lucas C. A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study. BMC Complement Altern Med. 2017 Aug 30;17(1):433. doi: 10.1186/s12906-017-1933-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: PiL-Obs-AntMIG-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No