Migraine
Conditions
Keywords
Migraine, Ginger, Acute treatment
Brief summary
The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.
Detailed description
Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.
Interventions
DIETARY_SUPPLEMENTExtract of ginger
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).
OTHERCellulose
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Migraine diagnosis for at least one year; * Migraine attack with moderate or severe pain intensity; * One to six migraine attacks per month. *
Exclusion criteria
* Patients with headaches not characterized as migraine; * Pregnant or lactating women; * Fertile and sexually active women who do not use contraception; * Abuse of painkillers, alcohol or drugs; * People with hypersensitivity to ginger; * People with other neurological diseases; * People in use of anticoagulant drugs; * People who have started the disease after 50 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Severity. | 2 hours | The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Levels of Biomarkers. | 2 hours | Evaluated biomarkers: neurotrophic factors and inflammatory mediators. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extract of Ginger People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).
Extract of ginger: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).
Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg). | 30 |
| Cellulose People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
Cellulose: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
Intravenous ketoprofen: People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg). | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Extract of Ginger | Cellulose | Total |
|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 8.8 | 34.3 years STANDARD_DEVIATION 9.1 | 33.5 years STANDARD_DEVIATION 8.9 |
| Age of onset the disease | 21.0 years STANDARD_DEVIATION 9.8 | 23.1 years STANDARD_DEVIATION 9.4 | 22.7 years STANDARD_DEVIATION 9.6 |
| BDI | 11.2 units on a scale STANDARD_DEVIATION 6.8 | 13.9 units on a scale STANDARD_DEVIATION 9.3 | 12.5 units on a scale STANDARD_DEVIATION 8 |
| Headache Impact Test, version 6 (HIT-6) | 64.6 units on a scale STANDARD_DEVIATION 5.5 | 66.9 units on a scale STANDARD_DEVIATION 4.2 | 65.7 units on a scale STANDARD_DEVIATION 4.8 |
| Length of disease | 11.0 years STANDARD_DEVIATION 10.7 | 10.0 years STANDARD_DEVIATION 9.6 | 10.5 years STANDARD_DEVIATION 10.1 |
| Marital Status Married | 12 Participants | 13 Participants | 25 Participants |
| Marital Status Single | 17 Participants | 15 Participants | 32 Participants |
| Marital Status Widowed/Divorced | 1 Participants | 2 Participants | 3 Participants |
| Migraine Diagnosis Migraine with aura | 15 Participants | 12 Participants | 27 Participants |
| Migraine Diagnosis Migraine without aura | 15 Participants | 18 Participants | 33 Participants |
| Migraine Disability Test (MIDAS) | 17.4 units on a scale STANDARD_DEVIATION 14.2 | 14.2 units on a scale STANDARD_DEVIATION 8.3 | 15.8 units on a scale STANDARD_DEVIATION 11.2 |
| Number of migraine attacks/month | 2.2 migraine attacks/month STANDARD_DEVIATION 1.3 | 2.7 migraine attacks/month STANDARD_DEVIATION 1.2 | 2.4 migraine attacks/month STANDARD_DEVIATION 1.2 |
| Occupation Do not work | 0 Participants | 5 Participants | 5 Participants |
| Occupation Work | 30 Participants | 25 Participants | 55 Participants |
| Pain intensity (Faces Pain Scale) | 2.90 units on a scale STANDARD_DEVIATION 0.17 | 2.96 units on a scale STANDARD_DEVIATION 0.17 | 2.93 units on a scale STANDARD_DEVIATION 0.17 |
| Pain intensity (Four-point Scale) | 2.46 units on a scale STANDARD_DEVIATION 0.09 | 2.56 units on a scale STANDARD_DEVIATION 0.09 | 2.51 units on a scale STANDARD_DEVIATION 0.09 |
| Pain intensity (Visual Numeric Scale) | 7.03 units on a scale STANDARD_DEVIATION 0.26 | 7.63 units on a scale STANDARD_DEVIATION 0.25 | 7.33 units on a scale STANDARD_DEVIATION 0.25 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 30 | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Headache Severity.
The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extract of Ginger | Change in Headache Severity. | 0.81 units on a scale | Standard Deviation 0.04 |
| Cellulose | Change in Headache Severity. | 0.97 units on a scale | Standard Deviation 0.07 |
Primary
Change in Headache Severity.
The severity of headache was assessed with visual numeric scale. Scale ranges: from zero (absence of pain) to 10 (maximum intensity of pain). Higher scores mean a worse outcome.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extract of Ginger | Change in Headache Severity. | 1.03 units on a scale | Standard Deviation 0.29 |
| Cellulose | Change in Headache Severity. | 2.30 units on a scale | Standard Deviation 0.46 |
Primary
Change in Headache Severity.
The severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain). Higher scores mean a worse outcome.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extract of Ginger | Change in Headache Severity. | 0.43 units on a scale | Standard Deviation 0.13 |
| Cellulose | Change in Headache Severity. | 0.90 units on a scale | Standard Deviation 0.18 |
Secondary
Change in Serum Levels of Biomarkers.
Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
Time frame: 2 hours
Population: Brain derived neurotrophic factor - BDNF (pg/mL)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extract of Ginger | Change in Serum Levels of Biomarkers. | 6077 BDNF (pg/mL) |
| Cellulose | Change in Serum Levels of Biomarkers. | 6503 BDNF (pg/mL) |