A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity and duration of headaches in healthy participants aged 18 years and older.

Palmitoylethanolamide (PEA) can be sold as a dietary supplement for medical purposes under FSANZ (Food Standards Australia and NZ). PEA will be taken as a single 525mg dose in capsule form with water. Ibuprofen will be dosed at the manufacturers recommendation (400 mg). Approximately 80 adult male and female participants aged between 18 years and older will be recruited from databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, physical assessment (weight and height) and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. A standardised questionnaire will be administered to assess participants lifestyle including questions about their: age, weight, height, partner status, level of physical activity, alcohol and cigarette consumption, and work status. Participants will be enrolled in the study for a maximum of 4 months, with participation concluding once 5 headache events have been recorded. Upon the onset of headache symptoms, participants will record the time and date of the occurrence and score the perceived headache pain using a Visual Analog Score (VAS) system in a diary provided. Participants will also record gastrointestinal (GIT) tolerance. Participants will immediately supplement with a single dose (525 mg) of PEA with water or ibuprofen (400 mg) with water. After supplementation, participants will score the headache pain (using the VAS) and GIT tolerance every 30 minutes until the headache subsides, or until 4 hours has passed from headache onset (whichever occurs first). This will provide pain and frequency data for analysis. Data on the type (e.g. neural, hormonal, musculoskeletal) for subgroup analysis will also be collected. If a headache / pain occurs and does not subside within two hours, rescue medication (paracetamol) may be used. Any rescue medication use will be noted in the diary and the participant will still score the headache pain using the VAS until the headache subsides, or a further 2 hours has passed since rescue medication use (4 hours from headache onset). Participants will be given enough product for 5 episodes of pain and therefore may provide data for more than one pain event. During the trial period, participants will be followed up every 4 weeks via phone calls until all 5 episodes have occurred or their involvement in the study stops (maximum 4 months).