Table: Randomised, double blind controlled trials of paracetamol for acute migraine treatment
Reference Patients Design Intervention Outcomes Results (main outcomes) Quality
Diamond 1976 Adults with migraine with or without aura, DNS diagnostic criteria used, men and women, n=56 RCT, DB, CO, 6 migraine attacks treated, each patient took each treatment twice, study med taken at migraine onset 1. Paracetamol 325 mg 2. Midrin (isometheptene mucate 65 mg, dichloralphenazone 100 mg, paracetamol 325 mg) 3. Placebo 2 tabs taken initially, then 1 tab every hour if needed, max 5 tabs in 4 hours Headache severity (severe, moderate, mild, none) Headache relief (complete, good, fair, none) Physician global assessment NSD between paracetamol and placebo for reduction in migraine severity # patients with adverse effects: Paracetamol 10/56 with 12 AEs Isometheptene 14/56 with 19 AEs Placebo 1/56 with 2 AEs R=1 DB=2 W=0 Total=3
Hoernecke and Doenicke 1993 Adults with migraine according to diagnostic criteria of Soyka, study med taken at first sign of headache, n=474 RCT, DB, CO, 4 attacks 1. Paracetamol 1000 mg 2. DHE 2 mg 3. Paracetamol 1000 mg + DHE 2 mg 4. Placebo Headache severity (0= no pain, 9= unbearable pain), duration, nausea, vomiting, associated symptoms n=288 patients analysed for 4 consecutive attacks All active treatment groups gave significantly better pain relief than placebo at 1 and 2 hours. Number with at least 50% pain relief at 2 hours: Paracetamol 1000 mg 145/288 (50%) DHE 2 mg 124/288 (43%) P R=1 DB=1 W=1 Total=3
Karabestos et al 1997 Adults with migraine without aura according to non-IHS criteria, at least 2 attacks per month, study med taken within 2 hours of migraine onset, n=64 RCT, DB, CO, rescue with ketoprofen 100 mg IM if needed during 2 hour study period 1. Paracetamol 500 mg IM n=30 2. Ketoprofen 100 mg IM n=34 Headache severity (1=mild, 2=moderate, 3=severe), headache duration, nausea, vomiting, photophobia, phonophobia, patient global assessment n=64 patients analysed for single dose. Crossover data not presented. Ketoprofen significantly more effective than paracetamol for reduction in pain and nausea. Number of patients reporting complete relief within 40 minutes: Paracetamol 5/30 (18%) Ketopro R=1 DB=1 W=1 Total=3
Larsen et al. 1990 Adults without aura according to Ad Hoc criteria (IHS-like), study med taken at first sign of headache, n=83 RCT, DB, CO, 8 attacks, 2nd study dose at 2 hours if needed, rescue with non-study med at 4 hours if needed 1. Paracetamol 500 mg 2 Paracetamol 1000 mg 3. Tolfenamic acid 200 mg 4. Tolfenamic acid 400 mg Headache severity (none, mild, moderate, severe), duration, nausea, vomiting, functional ability, patient global assessment n=70 treated at least 4 attacks. Authors combined both doses paracetamol and tolfenamic acid for analysis. Tolfenamic acid significantly better pain relief at 2 hours than paracetamol: # attacks with mild or no headache at 2 hours: Tolfenamic acid 44% Par R=1 DB=1 W=1 Total=3
MacGregor et al 1993 Adults with migraine with or without aura according to IHS criteria, study med taken at migraine onset, n=59 RCT, DB, CO, 3 attacks, up to 4 doses study med per attack, rescue at 1 hour if needed with additional med. 1. Paracetamol 1000 mg, n=44 2. Paracetamol 1000 mg + domperidone 30 mg, n=46 3. Paracetamol 1000 mg + domperidone 20 mg, n=44 Headache severity (none, mild, moderate, severe), duration, nausea, vomiting, patient and physician global assessment NSD between groups for 24 hour SPID. Duration significantly less in groups 2 and 3 compared with paracetamol alone. Number of patients reporting slight or complete relief: Paracetamol 15/44 (35%) Paracetamol + domperidone 30 mg 26/46 (57%) Paracetamol + R=1 DB=1 W=1 Total=3
Norrelund et al 1989 Adults with migraine according to NIH Ad Hoc committee criteria, n=149 RCT, DB, CO, 2 attacks 1. Paracetamol 1000 mg 2. Tolfenamic acid 400 mg Headache severity, associated symptoms, analgesic consumption n=116 analysed for 2 attacks NSD between groups on any outcome at 3 hours R=1 DB=1 W=0 Total=2
Pearce et al 1983 Adults with migraine with or without aura according to non-IHS criteria, study med taken at migraine onset, n=30 RCT, DB, CO, up to 10 attacks, study med taken 4 to 6 hourly as needed 1. Ibuprofen 400 mg (4 to 6 hourly as needed) 2. Paracetamol 900 mg (4 to 6 hourly as needed) Headache severity (mild, moderate, severe), duration, relief (none, moderate, complete) n=27 patients analysed. Number of attacks studied: Ibuprofen 73 Paracetamol 73 Ibuprofen significantly better than paracetamol at reducing severity and duration of attacks. Number of patients reporting adverse effects: Ibuprofen 2 Paracetamol 3 R=1 DB=2 W=1 Total=4
Peatfield et al 1983 Adults with migraine with or without aura according to Vahlquist's criteria, study med taken at migraine onset, n=40 RCT, DB, CO, 6 attacks, rescue after 3 hours if needed 1. Paracetamol 500 mg + metoclopramide 10 mg 2. Mefenamic acid 500 mg + metoclopramide 10 mg Headache intensity (VAS), analgesic consumption, patient global assessment n=22 analysed for at least 4 attacks (2 each drug) NSD between groups for reduction in headache intensity R=1 DB=1 W=1 Total=3
Abbreviations: IHS=International Headache Society; RCT=randomised controlled trial; DB=double blind; CO=crossover; DNS=did not state; VAS=visual analogue scale; NNT=number-needed-to-treat; NSD=no significant difference; R=randomised; W=withdrawals and dro

Last Updated on 11/12/00
By Andrew Moore