Included studies

Table 1: Randomised, double blind controlled trials of sodium valproate for migraine prevention
Reference Study Design Patients Drug groups & dosing regimes Outcomes Results Quality Score
Hering et al., 1992 Randomised, double blind, 2 groups, crossover, placebo controlled, Migraine history for 2 or more years and 4 attacks per month, migraine diagnosis non-IHS criteria though similar. Age 18-54 Two week run in with no prophylactic medication, 8 week treatment phase then cross over to alternative treatment for 8 weeks 1. Sodium valproate 400 mg twice daily n=32 2. Placebo n=32 Number of attacks, duration, pain intensity Mean number of attacks per 8 weeks: Sodium valproate 8.8 placebo 15.5 p<0.001 Severity and duration of migraines significantly reduced on sodium valproate compared with placebo R = 1 DB = 1 W = 1 Total = 3
Jensen et al 1994 Randomised, double blind, crossover, placebo controlled 4 week run-in not randomised or blind IHS diagnosis migraine without aura, migraine history at least 1 year, 2 to 10 days per month with migraine, age 18 to 70, men and women, n=43 Baseline values: mean migraine days/4 weeks 6.1 (range 2 to 10) Slow release sodium valproate (Deprakine Retard) or placebo: 4 week run-in (no meds), 12 week treatment period, 4 week washout, 12 week treatment period 1.Sodium valproate 1000mg/day if serum concentration > 50mg/L, increased to 1500 mg/day if < 50mg/L af Mean frequency of migraine days/ 4 week period Number of responders = number of patients with at least 50% reduction in baseline headache frequency after treatment period Headache intensity, duration and additional drug consumption Mean frequency (migraine days/4 weeks): sodium valproate 3.5 (95%CI 2.7 to 4.3) placebo 6.1 (4.8 to 7.4) p=0.0018 Responders (50% reduction in migraine days) Sodium valproate 50% (17/34) placebo 18% (6/34) NSD between sodium valproate and placebo for R = 1 DB = 2 W = 1 Total = 4
Klapper 1997 Randomised, double blind, 4 parallel groups, placebo controlled 4 week baseline phase, not randomised, single (patient) blind IHS diagnosis migraine with or without aura, migraine history at least 6 months,at least 2 attacks per month , at least 16 years, men and women, n=176 Baseline values: mean migraine days/4 weeks 6.1 in placebo, 4.5, 4.7, 4.7 in sodium valproate 500, 1000 4 week baseline phase (all received placebo), 12 week treatment phase comprising 4 week dose titration, 8 week dose maintenance period 1. Sodium valproate 500 mg/day n=45 2. Sodium valproate 1000 mg/day n=43 3. Sodium valproate 1500 mg/day n=44 4. Placebo Mean frequency of migraine attacks/ 4 week period Duration and peak severity of migraine attacks with Impaired function,additional medication use and with associated symptoms (nausea, vomiting, photophonia & phonophonia) Mean reduction in 4 week migraine attack frequency: sodium valproate 500 mg 1.7 sodium valproate 1000 mg 2.0 sodium valproate 1500 mg 1.7 placebo 0.5 p<0.05 % reporting at least 50% reduction from baseline: sodium valproate (all doses combined) 44% (58/13 R = 1 DB = 1 W = 1 Total = 3
Mathew et al. 1995 Randomised, double blind, 2 parallel groups, placebo controlled 4 week baseline phase, not randomised, single blind (patient) IHS diagnosis migraine with or without aura, migraine history at least 6 months,at least 2 attacks per month, aged 16 to 75 years, men and women, n=107 Baseline values: mean migraine frequency per 4 weeks: placebo 6.4 sodiumvalproate 6.0 4 week baseline phase (all received placebo), 12 week treatment phase comprising 4 week dose titration, 8 week dose maintenance period, blinding maintained throughout 1. Sodium valproate 250 mg/day increasing in increments of 250 mg until trough plasma va Mean frequency of migraine attacks/ 4 week period Number of responders = number of patients with at least 50% reduction in 4 week headache frequency compared with baseline Duration and peak severity of migraine attacks functional ability, medication use Mean treatment phase dose sodium valproate 1087 mg/day. Mean trough concentration during maintenance phase 66 mg/L Mean 4 week headache frequency: sodium valproate 3.5 placebo 5.7 p<0.01 at least 50% reduction migraine frequency from baseline: sodium val R = 1 DB = 2 W = 1 Total = 4
Abbreviations: IHS=International Headache Society; DB=double blind; NSD=no significant difference; R=randomised; W=withdrawals and dropouts; CI=confidence interval

Last Updated on 6/12/00
By Andrew Moore