The present registry study investigated effects of the dietary supplement Pycnogenol® on migraine headache attacks and oxidative stress in otherwise healthy subjects with migraine mild-moderate headache (MH) that were considered. To manage MH, these subjects used only a few drugs (anti-emetics, analgesics on demand) and lifestyle changes; only very occasionally they used other, more specific products such as triptans.Study GROUPS: one group used only standard management (SM), basically, management on demand. Oral magnesium and riboflavin (vitamin B2) were used with lipoic acid as they are considered useful to improve MH. Another group used the supplement Pycnogenol® (150 mg/day for 8 weeks) in addition to SM. These two groups were compared to a third (non-parallel, observational) group using topiramate (50 mg/day). If needed, subjects were allowed to use rescue medications.46 subjects were included in the study. 22 used the standard management and 24 were supplemented with Pycnogenol® in association with SM. In addition, 21 subjects were treated with topiramate. Safety with Pycnogenol® was very good. The two main management groups and the third non-parallel group had comparable baseline characteristics. The number of migraine attacks were significantly reduced during the observation period with Pycnogenol® (p<0.05) in comparison with SM. Supplementation was more effective in reducing the use of rescue medications (p<0.05) including analgesics compared to SM. At 8 weeks, the pain score was lower with Pycnogenol in comparison with SM (p<0.05). The working incapacity was significantly lower with Pycnogenol® than in the SM group (P<0.05). The number of migraine attacks was lower with topiramate compared to SM. Pain score, working incapacity and use of rescue medication were lower with topiramate than in SM. However, adverse effects with topiramate, included paresthesia, fatigue, dizziness and nausea even at low dosages complicated management. Some 50% of these side effects require a form of further treatment including medication. Oxidative stress: all included subjects had high oxidative stress at baseline. At 8 weeks, the level of plasma free radicals was significantly lowered with Pycnogenol® (p<0.05), but not in the SM or topiramate group.In conclusion Pycnogenol® used as prophylaxis appears to reduce pain and the number and severity of symptoms in MH in parallel with a reduction on oxidative stress.
