Elimination of histamine liberator (acetaldehyde) by L-cysteine in prevention of migraine attacks: Randomized controlled trial with a medical device (Acetium® Capsules)

Background & Study Design: Endorsements from migraine patients testifying that L-cysteine effectively prevented their headache attacks, prompted us to design a double-blind, randomized placebo-controlled, multi-centre trial (with 218 patients) comparing Acetium® capsules (100mg L-cysteine, inactivating acetaldehyde in the stomach) and placebo in prevention of migraine attacks during a 3-month trial period. Methods: Migraine diaries were evaluated at monthly intervals for study compliance. The primary study endpoint was reduction in the number of migraine days (NMD), assessed at 4 cut-offs: ≥50%, ≥30%, ≥25% and ≥20%. Results : Altogether, 146 patients had completed the study per protocol. Using the most stringent cut-off (≥50%) for reduction of NMD, the success rate in the Acetium® arm was 26.0% and in the placebo arm 25.4%; OR=1.027 (95%CI 0.589-1.79) (p=NS). Among the patients with a potential acetaldehyde-associated trigger (alcohol, smoking, dietary), Acetium® was up to 50% more effective than placebo in NMD reduction by various cut-offs, with the highest OR=1.569 (95%CI 0.743-3.312). Conclusions : Although Acetium® was not more effective than placebo in reducing the NMD in the global analysis, certain sub-groups might benefit from Acetium® intervention considerably more than migraine patients collectively.