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Objectives: To evaluate the efficacy and safety of pregabalin compared with lamotrigine for the prophylaxis of medication overuse headache (MOH) using an open-label prospective study.Methods: Out of 90 consecutive patients with MOH recruited into the study and randomly assigned to receive 75 mg/d pregabalin or 25 mg/d lamotrigine, 81 completed the trial in their group: pregabalin (39), and lamotrigine (42).After a titration period of 8 weeks (T0), patient information was assessed at enrollment and a follow-up visit was scheduled at the end of months 1, 2, 3, 6, and 12 (T1, T2, T3, T4, and T5) to evaluate headache frequency, severity of headache, the amount of rescue medication intake, and adverse reactions.Results: Of the 39 pregabalin-treated patients, the mean monthly headache frequency significantly decreased from 18.2 ± 7.3 (T0) to 6.8 ± 1.9 (T2), the monthly headache days decreased from 21.7 ± 5.1(T0) to 8.5 ± 3.1 (T2), the severity of headache decreased from 8.6 ± 0.9 (T0) to 5.7 ± 1.0 (T2), and the monthly taking analgesics frequency decreased from 26.2 ± 6.8 (T0) to 4.0 ± 2.0 (T2).Similarly, of the 42 lamotrigine-treated patients, the mean monthly headache frequency significantly decreased from 18.1 ± 5.8(T0) to 6.1 ± 1.6 (T2), the monthly headache days decreased from 22.7 ± 5.7 (T0) to 7.6 ± 2.5 (T2), the severity of headache decreased from 8.6 ± 0.9 (T0) to 6.1 ± 1.0 (T2), and the monthly taking analgesics frequency decreased from 28.1 ± 7.8 (T0) to 4.8 ± 2.0 (T2).A significant improvement of disability score was reported in both groups.These indexes in the two treatment groups both significantly declined from T0 to T1 (P < 0.001).In the other follow-up time points, these efficacy parameters continue to decline until T4.At T1, the monthly headache frequency in lamotrigine group was lower than in pregabalin group (P < 0.05), on the contrary,the severity of headache in the pregabalin group was lower than in the lamotrigine group (P < 0.05).Between the two groups, adverse reactions rates have no significant difference.Conclusion: Both of the two drugs, Pregabalin and lamotrigine, seem to be effective and well-tolerated preventive therapy in MOH prophylaxis.In the early stage, comparison between pregabalin and lamotrigine, the former is better in reduction efficacy of the severity of headache, on the contrary, the later is better in reduction efficacy of the monthly headache frequency.