KUZIK® in prophylaxis of migraine: a retrospective observational study
F. Solinas 1,M. Loiero 2, R. Galante 3,E.Pucci 4
1. Private neurological outpatient clinic, Olbia. Italy
2. U.O. of Neurology , Gaetano Pini Hospital Milan.Italy
3. Gam Farma Srl. Milan.Italy
4.Headache Science Center ,University of Pavia.Department of Brain and Behavioral Sciences,
University of Pavia - IRCCS “C. Mondino” Pavia.Italy
Migraine is a primary headache characterized by moderate or strong headache attacks and has a significant impact on the social and working life of patients, especially when attacks become very frequent. In recent years there is growing interest in the use of nutraceuticals for the prevention of migraine as there are no specific drugs for this indication. Kuzik®., a new kudzu based foodsupplement, thanks to its innovative mechanism of action has attracted our interest in this use and has already shown its effectiveness in a preliminary study (Pucci et al, J. Headache and Pain 2017)
Materials and Methods:
Between September and December 2018 28 patients with migraine , with and without aura , were treated with Kuzik® twice dailyfor 2 months , recruited in various neurological structures including university centers, general hospitals and private outpatient clinic; for all patients the diary was completed and full fill the headache card (ICHD-III criteria) .Patients were evaluated at baseline and after 2 months regarding number of crisis, headache days and VAS (Visual Analogue Scale): data relative to efficacy and tolerability were collected. Patient's characteristics: 26 female and 2 male ; median age 37 (range 18-58 ) ;26 migraine without aura and 2with aura; median years of disease 15,4 ( range 4-34 ) and previous treatments in 19 of 28 patients .At baseline in total population average number of crisis/month was 6,7 (range 4-10 ) , headache days/month 13,5 ( range 7-21) and medium VAS 7,8 (range 6-10 ) .In the12 patients with chronic migraine ( > 15headache days/month ): average number of crisis/ month was 7,2 ( range 5-10 ) , headache days/month 17,4 ( range 15-21 ) and medium VAS 8,1 ( range 7-10).
Kuzik® was well tolerated: in a numerical scale from 1 to 10 the average score was 9,5 ( range 8 -10) ; the compliance of patients was optimal, no side effect related to product were reported and no weight gain in patients occurred.A clear improvement of the patient’s astheniashould be noted. Regarding efficacy, at the end of treatment , in total population all parameters analyzed were significantly improved : average number of crisis/ month was 2,8 ( range 1-4 ) , headache days/month 6 ( range 2-14 ) and medium VAS 3,2 ( range 2-5) .In the group of patients with chronic migrainethe results wereconfirmed signification improved : average number of crisis/ month was 3,2 ( range 1-4 ) , headache days/month 9 ( range 5-14 ) and medium VAS 3,5 ( range 2-5).
Our study clearly demonstrated the benefits, safety, and good tolerability of Kuzik® in the prophylaxis of migraine, with and without aura. This study confirms the data obtained in the previous trial and highlights the positive data obtained with Kuzik® twice daily in patients with chronic disease. The use of this medication should be taken in consideration as a good practice in this setting of patients.