LAUSR

Migraine without aura (MO) is the most frequent form of primary headaches; it has a high prevalence (60–80% of all migraines) and frequently is highly disabling, with a significant impact on the social and working life of patients. Lifetime prevalence is between 2 and 10% in men and between 15 and 25% in women. Typical migraine symptoms are unior bilateral attacks of throbbing pain lasting from 4 to 72 h, often accompanied by photophobia, phonophobia, nausea, and vomiting. Preventive treatment for migraine helps to reduce disability by decreasing the frequency, severity, and duration of migraine attacks, improving patient’s quality of life (Fig. 1). In the last decade, there has been a growing interest in the use of nutritional supplements (nutraceuticals) in MO prophylaxis, as an alternative to pharmacological treatments. In addition, some investigations highlighted that people who suffer from headaches often prefer treatment with nutraceuticals over traditional pharmacological approaches, due to fear of possible side effects, drug dependence, or addiction. Kudzu (Pueraria lobata), a wild climbing plant native to Central Asia belonging to the Fabaceae family, has long been widely used in Traditional Chinese Medicine for the treatment of migraine, hypertension, substance dependence, tinnitus, vomiting, diarrhea, and climacteric; it has recognized antioxidant properties and vasomodulating action on the cerebral arteries. Kudzu root has a high content of isoflavones which act on some neurotransmitters involved in the physiopathogenesis of migraine (dopamine, serotonin, GABA, and glutamate) [1]. In 2008, an open study showed in 11 patients affected by episodic cluster headache the effectiveness of a kudzu extract: 73% of patients showed a decrease in the intensity of attacks, 64% a decrease in frequency, 36% a decrease in duration with minimal side effects [2]. A new kudzu-based food supplement (Kuzik®), developed with innovative programmed release technologywhich allows the active ingredient to be transported through the blood-brain barrier, has attracted our interest. A preliminary multicentric study, including 30 patients with MO treated with Kuzik® at the dosage of one capsule/day for 60 days, demonstrated a significant improvement in number of days with migraine, number of attacks, and migraine intensity. Moreover, the treatment demonstrated good tolerability, optimal compliance of patients, and no side effects [3]. We now present a larger study aimed to assess the effectiveness of Kuzik® in the reduction of headache attacks/ month in patients affected by episodic MO, as the primary endpoint. Secondary endpoints were the reduction of the number of symptomatic drug assumptions and disability scores measured by MIDAS. Inclusion criteria were patients suffering from MO, diagnosed according to ICHD-3 beta criteria, age ≥ 18 years, and migraine frequency between 4 and 15 days/month calculated in the last 3 months. Included patients were without preventive therapy in progress or with an unchanged preventive therapy judged to be ineffective for at least 3 months: in this case a washout of at least 30 days before starting treatment with Kuzik® was requested. Exclusion criteria were migraine days less than 4 and more than 15 a month, pregnancy or lactation, women treated with tamoxifen. During the first visit, the headache diary of the * Marcella Curone [email protected]