Combination of Tanacethum Partenium, 5-Hydrossitriptophan (5-Http) and Magnesium in the Prophylaxis of Episodic Migraine without Aura (AURASTOP®) An Observational Study

Objective: The study aim is to verify whether treatment with a new combination of tanacethum partenium, 5-hydrossitriptophan (5-http) and magnesium (Aurastop®) reduces headache frequency and intensity in patients suffering from episodic migraine without aura when used in migraine prevention. Methods: Forty patients, suffering from migraine without aura for at least 6 months with monthly frequency of 3 to 8 crises and presence of headache of 4 to12 days, were enrolled in this open study and treated orally with Aurastop twice daily for 3 months. The primary endpoint was reduction of migraine frequency (headache days per month) over an observation period of 3 months. The secondary endpoint was a composite of monthly frequency and intensity of pain crises, analgesics use (number of medications) and subjective change of pain intensity. Results: All the parameters significantly improved at the end of treatment with Aurastop. We observed a significant reduction of the number of headache days (from 8.8 ± 2.0 before treatment to 2.7 ± 1.7 post treatment, p < 0.001), as well as of the number of attacks (from 5.0 ± 1.2 per month to 2.1 ± 0.9 per month, p < 0.001), of pain intensity (from Visual Analogic Scale [VAS] 6.9 ± 1.0 to 3.3 ± 1.5, p < 0.001), and of the number of analgesics assumed by each subject (from 8.5 ± 1.6 per month to 2.4 ± 1.5 per month, p < 0.001). No serious adverse events were observed. Conclusion: Though obtained in the setting of an open-trial, our findings suggest that the new combination of tanacethum partenium, 5-hydrossitriptophan (5-http) and magnesium (AURASTOP®) is a promising approach for migraine prevention and warrant further investigation to confirm the safety and efficacy of this treatment

Assessment of the incremental diagnostic value of florbetapir F 18 imaging in patients with cognitive impairment: The incremental diagnostic value of amyloid PET with [ 18 F]-florbetapir (INDIA-FBP) study

Importance Cerebral amyloidosis is a key abnormality in Alzheimer disease (AD) and can be detected in vivo with positron emission tomography (PET) ligands. Although amyloid PET has clearly demonstrated analytical validity, its clinical utility is debated. Objective To evaluate the incremental diagnostic value of amyloid PET with florbetapir F 18 in addition to the routine clinical diagnostic assessment of patients evaluated for cognitive impairment. Design, Setting, and Participants The Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Study is a multicenter study involving 18 AD evaluation units from eastern Lombardy, Northern Italy, 228 consecutive adults with cognitive impairment were evaluated for AD and other causes of cognitive decline, with a prescan diagnostic confidence of AD between 15% and 85%. Participants underwent routine clinical and instrumental diagnostic assessment. A prescan diagnosis was made, diagnostic confidence was estimated, and drug treatment was provided. At the time of this workup, an amyloid PET/computed tomographic scan was performed, and the result was communicated to physicians after workup completion. Physicians were asked to review the diagnosis, diagnostic confidence, and treatment after the scan. The study was conducted from August 5, 2013, to December 31, 2014. Main Outcomes and Measures Primary outcomes were prescan to postscan changes of diagnosis, diagnostic confidence, and treatment. Results Of the 228 participants, 107 (46%) were male; mean (SD) age was 70.5 (7) years. Diagnostic change occurred in 46 patients (79%) having both a previous diagnosis of AD and an amyloid-negative scan (P\u2009<\u2009.001) and in 16 (53%) of those with non-AD diagnoses and an amyloid-positive scan (P\u2009<\u2009.001). Diagnostic confidence in AD diagnosis increased by 15.2% in amyloid-positive (P\u2009<\u2009.001; effect size Cohen d\u2009=\u20091.04) and decreased by 29.9% in amyloid-negative (P\u2009<\u2009.001; d\u2009=\u2009 121.19) scans. Acetylcholinesterase inhibitors and memantine hydrochloride were introduced in 61 (65.6%) patients with positive scan results who had not previously received those drugs, and the use of the drugs was discontinued in 6 (33.3%) patients with negative scan results who were receiving those drugs (P\u2009<\u2009.001). Conclusions and Relevance Amyloid PET in addition to routine assessment in patients with cognitive impairment has a significant effect on diagnosis, diagnostic confidence, and drug treatment. The effect on health outcomes, such as morbidity and mortality, remains to be assessed