Oral Administration of S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9 Improves the Mild-To-Moderate Symptoms of Depression: A Randomized, Double-Blind, Placebo-Controlled Study.

OBJECTIVE: To assess the effects of the combination of SAMe (S-adenosylmethionine) 200 mg and Lactobacillus plantarum (L. plantarum) HEAL9 1 × 109 CFU for the overall symptomatology of mild-to-moderate depression. METHODS: This 6-week randomized, double-blind, placebo-controlled study included subjects aged 18-60 years with mild-to-moderate depression (according to ICD-10 diagnostic criteria) recruited from September 17, 2018, to October 5, 2018. Difference between groups in change from baseline to treatment week 6 on the Zung Self-Rating Depression Scale (Z-SDS) was the primary outcome. Comparisons between groups in change from baseline to treatment week 2 of the Z-SDS and from baseline to treatment weeks 2 and 6 of other scales (related to insomnia, anxiety, irritable bowel syndrome, and health status) were also analyzed. RESULTS: Ninety patients were randomized to SAMe plus L. plantarum HEAL9 (n = 46) or placebo (n = 44) groups. A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247). A significant reduction in favor of the combination was shown at treatment week 2 for the Z-SDS total score (P = .0330), the cognitive and anxiety subdomains (P = .0133 and P = .0459, respectively), and the anxiety questionnaire (P = .0345). No treatment-related adverse events occurred. CONCLUSIONS: Supplementation of SAMe and L. plantarum HEAL9 in adults with subthreshold or mild-to-moderate symptoms of depression resulted in fast and clinically relevant effects after 2 weeks. The combination was safe and significantly improved symptoms of depression, anxiety, and cognitive and somatic components. The effect of this novel product is independent from the severity of the symptoms unlike traditional antidepressants available on the market that have minimal benefits for subthreshold or mild-to-moderate symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03932474.

[Implementing cardiovascular prevention in the real world: presentation of an integrated hospital-field model]. / Implementare la prevenzione cardiovascolare nel mondo reale: presentazione di un modello integrato ospedale-territorio.

Numerous studies have documented that cardiovascular prevention in subjects at high risk has a large impact on the clinical outcomes. Data also show the efficacy of an early, intensive, well-structured, professionally expert, multidisciplinary intervention, making use of adequate behavioural and pharmacologic instruments, on the global risk. Such intervention is, however, available at present for very few healthcare users, while the majority, above all in primary prevention, receive a programme of low impact, with poor feedback between the hospital specialist and general practitioner (GP), and often limited to the simple prescription of treatment or to specialist check-ups and/or general advice on lifestyle. The project of implementation takes as its starting point this analysis and the premise that for an intervention of cardiovascular prevention to be effective, particularly in the long term, and really applicable to the broad population, it must be governed primarily by the GP--providing that s/he be adequately trained, utilize new and more dynamic caring modes, and be able to count concretely both on integration with the specialist and on the support of a multidisciplinary team for specific interventions. The paper presents the various stages of the project: from definition of the resources available (health district, GPs, hospital specialists) to the need for GP training, to the modes of operation: instruments for risk calculation, procedures followed, model of integration between GP and specialist, identification of the goals and indicators. This is a low cost project in terms of both the human and structural resources employed, utilizing what is already available in the healthcare system of our country. One of its most original aspects is the medical visit jointly conducted by the GP and hospital specialist, which realizes in concrete terms the integration of the skills: GPs can finally confront in the field the specialist of referral, acquire new skills, improve their daily mode of operating, while they will be gratified by a work more in line with their professional image, and become promoters of health. Finally, this project highlights the propositive and operative role assumed by cardiac rehabilitation and prevention, which, after developing over the years a specific know-how on the subject, now transmits these skills to other healthcare resources and creates a link with the local territory, so providing an appropriate response to the need to put into practice primary and secondary cardiovascular prevention.