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.

[Italian cardiologists and tobacco smoking. A survey on the prevalence and knowledge of smoking and strategies for smoking cessation in a cohort of Italian cardiologists]. / Cardiologi italiani e fumo di tabacco. Survey su prevalenza e conoscenza del tabagismo e delle strategie antifumo di una coorte di cardiologi italiani.

BACKGROUND: Tobacco use is the single most preventable cause of death. Its cessation is the most cost-effective strategy for reducing long-term cardiovascular morbidity and mortality. Although both healthcare professionals and the general population are aware of the detrimental effects of smoking on health, more than 25% of Italians are current smokers. Recent surveys showed that almost 50% of smoker patients relapse to smoke after having been discharged for acute coronary syndrome. Physicians who smoke may be a barrier for effective cessation interventions. Thus, it is important to assess cardiologists' attitude toward smoking habits and the implementation of smoking cessation programs. METHODS: The survey "Italian cardiologists and smoking habits" has been held in 2013 during the 44° National Congress of the Italian Association of Hospital Cardiologists (ANMCO) to assess cardiologists' smoking status, their level of knowledge about smoking cessation interventions and their involvement in the management of smoking cessation. Out of more than 1200 cardiologists attending the ANMCO congress, 610 subjects (aged 51 ± 11 years) answered an anonymous 35-item questionnaire; they were asked to declare their smoking status (9.5% current smokers). RESULTS: Among doctors who attended the survey, 58% correctly indicated smoking as an addiction and 45% regularly advised their patients to stop smoking. The majority of cardiologists (93%) reported a positive attitude toward smoking cessation strategies, 62% of them thought that cardiologists themselves should treat smoking dependence, though specific tools (70%) and education for the management of smoking cessation are lacking (66%). Two thirds of the entire sample of ANMCO cardiologists declared their willingness to participate in specialized educational programs. CONCLUSIONS: More than a half of Italian cardiologists are aware that smoking is an addiction. Although they feel themselves yet inadequate toward this approach, they are favorable to implement their own knowledge and skills toward smoking cessation.

Efficacy and tolerability of a prolonged release ferrous sulphate formulation in iron deficiency anaemia: a non-inferiority controlled trial.

BACKGROUND: Iron deficiency anaemia (IDA) is the last stage of iron deficiency, consecutive to an imbalance between iron supply through food intake and iron loss through physiological or pathological processes. As well as by haemoglobin levels, IDA is diagnosed by measuring biomarkers of iron stores. Women are most affected by IDA since their teenage years, as menstruation constitutes a chronic iron loss. Oral supplementation with ferrous sulphate is an effective therapy, but gastrointestinal side effects may impair treatment compliance. METHODS: The present multicentric randomised controlled trial was designed to assess the non-inferiority of a ferrous sulphate prolonged release formulation called V0355 with the referential ferrous sulphate Ferrograd® in a population of Italian women aged 18-50 years diagnosed for IDA. Three hundred and ninety-nine patients were randomised to receive V0355 (80 mg Fe/day) or Ferrograd® (105 mg Fe/day). RESULTS: After 12 weeks of treatment, the difference in the mean haemoglobin level between the two groups was 0.081 g/dL ([-2.986;1.361], p = 0.54), which confirmed the hypothesis of non-inferiority. All the other biochemical parameters (serum iron, serum ferritin, transferrin, and soluble transferrin receptor) and haematological parameters (erythrocytes count, reticulocytes count, haematocrit, and mean corpuscular volume), as well as patient's anaemia-related symptoms, were not different between treatment groups throughout the study. Furthermore, the incidence of gastrointestinal adverse events of moderate and severe intensity was significantly lower (p = 0.007) in the V0355 group (5.6%) than in the Ferrograd® group (13.9%). CONCLUSION: V0355 was as efficient as Ferrograd® in the treatment of anaemia and exhibited a better gastrointestinal tolerance profile.