Private practice, Genova, Italy.
Hippocrates Research SRL, Genova, Italy.
Prim Care Companion CNS Disord. 2020 Jun 25;22(4):19m02578. doi: 10.4088/PCC.19m02578.
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.
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.
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.
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.
ClinicalTrials.gov identifier: NCT03932474.
评估 SAMe（S-腺苷甲硫氨酸）200mg 与植物乳杆菌（L. plantarum）HEAL9 1×10⁹ CFU 联合用于轻度至中度抑郁症整体症状的效果。
这是一项为期 6 周的随机、双盲、安慰剂对照研究，纳入了 2018 年 9 月 17 日至 2018 年 10 月 5 日招募的年龄在 18-60 岁之间的轻度至中度抑郁症（根据 ICD-10 诊断标准）患者。主要结局是从基线到治疗第 6 周时，Zung 自评抑郁量表（Z-SDS）评分的组间差异。还分析了从基线到治疗第 2 周和第 2、6 周时 Z-SDS 和其他量表（与失眠、焦虑、肠易激综合征和健康状况相关）的组间变化。
90 例患者被随机分配至 SAMe+L. plantarum HEAL9 组（n=46）或安慰剂组（n=44）。与安慰剂相比，新组合在治疗第 6 周时在 Z-SDS 总分（P=.0165）和核心抑郁亚域（P=.0247）方面的降幅更大。与安慰剂相比，组合在治疗第 2 周时在 Z-SDS 总分（P=.0330）、认知和焦虑亚域（P=.0133 和 P=.0459）以及焦虑问卷（P=.0345）方面的降幅更显著。未发生与治疗相关的不良事件。
在亚临床或轻度至中度抑郁症状的成年人中补充 SAMe 和 L. plantarum HEAL9，在 2 周后即可产生快速且具有临床相关性的效果。该组合安全且显著改善了抑郁、焦虑以及认知和躯体症状。与市场上现有的传统抗抑郁药不同，该新型产品的疗效不依赖于症状的严重程度，而后者对亚临床或轻度至中度症状的改善作用有限。
ClinicalTrials.gov 标识符：NCT03932474。
