Daacro (Germany)

Objective This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia. Methods This monocenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial (registration number: DRKS00003261) was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. Results In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505–0.773, Student’s t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student’s t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment. Conclusions Trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia.

Abstract BackgroundCognitive health is a major concern for many people, and with potential benefits to academic and professional life, maximising cognitive performance is of interest far beyond the older demographics. Several natural products have been suggested as nootropics, including the herb sage. Previous assessments of various Salvia species have reported a range of effects on cognitive performance and mood in both older adult and younger adult populations. This study was conducted with Sibelius™: Sage, an aqueous-ethanol extract of S. officinalis, to assess for the beneficial effects on cognitive performance in adolescents (12-14 year olds) and young adults (18-25 year olds).Methods and FindingsAn acute, double-blind, placebo-controlled study was conducted with two single doses of Sibelius™: Sage (150 mg and 300 mg). Cognitive performance was evaluated using CogTrack™, which probes aspects of cognitive performance covering attention, working memory and episodic/declarative memory through a series of computer-based tasks. Consistent with previous study of Sibelius™: Sage a significant effect was seen on the Immediate Word Recall task in young adults; suggesting acute treatment benefits to verbal episodic/declarative memory performance. Physiological effects of the treatment on salivary cortisol and oxytocin levels, as well as blood pressure and heart rate were also assessed, with limited evidence of an effect on these factors. No adverse events or side-effects linked to the study product intake was observed. The study was registered at the German Clinical Trials Register (DRKS-ID: DRKS00015716).ConclusionsA significant improvement due to the Sage extract was shown for a task assessing short-term episodic memory (Immediate Word Recall), supporting beneficial effects on cognitive performance in young adults that are consistent with previous reports in healthy older adults. These findings suggest that further investigation of the effects observed in this study in larger, long-term human volunteer studies could be beneficial to pursue.

Translational research is most prominently represented by the search for biomarkers and preclinical research. Aside from generating such new measures and methodologies, translational research additionally refers to translation of integrated knowledge. This strategy involves synthesis, exchange, and dissemination of available knowledge, with the goal of improving health services and health care systems. For stress-related disorders, such as depression and anxiety disorders, this strategy meets numerous challenges, as the great majority of these patients are treated by family physicians. Here, we introduce Neuropattern, a new diagnostic tool, which allows translation of psychobiological knowledge to this stress “bedside.” Neuropatterns are conceptualized endophenotypes of the activity and reactivity status of neurobiological interfaces, which participate in the crosstalk between the brain and peripheral organs under stressful conditions. Neuropattern can easily be implemented in routine clinical work, and helps the physician to individualize those therapeutic interventions that are already available.