[Efficacy of potassium N-acetylaminosuccinate (Cogitum) in the treatment of asthenic syndrome: results of double-blind placebo-controlled trial].

Abstract

Objective: Study of the effectiveness of monotherapy with potassium N-acetylaminosuccinate (Cogitum) for asthenic syndrome (fatigue) in individuals, uncharacteristic somatic, neurological diseases, anxiety disorders, depression and other diseases that may interfere with asthenia.

Material and methods: Patients with fatigue scores of 22 or more on the Fatigue Assessment Scale (FAS) were randomly divided into the main group (MG) - 37 people, mean age 22 years [21; 24] and the control group (CG) - 34 people, mean age 21 years [19; 23]. The Trail Making Test (TMT-A and TMT-B), the assessment of general well-being on a visual analogue scale (VAS), where 0 is the worst state of health, 10 is the state of absolute well-being, was assessed. MG patients received a solution of potassium N-acetylaminosuccinate (Cogitum) 750 mg per day in a sterile container, CG patients received sterile water with banana flavor in a sterile container. The duration of the study was 21 days.

Results: Prior to the start of the study, there were no statistically significant differences in FAS, TMT, and VAS between MG and CG. After 21 days, the FAS score in the MG decreased (p=0.00001), the time of TMT-A (p=0.000012) and TMT-B (p=0.000033) decreased, the VAS score increased (p=0.00024). There were no statistically significant changes in the CG. Placebo effect was noted in 10 patients of the CG (29.4%).

Conclusion: Potassium aminosuccinate (Cogitum) at a daily dose of 750 mg and a duration of treatment of 21 days effectively eliminates the symptoms of asthenic syndrome (fatigue), while accompanied by an improvement in complex cognitive functions. The results of our study suggest that fatigue (asthenic syndrome) and cognitive impairment may have a common pathogenetic mechanism - a deficiency of systems in which mediators are N-acetylaspartate and N-acetylaspartylglutamate. Cogitum had no side effects and was well tolerated. Cogitum is superior to placebo in the treatment of fatigue (asthenic syndrome).