Aspects of asthenia correction in real clinical practice in therapeutic patients

Correction of asthenia symptoms is an urgent task of primary care physicians in their clinical practice. The multicenter randomized controlled trial TONUS, which took place in 26 cities of Russia in 2021, demonstrated the efficacy and safety of asthenia treatment with Mildronate (meldonium) in patients who were consulted by primary care physicians - general practitioners, cardiologists and neurologists. Material and methods. TONUS study was an observational study in two parallel branches, one of which, TONUS-1, is discussed in details in this article. Patients without chronic cardiovascular or cerebrovascular disease were included in that study. After randomization, Mildronat® 500 mg/day for 14 days was added to therapy in the main study group; in the control group, standard vitamin complex in prophylactic doses served as a comparison medicine. The dynamics of asthenia symptoms and efficacy of therapy were estimated by MFI-20 asthenia self-assessment scale, Schulte Table test and the General Clinical Impression (CGI) scale with assessment of the efficacy index. Results. By the end of oservation period, all groups and subgroups showed an improvement in patients' condition comparatively to the first visit. Clinically significant reduction in asthenic symptoms, as assessed by the MFI-20 scale, was fixed only in the main group of patients. In the control group subgroups, a significant reduction in MFI-20 scores was observed, mostly only by the 3rd visit, and was almost three times less expressed than in the main group subgroups. In both subgroups of patients receiving Mildronat®, there was a significant improvement in the characteristics of attention and workability according to the Schulte table test. According to the CGI-I scale, there was a significant increase in the percentage of participants with «significant» and «marked»clinical improvement in the main group already by the 7th day of therapy comparatively to the control group of patients. At the end of observation, the proportion of participants in the Mildronat® group whose clinical improvement was considered «significant» and «marked» by physicians was over 90%, whereas the control group had less than 41%. Conclusion. In the TONUS-1 study branch, patients receiving Mildronat® showed positive dynamics and regression of all major symptoms of asthenia comparatively to patients receiving multivitamins. No serious adverse events were noted in either group.

asthenia, meldonium (Mildronat®), multivitamin complex