OBJECTIVE
To study the efficacy and safety of Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) tablets in the combination therapy of comorbid patients with tension-type headaches (TTH) associated with asthenic syndrome (AS).
MATERIAL AND METHODS
The study included 150 patients aged 44.2±5.0 years, diagnosed with stage 1—2 arterial hypertension, severe asthenic syndrome. Frequent episodic TTH combined with pericranial muscle tension. All patients were randomly divided into 3 groups, age-matched, depending on the therapy they received: Group 1 — Nonsteroidal anti-inflammatory drugs — ibuprofen 400 mg) 7 days+tolperisone 150 mg 3 times a day for 14 days; Group 2 — ibuprofen 400 mg) 7 days+tolperisone 150 mg 3 times a day for 14 days+tablet form of Cytoflavin according to the protocol-approved regimen of 2 tablets 2 times per day for a duration of 25 days; Group 3 — ibuprofen 400 mg for 7 days and a tablet form of Cytoflavin according to the protocol approved regimen without the appointment of a muscle relaxant. All patients were examined on the day of treatment, on day 30±2, and after 60±2 days. A telephone survey was conducted on day 15. The analysis of the dynamics of complaints, clinical manifestations of TH, scale indicators, and Headache Diary data was conducted, and side effects of therapy were recorded. For clinical assessment, the following were used: the scale of asthenic conditions SHAS; headache index HIT-6; visual analog scale VAS; anxiety and depression scale HADS; Pittsburgh sleep quality questionnaire; quality of life assessment scales (EQ-5D) and overall clinical impression.
RESULTS
After the therapy, positive dynamics were observed on day 30±2 in all groups: a decrease in the frequency, duration, and intensity of TH, more pronounced in the groups with Cytoflavin. By day 60±2 there was a decrease in the number of TTH episodes in groups 2 and 3 by 76.7% and 62.5%, respectively, compared to the group receiving only standard therapy (group 1). The duration of TTH attacks decreased 32.3% (group 1), 62.96% (group 2) and 38.10% (group 3). In groups 2—3, the HIT-6 index decreased by 47%, VAS by 68% compared to standard therapy (p<0.001), manifestations of anxiety by 57.5% and depression by 68%; sleep disorders by 86% compared to the 1 group (p<0.001). The severity of asthenia in group 1 decreased by 37.9%; in group 2 — by 64.51%; in 3—58.77%. The quality of life of patients in groups 2—3 improved by 91% compared to 57% in the standard therapy group without Cytoflavin. During the observation period, no patient had serious adverse events or side effects associated with taking the drug.
CONCLUSION
The results of the study allow us to consider the drug Cytoflavin in the treatment regimens for comorbid patients with TTH in asthenic disorders.
