Clinical efficacy and safety of L-lysine aescinate in the complex therapy of painful radiculopathy due to lumbar compression: results of a randomized, double-blind, placebo-controlled study

A randomized, placebo-controlled study was conducted to evaluate the efficacy and safety of L-lysine aescinate as part of the combination therapy for acute lumbar compressive radiculopathy with pain. The study included 246 patients, 123 of whom received the study drug and 123 received placebo. The study showed that the inclusion of a 10-day course of L-lysine aescinate in the standard therapy regimen for acute lumbar compressive radiculopathy provided an additional reduction in pain intensity according to the visual analogue scale by an average of 13.7 mm (lower limit of 95% Confidence Interval (CI) is 11 mm); reliable differences appeared as early as the 5th day of therapy and persisted by the 11th day from the start of treatment. L-lysine aescinate added to the standard therapy regimen provided complete pain relief 11 times more often (27% vs. 2.4% of patients) compared to standard therapy in combination with placebo. The addition of L-lysine aescinate to the standard treatment regimen for radiculopathy provided additional improvement in patients’ daily living parameters. The magnitude of additional improvement on the 11th day from the start of treatment averaged 9.6% (lower limit of 95% CI is 7.4%) according to the Oswestry questionnaire, on average 2.8 points (lower limit of 95% CI is 2.0 points) according to the Roland-Morris questionnaire; reliable differences were noted as early as the 5th day of therapy and were maintained. Furthermore, the inclusion of a 10-day course of L-lysine aescinate in the standard therapy regimen, compared with standard therapy in combination with placebo, resulted in a 2.4-fold decrease (15% vs. 37%) in the proportion of patients experiencing difficulty or requiring assistance in performing daily activities, a 6.8-fold increase (28% vs. 4%) in the proportion of patients who could cope with all daily activities, and a 10.5-fold increase (34% vs. 3%) in the proportion of patients with no impairments in daily activities. The clinical improvements described above were achieved with acceptable safety, represented by an adverse reaction rate of 4.5% and the absence of serious adverse events and drug discontinuations due to intolerance. Thus, the inclusion of L-lysine aescinate in the standard treatment regimen for acute lumbar radiculopathy can increase the effectiveness of treatment and provide additional benefits in the form of a significantly more significant reduction in pain intensity and improvement in the daily functioning of patients with acceptable safety of such treatment.