OBJECTIVE
To study the effectiveness and safety of the use of Traumeel S and Spascupreel in the treatment of patients with acute dorsalgia in real clinical practice.
MATERIAL AND METHODS
In a prospective non-interventional observational study, 110 patients were observed in outpatient settings. Group 1 patients (n=55, age — 46.5±8.7 years) received Traumeel S and Spascupreel, Group 2 (n=55, age — 44.9±7.8 years) received oral central myorelaxants. All patients received standard treatment with non-steroidal anti-inflammatory drugs (NSAIDs). The intensity of pain syndrome (visual analogue scale, VAS), the limitation of daily activity (Roland—Morris’s questionnaire, RMQ), the duration of exacerbations, the need for additional intake of NSAIDs, the number of exacerbations of lumbalgia for 3 months from the start of participation in the study were considered as criteria of therapy effectiveness. The adverse events (AEs) during treatment were registered.
RESULTS
The intensity of pain syndrome (VAS) in 1st group decreased statistically significantly from 61.0 to 35.6 by day 7 and to 19.5 by day 14 of treatment, and in 2nd group — from 61.2 to 41.1 and 25.8 points accordingly (p<0.05 compared to baseline). More pronounced and faster pain relief was observed in 1st group. The number of exacerbations during the period was statistically significantly lower in 1st group (p<0.05). Patients in 1st group were less likely to require additional NSAIDs (p<0.05). The frequency and severity of AEs did not differ in both groups.
CONCLUSION
Patients who received NSAIDs, Traumeel S and Spascupreel had statistically significantly faster pain relief (VAS) on days 7 and 14 and increased volume of daily activity (RMQ) compared to standard therapy. There was also a statistically significant lower number of relapses on the day 60 from the beginning of the study and a statistically significant lower number of cases of NSAID on demand additional intake during 60 days from the beginning of the study than in the standard therapy group (NSAIDs and myorelaxants). The use of Traumeel S and Spascupreel did not cause significant AEs and drug interactions.
