Affiliation:
1. Department of Nervous System Diseases and Neurosurgery, N.V. Sklifosovsky Institute of Clinical Medicine, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Abstract
Treatment of acute non-specific back pain (ANSBP) is one of the current issues of modern medicine, as ANSBP is one of the most common causes of temporary disability in the population. Non-steroidal anti-inflammatory drugs (NSAIDs) are used in ANSBP , with the drug Nalgesin® forte (naproxen 550 mg) being widely used in clinical practice.Objective: to evaluate the efficacy and safety of the drug Nalgesin® forte in patients with ANSBP.Material and methods. The observational study “Nalgesin® forte (naproxen) in real-life clinical practice: treatment outcomes in patients with acute non-specific (musculoskeletal) pain” included 12,434 patients (46.51% men, 53.49% women; mean age of patients – 47.3±13.8 years) with ANSBP. Pain in the lumbar region and in the neck prevailed (lumbodynia – 25.5%, lumboischialgia – 26.28%, cervicalgia – 33.03%), less frequently the pain was localized in the thoracic region (thoracalgia – 15.18%). We assessed pain intensity using numeric rating scale (NRS), indicators of the Russian version of the Kiel questionnaire, duration of therapy with Nalgesin® forte, satisfaction with the therapy and tolerability of the treatment. The patients were informed about the benign nature of the ANSBP and took the medication Nalgesin® forte 550 mg 1–3 times a day for pain relief; the medication was discontinued when the pain resolved or decreased significantly.Results. The majority (75.9%) of patients received Nalgesin® forte at a dose of 550 mg twice daily, 14.3% – 550 mg once daily and 9.8% – 550 mg three times daily. The duration of therapy was 6–14 days in the majority (80.03%) of patients, while it did not exceed 1 week in more than one third of patients (37.2%). During treatment, the average pain intensity decreased from 6.6±1.60 to 1.82±1.32 points according to the NRS (p<0.001), the proportion of patients with initially unbearable pain decreased from 2.79 to 0.28%, with severe pain – from 27.16 to 1.10%, with moderate pain – from 60.42 to 2.82%, and the proportion of patients with mild pain increased from 9.63 to 95.8% (p<0.001). Most physicians (91.7%) were satisfied with the treatment results, and most patients (94.5%) and physicians (95.7%) were satisfied with the tolerability of the treatment. Patients with a high and medium risk of chronic pain according to the Kiel questionnaire required longer treatment than patients with a low risk of chronic pain (p=0.002). A low incidence of adverse events (AEs) was observed when taking Nalgesin® forte; no serious AEs were recorded.Conclusion. Favourable therapeutic outcomes in ANSBP, efficacy and safety of the drug Nalgesin® forte in ANSBP of different localisations were noted.