Evaluation of the efficacy and safety of bioactive concentrate from small sea fish in elderly patients with knee osteoarthritis

Abstract

Objective: to evaluate the efficacy and safety of Alflutop (the bioactive concentrate from small sea fish) in patients aged 75 years and older with knee osteoarthritis (OA). Patients and methods. The investigation enrolled 38 patients aged 75 years and older with knee OA (according to the American College of Rheumatology (ACR) criteria, 1986), Kellgren–Lawrence grades II–III, ≥40 mm pain visual analogue scale (VAS), who required continuous non-steroidal anti-inflammatory drug (NSAID) use. All the patients received Alflutop in the standard regimen: a 1-ml intramuscular injection daily for 20 days. The dynamics of pain during movement was assessed using the VAS scale, the WOMAC, and the EQ-5D questionnaire. Comorbidity was determined according to the Charlson comorbidity index, polypharmacy, and the safety of therapy in all the patients. The investigation duration was 8 weeks.Results and discussion. On day 21 of Alflutop therapy, there was a statistically significant reduction in pain, stiffness, and functional insufficiency according to the WOMAC index (p< 0.001) and improvements in quality of life as shown by the EQ-5D questionnaire (p< 0.001); on day 56, the number of NSAID intake days decreased (p=0.005). The findings suggest that there is a high level of comorbidity in the majority (94.7%) of patients. The mean number of drugs taken was 5.0±1.5, which indicates the presence of polypharmacy. No serious or severe adverse events were recorded.Conclusion. The results of the investigation showed the statistically significant efficacy and safety of Alflutop in patients with knee OA in the elderly group.