Bioactive concentrate from small sea fish: evaluation of the efficacy and safety of the drug on the basis of the analysis of 37 clinical trials

Abstract

Injectable Alflutop® (the bioactive concentrate from small sea fish (BCSSF)) belongs to the pharmacological group of symptomatic slow-acting drugs for osteoarthritis. This drug has been widely used in our country for 25 years. During this time, 37 of its clinical trials (n=3676) have been conducted in Russia and post-Soviet countries, mainly in patients with knee osteoarthritis (OA) and nonspecific back pain. These are mainly open-label trials, a major portion of which has been performed at the good methodological level, by using active control and up-to-date methods to assess treatment results. Two works are double-blind placebo-controlled trials (DBPCTs) conducted in compliance with the modern requirements of evidence-based medicine – this is an evaluation of the efficacy of BCSSF in knee OA and vertebrogenic lumbar ischialgia. All the trials have shown a good therapeutic potential of BCSSF: on the average, after the cycle use of the agent, there is a 40–60% decrease in pain intensity as compared to the baseline level. A two-year DBPCT of the efficacy of BCSSF in knee OA has also confirmed that the concentrate has a structure-modifying effect. At the same time, all the trials have demonstrated that BCSSF is well tolerated and very rarely causes adverse reactions that require discontinuation of treatment.