[Efficacy of combined use of glycosaminoglycan peptide complex for intramuscular administration and oral diacerein in osteoarthritis: evaluation according to an observational multicenter clinical trial]

Karateev AE, Alekseeva LI, Pogozheva EY, Amirdzhanova VN, Filatova ES, Nesterenko VA, Lila AM · Terapevticheskii Arkhiv

Pain fell by at least half in 54.3% on the extract alone and 62.8% on the combination, and NSAIDs were stopped entirely in 66.7% and 77.5%; both between-group differences are reported as significant at p<0.001, and the paper concludes the combination outperformed monotherapy. Gastrointestinal adverse events occurred in 7.8% and 8.9%, allergic reactions in 0.3% and 0.5%. Neither arm was compared with no treatment.

Population

Russian patients with moderate to severe osteoarthritis needing regular NSAIDs

Intervention

Glycosaminoglycan peptide complex (Rumalon), 25 intramuscular injections over 12 weeks, alone (n = 2541) or with diacerein 100 mg/day (n = 414)

Comparator

The two treated groups against each other; no untreated or placebo arm

Limitations

Retrospective, non-interventional and open, with no untreated comparator, so the response rates carry the full placebo and regression-to-the-mean effect; a different product from Sigumir and given by injection.