Comparison of continuous and intermittent treatment of patients with knee osteoarthritis with combined drug “Teraflex”

Abstract

Objective. To assess efficacy, safety and aftereffect duration of continuous and intermittent treatment of patients with knee osteoarthritis with “Teraflex”. Material and methods. 100 outpatients (2 groups 50 pts in each) mainly women (99 pts) with knee osteoarthritis 0I-III stage according to Kellgren-Lawrence) fulfilling ACR criteria aged 45 to 73 years (mean age 57,8+7,39 years) with pain at walking 40 mm and more on visual analog scale (VAS), regularly receiving NSAIDs for 30 days during previous 3 months were included. Follow up duration was 12 months (9 months — treatment and 3 months follow up to assess drug effect in both groups). Group 1 pts received continuous treatment with “Teraflex” during 9 months. Group 2 pts received the drug during 3 months, then treatment was interrupted for 3 months and after that 3-months course was repeated. Ibuprofen was given as a rescue medication 400 mg trice a day with possibility of subsequent decrease of dose. WOMAC index (assessment of pain, stiffness and functional disability), walking speed (15 m), efficacy assessment by doctor ant pt (improvement, absence of response, deterioration), status assessment by doctop and pt (very good, good, moderate, bad, veiy bad), daily requirement in NSAIDs, knee joint sonographic examination data were used as outcome measures. Results. Analgesic effect was achieved in both groups already after 1 month of therapy. At three months not only pain but also stiffness, joint function, WOMAC summated index and walking speed significantly improved in both groups. This improvement was maintained till the end of treatment in both groups. But group 2 pts at 6 months (before the beginning of the second course of treatment) showed small increase of pain in damaged joint and summated WOMAC index which significantly differed from group 1 pts. At the end of treatment and in 3 months after the end of treatment these measures did not significantly differed in both groups. At the end of treatment 34% on pts of both groups completely discontinued ibuprofen what also shows similar efficacy of both treatment schemes. Only 2 pts had adverse events. Epigastric pain appeared in 1 pt of group 1 after 4 months and disappeared after the drug was withdrawn. 1 pt of group 2 discontinued the treatment because of allergic reaction (papulous itching rash) after 1,5 months of treatment. Conclusion. Intermittent treatment with teraflex (3 months courses of treatment with 3 months breaks) and continuous drug administration showed equivalent influence on pain, joint function, NSAID dose decrease and aftereffect duration.