Experience of Tizol gel administration for local therapy of rheumatoid arthritis

Abstract

Objective. To assess efficacy, tolerability and safety of 1% Tizol gel in monotherapy and in combination with diclofenac (0,5%) and hydrocortisone (0,05%) in rheumatoid arthritis (RA). Material and methods. 88 RA pts with exudation in damaged joints were included in the study. They were randomized into 3 groups. Group I (30 pts) received local therapy with 1% Tizol gel. Group U (30 pts) - a complex drug contained 1% Tizol, diclofenac 0,5% and hydrocortisone 0,05%. Group 111 served as control and was treated locally with 1% diclofenac gel (Hiperion S.A., Rumania). Preparations were administered as thin layer on the whole surface of the inflamed joint trice a day for 14 days. Efficacy was assessed after the course of treatment. Pain intensity (VAS), joint circumference and functional impairment degree (WOMAC index) were used as outcome measures. Laboratory examination included complete blood count, hepatic enzymes level and urinanalysis. Results. Local therapy provided decrease of pain and joint circumference, increase mobility and allowed to diminish NSAID dose. Good effect was achieved in group I and II (53% and 60% respectively). Local effect of the drug in group 1 lasted in average 2,5 hours according to pts' opinion. Tolerability of the local therapy was good in ail pts. Systemic adverse events were absent. Conclusion. 1% Tizol gel and its combination with diclofenac (0,5%) and hydrocortisone (0,005%) are effective for local therapy of RA, decrease pain and inflammation in damaged joints. They can be used for treatment of inflammatory joint diseases particularly in pts with concomitant gastrointestinal diseases, hypertension absence of possibility of oral administration of NSAIDs and/or necessity of decrease of their dose.