DHEP PLASTERS AS A TOPICAL TREATMENT OF KNEE OSTEOARTHRITIS - A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY

A double-blind, placebo (PBO)-controlled trial was carried out on 155 adult outpatients with painful (Huskisson's analogical scale >40 mm) m ono/bilateral femorotibial and/or femoropatellar osteoarthritis of the knee, radiologically confirmed. Patients were randomly given either d iclofenac hydroxyethylpyrrolidine plasters (DHEP, 78 patients), contai ning 180 mg of active drug each, or matched PBO (77 ptns). Plasters we re applied b.i.d. (at 8 a.m. and 8 p.m.) on the affected joint, for 15 days. No NSAID treatment was allowed during the trial, while paraceta mol was admitted from the 4th day on and its daily intake carefully re corded. Huskisson's test and Lequesne's index were assessed at days 0, 4, 7 and 15. Patients were asked to fill in a daily card with Huskiss on's scale and subjective evaluations. Differences in favour of DHEP w ere observed from the first assessment (4th d.) on Huskisson's scale a nd Lequesne's index (p<0.001). According to the patients' subjective e valuation, pain decreased as soon as the first day in both groups, wit h significant differences in favour of DHEP (p<0.005). Even the number of night awakenings recorded by the patient was significantly in favo ur of DHEP (p<0.005). It is worth noting that these results were obtai ned in spite of a significant reduction of paracetamol intake in DHEP patients in comparison with PBO patients (p<0.01). Tolerability was ju dged good or excellent in the majority of cases: only minor side effec ts occurred in five patients (4 PBO, ir DHEP) and the interruption of treatment was required for only one of the PBOs. This study shows that DHEP plaster significantly differs from matched PBO in the improvemen t of pain and patient's condition in painful knee osteoarthritis.