A placebo-controlled study of the efficacy and tolerability of a nonsteroidal anti-inflammatory drug, DHEP plaster, in inflammatory peri- and extra-articular rheumatological diseases
Galeazzi, M.; Marcolongo, R.
Drugs under Experimental and Clinical Research 19(3): 107-115
1993
ISSN/ISBN: 0378-6501 PMID: 8112199 Document Number: 416224
A double-blind, randomized, placebo-controlled study has been carried out in order to assess the effects of the new topical cutaneous formulation, diclofenac hydroxyethylpyrrolidine (DHEP) plaster. Sixty patients (10 M + 50 F, mean age 56.6 yrs) suffering from local inflammatory processes in peri-articular/tendinous and/or extra-articular sites were involved in this study and randomly given either DHEP plaster or placebo plaster. Plasters were applied and left on the site of inflammation b.i.d. (at 8 a.m. and 8 p.m.) for 14 days. Patients under stabilized systemic treatment with NSAIDs, glucocorticoids and/or basic therapy for over 2 months, maintained this treatment unchanged during the course of the study, Patients were examined on days 3, 5, 7 and 14. The effects of the treatments were assessed using subjective, semi-quantitative (provoked pain, peri-articular swelling, doctor-patient judgement, telethermographic index) and quantitative variables (spontaneous pain measured using a visual analogical scale), In the peri-articular pathologies, spontaneous and provoked pain decreased faster and in a clinically relevant manner in the group treated with DHEP plaster compared to the control group (p lt 0.01). Local inflammation, objectively evaluated using the telethermographic index, showed consistent reduction during the study which was statistically significant from day 3 onwards and significantly different compared to the control group. Global assessment of efficacy, expressed by the investigator and the patients, was significantly better (good to excellent after only 7 days in 70% of the cases) in the DHEP group compared to the placebo group. In the extra-articular pathologies, results similar to those reported earlier were obtained. No side effects were observed during the treatment. The results obtained in this study suggest this new auto-adhesive plaster is a safe and effective treatment in isolated peri- and extra-articular rheumatological diseases.