Double-blind controlled clinical study of the efficacy and tolerability ofdiclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel compared with diclofenac-N-(2-hydroxyethyl)pyrrolidine gel in patients with peri and extraarticular inflammatory diseases

To evaluate the efficacy and tolerability of the new diclofenac-N-(2-hydrox yethyl)-pyrrolidine lecithin gel (DHEP lecithin gel, with 1.3% DHEP and 2.4 % lecithin) compared with the efficacy and tolerability of diclofenac-N-(2- hydroxyethyl)-pyrrolidine gel (DHEP gel) in peri and extraarticular inflamm atory states a controlled randomized, double-blind clinical study was condu cted. Two groups of 50 patients each were enrolled and were given one of th e two different formulations with a slight massage on the painful area thre e times a day for 10 consecutive days. Patients received a self-evaluation notebook in which to record daily assessment of spontaneous pain (Huskisson 's visual analogue scale). On days 0, 3 and 10, the patients were visited b y the investigator. All patients completed the study. The assessment of spo ntaneous pain showed that although pain decreased in both groups, the decre ase was more marked in patients taking DHEP lecithin gel and that it reache d a statistically significant difference at days 5, 6, 7 and 8. This decrea se was also confirmed by assessments on the ordinal scale. Although periart icular swelling disappeared in both groups, swelling severity decreased soo ner in patients laking DHEP lecithin gel. The efficacy and safety of both t reatments was judged to be good or excellent by 70% of the patients in each group. The efficacy of the active principle, pyrrolidine sail, is confirme d. Moreover the formulation containing lecithin passes through the skin lip id barrier more easily than the formulation without lecithin and is as vali d as the other in the therapy of rheumatic disorders. Finally DHEP lecithin gel preparation has a quicker therapeutic action on symptoms, such as spon taneous pain and local swelling than DHEP gel.