The aim of this randomized, double-blind study was the comparison of nimesulide (100 mg p.o., Aulin (R), Roche) vs, diclofenac (50 mg p.o., Dicloreuma (R), Alpha-Wassermann) in the treatment of primary dysmenorrhea. Patients requiring drug treatment in the last 6 months and having regular menstrual cycles were enrolled. Three hundred and eight subjects were randomized in two groups to receive up to 3 tablets/day (according to need), for the first 3 days of the cycle for two menstrual cycles. Abdominal pain was the primary endpoint and it was evaluated before and 30, 60, 120 min after the first drug administration, each of the two cycles, through a 100 mm visual analog scale (VAS). Secondary parameters were the associated symptoms (evaluated through a Likert scale 0-3) as well as the subjective global judgement. Side effects were also recorded. Statistical evaluations were done on 304 subjects (149 nimesulide and 155 diclofenac) who completed the study. Sociodemographic and clinical features of patients assigned to the two groups. were superimposable. Baseline pain was similar in the two cycles: 73.5 +/- 10.8 for nimesulide and 72.1 +/- 11.4 for diclofenac. Both drugs progressively and significantly decreased pain which was reduced by 82% (nimesulide) and 79% (diclofenac), at the second hour. However, nimesulide showed faster activity than diclofenac starting from 30 min, with a reduction of 35% vs. 27% (p < 0.01), at both the first and second cycle. Headache and lumbar pain were significantly and equally improved by both treatments. At the end of each cycle, a good efficacy assessment was indicated in 86% of the nimesulide cases and 81% of those with diclofenac. Tolerability was good with both drugs. However, 16 cases reported gastric side effects in the diclofenac group, whereas they were only seven in the nimesulide group.
Nimesulide in the treatment of primary dysmenorrhea: A double-blind study versus diclofenac / Facchinetti, Fabio; F., Piccinini; L., Sgarbi; D., Renzetti; Volpe, Annibale. - In: DRUGS OF TODAY. - ISSN 1699-3993. - STAMPA. - 37:(2001), pp. 39-45.