Simultaneous objective and subjective evaluation of meclofenamate sodium in the treatment of primary dysmenorrhea

Abstract

Eighteen patients participated in a double-blind, placebo-controlled, single-dose, crossover study of meclofenamate sodium in women with primary dysmenorrhea. Simultaneous evaluations of pain intensity and pain relief, sampling of continuous intrauterine pressure recording, and monitoring of blood meclofenamate levels were carried out. Improvements in pain intensity and pain relief were observed at 45 minutes and reached statistical significance at and beyond 1 hour 45 minutes after meclofenamate therapy. Ten of 14 uterine pressure parameters showed statistically significant responses after drug therapy and 12 of the 14 parameters showed statistically significant differences in time-response patterns. Statistically significant changes were noted as early as 45 minutes after meclofenamate therapy. Statistically significant correlations were found between and among the parameters of blood drug level and the subjective and objective measures. No drug-related adverse effects were found.