Comparative efficacy of diclofenac dispersible 50 mg and ibuprofen 400 mg in patients with primary dysmenorrhea. A randomized, double-blind, within-patient, placebo-controlled study.

摘要: Sixty female out-patients suffering from moderate to severe primary dysmenorrhea, aged 14-40 years (mean 27 years), entered this randomized, double-blind, 3-period, within-patient study, evaluating the efficacy and tolerability of diclofenac dispersible 46.5 mg (equivalent 50 sodium), ibuprofen 400 placebo taken up 4 times daily for a maximum 3 days. Pain relief was evaluated on verbal rating scale (0 = none, 1 slight, 2 moderate, considerable, complete) at 0.5, 1,2,3,4,5 6 hours after first dose; weighted sum pain scores over 6-hour observation period also investigated (TOTPAR-6). intensity assessed nil, mild, severe) baseline above mentioned time points; differences each point analyzed (SPID-6). A rescue medication permitted hour or more intake test drug: in such cases last value intensity/relief carried forward used analysis. global evaluation trial as compared her usual performed by patient end treatment period. Finally, adverse experiences were recorded throughout study Analysis covariance Koch's adaptation Wilcoxon-Mann-Whitney rank used, where appropriate, statistical Mean TOTPAR-6 values dispersible, 16.5, 17.8 14.7, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)