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Clinical Trial
. 1979 Oct;18(4):647-53.
doi: 10.1016/0090-6980(79)90032-7.

The refief of primary dysmenorrhea by ketoprofen and indomethacin

Clinical Trial

The refief of primary dysmenorrhea by ketoprofen and indomethacin

A Kauppila et al. Prostaglandins. 1979 Oct.

Abstract

The prostaglandin biosynthesis inhibitors ketoprofen and indomethacin were compared in the treatment of primary dysmenorrhea in a double-blind, cross-over trial involving 23 patients. Each drug was used for 2-4 days during 3 consecutive menstruations in randomized order. Good or moderate overall relief was obtained in 60 of the 68 ketoprofen-treated menstruations (88%). A dysmenorrhea score, based on subjective estimations of 8 symptoms, similarly decreased from a mean (+/- S.E.M.) basal level of 9.6 +/- 0.6 to 3.6 +/- 0.3 during ketoprofen treatment and to 4.0 +/- 0.3 during indomethacin. Both drugs relieved pelvic and lower back pains and eliminated vomiting and diarrhea in 82-97% of the cycles whereas headache, fatigue and nervousness were less frequently alleviated (40-67%). Eighteen of the 23 women (78%) had been unable to work during the first day of menstruation, the rate of working days lost was reduced to 4% with ketoprofen and 9 with indomethacin. Mild side-effects occurred during 12 ketoprofen and 14 indomethacin therapies. Ketoprofen thus seems to be as effective and tolerable as indomethacin in the treatment of primary dysmenorrhea.

PIP: Ketoprofen and indomethacin were compared as specific therapies for primary dysmenorrhea in this study involving 23 primary dysmenorrheic women; the study was double-blind and cross-over. Each patient was given a code-numbered package of capsules of ketoprofen (50 mg) or indomethacin (25 mg); medication (1 capsule 3 times daily) was started 1 day before menstruation and was continued until cessation of dysmenorrheic symptoms (no longer than 4 days). Patient estimation of the effect of ketoprofen was ranked as good in 70% of cases, moderate in 18%, and nil in 12%. For indomethacin, the figures were 58, 31, and 10%, respectively. Initial dysmenorrhea score of 9.6 was reduced to 3.6 during ketoprofen therapy and to 4 with indomethacin (P.001). Ketoprofen alleviated pelvic pain in 84% of cases; indomethacin in 78%. Mean duration of pelvic pain was reduced to 5.1 hours from an initial period of 10.6 hours with ketoprofen and 5 hours with indomethacin (P.01); this statistic excluded cycles of total relief. Other symptoms relieved were similar with both drugs, including: lower back pain, vomiting, diarrhea, and dizziness (alleviated in 82-97%) and headache, fatigue, and nervousness (alleviated in 40-67%). Blood loss was subjectively estimated to decrease in 42% and increase in 4% of ketoprofen-treated patients, whereas for indomethacin these figures were 36% and 7%, respectively. All side effects were mild. The rate of lost working days was significantly decreased under both treatments.

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