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Clinical Trial
. 1978 May;20(5):246-52.

Ibuprofen therapy for dysmenorrhea

  • PMID: 353274
Clinical Trial

Ibuprofen therapy for dysmenorrhea

S L Corson et al. J Reprod Med. 1978 May.

Abstract

Thirty-three dysmenorrheic patients were given ibuprofen, aspirin and a placebo in a double-blind crossover study, with each drug taken during one of three successive menstrual cycles in random sequence. Paired drug comparisons demonstrated the statistical superiority of ibuprofen, as compared with the other two, for the relief of pain. Data evaluated according to patient drug preference showed similar results. The role of nonsteroidal antiinflammatory drugs in therapy for dysmenorrhea is discussed.

PIP: 40 women with regular menstrual cycles and who had experienced dysmenorrhea requiring analgesic use for pain relief for at least 1 year and for each of 3 preceding cycles were evaluated. The protocol featured a double blind crossover study of 2 medications and a placebo, each taken during 1 of 3 successive menstrual cycles in random sequence. The medications used were ibuprofen (200 mg), aspirin (325 mg), and placebo made to appear grossly identical to the other medications. The intended dosage was 2 tablets every 4 hours as necessary for relief of menstrual pain. A propoxyphene preparation was allowed for those receiving little or no relief of severe pain. A patient report card was used to document the severity of pain, the quantity of medication taken, and the relief of pain. At the termination of the 3 month study period, the patients were asked to rank the preparations in order of effectiveness. 7 women dropped out of the study, leaving 33 patients for evaluation. For 7 patients, the report forms showed that during at least 1 cycle 1 rather than 2 tablets were taken on 1 or more occasions. The data were analyzed with and without these 7 patients, and in only 1 area, i.e., "ability to pursue normal daily functions," was a significant difference noted. The data presented reflect the results from 33 patients unless otherwise indicated. The patients' mean age was 24.7 years. 23 patients were nulligravidas and 24 were nulliparas. The prestudy menstrual intervals averaged 29.8 days (23-33) and remained regular during the study period in 31 of 33 patients. The menstrual flow averaged 5.3 days (1-9), with most patients reporting a "moderate" among (24), l "light," and 8 "heavy." 14 of the patients used no contraceptive technique or were not sexually active; 5 used oral contraceptives (OCs) and continued doing so throughout the study; 4 were IUD wearers; 4 used a diaphragm; 3 had condom protected coitus; and 3 had had prior laparoscopic sterilization. With the exception of IUD wearers, no pathology or medical reason accounting for dysmenorrhea was obvious, and no patient had physical findings suggestive of endometriosis. Most (18) symptoms started on day 0, but 13 patients suffered symptoms prior to the onset of menstrual bleeding. The symptoms lasted an average of 2.6 days but as long as 7 days. The usual severity of dysmenorrhea was reported as mild in 4, moderate in 18, and severe in 11. When paired comparisons were made of each of the 3 drug pairs, ibuprofen was significantly more effective than either aspirin or the placebo. Aspirin was not significantly superior to the placebo. Data evaluated according to patient drug preference showed similar results.

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