Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies

doi:10.1016/S0149-2918(02)80043-1

Clinical Therapeutics

Volume 24, Issue 9, September 2002, Pages 1384-1400

https://doi.org/10.1016/S0149-2918(02)80043-1 Get rights and content

Abstract

Background: Dysmenorrhea is the most common menstrual complaint in young women, with a prevalence as high as 90%. It is responsible for substantial repeated short-term absenteeism from school and work in young women. Effective treatments are available, including nonsteroidal anti-inflammatory drugs (NSAIDs). In many countries, a variety of NSAIDs have become available as over-the-counter (OTC) drugs.

Objective: The goal of this study was to compare the efficacy and safety of OTC doses of naproxen (400 mg) and naproxen/naproxen sodium (200/220 mg) with acetaminophen (1000 mg), ibuprofen (200 mg), and placebo in the treatment of primary dysmenorrhea.

Methods: A pooled analysis of 5 trials was performed. Efficacy was assessed by pain relief, relief of other dysmenorrheic symptoms, time to backup medication or remedication, and treatment preference. Tolerability was assessed by recording adverse events (AEs).

Results: A total of 443 women were enrolled in the combined studies. Naproxen 400 mg provided greater pain relief than acetaminophen and placebo within 30 minutes of administration (P < 0.01 and P < 0.05, respectively). Furthermore, naproxen 400 mg and 200 mg provided greater pain relief than both acetaminophen (P < 0.01 and P < 0.05, respectively) and ibuprofen (P < 0.001 and P < 0.01, respectively) at 6 hours after administration. Both doses of naproxen had higher scores than placebo for symptom relief and drug preference (all P < 0.001). The AEs and their frequency were similar among the treatment groups. No serious AEs were reported.

Conclusion: When administered at OTC doses, naproxen was effective in the relief of pain and other symptoms of primary dysmenorrhea and had a good safety profile in the population studied.

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A key step involving in prostaglandin production is the conversion of arachidonic acid to prostanoids catalyzed by cyclooxygenase-1 and -2 (COX1, COX2). Therefore, cyclooxygenase inhibitors, such as ibuprofen, naproxen, and ketoprofen are effective against primary dysmenorrhea (Marjoribanks et al., 2015; Milsom et al., 2002) since they reduce the amount of menstrual prostanoids released, with concomitant reduction in uterine hypercontractility (Dawood, 2006). The nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen were significantly more effective for pain relief than placebo.
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Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies

Abstract

J Pediatr Adolesc Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Bailliere's Clin Obstet Gynaecol

J Pediatr Adolesc Gynecol

Int J Gynaecol Obstet

Am J Obstet Gynecol

Contraception

Am J Obstet Gynecol

Obstet Gynecol

Curr Ther Res Clin Exp

Prostaglandins

Am J Obstet Gynecol

Clin Ther

Primary dysmenorrhea

Am Fam Physician

Dysmenorrhea

Prevalence of dysmenorrhea in Wellington women

New Zealand Med J

Ibuprofen and dysmenorrhea

Am J Med

Factors influencing the prevalence and severity of dysmenorrhoea in young women

Br J Obstet Gynaecol