PMID- 12380631
OWN - NLM
STAT- MEDLINE
DCOM- 20030211
LR  - 20240109
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 24
IP  - 9
DP  - 2002 Sep
TI  - 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.
PG  - 1384-400
AB  - 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.
FAU - Milsom, Ian
AU  - Milsom I
AD  - Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, 
      Goteborg, Sweden. ian.milsom@obgyn.gu.se
FAU - Minic, Milos
AU  - Minic M
FAU - Dawood, M Yusoff
AU  - Dawood MY
FAU - Akin, Mark D
AU  - Akin MD
FAU - Spann, June
AU  - Spann J
FAU - Niland, Nona F
AU  - Niland NF
FAU - Squire, R Anne
AU  - Squire RA
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Nonprescription Drugs)
RN  - 362O9ITL9D (Acetaminophen)
RN  - 57Y76R9ATQ (Naproxen)
RN  - WK2XYI10QM (Ibuprofen)
SB  - IM
MH  - Acetaminophen/*therapeutic use
MH  - Adult
MH  - Analgesics, Non-Narcotic/*therapeutic use
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Tolerance
MH  - Dysmenorrhea/*drug therapy
MH  - Female
MH  - Humans
MH  - Ibuprofen/*therapeutic use
MH  - Naproxen/*therapeutic use
MH  - Nonprescription Drugs
MH  - Pain/drug therapy
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2002/10/17 04:00
MHDA- 2003/02/13 04:00
CRDT- 2002/10/17 04:00
PHST- 2002/10/17 04:00 [pubmed]
PHST- 2003/02/13 04:00 [medline]
PHST- 2002/10/17 04:00 [entrez]
AID - S0149-2918(02)80043-1 [pii]
AID - 10.1016/s0149-2918(02)80043-1 [doi]
PST - ppublish
SO  - Clin Ther. 2002 Sep;24(9):1384-400. doi: 10.1016/s0149-2918(02)80043-1.