PMID- 15225193
OWN - NLM
STAT- MEDLINE
DCOM- 20040802
LR  - 20220419
IS  - 0001-6349 (Print)
IS  - 0001-6349 (Linking)
VI  - 83
IP  - 7
DP  - 2004 Jul
TI  - Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg 
      versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea.
PG  - 667-73
AB  - OBJECTIVE: Assessment of efficacy and safety of meloxicam 7.5 mg and 15 mg once a 
      day (o.a.d.) compared with mefenamic acid 500 mg three times a day (t.i.d.), over 
      a treatment period of 3-5 days, during three menstrual cycles, for primary 
      dysmenorrhea. STUDY DESIGN: Multicenter, multinational, double-blind, 
      double-dummy, three parallel groups, randomized trial, phase IIb, 337 patients. 
      Treatment group comparisons of continuous variables were carried out using the 
      Kruskal-Wallis test and Wilcoxon signed rank tests. Efficacy was analyzed using 
      Fisher and chi(2)-tests. RESULTS: Meloxicam 7.5 mg and 15 mg showed a similar 
      profile in pain reduction and dysmenorrhea symptoms when compared with mefenamic 
      acid. Thirty-five subjects presented with gastrointestinal (GI) adverse events 
      (AEs). Two-thirds of those 35 subjects were in the mefenamic acid group. There 
      were no differences between the safety profiles of the two meloxicam dosages. 
      Laboratory abnormalities did not differ in incidence among the treatment groups. 
      CONCLUSION: Both of the daily doses of meloxicam tested were comparable to 500 mg 
      mefenamic acid t.i.d. in relieving dysmenorrhea symptoms, and meloxicam seems to 
      have a better gastrointestinal tolerability profile.
FAU - de Mello, Nilson Roberto
AU  - de Mello NR
AD  - University of Sao Paulo, Sao Paulo City, Brazil.
FAU - Baracat, Edmund Chada
AU  - Baracat EC
FAU - Tomaz, Geraldez
AU  - Tomaz G
FAU - Bedone, Aloisio Jose
AU  - Bedone AJ
FAU - Camargos, Aroldo
AU  - Camargos A
FAU - Barbosa, Ione Cristina
AU  - Barbosa IC
FAU - de Souza, Rosival Nassar
AU  - de Souza RN
FAU - Rumi, Demetrio Ortega
AU  - Rumi DO
FAU - Martinez Alcala, Felix Octavio
AU  - Martinez Alcala FO
FAU - Velasco, Jorge Antonio Aldrete
AU  - Velasco JA
FAU - Cortes, Roberto Jose Risco
AU  - Cortes RJ
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Acta Obstet Gynecol Scand
JT  - Acta obstetricia et gynecologica Scandinavica
JID - 0370343
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Thiazines)
RN  - 0 (Thiazoles)
RN  - 367589PJ2C (Mefenamic Acid)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Tolerance
MH  - Dysmenorrhea/*drug therapy
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced/epidemiology
MH  - Humans
MH  - Mefenamic Acid/adverse effects/*therapeutic use
MH  - Meloxicam
MH  - Thiazines/adverse effects/*therapeutic use
MH  - Thiazoles/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2004/07/01 05:00
MHDA- 2004/08/03 05:00
CRDT- 2004/07/01 05:00
PHST- 2004/07/01 05:00 [pubmed]
PHST- 2004/08/03 05:00 [medline]
PHST- 2004/07/01 05:00 [entrez]
AID - AOG433 [pii]
AID - 10.1111/j.0001-6349.2004.00433.x [doi]
PST - ppublish
SO  - Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. doi: 
      10.1111/j.0001-6349.2004.00433.x.