Randomised comparative trial of the levonorgestrel intrauterine system and mefenamic acid for the treatment of idiopathic menorrhagia: a multiple analysis using total menstrual fluid loss, menstrual blood loss and pictorial blood loss assessment charts.
OBJECTIVE
To compare the efficacy and tolerability of the levonorgestrel intrauterine system (LNG IUS) with mefenamic acid in the management of objective idiopathic menorrhagia.


METHODS
Phase III, Single centre, open, randomised, comparative, parallel group study.


METHODS
District General Hospital in the United Kingdom.


METHODS
Fifty-one women with objective menorrhagia.


METHODS
Twenty-five women randomised to receive the LNG IUS and 26 to oral mefenamic acid for six cycles.


METHODS
Change from baseline in menstrual blood loss (MBL), total menstrual fluid loss (TMFL) and pictorial blood loss assessment chart (PBAC) score at the third and sixth cycle of treatment.


RESULTS
After six cycles the median menstrual blood loss was 5 mL in the LNG IUS group and 100 mL in the mefenamic acid group (P < 0.001). Median TMFL was 27 mL in the LNG IUS group and 157 mL in the mefenamic acid group (P < 0.001). Median PBAC score was 25 in the LNG IUS group and 159 in the mefenamic acid group. Changes in menstrual blood loss correlated strongly to changes in TMFL (r= 0.88) but PBAC correlated less well to blood loss and total fluid loss (r= 0.53 and r= 0.58).


CONCLUSIONS
Both the LNG IUS and mefenamic acid significantly decreased menstrual blood loss, TMFL and PBAC scores. The LNG IUS produced greater reductions in all parameters than mefenamic acid. Comparison of the different measurements suggests that TMFL assessment may be an easier and a more relevant measure of symptom severity than menstrual blood loss.
Reid
Peter C
PC
Luton and Dunstable NHS Trust, Luton, UK.
Virtanen-Kari
Susanna
S
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008499:Medical Records; D008528:Mefenamic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008595:Menorrhagia / Q000188:drug therapy*; D008598:Menstruation; D008875:Middle Aged; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003271:Contraceptive Agents, Female; D008528:Mefenamic Acid; D016912:Levonorgestrel