title: 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.
abstract: 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.
authors.affiliation: Luton and Dunstable NHS Trust, Luton, UK.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Reid
authors.forename: Susanna
authors.initials: S
authors.lastname: Virtanen-Kari
mesh_terms: 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
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003271:Contraceptive Agents, Female; D008528:Mefenamic Acid; D016912:Levonorgestrel