title: Randomized controlled trial comparing ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia due to abnormal uterine bleeding.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of intravenous ferric carboxymaltose (FCM) in comparison with intravenous iron sucrose (ISC) in the treatment of anemia due to abnormal uterine bleeding (AUB).
  
  
  METHODS
  A randomized controlled trial was conducted between April 2013 and May 2014 in patients older than 18 years of age presenting at a hospital in New Delhi, India, with anemia due to AUB. Patients were randomized in a 1:1 ratio to receive treatment with intravenous FCM or ISC. The primary outcome, increase in hemoglobin above baseline, was monitored over a 12-week period. Patients completing the full treatment and follow-up protocol were included in the analyses. Participants and investigators were not masked to treatment allocations.
  
  
  RESULTS
  Overall, 30 patients were assigned to each group. Increases in mean hemoglobin levels from baseline were significantly higher in the FCM group at 6 weeks (P=0.005). At 12 weeks, there was no significant difference in hemoglobin increase from baseline between the two groups (P=0.11). Adverse events were similar between both treatment groups.
  
  
  CONCLUSIONS
  Treatment with FCM resulted in a rapid increase in hemoglobin levels in patients with anemia due to AUB, with similar increases in hemoglobin over a 12-week period. Clinical Trial Registration (www.ctri.nic.in):CTRI/2015/09/006224.
authors: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
authors: Reeta
authors: R
authors: Mahey
authors: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: kriplanialka@gmail.com.
authors: Alka
authors: A
authors: Kriplani
authors: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
authors: Krishna D
authors: KD
authors: Mogili
authors: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
authors: Neerja
authors: N
authors: Bhatla
authors: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
authors: Garima
authors: G
authors: Kachhawa
authors: Department of Hematology, All India Institute of Medical Sciences, New Delhi, India.
authors: Renu
authors: R
authors: Saxena
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005500:Follow-Up Studies; D005937:Glucaric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007194:India; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000150:complications*
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid
keywords: Abnormal uterine bleeding; Ferric carboxymaltose; Iron deficiency anemia; Iron sucrose