title: A double-blind, randomized, and active-controlled phase III study of Herbiron drink in the treatment of iron-deficiency anemia in premenopausal females in Taiwan.
abstract: BACKGROUND
  About 468 million non-pregnant women are estimated to suffer from iron-deficiency anemia (IDA) worldwide. The highest prevalence of IDA occurs in the Taiwanese population.
  
  
  OBJECTIVE
  To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.
  
  
  METHODS
  Phase III double-blind, randomized, active-controlled, and parallel comparative study enrolled 124 patients with IDA and consisted of a 2-week run-in period, randomization, 12 weeks of supplementation, and 4 weeks of follow-up. The treatment group received Herbiron drink 50 mL p.o., b.i.d., before meals (daily iron intake: 21 mg/day) plus placebo tablets. The control group received a ferrous sulfate tablet, t.i.d., plus placebo 50-mL drink before meals (daily iron intake: 195 mg/day).
  
  
  RESULTS
  Both treatments significantly improved hemoglobin and all secondary efficacy endpoints. Most IDA patients treated with Herbiron or ferrous sulfate finished the study in the normal range. Ferrous sulfate treatment induced a rapid rate of hemoglobin synthesis, which plateaued by week 8, whereas Herbiron treatment increased the rate of hemoglobin synthesis more slowly, likely due to its nine-fold lower iron content. Gastrointestinal adverse events (diarrhea, abdominal pain, dyspepsia, and nausea) but not infectious adverse events were significantly more common in the ferrous sulfate group (n=11, 18.3%) than those in the Herbiron group (n=1, 1.6%) (p=0.004).
  
  
  CONCLUSIONS
  Twelve weeks of Herbiron treatment delivering 21mg of iron or ferrous sulfate treatment delivering 195 mg of iron induced normal hemoglobin levels in 62 or 91% of non-pregnant women with IDA in Taiwan, respectively, suggesting dose-dependent and bioavailability effects.
authors.affiliation: Chinese Medicine Division, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
authors.forename: Ching-Tzu
authors.initials: CT
authors.lastname: Lee
authors.affiliation: Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.|School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Cherng-Jye
authors.initials: CJ
authors.lastname: Jeng
authors.affiliation: Department of Obstetrics and Gynecology, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Lian-Shung
authors.initials: LS
authors.lastname: Yeh
authors.affiliation: Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Ming-Shyen
authors.initials: MS
authors.lastname: Yen
authors.affiliation: Department of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan.
authors.forename: Shih-Ming
authors.initials: SM
authors.lastname: Chen
authors.affiliation: Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Chyi-Long
authors.initials: CL
authors.lastname: Lee
authors.affiliation: Microbio Co., Ltd., Taipei, Taiwan.
authors.forename: Willie
authors.initials: W
authors.lastname: Lin
authors.affiliation: Department of Obstetrics and Gynecology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan; forest@w.tmu.edu.tw.
authors.forename: Chun-Sen
authors.initials: CS
authors.lastname: Hsu
keywords: elemental iron; ferrous bisglycinate chelate; herbiron; iron-deficiency anemia; paeoniae radix; premenopausal women