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

  • Ching-Tzu Lee
  • Cherng-Jye Jeng
  • Lian-Shung Yeh
  • Ming-Shyen Yen
  • Shih-Ming Chen
  • Chyi-Long Lee
  • Willie Lin
  • Chun-Sen Hsu

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.

Design: 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).

Conclusion: 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.

Keywords: iron-deficiency anemia; herbiron; ferrous bisglycinate chelate; elemental iron; paeoniae radix; premenopausal women

(Published: 23 June 2016)

Citation: Food & Nutrition Research 2016, 60: 31047 - http://dx.doi.org/10.3402/fnr.v60.31047

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Published
2016-06-23
How to Cite
1.
Lee C-T, Jeng C-J, Yeh L-S, Yen M-S, Chen S-M, Lee C-L, Lin W, Hsu C-S. 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. fnr [Internet]. 2016Jun.23 [cited 2019Jul.20];600. Available from: https://foodandnutritionresearch.net/index.php/fnr/article/view/1007
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Original Articles