TY - JOUR
T1 - 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
AU - Lee, Ching Tzu
AU - Jeng, Cherng Jye
AU - Yeh, Lian Shung
AU - Yen, Ming Shyen
AU - Chen, Shih Ming
AU - Lee, Chyi Long
AU - Lin, Willie
AU - Hsu, Chun Sen
N1 - Publisher Copyright:
© 2016 Ching-Tzu Lee et al.
PY - 2016/6/23
Y1 - 2016/6/23
N2 - 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 (n11, 18.3%) than those in the Herbiron group (n1, 1.6%) (p0.004). 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.
AB - 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 (n11, 18.3%) than those in the Herbiron group (n1, 1.6%) (p0.004). 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.
KW - Elemental iron
KW - Ferrous bisglycinate chelate
KW - Herbiron
KW - Iron-deficiency anemia
KW - Paeoniae radix
KW - Premenopausal women
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U2 - 10.3402/fnr.v60.31047
DO - 10.3402/fnr.v60.31047
M3 - Article
AN - SCOPUS:84979306715
SN - 1654-6628
VL - 60
JO - Food and Nutrition Research
JF - Food and Nutrition Research
M1 - 31047
ER -