Open AccessA double-blind, randomized, and active-controlled phase III study of Herbiron drink in the treatment of iron-deficiency anemia in premenopausal females in Taiwan
Author(s) -
Ching Tzu Lee,
Cherng Jye Jeng,
Lian Shung Yeh,
Ming Shyen Yen,
Shih Ming Chen,
Chyi Long Lee,
W Lin,
Chien Chin Hsu
Publication year - 2016
Publication title -
food and nutrition research/food and nutrition research. supplement
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.041
H-Index - 37
eISSN - 1654-6628
pISSN - 1654-661X
DOI - 10.3402/fnr.v60.31047
Subject(s) - medicine , anemia , ferrous , nausea , placebo , hemoglobin , iron deficiency anemia , adverse effect , diarrhea , gastroenterology , population , iron deficiency , randomization , surgery , randomized controlled trial , chemistry , alternative medicine , environmental health , organic chemistry , pathology
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.