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
Engelsk titel: 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
Författare:
Lin, Willie
;
Hsu, Chun-Sen
;
Lee, Ching-Tzu
;
Jeng, Cherng-Jye
;
Yeh, Lian-Shung
;
Yen, Ming-Shyen
;
Chen, Shih-Ming
;
Lee, Chyi-Long
Email: forest@w.tmu.edu.tw
Språk: Eng
Antal referenser: 43
Dokumenttyp:
RCT
UI-nummer: 16083032
Sammanfattning
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.