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
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 II...
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| Format: | Article |
| Language: | English |
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Swedish Nutrition Foundation
2016-06-01
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| Series: | Food & Nutrition Research |
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| Online Access: | http://www.foodandnutritionresearch.net/index.php/fnr/article/view/31047/47325 |
| _version_ | 1828769138378539008 |
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| author | Ching-Tzu Lee Cherng-Jye Jeng Lian-Shung Yeh Ming-Shyen Yen Shih-Ming Chen Chyi-Long Lee Willie Lin Chun-Sen Hsu |
| author_facet | Ching-Tzu Lee Cherng-Jye Jeng Lian-Shung Yeh Ming-Shyen Yen Shih-Ming Chen Chyi-Long Lee Willie Lin Chun-Sen Hsu |
| author_sort | Ching-Tzu Lee |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T13:42:28Z |
| format | Article |
| id | doaj.art-3f7c355e2a814238baeab58cf197aa5f |
| institution | Directory Open Access Journal |
| issn | 1654-661X |
| language | English |
| last_indexed | 2024-12-11T13:42:28Z |
| publishDate | 2016-06-01 |
| publisher | Swedish Nutrition Foundation |
| record_format | Article |
| series | Food & Nutrition Research |
| spelling | doaj.art-3f7c355e2a814238baeab58cf197aa5f2022-12-22T01:04:41ZengSwedish Nutrition FoundationFood & Nutrition Research1654-661X2016-06-016001910.3402/fnr.v60.3104731047A double-blind, randomized, and active-controlled phase III study of Herbiron drink in the treatment of iron-deficiency anemia in premenopausal females in TaiwanChing-Tzu Lee0Cherng-Jye Jeng1Lian-Shung Yeh2Ming-Shyen Yen3Shih-Ming Chen4Chyi-Long Lee5Willie Lin6Chun-Sen Hsu7 Chinese Medicine Division, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan Department of Obstetrics and Gynecology, China Medical University Hospital, Taichung, Taiwan Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan Department of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan Microbio Co., Ltd., Taipei, Taiwan Department of Obstetrics and Gynecology, Wan Fang Hospital, Taipei Medical University, Taipei, TaiwanBackground: 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.http://www.foodandnutritionresearch.net/index.php/fnr/article/view/31047/47325iron-deficiency anemiaherbironferrous bisglycinate chelateelemental ironpaeoniae radixpremenopausal women |
| spellingShingle | Ching-Tzu Lee Cherng-Jye Jeng Lian-Shung Yeh Ming-Shyen Yen Shih-Ming Chen Chyi-Long Lee Willie Lin Chun-Sen Hsu 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 Food & Nutrition Research iron-deficiency anemia herbiron ferrous bisglycinate chelate elemental iron paeoniae radix premenopausal women |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | double blind randomized and active controlled phase iii study of herbiron drink in the treatment of iron deficiency anemia in premenopausal females in taiwan |
| topic | iron-deficiency anemia herbiron ferrous bisglycinate chelate elemental iron paeoniae radix premenopausal women |
| url | http://www.foodandnutritionresearch.net/index.php/fnr/article/view/31047/47325 |
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