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
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. To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA. Phase III double-blind, randomized, act...
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| description | 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.
To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.
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).
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).
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. |
| doi_str_mv | 10.3402/fnr.v60.31047 |
| format | Article |
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To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.
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).
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).
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.</description><identifier>ISSN: 1654-6628</identifier><identifier>ISSN: 1654-661X</identifier><identifier>EISSN: 1654-661X</identifier><identifier>DOI: 10.3402/fnr.v60.31047</identifier><identifier>PMID: 27343206</identifier><language>eng</language><publisher>Sweden: Taylor & Francis</publisher><subject>Active control ; Anemia ; Bioavailability ; Clinical trials ; Comparative studies ; Diarrhea ; Dietary supplements ; Double-blind studies ; Dyspepsia ; elemental iron ; Females ; ferrous bisglycinate chelate ; Ferrous sulfate ; Hemoglobin ; herbiron ; Hospitals ; Iron ; Iron deficiency ; Iron sulfates ; iron-deficiency anemia ; Meals ; Menstruation ; Nausea ; Nutrient deficiency ; Original ; paeoniae radix ; Pain ; Patient safety ; Patients ; Pregnancy ; premenopausal women ; Randomization ; Sucrose ; Sulfates ; Supplements ; Synthesis ; Tablets ; Womens health</subject><ispartof>Food & nutrition research, 2016-01, Vol.60 (1), p.31047-9</ispartof><rights>2016 Ching-Tzu Lee et al. 2016</rights><rights>Copyright Taylor & Francis Ltd. 2016</rights><rights>2016 Ching-Tzu Lee et al. This work is licensed under the Creative Commons Attribution License http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c519t-a264bef398ea39ab12089fe2f7a0c2b0ed916874caa7ebc27acd20d6d5aeded73</citedby><cites>FETCH-LOGICAL-c519t-a264bef398ea39ab12089fe2f7a0c2b0ed916874caa7ebc27acd20d6d5aeded73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920941/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920941/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,4125,27479,27901,27902,53766,53768,59116,59117</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27343206$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lee, Ching-Tzu</creatorcontrib><creatorcontrib>Jeng, Cherng-Jye</creatorcontrib><creatorcontrib>Yeh, Lian-Shung</creatorcontrib><creatorcontrib>Yen, Ming-Shyen</creatorcontrib><creatorcontrib>Chen, Shih-Ming</creatorcontrib><creatorcontrib>Lee, Chyi-Long</creatorcontrib><creatorcontrib>Lin, Willie</creatorcontrib><creatorcontrib>Hsu, Chun-Sen</creatorcontrib><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><title>Food & nutrition research</title><addtitle>Food Nutr Res</addtitle><description>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.
To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.
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).
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).
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.</description><subject>Active control</subject><subject>Anemia</subject><subject>Bioavailability</subject><subject>Clinical trials</subject><subject>Comparative studies</subject><subject>Diarrhea</subject><subject>Dietary supplements</subject><subject>Double-blind studies</subject><subject>Dyspepsia</subject><subject>elemental iron</subject><subject>Females</subject><subject>ferrous bisglycinate chelate</subject><subject>Ferrous sulfate</subject><subject>Hemoglobin</subject><subject>herbiron</subject><subject>Hospitals</subject><subject>Iron</subject><subject>Iron deficiency</subject><subject>Iron sulfates</subject><subject>iron-deficiency anemia</subject><subject>Meals</subject><subject>Menstruation</subject><subject>Nausea</subject><subject>Nutrient deficiency</subject><subject>Original</subject><subject>paeoniae radix</subject><subject>Pain</subject><subject>Patient safety</subject><subject>Patients</subject><subject>Pregnancy</subject><subject>premenopausal women</subject><subject>Randomization</subject><subject>Sucrose</subject><subject>Sulfates</subject><subject>Supplements</subject><subject>Synthesis</subject><subject>Tablets</subject><subject>Womens health</subject><issn>1654-6628</issn><issn>1654-661X</issn><issn>1654-661X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>0YH</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNp9kk1rFTEUhgdRbK0u3UrAjQun5mM-N0Ipai8U3FRwF84kJ72pmeSazNxy_Tf-UzO99WJFXOUk5-Hh5PAWxUtGT0VF-Tvj4-m2yRdGq_ZRccyauiqbhn19fKh5d1Q8S-mG0kbQrnpaHPFWVILT5rj4eUZ0mAeH5eCs129JBK_DaH9grnNJQE12i6UKforBOdRks4aEZLVakTTNekeCIRcYBxuDJzpa_41YT6Y1kikiTCP6aUGWdqnRWGXRq11242hhQTcRMxQ2MCdwxOAIDtPSuAJ7C_558cSAS_ji_jwpvnz8cHV-UV5-_rQ6P7ssVc36qQTeVAMa0XcIooeBcdr1BrlpgSo-UNQ9a7q2UgAtDoq3oDSnutE1oEbdipNitffqADdyE-0IcScDWHn3EOK1hDhZ5VAK0ypR18ihYxUX3QAIQ90pw_oWoDbZ9X7v2szDiFrlHURwD6QPO96u5XXYyqrntK9YFry5F8TwfcY0ydEmhc7ltYU5Sdb2fd1Q2jYZff0XehPm6POqJOes5kL0ffVfKueiy7lou0yVe0rFkFJEcxiZUbnETea4yRw3eRe3zL_6858H-ne-MtDtAetNiCPchui0nGDnQjQ5asqmRfUv9y8Jgufo</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Lee, 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Herbiron drink in the treatment of iron-deficiency anemia in premenopausal females in Taiwan</title><author>Lee, Ching-Tzu ; Jeng, Cherng-Jye ; Yeh, Lian-Shung ; Yen, Ming-Shyen ; Chen, Shih-Ming ; Lee, Chyi-Long ; Lin, Willie ; Hsu, Chun-Sen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c519t-a264bef398ea39ab12089fe2f7a0c2b0ed916874caa7ebc27acd20d6d5aeded73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Active control</topic><topic>Anemia</topic><topic>Bioavailability</topic><topic>Clinical trials</topic><topic>Comparative studies</topic><topic>Diarrhea</topic><topic>Dietary supplements</topic><topic>Double-blind studies</topic><topic>Dyspepsia</topic><topic>elemental iron</topic><topic>Females</topic><topic>ferrous bisglycinate chelate</topic><topic>Ferrous sulfate</topic><topic>Hemoglobin</topic><topic>herbiron</topic><topic>Hospitals</topic><topic>Iron</topic><topic>Iron deficiency</topic><topic>Iron sulfates</topic><topic>iron-deficiency anemia</topic><topic>Meals</topic><topic>Menstruation</topic><topic>Nausea</topic><topic>Nutrient deficiency</topic><topic>Original</topic><topic>paeoniae radix</topic><topic>Pain</topic><topic>Patient safety</topic><topic>Patients</topic><topic>Pregnancy</topic><topic>premenopausal women</topic><topic>Randomization</topic><topic>Sucrose</topic><topic>Sulfates</topic><topic>Supplements</topic><topic>Synthesis</topic><topic>Tablets</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, Ching-Tzu</creatorcontrib><creatorcontrib>Jeng, Cherng-Jye</creatorcontrib><creatorcontrib>Yeh, Lian-Shung</creatorcontrib><creatorcontrib>Yen, Ming-Shyen</creatorcontrib><creatorcontrib>Chen, Shih-Ming</creatorcontrib><creatorcontrib>Lee, 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Willie</au><au>Hsu, Chun-Sen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Food & nutrition research</jtitle><addtitle>Food Nutr Res</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>60</volume><issue>1</issue><spage>31047</spage><epage>9</epage><pages>31047-9</pages><issn>1654-6628</issn><issn>1654-661X</issn><eissn>1654-661X</eissn><abstract>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.
To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.
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).
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).
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.</abstract><cop>Sweden</cop><pub>Taylor & Francis</pub><pmid>27343206</pmid><doi>10.3402/fnr.v60.31047</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | Taylor & Francis Open Access; DOAJ Directory of Open Access Journals; Co-Action Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Norart Open Access |
| subjects | Active control Anemia Bioavailability Clinical trials Comparative studies Diarrhea Dietary supplements Double-blind studies Dyspepsia elemental iron Females ferrous bisglycinate chelate Ferrous sulfate Hemoglobin herbiron Hospitals Iron Iron deficiency Iron sulfates iron-deficiency anemia Meals Menstruation Nausea Nutrient deficiency Original paeoniae radix Pain Patient safety Patients Pregnancy premenopausal women Randomization Sucrose Sulfates Supplements Synthesis Tablets Womens health |
| 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 |
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