Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial

Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previo...
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Autor*in:	Qin Zheng [verfasserIn] Haitao Xu [verfasserIn] Luxi Song [verfasserIn] Zeying Yan [verfasserIn] Manqin Sun [verfasserIn] Xia Peng [verfasserIn] Yiling Jiang [verfasserIn] Ling Shi [verfasserIn] Aiping Zhang [verfasserIn] Zhihao Wu [verfasserIn] Jiahui Lu [verfasserIn] Meihong Luo [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials

Übergeordnetes Werk:	In: Trials - BMC, 2006, 22(2021), 1, Seite 9
Übergeordnetes Werk:	volume:22 ; year:2021 ; number:1 ; pages:9

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s13063-021-05646-2

Katalog-ID:	DOAJ071795529

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520			\|a Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019.
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allfields	10.1186/s13063-021-05646-2 doi (DE-627)DOAJ071795529 (DE-599)DOAJ1499970bc7ce4e4d8f6e330048ab92fe DE-627 ger DE-627 rakwb eng R5-920 Qin Zheng verfasserin aut Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019. Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General) Haitao Xu verfasserin aut Luxi Song verfasserin aut Zeying Yan verfasserin aut Manqin Sun verfasserin aut Xia Peng verfasserin aut Yiling Jiang verfasserin aut Ling Shi verfasserin aut Aiping Zhang verfasserin aut Zhihao Wu verfasserin aut Jiahui Lu verfasserin aut Meihong Luo verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 9 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:9 https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe kostenfrei https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 9
spelling	10.1186/s13063-021-05646-2 doi (DE-627)DOAJ071795529 (DE-599)DOAJ1499970bc7ce4e4d8f6e330048ab92fe DE-627 ger DE-627 rakwb eng R5-920 Qin Zheng verfasserin aut Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019. Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General) Haitao Xu verfasserin aut Luxi Song verfasserin aut Zeying Yan verfasserin aut Manqin Sun verfasserin aut Xia Peng verfasserin aut Yiling Jiang verfasserin aut Ling Shi verfasserin aut Aiping Zhang verfasserin aut Zhihao Wu verfasserin aut Jiahui Lu verfasserin aut Meihong Luo verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 9 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:9 https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe kostenfrei https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 9
allfields_unstemmed	10.1186/s13063-021-05646-2 doi (DE-627)DOAJ071795529 (DE-599)DOAJ1499970bc7ce4e4d8f6e330048ab92fe DE-627 ger DE-627 rakwb eng R5-920 Qin Zheng verfasserin aut Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019. Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General) Haitao Xu verfasserin aut Luxi Song verfasserin aut Zeying Yan verfasserin aut Manqin Sun verfasserin aut Xia Peng verfasserin aut Yiling Jiang verfasserin aut Ling Shi verfasserin aut Aiping Zhang verfasserin aut Zhihao Wu verfasserin aut Jiahui Lu verfasserin aut Meihong Luo verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 9 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:9 https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe kostenfrei https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 9
allfieldsGer	10.1186/s13063-021-05646-2 doi (DE-627)DOAJ071795529 (DE-599)DOAJ1499970bc7ce4e4d8f6e330048ab92fe DE-627 ger DE-627 rakwb eng R5-920 Qin Zheng verfasserin aut Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019. Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General) Haitao Xu verfasserin aut Luxi Song verfasserin aut Zeying Yan verfasserin aut Manqin Sun verfasserin aut Xia Peng verfasserin aut Yiling Jiang verfasserin aut Ling Shi verfasserin aut Aiping Zhang verfasserin aut Zhihao Wu verfasserin aut Jiahui Lu verfasserin aut Meihong Luo verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 9 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:9 https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe kostenfrei https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 9
allfieldsSound	10.1186/s13063-021-05646-2 doi (DE-627)DOAJ071795529 (DE-599)DOAJ1499970bc7ce4e4d8f6e330048ab92fe DE-627 ger DE-627 rakwb eng R5-920 Qin Zheng verfasserin aut Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019. Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General) Haitao Xu verfasserin aut Luxi Song verfasserin aut Zeying Yan verfasserin aut Manqin Sun verfasserin aut Xia Peng verfasserin aut Yiling Jiang verfasserin aut Ling Shi verfasserin aut Aiping Zhang verfasserin aut Zhihao Wu verfasserin aut Jiahui Lu verfasserin aut Meihong Luo verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 9 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:9 https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe kostenfrei https://doi.org/10.1186/s13063-021-05646-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 9
language	English
source	In Trials 22(2021), 1, Seite 9 volume:22 year:2021 number:1 pages:9
sourceStr	In Trials 22(2021), 1, Seite 9 volume:22 year:2021 number:1 pages:9
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials Medicine (General)
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Qin Zheng @@aut@@ Haitao Xu @@aut@@ Luxi Song @@aut@@ Zeying Yan @@aut@@ Manqin Sun @@aut@@ Xia Peng @@aut@@ Yiling Jiang @@aut@@ Ling Shi @@aut@@ Aiping Zhang @@aut@@ Zhihao Wu @@aut@@ Jiahui Lu @@aut@@ Meihong Luo @@aut@@
publishDateDaySort_date	2021-01-01T00:00:00Z
hierarchy_top_id	326173552
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language_de	englisch
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callnumber-first	R - Medicine
author	Qin Zheng
spellingShingle	Qin Zheng misc R5-920 misc Anemia of lower-risk myelodysplastic syndrome misc Traditional Chinese medicine misc Treatment misc Clinical trials misc Medicine (General) Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
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topic_title	R5-920 Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials
topic	misc R5-920 misc Anemia of lower-risk myelodysplastic syndrome misc Traditional Chinese medicine misc Treatment misc Clinical trials misc Medicine (General)
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title	Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
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title_full	Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
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author_browse	Qin Zheng Haitao Xu Luxi Song Zeying Yan Manqin Sun Xia Peng Yiling Jiang Ling Shi Aiping Zhang Zhihao Wu Jiahui Lu Meihong Luo
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title_sort	integrated traditional chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
callnumber	R5-920
title_auth	Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
abstract	Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019.
abstractGer	Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019.
abstract_unstemmed	Abstract Background Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. Methods A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. Discussion This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. Trial registration Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019.
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title_short	Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
url	https://doi.org/10.1186/s13063-021-05646-2 https://doaj.org/article/1499970bc7ce4e4d8f6e330048ab92fe https://doaj.org/toc/1745-6215
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Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial

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