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...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-10-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05646-2 |
| _version_ | 1818918305421852672 |
|---|---|
| author | Qin Zheng Haitao Xu Luxi Song Zeying Yan Manqin Sun Xia Peng Yiling Jiang Ling Shi Aiping Zhang Zhihao Wu Jiahui Lu Meihong Luo |
| author_facet | Qin Zheng Haitao Xu Luxi Song Zeying Yan Manqin Sun Xia Peng Yiling Jiang Ling Shi Aiping Zhang Zhihao Wu Jiahui Lu Meihong Luo |
| author_sort | Qin Zheng |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-20T00:47:51Z |
| format | Article |
| id | doaj.art-1499970bc7ce4e4d8f6e330048ab92fe |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T00:47:51Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1499970bc7ce4e4d8f6e330048ab92fe2022-12-21T19:59:21ZengBMCTrials1745-62152021-10-012211910.1186/s13063-021-05646-2Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trialQin Zheng0Haitao Xu1Luxi Song2Zeying Yan3Manqin Sun4Xia Peng5Yiling Jiang6Ling Shi7Aiping Zhang8Zhihao Wu9Jiahui Lu10Meihong Luo11Department of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Jiao Tong University Affiliated Sixth People’s HospitalDepartment of Hematology, Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)Department of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)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.https://doi.org/10.1186/s13063-021-05646-2Anemia of lower-risk myelodysplastic syndromeTraditional Chinese medicineTreatmentClinical trials |
| spellingShingle | Qin Zheng Haitao Xu Luxi Song Zeying Yan Manqin Sun Xia Peng Yiling Jiang Ling Shi Aiping Zhang Zhihao Wu Jiahui Lu Meihong Luo 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 Trials Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials |
| 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 |
| 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| 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 |
| 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 |
| topic | Anemia of lower-risk myelodysplastic syndrome Traditional Chinese medicine Treatment Clinical trials |
| url | https://doi.org/10.1186/s13063-021-05646-2 |
| work_keys_str_mv | AT qinzheng integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT haitaoxu integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT luxisong integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT zeyingyan integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT manqinsun integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT xiapeng integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT yilingjiang integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT lingshi integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT aipingzhang integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT zhihaowu integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT jiahuilu integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial AT meihongluo integratedtraditionalchineseandconventionalmedicineinthetreatmentofanemiaduetolowerriskmyelodysplasticsyndromestudyprotocolforarandomizedplacebocontrolledtrial |