The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
권호 표지
DOI QR코드

DOI QR Code

Gwibi-tang for Renal Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

귀비탕이 신성빈혈에 미치는 효과에 대한 체계적 문헌 고찰 및 메타분석

  • Mikyung Kim (Department of Internal Medicine, Dongguk University Ilsan Oriental Medicine Hospital ) ;
  • Chang-ho Han (Department of Internal Medicine, College of Korean Medicine, Dongguk University)
  • 김미경 (동국대학교 일산한방병원 한방내과) ;
  • 한창호 (동국대학교 한의과대학 내과학교실)
  • Received : 2023.07.22
  • Accepted : 2023.08.17
  • Published : 2023.09.01
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives: The purpose of this study was to evaluate the effect of Gwibi-tang (GBT) on renal anemia. Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to investigate changes in anemia levels before and after oral administration of GBT in patients with renal anemia. Relevant literature published up to May 25, 2023, was searched in 10 academic electronic databases. Results: Data from 489 patients from 7 RCTs were obtained and analyzed. All participants were receiving erythropoietin-stimulating agent treatment, and most of them were under hemodialysis. Additional administration of GBT to the participants significantly increased the hemoglobin concentration (10.55 g/L, 95% CI 6.99 to 14.11) compared to the control group. Hematocrit, red blood cell count, serum ferritin concentration, transferrin saturation, and the total effective rate for anemia was also significantly higher in the GBT-treated group than in the control group. Conclusions: This study suggests that GBT may be considered to be a promising option for the effective management of patients with renal anemia under conventional treatment. However, the limitations of this study, including the quantitative and qualitative weakness of the RCTs, the lack of safety-related evidence, and the absence of long-term follow-up data, should be taken into account when interpreting the results of this study.

Keywords

References

  1. Korean Academy of Medical Sciences. Evidence-based Chronic Kidney Disease Clinical Practice Guidelines for Primary Medical Use. Seoul: Korean Academy of Medical Sciences & Korea Disease Control and Prevention Agency. 2022 [cited 2023 June 19]. Available from: ULR: https://www.ksn.or.kr/bbs/?code=g_guideline 
  2. Fishbane, S., & Coyne, D.W. (2020). How I treat renal anemia. Blood, 136(7), 783-789. https://doi.org/10.1182/blood.2019004330 
  3. Portoles, J., Martin, L., Broseta, J. J., & Cases, A. (2021). Anemia in chronic kidney disease: from pathophysiology and current treatments, to future agents. Frontiers in Medicine, 8:642296. https://doi: 10.3389/fmed.2021.642296 
  4. Santos, E. J. F., Dias, R. S. C, Lima, J. F. d. B., Filho N. S., & Dos Santos, A., M. (2020). Erythropoietin resistance in patients with chronic kidney disease: current perspectives. International journal of nephrology and renovascular disease, 13, 231-237. https://doi: 10.2147/IJNRD.S239151 
  5. Mimura, I., Tanaka, T., & Nangaku, M. (2015). How the target hemoglobin of renal anemia should be? Nephron, 131(3), 202-209. https://doi: 10.1159/000440849 
  6. Kliger, A.S., Foley, R.N., Goldfarb, D.S., Goldstein, S.L., Johansen, K., Singh, A., & et al. (2013). KDOQI US commentary on the 2012 KDIGO clinical practice guideline for anemia in CKD. American Journal of Kidney Diseases, 62(5), 849-859. https://doi: 10.1053/j.ajkd.2013.06.008 
  7. Singh, A.K. (2010). What is causing the mortality in treating the anemia of chronic kidney disease: erythropoietin dose or hemoglobin level? Current Opinion in Nephrology and Hypertension, 19(5), 420-424. https://doi: 10.1097/MNH.0b013e32833cf1d6 
  8. US Food & Drug Administration. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease. 2017 [cited 2023 June 19]. Available from: URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-modified-dosing-recommendations-improve-safe-use-erythropoiesis 
  9. Geng, F., Ma, L., Li, J., & Jiang, C. (2021). Research progress of Chinese and Western Medicine in the Treatment of Renal Anemia (中西医药治疗肾性贫血的研究进展). Popular Science & Technology, 11, 103-108. https://doi: 10.16040/j.cnki.cn15-1101.2023.01.049 
  10. Zheng, L., Liu, M., & Sun, X. (2023). Analysis of medication rules of traditional Chinese medicine in treatment of renal anemia based on data mining (基于数据挖掘的中药治疗肾性贫血的用药规律研究). China Pharmacy, 34(05), 591-594+619. https://doi: 10.6039/j.issn.1001-0408.2023.05.15 
  11. Zhao, M., Zhang, Y., Li, L., Yu ,Z., & Li, B. (2017). Efficacy and safety of Danggui Buxue Decoction in combination with western medicine treatment of anemia for renal anemia: a systematic review and meta-analysis. Annals of Translational Medicine, 5(6), 136. https://doi: 10.21037/atm.2017.01.17 
  12. Park, J. K., & Kim, K. H. (2017). A Survey on Uncovered Services in National Health Insurance of Traditional Korean Medicine Institution. Journal of Society of Preventive Korean Medicine, 21(3), 43-50. https://doi: 10.25153/spkom.2017.21.3.005 
  13. Chen, W. D., Huang, H. S., Su, Y. C., Chou, S. C., Ho ,W. C., Kao, M. C., & et al. (2018). The characteristics and prescription patterns of Chinese herbal medicine in clinical practice for the treatment of anemia. Taiwanese Journal of Obstetrics and Gynecology, 57(4), 570-577.  https://doi.org/10.1016/j.tjog.2018.06.030
  14. Faculty of Internal Medicine of Liver System of Korean Medicine. (2016). Textbook of Internal Medicine of Liver System in Korean Medicine. Seoul: Book Publisher Nadoh. 540. 
  15. East-West Medical Convergence Research Society. (1997) East-West Clinical Medicine. Seoul: Younglim Publishing Company. 113-116. 
  16. Chen, L. J., Yu, Y., & Xiong, W.S. (2019). A Meta-analysis of Randomized Controlled Trials of Guipi Decoction in Assisting Treatment of Iron Deficiency Anemia Journal of Zhejiang University of TCM, 43(12), 1368-1376. https://doi: 10.16466/j.issn1005-5509.2019.12.015 
  17. Yang, M., Geng, S., Zhu, Y., Fei, Z., Li, X., Zhang, J. & et al. (2020). Meta-analysis of Guipi Decoction Combined with Western Medicine on Iron Deficiency Anemia. Clinical Journal of Chinese Medicine, 15, 49-52+55. https://doi: doi:10.3969/j.issn.1674-7860.2020.15.021 
  18. Li, J., & Cai, Y. (2010). Thirty cases of megaloblastic anemia treated by Guipi decoction combined with Western medicine (归脾汤联合西药治疗巨幼细胞贫血30例). Shaanxi Journal of Traditional Chinese Medicine , 31(10), 1347-1348. 
  19. Dong, L., Liu, H., Gu, Q., & Han, Z. (2015). Effect of Guipi Decoction on Bone Marrow Serum FGF-1 in Patients with Chronic Aplastic Anemia of Heart and Spleen Deficiency. China Tranaslational Medicine and Integrative Medicine Symposium (Guangzhou station) Papers Comprehensive Journal Chinese Journal of Hypertension Publishing Society Proceedings, 2. 
  20. Yang, Y. (2020). Clinical observation of Guipi decoction combined with ferrous sulfate folic acid tablets in the treatment of perioperative anemia in elderly patients with intertrochanteric fractures (归脾汤结合硫酸亚铁叶酸片治疗老年股骨转子间骨折围手术期贫血的临床观察). Nei Mongol Journal of Traditional Chinese Medicine, 39(05), 69-71. https://doi: 10.16040/j.cnki.cn15-1101.2020.05.043 
  21. Wang, C., & Li, T. (2020). Efficacy evaluation of traditional Chinese medicine for nourishing qi, nourishing blood and promoting blood circulation in the treatment of myelodysplastic syndrome-refractory anemia (益气养血活血中药治疗骨髓增生异常综合征-难治性贫血的疗效评价). Guide of China Medicine, 18(07), 182-183. https://doi: 10.15912/j.cnki.gocm.2020.07.136 
  22. Liu, X., Su, L., Zhu, X. (2019). Clinical Study on Modified Guipi Tang Combined with Routine Therapyfor Cirrhosis Complicated with Anemia. Journal of New Chinese Medicine, 51(05), 76-78. https://doi: 10.13457/j.cnki.jncm.2019.05.022 
  23. Song, C., Wang, C., & Shen, F. (2013). Clinical Study of Guipi Soup in the Treatment of Anemiaof Cancer. China Journal of Chinese Medicine, 28(03), 320-321. https://doi: 10.16368/j.issn.1674-8999.2013.03.019 
  24. Li, S. (2020). Clinical Study of Jiawei Guipi Decoction in Treating Tumor-Related Anemia in Patients with Gastric Cancer. Anhui University of Traditional Chinese Medicine, Master's thesis. https://doi: 10.26922/d.cnki.ganzc.2020.000023 
  25. Bao, Y., Zhou, H., Ni, Y., & Qian, H. (2023). Clinical Study on Guipi Decoction Combined withRoxadustat for Chronic Kidney DIsease Complicated with Renal Anemia. New Chinese Medicine, 55(09):64-67. https://doi: 10.13457/j.cnki.jncm.2023.09.011 
  26. Federation of Herbal Formula Professors of Colleges of Korean Medicine. (2019). Textbook of Herbal Formula. Seoul: Yeonglimsa. 290-291. 
  27. Korea Institute of Oriental Medicine. OASIS Traditional Medicine Information Portal: Herbal Formula Search. 2021. [cited 2023 June 19]. Available from: https://oasis.kiom.re.kr/oasis/pres/prdetailView.jsp?idx=3#view02 
  28. TSUMURA. Product information: Kihi-to. [cited 2023 June 19]. Available from: https://www.tsumura.co.jp/kampo/list/detail/065.html. 
  29. Sterne, J. A. C., Savovic, J., Page, M. J., Elbers, R. G., Blencowe, N. S., Boutron, I., & et al. (2019). RoB 2: a revised tool for assessing risk of bias in randomised trials. Bmj, 366, l4898. https://doi: 10.1136/bmj.l4898 
  30. National Evidence-based Healthcare Collaborating Agency. (2022). Handbook for Clinical Practice Guideline Developer. Seoul: NECA. 135-143, 343-347. 
  31. Higgins, J. P. T., Savovic, J., Page, M. J., Elbers, R. G., & JAC, S. Cochrane Handbook for Systematic Reviews of Interventions version 6.3. 2022 [cited 2023 June 19]. Available from: URL: www.training.cochrane.org/handbook 
  32. Cheng, J., Yi, W., Pan, X., Qi, A., & Cheng, S. (2005). Efficacy of GuiPiWan Treating Anemia Patients During Hemodialysis. Journal of Nursing Science, 20(01), 41-42. 
  33. Cheng, X., Huang, X., & Yao, L. (2014). Clinical Efficacy Analysis of Guipi Decoction in the Treatment of Anemia in Patients undergoing Hemodialysis, 9(11), 1482-1484. 
  34. Fang, H., Wu, G., Xu, W., & Fu, S. (2011), Curative Effect Observation on 30 Cases of Maintenance Hemodialysis Anemia Treated by Guipi Pill (归脾丸治疗维持性血液透析贫血30例疗效观察). Zhejiang Journal of Traditional Chinese Medicine, 46(06), 423-424. 
  35. Huang, T., Li, X., & Guo, T. (2022). Effect of modified Guipi decoction on renal anemia and its effect on erythropoietin level (归脾汤加减治疗肾性贫血的效果及对促红细胞生成素水平的影响). Heilongjiang Medicine Journal, 35(04), 847-849. https://doi: 10.14035/j.cnki.hljyy.2022.04.037 
  36. Jia, Z., Wang, L., Zhou, L., & Cai, X. (2021). Improvement effect of Guipi Capsule on erythropoietin resistance in maintenance hemodialysis patients (归脾胶囊对维持性血液透析患者促红细胞生成素抵抗的改善作用). Chinese Journal of Traditional Medical Science and Technology, 28(06), 946-947. 
  37. Ma, J., Zhang, S. (2014). Discussion on "Enriching Blood by Tonifying Spleen" Connotation from Adjusting of Micro -inflammatory State in Renal Anemia Patients with MHD Technique Interfering by Gui-Pi Pills. Modernization of Traditional Chinese Medicine and Materia Medica-WOrld Science and Technology, 16(03), 634-647. 
  38. Qu, W. (2019). Observation on the application effect of traditional Chinese medicine Guipi decoction in patients with uremia hemodialysis anemia (中药归脾汤在尿毒症血液透析贫血患者中的应用效果观察). Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2019;19(03):82-4. https://doi: 10.13638/j.issn.1671-4040.2019.03.041 
  39. Reinisch, W., Staun, M., Tandon, R. K., Altorjay, I., Thillainayagam, A.V., Gratzer, C., & et al. (2013). A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED). American Journal of Gastroenterology, 108(12), 1877-1888. https://doi: 10.1038/ajg.2013.335 
  40. Ministry of Food and Drug Safety. (2011). Guidelines for Non-Clinical and Clinical Evaluation of Biosimilars of Erythropoietin. Osong: MFDS. 
  41. Deved, V., Poyah, P., James, M. T., Tonelli, M., Manns, B. J., Walsh, M., & et al. (2009). Ascorbic acid for anemia management in hemodialysis patients: a systematic review and meta-analysis. American journal of kidney diseases, 54(6), 1089-1097. https://doi: 10.1053/j.ajkd.2009.06.040 
  42. Ryu ,S. R., Park, S. K., Jung, J. Y., Kim, Y. H., Oh, Y. K., Yoo, T. H., & et al. (2017). The prevalence and management of anemia in chronic kidney disease patients: result from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). Journal of Korean medical science, 32(2): 249-56. https://doi: 10.3346/jkms.2017.32.2.249 
  43. Evans, M., Bower, H., Cockburn, E., Jacobson, S. H., Barany, P., & Carrero, J. J. (2020). Contemporary management of anaemia, erythropoietin resistance and cardiovascular risk in patients with advanced chronic kidney disease: a nationwide analysis. Clinical kidney journal, 13(5):821-827. https://doi: 10.1093/ckj/sfaa054 
  44. World Health Organization. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Vitamin and Mineral Nutrition Information System. 2011. Geneva. World Health Organization (WHO/NMH/NHD/MNM/11.1). 2016 [cited 2023 June 19]. Available from: http://www.who.int/vmnis/indicators/haemoglobin.pdf 
  45. Pfeffer, M. A., Burdmann, E. A., Chen, C. Y., Cooper, M. E., De Zeeuw, D., Eckardt, K. U., & et al. (2009). A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. New England Journal of Medicine, 361(21):2019-2032. https://doi: 10.1056/NEJMoa0907845 
  46. Leyland-Jones, B. (2003). Breast cancer trial with erythropoietin terminated unexpectedly. The lancet oncology, 4(8), 459-60. https://doi: 10.1016/s1470-2045(03)01163-x 
  47. Pollock, C., Johnson, D. W., Ho, W. H., Rossert, J., Casadevall, N., Schellekens, H., & et al. (2008). Pure red cell aplasia induced by erythropoiesis-stimulating agents. Clinical Journal of the American Society of Nephrology, 3(1):193-199. https://doi: 10.2215/CJN.02440607 
  48. HIRA, Details on application standards and methods of medical care benefits (drugs), Lucy design. July 2022 edition. 
  49. Shaikh, H., Hashmi, M. F., Aeddula, N. R. (2023). Anemia of Chronic Renal Disease. In StatPearls [Internet]. 2023 [cited 2023 June 19]. Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK539871 
  50. Li, L. (2020). Clinical Observation on Modified Guipi Decoction Combined with Erythropoietin in Treating Anemia in Patients with Maintenance Hemodialysis (加减归脾汤联合促红细胞生成素治疗维持性血液透析患者贫血的临床观察). Health for Everyone, 12, 104. 
  51. Zhou X. (2017). Clinical Study of the Effect of Guipi Decoction on Bone Marrow Suppression after Chemotherapy for NSCLC, Hubei University of Traditional Chinese Medicine, Master's thesis. 
  52. 殷丽娟, 刘立, 许瑞, 彭晓明, 杨欢, 归脾汤对苯中毒小鼠骨髓造血干细胞表型 Sca-1 和 CD34+, 细胞分裂周期的影响. 北京中医药大学学报, 2014;37(4):255-8. 
  53. 李龙龙, 刘立, 高丽娟, 周亚兰, 归脾汤对苯中毒小鼠外周血, 骨髓有核细胞及细胞凋亡蛋白 Fas, FasL 表达的影响. 中医临床研究, 2018;10(3):31-5. 
  54. Chang, M. S., Kim, D. R., Ko, E. B., Choi, B. J., Park, S. Y., Kang, S. A, & et al. (2009). Treatment with Astragali radix and Angelicae radix enhances erythropoietin gene expression in the cyclophosphamide-induced anemic rat. Journal of Medicinal Food, 12(3), 637-642. https://doi: 10.1089/jmf.2007.0727 
  55. Zhang, L., Gong, A. G., Riaz, K., Deng, J. Y., Ho, C. M., Lin, H. Q., & et al. (2017). A novel combination of four flavonoids derived from Astragali Radix relieves the symptoms of cyclophosphamide-induced anemic rats. FEBS Open Bio, 7(3):318-323. https://doi: 10.1002/2211-5463.12146 
  56. Jang, E., Kwon, S., Cho, Y., Woo, H., Kim, Y., Lee, J. (2013). A case of Guibitanggami treatmentto an iron deficiency anemia patient, The Journal of Internal Korean Medicine, spr(1), 142-147. 
  57. Pyeon, B. (2012). Anemia correction in patients with chronic renal failure (administration of hematopoietic hormones). Journal of Korean Society of Health-System Pharmacists, 29(1), 87-94. 
  58. Li, J., Ha, H., Jung, D., Lee, H., Lee, J., Huang, D., Shin, H, & et al. (2010). Comparative Study of 25 Herbal Formulas on Anti-Inflammatory Effect. The Jorunal of Oriental Obstetrics & Gynecology, 23(3):101-111. 
  59. Shin, N. R., Jung, T. Y., Seo, C. S., Park, S. W., Ko, J. W., Kim, J. C., & et al. (2018). Protective effect of water extract of guibi-tang against pulmonary inflammation induced by cigarette smoke and lipopolysaccharide. Laboratory Animal Research, 34:92-100. https://doi: 10.5625/lar.2018.34.3.92 
  60. Kim, J., Lee, J., Ha, H., Seo, C., Lee, M., Lee, H., & et al. (2009). Analysis of Studies on Guibi-tang (Guipitang) for Fundamental Establishment of Evidence Based Medicine. Journal of oriental neuropsychiatry, 20(3), 205-216. 
  61. Gluba-Brzozka, A., Franczyk, B., Olszewski, R., & Rysz, J. (2020> The Influence of Inflammation on Anemia in CKD Patients. International Journal of Molecular Sciences, 21(3):725. https://doi: 10.3390/ijms21030725 
  62. Dai, C., Shi, L., Ji, Y., Xia, L., Jiang, Y, Zhang, A, & et al., (2019). Clinical study of the effects of guipi decoction on oxygen carry capacity of red blood cells in the patients with anemia of heart and spleen deficiency. World Journal of Integrated Traditional and Western Medicine, 9, 1283-1287. https://doi: 10.13935/j.cnki.sjzx.190924 
  63. Rong, Y., Wu, D., Li, M., & Teng, J. (2023). Efficacy and safety of Guipi Decoction in the treatment of chronic heart failure: A systematic review and meta-analysis of randomized controlled trials. Medicine, 102(9), e33181. https://doi: 10.1097/MD.0000000000033181. 
  64. Hwang, J., Yang, M., & Shin, H. (1997). Survey for approximate composition and mineral content of medicinal herbs. Korean Journal of Food Science and Technology, 29(4):671-9. 
  65. Lee, J. (2007). A Study on effectiveness of dietary self-efficacy, dietary knowledge and social support for exercise diet compliance of patients on hemodialysis, Yonsei University, Master's thesis. 
  66. Chang, D., & Zhang, G. (2019). Curative effect of modified Guipi decoction on renal anemia in patients with chronic kidney disease and its influence on blood routine and blood biochemical indicators (加味归脾汤治疗慢性肾脏病患者肾性贫血的疗效及对血常规和血生化指标的影响). Journal of North Pharmacy, 16(04):104-105. 
  67. Qiu, S. (2021). Application effect of modified Guipi decoction combined with erythropoietin in the treatment of anemia in patients with maintenance hemodialysis (加减归脾汤联合促红细胞生成素在维持性血液透析患者贫血治疗中的应用效果). Clinical Research, 29(08):128-9. 
  68. Lee, J., Eum, H., Chung, T., Lee, Y., Um, Y., Yim, N., & et al. Single Dose Oral Toxicity Study of the Gwibi-tang Extract in ICR Mice. The Journal of Oriental Obstetrics & Gynecology, 23(4), 47-56. 
  69. Lee, M., Seo, C., Kim, Y., Shin, H. (2015). Safety assessment of Guibi-tang: Subchronic toxicity study in Crl: CD SD rats. Regulatory Toxicology and Pharmacology, 73(2):485-493.  https://doi.org/10.1016/j.yrtph.2015.09.030
  70. Ministry of Food and Drug Safety. (2011). Information Book for Proper Use of Drugs for Patients with Renal Diseases. Seoul: Ministry of FDS. 20.