title: [Prospective clinical study of radix astragali and its compound prescription for treatment of β-thalassemia in children].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of radix astragali and its compound prescription for treatment of β-thalassemia in children.
  
  
  METHODS
  This study was a randomized, controlled, double-blind clinical trial. Fifty-seven children with β-thalassemia were randomly assigned to radix astragali, compound prescription (radix astragali+ codonopsis pilosula + tortoise plastron) and placebo control groups after stratifying the patients according to disease type (intermedia and major). The parameters of hematology and safety were assessed after 12 weeks of treatment.
  
  
  RESULTS
  After 12 weeks of treatment, the mean Hb elevation levels in children with β-thalassemia intermedia from the compound prescription and the radix astragali groups were 1.21±1.12 and 1.05±0.80 g/dL respectively compared with -(0.28±0.51) g/dL in the placebo control group (P<0.01). Mean Hb levels in the compound prescription and radix astragali groups were significantly higher than in the placebo control group (P<0.05). Therapy with both radix astragali and its compound prescription increased fetal hemoglobin, red blood cell, mean corpuscular hemoglobin and reticulocyte levels in children with β-thalassemia intermedia. The total effective rates were 64% and 62% in children with β-thalassemia intermedia from the compound prescription and radix astragali groups respectively, which was significantly higher than in the placebo control group (9%; P<0.01). Therapy with radix astragali or its compound prescription in children with β-thalassemia major had similar but less favourable effects than the same therapy in children with β-thalassemia intermedia. White blood cell, neutrophil, platelet and hepatic and renal functions were not adversely affected by the medicines.
  
  
  CONCLUSIONS
  Therapy with radix astragali or its compound prescription is effective and safe in children with β-thalassemia.
authors.affiliation: Southern Medical University Nanfang Hospital, Guangzhou, China.
authors.forename: Zhuo-Ming
authors.initials: ZM
authors.lastname: Lu
authors.forename: Xin-Hua
authors.initials: XH
authors.lastname: Qian
authors.forename: Zhi-Wen
authors.initials: ZW
authors.lastname: Chen
authors.forename: Chun-Hong
authors.initials: CH
authors.lastname: Zhang
authors.forename: Li-Shan
authors.initials: LS
authors.lastname: Guo
authors.forename: Jia
authors.initials: J
authors.lastname: Chen
mesh_terms: D027883:Astragalus Plant / Q000009:adverse effects; D027885:Astragalus propinquus; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D011446:Prospective Studies; D017086:beta-Thalassemia / Q000097:blood / Q000188:drug therapy*
chemical_list: D004365:Drugs, Chinese Herbal; D006454:Hemoglobins; C027492:Huang Qi