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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (2): 137-140.doi: 10.3736/jcim20070207

• Original Clinical Research • Previous Articles     Next Articles

Treatment of β-thalassemia with Bushen Yisui therapy: a randomized controlled trial

Zhi-kui Wu1, Yong-mei Liu1, Xin-hua Zhang2, Wen-jun Liu1, Min Li1, Rong-xin Wang2, Li-min Chai1, Wen-juan Wang1, Chong Zhang1, You-wen Huang2, Yu-ying Chen1, Xin-xia LV2   

  1. 1. Department of Molecular Biology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
    2. Department of Haematology, 303 Hospital of People's Liberation Army of China, Nanning, Guangxi Zhuang Autonomous Region 530021, China
  • Online:2007-03-31 Published:2007-03-15

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Objective: To investigate the efficacy and safety of Yisui Shengxue Granule (YSSXG), a compound traditional Chinese herbal medicine, in treating β-thalassemia. 

Methods: A randomized single-blinded trial was designed. Sixty patients with β-thalassemia were divided into two groups: 30 patients in YSSXG-treated group and 30 in placebo parallel-control group. The patients in the two groups were assigned to receive either YSSXG or placebo for three months. The patients' symptoms and their blood indexes such as hemoglobin (Hb), red blood cell (RBC), reticulocytes (Ret) and fetal hemoglobin (HBF) were examined before and after the treatment. Meanwhile, the liver and spleen were examined with B-mode ultrasound. 

Results: In the YSSXG-treated group, the blood indexes (Hb, RBC, Ret and HBF) and the symptoms of the patients were improved after three-month treatment, with statistical significance compared to those before treatment (P＜0.01); hepatauxe and splenomegaly were also relieved (P＜0.05) and no adverse reactions were monitored. In the placebo parallel-control group, no significant improvement of the blood indexes and symptoms, as well as the hepatauxe and splenomegaly had been found (P>0.05). 

Conclusion: YSSXG demonstrates obvious clinical efficacy and no adverse reactions in treating β-thalassemia.

Key words: beta-thalassemia, traditional Chinese medicine, clinical trials, controlled

CLC Number: 

  • R285.6

Table 1

Changes of blood indexes in YSSXG-treated group and placebo group（ヌ±S）"

GroupnHb (g/L)RBC (×1012/L)Ret (%)HBF (%)
YSSXG-treated group22222
Before treatment3075.13±5.593.54±0.676.47±5.0337.19±23.32
After one-month treatment3082.27±7.54**3.84±0.65**8.38±7.25**40.99±24.36**
After two-month treatment3086.47±9.43**4.02±0.75**9.39±8.15**43.41±25.62**
After three-month treatment3087.87±0.10**4.01±0.83**9.48±8.08**43.05±25.17**
Placebo group22222
Before treatment3065.37±20.603.26±0.943.73±3.3445.64±27.01
After one-month treatment3064.20±20.333.22±0.903.95±3.5045.72±26.34
After two-month treatment3064.87±20.983.20±0.963.85±3.1646.07±26.46
After three-month treatment3065.17±21.213.27±0.984.01±3.2246.91±26.77

Table 2

Traditional Chinese symptom CRF scores in YSSXG-treated group and placebo group（ヌ±S）"

GroupnSallow complexionDizzinessPalpitationShortness of breathLassitudeAnorexia
YSSXG-treated group2222211
Before treatment303.9±1.51.9±1.72.5±1.62.8±1.63.1±1.61.2±1.6
After one-month treatment303.2±1.10.9±1.1*1.5±1.3*1.5±1.3*1.9±1.0*0.6±1.2
After two-month treatment302.9±1.1*0.8±1.6*1.2±1.4*1.3±1.4*1.7±1.1*0.5±1.0
After three-month treatment302.7±1.2*0.9±1.5*1.2±1.5*1.3±1.4*1.7±1.3*0.5±1.6
Placebo group2222222
Before treatment304.1±1.51.7±1.91.9±1.72.0±1.93.1±1.61.5±1.7
After one-month treatment303.8±1.61.8±1.91.6±1.71.8±2.02.7±1.61.0±1.6
After two-month treatment303.4±1.61.2±1.81.3±1.51.4±1.92.3±1.61.0±1.6
After three-month treatment303.4±1.51.3±1.81.3±1.51.2±1.92.2±1.60.8±1.4

Table 3

B-mode ultrasound examination results of liver and spleen in YSSXG-treated group and placebo group （ヌ±S, cm）"

GroupnLiver oblique diameterSpleen transverse diameter
YSSXG-treated group222
Before treatment2812.33±1.563.96±2.13
After three-month treatment2812.21±1.613.84±2.12*
Placebo group222
Before treatment2811.72±2.293.93±1.75
After three-month treatment2811.79±2.393.84±1.75
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