[Treatment of beta-thalassemia with Bushen Yisui therapy: a randomized controlled trial].

OBJECTIVE:To investigate the efficacy and safety of Yisui Shengxue Granule (YSSXG), a compound traditional Chinese herbal medicine, in treating beta-thalassemia. METHODS:A randomized single-blinded trial was designed. Sixty patients with beta-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 beta-thalassemia.