Cross over placebo control trial of dilazep in beta-thalassemia/hemoglobin E patients

Abstract

An attempt was made to find better symptomatic treatment for beta-thalassemia/hemoglobin E (β-thal/Hb E) patients in order to reduce their blood demand. Oral administration of dilazep was prescribed for these patients and a clinical trial was conducted over a 2-year period as a cross over placebo control study. Seventeen β-thal/Hb E patients were enrolled in the study. All of them received dilazep and placebo for 10 months at different periods of time and were taken care of by the same doctor throughout the study. The blood demand of the same patients during the period of receiving dilazep with the period of receiving placebo, was 1.5 ± 1.8 U/10 months versus 2.2 ± 2.6 U/10 months, respectively. Thus dilazep showed a benefit in decreasing the blood demand by about 50% although the results did not reach statistical significance (p = 0.1). There was a statistical difference ir hemoglobin concentration of the patients receiving dilazep compared with placebo (p = 0.038). While receiving dilazep the mean ± SD hemoglobin level was 5.82 ± 0.8 g/dl, significantly higher than while receiving placebo (5.66 ± 0.9 g/dl) ( p = 0.038). The liver, and renal function tests, and cardiac enzyme levels of the patients showed no significant changes throughout the study. However, one case had a problem with bleeding following tooth extraction whilst receiving dilazep and needed 1 unit of blood transfusion. In conclusion, administration of dilazep to patients with β-thal/Hb E increased the patients' hemoglobin and reduced their blood demand with few side effects.