Effect of Immunozin on Sickle Cell Disease in Sub Saharan Africa A Pilot Study

Abstract

Introduction: Sickle cell disease, a genetic blood disorder of public health significance, is associated with high morbidity and mortality among many Nigeria children. There is a gap in the use of local medicinal herbal products in its management. As such, the study intended to document the outcome of the administration of the test drug in Sickle Cell patients in Nigeria. Objective:To determine the effect of the test drug on hematological, biochemical, and liver enzyme parameters in Sickle Cell patients.Material and Methods: Thirty-three sickle cell disease (SCD) patients, were recruited into an open-label, one-arm, randomized control pilot study from January to May 2018. After enrollment into the study, subjects were seen on Day 0 (1 st visit) and then monthly for 5 months. On each visit, each patient was given age-specific dosage of the test drug and blood was taken for the analysis of serum electrolytes, creatinine, urea, reticulocytes, thrombocytes, white and red blood cells, liver function tests, conjugated and total bilirubin and albumin. STATA 13 was used for statistical analysis. Results:The means (±sd) of age (years) and weight (Kg) of the study subjects (15 males and 18 females) were 13.6 (6.3) and 33.6 (13.9) respectively. Overall there were significant variations in the means (±sd) of monocyte count (t= -2.86, P-value=0.003), eosinophils (t= -2.71, P-value=0.004), reticulocytes (t= 3.38, P-value=0.0007), bicarbonate (t= -4.51, P-value=0.0001), creatinine (t= -2.86, P-value=0.003) and alkaline phosphatase (t= -4.68, P-value=0.000001) values at recruitment and at end of study after monthly administration of the test drug. Study subjects were 3.5 times more likely to have reduced reticulocyte count after administration of the test drug (χ²=3.57, P-value=0.06, OR=2.93, 95% CI: 0.95, 9.03). Mean (±sd) creatinine level was significantly higher (44.8 [11.5]) among patients with reticulocyte count <2.5% than among those (34.4 [7.9]) with reticulocyte count ≥2.5% at recruitment but was lower (52.4 [10.7]) among patients with reticulocyte count <2.5% than among those (78.8 [70.4]) with reticulocyte count ≥2.5% at end of study. The significant negative correlation between hemoglobin concentration and reticulocyte (r = -9.96, t= -5.41, P-value=0.00001) and between creatinine and reticulocyte (r = -6.90, t= -3.11, P-value=0.004) at recruitment was not evidenced at end of study. Conclusion:The study revealed overall pre-and post-hoc leucocytosis, thrombocytosis, hyperkalemia and significant variations in reticulocytes, monocytes, eosinophils, and some liver enzymes which may be due to the administration of the test drug. There is need to conduct a multi-disciple and multi-center study on the test drug in SCD patients to further verify its effect on hematological, electrolytes and liver enzyme parameters in different age groups.