The Clinical Effects of Fermented Papaya Preparation® (FPP®) on Oxidative Stress in Patients with HbE/ β -Thalassaemia

Background: Red blood cells (RBC) of patients with thalassaemia are under continuous oxidative stress. Fermented papaya preparation® (FPP®) has been shown to have an antioxidative effect and is postulated to reduce the oxidative stress on RBC. Objective: To study the clinical effects of FPP® treatment in patients with HbE/β-thalassaemia on RBC indices, oxidative stress and quality of life scores. Method: Patients with HbE/β-thalassaemia who do not receive regular blood transfusion were included in the study and were given FPP® daily (3gm 2 times a day) for 12 weeks. Peripheral blood samples were obtained at the initiation of the study and at 4-weekly intervals thereafter for a period of 12 weeks. The following parameters were measured: Haemoglobin (Hb), mean corpuscular volume (MCV), reticulocyte count; Oxidation studies: production of reactive oxygen species (ROS) and intracellular glutathione content (GSH), spontaneously and in response to oxidative stress; Quality of life (QoL) at the start and at the end of 12 weeks using health survey questionnaires. Results: Seven patients (5 females and 2 males) were recruited to the study from January 2006 to April 2006. Median age of the study population was 19 years (range 4 to 27yrs). In vitro analyses showed production of significantly less ROS and more GSH following treatment. There was no significant difference in the Hb, MCV, reticulocyte count, clinical parameters or QoL scores. FPP® was well tolerated by all the patients. Conclusion: Although oxidative stress parameters were decreased, FPP® did not have any significant effect on the Hb levels or QoL. Longer studies on larger sample size are required to study the long-term clinical effect of FPP® on clinical parameters in patients with Hb E/β-thalassaemia.