Human Chemotherapy by China-Made Praziquantel in Zanzibar: Efficacy and Safety

Schistosomiasis is a global neglected tropical parasitic disease of great medical and economic significance. Since praziquantel was developed in 1970s, it has replaced other antischistosomal agents to become the only drug of choice for the treatment of human schistosomiases. Currently, mass drug administration with praziquantel remains the global strategy for schistosomiasis control. In the roadmap on the neglected tropical diseases (NTD) the World Health Organization (WHO) aims at attaining at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. A randomized controlled trial was performed to compare the effectiveness and safety of praziquantel in treating Schistosoma haematobium in Africa using two different sources for the drug, Merck Limited Partnership (KgaA), Germany and Nanjing Pharmaceutical Factory (NPF), China. More than 6000 participants testing positive for S. haematobium infection were enrolled from three villages (shehias) situated in the northern, middle and southern part of Pemba Island, Zanzibar. Applying criteria of inclusion and exclusion, resulted in a study population of 152 people (84 males, 68 females). A randomized controlled trial was conducted assigning participants to either praziquantel from NPF or Merck KGaA. After 1 month, the cure rate of S. haematobium and adverse events were compared. The ratio of male to female, the ratio of light/high infection intensity, and the average value of age were calculated between the two drug manufacturers. Chi-squared test and T-test were used for consistency analysis. Out of the total of 73 cases receiving praziquantel from NPF, the cure rate achieved was 97.3% (73/75), while the 74 cases receiving the drug from Merck KgaA reached a similar cure rate (96.1% or 74/77). There was no significant difference between the two outcomes (chi(2) = 0.003, P = 0.956). Among the 75 patients treat, only one (a 16-years old female student), who had received the drug made in China had slight adverse reactions manifested as dizziness, headache and abdominal pain. The efficacy of China-made praziquantel does not differ significantly from praziquantel made by Merck KGaA in Germany.