Efficiency of Drugs in Treatment of Schistosomiasis - Report Example

Clinical field trial to compare the efficiency of drugs in treatment of schistosomiasis Background Schistosomiasis is a major health problem in many countries. Across the world over 200 million populations are infected by this parasitic disease and many more at high risk with Africa representing 85% of the affected (Chitsulo et al., 2000). It is much prevalent in under developed countries. Severly affected among them are Angola, Ghana, Madagascar, Malawi, etc., So no proper primary health care programmes are available in most cases. This infection is very difficult to reduce because it is highly transmitted through water bodies. With increasing population the risk of infection also increases. Schistosomiasis is a highly infectious disease and largely affects the school children. So it is much important to take preventive measures against this infection to safeguard the future generation. Control programmes are being implemented for many years but eradication of this disease proves to be a very difficult job due to high transmission rates. Political support is needed to improve the conditions. There are two drugs mainly available for the treatment of this disease- Praziquantel, solely for this and artesunate which is effective against both malaria and schistosomiasis. So a trial was conducted in two villages, Lampsar and Makhana in an effect to compare the efficacy of these two drugs. This result can be considered during the planning of any further control measures. 2. Study area This field trial was conducted in two villages, Lampsar and Makhana located along the river Lampsar in Senegal River Basin (West Africa). Lampsar has been affected by this disease for quite a long time whereas Makhana only two decades back. Lampsar was selected because the transmission rate of schistosomiasis is higher due to the water resources used for irrigation here (Clercq et al., 2002). 3. Subject selection criteria School children were mainly selected for this trial because they are more prone to this disease. Only those children whose urine samples showed the presence of S.haematobium eggs were indulged in this test (Clercq et al., 2002). They were split into two groups and any one treatment was administered. Care should be taken to avoid any effects due to co-occurring diseases. 4. Study design Baseline sampling The following trial has to be carried out in order to test the efficacy of single drug artesunate with a combination of artesunate and praziquantel in the treatment of schistosomiasis. Primary school children in the age group of 7-14 years were involved in the test. The number of children involved in this trial was 200 and 211 in Lampsar and Makhana respectively (Clercq et al., 2002). Urine samples were taken for 2 consecutive days at the hour of maximum excretion and eggs were counted. Those children who showed positive signs of S.haematobium during this were only taken into further consideration. Cure rate was determined by observing 5 weeks after post treatment and urine samples were taken after 12 and 24 weeks to study the re-infection patterns. The infected children were separated into two groups. One group was administered with a single dose (40 mg/kg) of praziquantel and the other with artesunate (8 tablets of 50 mg for 5 days). Any side effects produced during this period was taken care of. In the second group, the children who were still found positive for this parasite were treated with praziquantel and the cure rate was determined. Geometric mean calculations were involved to asses the egg counts. . The analysis was conducted at the Espoir laboratory in Saint Louis and a few samples were preserved in 10% formalin and taken to Kingston University for further analysis. Randomization of subjects and double-blinding of experiment Randomization is very important in assessing a drug’s efficiency since this is going to be used in a random environment in the world. The subjects under trial are split randomly in groups using any method, may be using computer software. The result obtained from this type of environment resembles the real time effects. Double-blinding is required to get the actual result and not the expected result. In this, both the subject and the investigator are unaware of the treatment being given. This ensures that the results generated are correct. It is the duty of the manufacturers to maintain a placebo controlled environment. A person who is not a part of the investigating team collects the coded results at each stage and does not release it till the end of the trial. In-treatment and post-treatment sampling The children affected by schistosomiasis were continually administered with the drugs and their effect on the disease was analysed from their urine sample during the treatment period to determine the cure rate. There seemed to be an efficient increase in the cure rate of praziquantel than artesunate. The urine samples are analysed to determine the egg count even after the dosage period for a period of 5, 12 and 24 weeks to determine any cases of re-infection. This procedure is carried out in all cases. Observation of side effects During the period of treatment and as well as after treatment care should be taken to note all the side effects and required measures be taken. An elderly person in the subject’s family or any other responsible person may be assigned the job of observing the patient’s condition and making note of any side effects produced. A checklist furnishing the side effects such as gastric pain, pollakiuria, fever, nausea, diarrhoea was being distributed to enable them keep track of any side effects (Clercq et al., 2002). The checklist was translated in local language to enhance improved understanding. 5. Subject compliance It is indeed necessary to administer the drugs to every individual at correct time and make a periodic note of their condition. It may be difficult for us to carry out this. So a supervisory team may be employed to take care of all this. The team may consist of people from that village. They can be trained in a local level to carry out the job (Fenwick., 2003). This reduces the complexity of the problem. They are provided with the drugs along with the instructions to be carried out. Children may be given treatment in school with the aid of teachers and non-health personnel after the required training. It is much easier to accomplish this trial in school than at home (Fenwick., 2003). Prior permission was obtained from Region Medicale, Saint Louis. Before beginning the study, a meeting was held in the village and the purpose of study was explained to all village authorities, health representatives and the parents of the children involved and their consent was sought. 6. Health and safety Health and safety is of major concern in any field and particularly in our trial where all testing has to be carried out in a laboratory using hazardous chemicals care should be taken to avoid any toxic exposure thereby providing safety to the personnel working there. Here we are using formalin to preserve the samples for further analysis. So in order to use any chemical in our trial we need to complete a COSHH form to ensure safety. The laboratory personnel should take all the measures to avoid infection such as to wear lab coat etc., The health and safety of the subjects involved in the treatment is very important. There should be available resources to take care of any side effects produced. The risks should be assessed and necessary precaution should be taken. Appropriate health surveillance plans to be carried out and arrangements be made for accidents incidents and emergencies. And the most important of all, the employees should be properly trained and supervised to carry out the study successfully. References Chistulo, L,. Engles, D., Montresor, A., & Savioli (2000) The global status of schistosomiasisi and its control. Acta tropica 77, 41-51 De Clercq, D., Vercruysse, J., Kongs, A., Verle, P., Dompnier, J.P and Faye. P.C (2002) Efficacy of artesunate and praziquantel in schistosoma haematobium infected schoolchildren. Acta tropica 82, 61-66 Fenwick, A., Savioli, L., Engles, D., Bergquist, N.R and Todd, M.H. (2003) Drugs for the control of parasitic disease: Current status and development in schistosomasis. Trends in Parasitology 19 (11), 509-515 Helmby, H,. (2007) Schistosomiasis and malaria: another piece of the crossreactivity puzzle. Trends in Parasitology 23, 88-90 Read More