Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Randomized placebo-controlled trial of the efficacy of mebendazole polymorphs in the treatment of hookworm infections(American Society of Tropical Medicine and Hygiene, 2013) Gunawardena, N.K.; Kumarendran, B.; Manamperi, N.H.; Senarathna, B.P.; Silva, M.; Pathmeswaran, A.; de Silva, N.R.Mebendazole has three polymorphic forms, identified as A, B and C. It has been suggested that unlike polymorph C, A is ineffective in the treatment of hookworm and whipworm infections. A randomized doubleblind, placebo-controlled trial was carried out to compare the efficacy of single dose 500 mg tablets of pure mebendazole Polymorph C with those containing a 1:1 mixture of Polymorphs A and C, for the treatment of hookworm infections. All eligible individuals living in 219 households were recruited after obtaining written, informed consent. A single fecal sample was obtained and examined the same day, using the Kato-Katz technique for intestinal nematode infections. Those who were found infected with hookworms were randomized to one of three treatment arms and requested to provide a second faecal sample 10 - 14 days after treatment. This was examined in the same manner as the first. A total of 892 individuals were recruited; 601 provided fecal samples; 214 were found positive for hookworm; 70, 74 and 70 individuals were randomized to treatment arms A (mixture of polymorphs A and C), B (pure polymorph C) and C (placebo) respectively. Follow-up samples were provided by 53, 48 and 49 persons respectively in each treatment arm. The cure rates in the three treatment arms were 28.3%, 18.8% and 16.3% respectively; they were not significantly different from one another. Comparison of fecal egg count reductions (FECR) in the 3 treatment arms (86.1%, 84.5% and -6.6% in Arms A, B and C respectively) showed that both mebendazole formulations performed significantly better than placebo, but there was no statistically significant difference between FECR with the two drug formulations. It is concluded that a single 500mg dose of mebendazole, either as Polymorph C alone, or as a mixture of Polymorphs A and C, has little efficacy in curing hookworm infections. However, both formulations were significantly better than placebo in reducing the intensity of infection, with no statistically significant difference between the two formulations.Item Effect of mebendazole therapy in pregnancy on birth outcome(Lancet Publishing Group, 1999) de Silva, N.R.; Sirisena, J.; Gunasekera, D.P.S.; Ismail, M.M.; de Silva, H.J.BACKGROUND: In areas endemic for hookworm, routine antenatal mebendazole therapy could greatly reduce the prevalence of anaemia in pregnancy. At present, however, this is not a widely accepted control strategy because of a lack of data on the safety of the drug. We assessed the effect of mebendazole therapy during pregnancy on birth outcome. METHODS: A cross-sectional study was done in Sri Lanka, where prescription of mebendazole to women in the second trimester of pregnancy is recommended. Two hospitals were chosen for the study, and women who gave birth there between May, 1996, and March, 1997, were recruited. We compared the rates of major congenital defects, stillbirth, perinatal death, and low birthweight (less or equal 1500 g) among babies of mothers who had taken mebendazole during pregnancy with those whose mothers had not taken an anthelmintic (controls). FINDINGS: The rate of major congenital defects was not significantly higher in the mebendazole group than in the control group (97 [1.8 percent] of 5275 vs 26 [1.5 percent] of 1737; odds ratio 1.24 [95 percent CI 0.8-1.91], p equal 0.39). Among 407 women who had taken mebendazole in the first trimester (contrary to medical advice), 10 (2.5 percent) had major congenital defects (odds ratio vs controls 1.66 [0.81-3.56], p equal 0.23). The proportions of stillbirths and perinatal deaths were significantly lower in the mebendazole group (1.9 vs 3.3 percent, 0.55 [95 percent CI 0.4-0.77]), as was the proportion of low-birthweight babies (1.1 vs 2.3 percent 0.47 [95 percent CI 0.32-0.71]). INTERPRETATION: Mebendazole therapy during pregnancy is not associated with a significant increase in major congenital defects, but our results indicate that it should be avoided during the first trimester. This therapy could offer beneficial effects to pregnant women in developing countries, where intestinal helminthiases are endemic.