Chiranjib Bagchi1 , Netai Pramanik2 , Pratip Kumar Kundu3 , Santanu Kumar Tripathi4
BACKGROUND Artemisinin Combination Therapy (ACT) is presently the recommended treatment of uncomplicated falciparum malaria in India but poor adherence and emerging resistance is a concern. We wanted to compare patient adherence and treatment outcome (efficacy and tolerability) of supervised versus non-supervised artesunate -sulphadoxine-pyrimethamine (AS-SP) therapy in uncomplicated falciparum malaria. METHODS Study participants were randomly distributed into supervised (S) and nonsupervised (NS) treatment groups to receive a three day AS-SP plus single dose of primaquine (PMQ) on second day. They were followed up on the fourth day (Day 3) for adherence check (NS group) and on Day 3, (7 ± 1) and (28+2) day of study for efficacy and tolerability assessment (both S and NS groups). A total of 64 patients (33 in group NS and 31 in S) was enrolled in this 18-month study. Adherence was evaluated in the NS group by counting left-over tablets and oral interview. RESULTS Altogether 29 (87%) and 31 (100%) patients were treatment adherent in NS and S group respectively (p-0.114). Four subjects (12.1%) did not bring the empty strips i.e. non-adherent but on verbal interview confirmed medicine intake correctly. In spite of an increased total delay in dosing (0.61 ± 1.171 vs. 0.064 ± 0.250 hours, p-0.035) in group NS, no significant difference in (28+2 day) in clinical and parasitological (100% clearance in both groups), efficacy and safety parameters were found. One case of late clinical failure (Day 40) and another possibly re-infection case (Day 57) were successfully treated with the same drug regimen, both in group NS. CONCLUSIONS AS - SP combination possessed a very good adherence, efficacy, and tolerability profile, in both study groups and the supervised dosing didn’t have any additional benefit over currently practiced non-supervised therapy.
