Abstract
BackgroundIn a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency, which was associated with a higher incidence of adverse events. Thiamin supplementation might, therefore, reduce adverse events in this population.MethodsAn exploratory, double-blind, parallel group, placebo-controlled, superiority trial of thiamin supplementation in patients of all ages with uncomplicated and severe falciparum malaria was conducted in Xepon District, Savannakhet Province, southern Laos. Patients were randomly assigned to either oral thiamin 10 mg/day for 7 days immediately after standard anti-malarial treatment then 5 mg daily until day 42, or identical oral placebo.ResultsAfter interim analyses when 630 patients (314 in thiamin and 316 in placebo groups) had been recruited, the trial was discontinued on the grounds of futility. On admission biochemical thiamin deficiency (alpha ≥ 25%) was present in 27% of patients and 9% had severe deficiency (alpha > 31%). After 42 days of treatment, the frequency of thiamin deficiency was lower in the thiamin (2%, 1% severe) compared to the placebo (11%, 3% severe) groups (p < 0.001 and p = 0.05), respectively. Except for diarrhoea, 7% in the placebo compared to 3% in the thiamin group (p = 0.04), and dizziness on day 1 (33% vs 25%, p = 0.045), all adverse events were not significantly different between the groups (p > 0.05). Clinical, haematological, and parasitological responses to treatment did not differ significantly between the two groups.ConclusionThiamin supplementation reduced biochemical thiamin deficiency among Lao malaria patients following anti-malarial drug treatment, but it did not reduce the frequency of adverse events after anti-malarial therapy or have any detected clinical or parasitological impact.Trial registrationISRCTN 85411059
Highlights
In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency, which was associated with a higher incidence of adverse events
Infantile beriberi is common in some communities in Laos [7,8] but there are no data on biochemical thiamin deficiency in older Lao children or adults without malaria
In the malaria studies the proportion of patients with biochemical thiamin deficiency was significantly lower at 42 day follow up, but patients received thiamin supplementation during recovery so it was uncertain whether this reduction was a consequence of recovery from malaria or thiamin supplementation or both
Summary
In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency, which was associated with a higher incidence of adverse events. In a post-hoc analysis (unpublished), the estimated median (range) admission basal erythroycte transketolase activity (ETK) but not the activation coefficient (alpha), was significantly lower in those who developed one or more adverse effects during or after treatment than those who did not (p = 0.003). This measure was significantly lower in those with dizziness, headache, and nightmares than in those without (p < 0.001). In the earlier studies in Laos Mayxay et al [6] did not include patients with severe malaria, young children or pregnant women, who would be expected to have a higher incidence of thiamin deficiency
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