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Randomized Controlled Trial
. 2013;8(3):e57899.
doi: 10.1371/journal.pone.0057899. Epub 2013 Mar 19.

The Effect of Three-Monthly Albendazole Treatment on Malarial Parasitemia and Allergy: A Household-Based Cluster-Randomized, Double-Blind, Placebo-Controlled Trial

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Free PMC article
Randomized Controlled Trial

The Effect of Three-Monthly Albendazole Treatment on Malarial Parasitemia and Allergy: A Household-Based Cluster-Randomized, Double-Blind, Placebo-Controlled Trial

Aprilianto E Wiria et al. PLoS One. .
Free PMC article

Erratum in

  • PLoS One. 2013;8(9). doi:10.1371/annotation/fd262a2e-9dc2-40de-ac18-a46d5b92ce9e

Abstract

Background: Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy.

Methods and findings: A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5-15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35-12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74-1.86) at 9 months or 1.37 (0.93-2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported.

Conclusions: The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies.

Trial registration: Controlled-Trials.com ISRCTN83830814.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Trial Profile.
HH: Household. Lost to follow up implies that the participants have no data from this time point onward. Temporarily absent implies that the participants have no data at this time point but have data available at other time point.
Figure 2
Figure 2. A) Percentage of helminth infected subjects in placebo and albendazole treatment arms.
The presence of hookworms (by PCR), Ascaris lumbricoides (by PCR) and Trichuris trichiura (by microscopy) or any of these helminth infections in subjects who provided stool samples at baseline, 9 and 21 months post treatment (numbers are given in table S1A in Appendix S1). B) Effect of albendazole treatment on reduction in the intensity as well as percentage of subjects positive for hookworm and Ascaris infection as determined by PCR. Negative is when no helminth specific DNA was found. Positive Ct- values were grouped into three categories: Ct<30.0, 30.0≤Ct<35.0 and ≥35.0 representing a high, moderate and low DNA load, respectively.
Figure 3
Figure 3. Effect of albendazole treatment on malarial parasitemia based on two age categories.
Malarial parasitemia A) ≤15 and B) >15 years of age. The risk of malarial parasitemia after albendazole treatment compared to placebo is shown as odds ratio with 95% CI. The reference line is set at 1, indicating that symbols at the right of this line represent an increased risk, while symbols at the left of the line would predict decreased risk of malarial parasitemia. Note: at 9 month time point in those >15 years of age, the OR is ∞.

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Grant support

This study was funded by The Royal Netherlands Academy of Arts and Science (KNAW), Ref.KNAW-05-PP-35, European Commission contracts INCO-CT-2006-031714 and INCO-CT-2006-032436, Glofal FP6-2003-FOOD-2-B, and the Prof. Dr. P.C. Flu Foundation. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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