title: The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebo-controlled trial.
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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN83830814.
authors.affiliation: Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
authors.forename: Aprilianto E
authors.initials: AE
authors.lastname: Wiria
authors.forename: Firdaus
authors.initials: F
authors.lastname: Hamid
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Wammes
authors.forename: Maria M M
authors.initials: MM
authors.lastname: Kaisar
authors.forename: Linda
authors.initials: L
authors.lastname: May
authors.forename: Margaretta A
authors.initials: MA
authors.lastname: Prasetyani
authors.forename: Sitti
authors.initials: S
authors.lastname: Wahyuni
authors.forename: Yenny
authors.initials: Y
authors.lastname: Djuardi
authors.forename: Iwan
authors.initials: I
authors.lastname: Ariawan
authors.forename: Heri
authors.initials: H
authors.lastname: Wibowo
authors.forename: Bertrand
authors.initials: B
authors.lastname: Lell
authors.forename: Robert
authors.initials: R
authors.lastname: Sauerwein
authors.forename: Gary T
authors.initials: GT
authors.lastname: Brice
authors.forename: Inge
authors.initials: I
authors.lastname: Sutanto
authors.forename: Lisette
authors.initials: L
authors.lastname: van Lieshout
authors.forename: Anton J M
authors.initials: AJ
authors.lastname: de Craen
authors.forename: Ronald
authors.initials: R
authors.lastname: van Ree
authors.forename: Jaco J
authors.initials: JJ
authors.lastname: Verweij
authors.forename: Roula
authors.initials: R
authors.lastname: Tsonaka
authors.forename: Jeanine J
authors.initials: JJ
authors.lastname: Houwing-Duistermaat
authors.forename: Adrian J F
authors.initials: AJ
authors.lastname: Luty
authors.forename: Erliyani
authors.initials: E
authors.lastname: Sartono
authors.forename: Taniawati
authors.initials: T
authors.lastname: Supali
authors.forename: Maria
authors.initials: M
authors.lastname: Yazdanbakhsh
mesh_terms: D000293:Adolescent; D000328:Adult; D015766:Albendazole / Q000008:administration & dosage* / Q000009:adverse effects*; D000871:Anthelmintics / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006373:Helminthiasis / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D007214:Indonesia; D008288:Malaria / Q000209:etiology* / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000209:etiology* / Q000276:immunology*; D012987:Soil / Q000469:parasitology; D055815:Young Adult
chemical_list: D000871:Anthelmintics; D012987:Soil; D015766:Albendazole