Volume 97, Issue 6
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for and infection treatment. Pediatric patients (1–15 years; = 295; from Ethiopia and Rwanda) excreting and/or eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 ± 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for (83.7% [72/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9/81; 95% CI: 5.2%; 20.1%], < 0.001) and for (33.9% [42/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9/119; 95% CI: 3.5%; 13.9%], < 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: −5.9; 41.5]; < 0.001) and (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: −16.8; 32.9]; = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9/144) of patients during DBP and 2.5% (7/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of and infections in pediatric patients, and no safety concerns were identified.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Article metrics loading...

The graphs shown below represent data from March 2017
Loading full text...

Full text loading...



  1. WHO, 2006. Preventive Chemotherapy in Human helminthiasis: Coordinated Use of Anthelminthic Drugs in Control Interventions: A Manual for Health Professionals and Programme Managers. Geneva, Switzerland: World Health Organization.
  2. GBD 2015 DALYs and HALE Collaborators, 2016. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 388: 16031658. [Google Scholar]
  3. Hotez PJ, Alvarado M, Basáñez M-G, Bolliger I, Bourne R, Boussinesq M, Brooker SJ, Brown AS, Buckle G, Budke CM, , 2014. The global burden of disease study 2010: interpretation and implications for the neglected tropical diseases. PLoS Negl Trop Dis 8: e2865. [Google Scholar]
  4. Brooker S, Clements AC, Bundy DA, , 2006. Global epidemiology, ecology and control of soil-transmitted helminth infections. Adv Parasitol 62: 221261. [Google Scholar]
  5. WHO, 2015. WHO Media Centre. Soil-Transmitted Helminth Infections (Fact Sheet No. 366). Geneva, Switzerland: World Health Organization.
  6. WHO, 2015. Soil-transmitted helminthiases: number of children treated in 2014. Wkly Epidemiol Rec 90: 152. [Google Scholar]
  7. Hotez PJ, 2006. Helminth infections: soil-transmitted helminth infections and schistosomiasis. Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, eds. Disease Control Priorities in Developing Countries. Washington, DC: World Bank.
  8. Tchuem Tchuenté LA, , 2011. Control of soil-transmitted helminths in sub-Saharan Africa: diagnosis, drug efficacy concerns and challenges. Acta Trop 120 (Suppl 1): S4S11. [Google Scholar]
  9. Miguel E, Kremer M, , 2004. Worms: identifying impacts on education and health in the presence of treatment externalities. Econometrica 72: 159217. [Google Scholar]
  10. van der Werff SD, Vereecken K, van der Laan K, Campos Ponce M, Junco Diaz R, Nunez FA, Rojas Rivero L, Bonet Gorbea M, Polman K, , 2014. Impact of periodic selective mebendazole treatment on soil-transmitted helminth infections in Cuban schoolchildren. Trop Med Int Health 19: 706718. [Google Scholar]
  11. WHO, 2007. Action Against Worms (Issue 8). Available at: http://www.bio.umass.edu/micro/klingbeil/590s/Reading/WHOWorms8.pdf. Accessed December 16, 2016.
  12. Friedman AJ, Ali SM, Albonico M, , 2012. Safety of a new chewable formulation of mebendazole for preventive chemotherapy interventions to treat young children in countries with moderate-to-high prevalence of soil transmitted helminth infections. J Trop Med 2012: 590463. [Google Scholar]
  13. Katz N, Chaves A, Pellegrino J, , 1972. A simple device for quantitative stool thick-smear technique in schistosomiasis mansoni. Rev Inst Med Trop Sao Paulo 14: 397400. [Google Scholar]
  14. Kure A, Mekonnen Z, Dana D, Bajiro M, Ayana M, Vercruysse J, Levecke B, , 2015. Comparison of individual and pooled stool samples for the assessment of intensity of Schistosoma mansoni and soil-transmitted helminth infections using the Kato-Katz technique. Parasit Vectors 8: 489. [Google Scholar]
  15. WHO, 2013. Assessing the Efficacy of Anthelminthic Drugs Against schistosomiasis and Soil-Transmitted Helminthiases. Geneva, Switzerland: World Health Organization.
  16. Vercruysse J, 2011. Assessment of the anthelmintic efficacy of albendazole in school children in seven countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis 5: e948. [Google Scholar]
  17. Keiser J, Utzinger J, , 2008. Efficacy of current drugs against soil-transmitted helminth infections: systematic review and meta-analysis. JAMA 299: 19371948. [Google Scholar]
  18. WHO, 2012. Eliminating Soil-Transmitted Helminthiases as a Public Health Problem in Children: Progress Report 2001–2010 and Strategic Plan 2011–2020. Geneva, Switzerland: World Health Organization.
  19. Dana D, Mekonnen Z, Emana D, Ayana M, Getachew M, Workneh N, Vercruysse J, Levecke B, , 2015. Prevalence and intensity of soil-transmitted helminth infections among pre-school age children in 12 kindergartens in Jimma Town, southwest Ethiopia. Trans R Soc Trop Med Hyg 109: 225227. [Google Scholar]
  20. Brooker S, 2009. An updated atlas of human helminth infections: the example of East Africa. Int J Health Geogr 8: 42. [Google Scholar]
  21. Brooker S, Clements AC, Bundy DA, , 2006. Global epidemiology, ecology and control of soil-transmitted helminth infections. Adv Parasitol 62: 221261. [Google Scholar]
  22. Albonico M, Bickle Q, Ramsan M, Montresor A, Savioli L, Taylor M, , 2003. Efficacy of mebendazole and levamisole alone or in combination against intestinal nematode infections after repeated targeted mebendazole treatment in Zanzibar. Bull World Health Organ 81: 343352. [Google Scholar]
  23. Steinmann P, Utzinger J, Du Z-W, Jiang J-Y, Chen J-X, Hattendorf J, Zhou H, Zhou X-N, , 2011. Efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminths and Taenia spp.: a randomized controlled trial. PLoS One 6: e25003. [Google Scholar]
  24. Levecke B, Montresor A, Albonico M, Ame SM, Behnke JM, Bethony JM, Noumedem CD, Engels D, Guillard B, Kotze AC, , 2014. Assessment of anthelmintic efficacy of mebendazole in school children in six countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis 8: e3204. [Google Scholar]
  25. Mrus J, Baeten B, Engelen M, Silber SA, , 2017. Efficacy of single-dose 500 mg mebendazole in soil-transmitted helminth infections: a review. J Helminthol 18: 110. [Google Scholar]
  26. Joseph SA, Montresor A, Casapia M, Pezo L, Gyorkos TW, , 2016. Adverse events from a randomized, multi-arm, placebo-controlled trial of mebendazole in children 12–24 months of age. Am J Trop Med Hyg 95: 8387. [Google Scholar]

Data & Media loading...

Supplemental Table

  • Received : 13 Feb 2017
  • Accepted : 11 Jul 2017
  • Published online : 05 Sep 2017

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error