22
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Summary

          Background

          Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia.

          Methods

          We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210.

          Findings

          Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9–19·9) in the intervention group and 23·9 episodes per person-year (23·4–24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of −4·5 (−5·1 to −3·8) episodes per person-year. No serious adverse events related to the intervention were reported.

          Interpretation

          A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries.

          Funding

          Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).

          Related collections

          Author and article information

          Contributors
          Journal
          Lancet Glob Health
          Lancet Glob Health
          The Lancet. Global Health
          Elsevier Ltd
          2214-109X
          15 May 2018
          July 2018
          15 May 2018
          : 6
          : 7
          : e795-e803
          Affiliations
          [a ]Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK
          [b ]Centre for Environmental and Developmental Studies, Addis Ababa University, Addis Ababa, Ethiopia
          [c ]School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia
          [d ]KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
          [e ]Swansea University Medical School, Swansea, UK
          [f ]International Orthodox Christian Charities, Debre Markos, Ethiopia
          [g ]Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK
          [h ]Department of Economics, University of Sussex, Brighton, UK
          Author notes
          [* ]Correspondence to: Prof Gail Davey, Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, East Sussex BN1 9PX, UK g.davey@ 123456bsms.ac.uk
          [*]

          Contributed equally

          [†]

          Dr Negussie died in February, 2018

          Article
          S2214-109X(18)30124-4
          10.1016/S2214-109X(18)30124-4
          6562300
          29773516
          c551480a-ab93-462f-81de-5f8ac24e44d1
          © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

          This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

          History
          Categories
          Article

          Comments

          Comment on this article