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

Negussie, Henok, Molla, Meseret, Ngari, Moses, Berkley, James A, Kivaya, Esther, Njuguna, Patricia, Fegan, Greg, Tamiru, Abreham, Kelemework, Abebe, Lang, Trudie, Newport, Melanie, McKay, Andy, Enquoselassie, Fikre and Davey, Gail (2018) Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis (GoLBeT): a pragmatic randomised controlled trial in northern Ethiopia. The Lancet Global Health. ISSN 2214-109X (Accepted)

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Abstract

Background
Podoconiosis (endemic, non-filarial elephantiasis) affects ~4 million subsistence farmers in tropical Africa. Limited awareness of the condition and lack of evidence for treatment mean that no endemic-country government yet offers lymphoedema management for podoconiosis patients. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: acute dermatolymphangioadenitis (ADLA) episodes.

Methods
We conducted a pragmatic randomised controlled trial to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of ADLA in adult podoconiosis patients in northern Ethiopia. Patients were individually randomised to a package comprising instruction in foot hygiene, skin care, bandaging, exercises, use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings; or no intervention. The primary outcome was incidence of ADLA, measured using a validated patient-held pictorial diary. Assignment was not masked, but those performing the primary analysis were. The trial was registered at the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210.

Findings
A total of 350 patients were randomised to the intervention and 346 to the control group, with 93.4% follow-up at one year. During the 12 months of follow up, 16,550 new episodes of ADLA occurred during 765.2 person years observed. The incidence of ADLA was 19.4 (95% CI 18.9 to 19.9) and 23.9 (95% CI 23.4 to 24.4) episodes per person year in the intervention and control groups respectively; incidence rate ratio 0.81 (95% CI 0.69 to 0.96, p=0.02), rate difference -4.5 (95% CI -5.1 to -3.8) episodes per person year. No important adverse events related to the intervention were reported.

Interpretation
A simple, inexpensive package of lymphoedema self-care is effective in reducing frequency and duration of ADLA. We recommend its implementation by endemic-country governments.

Item Type: Article
Keywords: podoconiosis, trials
Schools and Departments: Brighton and Sussex Medical School > Global Health and Infection
Research Centres and Groups: Wellcome Trust Brighton and Sussex Centre for Global Health Research
Related URLs:
Depositing User: Esther Garibay
Date Deposited: 20 Mar 2018 12:43
Last Modified: 20 Mar 2018 12:43
URI: http://sro.sussex.ac.uk/id/eprint/74523

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