Abstract
SummaryBackgroundPodoconiosis (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.MethodsWe 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.FindingsBetween 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.InterpretationA 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.FundingJoint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).
Highlights
This disease is an important problem in tropical Africa, where irritant volcanic soils that are rich in silicates have been generated by the environmental conditions of high altitude (>1000 m) and high rainfall (>1000 mm per year), and these soils are farmed by very poor people who cannot afford shoes or water for washing.[3]
Between Dec 1, 2014, and June 30, 2015, 1339 patients with podoconiosis were screened for eligibility; 696 patients were enrolled and 643 were excluded. 350 study participants were randomly assigned to the intervention group and 346 to the control group. 46 (7%) patients did not complete the study. 29 patients (4% of all patients enrolled; 63% of non-completers) dropped out in the intervention group and 17 (2%; 37%)
There was no difference in the incidence of acute dermatolymphangioadenitis episodes by sex at baseline (p=0·10), we found greater efficacy of the intervention in men than women; women had a higher incidence of acute dermatolymphangioadenitis episodes and higher ratio of acute dermatolymphangioadenitis incidence relative to the control group than did men
Summary
Podoconiosis is a form of lymphoedema that arises in tropical highland areas in genetically susceptible people who do not use footwear.[1,2] This disease is an important problem in tropical Africa, where irritant volcanic soils that are rich in silicates have been generated by the environmental conditions of high altitude (>1000 m) and high rainfall (>1000 mm per year), and these soils are farmed by very poor people who cannot afford shoes or water for washing.[3]. Two studies on management of podoconiosis lymphoedema have been done The first of these studies was an uncontrolled follow-up study of 30 patients with podoconiosis for 1 year, which found reductions in disease stage and leg circumference and increased quality of life associated with a programme comprising foot hygiene, bandaging, and use of socks and shoes. The second study was a randomised trial that used 2% glycerine in the soaking water, with a primary outcome of skin barrier function. Neither of these studies assessed the incidence of acute dermatolymphangioadenitis. Several observational studies of patients with filarial lymphoedema have suggested the value of hygiene treatment in prevention of acute dermatolymphangioadenitis but, to our knowledge, no trial had been done
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