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

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.