02969nas a2200289 4500000000100000008004100001653003900042653001700081653002700098653003000125653001300155100001500168700001200183700001200195700001400207700001300221700001400234700001200248700001300260700001700273700001100290700001400301700001200315700002000327245015900347520217300506 2018 d 10 aNeglected tropical diseases (NTDs) 10 aPodoconiosis 10 aLymphoedema management 10 adermatolymphangioadenitis 10 aEthiopia 1 aNegussie H 1 aMolla M 1 aNgari M 1 aBerkley J 1 aKivaya E 1 aNjuguna P 1 aFegan G 1 aTarimu A 1 aKelemework A 1 aLang T 1 aNewport M 1 aMcKay A 1 aEnquoselassie F 00 aLymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis (GoLBeT): a pragmatic randomised controlled trial in northern Ethiopia. 3 aBackground
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.