Suchergebnisse

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 ...

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.