Negussie H, et al. - Whether or not a simple, inexpensive lymphoedema management package (containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes) would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia. Outcomes revealed this package as effective in reducing the frequency and duration of acute dermatolymphangioadenitis. The governments of endemic countries are recommended to implement this package.

Methods

• At health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia, researchers performed a pragmatic randomised controlled trial.
• Participants were the adults (aged 18 years and older) with 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.
• They performed a random assignment of patients (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).
• In this study, participants were aware of their group assignment; however, researchers doing all analyses were masked to treatment group.
• Incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant was assessed as the primary outcome; it was measured by using validated patient self-reported pictorial diaries.

Results

• Between Dec 1, 2014, and June 30, 2015, screening of 1339 patients was performed; of these, 696 patients were enrolled and randomly allocated to treatment groups.
• To the intervention group, 350 patients and to the control group, 346 patients were allocated
• 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months.
• Reports of 16,550 new episodes of acute dermatolymphangioadenitis during 765·2 person-years were noted during the 12 months of follow-up.
• The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9–19·9) and 23·9 episodes per person-year (23·4–24·4) in the intervention group and in the control group, respectively.
• The ratio of incidence rate in the intervention group to that of the control group of 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.
• They recognized no serious adverse events related to the intervention.