Interventions for erythema nodosum leprosum.
BACKGROUND
Erythema nodosum leprosum (ENL) is a serious immunological complication of leprosy, causing inflammation of skin, nerves, other organs, and general malaise. Many different therapies exist for ENL, but it is unclear if they work or which therapy is optimal.


OBJECTIVE
To assess the effects of interventions for erythema nodosum leprosum.


METHODS
We searched the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 1, 2009), MEDLINE (from 2003), EMBASE (from 2005), LILACS and AMED (from inception), CINAHL (from 1981), and databases of ongoing trials, all in March 2009. We checked reference lists of articles and contacted the American Leprosy Missions in Brazil to locate studies.


METHODS
Randomised controlled trials (RCTs) of interventions for ENL in people with leprosy.


METHODS
Two authors performed study selection, assessed trial quality, and extracted data.


RESULTS
We included 13 studies with a total of 445 participants. The quality of the trials was generally poor and no results could be pooled due to the treatments being so heterogeneous. Treatment with thalidomide showed a significant remission of skin lesions compared to acetylsalicylic acid (aspirin) (RR 2.43; 95% CI 1.28 to 4.59) (1 trial, 92 participants). Clofazimine treatment was superior to prednisolone (more treatment successes; RR 3.67; 95% CI 1.36 to 9.91) (1 trial, 24 participants), and thalidomide (fewer recurrences; RR 0.08; 95% CI 0.01 to 0.56) (1 trial, 72 participants). We did not find any significant benefit for intravenous betamethasone compared to dextrose (1 trial, 10 participants), pentoxifylline compared to thalidomide (1 trial, 44 participants), indomethacin compared to prednisolone, aspirin or chloroquine treatments (2 trials, 80 participants), or levamisole compared to placebo (1 trial, 12 participants). Mild to moderate adverse events were significantly lower in participants taking 100 mg thalidomide compared to 300 mg thalidomide daily (RR 0.46; 95% CI 0.23 to 0.93). Significantly more minor adverse events were reported in participants taking clofazimine compared with prednisolone (RR 1.92; 95% CI 1.10 to 3.35). None of the studies assessed quality of life or economic outcomes.


CONCLUSIONS
There is some evidence of benefit for thalidomide and clofazimine, but generally we did not find clear evidence of benefit for interventions in the management of ENL. However, this does not mean they do not work, because the studies were small and poorly reported. Larger studies using clearly defined participants, outcome measures, and internationally recognised scales are urgently required.
Van Veen
Natasja H J
NH
Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, Rotterdam, Netherlands, 3000 CA.
Lockwood
Diana N J
DN
van Brakel
Wim H
WH
Ramirez
Jose
J
Richardus
Jan Hendrik
JH
D001241:Aspirin / Q000627:therapeutic use; D002991:Clofazimine / Q000627:therapeutic use; D004893:Erythema Nodosum / Q000188:drug therapy*; D006801:Humans; D007917:Leprostatic Agents / Q000627:therapeutic use*; D015440:Leprosy, Lepromatous / Q000188:drug therapy*; D011239:Prednisolone / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D013792:Thalidomide / Q000627:therapeutic use
D007917:Leprostatic Agents; D013792:Thalidomide; D011239:Prednisolone; D002991:Clofazimine; D001241:Aspirin