title: Interventions for erythema nodosum leprosum.
abstract: 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.
authors: Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, Rotterdam, Netherlands, 3000 CA.
authors: Natasja H J
authors: NH
authors: Van Veen
authors: Diana N J
authors: DN
authors: Lockwood
authors: Wim H
authors: WH
authors: van Brakel
authors: Jose
authors: J
authors: Ramirez
authors: Jan Hendrik
authors: JH
authors: Richardus
mesh_terms: 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
chemical_list: D007917:Leprostatic Agents; D013792:Thalidomide; D011239:Prednisolone; D002991:Clofazimine; D001241:Aspirin