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. 2009 Jul 8;2009(3):CD006949.
doi: 10.1002/14651858.CD006949.pub2.

Interventions for erythema nodosum leprosum

Natasja H J Van Veen  1 , Diana N J Lockwood, Wim H van Brakel, Jose Ramirez Jr, Jan Hendrik Richardus
Affiliations

Interventions for erythema nodosum leprosum

Natasja H J Van Veen et al. Cochrane Database Syst Rev. .

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.

Objectives: To assess the effects of interventions for erythema nodosum leprosum.

Search strategy: 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.

Selection criteria: Randomised controlled trials (RCTs) of interventions for ENL in people with leprosy.

Data collection and analysis: Two authors performed study selection, assessed trial quality, and extracted data.

Main 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.

Authors' 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.

PubMed Disclaimer

Conflict of interest statement

DNL has been a paid advisor to the drug company Pharmion (who makes thalidomide) advising them on their application to have thalidomide registered within the EU.

Figures

1.1
1.1. Analysis
Comparison 1 Thalidomide versus aspirin, Outcome 1 Remission of skin lesions.
2.1
2.1. Analysis
Comparison 2 100 mg thalidomide versus 300 mg thalidomide, Outcome 1 Remission of skin lesions.
2.2
2.2. Analysis
Comparison 2 100 mg thalidomide versus 300 mg thalidomide, Outcome 2 Change in ENL severity (proportion improved).
2.3
2.3. Analysis
Comparison 2 100 mg thalidomide versus 300 mg thalidomide, Outcome 3 Time to next clinical ENL episode.
2.4
2.4. Analysis
Comparison 2 100 mg thalidomide versus 300 mg thalidomide, Outcome 4 Adverse effects.
3.1
3.1. Analysis
Comparison 3 Pentoxifylline versus thalidomide, Outcome 1 Remission of skin lesions.
4.1
4.1. Analysis
Comparison 4 Clofazimine versus prednisolone, Outcome 1 Remission of skin lesions.
4.2
4.2. Analysis
Comparison 4 Clofazimine versus prednisolone, Outcome 2 Time to next clinical ENL episode.
4.3
4.3. Analysis
Comparison 4 Clofazimine versus prednisolone, Outcome 3 Adverse effects.
5.1
5.1. Analysis
Comparison 5 Clofazimine versus thalidomide, Outcome 1 Time to next clinical ENL episode.
6.1
6.1. Analysis
Comparison 6 Indomethacin versus prednisolone, Outcome 1 Remission of skin lesions.
6.2
6.2. Analysis
Comparison 6 Indomethacin versus prednisolone, Outcome 2 Change in ENL severity (proportion improved).
6.3
6.3. Analysis
Comparison 6 Indomethacin versus prednisolone, Outcome 3 Time to next clinical ENL episode.
6.4
6.4. Analysis
Comparison 6 Indomethacin versus prednisolone, Outcome 4 Adverse effects.
7.1
7.1. Analysis
Comparison 7 Indomethacin versus chloroquine, Outcome 1 Change in ENL severity (proportion improved).
7.2
7.2. Analysis
Comparison 7 Indomethacin versus chloroquine, Outcome 2 Time to next clinical ENL episode.
7.3
7.3. Analysis
Comparison 7 Indomethacin versus chloroquine, Outcome 3 Adverse effects.
8.1
8.1. Analysis
Comparison 8 Indomethacin versus aspirin, Outcome 1 Change in ENL severity (proportion improved).
8.2
8.2. Analysis
Comparison 8 Indomethacin versus aspirin, Outcome 2 Time to next clinical ENL episode.
8.3
8.3. Analysis
Comparison 8 Indomethacin versus aspirin, Outcome 3 Adverse effects.
9.1
9.1. Analysis
Comparison 9 Levamisole versus placebo, Outcome 1 Change in ENL severity (proportion improved).
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