Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in ENL

Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

Erythema nodosum leprosum (ENL) is characterized by painful nodules and systemic compromising. It is usually recurrent and/or chronic and has both physical and economic impact on the patient, being a very important cause of morbidity and mortality. In addition, ENL is a major health problem in developing countries like Bangladesh where leprosy is endemic. Therefore, adequate control of this condition is important to reduce morbidity and mortality.

The treatment of ENL is usually started with steroids which have many adverse effects when given for prolonged periods and in high doses. However, recently in some case reports MTX appears to have a beneficial effect in cases of ENL. Also, MTX may provide a cheaper and convenient option in management of ENL.

However, there is paucity of well-designed randomized controlled trial on the effectiveness of MTX in the treatment of ENL. In this context such studies are needed. The investigator therefore designed this randomize trial to evaluate the efficacy and safety of combined MTX and Prednisolone over Prednisolone monotherapy in local setting. The investigator combined reducing doses of Prednisolone with a low dose MTX to minimize dose related complications, while maximizing benefit in controlling ENL. If the study results would show the superiority of combined regimen as found elsewhere in the World, it would be helpful to reduce the morbidity of ENL Patients.

Inclusion criteria:

1. Patient with ENL had crops of tender subcutaneous skin lesions with systemic features including fever (temperature >38°C), neuritis, joint pain, bone tenderness, orchitis, iritis, oedema, malaise, anorexia and lymphadenopathy.
2. Patients of both sexes with age ranging 18 years to 65 years.

Exclusion criteria:

1. Erythema nodosum associated with other disorder.
2. Pregnant and lactating women.
3. Diagnosed case of chronic hepatic, renal, hematological or other connective tissue disorders, Osteoporosis.
4. Severely ill, immune-suppressed patients like HIV/AIDS and patients of internal malignancy.
5. Patients or guardians not willing to participate in the study by signing informed consent form.