title: A phase two randomised controlled double blind trial of high dose intravenous methylprednisolone and oral prednisolone versus intravenous normal saline and oral prednisolone in individuals with leprosy type 1 reactions and/or nerve function impairment.
abstract: BACKGROUND
  Leprosy Type 1 reactions are a major cause of nerve damage and the preventable disability that results. Type 1 reactions are treated with oral corticosteroids and there are few data to support the optimal dose and duration of treatment. Type 1 reactions have a Th1 immune profile: cells in cutaneous and neural lesions expressing interferon-γ and interleukin-12. Methylprednisolone has been used in other Th1 mediated diseases such as rheumatoid arthritis in an attempt to switch off the immune response and so we investigated the efficacy of three days of high dose (1 g) intravenous methylprednisolone at the start of prednisolone therapy in leprosy Type 1 reactions and nerve function impairment.
  
  
  RESULTS
  Forty-two individuals were randomised to receive methylprednisolone followed by oral prednisolone (n = 20) or oral prednisolone alone (n = 22). There were no significant differences in the rate of adverse events or clinical improvement at the completion of the study. However individuals treated with methylprednisolone were less likely than those treated with prednisolone alone to experience deterioration in sensory function between day 29 and day 113 of the study. The study also demonstrated that 50% of individuals with Type 1 reactions and/or nerve function impairment required additional prednisolone despite treatment with 16 weeks of corticosteroids.
  
  
  CONCLUSIONS
  The study lends further support to the use of more prolonged courses of corticosteroid to treat Type 1 reactions and the investigation of risk factors for the recurrence of Type 1 reaction and nerve function impairment during and after a corticosteroid treatment.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN31894035.
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom. steve.walker@lshtm.ac.uk
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Walker
authors.forename: Peter G
authors.initials: PG
authors.lastname: Nicholls
authors.forename: Sushmita
authors.initials: S
authors.lastname: Dhakal
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Hawksworth
authors.forename: Murdo
authors.initials: M
authors.lastname: Macdonald
authors.forename: Kishori
authors.initials: K
authors.lastname: Mahat
authors.forename: Shudan
authors.initials: S
authors.lastname: Ruchal
authors.forename: Sushma
authors.initials: S
authors.lastname: Hamal
authors.forename: Deanna A
authors.initials: DA
authors.lastname: Hagge
authors.forename: Kapil D
authors.initials: KD
authors.lastname: Neupane
authors.forename: Diana N J
authors.initials: DN
authors.lastname: Lockwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007275:Injections, Intravenous; D007918:Leprosy / Q000150:complications*; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011239:Prednisolone; D008775:Methylprednisolone