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 |
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Authors: | Walker Stephen L Nicholls Peter G Dhakal Sushmita Hawksworth Rachel A Macdonald Murdo Mahat Kishori Ruchal Shudan Hamal Sushma Hagge Deanna A Neupane Kapil D Lockwood Diana N J |
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Institution: | 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 |
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Abstract: | BackgroundLeprosy 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.ResultsForty-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.ConclusionsThe 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.Trial RegistrationControlled-Trials.comISRCTN31894035 |
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