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
Publication Date
April 12, 2011
Journal
PLOS Neglected Tropical Diseases
Authors
Stephen L. Walker, Peter G. Nicholls, Sushmita Dhakal, Rachel A. Hawksworth, et al
Volume
5
Issue
4
Pages
e1041
DOI
https://dx.plos.org/10.1371/journal.pntd.0001041
Publisher URL
http://journals.plos.org/plosntds/article?id=10.1371%2Fjournal.pntd.0001041
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/21532737
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3075223
Europe PMC
http://europepmc.org/abstract/MED/21532737
Web of Science
000289937400022
Scopus
79955810298
Mendeley
http://www.mendeley.com/research/phase-two-randomised-controlled-double-blind-trial-high-dose-intravenous-methylprednisolone-oral-pre
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Mendeley | Further Information

{"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", "type"=>"journal", "authors"=>[{"first_name"=>"Stephen L.", "last_name"=>"Walker", "scopus_author_id"=>"7403746154"}, {"first_name"=>"Peter G.", "last_name"=>"Nicholls", "scopus_author_id"=>"35367766100"}, {"first_name"=>"Sushmita", "last_name"=>"Dhakal", "scopus_author_id"=>"39061178000"}, {"first_name"=>"Rachel A.", "last_name"=>"Hawksworth", "scopus_author_id"=>"22734152200"}, {"first_name"=>"Murdo", "last_name"=>"Macdonald", "scopus_author_id"=>"55543638500"}, {"first_name"=>"Kishori", "last_name"=>"Mahat", "scopus_author_id"=>"23492934200"}, {"first_name"=>"Shudan", "last_name"=>"Ruchal", "scopus_author_id"=>"7801640517"}, {"first_name"=>"Sushma", "last_name"=>"Hamal", "scopus_author_id"=>"39061191300"}, {"first_name"=>"Deanna A.", "last_name"=>"Hagge", "scopus_author_id"=>"6506609083"}, {"first_name"=>"Kapil D.", "last_name"=>"Neupane", "scopus_author_id"=>"6507131035"}, {"first_name"=>"Diana N J", "last_name"=>"Lockwood", "scopus_author_id"=>"55543771700"}], "year"=>2011, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"issn"=>"19352727", "scopus"=>"2-s2.0-79955810298", "sgr"=>"79955810298", "pui"=>"361746055", "isbn"=>"1935-2735 (Electronic) 1935-2727 (Linking)", "pmid"=>"21532737", "doi"=>"10.1371/journal.pntd.0001041"}, "id"=>"8d4892fb-92cc-3915-b146-6d7c3f46cdd2", "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.\\n\\nRESULTS: 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.\\n\\nCONCLUSIONS: 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.\\n\\nTRIAL REGISTRATION: Controlled-Trials.com ISRCTN31894035.", "link"=>"http://www.mendeley.com/research/phase-two-randomised-controlled-double-blind-trial-high-dose-intravenous-methylprednisolone-oral-pre", "reader_count"=>28, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>2, "Student > Master"=>6, "Other"=>2, "Student > Bachelor"=>2, "Unspecified"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>2, "Student > Master"=>6, "Other"=>2, "Student > Bachelor"=>2, "Unspecified"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Medicine and Dentistry"=>17, "Agricultural and Biological Sciences"=>5, "Social Sciences"=>1, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>17}, "Social Sciences"=>{"Social Sciences"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Unspecified"=>{"Unspecified"=>4}}, "reader_count_by_country"=>{"Brazil"=>1}, "group_count"=>1}

Scopus | Further Information

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/784687"], "description"=>"<p>(The vertical broken line is placed at day 113).</p>", "links"=>[], "tags"=>["adverse"], "article_id"=>455049, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.g002", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_to_first_adverse_event_/455049", "title"=>"Time to first adverse event.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-04-12 01:24:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/785167"], "description"=>"<p>Minor and major adverse events.</p>", "links"=>[], "tags"=>["adverse"], "article_id"=>455530, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.t002", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Minor_and_major_adverse_events_/455530", "title"=>"Minor and major adverse events.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-04-12 01:32:10"}
  • {"files"=>["https://ndownloader.figshare.com/files/784551"], "description"=>"<p>CONSORT flow diagram for the pilot study of individuals randomized to\n either intravenous methylprednisolone and oral prednisolone or oral\n prednisolone alone.</p>", "links"=>[], "tags"=>["diagram", "individuals", "randomized", "to", "intravenous", "methylprednisolone", "prednisolone", "oral"], "article_id"=>454897, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.g001", "stats"=>{"downloads"=>0, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_flow_diagram_for_the_pilot_study_of_individuals_randomized_to____either_intravenous_methylprednisolone_and_oral_prednisolone_or_oral____prednisolone_alone_/454897", "title"=>"CONSORT flow diagram for the pilot study of individuals randomized to\n either intravenous methylprednisolone and oral prednisolone or oral\n prednisolone alone.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-04-12 01:21:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/784924"], "description"=>"<p>Time to deterioration of sensory function.</p>", "links"=>[], "tags"=>["deterioration", "sensory"], "article_id"=>455286, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.g004", "stats"=>{"downloads"=>1, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_to_deterioration_of_sensory_function_/455286", "title"=>"Time to deterioration of sensory function.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-04-12 01:28:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/393304", "https://ndownloader.figshare.com/files/393374"], "description"=>"<div><h3>Background</h3><p>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.</p> <h3>Results</h3><p>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.</p> <h3>Conclusions</h3><p>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.</p> <h3>Trial Registration</h3><p>Controlled-Trials.com<a href=\"http://www.controlled-trials.com/ISRCTN31894035\">ISRCTN31894035</a></p> </div>", "links"=>[], "tags"=>["randomised", "controlled", "dose", "intravenous", "methylprednisolone", "prednisolone", "normal", "saline", "individuals", "leprosy", "reactions", "impairment"], "article_id"=>137657, "categories"=>["Cancer", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0001041.s001", "https://dx.doi.org/10.1371/journal.pntd.0001041.s002"], "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/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_Impairme/137657", "title"=>"A Phase Two Randomised Controlled Double Blind Trial of High Dose\n Intravenous Methylprednisolone and Oral Prednisolone versus Intravenous Normal\n Saline and Oral Prednisolone in Individuals with Leprosy Type 1 Reactions and/or\n Nerve Function Impairment", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-04-12 02:07:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/785021"], "description"=>"<p>Time to requiring first course of additional prednisolone.</p>", "links"=>[], "tags"=>["requiring"], "article_id"=>455386, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.g005", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_to_requiring_first_course_of_additional_prednisolone_/455386", "title"=>"Time to requiring first course of additional prednisolone.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-04-12 01:29:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/784821"], "description"=>"<p>Total severity score at days 1, 4, 29, 113, 337 (Circles denote\n individuals 1.5 times the interquartile range (IQR) outside the box and\n asterisks denote individuals 3 times the IQR outside the box).</p>", "links"=>[], "tags"=>["severity", "days", "337", "denote", "individuals", "times", "interquartile", "and", "asterisks", "denote", "iqr"], "article_id"=>455164, "categories"=>["Infectious Diseases", "Medicine"], "users"=>["Stephen L. Walker", "Peter G. Nicholls", "Sushmita Dhakal", "Rachel A. Hawksworth", "Murdo Macdonald", "Kishori Mahat", "Shudan Ruchal", "Sushma Hamal", "Deanna A. Hagge", "Kapil D. Neupane", "Diana N. J. Lockwood"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0001041.g003", "stats"=>{"downloads"=>0, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Total_severity_score_at_days_1_4_29_113_337_Circles_denote____individuals_1_5_times_the_interquartile_range_IQR_outside_the_box_and____asterisks_denote_individuals_3_times_the_IQR_outside_the_box_/455164", "title"=>"Total severity score at days 1, 4, 29, 113, 337 (Circles denote\n individuals 1.5 times the interquartile range (IQR) outside the box and\n asterisks denote individuals 3 times the IQR outside the box).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-04-12 01:26:04"}

PMC Usage Stats | Further Information

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Relative Metric

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