Methylprednisolone

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Satman et al, 19966331 children with type 1 diabetes who had a remission phase within 12 weeks of receiving multiple subcutaneous insulin injection
Mean age 11.7 ± 3.6 in intervention group, 11.8 ± 3.1 in control group (range 6–19 years)
Turkey
Methylprednisolone pulse therapy, 4 times a day on alternate days, dose of 30 mg/kg (maximum 1000 mg/day) by intravenous bolus in hospital (n = 20) (unknown duration of treatment)
versus
control group (n = 11)
Trial length: unknown
Outcomes looked at 12 months after treatment
  1. Remission period
  2. Duration of remission
  1. Complete remission: 4/16 vs. 1/11
    Partial remission: 9/16 vs. 1/11
    p < 0.01
  2. 6.6 ± 4.6 vs. 3.1 ± 2.3 months, p < 0.01
  3. 9.2 ± 3.6 vs. 10.5 ± 1.9%, p < 0.01
Control group did not accept methylprednisolone pulse, baseline characteristics were the same other than islet cell antibody assay
Unknown duration of methylprednisolone pulse therapy (? 2 days)
Controlled study without randomisationIIa
Yilmaz et al, 19936425 patients with type 1 diabetes
Mean age 23.8 ± 6.2 years in intervention group, 21.8 ± 8.9 years in control group (range 7–31 years)
Turkey
Oral methylprednisolone, dosage of 0.7–1.0 mg/kg/day for 2 weeks, dosage was tapered 5 mg/week, treated in hospital, overall continued for 17–12 weeks (n = 15)
versus
control group (n = 10)
Trial length: unknown
Outcomes looked at 12 months after treatment
  1. Clinical remission
  2. HbA1c at clinical remission
  3. Adverse effects
  1. 15/15 vs. 10/10
    Duration of remission in oral methylprednisolone group: 10/15 patients in non-insulin-requiring remission for a period of 16–91 months, 5/15 relapse after 3–15 months of therapy, control group: 3.4 ± 0.6 months, p < 0.001
  2. 6.7 ± 1.3 vs. 6.9 ± 1.1% (no significant difference)
  3. Adverse effects: acne (6/15), stress (4/15), fatigue (5/15), irritation of gastrointestinal tract (4/15), infection (2/15), weight loss (12/15), hyperglycaemia (12/15); weight loss and hyperglycaemia were reversed with administration of insulin
Control group did not accept oral methylprednisolone, baseline characteristics were the same
Unknown how many times intervention drug was used
Controlled study without randomisationIIa

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Collaborating Centre for Women’s and Children’s Health to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.