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Meta-Analysis
. 2012 Dec 12;12(12):CD006921.
doi: 10.1002/14651858.CD006921.pub3.

Oral versus intravenous steroids for treatment of relapses in multiple sclerosis

Jodie M Burton  1 , Paul W O'Connor, Marika Hohol, Joseph Beyene
Affiliations
Meta-Analysis

Oral versus intravenous steroids for treatment of relapses in multiple sclerosis

Jodie M Burton et al. Cochrane Database Syst Rev. .

Abstract

Background: This is an updated Cochrane review of the previous version published (Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006921. DOI: 10.1002/14651858.CD006921.pub2).Multiple sclerosis (MS), a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS), is characterized by recurrent relapses of CNS inflammation ranging from mild to severely disabling. Relapses have long been treated with steroids to reduce inflammation and hasten recovery. However, the commonly used intravenous methylprednisolone (IVMP) requires repeated infusions with the added costs of homecare or hospitalization, and may interfere with daily responsibilities. Oral steroids have been used in place of intravenous steroids, with lower direct and indirect costs.

Objectives: The primary objective was to compare efficacy of oral versus intravenous steroids in promoting disability recovery in MS relapses <= six weeks. Secondary objectives included subsequent relapse rate, disability, ambulation, hospitalization, immunological markers, radiological markers, and quality of life.

Search methods: A literature search was performed using Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group's Trials Register (January 2012), abstracts from meetings of the American Academy of Neurology (2008-2012), the European Federation of Neurological Sciences (2008-2012), the European Committee for Treatment and Research in Multiple Sclerosis and American Committee for Treatment and Research in Multiple Sclerosis (2008-2012) handsearching. No language restrictions were applied.

Selection criteria: Randomized or quasi-randomized trials comparing oral versus intravenous steroids for acute relapses (<= six weeks) in patients with clinically definite MSover age 16 were eligible.

Data collection and analysis: Three review authors (JB, PO and MH) participated in the independent assessment of all published articles as potentially relevant to the review. Any disagreement was resolved by discussion among review authors.We contacted study authors for additional information.Methodological quality was assessed by the same three review authors. Relevant data were extracted, and effect size was reported as mean difference (MD), mean difference (MD), odds ratio (OR) and absolute risk difference (ARD).

Main results: With this current update, a total of five eligible studies (215 patients) were identified. Only one outcome, the proportion of patients with Expanded Disability Status Scale (EDSS) improvement at four weeks, was common to three trials, while two trials examined magnetic resonance imaging (MRI) outcomes. The results of this review shows there is no significant difference in relapse recovery at week four (MD -0.22, 95% confidence interval (95% CI), 0.71 to 0.26, P = 0.20) nor differences in magnetic resonance imaging (MRI) gadolinium enhancement activity based on oral versus intravenous steroid treatment. However, only two of the five studies employed more current and rigorous methodological techniques, so these results must be taken with some caution. The Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) trial and the "Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses" (COPOUSEP) trial, designed to address such limitations, are currently underway.

Authors' conclusions: The analysis of the five included trials comparing intravenous versus oral steroid therapy for MS relapses do not demonstrate any significant differences in clinical (benefits and adverse events), radiological or pharmacological outcomes. Based on the evidence, oral steroid therapy may be a practical and effective alternative to intravenous steroid therapy in the treatment of MS relapses.

PubMed Disclaimer

Conflict of interest statement

The authors have no conflict of interest to disclose.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Improvement in EDSS after treatment with oral vs. intravenous steroids, Outcome 1 Mean decrease in EDSS after steroid treatment at week 1.
1.2
1.2. Analysis
Comparison 1 Improvement in EDSS after treatment with oral vs. intravenous steroids, Outcome 2 Mean decrease in EDSS after steroid treatment at week 4.
2.1
2.1. Analysis
Comparison 2 Proportion of patients with improvement on EDSS after treatment with oral vs. intravenous steroids, Outcome 1 Proportion of patients with improvement on EDSS after steroid treatment at 4 weeks.
3.1
3.1. Analysis
Comparison 3 Change in Ambulation Index after treatment with oral vs. intravenous steroids, Outcome 1 Change in Ambulation Index at week 1 after treatment with oral vs. intravenous steroids.
3.2
3.2. Analysis
Comparison 3 Change in Ambulation Index after treatment with oral vs. intravenous steroids, Outcome 2 Change in Ambulation Index at week 4 after treatment with oral vs. intravenous steroids.
4.1
4.1. Analysis
Comparison 4 Longterm relapse rate after treatment with oral vs. intravenous steroids, Outcome 1 Relapse rate 6 months after treatment with oral vs. intravenous steroids.
4.2
4.2. Analysis
Comparison 4 Longterm relapse rate after treatment with oral vs. intravenous steroids, Outcome 2 Relapse rate at one year after treatment with oral vs. intravenous steroids.
4.3
4.3. Analysis
Comparison 4 Longterm relapse rate after treatment with oral vs. intravenous steroids, Outcome 3 Relapse rate at years 1‐2 after treatment with oral vs. intravenous steroids.
4.4
4.4. Analysis
Comparison 4 Longterm relapse rate after treatment with oral vs. intravenous steroids, Outcome 4 Relapse rate at two years after treatment with oral vs. intravenous steroids.
4.5
4.5. Analysis
Comparison 4 Longterm relapse rate after treatment with oral vs. intravenous steroids, Outcome 5 Proportion relapse free at 2 years after treatment with oral vs. intravenous steroids.
5.1
5.1. Analysis
Comparison 5 Days to next relapse after treatment with oral vs. intravenous steroids, Outcome 1 Mean number of days to next relapse after treatment with oral vs. intravenous steroids.
6.1
6.1. Analysis
Comparison 6 EDSS at first relapse after treatment with oral vs. intravenous steroids, Outcome 1 Mean change in EDSS at first relapse within 2 year period after treatment with oral vs. intravenous steroids.
7.1
7.1. Analysis
Comparison 7 Proportion hospitalized for relapse after treatment with oral vs. intravenous steroids, Outcome 1 Proportion hospitalized at week 1 after treatment with oral vs. intravenous steroids.
7.2
7.2. Analysis
Comparison 7 Proportion hospitalized for relapse after treatment with oral vs. intravenous steroids, Outcome 2 Proportino hospitalized at week 4 after treatment with oral vs. intravenous steroids.
8.1
8.1. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 1 Area under curve for steroid absorption at 1 hour with oral vs. intravenous steroids.
8.2
8.2. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 2 Area under curve for steroid absorption at 2 hours with oral vs. intravenous steroids.
8.3
8.3. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 3 Area under curve for steroid absorption at 4 hours with oral vs. intravenous steroids.
8.4
8.4. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 4 Area under curve for steroid absorption at 8 hours with oral vs. intravenous steroids.
8.5
8.5. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 5 Area under curve for steroid absorption at 8 hours with oral vs. intravenous steroids (SA, outlier removed).
8.6
8.6. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 6 Area under curve for steroid absorption at 24 hours with oral vs. intravenous steroids.
8.7
8.7. Analysis
Comparison 8 Bioavailability of oral vs. intravenous steroids, Outcome 7 Area under curve for steroid absorption at 48 hours with oral vs. intravenous steroids.
10.1
10.1. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 1 Mean percentage reduction in gadolinium lesions on MRI weeks 0‐1.
10.2
10.2. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 2 Mean percentage reduction in gadolinium positive MRI lesions weeks 0‐4.
10.3
10.3. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 3 Mean change in gadolinium enhancing lesions on MRI between weeks 0 and 1.
10.4
10.4. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 4 Mean change in gadolinium enhancing lesions on MRI between week 0 and 4.
10.5
10.5. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 5 Proportion with gadolinium enhancing lesions on MRI at week 1.
10.6
10.6. Analysis
Comparison 10 Changes in gadolinium enhancing lesions on MRI, Outcome 6 Proportion with gadolinium enhancing lesions at week 4.
11.1
11.1. Analysis
Comparison 11 Changes in T2 lesion number, Outcome 1 Mean change in T2 lesions at week 1 with respect to baseline in T2 lesion number between oral and iv.
11.2
11.2. Analysis
Comparison 11 Changes in T2 lesion number, Outcome 2 Mean change in T2 lesions at week 4 with respect to week 1.
12.1
12.1. Analysis
Comparison 12 Proportion with HTN, Outcome 1 Proportion with HTN.
13.1
13.1. Analysis
Comparison 13 Proportion with rash, Outcome 1 Proportion with rash.
14.1
14.1. Analysis
Comparison 14 Proportion with hypertricosis, Outcome 1 Proportion with hypertricosis.
15.1
15.1. Analysis
Comparison 15 Proportion with anxiety, Outcome 1 Proportion with anxiety.
16.1
16.1. Analysis
Comparison 16 Proportion with insomnia, Outcome 1 Proportion with insomnia.
17.1
17.1. Analysis
Comparison 17 Proportion with dysgeusia, Outcome 1 Proportion with dysgeusia.
18.1
18.1. Analysis
Comparison 18 Proportion with hiccups, Outcome 1 Proportion with hiccups.
19.1
19.1. Analysis
Comparison 19 Proportion with hyperglycemia, Outcome 1 Proportion with hyperglycemia.
20.1
20.1. Analysis
Comparison 20 Proportion with headache, Outcome 1 Proportion with headache.
21.1
21.1. Analysis
Comparison 21 Proportion with mood disturbance (euphoria, depression), Outcome 1 Proportion with mood disturbance.
22.1
22.1. Analysis
Comparison 22 Proportion with hot flashes/flushing, Outcome 1 Proportion with hot flashes.
23.1
23.1. Analysis
Comparison 23 Proportion with swelling, Outcome 1 Proportion with swelling.
24.1
24.1. Analysis
Comparison 24 Proportion with pirosis, Outcome 1 Proportion with pirosis.
See this image and copyright information in PMC

Update of

References

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Burton 2009
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