4th March 10:04
Intravenous immunoglobulins for multiple (multiple sclerosis magnetic resonance imaging demyelination)
Intravenous immunoglobulins for multiple sclerosis (Cochrane Review)
Gray OM, McDonnell GV, Forbes RB.
A substantive amendment to this systematic review was last made on 14
Cochrane reviews are regularly checked and updated if necessary.
Background: From animal experiments, there is evidence to suggest that
intravenous immunoglobulins can reverse some of the disease process of
central nervous system demyelination. Subsequently, clinical trials of
intravenous immunoglobulins have been conducted in people with
multiple sclerosis (MS).
Objectives: To identify and summarise the evidence that intravenous
immunoglobulins are safe and beneficial for people with MS.
Search strategy: We searched the Cochrane Multiple Sclerosis Group
trials Register( January 2003) The Cochrane Central Register of
Controlled Trials (The Cochrane Library issue 4, 2002), MEDLINE
(January 1966 to April 2001), EMBASE (January 1988 to April 2001) and
reference lists of articles. We also contacted relevant pharmaceutical
companies and authors of identified trials.
Selection criteria: Randomised controlled trials of intravenous
immunoglobulins for the secondary prevention of relapses and disease
progression in MS.
Data collection and ****ysis: 913 titles and abstracts were obtained
from the literature search, and we eventually identified 10 clinical
trials. All reviewers agreed on the final dataset for entry into
RevMan 4.1, and summarised the results. Study authors were contacted
for additional information but no response was obtained.
Main results: Of 913 potential studies, 10 trials were identified with
a total of 918 participants, four of which are in progress or awaiting
publication. The remaining six trials were suitable for consideration
by this review (344 participants). Only two trials met our protocol's
inclusion criteria. The four remaining trials were excluded as they
did not use outcome measures specified in our review (2 trials, 122
participants), or were of insufficient methodological quality (2
trials, 34 participants). From the two included trials (168
participants) there was a reduction in relapse rate and increased time
to first relapse during treatment with intravenous immunoglobulins,
but reliable disease progression outcomes were not reported, nor were
magnetic resonance imaging (MRI) data available to support clinical
information. There may be as many as 574 participants in ongoing or
yet to be published trials.
Reviewers' conclusions: There is some evidence to support use of
intravenous immunoglobulins as a preventative treatment for relapses
in relapsing remitting MS, but further studies should be performed
using MRI and disease progression endpoints. It may be possible to
draw more robust conclusions when ongoing or recently completed trials
make their data available for review. Two rigorously conducted trials
with a total of 122 participants did not demonstrate a positive
clinical benefit, but were excluded from this review as they employed
outcome measures not specified in our protocol. Immunoglobulins were
well tolerated with a less than 5% risk of adverse events in
participants in included trials.
Citation: Gray OM, McDonnell GV, Forbes RB.. Intravenous
immunoglobulins for multiple sclerosis (Cochrane Methodology Review).
In: The Cochrane Library, Issue 4, 2003. Chichester, UK: John Wiley &