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Gangliosides for acute spinal cord injury

  1. Paul Chinnock*,
  2. Ian Roberts

Editorial Group: Cochrane Injuries Group

Published Online: 20 APR 2005

Assessed as up-to-date: 3 JUN 2008

DOI: 10.1002/14651858.CD004444.pub2


How to Cite

Chinnock P, Roberts I. Gangliosides for acute spinal cord injury. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD004444. DOI: 10.1002/14651858.CD004444.pub2.

Author Information

  1. London School of Hygiene & Tropical Medicine, Cochrane Injuries Group, London, UK

*Paul Chinnock, Cochrane Injuries Group, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. paul.chinnock@lshtm.ac.uk. paul_chinnock@btinternet.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 APR 2005

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Characteristics of included studies [ordered by study ID]
Geisler 1991

MethodsRandomised, placebo, double-blind trial.


Participants37 patients with spinal cord injury, either cervical or thoracic. Entry criteria excluded patients with no or minor neurological deficit and various other criteria; thus 314 other patients seen during the trial were not included.


InterventionsGM1 ganglioside, 100mg daily i.v., starting within 72 hours of injury. Number of doses varied between 18 and 32. Exact mode of administration varied slightly.


OutcomesThe following at one year:
1) Frankel grades (patients who improved two or three grades, but six excluded as their grade at entry was such that they did not have 'room to improve' by 2+ grades.
2) ASIA motor scores
3) all adverse effects.


Notes1) Allocation: each patient assigned the next sequential pre-randomised drug-study number.
2) Three patients (one treatment, two placebo) did not receive all the study doses for 'technical reasons'.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Geisler 2001

Methods'Prospective, double-blind, randomised, stratified, multicenter trial' . Stratification according to severity of injury and whether thoracic or cervical.


ParticipantsSCI patients: 3165 screened according to several eligibility criteria and 760 randomised. (A further 37 were randomised in error but no data is available on these patients).


Interventions1) 300mg loading dose of GM1 ganglioside ('Sygen') followed by 100mg/day for 56 days, plus MPSS [n=331].
2) 600mg loading dose of GM-1 ganglioside followed by 200mg/day for 56 days, plus MPSS [n=99].
3) Placebo plus MPSS [n=330].


OutcomesThe following at six months and one year:
1) mortality
2) patients considered to have made 'marked recovery'
3) motor and sensory scores
4) bowel and bladder function
5) safety.


Notes


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Walker 1993All patients had chronic (not acute) SCI.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Liu 2002

MethodsMulti-centre, double-blinded, parallel, randomised study.

Participants144 (72 in each group) patients with acute spinal cord injury aged between 12 and 70.

Interventions100mg of drug A (GM-1) for 14 days followed by 40mg of drug B (placebo) for 7 days [n=72].

OutcomesAfter 3 weeks and 3 months;
1) Ability to urinate and defecate,
2) Modified Benzel classification,
3) Changes in sensational responses (skin touch, skin prick, anus sensation).

Notes

 
Comparison 1. Mortality

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 All-cause mortality at 365 days2797Odds Ratio (M-H, Fixed, 95% CI)1.13 [0.61, 2.07]

 
Comparison 2. Adverse events

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Numbers of patients experiencing any kind of adverse effect(s)137Odds Ratio (M-H, Fixed, 95% CI)0.84 [0.05, 14.57]