Meta AnalysisID 2831

肌苷治疗多发性硬化 [Cochrane方案]

CRD42017083037

To assess the effectiveness and safety of inosine to modify disease course and prognosis in people with multiple sclerosis.

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Record Fields

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Meta Analysis Id
2831
Evidence Id
11389
Core Evidence Id
11389
Source Meta Analysis Id
2774
Herb2 Meta Analysis Id
HBMA002774
Crd Id
CRD42017083037
Title
Inosine for multiple sclerosis [Cochrane protocol]
Review Question
To assess the effectiveness and safety of inosine to modify disease course and prognosis in people with multiple sclerosis.
Study Type Included
We will include all relevant randomised controlled trials (RCTs), irrespective of publication status or language. We will include data from the first phase of included cross-over trials.
Condition Being Studied
The Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group
Participant
People with a confirmed diagnosis of multiple sclerosis (MS) according to published criteria (<link ref=REF-McDonald-2001 type=REFERENCE/>McDonald 2001; <link ref=REF-Polman-2005 type=REFERENCE/>Polman 2005; <link ref=REF-Polman-2011 type=REFERENCE/>Polman 2011; <link ref=REF-Poser-1983 type=REFERENCE/>Poser 1983) regardless of age, sex, degree of disability, duration, type and course of the disease. All concomitant treatments will be accepted.
Animal
Human Disease Modelled
Intervention
We will evaluate trials independent of dosage, route of administration, frequency of administration and duration of treatment. Comparisons include: inosine versus placebo or no intervention; inosine plus approved treatments (such as beta interferon) versus placebo or no intervention plus approved treatments. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
Comparator Control
We will evaluate trials independent of dosage, route of administration, frequency of administration and duration of treatment. Comparisons include: inosine versus placebo or no intervention; inosine plus approved treatments (such as beta interferon) versus placebo or no intervention plus approved treatments. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
Main Outcome
<heading level=5>Benefit</heading><ol> The number of participants who experienced disability progression at one year and after, or at the end of the study. Disability progression is defined as a one-point increase in the Expanded Disability Status Scale (EDSS) score (<link ref=REF-Kurtzke-1983 type=REFERENCE/>Kurtzke 1983) (or a half-point increase for participants with a baseline score ≥ 5.5) confirmed in the absence of relapse. Other definitions of disability progression reported in the trials will be accepted. The number of participants experiencing at least one relapse at one year and after, or at the end of the study. Relapse is defined as the appearance of one or more new symptoms due to MS or the deterioration of pre-existing symptoms, persisting more than 24 hours in the absence of fever and preceded by a period of stability of at least 1 month (<link ref=REF-McDonald-2001 type=REFERENCE/>McDonald 2001). Definitions of relapse reported in the trials will be accepted.</ol><heading level=5>Safety profile</heading><ol> The number of participants experiencing serious adverse events (e.g. major haematological abnormalities) at one year and after, or at the end of the study. The number of participants who withdrew or dropped out from the study because of adverse events at one year and after, or at the end of the study.</ol>
Outcome Measure
Additional Outcome
<ol> The mean change in EDSS at one year and after, or at the end of the study. Annualised relapse rate (number of relapses per patient-year). Mean serum uric acid levels at one year and after, or at the end of the study. The number of gadolinium-enhancing T1-weighted lesions at one year and after, or at the end of the study. Quality of life assessed using any validated disease-specific or generic instruments at one year and after, or at the end of the study. The number of participants experiencing any adverse event at one year and after, or at the end of the study. The number of participants experiencing urinary tract stones or gout at one year and after, or at the end of the study. Definitions of urinary tract stones or gout reported in the trials will be accepted.</ol>
Study Method
Intervention, Systematic review
Keyword
Humans; Inosine; Multiple Sclerosis
Contact
Yi Yang [email protected]
Organisational Affiliation
The Cochrane Collaboration http://www.cochrane.org/
Funding Source
None None
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012772/abstract
Review Type
Language
English
Country
China
Review Stage
Review Ongoing
First Submission Date
Registration Date
2017-12-02
Anticipated Start Date
2017-08-15
Anticipated Completion Date
2018-02-20
Title Cn
肌苷治疗多发性硬化 [Cochrane方案]
Title En
Inosine for multiple sclerosis [Cochrane protocol]
Bilingual Status
complete