ISSN:0251-5350    

DOI:10.1159/000110094

出版商:S. Karger AG    

年代:1987

数据来源: Karger

ISSN:0251-5350    

DOI:10.1159/000110095

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

The problems of organising clinical trials in MS include the general aspects relating to clinical trials in any discipline but extend also to specific problems arising in the assessment of a relapsing remitting condition. These factors relating to the clinical characteristics of the disease, the diagnosis, the selection of patients and the methods of clinical and laboratory assessment are described and discussed. Suggestions are made for the use of internationally accepted diagnostic criteria for MS and a review is made of the other recognised problems in this field.

ISSN:0251-5350    

DOI:10.1159/000110096

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

In MS only the results of a properly randomized, double-blind, placebo-controlled trial can provide adequate evidence of efficacy. When therapy cannot be blinded one can conclude only that a therapeutic regimen which includes the test agent or procedure differs from one without it, but not that the difference is necessarily due to the agent. Measure of treatment effect in MS requires a standardized schema of assessing neurologic dysfunction due to the disease as the criterion for change (better, same, worse). Quantitation of impairment as measured by such scales can be compared between regimens only by means of nonparametric statistical tests, since no scale in use is a true numerical (equal-interval, additive, multiplicative) scale. The specific scale employed is not irrelevant; in the ACTH study of acute bouts the agent was concluded only to ‘hasten improvement’ with one scale, but to be an effective treatment with anot

ISSN:0251-5350    

DOI:10.1159/000110097

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

Since there is no treatment of proven value in patients with MS it is necessary still to select those patients for inclusion in clinical trials who have most to gain and can demonstrate rapidly the effectiveness or not of each new treatment. Experience gained in these trials can be then extrapolated to the disease as a whole.

ISSN:0251-5350    

DOI:10.1159/000110098

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

A review has been performed of the trials of steroids in MS published between 1958 and 1970. None of the trials concerned with the long-term treatment of the disease, whether with ACTH or oral steroids, revealed any benefit. Some advantage of steroids over placebo in accelerating the recovery of acute exacerbations can be claimed, though in no study has the gain been substantial.

ISSN:0251-5350    

DOI:10.1159/000110099

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

At present many trials appear to be using subjective data, but using these data in an unsystematic and inappropriate way. In this context it is not surprising that subjective measures have a generally low status amongst investigators in clinical trials in MS. A more careful approach to such subjective measures would enable trials to take into account a significantly wider range of features. Controlled trials can then act as an important psychosocial as well as biomedical laboratory in the understanding of MS.

ISSN:0251-5350    

DOI:10.1159/000110100

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

The paper describes a number of methodological problems experienced in a long-term evaluation of hyperbaric treatment for MS. Among the problems discussed are those relating to the locus and logistics of assessment, the reliability of ‘subjective’ assessments, the feasibility of ‘objective’ measurements, the identification of outcome categories and patient drop-out and sele

ISSN:0251-5350    

DOI:10.1159/000110101

出版商:S. Karger AG    

年代:1987

数据来源: Karger

摘要:

The design and course of a placebo-controlled alpha-2 interferon trial in MS patients are described. No beneficial effect of the interferon on the course of MS could be shown.

ISSN:0251-5350    

DOI:10.1159/000110102

出版商:S. Karger AG    

年代:1987

数据来源: Karger