The impact of blinding on the results of a randomized, placebo‐controlled multiple sclerosis clinical trial

  title={The impact of blinding on the results of a randomized, placebo‐controlled multiple sclerosis clinical trial},
  author={J. Noseworthy and G. Ebers and M. Vandervoort and R. Farquhar and E. Yetisir and R. Roberts},
  pages={16 - 16}
In the randomized, placebo-controlled, physician-blinded Canadian cooperative trial of cyclophosphamide and plasma exchange, neither active treatment regimens (group I: IV cyclophosphamide and prednisone; group II: weekly plasma exchange, oral cyclophosphamide, and prednisone) were superior to placebo (group III: sham plasma exchange and placebo medications) using the blinded, evaluating neurologists' assessments of disease course (primary analysis). All patients were examined by both a blinded… Expand
Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome
It is suggested that mitoxantrone might be effective in reducing disease activity, both by decreasing the mean number of exacerbations and by slowing the clinical progression sustained by most patients after 1 year from the end of treatment. Expand
Can knowledge of Placebo and Nocebo Mechanisms Help Improve Randomized Clinical Trials?
The placebo-mechanism literature is used to debate the strengths and weaknesses of attempts to identify and exclude placebo responders from trials, including the uncertainties of the active arm, the placebo arms, the additivity assumption, and the double-blind procedure. Expand
Randomized controlled trials to assess therapies for multiple sclerosis
There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage. Expand
Meta‐analysis of clinical studies of the efficacy of plasma exchange in the treatment of chronic progressive multiple sclerosis
There is a need for further clinical research into the possibility of a beneficial effect of TPEX in patients with CPMS likely to experience neurologic decline over the ensuring 12 months, and targeting treatment to a particular subgroup of CPMS patients may be necessary. Expand
An open‐trial evaluation of mitoxantrone in the treatment of progressive MS
This small, open-labeled pilot study did not provide strong support for proceeding with a randomized, controlled trial of this dosage regimen of mitoxantrone in patients with progressive MS, and comparison with two historical control groups does not suggest that mitoxanrone was efficacious. Expand
Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials.
Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials. Expand
Blinded Outcome Assessment Was Infrequently Used and Poorly Reported in Open Trials
Blinding of outcome assessors is infrequently used and poorly reported, and increased use of independent assessors could increase the frequency of blinded assessment. Expand
Placebo controlled trials in neuromyelitis optica are needed and ethical.
  • B. Cree
  • Medicine
  • Multiple sclerosis and related disorders
  • 2015
The case for clinical equipoise in NMO is outlined by addressing the uncertainty regarding the relative scientific and clinical merits of current empirically used treatments and showing that a placebo arm is consistent with competent medical care. Expand
MRI findings in blinded trials should be available to treating physicians – No
It is argued that providing treating physicians access to MRI results is both unnecessary and inadvisable. Expand
Assessment of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex®) in people with multiple sclerosis: a new approach
There is no evidence to suggest that there was widespread unblinding to treatment allocation in these three studies of Sativex and Placebo, and this methodology may be suitable for assessment of the integrity of the blind in other randomized clinical trials. Expand


Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH.
Fifty-eight patients with severe, progressive multiple sclerosis were prospectively randomized to one of three treatments: 20 received intravenous ACTH, 20 received high-dose intravenousExpand
Chronic progressive multiple sclerosis
Fifty-four patients with chronic progressive multiple sclerosis received prednisone plus oral low-dose cyclophosphamide and either true plasmapheresis (PP) or “sham” PP weekly for 20 weeks in aExpand
Double blind: double talk or are there ways to do better research.
The patient's and the observer's awareness of changes as useful information to obtain: a guess factor, the percentage of correct guesses whether the patient is on medication or placebo; a direction factor,Whether the patient considers the change beneficial or detrimental; an attributional factor, whether the change is considered to result from medication or other intervening variables. Expand
Reporting standards and research strategies for controlled trials
Abstract From a study in Part I of many papers using controlled clinical trials in cancer research, we summarize quantitatively the frequency of reporting important statistical and proceduralExpand
Rating neurologic impairment in multiple sclerosis
A new Expanded Disability Status Scale (EDSS) is presented, with each of the former steps (1,2,3 … 9) now divided into two (1.0, 1.5, 2.0 … 9). Expand
A generalized Kruskal-Wallis test for comparing K samples subject to unequal patterns of censorship
SUMMARY A generalization of the Kruskal-Wallis test, which extends Gehan's generalization of Wilcoxon's test, is proposed for testing the equality of K continuous distribution functions whenExpand
Cyclophosphamide and plasma exchange in multiple selerosis [letter
  • Lancet
  • 1991
A method for assessing t h e quality of a randomized control trial
  • Controlled Clin Trials
  • 1981