Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue
syndrome is not effective and unsafe. Re-analysis of a Cochrane
review

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

The analysis of the 2017 Cochrane review reveals flaws, which means that contrary to its findings, there is no evidence that graded exercise therapy is effective. Because of the failure to report harms adequately in the trials covered by the review, it cannot be said that graded exercise therapy is safe. The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.

Related collections

Most cited references 66

Record: found
Abstract: found
Article: found

Is Open Access

Why clinical trial outcomes fail to translate into benefits for patients

Carl Heneghan, Ben Goldacre, Kamal R Mahtani (2017)

Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets. Trial outcomes can be developed with patients in mind, however, and can be reported completely, transparently and competently. Clinicians, patients, researchers and those who pay for health services are entitled to demand reliable evidence demonstrating whether interventions improve patient-relevant clinical outcomes.

0 comments Cited 142 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

Michael E. Wechsler, John M Kelley, Ingrid O.E. Boyd … (2011)

In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients' self-reported improvement ratings were recorded. Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients' reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.).

0 comments Cited 105 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: not found
Article: not found

A report--chronic fatigue syndrome: guidelines for research.

M C Sharpe, L Archard, J E Banatvala … (1991)

0 comments Cited 96 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): Health Psychol Open

Journal ID (iso-abbrev): Health Psychol Open

Journal ID (publisher-id): HPO

Journal ID (hwp): sphpo

Title: Health Psychology Open

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Electronic): 2055-1029

Publication date (Electronic): 08 October 2018

Publication date Collection: Jul-Dec 2018

Volume: 5

Issue: 2

Electronic Location Identifier: 2055102918805187

Affiliations

[1 ]Soerabaja Research Center, The Netherlands

[2 ]Independent Researcher, Germany

Author notes

[*]Mark Vink, Family and Insurance Physician, Soerabaja Research Center, 1096 HH Amsterdam, The Netherlands. Email: markvink.md@ 123456outlook.com

Article

Publisher ID: 10.1177_2055102918805187

DOI: 10.1177/2055102918805187

PMC ID: 6176540

PubMed ID: 30305916

SO-VID: ee87a566-e29e-4c67-b891-79fcec0fc1c3

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Custom metadata

cover-date July-December 2018

Keywords: chronic fatigue syndrome,cochrane review,graded exercise therapy,myalgic encephalomyelitis

Data availability:

Keywords: chronic fatigue syndrome, cochrane review, graded exercise therapy, myalgic encephalomyelitis

Comments

Comment on this article

scite_

Smart Citations

Citing PublicationsSupportingMentioningContrasting

View Citations

See how this article has been cited at scite.ai

scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.

Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review

Read this article at

Abstract

Related collections

Cures Within Reach: Autoimmune Lymphoproliferative Syndrome (ALPS)

Most cited references 66

Why clinical trial outcomes fail to translate into benefits for patients

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

A report--chronic fatigue syndrome: guidelines for research.

Author and article information

Journal

Affiliations

Author notes

Article

History

Categories

Custom metadata

Comments

Comment on this article

Similar content 366

Cited by 17

Most referenced authors 566