The full content of Annals is available to subscribers

Subscribe/Learn More  >
Original Research |

Reporting of Harm in Randomized, Controlled Trials of Nonpharmacologic Treatment for Rheumatic Disease

Morgane Ethgen, MSc; Isabelle Boutron, MD; Gabriel Baron, MSc; Bruno Giraudeau, PhD; Jean Sibilia, MD, PhD; and Philippe Ravaud, MD, PhD
[+] Article, Author, and Disclosure Information

From Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France; Hôpital Bretonneau, Tours, France; and Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe Hospitalier Bichat-Claude Bernard, and Université Paris VII, Paris, France.

Acknowledgments: The authors thank David Moher (Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, and University of Ottawa) for his comments and help in improving this report.

Grant Support: Dr. Boutron was supported by a grant from the Caisse Nationale d'Assurance Maladie des Professions Indépendantes and Assistance Publique des Hôpitaux de Paris.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Isabelle Boutron, MD, Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM U738, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 Paris Cedex 18, France; e-mail, isabelle.boutron@bch.ap-hop-paris.fr.

Current Author Addresses: Ms. Ethgen: Service de Rhumatologie, INSERM U738, Centre Hospitalier Universitaire de Hauptpierre, 1 Avenue Molière, 67098, Strasbourg, France.

Dr. Sibilia: Service de Rhumatologie, Centre Hospitalier Universitaire de Hautepierre, 1 Avenue Molière, 67098 Strasbourg, France.

Drs. Boutron and Ravaud and Mr. Baron: Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM U738, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 Paris, France.

Dr. Giraudeau: INSERM CIC 202, Hôpital Bretonneau, 2 boulevard Tonnelle, 37044 Tours CEDEX 9, France.

Author Contributions: Conception and design: M. Ethgen, I. Boutron, J. Sibilia, P. Ravaud.

Analysis and interpretation of the data: M. Ethgen, I. Boutron, G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Drafting of the article: M. Ethgen, I. Boutron.

Critical revision of the article for important intellectual content: G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Final approval of the article: M. Ethgen, I. Boutron, G. Baron, B. Giraudeau, J. Sibilia, P. Ravaud.

Provision of study materials or patients: M. Ethgen, I. Boutron.

Statistical expertise: G. Baron, B. Giraudeau.

Ann Intern Med. 2005;143(1):20-25. doi:10.7326/0003-4819-143-1-200507050-00006
Text Size: A A A

We assessed the reporting of harm in published randomized, controlled trials of pharmacologic and nonpharmacologic treatment for rheumatoid arthritis and hip or knee osteoarthritis during a 6-year period. Our results highlight that harm was described less in reports of nonpharmacologic treatment trials than in reports of pharmacologic treatment trials. These results remained true after adjustment for confounding factors and are consistent with those of a study of mental health interventions (6).

First Page Preview

View Large
First page PDF preview


Grahic Jump Location
Study screening process.

RA = rheumatoid arthritis; TENS = transcutaneous electrical nerve stimulation.

Grahic Jump Location




Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).


Submit a Comment/Letter
Submit a Comment/Letter

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.


Buy Now for $32.00

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Related Articles
Topic Collections
PubMed Articles
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.