Vehicle or Placebo? Investigators Use Incorrect Terminology in Randomized Controlled Trials Half of the Time: A Systematic Review of Randomized Controlled Trials Published in Three Major Dermatology Journals

October 2010 | Volume 9 | Issue 10 | Original Article | 1221 | Copyright © 2010

Norashikin Shamsudin MRC P and Alan B. Fleischer Jr. MD

Abstract

Background: A topical comparison in a randomized controlled trial (RCT) should correctly be termed a vehicle rather than a placebo as the vehicle in a dermatologic drug product enhances delivery and efficacy of the active compound. Objectives: To conduct a systematic review of RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology for correct classification of studies as vehicle versus placebo-controlled. Methods: RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology from January 1999 to November 2008 were identified through PubMed, supplemented by citation lists from the individual journals’ web pages. Only original studies that involved using a topical control or used the term topical “vehicle” or “placebo” were selected. The studies were examined for correct classification as vehicle-controlled, the year of publication, country of origin, sample size, funding source and nature of study center. Results: Out of 132, 64 (49%) correctly classified their studies as vehicle-controlled. Pharmaceutical-funded studies (55%, P=0.01) were significantly associated with the use of correct classification. Limitations: As only three peer-reviewed dermatology journals were studied, findings may not be generalized to other dermatology journals and other types of publications. Conclusion: This systematic review highlights a common pitfall in the reporting of studies of topical dermatology drugs.

Purchase Original Article

Purchase a single fully formatted PDF of the original manuscript as it was published in the JDD.

Download the original manuscript as it was published in the JDD.

Contact a member of the JDD Sales Team to request a quote or purchase bulk reprints, e-prints or international translation requests.

To get access to JDD's full-text articles and archives, upgrade here.

Save an unformatted copy of this article for on-screen viewing.

Print the full-text of article as it appears on the JDD site.

→ proceed | ↑ close

Related Articles