Journal article
Use of deception to achieve double-blinding in a clinical trial of Melaleuca alternifolia (tea tree) oil for the treatment of recurrent herpes labialis
Contemporary Clinical Trials, Vol.29(1), pp.9-12
2008
Abstract
Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers from identifying their treatment allocation. Volunteers received placebo (n = 102) or tea tree oil (n = 112) ointment in preparation for their next episode of RHL and were told, falsely, that the aroma of the ointments had been changed to prevent identification of the treatment group. At the trial's end, of the volunteers who had used their ointment and presented for treatment assessment (n = 100), approximately 50% correctly guessed their treatment allocation (P = 0.774). Amongst volunteers that had not presented for treatment assessment (n = 114), 12 volunteers did not provide blinding data and 46 did not open their tube. For the 56 volunteers who opened their tube, less than half of those receiving tea tree oil (44.4%) and only a small proportion of those on placebo (17.2%) were able to correctly identify their treatment allocation. Among the volunteers that were not treated, the P-value was 0.083. This study showed that the ethical use of deception may provide effective blinding in challenging circumstances.
Details
- Title
- Use of deception to achieve double-blinding in a clinical trial of Melaleuca alternifolia (tea tree) oil for the treatment of recurrent herpes labialis
- Authors/Creators
- C.F. Carson (Author/Creator)D.W. Smith (Author/Creator)G.J. Lampacher (Author/Creator)T.V. Riley (Author/Creator)
- Publication Details
- Contemporary Clinical Trials, Vol.29(1), pp.9-12
- Publisher
- Elsevier
- Identifiers
- 991005544299207891
- Copyright
- © 2007 Elsevier Inc.
- Murdoch Affiliation
- Murdoch University
- Language
- English
- Resource Type
- Journal article
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Source: InCites
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- Collaboration types
- Domestic collaboration
- Citation topics
- 3 Agriculture, Environment & Ecology
- 3.16 Phytochemicals
- 3.16.314 Essential Oil
- Web Of Science research areas
- Medicine, Research & Experimental
- Pharmacology & Pharmacy
- ESI research areas
- Clinical Medicine