Ashwin Mathur1, Paul Jarrett2,3, Elizabeth Broadbent1, Keith J Petrie1. 1. Department of Psychological Medicine, University of Auckland, Auckland, New Zealand. 2. Department of Medicine, University of Auckland, Auckland, New Zealand. 3. Department of Dermatology, Middlemore Hospital, Auckland, New Zealand.
Abstract
Background: Open-label placebos are a novel treatment option, in which participants take placebos with full knowledge that they do not contain active medicine. Open-label placebo treatments have been shown to result in patient-reported symptom improvements, but they have not been tested on objectively measurable physiological outcomes such as wound healing. Purpose: The current study aimed to determine whether open-label placebos improved wound healing in punch biopsy wounds compared with no treatment. Methods: In a randomized controlled trial, 70 participants (mean age 27.6 ± 10.1, 58 female) were provided with information about the beneficial effects of placebos and given a 4 mm punch biopsy wound. Participants were then randomized to either an open-label placebo intervention (two placebo tablets twice a day for 10 days) or a no-treatment control group. Wounds were photographed at 7 days and 10 days to determine reepithelialization of the wound surface. Results: No significant differences were observed between the open-label placebo and control conditions in the percentage of wound area healed or for the number of participants with fully reepithelialized wounds at 7 days (placebo 7/32 wounds healed, control 10/33 wounds healed, (χ2[1, N = 65] = 0.60, p = .440, φ = 0.10) and 10 days after wounding (placebo 17/32, control 25/33 wounds healed (χ2[1, N = 65] = 3.64, p = .056, φ = 0.24). Conclusions: Open-label placebo treatment does not improve the healing rate of wounds. Open-label placebos may be beneficial for subjective patient-reported outcomes but do not influence wound healing. Australian New Zealand Clinical Trials Registration: ACTRN12616000411448.
RCT Entities:
Background: Open-label placebos are a novel treatment option, in which participants take placebos with full knowledge that they do not contain active medicine. Open-label placebo treatments have been shown to result in patient-reported symptom improvements, but they have not been tested on objectively measurable physiological outcomes such as wound healing. Purpose: The current study aimed to determine whether open-label placebos improved wound healing in punch biopsy wounds compared with no treatment. Methods: In a randomized controlled trial, 70 participants (mean age 27.6 ± 10.1, 58 female) were provided with information about the beneficial effects of placebos and given a 4 mm punch biopsy wound. Participants were then randomized to either an open-label placebo intervention (two placebo tablets twice a day for 10 days) or a no-treatment control group. Wounds were photographed at 7 days and 10 days to determine reepithelialization of the wound surface. Results: No significant differences were observed between the open-label placebo and control conditions in the percentage of wound area healed or for the number of participants with fully reepithelialized wounds at 7 days (placebo 7/32 wounds healed, control 10/33 wounds healed, (χ2[1, N = 65] = 0.60, p = .440, φ = 0.10) and 10 days after wounding (placebo 17/32, control 25/33 wounds healed (χ2[1, N = 65] = 3.64, p = .056, φ = 0.24). Conclusions: Open-label placebo treatment does not improve the healing rate of wounds. Open-label placebos may be beneficial for subjective patient-reported outcomes but do not influence wound healing. Australian New Zealand Clinical Trials Registration: ACTRN12616000411448.