Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.
Department of Medicine, University of Auckland, Auckland, New Zealand.
Ann Behav Med. 2018 Sep 13;52(10):902-908. doi: 10.1093/abm/kax057.
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.
The current study aimed to determine whether open-label placebos improved wound healing in punch biopsy wounds compared with no treatment.
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.
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).
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.
ACTRN12616000411448.
开放性安慰剂是一种新的治疗选择，参与者完全了解他们服用的安慰剂不含有活性药物。开放性安慰剂治疗已被证明可导致患者报告的症状改善，但尚未在可客观测量的生理结果（如伤口愈合）上进行测试。
本研究旨在确定与无治疗相比，开放性安慰剂是否能改善打孔活检伤口的愈合。
在一项随机对照试验中，70 名参与者（平均年龄 27.6 ± 10.1，58 名女性）获得了安慰剂有益效果的信息，并接受了 4 毫米打孔活检伤口。然后，参与者被随机分配到开放性安慰剂干预组（每天两次服用两片安慰剂，持续 10 天）或无治疗对照组。在第 7 天和第 10 天拍摄伤口照片，以确定伤口表面的再上皮化情况。
在第 7 天和第 10 天，开放性安慰剂和对照组在伤口面积愈合百分比或完全再上皮化的参与者人数方面均无显著差异（安慰剂组 7/32 个伤口愈合，对照组 10/33 个伤口愈合，（χ2[1，N = 65] = 0.60，p =.440，φ = 0.10）和受伤后 10 天（安慰剂组 17/32，对照组 25/33 个伤口愈合（χ2[1，N = 65] = 3.64，p =.056，φ = 0.24）。
开放性安慰剂治疗并不能提高伤口愈合率。开放性安慰剂可能对主观患者报告的结果有益，但不会影响伤口愈合。
ACTRN12616000411448。
