None listed
Conditions
Brief summary
Aim: The aim of the study is to establish if wound healing is faster for participants taking open-label placebo pills (i.e. known by the participant to be pharmacologically inert) than participants taking no treatment for their wound healing. Hypothesis: Photographs of a 4 mm diameter punch biopsy wound in the inner arm will show a greater area of re-epithelialisation at 7 days and 10 days after wounding for participants using daily open placebo treatment than participants using no treatment. Summary of the project: Placebo treatment can be effective for subjective complaints (Miller, Colloca, & Kaptchuk, 2009) and also results in physiological changes (Finniss et al., 2010), suggesting that it may be an effective treatment option for some people. However, it is currently unethical to prescribe placebo treatment, as this typically requires deception of patients, undermining the principle of informed consent. This study aims to establish whether open placebo treatment (i.e. placebo administration without deception, where participants are aware that they are taking placebos) is effective for wound healing, which would allow patients to benefit from harnessing placebo effects with full informed consent. Wound healing rates can be affected by psychosocial factors such as stress (Walburn et al., 2009), and psychosocial interventions can improve wound healing rates (Broadbent et al., 2012; Koschwanez et al., 2013). This means that a psychologically-based treatment such as placebo may affect wound healing rates through mechanisms such as expectation of improvement or conditioned physiological effects from ingesting medication (Benedetti & Amanzio, 2013). Kaptchuk et al. (2010) demonstrated that open placebo treatment was effective for improving symptoms and functioning for participants with Irritable Bowel Syndrome, setting a precedent for the use of open placebo treatment to improve participant outcomes. Given these results, it is worth investigating whether open placebo is effective in improving wound healing rates in healthy participants.
Interventions
The initial meeting with the study dermatologist will use a scripted introduction to the placebo effect to establish an expectation that placebo administration will be effective. In summary the script describes the following information: The placebo effect is any type of treatment – in this case, a pill – that doesn’t actually contain any drugs or active ingredients. The scientific evidence shows the placebo effect is powerful for conditions like pain and headaches, and previous research has dem
The initial meeting with the study dermatologist will use a scripted introduction to the placebo effect to establish an expectation that placebo administration will be effective. In summary the script describes the following information: The placebo effect is any type of treatment – in this case, a pill – that doesn’t actually contain any drugs or active ingredients. The scientific evidence shows the placebo effect is powerful for conditions like pain and headaches, and previous research has demonstrated that open placebo administration (with participants knowing they were taking placebos) was beneficial for physical health outcomes. This may be because the body is conditioned to respond to taking medications, or because taking the pills increases expectations of an effect. As the brain and immune system are highly interconnected, placebos can affect immune functioning and therefore wound healing. Psychological factors have been shown to affect wound healing in previous research, so it is plausible that expecting benefits through taking placebos would enhance healing. After this introduction and a final consent form for the wounding procedure, the dermatologist will make the punch biopsy wound. The procedure involves creating a 4 mm punch biopsy wound 7 cm superior to the medial epicondyle of the inner upper arm (the participant chooses which arm), delivered under local anaesthetic and covered with a hydrocolloid dressing and an additional opsite dressing. This wound will be cleaned and the dressing changed at 7 days post-wounding, and again at 10 days. Treatment will consist of placebo tablets containing lactose monohydrate, microcrystalline cellulose and magnesium stearate as the only 3 ingredients, Participants will be aware that they are receiving inert placebo tablets without active ingredients. Dosage will be two tablets twice per day, starting on the evening of the wounding procedure and continuing daily until the morning of the 10th day after wounding, which is the day the final measures will be taken. Adherence will be measured with a self-report item on the final questionnaire administered at 10 days post-wounding.
Sponsors
University of Auckland Masters Programme Funding
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy participants who are able to understand and write in English.
Exclusion criteria
Participants will be excluded if they smoke, have medical conditions that would affect wound healing (e.g. eczema, psoriasis, anemia, diabetes, etc.), regular use of other treatments affecting wound healing (e.g. anticoagulants, non-steroidal anti-inflammatories), or any surgery or tattoos within the last 30 days.
Outcome results
None listed