Clinical trial participants who were deliberately misled for the purpose of scientific inquiry still held a positive attitude toward the process after being debriefed, results from a small study in fibromyalgia patients and healthy people show.
Participants found the debriefing process — which explained how and why they were misled — to be helpful and worthwhile, and thus remain positive about taking part in future placebo-controlled clinical trials.
The study titled, “Attitudes and Perceptions Toward Authorized Deception: A Pilot Comparison of Healthy Controls and Fibromyalgia Patients,” was published in the journal Pain Medicine.
Clinical trials designed to assess the safety and efficacy of a new treatment generally include an experimental group, which receives the therapy being tested, and a control group, which gets a placebo.
However, the participants in these studies usually are “blinded,” meaning they are not informed as to whether they are receiving the experimental therapy or the placebo.
Recent studies have shown positive outcomes from open-label placebo treatments, in which patients are informed that they are receiving placebo instead of being deceived. However, deception in placebo studies is still widely used, and has led to many important findings.
“When the entirety of a study is not truthfully disclosed, the potential participant lacks information that may affect their decision about participating in the research study, which negates the process of making informed decisions,” the researchers said.
However, “[u]ntil there is better evidence that deception is not needed to create a full placebo response, studies of the placebo effect will continue to use deception,” they said.
Little is known about participants’ experiences and perceptions in regard to being deceived in these clinical trials.
To learn more, the investigators conducted a pilot study to measure perceptions about participation in an authorized-deception placebo trial in a group of chronic pain patients with fibromyalgia. The researchers also assessed whether the perceptions of people with the disease differed as compared with those of the healthy trial participants.
This study is part of a larger, parent study conducted prior to this one. The parent study was designed to determine whether placebo can induce a different pain-relieving response in fibromyalgia patients compared with healthy controls.
As part of the earlier study, researchers told participants they would apply a pain-relieving cream (placebo) on one small area of their legs, and a moisturizing cream (control) on the other. Next, they paired the control cream with a painfully hot stimulus, while the placebo cream was paired with a temperature stimulus 2°C lower than the control stimulus. Thus, participants believed that they experienced less pain with the placebo cream.
This was repeated in a second session, which took place in an MRI scanner. The participants then were asked to rate the intensity and unpleasantness of their pain after the heat stimulus.
After the completion of the parent study, participants were contacted via telephone for the debriefing process by the nurses who were involved in the study. After the debriefing, which included an explanation about how the participants were misled and why it was necessary for the study, the participants were asked if they would be willing to complete an anonymous survey.
This anonymous survey, mailed to all participants, questioned them about their trust in research, and their willingness to participate in future studies that involve deception.
Of the 64 participants who were debriefed and willing to take the survey, 48 — 16 with fibromyalgia, 31 healthy controls, and one in an unknown group — completed and returned it for evaluation.
Results indicated that the majority of the participants had little or no concern about being deceived, and still held trust in the scientific process. Most found the debriefing procedure helpful and worthwhile. No differences were found between the two groups, as 77.4% of the healthy participants, and 75% of the fibromyalgia patients, reported not being bothered at all by the deception.
Researchers then evaluated whether the particpants’ willingness to join in the parent study would have changed had the deceptive element been disclosed in advance. Interestingly, healthy controls said they would “definitely” participate, while the fibromyalgia patients said they would “probably” participate.
Next, researchers evaluated the willingness of participants to be a part of future studies. Again, healthy controls said that they would “definitely” participate, while fibromyalgia patients said they would “probably” participate. Altogether, “91.5% of respondents reported that they would probably (21.3%) or definitely (70.2%) participate in future research studies,” the investigators said.
“To our knowledge, this is the first study that has examined the impact of an authorized deception approach in a placebo analgesia study that included healthy participants and participants suffering from fibromyalgia,” they added.
“Despite slightly less favorable responses of fibromyalgia patients and the relatively small size of the study, these findings suggest that attitudes and perceptions about participating in an authorized placebo study remain positive in both healthy and chronic pain populations,” the researchers concluded.
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