Pain
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Randomized Controlled Trial
Is the rationale more important than deception? A randomized controlled trial of openlabel placebo analgesia.
Research on open-label placebos questions whether deception is a necessary characteristic of placebo effects. Yet, comparisons between open-label and deceptive placebos (DPs) are lacking. We therefore assessed effects of open-label placebos and DPs in comparison with no treatment (NT) with a standardized experimental heat pain paradigm in a randomized controlled trial in healthy participants. ⋯ Our findings reveal that placebos with a plausible rationale are more effective than without a rationale. Even more, open-label placebos did not significantly differ in their effects from DPs. Therefore, we question the ubiquitously assumed necessity of concealment in placebo administration.
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Randomized Controlled Trial
Emotional awareness and expression therapy, cognitive-behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial.
Patients with fibromyalgia (FM) experience increased lifetime levels of psychosocial adversity, trauma, and emotional conflict. To address these risk factors, we developed emotion awareness and expression therapy (EAET) and tested its benefits against an active control condition, FM education, and the field's gold standard intervention for FM, cognitive behavioral therapy (CBT) for symptom management. Adults with FM (N = 230) formed 40 treatment groups, which were randomized to EAET, CBT, or education and given 8, 90-minute sessions. ⋯ Emotional awareness and expression therapy did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and widespread pain (d = 0.37) and a higher percentage of patients achieving 50% pain reduction (22.5% vs 8.3%). In summary, an intervention targeting emotional awareness and expression related to psychosocial adversity and conflict was well received, more effective than a basic educational intervention, and had some advantages over CBT on pain. We conclude that EAET should be considered as an additional treatment option for FM.