Abstract
The aims of this study were to determine whether placebo treatment in randomised controlled trials (RCTs) is effective for fibromyalgia and to identify possible determinants of the magnitude of any such placebo effect. A systematic literature search was undertaken for RCTs in people with fibromyalgia that included a placebo and/or a no-treatment (observation only or waiting list) control group. Placebo effect size (ES) for pain and other outcomes was measured as the improvement of each outcome from baseline divided by the standard deviation of the change from baseline. This effect was compared with changes in the no-treatment control groups. Meta-analysis was undertaken to combine data from different studies. Subgroup analysis was conducted to identify possible determinants of the placebo ES. A total of 3912 studies were identified from the literature search. After scrutiny, 229 trials met the inclusion criteria. Participants who received placebo in the RCTs experienced significantly better improvements in pain, fatigue, sleep quality, physical function, and other main outcomes than those receiving no treatment. The ES of placebo for pain relief was clinically moderate (0.53, 95%CI 0.48 to 0.57). The ES increased with increasing strength of the active treatment, increasing participant age and higher baseline pain severity, but decreased in RCTS with more women and with longer duration of fibromyalgia. In addition, placebo treatment in RCTs is effective in fibromyalgia. A number of factors (expected strength of treatment, age, gender, disease duration) appear to influence the magnitude of the placebo effect in this condition.
Highlights
Fibromyalgia (FM) is a common chronic multiple regional pain syndrome, affecting approximately 2% of people in the general population [1]
3912 citations were retrieved from all databases
The literature search identified over 200 placebocontrolled trials examining a wide range of different treatments for FM including drugs, physical interventions such as exercise and balneotherapy, psychological treatments such as CBT, and complementary therapies such as homeopathy and acupuncture
Summary
Fibromyalgia (FM) is a common chronic multiple regional pain syndrome, affecting approximately 2% of people in the general population [1]. The main symptoms of fibromyalgia include widespread pain, fatigue, non-restorative sleep, and cognitive impairment [4]. Treatments for fibromyalgia include non-pharmacologic therapies such as patient education, aerobic exercise, acupuncture and cognitive behavioural therapy, and pharmacologic therapies such as analgesics and anti-depressants. Placebo has been proved to be effective in many conditions such as depression [5] chronic fatigue syndrome [6], Parkinson’s disease [7], irritable bowel syndrome [8] and osteoarthritis (OA) [9]. Whether a placebo is effective in FM and what the determinants are of any such effect remain unknown
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