Mind and body therapy for fibromyalgia.
Study Goal
The researchers aimed to evaluate the benefits and harms of mindfulness compared to usual care for adults with fibromyalgia, focusing on physical functioning, pain, mood, and withdrawals.
Results Summary
The study found no significant advantage for mindfulness over usual care in improving physical functioning, pain, or mood, with very low to moderate quality evidence. No adverse events were reported.
Population
Adults with fibromyalgia, predominantly female, with varying severity of the condition.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
psychological therapies | decrease | physical functioning | adults with fibromyalgia | SMD -0.4, 95% CI -0.6 to -0.3, -7.5% absolute change, 2 point shift on a 0 to 100 scale | have favourable effects on | #1 |
psychological therapies | decrease | pain | adults with fibromyalgia | SMD -0.3, 95% CI -0.5 to -0.2, -3.5% absolute change, 2 point shift on a 0 to 100 scale | have favourable effects on | #2 |
psychological therapies | decrease | mood | adults with fibromyalgia | SMD -0.5, 95% CI -0.6 to -0.3, -4.8% absolute change, 3 point shift on a 20 to 80 scale | have favourable effects on | #3 |
psychological therapies | increase | withdrawals | adults with fibromyalgia | RR 1.38, 95% CI 1.12 to 1.69, 6% absolute risk difference | more withdrawals in the psychological therapy group | #4 |
psychological therapies | no change | adverse events | adults with fibromyalgia | RR 0.38, 95% CI 0.06 to 2.50, 4% absolute risk difference | lack of evidence of a difference between the number of | #5 |
biofeedback | decrease | physical functioning | adults with fibromyalgia | SMD -0.1, 95% CI -0.4 to 0.3, -1.2% absolute change, 1 point shift on a 0 to 100 scale | had an effect on | #6 |
biofeedback | decrease | pain | adults with fibromyalgia | SMD -2.6, 95% CI -91.3 to 86.1, -2.6% absolute change | had an effect on | #7 |
biofeedback | increase | mood | adults with fibromyalgia | SMD 0.1, 95% CI -0.3 to 0.5, 1.9% absolute change, less than 1 point shift on a 0 to 90 scale | had an effect on | #8 |
biofeedback | increase | withdrawals | adults with fibromyalgia | RR 4.08, 95% CI 1.43 to 11.62, 20% absolute risk difference | led to more withdrawals from the study | #9 |
mindfulness | no change | physical functioning | adults with fibromyalgia | SMD -0.3, 95% CI -0.6 to 0.1, -4.8% absolute change, 4 point shift on a scale 0 to 100 | no advantage observed for | #10 |
mindfulness | no change | pain | adults with fibromyalgia | SMD -0.1, CI -0.4 to 0.3, -1.3% absolute change, less than 1 point shift on a 0 to 10 scale | no advantage observed for | #11 |
mindfulness | no change | mood | adults with fibromyalgia | SMD -0.2, 95% CI -0.5 to 0.0, -3.7% absolute change, 2 point shift on a 20 to 80 scale | no advantage observed for | #12 |
mindfulness | no change | withdrawals | adults with fibromyalgia | RR 1.07, 95% CI 0.67 to 1.72, 2% absolute risk difference | no advantage observed for | #13 |
movement therapies | decrease | pain | adults with fibromyalgia | MD -2.3, CI -4.2 to -0.4, -23% absolute change | improved | #14 |
movement therapies | decrease | mood | adults with fibromyalgia | MD -9.8, 95% CI -18.5 to -1.2, -16.4% absolute change | improved | #15 |
movement therapies | no change | physical functioning | adults with fibromyalgia | SMD -0.2, 95% CI -0.5 to 0.2, -3.4% absolute change, 2 point shift on a 0 to 100 scale | no advantage for | #16 |
movement therapies | increase | participant withdrawals | adults with fibromyalgia | RR 1.95, 95% CI 1.13 to 3.38, 11% absolute difference | no advantage for | #17 |
movement therapies | no change | adverse events | adults with fibromyalgia | RR 4.62, 95% CI 0.23 to 93.92, 4% absolute risk difference | no advantage for | #18 |
relaxation based therapies | decrease | physical functioning | adults with fibromyalgia | MD -8.3, 95% CI -10.1 to -6.5, -10.4% absolute change | showed an advantage for | #19 |
relaxation based therapies | decrease | pain | adults with fibromyalgia | SMD -1.0, 95% CI -1.6 to -0.5, -3.5% absolute change, 2 point shift on a 0 to 78 scale | showed an advantage for | #20 |
relaxation based therapies | no change | mood | adults with fibromyalgia | SMD -4.4, CI -14.5 to 5.6, -7.4% absolute change | not for | #21 |
relaxation based therapies | no change | withdrawals | adults with fibromyalgia | RR 4.40, 95% CI 0.59 to 33.07, 31% absolute risk difference | no difference between the groups for number of | #22 |
BACKGROUND: Mind-body interventions are based on the holistic principle that mind, body and behaviour are all interconnected. Mind-body interventions incorporate strategies that are thought to improve psychological and physical well-being, aim to allow patients to take an active role in their treatment, and promote people's ability to cope. Mind-body interventions are widely used by people with fibromyalgia to help manage their symptoms and improve well-being. Examples of mind-body therapies include psychological therapies, biofeedback, mindfulness, movement therapies and relaxation strategies. OBJECTIVES: To review the benefits and harms of mind-body therapies in comparison to standard care and attention placebo control groups for adults with fibromyalgia, post-intervention and at three and six month follow-up. SEARCH METHODS: Electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), AMED (EBSCO) and CINAHL (Ovid) were conducted up to 30 October 2013. Searches of reference lists were conducted and authors in the field were contacted to identify additional relevant articles. SELECTION CRITERIA: All relevant randomised controlled trials (RCTs) of mind-body interventions for adults with fibromyalgia were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, extracted the data and assessed trials for low, unclear or high risk of bias. Any discrepancy was resolved through discussion and consensus. Continuous outcomes were analysed using mean difference (MD) where the same outcome measure and scoring method was used and standardised mean difference (SMD) where different outcome measures were used. For binary data standard estimation of the risk ratio (RR) and its 95% confidence interval (CI) was used. MAIN RESULTS: Seventy-four papers describing 61 trials were identified, with 4234 predominantly female participants. The nature of fibromyalgia varied from mild to severe across the study populations. Twenty-six studies were classified as having a low risk of bias for all domains assessed. The findings of mind-body therapies compared with usual care were prioritised.There is low quality evidence that in comparison to usual care controls psychological therapies have favourable effects on physical functioning (SMD -0.4, 95% CI -0.6 to -0.3, -7.5% absolute change, 2 point shift on a 0 to 100 scale), pain (SMD -0.3, 95% CI -0.5 to -0.2, -3.5% absolute change, 2 point shift on a 0 to 100 scale) and mood (SMD -0.5, 95% CI -0.6 to -0.3, -4.8% absolute change, 3 point shift on a 20 to 80 scale). There is very low quality evidence of more withdrawals in the psychological therapy group in comparison to usual care controls (RR 1.38, 95% CI 1.12 to 1.69, 6% absolute risk difference). There is lack of evidence of a difference between the number of adverse events in the psychological therapy and control groups (RR 0.38, 95% CI 0.06 to 2.50, 4% absolute risk difference).There was very low quality evidence that biofeedback in comparison to usual care controls had an effect on physical functioning (SMD -0.1, 95% CI -0.4 to 0.3, -1.2% absolute change, 1 point shift on a 0 to 100 scale), pain (SMD -2.6, 95% CI -91.3 to 86.1, -2.6% absolute change) and mood (SMD 0.1, 95% CI -0.3 to 0.5, 1.9% absolute change, less than 1 point shift on a 0 to 90 scale) post-intervention. In view of the quality of evidence we cannot be certain that biofeedback has a little or no effect on these outcomes. There was very low quality evidence that biofeedback led to more withdrawals from the study (RR 4.08, 95% CI 1.43 to 11.62, 20% absolute risk difference). No adverse events were reported.There was no advantage observed for mindfulness in comparison to usual care for physical functioning (SMD -0.3, 95% CI -0.6 to 0.1, -4.8% absolute change, 4 point shift on a scale 0 to 100), pain (SMD -0.1, CI -0.4 to 0.3, -1.3% absolute change, less than 1 point shift on a 0 to 10 scale), mood (SMD -0.2, 95% CI -0.5 to 0.0, -3.7% absolute change, 2 point shift on a 20 to 80 scale) or withdrawals (RR 1.07, 95% CI 0.67 to 1.72, 2% absolute risk difference) between the two groups post-intervention. However, the quality of the evidence was very low for pain and moderate for mood and number of withdrawals. No studies reported any adverse events.Very low quality evidence revealed that movement therapies in comparison to usual care controls improved pain (MD -2.3, CI -4.2 to -0.4, -23% absolute change) and mood (MD -9.8, 95% CI -18.5 to -1.2, -16.4% absolute change) post-intervention. There was no advantage for physical functioning (SMD -0.2, 95% CI -0.5 to 0.2, -3.4% absolute change, 2 point shift on a 0 to 100 scale), participant withdrawals (RR 1.95, 95% CI 1.13 to 3.38, 11% absolute difference) or adverse events (RR 4.62, 95% CI 0.23 to 93.92, 4% absolute risk difference) between the two groups, however rare adverse events may include worsening of pain.Low quality evidence revealed that relaxation based therapies in comparison to usual care controls showed an advantage for physical functioning (MD -8.3, 95% CI -10.1 to -6.5, -10.4% absolute change) and pain (SMD -1.0, 95% CI -1.6 to -0.5, -3.5% absolute change, 2 point shift on a 0 to 78 scale) but not for mood (SMD -4.4, CI -14.5 to 5.6, -7.4% absolute change) post-intervention. There was no difference between the groups for number of withdrawals (RR 4.40, 95% CI 0.59 to 33.07, 31% absolute risk difference) and no adverse events were reported. AUTHORS' CONCLUSIONS: Psychological interventions therapies may be effective in improving physical functioning, pain and low mood for adults with fibromyalgia in comparison to usual care controls but the quality of the evidence is low. Further research on the outcomes of therapies is needed to determine if positive effects identified post-intervention are sustained. The effectiveness of biofeedback, mindfulness, movement therapies and relaxation based therapies remains unclear as the quality of the evidence was very low or low. The small number of trials and inconsistency in the use of outcome measures across the trials restricted the analysis.