There is insufficient evidence to determine the use of mindfulness or relaxation exercise interventions for adults with FM for improving functional ability, pain or mood. Meditative exercise interventions may decrease overall fibromyalgia symptoms slightly and have little or no impact on pain, but the evidence was very limited considering both outcomes. Similarly, based on very low quality evidence, meditative exercise programs may improve sleep quality but have little or no impact on fatigue compared with other types of exercise. Meditative exercise interventions of varying lengths and content were evaluated. The results might not be directly transferable to the Finnish context, as the content of mindfulness and relaxation programs may differ. Furthermore, the follow-up periods were relatively short, from <2 weeks to 6 months, which may also limit the applicability of evidence.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; FIQ = Fibromyalgia Impact Questionnaire; VAS = Visual analog scale | |||||
| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Cochrane SR | 61 studies including 4234 adults with mild to severe fibromyalgia | Mind-body therapies (mindfulness and relaxation strategies) compared with usual care (medication or attention control therapy). | FIQ, VAS, Mood, Fatigue, Sleep | high |
| «Estévez-López F, Maestre-Cascales C, Russell D, et...»2 | SR+MA | 21 studies including 1254 adults with fibromyalgia diagnosed using 1 of the recognized American College of Rheumatology criteria (1990, 2010, 2011, or 2016). Spain, Ireland |
Meditative exercise (ie, tai chi, yoga, qigong) compared to different exercise interventions (ie, aerobic, muscular resistance, flexibility). | Fatigue, Sleep | high |
| Reference | Comments |
|---|---|
| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Outcomes: Mood (Mindfulness: State Trait Anxiety Inventory State Scale, 0-60); Relaxation: Center
for Epidemiologic Disease Depression Scale, 0-60), Fatigue (Multidimensional Assessment of Fatigue scale), Sleep (the Pittsburgh Sleep Quality Index). The small number of trials and inconsistency in the use of outcome measures across the trials restricted the analysis. The studies on mindfulness or relaxation reported no adverse effects. The Cochrane review evaluated also other mind-body therapies (psychological therapies, biofeedback and movement therapies) which are not included in this evidence summary. Fixed effects model was used in the meta-analysis, which likely leads to too narrow confidence intervals. 2 trials measured the effect of mindfulness, one had mindfulness-based cognitive therapy, and another had mindfulness-based stress reduction program for groups. Risk of bias: studies were not blinded, dropouts in the first study 2/33 and in the second one 18%. |
| «Estévez-López F, Maestre-Cascales C, Russell D, et...»2 | The limitations were: 1) the long-term effects of the interventions were not reported; 2) results were not stratified by sex, and most of the participants were women. Studies comparing all types of exercise with usual care not included in this evidence summary. |
Results
| Reference | Number of studies and number of patients (I/C) | Illustrative comparative risks (95% CI) | Follow-up time | Standardized mean difference, (95% CI) | ||
|---|---|---|---|---|---|---|
| Assumed risk (Usual care) | Corresponding risk | |||||
| Level of evidence: very low The quality of evidence is downgraded due to study limitations, imprecision (two levels). The quality of evidence is also limited by indirectness (It is uncertain how well the evidence is applicable to Finnish context as mindfulness and relaxation programs used may be very different from interventions used in the trials). I=intervention; C=comparison; CI=confidence interval |
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| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Mindfullness | 2 studies, 60/68 | The mean functioning as assessed post-intervention in the control groups was 17.22 | The mean functioning as assessed post-intervention in the mindfullness groups was 0.26 standard deviations lower (0.6 lower to 0.09 higher) | mean 8 weeks | -0.3 (95% CI -0.6 to 0.1) Relative improvement: -8.5% (-19.3 to 3.5) |
| Relaxation | 2 studies, 33/34 | The mean functioning as assessed post-intervention in the control groups was 3.16 |
The mean functioning as assessed post-intervention in the relaxation groups was 1.63 standard deviations lower (10.14 to 6.53 lower) | 6-10 weeks | MD -8.3 (95% CI -10.1 to -6.5) relative improvement: 20% |
|
| Reference |
Number of studies and number of patients (I/C) | Illustrative comparative risks (95% CI) | Follow-up time | Standardized mean difference, (95% CI) |
||
|---|---|---|---|---|---|---|
| Assumed risk (Usual care) | Corresponding risk | |||||
| Level of evidence: very low The quality of evidence is downgraded due to study limitations, imprecision (two levels). The quality of evidence is also limited by indirectness (It is uncertain how well the evidence is applicable to Finnish context as mindfulness and relaxation programs used may be very different from interventions used in the trials). I=intervention; C=comparison; CI=confidence interval |
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| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Mindfullness | 2 studies 60/68 | The mean pain as assessed post-intervention in the control groups was 0.21 | The mean pain as assessed post-intervention in the intervention groups was 0.09 standard deviations lower (0.44 lower to 0.26 higher) | mean 8 weeks | -0.09 (95% CI -0.4 to 0.3) relative improvement: -2.3% (-11.1 to 6.6) |
| Relaxation | 2 studies, 33/34 | The mean pain as assessed post-intervention in the control groups was 1.86 |
The mean pain as assessed post-intervention in the intervention groups was 1.02 standard deviations lower (1.55 to 0.5 lower) | 6-10 weeks | -1.0 (95% CI -1.6 to -0.5) relative improvement: -9.5% (-14.5 to -4.8) |
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| Reference | Number of studies and number of patients (I/C) | Illustrative comparative risks (95% CI) | Follow-up time | Standardized mean difference, (95% CI) | ||
|---|---|---|---|---|---|---|
| Assumed risk (Usual care) | Corresponding risk | |||||
| Level of evidence: moderate to very low The quality of evidence is downgraded due to study limitations, inconsistency and imprecision. I=intervention; C=comparison; CI=confidence interval |
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| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Mindfullness | 3 studies, 111/107 | The mean mood as assessed post-intervention in the control groups was 10.28 | The mean mood as assessed post-intervention in the intervention groups was 0.24 standard deviations lower (0.51 lower to 0.03 higher) | mean 8 weeks | -0.24 (95% CI -0.5 to 0.0) |
| Relaxation | 1 study, 9/10 | The mean mood as assessed post-intervention in the control groups was -1.9 | The mean mood as assessed post-intervention in the intervention groups was 4.44 lower (14.46 lower to 5.58 higher) | mean 6 weeks | -1.0 (95% CI -1.6 to -0.5) |
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| Reference | Number of studies and number of patients (I/C) | Follow-up time | Standardized mean difference, (95% CI) |
|---|---|---|---|
| Level of evidence: low to very low The quality of evidence is downgraded due to study limitations, inconsistency. I=intervention; C=comparison; CI=confidence interval |
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| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Relaxation: 1 study, 9/10 | <2 weeks | -0.82 (95% CI -2.91 to 1.27) |
| «Estévez-López F, Maestre-Cascales C, Russell D, et...»2 | 4 studies, 105/102 | <6 months | -0.80 (95% CI -1.57 to -0.02) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Standardized mean difference, (95% CI) |
|---|---|---|---|
| Level of evidence: low to very low The quality of evidence is downgraded due to study limitations, inconsistency, imprecision. I=intervention; C=comparison; CI=confidence interval |
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| «Theadom A, Cropley M, Smith HE, et al. Mind and bo...»1 | Mindfulness: 2 studies, 62/72 | 3 months <2 weeks |
-0.24 (95% CI -0.59 to 0.1) 1.03 (95% CI -2.23 to 4.29) |
| Relaxation: 1 study, 9/10 | |||
| «Estévez-López F, Maestre-Cascales C, Russell D, et...»2 | 5 studies, 141/177 | 3-6 months | -0.39 (95% CI -0.88 to 0.11) |