Interventions focusing on the link between the mind and body for adults with fibromyalgia

Research question

What are the effects of mind and body therapy for fibromyalgia on pain, physical function, mood and side effects?

What problems does fibromyalgia cause?
People with fibromyalgia have chronic, widespread body pain, and often have fatigue (feeling tired), stiffness, depression and problems sleeping.

What are mind-body interventions?

Mind-body interventions include treatments such as biofeedback, mindfulness, movement therapies, psychological therapy and relaxation therapies. Biofeedback is when you are connected to electrical sensors that help you receive information about your body to make subtle changes in your body, such as relaxing. Mindfulness means having awareness of thoughts, feelings and bodily sensations. All mind-body therapies make the link between thoughts, behaviour and feelings to help people to cope with their symptoms.

Study characteristics

We conducted a review of the effect of mind-body therapies for adults with fibromyalgia. After searching for all relevant studies until October 2013, we found 61 studies including 4234 adults.

- Many studies only included female participants, but some males were included in a few studies.
- Participants had mild to severe fibromyalgia.
- Mind-body interventions were compared to 'usual care', such as medication use. Secondary analysis also compared findings in comparison to an 'attention control therapy' which involved receiving information for the same amount of time as the mind-body therapy.

Key results at the end of treatment

- Low quality evidence revealed that psychological therapies improved physical functioning, pain, mood and side effects compared to usual care. More people withdrew from the psychological therapy group compared to usual care.

- There was little or no difference in physical functioning, pain and mood between people receiving biofeedback and usual care but this may have happened by chance. More people withdrew from the biofeedback than the usual care group. No studies reported any side effects.

- There was little or no difference in physical functioning, pain, mood and the number of withdrawals between people receiving mindfulness therapy and usual care. No studies reported any adverse events.

- We are uncertain whether movement therapies improve physical functioning, pain, mood, side effects or the number of people who withdrew from the treatment. There were improvements in pain and mood for people receiving movement therapies but the quality of the evidence was very low. More people withdrew and two participants reported experiencing increased pain in the intervention group.

- We are uncertain whether relaxation therapies improve physical functioning and pain compared to usual care because the quality of evidence was very low. There was little or no difference in mood and withdrawal from treatment between people receiving relaxation therapies and those receiving usual care. No adverse events were reported.

Best estimates of what happens at the end of treatment in people with fibromyalgia when they use mind-body therapies

The main findings on the use of psychological therapies are summarised below.

- Physical functioning after 1 to 25 weeks (higher scores mean greater limitations)

People who used psychological therapies rated their physical functioning as 2 points lower on a scale of 0 to 100 compared to those who received usual care (7.5% absolute improvement).

- Pain after 3 to 14 weeks (higher scores mean worse or more severe pain)

People who used psychological therapies rated their pain as 2 points lower on a scale of 0 to 100 compared to those who received usual care (3.5% absolute improvement).

- Mood (higher scores mean worse or more severe pain)

People who used psychological therapies rated their mood as 3 points lower on a scale of 20 to 80 compared to those who received usual care (4.8% absolute improvement).

- Withdrawing from the treatment for any reason

A total of 204 out of 1000 people withdrew from psychological therapies compared with 148 out of 1000 from usual care (6% absolute improvement).

- Side effects

Nineteen people out of 1000 who received psychological therapies experienced a side effect compared with 51 out of 1000 who had usual care (4% absolute improvement). This may have happened by chance.

We do not have precise information about side effects and complications of mind-body therapies. Rare adverse events may include worsening of pain.

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.

Read the full abstract...
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 strategy: 

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.

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