Mind and body therapy for fibromyalgia
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
1. To review the efficacy of mind and body therapies in comparison to standard care
2. To review the efficacy of mind and body therapies in comparison to an attention placebo
3. To review the comparative efficacy of different types of mind and body therapies
4. To compare the efficacy of mind and body therapies at 1, 3 and 6 month follow‐up
Background
Description of the condition
Fibromyalgia syndrome (FM) is a complex and chronic condition of unknown aetiology, which is characterised by widespread persistent pain and multiple tender points (Wolfe 1990). A diagnosis of fibromyalgia is usually based on the exclusion of other potential causes of symptoms through clinical evaluations and using the American College of Rheumatology (ACR) criteria: pain distributed across the four quadrants of the body (i.e., pain above the waist, below the waist, on the left and right sides of the body) and in the axial skeleton and tenderness in 11 or more of the 18 specific sites known as tender points during digital palpation (using 4 kg pressure) or dolorimetry (Wolfe 1990). Other symptoms include fatigue, cognitive difficulties and sleep disturbance (Mease 2005).
Prevalence estimates of FM in the general population ranges between 2 to 5% (Branco 2009; Wolfe 1995) and the prevalence rises up to 8% in women between 55 and 64 years of age (White 1999). Fibromyalgia syndrome has been associated with high individual and societal health care costs (Berger 2007; Sicras‐Mainar 2009) with many patients reporting reduced physical functioning and poor quality of life (Burckhardt 1991). While the aetiology of this syndrome remains unknown, emerging evidence suggests that the condition may be due to the dysregulation of the central and sympathetic nervous systems (Mease 2005).
Description of the intervention
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 and aim to promote peoples' ability to cope.
How the intervention might work
Fibromyalgia is a complex condition and psychological, social and lifestyle factors have all been found to play an important role in the symptom experience (Bergman 2005; Nicassio 2002; Theadom 2008). Interventions that aim to improve well‐being, self esteem, coping ability and those that aim to reduce stress may therefore improve physical symptoms and quality of life for people with fibromyalgia syndrome.
Why it is important to do this review
Pharmacologic therapy is the primary mode of treatment for FM which is commonly based on a symptom management approach. The most often prescribed medications are tricyclic antidepressants (TCAs), selective serotonin uptake inhibitors (SSRIs), simple analgesics and serotonin norepinephrine reuptake inhibitors (SNRIs) which have demonstrated efficacy for reducing pain and sleep (Dworkin 2003; Moore 2009). However, a recent systematic review of guidelines on the management of FM (Hauser 2009) highlights the importance of a multidimensional approach including a combination of non‐pharmacological and pharmacological therapies.
A previous review (Hadhazy 2000) revealed that mind and body therapies were more effective in comparison to a waiting list (people who act as a control group while an experimental group receives an intervention, who receive the intervention when the study is completed) or placebo control group on self efficacy and quality of life outcomes. Since the publication of this review in 2000, a wealth of studies have since been published in this area. This review aims to provide up to date evidence of the efficacy of mind‐body therapies for people with FM.
Objectives
1. To review the efficacy of mind and body therapies in comparison to standard care
2. To review the efficacy of mind and body therapies in comparison to an attention placebo
3. To review the comparative efficacy of different types of mind and body therapies
4. To compare the efficacy of mind and body therapies at 1, 3 and 6 month follow‐up
Methods
Criteria for considering studies for this review
Types of studies
All randomised controlled trials exploring the effectiveness of at least one mind‐body therapy in comparison to a standard care (pharmacological management of symptoms) or an attention placebo group (a group of people who receive a treatment that is not thought to have therapeutic effects but is delivered by an equivalent therapist and for the same amount of time as the mind body therapy group) for people diagnosed with fibromyalgia syndrome will be included in the review. Case studies, clinical observations and quasi‐randomised controlled trials will be excluded from the review in order to minimise bias.
Types of participants
All persons 18 years of age or older with a clinical diagnosis of fibromyalgia (as defined by the American College of Rheumatology, ACR 1990 criteria) (Wolfe 1990).
Types of interventions
Interventions incorporating at least one type of mind body therapy will be included. Due to the wide diversity of available mind‐body therapies, interventions will be categorised into broad groups to enable comparison:
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Relaxation based therapies (e.g. breathing techniques, imagery, progressive muscle relaxation, aromatherapy)
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Mindfulness meditation therapies (being aware of the present moment in a non‐judgemental and accepting way)
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Biofeedback (providing immediate feedback on bodily functions, such as muscle tension to raise the patients awareness and enable the possibility of conscious control of those functions).
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Movement therapies (e.g. yoga, tai chi, Gi‐gong)
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Counselling (including psychoanalytic and humanistic approaches)
Interventions delivered in all settings including the community, primary care or in hospital will be included in the review to facilitate the generalisability of the review findings. The components of each intervention will be described in the review summary table.
Types of outcome measures
Primary outcomes
The primary outcome measures for this review will be self‐reported physical functioning (ability to complete everyday tasks e.g. scores on the Fibromyalgia Impact Questionnaire) and self reported levels of pain (e.g. pain intensity numerical rating scale, a 30% or two point reduction in the scale has been reported to be a relevant clinical outcome in evaluating trials in chronic pain, Farrar 2001). All outcome measures will be assessed at 1, 3 and 6 month follow‐up.
Secondary outcomes
Secondary outcome measures will include:
1. fatigue
2. mood (anxiety, depression)
3. self‐efficacy (perceived ability to manage their overall health)
4. tender point score (measured by dolorimetry or digital palpitation)
5. quality of life
6. sleep quality
Search methods for identification of studies
Electronic searches
The electronic search will identify trials using the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950 to present), EMBASE (1974 to present), PsycINFO (1806 to present) and CINAHL (1982 to present). The full search strategy is shown in Appendix 1.
Searching other resources
The reference lists of relevant articles will be searched for additional articles. Experts in the field will be contacted to identify any other unpublished or published studies.
Data collection and analysis
Selection of studies
Two review authors (AT, MC) will independently assess identified abstracts for relevance to the review. The full text articles will be acquired for trials that appear to meet the inclusion criteria. All articles will then be assessed against the inclusion criteria using a pre‐designed study selection form. Reasons for inclusion or exclusion will be recorded on the form. The results between the two review authors will be compared and any disagreement resolved through discussion, a third review author (MH) will act as arbitrator, if necessary. The original trial authors will be contacted for further details about the study if necessary to clarify eligibility for the review.
Data extraction and management
The data needed to conduct the systematic review will be extracted from the articles or correspondence with the authors using a data extraction form designed specifically for this review. This will include information on all the aspects of the trial including the interventions delivered such as length of programme, setting , therapeutic components and therapist details in addition to information on the study procedures, details of participants and outcome measures. Two review authors (AT, MC) will extract the data independently and any inconsistencies will be resolved through discussion.
Assessment of risk of bias in included studies
The methodological quality of studies included in the review will be assessed for possible risk of bias using the Cochrane Collaboration tool for assessing the risk of bias (Higgins 2008). The methodological components of each study will be assessed independently by two review authors to ascertain if the procedures applied in the study are adequate. Any disagreement identified between the review authors will be resolved through discussion or through the involvement of a third review author.
These components will include:
1) Sequence generation (e.g. was the sequence generation process truly random)
2) Concealment of treatment allocation
3) Blinding of the intervention provider, recipient and outcome assessor
4) Completeness of outcome data (e.g. are these reported for all groups, was intention to treat analysis carried out) and if the treatment and placebo groups were balanced in terms of number of treatments received and time spent in therapy
5) Selective reporting bias (e.g. were all pre‐specified outcomes reported)
6) Other sources of possible bias
7) Overall risk of bias (with reference to the outcome of the judgements made for potential risks of bias criteria 1 to 6, we will assess the direction and magnitude of the bias and the possible impact this may have on the findings through sensitivity analysis).
For each component the trials will be classified as 'yes' (low risk of bias), 'no' (high risk of bias) or 'unclear' (if there is insufficient information provided in the article to make a decision). If it is unclear if the procedures are adequate, the authors of the article will be contacted to yield the necessary information to make this decision on methodological quality. If the necessary information cannot be retrieved the article will be classified as being at a high risk of bias. This process will also be completed by two review authors independently and any disagreements resolved through discussion and consensus.
Measures of treatment effect
The data extracted from the studies included in the review will be entered into RevMan 5. A summary table describing the study characteristics will be completed. For continuous data, the weighted mean difference in end point scores between groups using the same self report questionnaires (such as the McGill Pain Questionnaire and Fibromyalgia Impact Questionnaire) will be calculated with 95% confidence intervals. Standardised mean differences will be calculated when different scales are used to measure end point scores. For dichotomous data, a 2x2 contingency table will be compiled including the number of participants with each outcome event and risk ratios (RR) with 95% confidence intervals.
Unit of analysis issues
Cross over trials will be excluded from this review as a 'washout' period is not possible after a mind‐body intervention.
Dealing with missing data
All data collected on participants will be analysed in the group to which participants were allocated whether the participant received the intervention or not. Where possible the original investigators will be contacted to request any missing data. If this approach is not possible, the impact of including the study in the overall assessment of the results will be explored using a sensitivity analysis.
Assessment of heterogeneity
The heterogeneity of trials will be assessed using forest plots and I2 statistic calculated using RevMan 5. A cut off point of I2 > 50% and a P value of <0.10 from the chi‐square test will be used to determine if significant heterogeneity is found between the trials. The possible reasons for the heterogeneity will be explored. If there is a high degree of heterogeneity the review will be completed without conducting a meta‐analysis of the results.
Assessment of reporting biases
Funnel plots will be used to identify potential reporting bias. Reasons for any asymmetry in the funnel plot will be explored.
Data synthesis
In the absence of statistical heterogeneity a fixed‐effect model of meta‐analysis will be used for combining data. If heterogeneity is found, a sensitivity analysis will be completed and followed by a random effects model for meta‐analysis if appropriate.
Subgroup analysis and investigation of heterogeneity
In order to meet the objectives of this review the following sub‐group analyses will be completed if a sufficient number of studies are found.
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Comparison of the different types of mind and body therapies
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Comparison of the efficacy of mind and body therapies at 1, 3 and 6 month follow‐up.
Sensitivity analysis
Sensitivity analyses will be conducted to explore the effect of trial quality and intervention duration on the findings. Studies rated as being of poor quality (e.g. where selection and attrition bias is rated as inadequate or unclear) will be excluded from the analysis to explore if there is any difference found in the overall result after the removal of this data.
Grading of evidence and Summary of Findings tables
The data will be presented using the GRADE Approach and Summary of Findings tables (Higgins 2008).
