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Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia
1Primary Care Sciences Research Center, Keele University, Keele, Staffordshire, UK. pta05@keele.ac.uk
Objective:
Little is known of the effectiveness of nonpharmacological interventions for fibromyalgia syndrome (FMS). The authors therefore carried out a systematic review from 1980 to May 2000 of randomized controlled trials (RCTs) of nonpharmacological interventions for FMS.
Method:
A search of computerized databases was supplemented by hand searching of bibliographies of key publications. The methodological quality of studies included in the review was evaluated independently by two researchers according to a set of formal criteria. Discrepancies in scoring were resolved through discussion.
Results:
The review yielded 25 RCTs, and the main categories of interventions tested in the studies were exercise therapy, educational intervention, relaxation therapy, cognitive-behavioral therapy, acupuncture, and forms of hydrotherapy. Methodological quality of studies was fairly low (mean score = 49.5/100). Most studies had small samples (median for individual treatment groups after randomization = 20), and the mean power of the studies to detect a medium effect ( > or = 0.5) was 0.36. Sixteen studies had blinded outcome assessment, but patients were blinded in only 6 studies. The median longest follow-up was 16 weeks. Statistically significant between-group differences on at least one outcome variable were reported in 17 of the 24 studies.
Conclusions:
The varying combinations of interventions studied in the RCTs and the wide range of outcome measures used make it hard to form conclusions across studies. Strong evidence did not emerge in respect to any single intervention, though preliminary support of moderate strength existed for aerobic exercise. There is a need for larger, more methodologically rigorous RCTs in this area.
Insights
This systematic review found limited evidence for nonpharmacological interventions for fibromyalgia syndrome (FMS). While aerobic exercise showed some promise, more rigorous randomized controlled trials (RCTs) are needed to confirm effectiveness.
Area of Science:
- Rheumatology
- Evidence-Based Medicine
- Clinical Trials
Background:
- Fibromyalgia syndrome (FMS) is a chronic condition with limited treatment options.
- The effectiveness of nonpharmacological interventions for FMS remains largely unknown.
- A comprehensive review of existing randomized controlled trials (RCTs) is necessary to assess current evidence.
Purpose of the Study:
- To systematically review the effectiveness of nonpharmacological interventions for fibromyalgia syndrome (FMS).
- To evaluate the methodological quality of randomized controlled trials (RCTs) investigating nonpharmacological treatments for FMS.
- To identify areas requiring further research in FMS management.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) from 1980 to May 2000.
- Searched computerized databases and bibliographies of key publications.
- Independently assessed methodological quality of included studies using formal criteria.
Main Results:
- 25 RCTs were identified, evaluating exercise therapy, education, relaxation, cognitive-behavioral therapy, acupuncture, and hydrotherapy.
- Studies generally had low methodological quality (mean score 49.5/100) and small sample sizes.
- While 17 of 24 studies reported statistically significant differences, strong evidence for any single intervention was lacking, with preliminary support for aerobic exercise.
Conclusions:
- The heterogeneity of interventions and outcome measures complicates definitive conclusions.
- Strong evidence for specific nonpharmacological interventions in FMS is currently insufficient.
- Larger, methodologically rigorous RCTs are crucial for advancing FMS treatment research.