Systematic Review of Randomized Controlled Trials of Nonpharmacological Interventions for Fibromyalgia

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The Clinical Journal of Pain 2002; 18(5):324-336

Systematic Review of Randomized Controlled Trials of Nonpharmacological

Interventions for Fibromyalgia

*Julius Sim, Ph.D.; Nicola , Ph.D., C.Psychol.

Abstract:

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 n for individual treatment

groups after randomization = 20), and the mean power of the studies to

detect a medium effect (d [ge] 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.