A low certainty of clinically relevant positive effects of aerobic and mixed exercise training for reducing mobility difficulties was observed in patients with fibromyalgia at the end of the intervention.
A low certainty of evidence of a clinically relevant reduction of mobility difficulties and improvement of health-related quality of life was reported among patients with fibromyalgia receiving aerobic and mixed exercise training and cognitive behavioral therapy, according to a study published in Seminars in Arthritis and Rheumatism.1 Further, there is a low certainty of evidence this combination of treatment reduces mobility difficulties post-treatment and improves health-related quality of life at follow-up based on clinically meaningful scores.
“Although many non-pharmacological interventions are used for fibromyalgia and there are published Cochrane Reviews of many of these interventions, the overall picture of which interventions work best, their safety profiles, and their acceptability has not yet been established,” wrote Julia Bidonde, PhD, associated with the School of Rehabilitation Science, College of Medicine, University of Saskatchewan, Canada, and colleagues. “The potential limitations of the available Cochrane Reviews, which might impact their reliability and the strength we can attach to their results, have also not been systematically assessed.”
A small percentage of patients with fibromyalgia experience a clinically relevant benefit from one intervention. Therefore, a multidisciplinary approach of combining non-pharmacological, such as physical or cognitive interventions, and pharmacological therapies is recommended for this patient population. Although the number and types of non-pharmacological treatments are unknown, many patients report using multiple interventions to treat their condition.2
Investigators evaluated the safety and efficacy of non-pharmacological interventions for patients with fibromyalgia in adults using systematic reviews of randomized controlled trials identified from the Cochrane Database of Systematic Reviews. The methodological quality was determined using the AMSTAR-2 tool and a set of methodological criterial critical for analgesic effects.
Primary outcomes were the clinically relevant pain relief, acceptability, safety, reduction of mobility difficulties, and improvement in health-related quality of life. The minimal clinically important difference (MCID) between interventions and controls of 15% was assumed. No pooled analyses were planned.
A total of 10 Cochrane reviews were eligible for inclusion, reporting on 181 randomized or quasi-randomized trials comprised of data from 11,917 participants with an average trial size of 66 participants. Eligible reviews assessed exercise training, psychological treatment, acupuncture, and transcutaneous electrical nerve stimulation. Of the reviews included, 1 was rated moderate according to AMSTAR 2 criteria, 2 were rated critically low, and 7 were rated low. However, all reviews met most of the methodological quality criteria and all included patient-reported outcomes for pain-related factors.
A low certainty of evidence of clinically relevant positive effects of aerobic and mixed exercise training and cognitive behavioral therapies for both reducing mobility difficulties and improving health-related quality of life was observed in this patient population at the end of the intervention.
The number needed to treat for an additional beneficial outcome values for a MCID ranged between 4 and 9. A low certainty of evidence clinically relevant for mixed exercises and cognitive behavioral therapies for reducing mobility difficulties was observed at an average of a 24-week follow-up. Further, a low certainty of evidence of clinically relevant positive effects of mixed exercise on health-related quality of life was also reported at an average of 24-week follow-up. The number needed to treat for an additional beneficial outcome values for MCID of 15% ranged from 5 to 11.
The certainty of evidence of acceptability, as measured by dropouts, of the different non-pharmacological interventions ranged from very low to moderate in the included studies. The dropout rate for any reason was not significantly different across intervention and control groups, expect for biofeedback and movement therapies. All systematic reviews reporting adverse events were inconsistent among analyses, which indicated very low evidence certainty.
“The availability of the non-pharmacological intervention reviewed in routine clinical care should be critically discussed,” investigators concluded.