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Evid Based Med 18:23-24 doi:10.1136/ebmed-2012-100781
  • Therapeutics
  • Randomised controlled trial

Telephone-based cognitive-behavioural therapy and a structured exercise programme are effective for chronic widespread pain (fibromyalgia)

  1. Kurt Kroenke
  1. Correspondence to : Kurt Kroenke
    Indiana University School of Medicine, 1050 Wishard Blvd, Regenstrief Institute, 5th Floor, Indianapolis, Indiana 46202, USA; kkroenke{at}regenstrief.org

Commentary on: [CrossRef][Medline][Web of Science]Google Scholar

Context

Chronic widespread pain (CWP) is the cardinal feature of fibromyalgia which is one of the three most common musculoskeletal disorders in clinical practice, the others being osteoarthritis and chronic low back pain. CWP is disabling as well as costly and difficult to treat.

Methods

In a 2×2 factorial randomised controlled trial, 442 patients with CWP were randomised to receive 6 months of telephone-delivered cognitive-behavioural therapy (TCBT), a structured exercise programme, combined TBCT-exercise or treatment as usual (TAU). The primary outcome, using a 7-point patient global assessment scale of change in health, was assessed at baseline and 6 months (intervention end) and 9 months after randomisation. A positive outcome was defined as ‘much better’ or ‘very much better.’

TCBT consisted of eight weekly sessions lasting approximately 30–45 min followed by two booster sessions at 3 and 6 months after randomisation. The exercise intervention consisted of seven fitness instructor-led monthly appointments with a goal of increasing exercise levels sufficient to achieve 40–85% of heart rate reserve. Exercise was tailored to patient preferences with a minimum goal of 20–60 min sessions at least twice a week. Although neither patients nor therapists could be masked to treatment allocation, outcome data were collected and analysed by research personnel blinded to treatment allocation.

Findings

Mean patient age was 56.2 years, 69.5% were women, and 33.9% had full-time employment. All three active treatment arms resulted in greater improvement in the primary outcome compared with the TAU control group. Compared with only an 8% improvement rate in the TAU control group, improvement rates in the treatment groups ranged from 30% to 37% for an absolute benefit increase of approximately 25% or a number needed to treat of 4. The ORs for improving in the three active treatment groups compared with TAU ranged from 5.0 to 7.1.

TBCT and exercise were similarly effective, and the combination of the two treatments was not superior to either treatment alone. Benefits were generally sustained at 9 months (3 months after the end of active intervention). The cost of the interventions ranged from approximately £40 000 to £60 000 (US$62 000 to US$95 000) per extra quality-adjusted life year (QALY). Applying a cost-effectiveness ceiling ratio of £30 000 per QALY, none of the active treatments were cost-effective at 6 months. In addition, after adjusting for multiple comparisons, active treatments were not superior to TAU on individual symptoms of fibromyalgia (pain, fatigue, sleep and psychological distress) which were assessed as secondary outcomes.

Commentary

Previous research has already established CBT and exercise as the two most effective non-pharmacological treatments for CWP/fibromyalgia, a finding further substantiated by McBeth et al. The fact that the combination of CBT and exercise was not superior to either treatment alone indicates that patient preferences should be a priority. Motivation and engagement are essential because both treatments require considerable patient participation and ‘work’. The recent Food and Drug Administration approval of three new medications for fibromyalgia coupled with other guideline-concordant medications provides pharmacological options as well.1 Having multiple evidence-based options allows switching to or adding alternative treatments. Indeed, CWP typically requires a multimodality approach.

Interestingly, the authors used the global rating of change as the primary outcome and did not use pre–post treatment change on a fibromyalgia-specific rating scale as do many other trials. These methods may yield differing estimates of treatment effectiveness, hence, experts recommend using both types of measures in pain clinical trials.2 The fact that active treatments did not clearly separate from TAU on individual symptom measures suggests that global rating of change might be overestimating treatment effect to some degree.

CBT is effective for a variety of somatic syndromes besides CWP, including irritable bowel syndrome, chronic fatigue syndrome and other symptom-based disorders.3 To make it readily available, however, would require a sufficient number of therapists trained in somatically-oriented CBT (distinct from CBT for depression or anxiety) and, in the USA, reforms in a reimbursement system that discourages treatment of CWP and other somatic conditions by mental health professionals. Alternatively, increasingly automated ways of delivering internet-based CBT may be effective for some patients.4 Exercise also may require resources beyond a simple ‘exercise prescription’. Indeed, this trial involved a structured exercise programme guided by a fitness instructor. Given the high non-adherence rates to exercise, efficient strategies (eg, telephone-based motivational interviewing) are sorely needed.5

Footnotes

  • Competing interests None.

References

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