Friday, 31 May 2013

Fatigue treatment trial

Believe it or not MS-related  can be treated with behavioural therapies. #MSBlog #MSResearch

Epub: Thomas et al. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.J Neurol Neurosurg Psychiatry. 2013 May 22.

BACKGROUND: Fatigue is a common and troubling symptom for MSers.

AIM: To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).

METHODS: Three-centre parallel arm randomised controlled trial with economic evaluation. MSers with significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months post-intervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire).

RESULTS: Between May 2008 and November 2009, 164 MSers were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue.

CONCLUSIONS: FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.

"Pragmatic trials; the new buzzword. What are pragmatic trials? A pragmatic trial aims to test a treatment or treatment policy in a 'real life' situation, when many MSers may not receive all of the treatment, and may use other treatments as well. This is as opposed to an explanatory trial, which is done under ideal conditions and is trying to determine whether a therapy has the ability to make a difference at all; i.e. testing its efficacy or effectiveness. In this pragmatic trial the investigators studied whether or or not a cognitive behavioural therapy and energy effectiveness techniques focusing on lifestyle helped MSers with fatigue. It appears it did. This is not surprising; in my experience when MSers with fatigue engage in a programme that requires them to be motivated and self-disciplined they note an improvement. In our area the local disability options teams help with this. Before embarking on this you need to makes sure that the person in question has addressed all the other elements associated with MS that affect fatigue, i.e. poor sleep hygiene, pain, spasms, nighttime stimulants, sedating medication, restless legs, bladder dysfunction, low mood or depression, anxiety, bladder and bowel dysfunction, etc. The good news is that fatigue may not be an intractable problem, if you have fatigue ask your neurological team if they can look into it."

"I am interested to know how many of you have had CBT or other  therapies for fatigue."

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