Treatments for chronic fatigue syndrome Peter White Bergen 2009

Treatments for chronic fatigue syndrome

Peter White Bergen, 2009

Agenda • • • •

Trials of graded exercise therapy Trials of cognitive behaviour therapy How do they work?

What we don’t know – PACE trial

How do you treat it?

• By helping the patient remove the barriers to their recovery….

• 5 systematic reviews all conclude that behavioural treatments work with little or no harm

Graded exercise therapy

Percentage improved with GET 70 60 50 GET Control

40 30 20 10 0 UK

UK

UK

NZ

Austral

Wearden A et al, 1998 • • • •

33% dropped out (<12% in other trials) Only 5 sessions in 3/12 Higher initial intensity of exercise Physiological improvement before increasing exercise

Graded Exercise Therapy Exercise = “an activity requiring physical effort”

Graded Exercise Therapy • • • • • • •

Explanation/education Assess physical capacity Establish baseline activity Individualised home exercise Duration then intensity Target heart rates Feedback and explanation

Cognitive behaviour therapy

Trials of CBT • • • •

10 randomised trials Excluding 2 not aimed to help recovery Excluding 2 not using CB therapists Excluding Lenny Jason’s trial

Percentage improved with CBT 80 70 60 50 CBT Control Control

40 30 20 10 0 UK

UK

NL

NL

UK

CBT for CFS (a) Assessment of illness beliefs and coping strategies (b) Structuring of daily rest, sleep and activity, with a gradual return to normal activity (c) Challenging unhelpful beliefs about symptoms and activity

Do effects last?

Yes 2 years after GET 5 years after CBT Those who stop self-management relapse?

Are they cures?

In some - Yes 23% recovered immediately after CBT 25 % recovered 5 years after CBT (compared to 5 % without treatment)

Fears of behavioural approaches • 50% report being worse after graded exercise therapy in a patient charity survey • CBT means “it’s all in my mind”

What’s the problem? “..when it comes to ICD10 G93.3 Myalgic Encephalomyelitis, the somatoform psychiatrists are fundamentally wrong.

Meanwhile the "fatigue" clinics will ….. be fiddling with ME patients - testing them with nothing other than psychological interventions that do not address the underlying biomedical abnormalities in people with Myalgic Encephalomyelitis.”

Banishing fears of behavioural approaches â&#x20AC;˘ Those reporting harm with GET had not received appropriately supervised graded exercise therapy, and diagnosis uncertain. â&#x20AC;˘ CBT is associated with 5 mls increase in grey matter in the brain and normalisation of HPA axis.

What we don’t know • • • • •

Why do some not improve?

Is pacing as effective?

How about therapy AND good medical care?

Mediators Moderators

Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation White PD, Sharpe MC, Chalder T, (PIs)

Aims • • • •

Efficacy and adverse effects Health economics and societal costs Moderators Mediators

Problems and solutions How to define the illness Oxford criteria â&#x20AC;&#x201C; widest generalisation Stratify by CDC and ME â&#x20AC;&#x201C; most different

Moderators Stratify by comorbid major depression

What are the outcomes?

Both symptoms and disability

Inclusion criteria Chalder Fatigue Questionnaire score is 6 or more SF-36 physical function sub-scale score is 65 or less > 17 years old

Exclusion criteria • Medical exclusions • Risk of self harm and other exclusionary psychiatric diagnoses, assessed by SCID • Those unable to do therapies e.g. language problems

Treatments • Manualised • Each based on different model – 1st session 90 minutes and subsequent sessions up to 50 mins – 14 + 1 booster follow up session at 36 weeks – Some by telephone if necessary

Integrity of therapy • • • • • • •

Group and individual supervision Manuals – patients and therapists Pilot patients Measuring competency Listening and rating tapes throughout trial What happens when some-one leaves Measures of treatment adherence

Primary Outcomes â&#x20AC;˘ Summary stats on fatigue and disability â&#x20AC;˘ Clinically significant?

Fatigue (50% reduction in fatigue or a score of 3 or less) SF-36 (a score of 75 or 50% increase from baseline)

Secondary outcomes • • • • • • •

Other CFS criteria & symptoms (ME) Clinical Global Impression change score Adverse effects Activity and fitness Mood Sleep Economic

Adverse Events • • • • •

Serious adverse events (SAEs) Serious adverse reactions (SARs) Non serious adverse events Follow up after adverse events Policy for deteriorating participants

What PM thought about PACE â&#x20AC;&#x153;As will all serious illnesses, it is important that patients, their families and the healthcare professionals looking after them have the best scientific information available and the PACE trial has been designed to help them decide for themselves what treatment is likely to be best from them.â&#x20AC;? www.number-10.gov.uk/output/Page14656.asp

Recruitment problems • • • •

New centre Extending trial Publicity Prime Minister’s support!

Other trial difficulties • Departures from protocol • Additional therapy during & after the trial • Absence of a therapist (holidays, sick leave, maternity cover) • Recruitment and training of new therapists

Treatment issues • • • •

Ownership Non-specific therapist effects Ensuring equipoise Doctors!

• • • • •

641 patients 3% drop out from follow up 6% drop out from treatment Follow up ends in December Results autumn 2010?

Conclusions • Individually delivered CBT and GET are the best evidence based treatments • We should offer them to all our patients • Which treatment for which patient?

• Can we do them more quickly?

• Can we do better?