Complementary and Alternative Medicine use by participants in the PACE Trial

Problem

Chronic Fatigue Syndrome (CFS) is a relatively common condition characterised by debilitating fatigue, muscle pain and other symptoms.

The PACE trial, whose main results were published in 2011, was a four arm randomised controlled trial comparing four treatments for CFS/ME ; Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET), Adaptive Pacing Therapy (APT) and standard medical care alone (SMC).

Approach

All 640 PACE participants had their complementary and alternative medicine use (CAM) recorded at baseline, and 52 weeks follow-up.

Logistic regression was used to explore relationships between patient characteristics at baseline and 52 weeks and CAM use. Variables which were significant at the 5% level were retained in the multivariable model. Associations between CAM use and the main trial outcomes, the Chalder Fatigue questionnaire and SF-36 were explored using a mixed linear regression model (White et al, 2011).

Findings

At baseline, 450/640 (70 %) of participants were using some kind of CAM. Of these, 199/640 (31%) participants were seeing a CAM practitioner and 410/640 (64%) were taking a CAM medication. By 52 week’s follow up the figure had fallen slightly to 379/589 (64 %). Of these 160/579 were seeing a CAM practitioner (28%) and 319/585 (55%) were taking a CAM medication.

The independent predictors of any CAM use at baseline, either seeing a practitioner or taking OTC medications, were sex, local ME group membership, prior duration of CFS and treatment preference. At 52 weeks, the variables associated with any CAM use were being female, membership of a local ME group and not having been randomised to the preferred trial arm.

Over the 52 week study period, there were no significant associations between any CAM use, CAM medication use or CAM practitioner consultations and the Chalder Fatigue Scale. Any CAM use at baseline and CAM medication use at baseline were associated with higher SF-36 scores (3.96 points higher for any CAM use and 4.10 points higher for CAM medication use). However, the trial defined a clinically useful difference in the SF-36 as at least 8 points indicating this is not a clinically significant change as defined by the a priori trial outcomes.

Consequences

CAM use in CFS is not associated with improvement in outcome in The PACE study. A number of interesting and significant associations involving CAM use were observed and will be discussed.